The Gemeinsamer Bundesausschuss (G-BA) has recently announced several significant procedural decisions from its latest meeting, affecting various medical treatments. These updates reflect the G-BA’s ongoing commitment to ensuring that patient treatments are backed by rigorous evaluation and comprehensive data collection.
One of the notable decisions involves Opdivo (nivolumab), a treatment for stage IIB or IIC melanoma used as adjuvant therapy in patients aged 12 and older. The G-BA has decided to remove the previously imposed time restriction on its use. This change means that Opdivo can now be used without a predefined endpoint, allowing for its continued administration based on ongoing patient needs and emerging clinical data.
G-BA Suspends Benefit Assessment for Carvykti, Terminates for Adcetris, and Calls for Real-World Evidence for Talvey
Carvykti (ciltacabtagene autoleucel), which is employed in treating multiple myeloma, has had its benefit assessment suspended for up to eight months. This suspension is intended to provide additional time for further data collection and analysis, ensuring that comprehensive evidence is available to support its continued use and to address any outstanding questions regarding its efficacy and safety.
In the case of Adcetris (brentuximab vedotin), which is used for treating CD30+ stage III Hodgkin lymphoma, the G-BA has terminated its benefit assessment. This decision comes after Adcetris lost its orphan drug status, having surpassed the £30 million sales threshold. The termination of the benefit assessment indicates a significant shift in its regulatory status, necessitating new evaluations and possibly altering its availability and use in clinical settings.
For Talvey (talqutamab), another treatment for multiple myeloma in patients who have undergone at least three previous therapies, the G-BA has called for the collection of real-world evidence (RWE). To facilitate this, the prescription of Talvey will now be restricted to centers participating in the RWE data collection initiative. This effort aims to gather practical, real-world data that can provide deeper insights into its effectiveness and safety outside of controlled clinical trials.
G-BA to Review Hemgenix and Roctavian Treatments for Hemophilia, Emphasizing Real-World Evidence
The G-BA has made decisions regarding Hemgenix (etranacogen dezaparvovec) and Roctavian (valoctocogen roxaparvovec), treatments for hemophilia B and hemophilia A, respectively. Both treatments will undergo a review of their study protocols and statistical analysis plans to ensure the robust collection of RWE. This review aims to solidify the evidence base for these therapies, ensuring that their use is supported by reliable and comprehensive data that accurately reflect patient outcomes in real-world settings.
These decisions underscore the G-BA’s dedication to data-driven decision-making in the healthcare sector. By emphasizing the importance of real-world evidence and thorough benefit assessments, the G-BA aims to ensure that medical treatments are both effective and safe for patients, while also being cost-effective and sustainable within the healthcare system. This approach helps to maintain high standards of patient care and ensures that therapeutic innovations are evaluated with the utmost rigor.
Resource: Gemeinsamer Bundesausschuss, July 18, 2024
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