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Study Outlines Rate of Specialty Drug Noninitiation in Medicare Part D Beneficiaries


New research published in Health Affairs details the rates of specialty medication noninitiation among Medicare Part D beneficiaries.

A review of electronic health record (EHR) data and fee-for-service (FFS) Medicare claims published in Health Affairs reveals many beneficiaries do not fill high-price specialty drug prescriptions.

According to the authors, their results support current legislative efforts to increase accessibility to these treatments by reducing out-of-pocket expenses under Medicare Part D, especially for individuals with low-income subsidies.

Medicare Part D serves as the primary course of prescription drug insurance for older adults in the United States, the researchers explained. Previous research has indicated that despite broad satisfaction with Part D coverage, a small fraction of beneficiaries may experience challenges paying for very high priced, or specialty, drugs and thus have limited access to these medications.

“Under the standard benefit, beneficiaries must pay a percentage of a medication’s list price with every medication fill, and Part D has no out-of-pocket spending limit,” the authors wrote. “For beneficiaries using expensive treatments, high up-front expenses may result in never starting a prescribed therapy, which could negatively affect clinical outcomes.”

In addition, failure to start treatment is estimated at over 20% for all prescribed medication, with noninitiation increasing with higher out-of-pocket spending requirements.

To better understand this phenomenon among FFS Medicare beneficiaries who do and do not receive low-income subsidies, the investigators examined data from 4 of the costliest disease areas to the Medicare Part D program: cancers, hepatitis C, immune system disorders, and hypercholesterolemia.

Part D event data, EHR information from 11 health systems, and FFS claims were assessed between 2012 and 2018. All included drugs were self-administered and had list prices of at least $670 per fill. Any patient who was prescribed a drug of interest during this window was linked with Medicare claims data via the Research Data Assistance Center.

In the primary analysis, noninitiation was defined as “patients not filling the drug prescribed (either brand name or generic) within 90 days,” while in the secondary analysis, the term was more narrowly defined as “patients not filling either the drug prescribed or any other new medication (that is, one not used in the previous 6 months) used for the same disease category within 90 days.”

A total of 17,076 new prescriptions were included in the analyses to treat cancers (8794 prescriptions; 6990 people), hepatitis C (1368 prescriptions; 1210 people), immune system conditions (5286 prescriptions; 4275 people), or hypercholesterolemia (1628 prescriptions; 1364 people).

Analyses revealed:

  • Beneficiaries receiving subsidies were nearly twice as likely to obtain the prescribed drug within 90 days as those without subsidies
  • Among beneficiaries without subsidies, noninitiation was observed in 30% of prescriptions written for anticancer drugs, 22% for hepatitis C treatments, and more than 50% for disease-modifying therapies for either immune system disorders or hypercholesterolemia
  • Mean patient age ranged from 69.1 to 74.5 years, and most beneficiaries were White (61.2% to 90.4%)

“Despite their higher incomes and assets, beneficiaries without low-income subsidies more frequently failed to initiate treatment as prescribed than those with low-income subsidies,” the researchers found, hypothesizing this may be due to the difference in expected out-of-pocket expenses for treatment among those with a low-income subsidy vs those without.

For example, data showed that in 2021—when nearly 75% of Medicare Part D beneficiaries had no subsidies—a single fill of lenalidomide for cancer cost over $3000 out of pocket for an individual without a low-income subsidy compared with less than $10 for someone with a full low-income subsidy.

Medicare Part D redesign provisions were included in President Biden’s Build Back Better Act in an effort to reduce financial burdens for beneficiaries needing high-price drugs. Although this legislation’s passage would result in improved affordability and could reduce noninitiation rates in this population, the authors cautioned “beneficiaries may still find it challenging to afford treatment if they reach the cap in a single fill late in a policy year and shortly thereafter must start contributing to the next year’s cap.”

One method of overcoming this hurdle would be to combine the overall annual cap with the monthly cap, they suggested, the benefits of which could be further explored by the Center for Medicare and Medicaid Innovation.

Clinical implications of the levels of noninitiation reported remain uncertain, while rates observed among those with a low-income subsidy suggest additional factors outside of cost may be at play, including formulary restrictions, priors authorization, or step therapy requirements, the researchers said.

Additional research on this topic should include data from beneficiaries from a greater number of sites and should follow patients for longer periods of time to better assess clinical outcomes of noninitiation.

Overall, the authors characterized the study findings as “concerning,” adding “the high levels of observed noninitiation among people without low-income subsidies, and the known magnitude of the out-of-pocket spending to which initiation may expose them, support current legislative efforts to help ensure the accessibility of medications by reducing out-of-pocket spending under Medicare Part D.”


Dusetzina SB, Huskamp HA, Rothman RL, et al. Many Medicare beneficiaries do not fill high-price specialty drug prescriptions. Health Aff (Millwood). Published online April 4, 2022. doi:10.1377/hlthaff.2021.01742

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