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Examine trends in the time between regulatory approval and launch/pricing and reimbursement in the EU5 and US and review EC authorised drugs not approved by FDA. Access to orphan drugs continues to be an issue in Spain; only 39% of all EC authorised drugs have completed pricing and reimbursement negotiations with average time to market being 67 weeks. Interestingly, however 23% of EC authorised drugs are not launched in the US. [Extracted from the article]

Understanding the global implications of proposed US international reference price (IRP) measures for drugs reimbursed through Medicare Part B. Methods Multiple 2019 proposals have been made to reform US drug pricing. Since both proposals cite Medicare Part B, the following criteria were used to select drugs for analysis: • Medicare Part B drugs with >$100M total 2017 spending • Single source drugs only (no generics or biosimilars as of Dec 2019) • Vaccines, immunoglobulins, blood products excluded • Drugs approved after January 2010 • Drug price data available in US and 6 reference markets (ex-factory prices analysed in all countries; reimbursed price used in Japan; ASP included for the US) Data collection cut-off Dec 10, 2019. [Extracted from the article]