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Scottish HTA Body Prepares For ‘Conditional Yes’ On Certain New Drugs

Executive Summary

Scotland’s HTA body, the Scottish Medicines Consortium, is about to embark on a new system allowing it to give a “conditional yes” to medicines for which data may be limited at the time of marketing authorization. At the same time, changes are being implemented to the system for allowing patient access to drugs that have not been recommended by the SMC.

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Scotland is to change the way it appraises new drugs for very rare diseases for use on the National Health Service, with a new “conditional yes” option for the Scottish Medicines Consortium that will require further evidence-gathering and subsequent reassessment, and a new appraisal procedure for “true ultra-orphan drugs” for very rare conditions where a cost-benefit assessment may not be appropriate. There will also be provision for earlier engagement on orphan drug pricing with the pharmaceutical industry and for more patient involvement in the SMC’s processes.

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