The Issue
Many state, non-profit and corporate prescription assistance and access programs (PAPs) help patients obtain free or nearly free medicines if they qualify. Serving as a safety net for the millions of Americans who lack health insurance or whose insurance does not sufficiently cover the cost of the medications they need, PAPs have been in existence for decades and come in different forms – some provide cash subsidies to needy patients, others offer free or discounted products, product coupons, and copayment assistance.
Yet, health insurers and other opponents claim PAPs remove the incentive for patients to seek less-expensive alternative treatments and both pharmacy benefit managers and federal and state lawmakers are taking action to stop drug manufacturers and nonprofit charities from offering prescription assistance. The consequence of these actions is obvious: in effort to reduce patients’ demand for branded medicines, opponents of PAPs are sacrificing the needs of financially needy Americans whose health will suffer because they can’t get the medicines their doctors prescribed.
Why Policy Change Is Necessary
In a perfect world, there would be no need for patient assistance programs (PAPs) but this is not the case today. As documented in a 2016 report from the Kaiser Family Foundation, patients now pay more in deductibles and coinsurance (a percentage of the drug’s cost, not a fixed copay) than ever before for their medicines, due to changes in insurance benefits.[1] At the same time, the number of uninsured Americans is going up. According to the Gallup-Sharecare Well-Being Index, 3.2 million more people entered the ranks of the uninsured in 2017, especially young adults, blacks, Hispanics and low-income Americans.[2] And with less federal and state funds for programs that subsidize healthcare coverage for low-income, disabled and elderly Americans, this trend will only continue in 2018 and beyond.
Recognizing that more funding is needed to help financially needy patients get access to the most effective medicines for their conditions, in the 1990s US drug manufacturers created prescription assistance and access programs as a way to give free or reduced-cost branded medications to those patients who could not afford them. At that time, the approach was simple: drug manufacturers provided their medicines at no or low cost to patients who could not afford to buy them based on the decision of the prescribing clinician.
Today, however, the realities of how insurance companies cover prescription medicines has caused patient assistance programs to expand and change in design to meet the needs of both the uninsured and those considered “functionally uninsured” because their private insurance does not cover medications or requires needy patients to pay high deductibles, copays and coinsurance. Based on recent estimates, more than 475 PAPs now operate across the across the country at an estimated annual cost of $5 billion.[3] Over the last decade alone, these programs have been credited with helping more than 36 million uninsured or underinsured patients obtain necessary medications[4], especially those requiring complex, multi-drug treatment regimens to treat cancer and serious chronic diseases. Additionally, a majority of nonprofit clinics that serve largely un- and underinsured patients help their patients obtain their medicines through PAPs and many states offer medication assistance programs, especially for the elderly, disabled, and those with a specific condition like HIV/AIDS or end-stage kidney disease.
One way PAPs have responded to the gap in financial help for patients is many industry programs have been incorporated as nonprofit charitable foundations. Additionally, a number of independent charities serve as the primary safety net for low-income Medicare and Medicaid beneficiaries, who are not eligible for manufacturer-sponsored PAPs. Both types of charities operate under requirements laid out by the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), including that charity PAPs cover a broad spectrum of treatments for a disease without reference to specific symptoms, drug stages, treatment types, severity of symptoms and other “narrowing” factors.
Yet, even though the policy of the OIG is that PAPs act as important safety nets for financially needy patients, these programs are under attack. The reasoning is that PAPs shield patients from the economic effects of drug pricing and discourage generic drug use, despite the fact that many of these programs cover medicines that do not have generic versions. Thus, a number of pharmacy benefit managers have moved forcefully to remove any branded medications supported by a PAP from the health plan’s formulary – meaning patients literarily cannot get these drugs. Additionally, states, such as California and Massachusetts, have passed laws preventing manufacturers from offering prescription assistance to financially disadvantaged patients unless there are no generic “equivalent” medications while others, like New Hampshire, are considering similar legislation.
In taking these actions, state lawmakers seem more interested in reducing the demand for branded medicines than in ensuring sick Americans have access to medically necessary drugs.
Our Position
In a health care system where many patients either lack prescription drug coverage or have coverage limitations, PAPs act as a critical safety net for financially needy patients. Moreover, research from the PBM Express Scripts shoes PAP assistance increases medication adherence rates[5] – an inconvenient truth that these programs help underserved Americans fill and take their medicines as prescribed, benefitting both patients in improved health and the health system in less need for costly medical services. Therefore, our goal is to work with stakeholders to advance policy solutions that focus on the medical needs of low-income patients so prescription assistance and access programs will remain available to them.
[1] Claxton,G, Levitt L, Long M. Payments for Cost-Sharing Increasing Rapidly Over Time. Health Brief. April 12, 2016. Accessible at: https://www.healthsystemtracker.org/brief/payments-for-cost-sharing-increasing-rapidly-over-time/
[2] Auter Z. US Uninsured Rate Steady at 12.2% in Fourth Quarter of 2017. Gallup-Sharecare Well-Being Index. January 16, 2018. Accessible at: http://news.gallup.com/poll/225383/uninsured-rate-steady-fourth-quarter-2017.aspx?utm_source=newsletter&utm_medium=email&utm_campaign=&stream=top-stories
[3] Pharmaceutical Executive. “The Vanishing Rx Patient Assistance Programs?” November 6, 2013. Accessible at: http://www.pharmexec.com/vanishing-rx-patient-assistance-programs
[4] Pharmaceutical Research and Manufacturers Association press release. “10 Years of Assisting Uninsured and Underinsured Patients.” April 7, 2015. Accessible at: https://www.phrma.org/press-release/partnership-for-prescription-assistance-celebrates-10th-anniversary-of-assisting-uninsured-and-underinsured-patients
[5] Express Scripts. Financial Assistance Programs Positively Impact Adherence. November 29, 2016. Accessible at: http://lab.express-scripts.com/lab/insights/adherence/patient-assistance-programs-positively-impact-adherence