Market Access & Reimbursement
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Latest From Market Access
The sponsors of two products in the European Medicines Agency’s popular PRIME scheme for speeding patient access to drugs for unmet medical needs appear to be close to filing their applications for marketing authorization. Five more products were accepted on the scheme this week.
The European Medicines Agency’s Committee for Advanced Therapies has revealed its priorities for addressing the challenges manufacturers face in the fast-growing field of advanced therapies.
“It didn’t take long for folk to start applying,” a US Food and Drug Administration official says of the 17 applications the agency has received so far for designation under its new regenerative medicine advanced therapy (RMAT) program for fostering the development of such products.
AbbVie’s investigational hepatitis C treatment has become the latest therapy to get the green light under the UK’s early access to medicines scheme. The scheme enables patients to access the treatment ahead of it receiving an EU marketing authorization.
The Australian government has promised not to implement any new therapeutic groups under the Pharmaceutical Benefits Scheme for the next five years, nor will it introduce any new pricing reforms without consulting the innovative drug industry first.
Turkey has agreed to provide the high-priced spinal muscular atrophy drug Spinraza for free to up to 20 children, but has so far not been able to reach an agreement with the producer to procure the drug at a reduced price or add it to the reimbursement list.
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