September 30th - October 6th, 2024 Week`s Update

We have compiled the week's top news for you at Market Access Today!

• During the 79th session of the United Nations General Assembly , global collaboration on antimicrobial resistance (AMR) was emphasized, with world leaders discussing strategies to tackle this global health threat. The UK's leadership, particularly through its National Action Plan and innovative antibiotic payment model, was highlighted. Colette Goldrick, the Executive Director of Corporate Affairs & Strategy at the The Association of the British Pharmaceutical Industry (ABPI), praised the political declaration from the UN meeting, reaffirming the need for global cooperation. The ABPI will continue its partnership with the UK government, the NHS, and international organizations like the World Health Organization to advance AMR solutions. (https://marketaccesstoday.com/abpi-welcomes-un-general-assemblys-renewed-commitment-to-combat-antimicrobial-resistance/)

• NHS England has issued new guidance for planning and developing Community Diagnostic Centres, with 170 approved sites, including 165 fully operational across the country. This guidance highlights best practices in areas such as commissioning, governance, regulatory compliance, and digital integration, all aimed at expanding diagnostic services within communities. The NHS England is leading this initiative, ensuring that core diagnostic services, including CT, MRI, and pathology tests, are available across CDCs, while also allowing flexibility for additional tests based on local priorities. The Integrated Care Boards will play a key role in commissioning these services, using the NHS Standard Contract. (https://marketaccesstoday.com/nhs-england-releases-updated-guidance-for-planning-and-implementing-community-diagnostic-centres-cdcs/)

• The NICE - National Institute for Health and Care Excellence is currently consulting on draft guidance that does not recommend elacestrant (KORSERDU by MENARINI Group) for advanced breast cancer due to uncertainties in the clinical evidence. This draft focuses on treating oestrogen receptor-positive, HER2-negative breast cancer with an ESR1 mutation after disease progression. NICE - National Institute for Health and Care Excellence is collaborating with Menarini Stemline, the developer of elacestrant, to address these concerns ahead of a review scheduled for November 2024. Helen Knight, Director of Health Technology at NICE - National Institute for Health and Care Excellence, highlighted the importance of resolving these issues to determine whether elacestrant can provide meaningful benefits for patients. (https://marketaccesstoday.com/nice-seeks-to-address-evidence-uncertainty-for-elacestrant-in-advanced-breast-cancer-treatment/)

• The Gemeinsamer Bundesausschuss (G-BA) has upheld existing pneumococcal vaccination guidelines, in line with recommendations from the Standing Committee on Vaccination (STIKO). Announced on September 19, 2024, this decision emphasizes the continued use of PCV13 or PCV15 for infants and high-risk children, ensuring comprehensive protection while carefully evaluating new vaccines like PCV20. STIKO's recommendations, released on August 1, 2024, highlight the importance of evidence-based practices in public health. By maintaining stable guidelines, the Gemeinsamer Bundesausschuss (G-BA) and STIKO aim to minimize healthcare disruptions while supporting long-term, cost-effective public health strategies. (https://marketaccesstoday.com/vaccination-guidelines-reinforced-as-g-ba-upholds-current-recommendations-for-pneumococcal-vaccines/)

• A recent study by the ISPOR—The Professional Society for Health Economics and Outcomes Research, titled "Integrating Price Benchmarks and Comparative Clinical Effectiveness to Inform the Medicare Drug Price Negotiation Program," analyzes how the Centers for Medicare & Medicaid Services determined initial price offers for high-cost drugs. Statutory ceiling prices, comparative clinical effectiveness, and net pricing were key factors influencing these offers. Sean D. Sullivan, PhD, lead author of the study, highlighted the importance of transparency in Medicare's price negotiations, which were enabled by the Inflation Reduction Act of 2022. CMS negotiated prices for 10 high-expenditure drugs, including ibrutinib, ustekinumab, and empagliflozin, with more drugs to be negotiated in the coming years. (https://marketaccesstoday.com/medicares-strategy-for-drug-price-negotiations-uncovered/)

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