Patient Assistance Program (PAP)

Key facts

Sponsors

Manufacturers, manufacturer-affiliated foundations and independent charities

Eligibility

Set by each program, often based on income and insurance status

Federal guidance

HHS OIG Special Advisory Bulletins issued in 2005 and 2014

Price reporting

Free goods not contingent on a purchase are excluded from AMP and Best Price

What is a patient assistance program?

Manufacturer PAPs provide product at no cost, typically shipped to the patient or the prescriber, when a patient meets program criteria such as household income limits and lack of adequate drug coverage. Applications usually require proof of income and a prescriber signature.

The term is used loosely. Some people apply it to any affordability support, but free drug programs, copay coupons and independent charity foundations operate under different rules and serve different patients.

Types of patient assistance

Affordability support generally falls into these categories:

• Manufacturer free drug programs: donate product directly to eligible patients, usually those who are uninsured or underinsured.
• Copay assistance: coupons or cards that reduce out-of-pocket costs for commercially insured patients. The federal Anti-Kickback Statute generally prevents manufacturers from offering copay coupons to Medicare, Medicaid and other federal health program patients.
• Independent charity programs: nonprofit foundations that help patients, including Medicare beneficiaries, with cost sharing within a disease area. OIG guidance says donors must not control or steer that assistance.
• Hub services: manufacturer-funded support that screens patients and routes them to the appropriate program.

Why patient assistance programs matter

Patient assistance affects whether patients can start and stay on high-cost therapies, so it is part of launch planning for many specialty brands. It also shapes channel data: free goods do not generate a paid pharmacy claim, so claims and prescription volume data can understate use of drugs with large free drug programs.

Compliance is a major concern. OIG guidance allows manufacturers to give free drugs to Part D enrollees outside the Part D benefit if certain conditions are met, but the Department of Justice has reached settlements with several manufacturers over payments to charities that allegedly covered copays for the donors' own drugs. Payer designs such as copay accumulators and maximizers, which change how assistance counts toward deductibles, also affect how far assistance goes.