Now that the UK Department of Health and Social Care has confirmed that companies covered by the Voluntary Scheme for Branded Medicines Access and Pricing (VPAS) will have to repay 26.5% of their sales of branded medicines, attention has shifted to the negotiations that will begin next year to agree on a follow-on deal that will apply from 2024 to 2028.
UK Pharma Industry Facing Difficult Price Scheme Talks in 2023
Negotiations on the successor to the UK’s 2019 voluntary drug pricing scheme are due to start in April 2023. The industry body, the ABPI, is calling for a clean sheet approach, but others suggest that could make it almost impossible to reach agreement in less than a year and that reform may be a more realistic proposition.
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The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
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Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.
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The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.
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Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.