Variation in Coverage of Specialty Therapies and Barriers to Fair Access


Beinfeld M1, Rucker J2, Chambers J2
1Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA, 2Tufts Medical Center, Boston, MA, USA

OBJECTIVES: In its recent Assessment of Barriers to Fair Access report, the Institute for Clinical and Economic Review (ICER), found a high degree of alignment between payers’ coverage requirements for 18 drugs that were subject to value assessment in 2021and ICER’s fairness criteria. However, despite ICER judging multiple policies for the same drug as ‘fair’, payers’ coverage requirements may vary, meaning that patients in different payers have inconsistent access to the same drug. We examined how patients’ access to the same drugs varied across 18 large commercial payers.

METHODS: We used the Tufts Medical Center Specialty Drug Evidence and Coverage Database (SPEC) to examine coverage policies issued by 18 large US commercial payers (current April 2023) for 14 of the 18 ICER-assessed drugs included in SPEC. To assess variation, we quantified how often payers included step therapy protocols (patients must first try an alternative therapy) and subgroup restrictions (patients must meet certain clinical criteria, e.g., disease severity).

RESULTS: ICER judged step therapy protocols and subgroup restrictions to be nearly universally “fair” for the 14 drugs in our sample, however we found coverage variation across payers for 11 drugs; only 3 were covered consistently. Most coverage policies included subgroup restrictions and step therapy protocols (64.7% and 52.9% of policies, respectively). Of the included drugs, only Benlysta was determined ‘fairly’ priced by ICER. However, despite this designation, 76.5% of policies included coverage restrictions beyond Benlysta’s FDA label.

CONCLUSIONS: We found significant variation in the largest payers’ coverage criteria for drugs ICER included in their latest fair access report. Payer coverage criteria varied across policies that ICER had judged as ‘fair’, irrespective of whether ICER judged the drug to be fairly priced. Variation in payers’ coverage criteria for the same drugs has important implications for patients’ access to care.

Conference/Value in Health Info

2024-05, ISPOR 2024, Atlanta, GA, USA

Value in Health, Volume 27, Issue 6, S1 (June 2024)




Health Policy & Regulatory

Topic Subcategory

Health Disparities & Equity, Insurance Systems & National Health Care, Reimbursement & Access Policy


Drugs, No Additional Disease & Conditions/Specialized Treatment Areas

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