Patients' access to 2018 FDA-approved drugs 1 year post approval.

Objectives: To examine US commercial health plans' adoption of 2018 FDA-approved drugs.

Study Design: Database analysis.

Methods: We identified novel drugs that the FDA approved in 2018 and categorized them as follows: cancer treatment, orphan drug, included in an expedited review program, and biosimilar.

Patients' access to rare neuromuscular disease therapies varies across US private insurers.

Background: The extent to which different US private insurers require their enrollees to meet the same coverage criteria before gaining access to treatment is unclear. Our objective was to scrutinize the patient access criteria imposed by US private insurers for a set of rare neuromuscular disease (NMD) disease-modifying therapies (DMTs).

Methods: We examined coverage policies issued by 17 large US private insurers for the following NMD treatments: nusinersen and onasemnogene abeparvovec for spinal muscular atrophy, edaravone for amyotrophic lateral sclerosis, and eteplirsen for Duchenne muscular dystrophy.

Is an Orphan Drug's Cost-Effectiveness Associated with US Health Plan Coverage Restrictiveness?

Background And Objectives: Orphan drugs' high prices raise questions about whether their costs are worth their benefits. We examined the association between an orphan drug's cost-effectiveness and health plan coverage restrictiveness.

Methods: We analyzed a dataset of US commercial health plan coverage decisions (information current as of 2019) for orphan drugs (n = 3298).

Variation in access to hemophilia A treatments in the United States.

Background: US commercial health plans have been found to vary in how they cover specialty drugs indicated for a range of diseases. In this study, we examined patients' access to hemophilia A (HemA) treatments across a set of large commercial health plans.

Objective: To examine variation in health plans' coverage policies for HemA treatments.

Variation in health plan coverage of ESAs for anemia due to chronic kidney disease.

Because health plans each issue their own policies, drug coverage can vary. This variation can result in patients having unequal access to treatment. In this study, we evaluate commercial health plans' coverage policies for erythropoiesis-stimulating agents (ESAs) for patients with anemia resulting from chronic kidney disease (CKD).

Coverage for Biosimilars vs Reference Products Among US Commercial Health Plans.

This study uses US commercial health plan insurance data to characterize coverage for biosimilar drugs compared with reference products.

What types of real-world evidence studies do U.S. commercial health plans cite in their specialty drug coverage decisions?

Purpose: To examine the RWE U.S. commercial health plans cite in their specialty drug coverage decisions.

Variation in US private health plans' coverage of orphan drugs.

Objectives: To compare coverage of orphan and nonorphan drugs, to examine variation in orphan drug coverage across the largest US private plans, and to evaluate factors influencing coverage decisions.

Study Design: Database and regression analyses.

Methods: We analyzed a data set of private health plan coverage decisions for specialty drugs (N = 5000) in 3 ways.