AstraZeneca On Bridging The Gap Between Accelerated Approval And HTA Requirements
Health technology assessment agencies are struggling to evaluate drugs on the basis of evidence generated for early approvals, says AstraZeneca.
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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.
Industry access to real world data for regulatory and market access purposes in Asia Pacific compares poorly with the US.
Draft guidelines due out for consultation this week in Italy are expected to shed more light on what companies will have to reveal during pricing and reimbursement negotiations.