Amid fierce criticism of the lottery style managed access program for the gene therapy Zolgensma, Novartis AG/AveXis Inc. say they are working “with a sense of urgency” with clinicians and patients to improve the program. Avexis also warned at the Expanded Access Summit in Washington, DC that bad press could persuade companies with gene therapies to avoid managed access programs altogether.
Novartis ‘Urgently’ Working To Improve Zolgensma Access Program
‘Lottery-Style’ Scheme Has Gone Down Better Outside Europe
Criticism of Novartis/Avexis’s controversial lottery style managed access program for Zolgensma has come largely from Europe, while other countries in Latin America and Asia have been far more receptive.
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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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Experts say PBMs should become familiar with transparency rules and prepare to release data, although more legal wrangling could occur.
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Optum Rx, one of the largest PBMs in the US, declared it was the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.
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FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.