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The United States and the United Kingdom have taken disparate approaches to the approval and coverage of medications, despite both providing incentives to develop therapies targeting rare diseases. The US requires less evidence for approval when compared with medications for common diseases and does not have a mechanism to ensure or even encourage cost\u2010effectiveness. The Institute of Clinical and Economic Review provides in\u2010depth cost\u2010effectiveness analyses in the US, but does not have the authority to negotiate drug costs. In contrast, the UK has maintained a similar scientific threshold for approval of all therapies, while requiring negotiation with National Institute for Health and Care Excellence to ensure that medications are cost\u2010effective for rare diseases. These differences have led to approval of medications for rare diseases in the US that have less evidence than required for common diseases. Importantly, these medications have not been approved in the UK. Even when medications meet traditional scientific thresholds, they uniformly arrive with high list prices in the US, whereas they are available at cost\u2010effective prices in the UK. The main downsides to the UK approach are that cost\u2010effective medications are often available months later than in the US, and some medications remain unavailable.<\/jats:p>","DOI":"10.1002\/mus.27380","type":"journal-article","created":{"date-parts":[[2021,8,27]],"date-time":"2021-08-27T08:58:19Z","timestamp":1630054699000},"page":"641-650","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Comparison of the United Kingdom and United States approaches to approval of new neuromuscular therapies"],"prefix":"10.1002","volume":"64","author":[{"given":"Gary W.","family":"Gallagher","sequence":"first","affiliation":[{"name":"University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dustin","family":"Nowacek","sequence":"additional","affiliation":[{"name":"University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Gutgsell","sequence":"additional","affiliation":[{"name":"University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian C.","family":"Callaghan","sequence":"additional","affiliation":[{"name":"University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,8,27]]},"reference":[{"key":"e_1_2_15_2_1","unstructured":"US Code of Federal Regulations.Title 21 Food and Drugs Part 316 Orphan Drugs Public Law 97\u2010414 HR 5238 January 4 1983."},{"key":"e_1_2_15_3_1","unstructured":"European Parliament and Council of the European Union.Regulation EC (No 141\/2000) of the European Parliament and the Council of December 16 1999 on orphan medicinal products.Off J Eur Commun. 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