By Michael Rigas, Pharm.D.
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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.
Patient Assistance Program Gateways
Partnership for Prescription Assistance (PPA): www.pparx.org
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.
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.
Nonprofit Patient Assistance Foundations
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.
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Poverty guidelines. ASPE. (n.d.). Retrieved March 29, 2023, from https://aspe.hhs.gov/topics/poverty-economic-mobility/poverty-guidelines.