Abstract
Background: Although specialty oral anticancer medications (SOAMs) have improved outcomes for patients with blood cancers, patients are often subject to high out-of-pocket (OOP) costs, hindering access and outcomes. To address affordability, drug manufacturers use two main financial support programs. Co-pay coupons help pay for deductibles, coinsurance, and copayments for insured patients, but Medicare and Medicaid beneficiaries are excluded due to federal antikickback statutes. Pharmaceutical assistance programs (PAP) are free-drug programs that provide eligible patients (all insurance types or uninsured) with the medication at no cost directly from the manufacturer. Patients ineligible for these programs may address affordability challenges through charitable foundations or the newly established voluntary Medicare Prescription Payment Plan (MPPP), which allows beneficiaries to spread Medicare Part D OOP costs into monthly payments throughout the year starting January 1, 2025. This study assessed the availability, eligibility, and/or information provided on such patient assistance programs across manufacturers of SOAMs for blood cancer.
Methods: We identified manufacturers of all SOAMs approved by the U.S. FDA within the past 20 years for the treatment of any blood cancer. We reviewed all patient cost sharing and affordability assistance programs for each SOAM listed on drug manufacturers' websites in July 2025 (direct telephone outreach was used when websites were unclear). We evaluated availability and eligibility (e.g., insurance coverage, income limits) of the two manufacturer-sponsored programs including copay coupons and PAPs. We also assessed whether manufacturers provided information and weblinks to external charities providing financial assistance and the new Medicare Part D MPPP.
Results: We identified 32 FDA-approved oral SOAMs across 20 manufacturers.
All manufacturers offered a copay coupon program across all SOAMs for commercially insured patients with no eligibility requirements. However, coupon assistance varied, with annual maximums ranging from $6,000 to $25,000.
85% of the manufacturers (17 of 20) offered 91% of drugs (29 of 32) for free via their PAP; 12 (60%) of the manufacturers offered free-drugs for the uninsured and all insurance types whereas 5 (25%) excluded commercially insured. Furthermore, the eligibility criteria for PAPs varied significantly across manufacturers. For example, some required fixed income cut-offs (such as $150,000 annual household income, regardless of family size) whereas others were based on meeting federal poverty level (FPL) limits based on household size. For the latter, the requirements further varied significantly ranging from 315% to 500% of the FPL. 7 (41%) of the manufacturers required documentation such as tax forms for income levels whereas the remainder accepted self-reported income. For insured patients, they must provide proof of underinsured by submitting their insurance coverage, or self-reporting no coverage for many. Two of the three manufacturers that did not offer a PAP had discontinued their free-drug program (idelalisib and duvelisib) whereas one never had a free drug program (revumenib).
In addition to PAPs, 9 manufacturers (45%) representing 9 drugs offered a Temporary Patient Assistance Program (TPAP) for any drug coverage delay of five days or more, including those due to change of insurance.
65% of the manufacturers (13 of 20) websites mentioned the availability of charitable foundations offering cost-sharing assistance for their blood cancer SOAMs, and only 40% (8 of 20) provided weblinks to these external organizations.
Only 6 manufacturers representing 16 of the 32 drugs (50%), provided information about the MPPP for Medicare Part D beneficiaries and only 3 hyperlinked to the CMS MPPP website
Conclusions: All SOAMs for blood cancer have copay assistance programs for commercially insured and nearly all directly provide free-drugs for select individuals. However, eligibility by insurance type, income level, and associated documentation requirements vary considerably across manufacturers. Future work needs to evaluate whether this variability results in inequitable access across SOAM agents within same indication. We identified a high rate of missed opportunities across manufacturer websites to direct patients to the availability of external charitable foundations and the new Medicare Part D MPPP program to help with SOAM affordability.
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