SKC Beratungsgesellschaft mbH

On October 7, 2024, the German Federal Ministry of Health (BMG) announced the more detailed regulations for the implementation of the additional discount on drug combinations. After a delay of almost two years after the "Act for the Financial Stabilization of the Statutory Health Insurance - Strategic implications for market access in Germany (GKV-FinStG)" came into force (November 2022), the regulation for the implementation of the 20%-discount on combinations without at least a considerable additional benefit for at least one indication or patient group was adopted. Previously, despite intensive negotiations, the GKV-SV and the representatives of the pharmaceutical industry at federal level were unable to agree on the implementation of the combination discount. The BMG has therefore defined the content for the practical implementation of this regulation, which will come into force on October 10, 2024 and could have drastic effects on the reimbursement of combinations of innovative medicinal products. 👉👈The decisive prerequisite for the application of the combination discount in accordance with Section 130e (1) sentence 1 SGB V is the designation of a medicinal product with a new active ingredient as a possible combination partner in a free combination by the G-BA in accordance with Section 35a (3) sentence 4 SGB V. The designation takes effect for both the combination partner assessed by the G-BA and the designated combination partners from the first day after designation. 1️⃣or5️⃣: For the combination discount to be applied, the named combination partners must have been prescribed as a combination therapy in practice in addition to being named by the G-BA. The determination and delimitation of a combination use subject to discount from the billing data of the health insurance funds was the most controversial point of a possible practical implementation between the GKV-SV and the pharmaceutical associations. According to the BMG's substitute measure, it is now clear that a combination use subject to deduction exists if the combination drugs were prescribed for the same insured person on the same day or at least twice within the same rolling five-month period. This aspect has already been strongly criticized by the pharmaceutical industry and could result in lawsuits against the regulation on the combination discount. 📆💲Furthermore, open topics regarding entitlements and obligations, invoicing, invoice verification by the pharmaceutical company as well as due dates and payment deadlines were determined as part of the implementation regulation. As the combination discount already came into force on October 15, 2023, companies must now expect corresponding repayments due to the retroactive application of the combination discount for all medicinal products that have been named by the G-BA as possible combination partners of free combinations since this date. #combinationdiscount #AMNOG #marketaccess #reimbursement

📢 Our EU HTA whitepaper, “One HTA to Assess Them All 2.0 - The Strategic Perspective on EU HTA Updated”, offers a comprehensive analysis of the European Health Technology Assessment (EU HTA) and delves into both the substantive and strategic aspects, providing valuable insights for stakeholders. 💡Key highlights: We have (re-)analyzed the implications of the newly defined EU HTA framework and updated the #operative, #strategic, and #structural #success #factors to optimally prepare for and handle the new process. In just a few pages, our whitepaper portrays the relevant factors of EU HTA and explains its strategic importance with concrete steps and food for thought. 📩You can download the full whitepaper on our website free of charge: https://lnkd.in/ecGmCare #EUHTA #JCA #marketaccess

SKC's market access special forces are looking forward to meeting you in Barcelona at the #WODC.

We are pleased to announce that SKC will be attending the Pharma MAR.CON 2024 congress in Berlin. From 6 to 8 October 2024, Fenja Lang, head of business development at SKC, will be participating at the event to discuss the latest developments and trends in market access. Take this opportunity to exchange ideas with her and gain valuable insights into innovative strategies and solutions. Feel free to make an appointment now.

Check out how the market access special forces developed an integrated global market access strategy guideline for an asset with multiple indication extensions over the next years in our recent case study on 👉 https://lnkd.in/eGn8sZhV #marketaccess #strategy #pharma #biotech

⏳It was about time: Today the long-awaited Implementing Act (IA) on Joint Scientific Consultations (JSC) was finally published for public consultation. While several “debatable” aspects of the JSC have already been defined in the HTA Regulation (such as restriction to “pivotal study in planning phase only”), the community looked forward to receiving an update. 👀At first glance, the published Draft IA does not offer surprising news in view of the already known process: it is about submission windows, information exchange between involved parties and the JSC outcome document. Furthermore, only few discrete details on the timeline of the actual JSC are included (e.g., 10 days before the advice discussion meeting all relevant materials need to be handed in) – rather the course of each consultation process will be defined in a separately provided timetable. Interesting: Stakeholders shall of course be included in the process, the selection and assessment of conflict of interests is already known from the JCA process. The JSC “will allow HTDs to obtain guidance from the Coordination Group on the information, data, analyses and other evidence that are likely to be required from clinical studies for the JCA.” Here, it was already criticized that actual impact and helpful guidance in view of expected PICOs will be highly limited – the actual JCA takes place years later and the PICOs will most likely not look the same. 💬 Our perspective: You should definitely consider confirming national PICOs and thereby challenge your strategy in focus markets, especially in Germany as the most important European market. Side note: There will be no more interims advice slots voluntarily provided by the G-BA and other HTA bodies to bridge the time until the JSC is possible. As always, we will analyze the implementing act in detail, contribute to the public consultation and keep you up to date. We are the market access special forces. #EUHTA #ImplementingAct #JSC

SKC is thrilled to be present at the World Orphan Drug Congress Europe 2024 in Barcelona next month (22-25 October), showcasing how we enable our orphan drug clients to master access and reimbursement challenges in Europe. We are looking forward to welcome you at our booth number 109 and discuss the topics that drive our industry forward, like the European Health Technology Assessment (#EUHTA) and our brandnew #AITool. 🎁 In case you do not have a ticket for the World Orphan Drug Congress yet, be our guest! To apply for a free ticket, send an email to contact@skc-beratung.de until October, 1. The winners will be informed on the next day. #orphandrugs #marketaccess #EUHTA #JCA #rarediseases

👀Dive into the latest insights and developments in the German orphan drug landscape with our July and August 2024 edition of the AMNOG orphan tracker. This issue provides information about the 6 new and 5 completed orphan drug procedures and an exlusive analysis on rebate development by added benefit. ⬇️ Download the complete tracker free of charge at https://lnkd.in/eDVjJRuS. 🌽All analyses are based on data from SKC‘s proprietary MAIS database, ensuring you have the most accurate and up-to-date information available. Stay informed about the latest trends and developments in the orphan drug sector with SKC. We are the market access special forces. #MarketAccess #OrphanDrugs #raredisease #AMNOG

🌟 Thank you to all participants! 🌟 We appreciate the valuable contributions from professionals across both big and boutique pharma and biotech companies during SKC’s “Ask the expert” Q&A session on EU HTA. It was valuable to explore the strategic implications of the forthcoming EU HTA process, especially in relation to the still existing uncertainties. For those who could not join us, don’t worry! We’ve got you covered. Our latest whitepaper on EU HTA “One HTA to assess them all 2.0 - The strategic perspective on EU HTA updated” is available for download. It’s packed with insights and key takeaways from the session. Download the whitepaper here: https://lnkd.in/e8E-GAZC Stay tuned for more exciting sessions and updates! #EUHTA #JCA #JSC #marketaccess

We are pleased to announce that SKC will be attending the Pharma MAR.CON 2024 congress in Berlin. From 6 to 8 October 2024, Fenja Lang, head of business development at SKC, will be participating at the event to discuss the latest developments and trends in market access. Take this opportunity to exchange ideas with her and gain valuable insights into innovative strategies and solutions. 📅 Feel free to make an appointment now. #marketaccess #AMNOG #pharma #biotech