• Ari D Panzer, Nikoletta M Margaretos, Naomi Bridger, Mikala C Osani, Rachel C Lai, and James D Chambers.
• Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, 800 Washington St #63, Boston, MA 02111. Email: apanzer@tuftsmedicalcenter.org.
• Am J Manag Care. 2022 Apr 1; 28 (4): e153-e156.

ObjectivesTo examine US commercial health plans' adoption of 2018 FDA-approved drugs.Study DesignDatabase analysis.MethodsWe 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. Using a data set of 17 large health plans' drug coverage policies and formularies, we examined coverage 1 year following FDA approval.ResultsThe FDA approved 66 drugs in 2018 (5 were not yet marketed 1 year following approval). For 60 of 61 drugs, some plans issued coverage policies whereas other plans included the drug in their formularies. Plans imposed restrictions (eg, step therapy) in 37% (275/742) of coverage policies. Plans covered biosimilars, orphan drugs, and cancer treatments more generously than drugs not in those categories (P < .05). Plans imposed restrictions in their policies with different frequencies (range, 7%-52%). Plans imposed utilization management (UM) in 82% (3837/4697) of formulary entries. Of those entries, plans required prior authorizations in 98%, included drugs on the highest patient co-payment tier in 70%, and imposed step therapy in 3%. Plans most often placed orphan drugs and cancer treatments on the highest cost-sharing formulary tiers (68% and 64% of the time, respectively). Plans imposed UM in their formularies with different frequencies (range, 62%-100% of entries).ConclusionsHealth plans imposed fewer coverage restrictions on cancer treatments, orphan drugs, and biosimilars than on drugs not in those categories. Some plans covered 2018 FDA-approved drugs more generously than others, which has implications for patients' access to innovative therapies.

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