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By Michael Rigas, PharmD

Biosimilars 101
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Biosimilars are also known as “follow-on biologics” or “subsequent entry biologics”

The Biologics Price Competition and Innovation Act (BPCI) was introduced by Senator Edward Kennedy in 2007. It was passed by Congress and signed by President Obama in 2010 as part of the Patient Protection and Affordable Care Act (ACA) (Center for Drug Evaluation and Research, 2016). The intent of the Act was to lower prescription costs to patients by having biosimilars priced 25-35% less than innovator drugs.

Biosimilars include large molecule drugs that are most commonly injectables or infused drugs. They are Food and Drug Administration (FDA)-approved copies of the original “innovator” drug product that are allowed to be licensed and approved by the FDA once the innovator product’s patent expires. Well-known oral generic drugs are small molecule drugs and typically taken orally. Biosimilars are large molecule drugs and are typically given via the intravenous or muscular route. The first drug that was FDA-approved as a biosimilar was a version of Neupogen® called ZARXIO in 2015. The most significant biosimilar available for pemphigus and pemphigoid (P/P) patients is the drug rituximab (innovator named Rituxan®), which now has three available approved biosimilar products. 

The concept of “similarity” includes these principles which were enacted and are enforced by the FDA:

  1. Any differences between the biosimilar and the innovator products must not be clinically significant.
  2. Must be similar in their ability to cause immunogenicity (meaning they have the ability of therapeutic protein products to stimulate an immune response in the patient).
  3. Must be similar in their pharmacokinetics (how the drug is absorbed and eliminated by the body).
  4. Must be similar in their pharmacodynamics (how the drug affects the body).
  5. Must be similar in their safety, purity, and potency.
  6. Must be FDA-approved for one or more of the indications that the FDA approved for the innovator product.
  7. Most commonly, the biosimilar product’s acquisition cost is 20-30% less than the innovator product, which is supposed to have a cost-reducing impact on insurance companies and patients.
  8. Currently, there are over one hundred biosimilars approved or in the process of approval for use in the US. Please see this link for a list of the currently FDA-approved biosimilars and which ones are in the application process with the FDA. (Center for Drug Evaluation and Research, 2023)) 

Cost reduction to the American healthcare system

As of late 2022, there were 39 approved biosimilars of 11 previously approved innovator products, with 22 biosimilars currently available on the market. It is estimated that biosimilars saved over $7 billion in 2021. It has also been shown that patient access to medications has improved for every drug with an available biosimilar. (Association for Accessible Medicines, 2022

Patient out-of-pocket costs

The cost savings impact of biosimilars in the US has not had the expected reducing impact on prices (due to many factors, which will be discussed below). Thus, many regulatory updates to the ACA have been proposed. The main issue has been the creativity shown by the innovator product’s drug makers and the insurance companies to manipulate the market pricing structure to make the most money by forcing patients to use the innovator product or a more expensive biosimilar product, meaning patients may be forced to pay more out-of-pocket than if they were able to use the least expensive biosimilar product.

Traditionally, generic and biosimilar drugs are priced 25-35% less than the innovator product. Insurance companies then pass these lesser acquisition prices to the patients in the form of lower out-of-pocket costs to the patient. However, many innovator product companies offer significant rebates to the insurance company that cause them to prefer these innovator products to the less costly biosimilar products. Patients are then forced to pay higher out-of-pocket costs with the innovator’s product. This innovator product rebate program circumvents the original intent of the biosimilar model concept. There are states and patient support groups advocating to end these practices so that more patients can experience lower out-of-pocket costs, as was intended to be part of the biosimilar concept. 

Prescribing physician

Biosimilars may adversely impact physicians since they may not have control over which products are approved for their patients (innovator products vs. biosimilar products) since individual insurance companies’ strategies vary dramatically. For example, a prescribing physician office with 20 patients that may need rituximab (the innovator product is Rituxan®) as part of their autoimmune blistering disease treatment plan may wind up with five patients on each of the four (one innovator and three biosimilars) available products. This presents a complex situation for the prescribing physician, who may face various concerns and responses from their patients about the drugs they are required to take by their insurance company. 

Insurance companies

Insurance companies have an excellent opportunity to create strategies that can save money for patients by encouraging them to use biosimilars. Alternatively, insurance companies can choose to make more money for themselves by obtaining rebates from innovator brand drug makers. This may then require patients to use the innovator product at a higher cost to the patient. Either way, the process is complex and time consuming for insurance companies and patients, alike. These policies are also very transient and may need to change whenever a new biosimilar product hits the market or as contracts and negotiations change yearly.

Patients and caregivers

The biosimilar concept significantly impacts patients and caregivers since they may be able to save out-of-pocket costs by using the least expensive biosimilar product instead of using the brand-name drug. However, based on some of the above-mentioned strategies, patients may have to pay higher out-of-pocket costs than expected if they are prescribed a drug other than the lowest cost biosimilar. Also, since patients might be on these drugs for a significant period of time, they may be forced to switch between products and experience a change in out-of-pocket costs as insurance companies update their formularies each year. (Note: Each payor has a drug formulary listing the drugs they prefer their patients to use, and which also explains the various extra or lesser costs the patient may qualify for if they do or don’t use the payors preferred formulary drugs.)

Pharmacies

Biosimilars challenge pharmacies since they must order and stock many versions of the same drug. They must arrange for the proper cost-effective purchasing of each product, have the ability to sell it to the insurance company at a reasonable profit, and be able to clinically manage patients on multiple versions of the same drug. Also, Boards of Pharmacy have enacted rules for the use of biosimilars. Typically, most states require a pharmacy to notify and obtain consent from the doctor when a biosimilar is substituted for an innovator product at the request of their payor or as a result of product availability to the pharmacy.

Suggestions for navigating a biosimilar future

For patients and their families involved with drugs for which biosimilars are available, it is important to consider these issues with their physician, insurance company, and pharmacy. The best way to obtain the best financial outcome from the biosimilar concept is to always be on the offensive. This involves knowing these critical facts about biosimilars that may be available. Creating a spreadsheet that includes the following information may be the best way to coordinate this complex data: 

  1. Which innovator drugs are currently available as biosimilars for your disease?
  2. Contact your insurance company to see which biosimilars or innovator products are on their preferred formulary for your diagnosis.
  3. Look up typical acquisition pricing for these drugs online so you know the acquisition cost differences between the innovator product and biosimilars. Less acquisition cost usually equates to less out-of-pocket costs for patients. 
  4. For each biosimilar and innovator product that might be an option for your disease and with your payor, determine available financial assistance program options by checking the drug’s website.
  5. Ask your prescribing physician which innovator brand or biosimilar they prefer so you can compare with what your payor prefers and its cost.
  6. Ask your pharmacist whether these innovator products or biosimilars require special purchasing actions, purchasing contracts, payor contracts, training, or Risk Evaluation and Mitigation Strategy programs. The presence of any of these items may make the innovator or biosimilar product hard to get or not obtainable by your pharmacy.

For more information about biosimilars, visit the following IPPF patient resources:

References

Association for Accessible Medicines. (2022). Generics & Biosimilars https://accessiblemeds.org/sites/default/files/2022-09/AAM-2022-Generic-Biosimilar-Medicines-Savings-Report.pdf

Center for Drug Evaluation and Research. (2016). Implementation of the biologics price competition and innovation act O. U.S. Food and Drug Administration. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/implementation-biologics-price-competition-and-innovation-act-2009

Center for Drug Evaluation and Research. (2023). Biosimilar Drug Information. U.S. Food and Drug Administration. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information

Michael Rigas, PharmD, is an IPPF Board Member and the Chief Clinical Officer, Emeritus of KabaFusion, LLC, in Cerritos, California.

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Information for those living with pemphigus and pemphigoid.
IPPF Guide to Pemphigus and Pemphigoid answers common questions.

We’re excited to share a new resource with our community: The IPPF Guide to Pemphigus and Pemphigoid. The guide is intended to provide medically reviewed information relevant to the most common questions people have when first diagnosed with pemphigus and pemphigoid, as well as educational information about ongoing disease management and treatment options.

Through this guide and other IPPF resources, we hope to empower the community with essential knowledge that can make living with pemphigus and pemphigoid much more bearable. In addition to English, Spanish and French translations of the guide are available to read and download on our website.  

*The information in this guide has been reviewed by the Education and Patient Support working group of the IPPF’s Medical Advisory Council. The IPPF does not endorse any drugs, treatments, or products in this
guide. Information is provided for informational purposes only. Because the symptoms and severity of pemphigus and pemphigoid vary among individuals, discuss all drugs and treatments with the reader’s physician(s) for proper evaluation, treatment, and care.

Access the Guide
Program will offer no-cost testing to pemphigus and pemphigoid patients in Southern California
Biopsies Save Lives

Quest Diagnostics, through the Quest for Health Equity (Q4HE) initiative, has teamed up with Western University of Health Sciences (WesternU) to offer no-cost diagnostic testing services to support Biopsies Save Lives. This multidisciplinary program will offer no-cost testing to patients in Southern California who are low-income, uninsured, and underinsured and who have rare erosive and blistering diseases, to enable more timely diagnosis of these conditions.

Pemphigus and pemphigoid patients must often see multiple health care providers before seeing a specialist and receiving a diagnosis. People of color are more likely to be misdiagnosed or experience delays in diagnosis because differences in pigmentation can affect the appearance of dermatologic diseases.

“The time it takes to get a correct diagnosis can be critical for people who are working-class or living in poverty. Compounding this, people of color are more likely to have delays in diagnosis because pathologic conditions can manifest differently on dark skin and mucosa, and health care professionals are trained mostly to diagnose them on white patients,” said WesternU Health Oral Pathology Laboratory Director Mark Mintline, DDS. “We are grateful for the support from Quest and its Quest for Health Equity initiative, as it will help eliminate a barrier to diagnosis and enable us to expedite the treatment of patients suffering from these diseases.”

The collaboration between Q4HE and WesternU, with additional support from the International Pemphigus and Pemphigoid Foundation (IPPF) and the University of California Irvine (UCI) Health Dermatology Immunobullous Clinic, aims to accelerate diagnosis times and help reduce the number of doctors needed to get a diagnosis. Local health care providers will be able to refer patients for intraoral biopsies and serum testing without worrying about the cost of laboratory tests thanks to no-cost diagnostic testing provided through the Q4HE initiative.

“We believe good health care should be in reach for everyone, and we are proud to support this important program to give access to lab testing that will help provide care to underserved patients in Southern California suffering from these rare autoimmune diseases,” said Michael Floyd, Senior Director and Leader, Q4HE. “We are hopeful that we can help break down some of the barriers to health care access that these patients are experiencing by making diagnostic testing more accessible.”

Biopsies Save Lives also connects patients to the IPPF, which offers peer coaching, patient education webinars, support groups, publications, and a network of doctors who are experienced in treating pemphigus and pemphigoid patients. This includes expert dermatologists from UCI Health Dermatology, which specializes in the diagnosis, treatment, and management of acquired autoimmune blistering diseases. WesternU also provides medical interpreters to facilitate communication between patients, doctors, and staff to ensure high-quality care. Learn more about the Biopsies Save Lives program here.

Healing Heroes are the heart of our community. They go above and beyond to support the IPPF community by making sustaining, monthly gifts to support our mission of improving the quality of life for all those affected by pemphigus and pemphigoid. Join Jesse and become a Healing Hero today.

It’s a fact.

Healing Heroes are at the heart of our community.

That’s why we’re putting the spotlight on current Healing Heroes who are going above and beyond to support the IPPF community.

They’re making sustaining, monthly gifts to support our mission of improving the quality of life for all those affected by pemphigus and pemphigoid. 

Now it’s your turn. 

Whether you’re a patient, caretaker, family, friend, medical professional, or rare disease advocate, your monthly gift allows us to sustain current programs and expand our key areas of operation. 

Jesse tells our story best . . . 

Jesse became a Healing Hero after experiencing loneliness and isolation while living with a rare disease. With the support and comfort provided by the IPPF, Jesse is thriving and wants to ensure that other pemphigus and pemphigoid patients receive the same high level of care. 

The Heart of Our Community: Jesse
BECOME A HEALING HERO

Monthly Sustaining Gift Options

IMPROVE PATIENT ACCESS TO CARE ($15)
Your monthly gift of $15 allows us to screen and add a new medical professional to our Find a Doctor map, increasing patients’ access to care.

HELP THE NEWLY DIAGNOSED ($30)
Your monthly gift of $30 allows our Peer Coaches to support 75 members of our community by providing them with resources, tips, and tricks on how to live and thrive with pemphigus and pemphigoid.

ACCELERATE DIAGNOSIS TIMES ($75)
Your monthly gift of $75 raises disease awareness by educating 75 medical professionals through our Biopsies Save Lives campaign. 

FUND ESSENTIAL RESEARCH ($100)
Your monthly gift of $100 helps us conduct the ongoing Natural History Study to better understand pemphigus and pemphigoid.

Become a Healing Hero

By becoming a Healing Hero, you provide for the greater good of our community by sharing our vision:

NO DISEASE IS TOO RARE FOR A CURE!

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By Michael Rigas, Pharm.D.

Economics of Patient Assistance Programs
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The latest video in our new series, Pass the Mic with Dr. Mike, the Pharmacist is available.

Insurance is a fundamental part of the health care delivery system. Many patients know all too well that they are frequently denied access to the therapies they need because of a lack of insurance, lack of payer authorization, or lack of ability to pay their out-of-pocket (OOP) costs.

According to a National Health Statistics Report published in 2022 by the Centers for Disease Control and Prevention (CDC), in 2021, 28.1 million (8.6%) people of all ages were uninsured. Unfortunately, with millions of Americans still uninsured and the US Census reporting that 37.9 million people (11.6%) were living in poverty in 2021, the problem is still pervasive.

We all know patients whose families have been affected by job loss, insurance loss, changes in benefits, large OOP expenses, or some combination thereof. These factors work together to increase the patient’s financial responsibility while decreasing their ability to pay for care. With the convergence of COVID-19 and significant inflation, these issues may persist, leaving patients scrambling to find ways to pay for their OOP costs.

Before getting into the nitty gritty parts of this issue, it is important to mention the negative impact of a patient not taking their medication as their doctor prescribed it. Patient compliance with their medication regimen has a direct effect on clinical outcomes. Non-adherence to essential medications results in greater morbidity (i.e., disease progression, disease complications, reduced functional abilities, lower quality of life) and mortality. In the US, medication non-compliance has been estimated to result in avoidable hospitalizations that cost the system more than $100 billion each year and may approach $300 billion per year in total direct costs.

Recently, it has been reported that one-third to one-half of all US patients fail to comply with their prescribed pharmacotherapy regimens. Financial concerns are pushing patients to new levels of non-compliance—essentially, they are forced to choose between medications and other staples of life. Patients who do not comply with medication regimens, or do not seek treatment or follow up with physician orders, are at risk of exacerbating their conditions. For chronic conditions that are controlled by medication, the symptoms of the illness will likely return, and the underlying disease may likely progress. This results in an increased need for care such as physician visits, emergency room (ER) visits, or hospitalizations. 

The sense of urgency is greater when considering the devastating effects of the past few years on the number of uninsured, as this group is more than twice as likely to delay or forgo needed care. This contributes to the spiral of more patients seeking treatment in the high-cost acute care setting, marked by surging numbers of ER visits, increased hospital admissions, and increased length of stay.

Patient (financial) assistance programs (PAPs) offer patients new avenues for accessing their prescribed medications, which may lead to higher levels of affordability and, thus, compliance. PAPs are not mandated or managed by the government; they are voluntary programs offered by pharmaceutical companies, nonprofit foundations, and some infusion and specialty pharmacies. Because they are subject to state and federal regulatory control, PAPs can vary in structure, number of patients served, services offered, and results. Their decentralized nature makes them cumbersome and time-consuming to navigate.

Often, the amount of assistance and method by which it reaches the patient depends on the payer, benefit model, drugmaker, patients’ diagnosis, and regulatory guidelines. For example, uninsured patients who qualify can typically receive drugs or coupons/cards used to purchase drugs through a manufacturer program or nonprofit program (i.e., Good RX). But the rules change when the payer is a government-funded program, such as Medicare or Medicaid because a direct financial benefit to the patient from the pharmaceutical company could be considered an inducement to use the drug in question by the Centers for Medicare and Medicaid (CMS).

Product life cycle and the specifics surrounding each individual medication also come into play. For example, as a drug approaches the end of patent protection, the PAP offered programs may become more generous, allowing the manufacturer to build brand loyalty and maximize market share before competing generic therapies become available or their product becomes a generic drug.

Clearly, the landscape of PAPs is multifaceted and a bit like peeling an onion—the further you go, the more there is. While this evaluation is not intended to tell you everything you need to know about PAPs, it provides a brief overview that can help reduce the learning curve for patients looking for patient assistance funding.

Pharmaceutical Manufacturer Programs

Nearly all major drug manufacturers provide assistance programs for their most popular drugs. Currently, there are about 2,000 PAPs offered by nearly 500 companies. This loose patchwork of programs lacks any semblance of standardization and is subject to continuous change. Each unique program has its own eligibility guidelines and application procedures. Patient assistance can range from discounts on drug purchases, direct reimbursement for OOP costs, to free medication.

Typically, these programs serve only patients with no prescription drug coverage—either through commercial insurance plans, Medicare, or Medicaid. Eligibility requirements vary from program to program, but most require US citizenship and a total household income between 2-4 times the Federal Poverty Level (FPL). According to the US Department of Health and Human Services, the federal poverty guideline for 2023 is $30,000 for a family of four. Depending on the PAP, the patient may be required to submit supporting documentation, such as proof of income, rejection letters from commercial insurance plans and/or Medicaid, original prescriptions, or physician signatures and clinical information. Some of the manufacturer PAPs send the medicines to the physician’s office for distribution to patients, while others send the medicine to a pharmacy or provide a credit card with a predefined value that the patient can use to pay their out-of-pocket costs. A few send a certificate to the patient who then gives it to the pharmacist.

Most of the programs offer an online application process. They can be found individually at the drug company’s website or can be accessed through one of the handful of national organizations that act as clearinghouses for patients (i.e., MedMonk.com). These “one-stop-shops” allow patients the ability to locate programs by drug and/or manufacturer, see consolidated program information, receive refill updates, and other information (Exhibit 1). Most of these sites also offer access to information on relevant insurance coverage and public benefits that might address other health care needs. Many of these sites offer a variety of resources to health care providers, which can be very useful for those just beginning the patient advocacy process.

Exhibit 1

Patient Assistance Program Gateways

Partnership for Prescription Assistance (PPA): www.pparx.org

Patientassistance.com: www.patientassistance.com

RxAssist: www.rxassist.org

NeedyMeds: www.needymeds.org

MedMonk: www.Medmonk.com

Because these PAPs are constructed around the drug itself, there is little continuity for patients dealing with complex diagnoses and multiple drugs. For example, depending on the drug their physician orders, a patient with pemphigus vulgaris (PV) could conceivably apply for assistance separately from the makers of several drugs that they may be taking. Unfortunately, the best clinical choice drugs for a given patient may not yield the best drug manufacturer’s PAP for the individual patient’s needs. Furthermore, there is no coordination between PAPs for patients with multiple diagnoses and those on multiple drug therapies. For example, a patient with PV might qualify for assistance for some of their medications but not all of them, especially if they have medications for other diseases besides their PV diagnosis.

These programs are by far the most common vehicle for delivering patient assistance—and have helped millions of Americans obtain needed medication—but they are not a complete resource for autoimmune skin blistering disease (AIBD) patients. For one, a great majority of the therapies covered by pharmaceutical manufacturer PAPs are for oral medications. There are fewer programs for injectable or infused medications compared to oral medications. There are even fewer programs dedicated to chronically infused medications. In addition, the programs are primarily designed for patients with no prescription drug insurance, versus the larger group of patients that have some coverage but still cannot afford their out-of-pocket costs. Despite these drawbacks, manufacturer PAPs can be a useful tool.

Third-Party Programs

For those insured by government sponsored programs, such as Medicare and Medicaid, receiving free medication, discounts, or other “inducements” from pharmaceutical companies runs afoul of Fraud, Waste, and Abuse regulatory guidelines. Therefore, patients with these types of insurance must receive assistance via a third party, typically a nonprofit patient advocacy group that coordinates the distribution of medications and financial assistance. In addition to delivering access to medication, third-party programs also help underinsured patients cover co-pays and often offer a wealth of other health care-related information and resources.

There are a variety of ways these organizations can be structured. The most common is the independent, nonprofit foundation. There are several large, national entities that operate disease-specific funds—some for dozens of different medical conditions. They are funded through donations from individuals and organizations, mainly pharmaceutical companies (Exhibit 2). Their size and reach allow them to cover a variety of medical interventions such as cancer treatments, chronic diseases, iron overload as a result of blood transfusions, and more.

Exhibit 2

Nonprofit Patient Assistance Foundations

Caring Voice Coalition: www.caringvoice.org

Chronic Disease Fund: www.cdfund.org

HealthWell Foundation: www.healthwellfoundation.org

Patient Access Network Foundation: www.panfoundation.org

Patient Advocate Foundation: www.co-pays.org

Accessia Health: https://accessiahealth.org/

In addition to these larger organizations, nonprofit patient advocacy groups may band together to administer third-party patient assistance programs. Typically, these groups have an advocacy-related mission, but coordinate programs to help patients with other issues related to their diseases. The National Organization for Rare Disorders (NORD) is one example. This unique federation of voluntary health organizations is dedicated to helping people with rare “orphan” diseases and assisting the organizations that serve them. NORD is active in patient education, advocacy, and research, but it also administers PAPs that provide medication assistance, co-pay assistance, early and expanded access to investigational drugs, and emergency product supplies.

Another type of third-party PAP is the for-profit organizations (outsourced, Hub-like models) that administer reimbursement support services for specific drug manufacturers. Typically, the manufacturers represented make therapies that are used to treat chronic diseases and the reimbursement issues the organization navigates are complex. These Hubs monitor health policy and reimbursement regulations in the commercial sector as well as for Medicare and Medicaid. They offer this knowledge to pharmaceutical companies as they develop and bring drugs to market, as well as perform complex patient assistance support on behalf of their patients. Some of the functions performed by these companies include screening patients for manufacturer-sponsored assistance programs, connecting them with charitable foundations that may offer financial assistance, resolving denied claims, locating clinical trials, and otherwise cobbling together resources that may maintain their access to therapy. This expertise is also available to health care providers, such as physicians, hospitals, and pharmacies.

Patients are often steered to these companies by advocacy groups and the pharmaceutical companies that make their life-saving drugs. To patients, they offer in-depth knowledge of their disease state and the complex reimbursement landscape surrounding it. They also offer comprehensive services designed to open or maintain their access to therapy, including appealing insurance company adverse coverage decisions. However, many times, these companies utilize closed distribution channel models, and may use their own preferred pharmacies as a means of providing affordable patient services which may limit patient choice of pharmacy options.

If you are a patient with a chronic disease who is experiencing financial pressure, third-party organizations are a good place to start. The foundations mentioned in Exhibit 2 all list the diagnoses covered on their websites—there is some crossover, and several types of cancer are included. Often, a disease-specific patient advocacy group can point you in the right direction as well.

Other Notable Programs

Perhaps one of the most frustrating situations for patients is when a patient has insurance coverage, but still cannot cover their own OOP costs. This scenario plays out for many chronic illnesses—particularly when they are treated with new, expensive biological drugs. A handful of nonprofit organizations have formed over the past couple of years to address the growing segment of patients who need help covering their drug co-pays.

Expenses for AIBD can accumulate and grow exponentially. Due to payers’ cost shifting through benefit design, co-pays for specialty pharmaceuticals are often a percentage of the cost of therapy rather than a flat fee, as they are for retail prescriptions. That means the patient’s OOP responsibility can run from several hundred to several thousand dollars per treatment.

Seeing how these obligations affected patient access to care, a former specialty pharmaceutical company executive founded the Assistance Fund (www.theassistancefund.org), a national charity that covers expensive prescription drug costs for those who have insurance but cannot afford their co-pay. Launched earlier this year, the Assistance Fund helps patients who earn up to seven times the federal poverty standard—so even middle-class patients can qualify.The Fund has already raised $20 million in donations, mostly from large corporations, including drug manufacturers—and is assisting patients across the country. Most of the third-party organizations mentioned earlier offer co-payment assistance and even insurance premium assistance, but the Assistance Fund is unique in its focus on the needs of patients treated with biologic drugs.

For AIBD patients, an interruption of therapy can be disastrous. And since the therapies are often life-long, issues such as a change in insurance coverage or even drug availability in the marketplace can threaten to disrupt treatment. That is why for certain therapies where there is no therapeutic equivalent, or the product is subject to shortages, it is advantageous for the patient to register for assistance programs even when there is no immediate need. Intravenous immune globulin (IVIG) is one such therapy where patients register to earn credits—typically certificates based on usage history with a specific IVIG product—that can be used toward future assistance during a loss of insurance coverage or for access to product during periods of tight allocation.

It is imperative that patients and their families familiarize themselves with the FAP terrain. The more you know about the way these programs operate, the more effective we can be in obtaining the therapies your doctor has ordered for you.

While there are limitations to the programs described here, perhaps the most significant challenge for AIBD patients is navigating what is available for their disease(s) and the drugs that have been ordered by their doctors.

I recommend that patients talk with their pharmacist (in the retail, infusion, or specialty pharmacy settings) about the insurance coverage and OOP costs they may face right after their prescriptions are sent to the pharmacy from the doctor’s office. This way the patient and their family can see the financial impact of each of the medications and understand which ones may be the costliest, which therapeutic alternatives may exist, and which products may have an FAP program available.

Please email me at DrMike@pemphigus.org for questions about medication-related financial issues.

Michael Rigas, Pharm.D., is an IPPF Board Member and the Chief Clinical Officer, Emeritus of KabaFusion, LLC, in Cerritos, California.

References

Cha AE, Cohen RA. Demographic variation in health insurance coverage: United States, 2021. National Health Statistics Reports; no 177. Hyattsville, MD: National Center for Health Statistics. 2022. DOI:

https://dx.doi.org/10.15620/cdc:121554.

Creamer, J. (2022, September 13). Poverty in the United States: 2021. Census.gov. https://www.census.gov/library/publications/2022/demo/p60-277.html.

Iuga AO, McGuire MJ. “Adherence and health care costs.” Risk Management and Healthcare Policy. 2014, 7:35-44.

Poverty guidelines. ASPE. (n.d.). Retrieved March 29, 2023, from https://aspe.hhs.gov/topics/poverty-economic-mobility/poverty-guidelines.

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COVID-19

The following Letter to the Editor was published in the Journal of the European Academy of Dermatology and Venereology on April 25, 2022 about the role of the IPPF during the COVID-19 pandemic.

Pemphigus and pemphigoid are rare and potentially life-threatening chronic inflammatory autoimmune blistering disorders (AIBDs) that require special guidance by experienced dermatologists during the COVID-19 pandemic. The International Pemphigus and Pemphigoid Foundation (IPPF), a long-standing, non-profit, patient-advocacy organization, hosts one of the largest worldwide registries of AIBD patients with currently over 500 enrolled participants from 7 different countries (www.pemphigus.org).

Patient-reported outcomes have been increasingly utilized across diverse clinical study settings and disease conditions including AIBDs, as evidenced by the growing number of IPPF-related publications showing efforts to engage this group of patients in research. Observational studies using web-based patient questionnaires have the advantage to collect data from a large representative cohort in a timely manner, which has been of particular interest during the COVID-19 era when in-person research may be temporarily limited.

Two COVID-19-related studies based on cross-sectional anonymous online surveys have been published in collaboration with the IPPF so far, both of which greatly contributed to the prompt gain of valuable knowledge about the influence of the SARS-CoV-2 outbreak and vaccines against its transmission on patients with AIBDs. In one study, we could demonstrate both a negative impact of the COVID-19 outbreak, including associated outdoor activity restriction and income loss, on health outcomes such as disease deterioration, stress, anxiety and depression, and a high satisfaction with telemedicine platforms in patients with AIBDs during this pandemic. In the other study, we could show that SARS-CoV-2 vaccine hesitancy is prevalent in about one-third of patients with AIBDs, with fear regarding a flare or worsening of the disease representing a major contributing factor.

In conclusion, we encourage researchers to make further use of the readily accessible IPPF database, especially in difficult times like pandemics during which potential restriction or delay with human subject research involving direct patient interactions can occur, and we are grateful to all patients participating in these important scientific investigations.

Read the letter here. The IPPF frequently updates COVID-19 information and resources for pemphigus and pemphigoid patients.

The following was published as a Letter to the Editor in the British Journal of Dermatology in November, 2021. The letter outlines a cross-sectional study of COVID-19 vaccine acceptance and hesitancy in patients with autoimmune bullous diseases. Out of the 707 total participants, 73.1% reported a willingness to accept the COVID-19 vaccination.

Patients with autoimmune bullous diseases (AIBDs) have faced considerable challenges during the COVID-19 outbreak. SARS-CoV-2 vaccines became an important public health solution, but the pandemic raised awareness of vaccine hesitancy. We aimed to investigate the currently unknown general vaccination status among patients with AIBDs to better inform vaccine practices in this cohort of patients with potentially life-threatening inflammatory disorders.

In this cross-sectional study, English-speaking patients with AIBDs aged ≥ 18 years, who were recruited from the database of the International Pemphigus and Pemphigoid Foundation, were asked to complete a COVID-19 vaccination-related web-based survey between 2 August 2021 and 30 August 2021. The online poll was adapted with minor modifications from Wang et al. Electronic informed consent was obtained from all patients, and the questionnaire was completed anonymously. The study was granted an exemption by the Institutional Review Board of the University of Southern California. The primary outcome was the rate of patients reporting COVID-19 vaccination willingness or hesitancy. Secondary outcomes were vaccination coverage, safety, and factors associated with vaccination willingness and hesitancy. Covariates included sex, age, country, ethnicity, education, income, type of AIBD and comorbidities. Logistic regression was used to estimate associations, with adjustments for potential confounders.

Read the full letter here. The IPPF frequently updates COVID-19 information and resources for pemphigus and pemphigoid patients.

We are rare, we are many,
we are strong, we are proud!

The purpose of Rare Disease Day® is to harness the creative energy of the millions of people around the world with rare diseases — and the millions who care about them — to raise awareness and generate action. 

Join the IPPF and get in on the action. Rare Disease Day is the biggest day of the year for rare diseases like pemphigus and pemphigoid. Get involved and make an impact!

As the IPPF community looks to the future, we need to be stronger and louder to make a difference in the lives of people with rare diseases and their families demanding equity and inclusion. Please consider participating in one or more of the activities below and help us continue to spread aware for rare diseases like pemphigus and pemphigoid.

Get Involved:

  • BioNews, will host an excellent panel discussion to explore what it means to be rare.
  • The National Institutes of Health (NIH) is holding a virtual conference with talented panelists and fascinating topics.
  • The National Organization for Rare Disorders (NORD), with it’s zebra-themed mantra “show your stripes,” will host various virtual activities.
  • NORD’s European sister organization, EURORDIS, is urging people to “share your colors” in a global campaign aimed at highlighting the more than 300 million rare disease sufferers in the world.
  • The U.S. Food and Drug Administration (FDA), the agency responsible for reviewing and approving treatments in the U.S., is hosting a virtual public meeting on March 4 in which “various stakeholders will share their perspectives on and experiences in rare disease product development.” Six panel discussions and other activities will be held.
  • Rare Disease Day at IndoUSrare on Monday, 28 February, 2022 from 7:30 pm to 9:30 pm IST, 9 am to 11 am ET invites you to join them for this year’s #rddindousrare, on the theme Celebrating 30 Years of Rare Disease Treatment, in honor of the millions of rare disease patients around the world, 95% who are still without any approved therapy for their condition. Featuring a stellar set of talks and panel discussion, the event commemorates the immense progress the rare disease community has achieved since the first commercial therapy for a rare disease came out in 1992. Register at: https://www.indousrare.org/event/rare-disease-day-at-indousrare-2022/
  • This Rare Disease Day, 28 February, the whole world will be watching the 2022 Global Rare Disease Day event in Dubai and hitting Rare Disease Day events in all parts of the world.
  • GlobalSkin is excited to take part in Rare Disease Day 2022 on February 28, by highlighting and raising awareness for rare dermatological diseases. They have created resources to assist with Members’ social media presence on Rare Disease Day. Visit their website to download materials!

Rare Disease Week on Capitol Hill (2/22- 3/2)

Rare Disease Week 2022

Rare Disease Week on Capitol Hill, organized by the the EveryLife Foundation for Rare Diseases brings together advocates to promote education about federal legislative issues that affect people with rare diseases and their caregivers, as well as public strategies to advocate for further change.

An easy way to spread disease awareness and make an impact is through sharing messages on social media! Raise awareness for the IPPF community and rare diseases by liking and sharing IPPF social media posts or creating your own.

by Carolyn Fota
As many in our community know, 2021 was a very successful year for the IPPF. From record attendance at our Virtual Patient Education Conference to creating connections for researchers at our Scientific Symposium, we found continued opportunities to grow the impact of our organization. Years of awareness efforts culminated in offering a continuing education course with the American Dental Association. Our peer health coaches adapted to the ongoing pandemic and provided additional support to patients and caregivers. These are just a few highlights from a year with many to choose from.

What you may not know is that Kevin Mead, the IPPF’s Executive Director, stepped down at the end of 2021 to pursue other opportunities. Though Kevin’s time with the IPPF lasted only 15 months, his impact was immediate. Kevin successfully applied for and received several high-profile grants, streamlined operations, and managed a virtual staff and team of volunteers with a deft hand.

Upon Kevin’s departure, the IPPF Board of Directors evaluated the needs of the Foundation to determine how to best move forward in the coming years. The Board conducted an exhaustive search and selected a staff member who shows a deep understanding of the IPPF’s vision, mission, and a commitment to the needs of our community. 

Patrick Dunn

I am pleased to announce Patrick Dunn as our newest Executive Director. Patrick has been working for the IPPF since 2014 when he joined the staff as a health communications specialist. His role grew over the years, and he has most recently worked as the IPPF Communications and Marketing Director. “It’s a tremendous honor to serve pemphigus and pemphigoid patients and their caregivers, as well as the medical professionals who support them every day,” Patrick said. “I’m excited to work in this new capacity, especially knowing the talent that the rest of our staff brings to their jobs. The IPPF has never been stronger, and there are many initiatives in the works to make a brighter future for patients.” 

Patrick Dunn will officially assume his new role as the IPPF Executive Director on February 28, 2022. We are all looking forward to this next chapter. Patrick can be reached directly by email or phone (916) 435-6751. 

Carolyn Fota is the Chair of the IPPF Board of Director’s, IPPF peer health coach, and Mid-Atlantic Support Group Leader.

We are happy to report that the IPPF had another great year in 2021. The infographic below highlights key areas in which we continue to work for all people affected by pemphigus and pemphigoid.

Despite the ongoing challenges of a global pandemic, we are optimistic about the future as we grow our efforts in patient support, awareness, advocacy, and research. Thank you to everyone in our community for your support. Together, we can expand hope for all people affected by P/P. We’re looking forward to 2022!

IPPF 2021 Year in Review

Hannah and Marc Yale.

The 2021 RareVoice Awards were held on December 15, 2021 by the EveryLife Foundation for Rare Diseases. The evening celebrated rare disease advocates who make their voices heard year-round to advance policies that benefit the rare disease community.

We’re so proud of Marc Yale for his nomination in the Federal Advocacy Patient/Organization category, which honors advocates or organizations that have worked to create and pass federal legislation. And we’re thrilled to share that Hannah Yale won the 2021 RareVoice award for State Advocacy by a Teenager, which honors teens who have advocated for state or federal legislation. Congratulations, Hannah!

Hannah has been an advocate for the EveryLife Foundation and the IPPF since 2017. She has attended Rare Disease Legislative Advocate’s (RDLA) Rare Disease Week on Capitol Hill annually since 2017, and she is also a member of the Young Adult Representatives of RDLA. In 2020, Hannah served on the Funding Committee for Living in the Light’s “I Stay Home for Rare” Emergency COVID-19 Relief Fund.

Hannah is living with Ehlers-Danlos Syndrome, although she began her rare disease advocacy to support her father, Marc, and her mother (who also has a rare disorder). Hannah is currently a student at St. Mary’s College of Maryland, where she is majoring in public policy and minoring in English and philosophy.

For more information about the event and to view the full list of award recipients, visit here.

About the EveryLife Foundation for Rare Diseases

The EveryLife Foundation for Rare Diseases is a 501(c)(3) nonprofit, nonpartisan organization dedicated to empowering the rare disease patient community to advocate for impactful, science-driven legislation and policy that advances the equitable development of and access to lifesaving diagnoses, treatments and cures.

December 15, 2021
The IPPF is grateful to share that we have received a one-time, $50,000 grant from the Chan Zuckerberg Initiative in support of accelerating research and finding treatments and cures for pemphigus and pemphigoid.

Recently, the Chan Zuckerberg Initiative (CZI) announced $13 million in funding for 40 patient-led, rare disease advocacy organizations that are working alongside researchers and clinicians to accelerate research in their disease areas. These grants are part of CZI’s Rare As One (RAO) Project, aimed at supporting and lifting up the work that patient communities are doing to drive progress in the fight against rare diseases.

Rare disease is not rare. As many as 7,000 rare diseases affect 400 million people globally. The Rare As One Project is committed to uniting rare disease patient advocates in their quest for cures.

To read more about the funding and CZI’s Rare As One Project, visit https://chanzuckerberg.com/.

The IPPF Patient Education Conference is an event that the pemphigus and pemphigoid (P/P) community looks forward to each year. For the IPPF staff, it’s remarkable to see the joy and relief that patients feel when they meet with other patients and learn valuable information about their diseases. When we held our first virtual Patient Education Conference in 2020, our goal was to connect with patients despite the inability to be together in person. Immediately following that event, we started planning the 2021 conference that was held this past October. We knew that the planning process would require us to be flexible due to the COVID-19 pandemic, but we hoped that with vaccines on the horizon, we’d be able to hold an in-person event in 2021. 

However, it became clear last spring that an in-person conference was unlikely due to ongoing COVID-19 case numbers and the uncertainty of travel guidelines. Nevertheless, the IPPF staff pored over the planning of another great virtual conference with the goal of connecting P/P patients, caregivers, and others affected by these diseases. Luckily, we had the resources and experience from planning a prior virtual conference, so we focused on the ways we could improve the 2021 Patient Education Conference.

I often talk to my two young children about silver linings, especially since the start of the COVID-19 pandemic. (Spending time at home together, FaceTiming more often with extended family, and Target drive-up are examples I often give to help ease the pain of events, school, and playdates getting cancelled.) One of the silver linings about the virtual conference is the ability to reach more attendees across the world. This year, we were able to reach even more conference attendees than last year, with 762 registered attendees from 46 countries.

The 2021 virtual conference started off with a welcome reception that also included regional support group breakout meetings. Since the start of the COVID-19 pandemic, finding creative ways to connect with each other has been imperative. At the start of the pandemic, IPPF support group leaders throughout the US have done an amazing job of hosting virtual meetings in order to maintain connections. Attendees at this year’s conference had the opportunity to gain more information about these support group meetings, as well as details about starting a group in their area.

The first day of the conference continued with Staci White’s remarkable story about her journey to diagnosis. Staci is an IPPF Board of Directors member, and her strength is inspiring. Friday’s agenda also included an introduction to P/P, a session on the mind-body connection, and a peer health coach panel discussion.

Day two began with sessions focused on oral care, topical treatments, and managing corticosteroids. Pemphigoid gestationis patient Ashton Brown then explained her harrowing experience with the disease and its effect on her health, pregnancy, and the delivery of her baby boy. Ashton reached out to the IPPF after going viral on TikTok about the condition. The day closed with a general Q&A panel hosted by Dr. Aimee Payne, Dr. Neil Korman, and Dr. Nasser Said-Al-Naief; a session on navigating insurance and Medicare; and an informative discussion on COVID-19 and P/P.

The final day of the conference kicked off with sessions on the role of immunosuppressants, rituximab/IVIg and next generation therapies, and research. IPPF Executive Director Kevin Mead discussed the impact of international support groups in the United Kingdom, France, Germany, and the exciting work Noel Mudibo is doing in Kenya. The final session of the conference focused on advocacy efforts, including recent legislative efforts and ways to get involved. 

As an IPPF staff member who works primarily behind the scenes, I don’t often have the opportunity to see patients and physicians face-to-face. This year, more than ever, I was able to experience that connection and strength within our community. Having a rare disease is hard; no one understands that more than P/P patients. The willingness to help one another, even through a computer screen, will always be a silver lining I will remember from the COVID-19 pandemic. We can’t wait until we can all be together in person again, but until that day, the IPPF is here for you.

Anna Lane is the IPPF Communications and Marketing Manager. She lives in Denver, CO, with her family. 

This page was last updated on February 14, 2023.

As news of coronavirus disease (COVID-19) changes frequently, one fact remains constant: The IPPF is dedicated to our community during this difficult time, and we are here to provide support and information. We are working hard to keep abreast of the situation and notify you about updates regarding the necessary precautions and recommendations to keep you safe during this pandemic. We will continue to update information on this page as it becomes available.

As always, we are listening to you during this time. When possible, we will try to answer general questions regarding the unique needs of pemphigus and pemphigoid patients. However, if you have specific questions or concerns about your condition, we recommend that you contact your physician.

IPPF Medical Advisory Council Statement: COVID-19 Update (Updated November 16, 2021)

Pemphigus and pemphigoid patients are recommended to receive an additional shot of the COVID-19 vaccine. Specific recommendations can vary based on whether or not you are currently taking immunosuppressive medications, described further below.

Why did the CDC recommend booster vaccines for immunosuppressed individuals as well as non-immunosuppressed individuals??

  • People who are immunocompromised are more likely to transmit the virus that causes COVID-19 to household contacts.
  • Studies suggest that fully vaccinated immunocompromised people accounted for nearly half of hospitalized breakthrough cases.
  • Studies have shown that 40% of solid-organ transplant recipients who had no detectable antibody response to an initial mRNA vaccine series developed an antibody response to an additional dose.  
  • The SARS-CoV2 Delta variant is surging, and the number of people with COVID-19 is increasing in the United States, which puts immunosuppressed individuals at further risk.

Am I immunosuppressed?

  • Pemphigus and pemphigoid patients who are not taking oral systemic therapies, and who have not received rituximab within the last 12 months, are generally not considered immunosuppressed and would not fall within the recent CDC guidance.
  • You are considered immunosuppressed if you are receiving active treatment with:
    • high-dose corticosteroids (i.e., ≥20mg prednisone or equivalent per day)
    • mycophenolate
    • azathioprine
    • methotrexate
    • rituximab within the last 12 months (rarely, patients who received rituximab more than 12 months ago may have prolonged B cell depletion and would be considered immunosuppressed).
  • Topical steroids, IVIg, doxycycline, dapsone, and dupilumab are not considered immunosuppressive.

Should I ask for an antibody test to determine if I need a booster vaccine?

  • Currently the CDC and FDA do not recommend blood tests to evaluate response to COVID-19 vaccines, except in the context of a research study.

Which booster vaccine should I get?

The FDA approved a “mix and match” approach, meaning that you can receive any of the available vaccines if the original vaccine you received is not available. The default choice is to receive the same vaccine you received for your original immunization.

(Recommendations from the CDC are updated frequently and as new information becomes available. For the most up-to-date recommendations from the US CDC, visit https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/specific-groups.html)

  • For Pfizer-BioNTech:
    • Immunosuppressed: all individuals 12 and older who are at least 4 weeks out from their 2nd shot
    • Booster for individuals 65 and older who are not immunosuppressed and are at least 6 months out from their last shot
    • Booster for individuals 18 and older who are at least 6 months out from their last shot
  • For Moderna:
    • Immunosuppressed: all individuals 18 and older who are at least 4 weeks out from their 2nd shot, should receive a full-dose booster
    • Half-dose booster for individuals 65 and older, who are not immunosuppressed and are at least 6 months out from their last shot
    • Half-dose booster for individuals 18 and older who are at least 6 months out from their last shot
  • For J&J/Janssen:
    • All individuals 18 and older who are at least 2 months out from their last shot.

Do I need to delay or change any of my treatments for the vaccine?

  • If you have been diagnosed with COVID-19 AND received monoclonal antibody therapy to treat infection, CDC recommends waiting at least 90 days to receive a COVID-19 vaccine or booster.
  • For individuals who have received rituximab within the last 2 months or are anticipating additional rituximab infusions within the next 2 months, you may speak with your physician about delaying the booster vaccine until at least 3-4 months after rituximab infusion, or conversely delaying repeat rituximab infusion until at least 2 months after the booster vaccine. Your likelihood of responding to booster vaccination depends on the timing of vaccination in relation to rituximab infusion, along with the dose of rituximab received.

What other precautions should I follow?

  • It is possible that the medications that prevented a response to initial vaccination will also prevent a response to booster vaccine. Hence, immunosuppressed individuals should follow general COVID-19 precautions, including:
  • Wear a mask
  • Stay 6 feet apart from individuals you don’t live with
  • Avoid crowds and poorly ventilated indoor spaces without masking
  • Close contacts should be encouraged to be vaccinated against COVID-19

Are there research studies in this field?

A clinical trial to study COVID-19 booster vaccine responses in pemphigus patients is currently enrolling at sites across the United States. You may wish to speak with a dermatologist at the study site to see if they are enrolling for the clinical trial. You must:

  • Have a documented diagnosis of pemphigus (pemphigoid is not included)
  • Have received 2 doses of either the Moderna or Pfizer COVID-19 vaccine, or one dose of the Janssen COVID-19 vaccine
  • Must currently be taking mycophenolate (1000 mg daily or greater), methotrexate (7.5 mg weekly or greater), or have received rituximab within the last 12 months
  • Have a negative or suboptimal response to COVID-19 vaccination based on a blood test performed at the time of screening
  • Have relatively stable disease activity such that an increase in immunosuppressive medication is not anticipated at the time of screening

Full inclusion and exclusion criteria are listed at: https://clinicaltrials.gov/ct2/show/NCT05000216?term=pemphigus

IPPF Medical Advisory Council Statement: COVID-19 Vaccination (May 14, 2021)

Based on the current information that is available, the IPPF Medical Advisory Council recommends that all people that have been diagnosed with pemphigus or pemphigoid and are considered immunocompromised receive a COVID-19 vaccination in conjunction with discussing their vaccine and treatment strategies with their physician.

The following information in this section originated from recommendations made by the European Reference Networks for Rare and Undiagnosed Skin Disorders (ERN-Skin) found here. This information has been reviewed and edited by the IPPF Medical Advisory Council to reflect the specific needs of pemphigus and pemphigoid patients.

Patients with autoimmune bullous diseases are at potential risk of having severe forms of viral infections, including COVID-19. This risk is particularly relevant in elderly patients and in patients taking oral steroid and/or immunosuppressive therapies such as methotrexate, mycophenolate mofetil, azathioprine, cyclophosphamide and rituximab.

The IPPF Medical Advisory Council, in accordance with the European reference center for autoimmune bullous diseases (MALIBUL), advises patients with autoimmune bullous diseases to be vaccinated against SARS-CoV-2.

The “mRNA vaccines” currently available are not live vaccines (i.e. they do not contain live attenuated virus or inactivated virus, but only the RNA for one small part of the virus). Thus, the benefit of vaccination is expected to outweigh any potential risk in patients with autoimmune bullous diseases, including those undergoing immunosuppressive treatment.

Concerning the effect of immunosuppressive treatments on the efficacy of vaccination, immunosuppression at the time of vaccination should be as low as possible in order to increase the chances of vaccine efficacy. However, if immunosuppressive treatment is underway, it should not be interrupted as this could lead to a relapse or flare-up of the disease.

In patients who are to be treated with rituximab, vaccination against SARS-Cov-2 should be completed 2 weeks prior to the start of rituximab treatment whenever possible. In other cases, it is best to wait 4-6 months after the last rituximab infusion since this is when the white blood cells (called B cells) start to rise.

Finally, it should be remembered that vaccination should not be accompanied by stopping other protective measures (wearing face masks, physically distancing, and hand-washing), especially in patients receiving oral steroid and/or immunosuppressive therapy, since it is currently unknown whether vaccinated individuals can transmit virus to non-vaccinated individuals.

Masks, Physical Distancing, and Hand Washing

The IPPF follows the recommendations for from the United States Centers for Disease Control and Prevention (CDC) in regard to masks and cloth face coverings, as well as the need for social distancing and hand washing. For the most up-to-date information, visit the CDC’s Considerations for Wearing a Mask page.

The IPPF maintains that the best way to protect yourself in the short-term is to stay at home to the extent possible; practice physical distancing; avoid touching your face; and wash your hands frequently. If you have to go out, wear a mask, use hand sanitizer, and wash your hands. Don’t go out if you are sick, unless you are seeking medical care.

In response to some common questions we’ve received recently, the IPPF Medical Advisory Council has provided the following answers:

  1. Do COVID-19 vaccines cause bullous pemphigoid?
    Bullous pemphigoid (BP) is the most common subepidermal autoimmune immunobullous disease. It characteristically affects the elderly, and its incidence has been rising. Given that there are hundreds of millions of vaccine doses administered each year, one would expect that by chance alone, there should be some individuals who develop BP following vaccination. However, to date, there have only been a relatively small number of reported cases of BP presenting after vaccination. Although the chance occurrence of BP following vaccination has led some to associate the two, carefully conducted studies have thus far not supported this conclusion. If you or a loved one has been diagnosed with BP after receiving a vaccination, it is most likely a chance occurrence.
  2. What precautions should patients with open P/P lesions do in light of COVID-19?
    Direct spread through the skin is not a known source of transmission for COVID-19. Keep lesions clean and covered if around others.
  3. If not on any treatment, does simply having an autoimmune disease like P/P make you more susceptible to this coronavirus?
    Pemphigus and pemphigoid patients who are not receiving immunosuppressive therapies are not known to be at greater risk for COVID-19.
  4. Does using topical treatments make you immunosuppressed?
    Not usually. However, if the dosage is more than 20g of a class I steroid (clobetasol or betamethasone, etc.) some steroid systemic absorption occurs. It is possible this absorption can make a patient slightly immune-suppressed.
  5. How long does it generally take for the following medicines to get out of a person’s system and for their immune system to return to normal levels:
    • Rituximab: The formal guidance is typically 1 year, although there is some variability in that response. We know from the published literature that many patients start to make new immune responses by 5-6 months after rituximab treatment.
    • Corticosteroids (systemic prednisone or prednisolone): Within days to weeks, but these cannot be arbitrarily stopped and will need to have the dose weaned properly due to adrenal suppression.
    • Class I Topical Steroids (Clobetasol/Betamethasone): These don’t affect the systemic immune system unless ~20g or more are applied daily. Even if high doses are used, these would “wash out” in days to weeks as above.
    • Azathioprine/mycophenolate mofetil: These take 3 months to “wash out” of a person’s system.
    • Cyclophosphamide: Cyclophosphamide should presumably take 3 months based on mycophenolate mofetil/azathioprine (MMF/AZA) data.
    • Cyclosporine: Cyclosporine should presumably take 3 months based on MMF/AZA data.
    • Dapsone: Dapsone doesn’t suppress the immune system in a way that would be expected to be problematic with COVID-19, and it “washes out” in a week or two.
    • IVIg: IVIg doesn’t suppress the immune system
  6. Is IVIg therapy better than nothing?
    Yes, there were randomized double-blind clinical trials of IVIg performed in Japan that showed that it was modestly effective at improving disease activity in bullous pemphigoid and also was beneficial in pemphigus. The main advantages of IVIg right now are that it is one of the only therapies for P/P that does not suppress the immune system. Additionally, it can be given by home infusion if your insurance approves that form of therapy.
  7. Does Rituxan put you more at risk of contracting a virus than being on high doses of prednisone?
    Rituximab is expected to increase risk of viral infections and the severity of disease if infected. However, a randomized controlled trial published in Lancet (2017) showed that rituximab is better at controlling disease and resulted in a lower rate of infections compared to high-dose prednisone alone, so this issue would best be left to an individualized discussion with your doctor to determine the risk of disease versus the risk of treatment.
  8. Rituximab treatments have been postponed. What can be done in the meantime?
    IVIg could be considered if the disease is significant, or topical steroids and other non-immunosuppressive measures if that is sufficient to control symptoms. However, severe disease should most likely still be treated, as the risk of hospitalization from severe disease could be worse than treating now to get disease symptoms under control and then self-isolating at home to avoid the risk of infection. Speak with your employer and doctor about flex hours or work-from-home options if immunosuppressive therapies are used.
  9. I work in a hospital where we are getting COVID-19 cases, and I’m on treatment for P/P. Should I stay home from work/take leave?
    You may be at higher risk for severe manifestation of COVID-19. You should speak with your supervisors about opportunities to work at home or in isolation.
  10. Does being on long term, low-dose prednisone make COVID-19 symptoms come slower?
    Published reports have suggested that prednisone at doses lower than 10 mg per day does not increase the risk of hospitalization from COVID-19 (Gianfresco et al, Annals of Rheumatic Diseases, 2020; 79:859). It is unknown but thought to be unlikely that prednisone would significantly delay symptoms of COVID-19 early in the disease course.
  11. I’ve been in remission, but now seem to be having a flare. Does taking medication put me at high risk for COVID-19?
    Many oral and IV medications may increase the chance that you will have a more severe course of COVID-19. IVIg is likely an exception.
  12. When a vaccine for COVID-19 is available later in the year or next year, would rituximab’s effects on B cells affect the efficacy of the vaccine?
    Rituximab is expected to decrease the efficacy of a COVID-19 vaccine if the vaccine is given in the first few months after rituximab.
  13. When should the vaccine be given in relation to the courses of rituximab? How many months before or after?
    These issues will affect when the patients should get their next infusion. We do not know for certain, but it is reasonable to think that the ideal time to vaccinate for COVID-19 would be at least 4-6 months after rituximab and at least 1 month before rituximab.
  14. What process should an undiagnosed person follow if they suspect they have a bullous disease?
    Call their local dermatology provider. Avoid the ER if possible. (NOTE: If you need assistance locating a dermatology provider in your local area who is experienced in dealing with pemphigus and pemphigoid, contact us.)
  15. Are there extra precautions that patients should observe as states begin to reopen?
    Different states may be recommending different levels of precautions. Wear a mask or face covering in public; stay 6 feet away from others; wash your hands or use hand sanitizer if you are out in public spaces and avoid touching your face, nose, eyes, and mouth with unwashed hands; wash your hands immediately after returning to your home. Avoid mass transit if possible. Work places may offer flex hours or work-from-home options to help avoid “rush hour” when many commuters are using mass transit. If you cannot work from home or avoid mass transit – follow the guidelines above (face covering, physical distancing to the best extent possible, avoid touching your face with unwashed hands while commuting). If you develop fever, chills, cough, shortness of breath, sudden loss of taste or smell, headache, sore throat, muscle pain, call your primary care doctor for guidance and remember to tell them if you are on immunosuppressive treatments.
  16. Should patients (whether on or off treatment) go out into society and businesses as they begin to reopen, or should we stay home or request letters from doctors to continue to work from home until we know if there will be a big uptick in cases?
    Patients who are off treatment have the same risk from infection as a non-pemphigus or pemphigoid patient. Patients who are on immunosuppressive therapy have greater risk of infection, as well as a more serious course of infection. Flex hours or work from home would be prudent if there is a resurgence of COVID-19 in your community. Speak with your employer and doctor about options.
  17. What precautions should be exercised if a member of the household has to work outside of the home?
    Greater precautions are recommended if you are immunosuppressed and a member of the household works in a high-risk environment (for example, health care or a workplace that requires contact with multiple individuals.) Precautions the household member should consider include wearing a mask, frequent hand washing or use of hand sanitizer, avoid touching the face with unwashed hands while at work, washing their hands immediately after they return home, and surveillance for any of the symptoms of COVID-19 above.

Resources

The following links are intended to be used for reference only. Each link leads to a website that is not maintained by the IPPF; inclusion in this list does not equal endorsement by the IPPF. The information on the following websites may change at any time. This information is also not intended to be used as personalized medical advice. As always, discuss the specifics of your situation with your personal physician.

Publications

Global

Australia

France

Italy

Japan

The Netherlands

United Kingdom

USA

The IPPF provides peer support and information to all those affected by pemphigus and pemphigoid. Our community is strong and we are all in this together. If there’s anything we can do to support you, contact us at info@pemphigus.org.

The IPPF Board of Directors and staff are excited to welcome three new board members: Carolyn Fota, Laurence Gallu, and Michael Rigas.

Carolyn Fota

Carolyn Fota

Carolyn Fota was a newly retired Lieutenant Colonel, United States Army, Medical Service, in October 2015 who was finally going to enjoy time with family after a simple surgical procedure at Walter Reed National Military Medical Center, Maryland. However, within 24 hours of the procedure, hives and then blisters broke out across her body. It was the beginning of a nightmare that no one ever expected.

By December, a small army of medical staff at Stafford Hospital, Virginia; Fort Belvoir Community Hospital, Virginia; Walter Reed National Medical Center, Maryland; and the Mayo Clinic, New York, were collaborating on Carolyn’s intense medical support.

Finally, in February 2016, she was diagnosed with bullous pemphigoid. Treatment consisted of oral and topical steroids, tetracycline, nicotinamide, probiotics, Benadryl, magic mouthwash, and vitamin D3. Topical steroids were applied to her legs and arms, which were then wrapped in sterile dressings. She underwent intensive wound care for the next six months.

Carolyn is active in the IPPF community through peer health coaching, Mid-Atlantic Support Group leadership, advocating on Capitol Hill to our nation’s leaders, and participating in various IPPF projects whenever asked. She resides in Stafford, Virginia, with her husband of over 27 years, Francis. Carolyn enjoys golf, walking, church activities, and writing. 

Laurence Gallu

Laurence Gallu

Laurence Gallu returned to her native France after living in New York City for 30 years. She currently lives in Paris with her husband. She taught French language and literature at Smith College, NYU, and at Professional Children’s School in NYC. In Paris, she worked for the Columbia University’s Paris annex as coordinator of studies, acting as liaison between the French university system and US professors and undergrads. She retired after 12 years in 2016.

Laurence was diagnosed with pemphigus vulgaris in 2015. She was offered the opportunity to enter in a clinical trial called Pemphix that evaluated rituximab versus CellCept.

The treatment was a success, and she has been blister free ever since. Her doctor told her about the autoimmune blistering disorder (AIBD) French patient organization, the Association Pemphigus Pemphigoïde France (APPF). Benefitting from the APPF’s support and advocacy, she wanted to help provide these invaluable services to others. She began using her knowledge of English to translate documents and brochures, and was soon going to English speaking congresses, meeting with other AIBD patient organizations, and acting as a liaison with AIBD patient organizations in other countries. 

Her involvement with the IPPF started when Marc Yale invited her to a conference in Lübeck, Germany, in 2017.  When the IADPO-Global Skin (Rare Derm, and Global Skin Europe) and the European Reference Networks (ERNs) were created that same year, she became the APPF representative. In the ERN SKIN network, she has been the European Patient Advocacy Group (e-PAG) representative for her AIBD’s group since 2018. 

Laurence has been closely linked to the IPPF especially since the last non-virtual IADPO-Global Skin conference (in Milan) where she met with Marc and patient advocates from PemFriends (UK) and the ANPPI (Italy) after discussing the creation of a consortium of AIBD organizations. When the time difference allows, she attends IPPF Patient Education Series webinars, which are always clear and informative. 

Michael Rigas

Dr. Michael Rigas is the Chief Clinical Officer emeritis, co-founder, and principal in KabaFusion, an infusion therapy company started in 2010 that is dedicated to managing IVIG, and other chronic and acute therapies nationwide. Before this, in 2008 he joined Geisinger Health System as its Associate Chief Innovation Officer for Pharmaceutical Care and Chief Clinical Officer for VITALine CareSite Pharmacy Services. Over the last 20 years, Dr. Rigas has managed or overseen the care of over 15,000 patients who have received over 20,000,000 grams of IVIG.

Before moving to Geisinger, Dr. Rigas served as the Senior Vice President of Clinical Affairs at Crescent HealthCare in Anaheim, California, a large alternate site pharmacy company specializing in infusion and specialty pharmacy therapies. 

Before this, Dr. Rigas was the Chief Clinical Pharmacist at three hospitals over a 10-year period. He graduated from the USC School of Pharmacy with his Pharm.D. Degree and completed his residency at UC San Francisco Hospitals and Clinics in 1982. He spent the first 10 years of his career in the hospital arena serving as the chief clinical pharmacist in three different, 200+ bed community hospitals. From 1998 to 2002, Dr. Rigas managed pharmacies and nursing operations for a nationwide infusion company with 32 pharmacies in 22 states at the vice president level.

Dr. Rigas’ areas of expertise includes antimicrobial therapy, immunoglobulin therapies, nutritional support, inotropic therapies, pain control, improving clinical and financial outcomes, and payer and contract relations. He is also active in the High-Cost Biologic/Specialty Pharmacy and infusion industries. He has worked on standardized coding for infusion billing, universal access via Patient Assistance Plans, and managing Medicare Part D issues in front of the California board of pharmacy and CMS regional managers. Dr. Rigas holds membership in the American Society of Hospital Pharmacists, the National Home Infusion Association, the American Academy of Neurology, and the Clinical Immunology Society.

Published April 19, 2021
On April 8, 2021, Marc Yale, IPPF Advocacy & Research Coordinator, issued a statement during the Medicaid and CHIP Payment and Access Commission (MACPAC) public meeting. MACPAC is a non-partisan legislative branch agency that provides policy and data analysis and makes recommendations to Congress, the Secretary of the U.S. Department of Health and Human Services, and the states on a wide array of issues affecting Medicaid and the State Children’s Health Insurance Program (CHIP). Thank you to Haystack Project for working with the IPPF on the implications for our community and helping with our remarks. We asked the commission to reconsider their recommendations to increase rebates for manufacturers who use the FDA Accelerated Approval Pathway. MACPAC’s recommendations have the unintended consequence of disproportionately harming ultra-rare patients like us.

The following is the prepared statement Marc Yale presented at the MACPAC public meeting.

Public Statement

My name is Marc Yale. I’m the Advocacy & Research Coordinator for the International Pemphigus & Pemphigoid Foundation. I also serve on the Board of Directors for Haystack Project.

Through my own personal experience as a rare disease patient living with pemphigus, as well as my involvement in advocacy for pemphigus patients and others living with extremely rare conditions through Haystack Project, I can tell you that accessing treatment can be an immense undertaking. Pemphigus and pemphigoid have been treated “off-label” with a variety of different therapies that have varying degrees of success in helping control our disease, and payers can make getting access to off-label treatments extremely challenging. We are now one of the handful of ultra-rare conditions with an FDA approved treatment- Rituxan, which is now considered a first-line therapy for pemphigus vulgaris.

  • There is no question that manufacturer incentives – like FDA Priority Review, Breakthrough Therapy Designation, and Orphan Drug Designation were vital to getting this therapy as quickly as possible to people with pemphigus who struggle every day to control their symptoms.  
  • We were fortunate that Rituxan has been on the market since its approval in 1997 and that, due to the nature of our condition, clinical trials could be completed without surrogate endpoints.  
  • The proposal to create an additional rebate for accelerated approval, though, could have been a significant deterrent to developing a new product in treating pemphigus.  
  • The proposal also raises questions that do not have good answers from a policy perspective. 
    • For example, if Rituxan’s pemphigus indication were achieved through accelerated approval, would an additional rebate apply? 
    • And would it only apply to the indication?  
    • It would seem that the proposal would decrease research rather than encourage post-market studies, especially when medically accepted off-label uses would be covered without the additional rebate.

Placing a disincentive on a pathway that is designed to encourage early access to promising treatments could have the greatest impact on ultra-rare disease patients. And your proposal today is basically a vote against investment in patients like us.

listening session

Published April 13, 2021
On February 8, 2021, the US Food and Drug Administration (FDA) held a Listening Session with patients representing the International Pemphigus & Pemphigoid Foundation (IPPF). Patient Listening Sessions are intended to be an opportunity for the FDA’s medical product centers to engage with patients and their advocates. The IPPF session was patient-led, meaning that the IPPF requested and received the permission to share its members’ perspectives with the FDA.

Listening session objective

The objective for this listening session was to have a dialogue with the FDA to share the emotional experience of the patient journey as well as the burden these diseases have on all aspects of a person’s life. This includes the time it takes to get a diagnosis, the burdens of treatment options, and the undertreated areas of the diseases that affect the physical, emotional/psychological, and financial health of five pemphigus and pemphigoid patients.

Summary of topics discussed

Pemphigus and pemphigoid are rare, ultra-orphan, autoimmune, blistering diseases that result in potentially life-threatening destruction of the skin and mucosa. The patient’s immune system makes antibodies that attack healthy cells in the skin or mucous membranes. As a result, skin cells separate from each other, fluid collects between skin layers, and blisters form. These blisters may cover a large area of skin. This results in fragile, extremely tender lesions that do not go away without proper treatment. It takes the average pemphigus or pemphigoid patient five healthcare providers and ten months to obtain a correct diagnosis. Currently, no cure exists for pemphigus or pemphigoid, only treatments and remission.

According to recent literature in the British Journal of Dermatology, pemphigus is rarer than pemphigoid. The approximate incidence of pemphigus is .58 – .80:100,000 people, and the approximate incidence of pemphigoid is 7.3 – 7.93:100,000 people.

These diseases are known to affect people across gender, racial, and cultural lines. However, there are certain groups of people who have a higher incidence of the diseases, such as Eastern Europeans of Jewish descent and people of Mediterranean, Northern India, and Persian descent.

The FDA Listening Session included further discussion on:

  • Diagnostic delays
  • Treatment options
  • Medical burdens
  • Investigational research
  • Mental and social burdens

Read the entire summary of the FDA Listening Session on Pemphigus and Pemphigoid by downloading the PDF.

Download Summary

Rare Disease Day 2021

We are rare, we are many,
we are strong, we are proud!

The purpose of Rare Disease Day® is to harness the creative energy of the millions of people around the world with rare diseases — and the millions who care about them — to raise awareness and generate action. 

Join the IPPF and get in on the action. Rare Disease Day is the biggest day of the year for rare diseases like pemphigus and pemphigoid. Get involved and make an impact by attending the following webinars/virtual meetings, interacting on social media, and taking action! 

National Advocacy Events:

Monday, 3/1 10:30am- 5:30pm (EST)
Virtual Rare Disease Day at the National Institutes of Health NIH

Sponsored by the National Center for Advancing Translational Sciences (NCATS) and Clinical Center at the National Institutes of Health (NIH), Rare Disease Day at NIH aims to raise awareness about rare diseases, the people they affect, and NIH research collaborations underway to address scientific challenges and to advance new treatments.

Friday, 3/5 9:00am- 4:00pm (EST)
FDA’s Rare Disease Day 2021 (virtual)

The purpose of this meeting is to highlight strategies to support rare disease product development. Patients, patient advocates, researchers, and medical product developers may benefit from attending this public meeting on rare disease product development. Register on the FDA website.

State Advocacy Events: 

Many states are hosting Rare Disease Day Events in February and early March. Visit the National Organization for Rare Disorders Event Page to register.

(Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maine, Massachusetts, Minnesota, Michigan, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, West Virginia)

Rare Across America (2/22- 3/5)

The IPPF is excited to participate in Rare Across America virtually this year. Rare advocates have already signed up and will be sharing their stories to make an impact on federal policy. Rare Disease Legislative Advocates (RDLA) organizes meetings for rare disease advocates with their Members of Congress and/or the Member’s staff. Meetings will take place virtually on March 3rd and 4th. The RDLA team also helps to prepare advocates for their meetings, provides legislative resource materials, and hosts pre-meeting training webinars.

Social Media:

An easy way to spread disease awareness and make an impact is through sharing messages on social media! Raise awareness for the IPPF community and rare diseases by liking and sharing IPPF social media posts or creating your own.

Monday, 2/22- Friday 2/26: Selfie Week – Post a picture on social media, tag the IPPF (@healourskin), and use these hashtags: #RareAcrossAmerica2021, #EveryVoiceMatters, #healourskin, #RareDiseaseDay2021, #ShowYourStripes 

Download the IPPF Rare Disease Awareness Social Media Toolkit for images to use.

Friday, 2/26: Share Your Rare Story – Take a video and share it on social media. Don’t forget to tag the IPPF (@healourskin) and use these hashtags: #healourskin #RareAcrossAmerica2021, #EveryVoiceMatters, #RareDiseaseDay, #ShowYourStripes 

Check out the National Organization for Rare Disorders (NORD) social media toolkit to find helpful tips, sample social media posts to share, graphic design templates, hashtags to use, and profiles to tag.

Take Action

The RISE Act

Take action by urging Congress to secure our nation’s strategically vital science and technology ecosystem: pass and sign into law the RISE Act, and designate at least $25 billion in supplemental funding – including at least $10 billion for the NIH – for research recovery.  

Representatives Diana DeGette (D-CO) and Upton were joined by 75 of their colleagues in introducing the Research Investment to Spark the Economy (RISE) Act. Senators Edward Markey (D-MA) and Thom Tillis (R-NC), joined by Senators Gary Peters (D-MI) and Susan Collins (R-ME), introduced a companion bill in the Senate. Read Research America’s statement detailing the crucial importance of the RISE Act .

Congressional Caucus

The IPPF urges you to contact your Members of Congress and ask them to join the Rare Disease Congressional Caucus.

A congressional caucus is a group of members of the United States Congress that meets to pursue common legislative objectives. Formally, caucuses are formed as congressional member organizations (CMOs) through the United States House of Representatives and governed under the rules of that chamber. There are hundreds of Caucuses. The most common caucuses consist of members united as an interest group. A Caucus can hold briefings to raise awareness on an issue. However, briefings are not actionable, ie: no bills can be introduced or voted on. A Caucus may join Members together in a voting block to support or oppose legislation, however most interest group caucuses are used to gain media attention and raise public awareness. Congressional Caucuses must be re-filed in the House at the start of each new Congress. The filing papers must be submitted by the majority party.

Together, we can drive favorable policies by reaching out to legislators and decision-makers to inform them of our public policy concerns, bring attention to the disease, and inform the public about pemphigus and pemphigoid.

The HEART Act

The IPPF needs your help to get a vital piece of legislation passed! We work collectively with other rare and ultra-rare groups to increase our voice and make a difference. Sharing our patients’ experiences with the Haystack Project has resulted in an especially important bill being re-introduced this year with the new Congress. This bill will have a significant and lasting impact for our community. 

The HEART Act, H.R. 1184, contains tangible and practical solutions for involving patients and rare disease experts in the FDA review process to better inform the review of drugs for safety and efficacy. 

The HEART Act contains 5 provisions critical to rare patients:

1.   Advisory Committees – Require a rare/ultra-rare expert in the science of small population studies at Advisory Committee meetings when the application under review is for a low prevalence condition.

2.   Review Division Transparency – Require annual report to Congress that sets out, by division, how many rare applications were reviewed, Agency actions, and the prevalence #s for that rare condition (this could be pulled from sponsor submission on orphan designation request.)

3.   Review Division Support – Require review divisions to consistently include Rare Disease Program staff as an integral part of review team when reviewing a first drug/biologic or a first disease modifying agent for a particular indication associated with an orphan condition with very low prevalence (not as a volunteer, advisor, or “guest” that can be removed if their participation is unwelcome). This same rare disease program staff support should be extended to support review division decisions beyond just approval to REMS, post market commitments, etc.

4.   REMS – For any very low prevalence orphan applications, require FDA to consult with patients/patient organizations in devising or reviewing any Risk Evaluation and Mitigation Strategy (REMS) elements that require patient action/participation.

5.   European System – Require a Government Accountability Office (GAO) study of how the European system reviews ultra-rare applications and its applicability in the US — Specifically, how the EU allows submission of updated data during the review, including from open label extension studies for patients who remain/continue on drug or cross-over from a control arm after clinical trial data has been gathered and submitted.

Ask your Congressional Representatives and Senators to support this bill easily and quickly:

Act Now

The following has been provided by the International Alliance of Dermatology Patient Organizations (also known as GlobalSkin).

The International Alliance of Dermatology Patient Organizations (also known as GlobalSkin) is inviting pemphigus and pemphigoid patient community members to participate in a unique research project where the dermatology patient is the expert and their opinion truly matters.

With the help and guidance of dermatology patients around the world, the Global Research on the Impact of Dermatological Diseases (GRIDD) project aims to develop a global instrument to measure the impact of living with skin diseases on a global scale. Further, it will document patient experiences including the extent of disease impact and burden for patients and their families.

By participating in GRIDD, patients will help design a new and credible measurement tool (questionnaire) that fully explains the impacts and challenges patients experience.

Dermatology patients are needed!

The GRIDD project is currently in Phase 3 and focused on a Patient Data Verification Delphi. The goal of the Delphi is to gather impact data from 2,000 adult dermatology patients representing as many different dermatological diseases as possible and from all regions of the globe.

As a participant, you would be asked to take part in two surveys – one now and then one in two
months. The survey will ask you questions about your experience living with pemphigus and pemphigoid and how it impacts your life and how much of a burden it is on your family.

By taking part in the Delphi and completing the two surveys, you will be making an important contribution to improving the lives of pemphigus and pemphigoid patients and all dermatology patients around the world now and in the future.

Make YOUR IMPACT: Take the DELPHI Survey Now 

For more information about GRIDD or GlobalSkin please visit: globalskin.org/research

by Marc Yale

It is with mixed emotions that I inform you that I am stepping down as the Executive Director of the IPPF. Over the past several months, the IPPF performed an intensive search for a new executive director to lead our community going forward. We were fortunate to find an experienced individual who is equipped to meet the unique challenges that our community faces. The IPPF is in good hands with Kevin Mead, who will be taking over as the Executive Director of the IPPF.

Although I am stepping down, I will continue to volunteer part-time with the IPPF and serve in the new role of Advocacy/Research Coordinator. I will continue to work to advance disease awareness, patient advocacy, and accelerate research and development for the IPPF community. After being diagnosed with MMP, I joined the IPPF in 2008 as a peer health coach. I have served, and will continue to serve, in that capacity as well.

Thank you for your unwavering support, and please join me in welcoming Kevin! I look forward to watching the IPPF continue to move forward in support of patients around the world, be a leading advocate for the rare disease community, and advance research toward finding a cure!

Kevin Mead

“I am delighted to join the Foundation. It is clear that the team of staff, Board of Directors, and volunteers have built a responsive and dynamic organization. I look forward to being a part of the next chapter for the IPPF and to “meeting” many of you at the upcoming Virtual Patient Education Conference.” –Kevin Mead

Kevin joins the IPPF from Spokane County United Way, where he was the VP of Resource Development. At United Way, Kevin developed fundraising and volunteerism initiatives. Before United Way, Kevin was the CEO of PrimeGlobal—a worldwide association of accounting firms— for 16 years. At PrimeGlobal, Kevin directed a remote staff of 16 on four continents organizing events, developing networking tools, and benchmarking member operations. He also merged three organizations into one and grew the organization 400%.

From 1994 to 2001, Kevin worked for the Institute of Internal Auditors (IIA). While at the IIA, Kevin held a number of positions, including Manager of Conferences, Manager of Field Services, and Manager of Certification Development.

Kevin has presented at seminars and conferences throughout Europe, North America, and Asia on topics that include association management, risk, and auditing. He holds a bachelor’s degree in economics and master’s degrees in audit and international association management. Kevin is a Certified Association Executive (CAE), a Certified Internal Auditor (CIA), and a Certified Information Systems Auditor (CISA).

In addition to his professional responsibilities, Kevin is a rugby referee and restores and rides old motorcycles.

Meet Kevin at the 2020 IPPF Virtual Patient Education Conference, Oct 2-4!

What are Pemphigus and Pemphigoid
Patients
Healthcare Professionals