Modifying criteria for orphan drug market exclusivity in USA
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Modifying criteria for orphan drug market exclusivity in USA Modifying criteria for orphan drug market exclusivity in the US would affect only a small number of dugs but could generate large cost savings, according to findings of a study published in Value in Health. Data from the FDA Orphan Drug Designations and Approvals database were used to assess the prevalence of orphan indications in 86 drugs with approvals for at least two orphan indications between 1983 and July 2017, and approval years of orphan and non-orphan indications for these drugs. Budget impact analysis of data from Medicare and Marketscan claims databases were used to evaluate potential savings from market entry of generic or biosimilar drugs under two policy options for reforming the Orphan Drug Act: denying market exclusivity for drugs which have exceed a combined prevalence threshold of over 200 000 patients across all orphan indications; or denying market exclusivity for drugs which have crossed the market approval threshold by gaining approval for a non-orphan indication. It was estimated that 21 and 18 of the drugs would have been denied orphan drug market exclusivity periods under the combined prevalence threshold policy and the market approval threshold policy, respectively, resulting in Medicare savings of $2 billion on eight drugs and $1.3 billion on twelve drugs, respectively, and private insurer savings of $814 and $919 million, respectively. Most denials of market exclusivity would have occurred after 2010. Over half of the savings would have been derived from nine drugs that were initially marketed for a non-orphan indication. "Modifying the orphan drug threshold would affect a small number of drugs but could generate large savings by contributing to increased competition," concluded th eauthors. "Alternative incentives such as grants or tax credits for clinical trials could be explored to incentivize research for new orphan indications for drugs that crossed either of the thresholds," they suggested. Socal MP, et al. Modifying the Criteria for Granting Orphan Drug Market Exclusivity. Value in Health : 28 Sep 2020. Available from: URL: https://doi.org/10.1016/ j.jval.2020.08.004
1173-5503/20/0864-0001/$14.95 Adis © 2020 Springer Nature Switzerland AG. All rights reserved
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PharmacoEconomics & Outcomes News 17 Oct 2020 No. 864
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