Commercial coverage of specialty drugs, 2017–2021

New study examines the role of NIH and industry in bringing new treatments into clinical settings.

Authors

Julia A. Rucker; Molly T. Beinfeld; Nola B. Jenkins; Daniel E. Enright; Rochelle R. Henderson; James D. Chambers.

Publication

Health Affairs Scholar. Published August 21, 2023.

Read the study

Objective

Health plans determine access to prescription drugs with coverage policies that aim to achieve safe, effective, and cost-effective care while also recognizing budgetary limits. For specialty drugs – which are typically complex, high-cost medications – commercial health plans often impose criteria that restrict coverage beyond the FDA’s label indications. This study examines a set of health plan policies to determine if they have become more stringent over time.

Methodology

Researchers examined coverage policies issued by 17 large U.S. commercial health plans from 2017 to 2021 for the same set of 187 specialty policies to determine how the policies had changed over time. Researchers analyzed plan removal or addition of restrictions in their coverage policies for each drug-indication pair. The 17 health plans examined in this study are among the largest in the United States, representing roughly 188 million people.

Findings

  • Overall, the proportion of policies that were consistent with the FDA label declined from 57.1% in 2017 to 45.1% in 2021.
  • The proportion of policies that were more restrictive than the FDA label increased from 39.5% in 2017 to 51.7% in 2021, a relative increase of over 30% during the five-year period.
  • Plans’ use of coverage restrictions for oncology drugs nearly doubled, increasing from 17.6% to 33.5%, whereas non-oncology drug restrictions increased from 53.2% to 63.5%.

Key Takeaways

Coverage restrictions, also known as utilization management tools, are conditions applied to health plan policies that narrow the eligible population for a medication or service. The study found clear increases in the use of certain restrictions among large health plans.

  • Use of prescriber requirements, when only a particular type of clinician can prescribe the drug, increased from 12% of policies in 2017 to 25% in 2021.
  • Use of step therapy protocols, which require that patients first experience an inadequate response to an alternative therapy before being eligible for a particular drug, increased from 25.8% of policies to 34% in the same span.

Trends in coverage restrictiveness also varied across plans.

  • For 13 plans, the proportion of policies with restrictions increased over time, while it declined for four plans.
  • Plans’ use of coverage restrictions increased more for certain indications, led by circulatory conditions (the proportion of policies with restrictions increased from 38.1% to 61.9%) and gastroenterology conditions (49.1% to 76.1%). 

These findings suggest that, on average, commercial coverage of these specialty drugs, particularly for oncology and orphan drugs, has become more limited. Our findings are consistent with research showing that pharmacy benefit managers have increasingly excluded drugs from their formularies.  

This study was conducted by the National Pharmaceutical Council and the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center and builds on previous NPC work with Tufts that showed the use of different coverage criteria and measures influence access to diverse types of therapies or access to similar therapies covered under medical and pharmacy benefit policies and may introduce inconsistencies and inefficient care.