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The American Journal of Managed Care June 2018
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Placement of Selected New FDA-Approved Drugs in Medicare Part D Formularies, 2009-2013
Bruce C. Stuart, PhD; Sarah E. Tom, PhD; Michelle Choi, PharmD; Abree Johnson, MS; Kai Sun, MS; Danya Qato, PhD; Engels N. Obi, PhD; Christopher Zacker, PhD; Yujin Park, PharmD; and Steve Arcona, PhD
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Cost Sharing for Antiepileptic Drugs: Medication Utilization and Health Plan Costs
Nina R. Joyce, PhD; Jesse Fishman, PharmD; Sarah Green, BA; David M. Labiner, MD; Imane Wild, PhD, MBA; and David C. Grabowski, PhD

Placement of Selected New FDA-Approved Drugs in Medicare Part D Formularies, 2009-2013

Bruce C. Stuart, PhD; Sarah E. Tom, PhD; Michelle Choi, PharmD; Abree Johnson, MS; Kai Sun, MS; Danya Qato, PhD; Engels N. Obi, PhD; Christopher Zacker, PhD; Yujin Park, PharmD; and Steve Arcona, PhD
There is significant heterogeneity in formulary placement and restrictions on new drug approvals in the Part D marketplace.
ABSTRACT

Objectives: To assess formulary decisions by Part D plans for selected newly approved drugs.

Study Design: Retrospective cohort study.

Methods: Formulary placement and restrictions were identified for 33 drugs in 8 therapeutic classes (antihyperglycemics, anticoagulants, antiplatelets, disease-modifying agents for multiple sclerosis [MS] and rheumatoid arthritis [RA], chronic obstructive pulmonary disease [COPD] drugs, antiepileptics, and antipsychotics) in 863 Part D plans with continuous CMS contracts between 2009 and 2013. Multivariable models estimated the impact of drug characteristics and Part D plan characteristics on probability of drug adoption and, for adopters, evaluated factors associated with months to adoption and requirements for prior authorization (PA) or step therapy (ST).

Results: First Part D formulary placements varied from 2 to 14 months post FDA approval. On average, 56.7% of plans placed each drug within 6 months and 64.1% placed within 1 year of the National Drug Code assignment date. The most rapid adoption was for antipsychotics and antiepileptics. The slowest was for COPD drugs. More than 90% of disease-modifying agents for MS and RA were subject to PA. ST was uncommon except for antihyperglycemic agents. In adjusted analyses, enhanced benefit plans had a 4% higher probability of formulary placement (P <.01), and each additional star in the CMS star rating system increased the probability of adoption by 4% (P <.01). Overall, Medicare Advantage prescription drug plans had higher placement rates due to greater reliance on enhanced plan offerings and higher star ratings.

Conclusions: We found significant heterogeneity in formulary placement and restrictions for 33 new drugs in the Part D marketplace between 2009 and 2013. Further research is necessary to determine whether this pattern applies to other drug classes.

Am J Manag Care. 2018;24(6):e175-e182

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