Study describes specialty drug non-initiation rate among Medicare Part D beneficiaries

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

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

Medicare Part D serves as the primary course of prescription drug insurance for seniors 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 have difficulty paying for very expensive or specialty drugs and thus have limited access to these drugs.

“Under the standard benefit, beneficiaries must pay a percentage of a drug’s list price with each drug refill, and Part D has no spending limit,” the authors wrote. “For recipients using expensive treatments, high upfront expenses may result in never starting a prescribed treatment, which could negatively affect clinical outcomes.”

Additionally, treatment non-initiation is estimated to be over 20% for all prescribed medications, with non-initiation increasing with higher spending needs.

To better understand this phenomenon among Medicare FFS beneficiaries who do and do not receive low-income subsidies, the investigators examined data from 4 of the most costly disease areas for 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 filling. Any patient who was prescribed a drug of interest during this window was linked to Medicare claims data through the Research Data Assistance Center.

In the primary analysis, non-initiation was defined as “patients who do not fill the prescribed medication (brand name or generic) within 90 days”, while in the secondary analysis the term was defined more narrowly as “patients who do not meet the prescribed or generic medication). any other new medicine (i.e. medicine 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 analyzes to treat cancers (8,794 prescriptions; 6,990 people), hepatitis C (1,368 prescriptions; 1,210 people), immune system conditions (5,286 prescriptions ; 4,275 people) or hypercholesterolemia (1,628 prescriptions; 1,364 people).

The analyzes revealed:

  • Beneficiaries receiving subsidies were almost twice as likely to get the prescribed drug within 90 days as those who did not
  • Among recipients without grants, non-initiation was observed in 30% of prescriptions written for cancer drugs, 22% for treatments for hepatitis C, and more than 50% for disease-modifying treatments for disorders of the brain. immune system or hypercholesterolemia.
  • The average patient age ranged from 69.1 to 74.5 years and most recipients were Caucasian (61.2% to 90.4%)

“Despite having higher incomes and assets, recipients without low-income subsidies failed to initiate prescribed treatment more often than those on low-income subsidies,” the researchers found, hypothesizing that this could be due to the difference in expected expenditure. treatment expenditure among those with low-income subsidy versus those without.

For example, data showed that in 2021, when nearly 75% of Medicare Part D beneficiaries had no subsidy, a single refill of lenalidomide for cancer cost more than $3,000 for someone without subsidy to low-income, compared to less than $10 for someone with a full low-income subsidy.

Medicare Part D overhaul provisions were included in President Biden’s Build Back Better Act in an effort to reduce financial burdens for beneficiaries in need of high-priced drugs. Although passage of this legislation would result in improved affordability and may reduce non-initiation rates in this population, the authors cautioned that “recipients may still find it difficult to pay for treatment if they reach the cap in one fill at the end of a policy year and shortly thereafter must begin contributing to the cap for the next year.

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

The clinical implications of the reported levels of non-initiation remain unclear, while the rates seen in low-income grant recipients suggest that additional factors besides cost may be at play, including formulary restrictions, prior authorization or step therapy requirements, the researchers said.

Further research on this topic should include data from recipients from more sites and should follow patients for longer periods of time to better assess the clinical outcomes of non-initiation.

Overall, the authors called the study results “worrying,” adding that “the high levels of non-initiation observed among those without low-income subsidies and the known magnitude of out-of-pocket spending to which the can expose them, support legislative efforts to help ensure drug accessibility by reducing out-of-pocket expenses under Medicare Part D.


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

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