GENERIC INJECTABLE SHORTAGES AND TRENDS IN AVERAGE SALES PRICE IN THE UNITED STATES
Author(s)
Hur P1, Ray D2, Vegesna A3, Obi EN2
1University of Maryland School of Pharmacy, Baltimore, MD, USA, 2Rutgers University, Piscataway, NJ, USA, 3Jefferson College of Population Health, Philadelphia, PA, USA
OBJECTIVES: This study examines trends in quarterly average sales price (Q-ASP) among generic injectable drugs recently on shortage in the US. METHODS: Shortages of generic injectable drugs (excluding vaccines) resolved between 2010 - 2015 were identified using the American Society of Health System Pharmacists (ASHP) “Resolved Drug Shortages” website. Only shortages starting after January 2006 with a minimum duration of 6 months were considered. The Q-ASP was identified from the Center for Medicare and Medicaid (CMS) Drug Pricing Files for the entire shortage duration as well as the 12 months preceding shortage onset (pre-shortage period), and adjusted to 2015 US dollars. The average % change in Q-ASPs per 6 month shortage interval was calculated and analyzed descriptively. Other shortage/drug characteristics including shortage reason, number of manufacturers, and therapeutic area were also analyzed descriptively. RESULTS: The sample included 29 generic injectable drugs (average shortage duration of 2.3 years; 20.7% single source generics). The greatest proportion of drug shortages were for oncology (27.6%) and central nervous system drugs (20.7%). Most commonly cited causes of shortage were manufacturing delays (65.5%) product discontinuation (37.9%), and increased demand (31.0%). The % change in average Q-ASP after shortage onset was higher at 6 months (+22.6%) and 1 year (+33.7%) during shortage, as compared to 6 months (-7.0%) and 1 year (-26.2%) pre-shortage. The greatest % inflection in average Q-ASP occurred 4 years into shortage (+84.1%; n=7). Despite some fluctuation, compared to shortage onset, average % Q-ASP increased 140.7% for drugs with maximum shortage duration of 4.5 years (n=5). CONCLUSIONS: Average generic injectable drug prices increased as shortage lengthened, with the most noticeable increase occurring 4 years after shortage onset. Findings may help healthcare stakeholders better anticipate generic injectable price fluctuations and plan pharmacy budgets.
Conference/Value in Health Info
2016-05, ISPOR 2016, Washington DC, USA
Value in Health, Vol. 19, No. 3 (May 2016)
Code
PR2
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care
Topic Subcategory
Hospital and Clinical Practices, Reimbursement & Access Policy
Disease
Multiple Diseases