Tuesday, June 18, 2024

May 2024 Milestones for Gemeinsame Bundesausschuss

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The G-BA (Federal Joint Committee) made significant strides in revising guidelines, enhancing pediatric and cancer care, funding innovative care models, and approving new treatments for various diseases. These updates reflect the G-BA’s ongoing commitment to improving healthcare quality and patient outcomes.

The German Federal Joint Committee (G-BA) has re-evaluated the drug Midostaurin and concluded that it no longer provides an additional benefit for treating acute myeloid leukemia (AML) with an FLT3 mutation, a significant shift from its 2018 assessment. Initially, Midostaurin was considered highly beneficial based on the RATIFY study, which showed improved long-term survival rates. However, as treatment standards have evolved, including the integration of Midostaurin itself, the G-BA’s recent review could not confirm its additional benefit.

This re-evaluation was prompted by Midostaurin surpassing the 30-million-euro sales threshold with statutory health insurance. Despite this, Midostaurin remains a crucial part of current AML treatment protocols, combining with chemotherapy to form the standard care for patients with FLT3 mutations. The G-BA’s decision reflects the progress in medical knowledge and the necessity to reassess treatments against up-to-date therapeutic standards.

The Innovation Committee at the Federal Joint Committee announced new transfer resolutions for significant projects. The AMSeC project developed a mathematical model to assess the effectiveness of booster vaccinations against meningococci. The REDARES project promoted guideline-compliant antibiotic prescriptions for uncomplicated urinary tract infections through supportive measures. The ZSE-DUO project improved diagnostics and care in centers for rare diseases by implementing a dual navigator structure consisting of psychiatric and somatic specialists. These results will now be strategically forwarded to assess and promote their implementation in medical care.

Additionally, the Innovation Committee announced funding for 48 new healthcare research projects. These projects, financed through the Innovation Fund, include studies on group settings in therapy, adverse treatment outcomes, patient empowerment, improving care for those with hearing loss, and addressing post-viral syndromes like Long COVID. The detailed list of projects will be published on the Innovation Fund’s website once applicants accept the funding conditions.

The Innovation Committee reported receiving 91 project proposals for new care models by the May 22 deadline. These ideas span topics such as oral health for the disabled, digitizing healthcare, addressing domestic violence, and enhancing emergency care processes. Decisions on which projects will proceed to full applications, supported by up to €75,000 each, are expected in the fourth quarter of 2024.

Gemeinsame Bundesausschuss

G-BA was assessing the benefits of Talazoparib (Talzenna) combined with Enzalutamide for metastatic castration-resistant prostate cancer (mCRPC). This process, started on February 15, 2024, and published on May 15, 2024, invites stakeholders to submit statements by June 5, 2024. The evaluation focuses on comparing treatments for two patient groups: those without prior mCRPC therapy and those who have had it. A public hearing is scheduled for June 24, 2024, with the final decision expected by early August 2024. This assessment will determine the therapeutic value and insurance coverage suitability under German law, ensuring new treatments are effective, safe, and economically viable.

The Federal Joint Committee also adopted a resolution to implement the STIKO (Standing Committee on Vaccination) recommendations from January 2024, along with amendments to Annex 2 of the vaccination directive. This decision, which aims to update vaccination protocols and guidelines, came into effect on May 22, 2024, following its publication in the Federal Gazette.

The German Federal Joint Committee (G-BA) issued guidelines restricting the substitution of methylphenidate drugs with different release mechanisms to ensure therapeutic consistency and patient safety in ADHD treatment. The decision, based on expert input and public consultations, addresses concerns about the equivalence and safety of different formulations. Variations in drug release profiles can lead to non-equivalent therapeutic effects, impacting efficacy and safety.

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The guidelines specifically target extended-release capsules with varying immediate and extended-release ratios. Experts emphasized the importance of maintaining specific release profiles to avoid adverse effects and ensure effective treatment. The G-BA’s evaluation included clinical studies and pharmacokinetic data, supporting the need for individualized therapy. The decision aims to improve patient outcomes by preventing substitutions that could compromise treatment effectiveness.

G-BA released initial evaluation reports for colorectal and cervical cancer screening programs, covering data from 2021 and 2022. These reports, by Gesundheitsforen Leipzig GmbH, provide early insights but are limited by incomplete data, which is being supplemented with clinical cancer registry data for better accuracy.

For colorectal cancer screening, around 1.5 million individuals participated in stool tests annually, with 9.7% testing positive, and nearly 487,000 underwent colonoscopies in 2022, with 0.37% diagnosed with carcinoma. Cervical cancer screening saw nearly 3 million women aged 20-34 participate annually, with 96.9% of tests unremarkable. For women aged 35 and over, 2.3 million utilized co-testing in 2021, decreasing to 1.3 million in 2022, with over 90% of results unremarkable.

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