SKC Beratungsgesellschaft mbH

Confidential reimbursement amounts in Germany only attractive for individual cases: For the first time, the law also establishes the regulatory possibility of agreeing confidential reimbursement amounts in Germany, which can create new opportunities for pharmaceutical companies to act but are linked to demanding challenges, which we discuss in our new blog: https://lnkd.in/eVnQPiTy #marketacess #pricing #reimbursement

❓ Do you need help or advice in understanding the new EU HTA framework? ❓ Do you have questions regarding the arising chances and risks for your business? ❓ Are you looking to expand your network and get in touch with strategic market access professionals? Our panel of industry and market access professionals has the answers for you! Apply now for free for our Q&A session on July, 16 at 5pm (CET) on https://lnkd.in/dWkqskXg

❓ Do you need help or advice in understanding the new EU HTA framework? ❓ Do you have questions regarding the arising chances and risks for your business? ❓ Are you looking to expand your network and get in touch with strategic market access professionals? Our panel of industry and market access professionals has the answers for you! Apply now for free for our Q&A session on July, 16 at 5pm (CET) on https://lnkd.in/e5UppcNN

Yesterday the Bundestag passed the new Medical Research Act (#Medizinforschungsgesetz / #MFG) that decisively strengthens Germany as a centre of medical research and aim at accelerating access to new therapeutic options. The law addresses framework conditions to improve the development of clinical trials, authorization procedures and reimbursement / pricing rules. 👇 ✔️ Adaptations of the AMNOG guardrails, that defined additional discounts or price caps, which might now be revised if a relevant proportion of the clinical trial takes place in Germany (= at least 5 % of German patients in the study population). ✔️ The introduction of confidential reimbursement prices, that has been highly discussed before the #MFG. Manufacturers might now request, the confidentiality of their negotiated prices if they accept additional rebates of 9% and fulfil requirements that show their substantial research activities in Germany ✔️Adaptations to speed up authorization procedures for clinical drug trials, by introduction of binding standard contractual clauses and the shortening of the negotiations and decision making between manufacturers and German hospitals on clinical trials. ✔️ Implications for DiGA and digitalization by addressing processes as certification of data protection and extending the deadline for the introduction of the TI messenger ePA. 💡 The MFG received positive feedback from pharmaceutical companies, medtech companies and digital health provider, although some critics as always remain. 📣The strategic implications and possible opportunities for actions, require a more detailed inspection, which we will gladly provide in the upcoming weeks. If you want to find out more about how the new reimbursement rules might offer opportunities for your business, check our first strategic digest of the 5%-hurdle in the comments. #AMNOG #MFG #reimbursement #pricing

💥 We present our newly released whitepaper titled “One HTA to Assess Them All 2.0 - The Strategic Perspective on EU HTA Updated”. In this comprehensive report, SKC delves into the substantive and strategic depths of the European Health Technology Assessment (EU HTA). 💡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/ebfjtZT9 👀 If you are interested or know someone within your organization who might be interested, please check out our new format “Ask the expert”. It is a Q&A session in which you and your colleagues have the chance to discuss EU HTA-specific challenges and questions with our EU HTA expert team. The first session is scheduled for July, 16 and you can apply for your registration at https://lnkd.in/eR_CFUFF #EUHTA #JCA #marketaccess

On June 26th, the European Commission published the draft Implementing Act (IA) on the cooperation with the EMA regarding the exchange of information. 👇 The document outlines the process of information exchange between the European Medicines Agency (EMA) and the Member State Coordination Group on Health Technology Assessment (HTACG), facilitated by the HTA secretariat. The IA provides clarification on: 📔Planning & Forecasting: The institutions should exchange information necessary for planning and forecasting JCAs and JSCs, including upcoming marketing authorization applications for medicinal products and medical devices. 🔀Selection of Devices: Information related to the selection of medical devices and in vitro diagnostic medical devices for JCAs should be shared. 🔬Identification of Experts: Information on individual experts to be involved in JCAs and JSCs is also to be exchanged when appropriate. 🛡️Protection of Information: Rules are established for the secure exchange and protection of confidential information shared within the context of JCAs and JSCs. The exchange aims to facilitate the preparation of reports on emerging health technologies, the annual work programme of the Coordination Group, and recommendations for the selection of health technologies for assessment. The information is shared through a secure IT platform, ensuring confidentiality and compliance with data protection regulations. ❗ Interestingly, the IA does not provide any information on the exact nature and extent of information that can be shared during the JCA, leaving pharmaceutical manufactures in doubt whether they will be able to retain control over the specific data submitted to HTA authorities for evaluation versus the mandatory data for EMA for marketing authorization. The IA is now open for public consultation until July 24th. Together with our partners and associations we as SKC will analyze the draft in detail and submit our statement. As always, we will keep you posted! #EUHTA #IA #marketaccess

Meet the industrial Professions! Wir haben uns sehr gefreut, am 11. Juni mehrere Mitglieder der Junior-GBM (Junior GBM - Gesellschaft für Biochemie und Molekularbiologie e.V., jGBM) bei SKC begrüßen zu dürfen, um die Karrieremöglichkeiten in unserem Unternehmen vorzustellen. Bei der jGBM sind Studierende verschiedener biowissenschaftlicher Studiengänge (u.a. Biochemie, Biomedizin, Mikrobiologie) vom Bachelorstudium bis hin zur Promotion vertreten, und es hat unserem Recruiting-Team sehr viel Spaß gemacht, den Studentinnen vorzustellen, wie wir in interdisziplinären Teams den erfolgreichen Market Access insbesondere von Medikamenten für seltene Erkrankungen und von Produkten, die neue Therapiestandards setzen, unterstützen. 🙏 Danke, liebes jGBM-Team, dass ihr trotz Unwetter und Bahnausfall in die Hannover-List gekommen seid, um Euch mit SKC zu vernetzen und neue Berufsfelder kennenzulernen! #jobshannover #marketaccess #hiring

On Friday, June 21st the EC informed health technology developers on how to submit early information when a product will be subject to a JCA: 👉According to the updated EMA pre-authorisation procedural guidance, applicants for a centralized European marketing authorization now have to state whether their product falls under the scope of Article 7 of Regulation (EU) 2021/2282 and therefore is subject to JCA. 👉In parallel, the developer is asked to inform the HTA Coordination Group of the intent to file an EMA submission for a product that needs to undergo a JCA via the IT platform/ HTA secretariat. If you have any questions regarding this update or your products JCA eligibility, get in touch with SKC! We are the market access special forces. #EUHTA #JCA #marketaccess

EU HTA Updates on JCA Product Eligibility Guidance and Adapted Implementation Rolling Plan 👇 1️⃣ JCA Product Eligibility Guidance - When does a specific product have to undergo a JCA? A new Coordination Group guidance document outlines the scientific specifications for medicinal products subject to JCA 👉Advanced Therapy Medicinal Products (#ATMPs): The Coordination Group follows the definition given in Regulation (EC) No 1394/2007, as laid down in the EU HTA regulation, to determine whether a product is an ATMP and therefore subject to JCA from January 12th, 2025. 👉Therapies for Cancer Treatment (#onco): The Coordination Group adopts the EMA’s definitions, basically declaring all anti-neoplastic agents and adjuvant treatments with direct anti-tumor cytotoxic or cytostatic effects subject to a JCA as an oncology drug from January 12th, 2025. Agents specifically intended to treat cancer associated symptoms or treatment-associated side-effects, diagnostics, and preventative medicines do not fall directly under that scope. 👉 Orphan Medicinal Products (#orphans): The Coordination Group follows the definition given in Regulation (EC) No 141/2000, as laid down in the EU HTA regulation, to determine whether a product is an OMP and therefore subject to JCA from January 13th, 2028. 2️⃣ Adapted Implementation Rolling Plan The rolling plan for the implementation of the EU HTA regulation was updated, specifying timelines for due Implementing Acts (e.g, Q2-Q3 for the Implementing Act on Joint Scientific Consultations was changed to Q3) and providing a comprehensive list of pending Coordination Group guidance documents, which interestingly again include guidances on JCA process timelines and templates for the JCA dossier. What do you think about those updates that provide certainty about JCA product eligibility on the one hand but maybe calling recent learnings about JCA timelines/ templates into question again on the other hand? #EUHTA #JCA

EU HTA: New guidance documents have been published as announced in the last meeting of the Member State Coordination Group on June 9th: 📝guidance on outcomes for joint clinical assessments (JCA) and 📝guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments, which represent updated versions of the EUnetHTA 21 guidance documents D4.4 Endpoints and D4.5 Applicability of Evidence. Both documents help to understand the expectations from assessors regarding the data presented in the JCA submission dossier, yet they are openly formulated to address both primary analyses regarding the PICOs or complementary analyses like additional subgroup analyses, specific post hoc analyses and sensitivity analyses as well as different outcome types like PROs or surrogate endpoints. This makes sense! 💡As a reminder, the actual rating and acceptance for an added benefit takes place on national level. The industry is welcoming every new official piece of the EU HTA puzzle, especially when it comes to the preparation of PICOs. Regardless, we should not forget that the aim is to help as many patients as possible and reach the desired reimbursed price level. It is not about flooding the assessors with tons of more or less acceptable PICOs. We have to be smart and think from the end! #JCA #PICO #EUHTA #marketaccess | Source: EC news announcements