New Research Finds Commercial Health Plans' Use of Prescriber Requirements Doubled and Use of Step Therapy Increased by More Than 31% for Specialty Drug Coverage

For immediate release: August 22, 2023

Michael Pratt, 202-827-2088, [email protected] 

Washington, DC – A new peer-reviewed study found that access to specialty drugs through commercial health plans decreased over a four-year span, with less than half of plans maintaining consistency with the U.S. Food and Drug Administration’s (FDA) drug label indications. The study, “Commercial coverage of specialty drugs 2017-2021,” was co-authored by the National Pharmaceutical Council and colleagues at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center (Tufts CEVR) and published in Health Affairs Scholar. 

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. 

Led at NPC by Rochelle R. Henderson, Ph.D., vice president of research, 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. The 17 health plans examined in this study are among the largest in the United States, representing roughly 188 million people. 

Clear trends emerged from the comparison of health plans and FDA label indications: 

• 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. 
• The proportion of policies excluding drug coverage remained roughly constant in the same span (3.4% in 2017; 3.2% in 2021).  
• 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%. 

“This analysis points toward increased use of coverage restrictions by health plans that result in limited patient access to specialty drugs,” said Henderson. “Organizations in health care, such as the American Medical Association, have raised alarms about the burden of overly restrictive coverage policies on patients, physicians and on associated health care system costs.“ 

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. Commonly used coverage restrictions include patient subgroup restrictions, which are clinical criteria patients must satisfy before receiving a drug; step therapy protocols, which require that patients first experience an inadequate response to an alternative therapy before being eligible for a particular drug; and prescriber requirements, meaning that only a particular type of physician can prescribe the drug. 

The study found clear increases in the use of certain restrictions among large health plans: 

• Use of prescriber requirements increased from 12% of policies in 2017 to 25% in 2021. 
• Use of step therapy protocols increased from 25.8% of policies to 34% in the same span. 
• Other forms of coverage restrictions remained relatively constant during the time period. 

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 some indications than for other indications, increasing most for circulatory conditions (the proportion of policies with restrictions increased from 38.1% to 61.9%) and gastroenterology conditions (49.1% to 76.1%).  

This study builds on previous NPC work with Tufts that showed that 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.   

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About the National Pharmaceutical Council 

The National Pharmaceutical Council (NPC) is a health policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. Founded in 1953 and supported by the nation's major research-based pharmaceutical companies, NPC focuses on research development, information dissemination and education on the critical issues of evidence, innovation and the value of medicines for patients. For more information, visit www.npcnow.org and follow NPC on LinkedIn.