The Ins & Outs of Patient Assistance Programs

Given the profound impact biologic drugs have on disease control, quality of life and potential reduction of long-term disability in patients with rheumatic disease, the ACR’s Committee on Rheumatologic Care released a position statement on patient access to biologics in August 2021. It states: “Patients should have affordable access to biologic therapy without undue delay.”¹ 

As practicing rheumatology providers, I know we all agree with that statement. However, the hefty price tags of biologic therapies create a plethora of access issues that burden providers and delay care for our patients—even those who have health insurance.

What about the 8.6% of American residents, about 28 million people, who don’t have health insurance?² And what about the millions more who are underinsured? These people are not immune to autoimmune disease. They often delay their own care due to out-of-pocket costs they simply cannot afford, so by the time they’re in your office, their disease is likely to be severe.³  

During the three years I spent caring for patients with rheumatic disease at a federally qualified health center in Austin, Texas, 73% of the patients I cared for were uninsured. Thirty-nine percent of rheumatoid arthritis patients already had erosive disease at their first visit with me.⁴ Based on this experience, I can share insights into how to obtain free biologics for uninsured patients via patient assistance programs (PAPs).

What Is a PAP?

Sponsored by drug companies, PAPs provide qualifying, uninsured or underinsured, low-income patients with free medications. Although no program is perfect and applications can be tedious (especially for non-English-speaking patients), PAPs are often the only means by which patients can obtain the biologic therapies they need.

In some ways, obtaining biologics via a PAP can be simpler than obtaining them for patients who have health insurance. Formulary restrictions, prior authorization headaches and step therapy protocols don’t apply to PAPs. Simply choose the therapy you feel is best for the patient and complete the application. If all required documents are received as quickly as possible, the patient could expect to be approved for a year of free drugs within a matter of weeks. Tips on how to streamline the process are discussed below.  

Does My Patient Qualify?

In general, for a patient to qualify for a free medication through a PAP, pharmaceutical companies request proof of the following:

• U.S. residency—of note, immigration or citizenship documents are not required for most applications;
• Lack of health insurance or lack of adequate coverage by current plan—for the uninsured, fulfilling this requirement is as simple as checking a box to that effect. For the underinsured, additional documentation of the coverage gap is requested; and
• Income below a designated threshold—Drug companies accept a wide array of proof-of-income documents, such as tax documents, pay stubs or a letter of declaration from the patient or responsible party stating they earn X amount monthly. Income eligibility thresholds are specific to each program.

Practical Tips

After a year of struggling to help hundreds of patients obtain medications via PAPs, my partner and I spent a day calling every rheumatology drug PAP we could think of (see Figure 1). Here, I share practical tips from that reconnaissance work:

1. Apply online when available. Turnaround time is substantially quicker—weeks rather than months—for online applications than for mailed or faxed applications.
2. Call the drug company directly with questions. PAP staff are responsive and great at troubleshooting. Calling is easier than finding answers on drug company websites, especially because PAP information is often buried beneath multiple clicks.
3. Involve one of your team members to follow up with the patient and assist with the application process as needed. This is especially important for non-English-speaking patients because PAP phone services all start with prompts in English.
4. Send in the provider part of the PAP application at the time of visit. Nearly all applications require a signed form from the prescriber as part of the application. These can be found on PAP websites.
5. Encourage the patient to follow up with the drug company every two weeks to confirm receipt of all required documents and to check on status. Drugs won’t be approved if any part of the application is missing, but companies don’t typically notify patients about missing paperwork. Delays in approval notification are also common, and the patient typically needs to call to arrange delivery of the first shipment. It’s frustrating to find out a free drug supply has been approved for months, unbeknownst to the patient or provider.
6. Remind the patient to call the drug company directly to set up refill deliveries. Some companies allow patients to sign up to receive text message reminders about refills.
7. Plan ahead. Most drug companies approve free drug supplies for one year, although some may approve the drug for up to three years. If therapy is to be continued via a PAP, the patient must reapply one to three months before their approval lapses.

Figure 1. PAP phone numbers as of January 2022.

Takeaways

PAPs can help uninsured patients obtain access to biologic medications. Calling PAP phone numbers is refreshingly easy, and the staff are helpful. Some patients, especially those who don’t speak English, will benefit from your team’s help to complete the application process. Although the PAP process is imperfect and requires extra work on the provider’s part, the benefit to uninsured patients with rheumatic disease is priceless. Literally.

Samantha C. Shapiro, MD, is an academic rheumatologist and an affiliate faculty member of the Dell Medical School at the University of Texas at Austin. She received her training in internal medicine and rheumatology at Johns Hopkins University, Baltimore. She is also a member of the ACR Insurance Subcommittee.

References

1. Position statement on access to biologics. American College of Rheumatology. 2021 Aug.
2. Keisler-Starkey K and Bunch LN. Health insurance coverage in the United States: 2020. United States Census Bureau. 2021 Sept 14.
3. Addington WW. No health insurance? It’s enough to make you sick—Scientific research linking the lack of health coverage to poor health. American College of Physicians policy statement. 1999.
4. Patel V, Patel R, Hackshaw K. Rheumatology care for the underserved in Central Texas [abstract]. Arthritis Rheumatol. 2021 Oct;73(suppl 10).