Heads of HTA Agencies Group’s Post

#AOTMiT & EU HTA European Commission adopted an Implementing Regulation that sets out the rules for cooperation with the European Medicines Agency #EMA in the joint work carried out under the #HTA Regulation. These rules define the information to be shared: ➡️for planning and forecasting of joint clinical assessments (JCA) and joint scientific consultations (JSC); ➡️for identifying patients, clinical experts and other relevant experts to be involved in these joint procedures; ➡️on general scientific and technical matters related to health technology assessment.

12 Weeks to 2025's #EUHTA Implementation - are we ready? Learnings from the Panel Discussion on #WorldOrphanDrugCongress 🔎Opportunities: ▪ EU HTA could give HTA bodies a better start, providing knowledge to smaller bodies and an alternative perspective to the larger ones. ▪ EU HTA will be important for national pricing decisions through PICO: unlikely that national decision makers will deviate from what was required as a PICO scheme. ▪ Hope that patient engagement practices that have proven valuable at national level could be implemented for JCA. 🏆Challenges: ▪ Comparator´s price impact will also impact the availability of medicines in all EU countries. ▪ Too strict conflict of interest checks (according to current draft implementing act) could limit participation of knowledgeable stakeholders. ▪ No good mechanism has yet been devised to deal with last-minute changes in regulatory labelling. 💡Conclusion: EU HTA is an important step towards harmonising HTA processes across Europe and improving access to new medicines, but there are still major doubts about whether it will achieve its goals if the hurdle is set too high. #WODC #WordOrphanDrugCongress2024 #GetReadyForEUHTA #EUHTA

#EUHTA #PatientAccess #ImplementingAct ⚖ Yesterday, the third public consultation of the Implementing Act (#IA) of the #EUHTARegulation on on EMA/EU HTA cooperation has been released for public consultation. It is open until⏰ July 24, 2024. European Commission is there a reason why the 'Have your say' notification sends me an email during the night even though it has already been available for hours 🤔? However, this implementing act lays down the rules with regards to the cooperation of the Coordination Group and the Commission acting as secretariat of the Coordination Group (‘the #HTAsecretariat’) with the European Medicines Agency in the form of exchange of information. This exchange of information will be relevant for the future joint work (i.e. joint clinical assessments #JCA and joint scientific consultations #JCA). https://lnkd.in/efXDrtje

💡 Methodological experts and assessors from HTA bodies and the European Medicines Agency came together for a joint workshop title “Understanding evidence challenges, managing uncertainties and exploring potential solutions”. The hybrid workshop was hosted by NCPE - National Centre for Pharmacoeconomics in Dublin with over 150 attendees online.   💡 This is part of an ongoing series bringing together assessors and methodologists from HTA and the EMA to discuss the common challenges in relation to evidence generation. There was a unified voice across both HTA and regulatory participants on the need to improve the evidence generation pathway and a first discussion on potential approaches to move this forward.    We look forward to continuing this discussion in the next webinar in early 2025! Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) Norwegian Medical Products Agency KCE - Federaal Kenniscentrum voor de Gezondheidszorg - Centre Fédéral d'Expertise des Soins de Santé RIZIV-INAMI INFARMED, I.P. Health Products Regulatory Authority (HPRA) Heads of HTA Agencies Group

12 Weeks to 2025's #EUHTA Implementation - are we ready? Learnings from the Panel Discussion on #WorldOrphanDrugCongress (#WODC) 🔎Opportunities: ▪ EU HTA could give HTA bodies a better start, providing knowledge to smaller bodies and an alternative perspective to the larger ones. ▪ EU HTA will be important for national pricing decisions through PICO: unlikely that national decision makers will deviate from what was required as a PICO scheme. ▪ Hope that patient engagement practices that have proven valuable at national level could be implemented for JCA.   🏆Challenges: ▪ Comparator´s price impact will also impact the availability of medicines in all EU countries. ▪ Too strict conflict of interest checks (according to current draft implementing act) could limit participation of knowledgeable stakeholders. ▪ No good mechanism has yet been devised to deal with last-minute changes in regulatory labelling.   💡Conclusion: EU HTA is an important step towards harmonising HTA processes across Europe and improving access to new medicines, but there are still major doubts about whether it will achieve its goals if the hurdle is set too high. #WODC #WordOrphanDrugCongress2024 #GetReadyForEUHTA #EUHTA

📰 As part of the roll out of the EU rules on health technology assessment (Regulation 2021/2282) six implementing acts will be adopted by the European Commission to govern the framework of operation.    One area which has piqued our interest is the management of conflicts of interest (COI) in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups.  The implementing act was released for comment at the end of May [1] and the final implementing act is due shortly.    A key element of the new Joint Clinical Assessment (JCA) is to engage patients, clinical experts and other relevant experts with expertise from a European or International perspective. [2]     The European Medicines Agency (EMA) have for a number of years managed COI but in April this year a key judgement by the European Courts has challenged the existing practice [3] meaning that as part of the roll out of JCA a more stringent approach to COI will likely be adopted.    With ATMPs in scope from January 2025 and Rare Disease medicines from 2028 it will be important to see how this fine balance is achieved to ensure patients and experts are able to be engaged in the JCA process.    🗣 If you would like to discuss how JCA roll-out will affect your organisation, please reach out to Kevin Asher or Esther Nzenza for an informal meeting.    1. https://lnkd.in/ekKtTCT7  2. https://lnkd.in/eEg3QQsz  3. https://lnkd.in/e3UtKKsn #hta #jca #heor #teamdecisive #rebelthinkers  

The South African Health Products Regulatory Authority (SAHPRA) and the TGA have signed a Memorandum of Understanding (MoU), which will strengthen collaboration between the two health products regulators. The MoU builds on the existing relationship between the health products regulators to improve capabilities in the assessment of medical products and therapeutic goods and their monitoring for continued efficacy, safety and quality once they are registered. SAHPRA and TGA will engage in data sharing aimed at improving the regulatory functions executed by both regulators. This will particularly focus on the assessment and approval of medical products and therapeutic goods, their monitoring for continued efficacy, and the surveillance for safety and adverse reaction (event) concerns. Read more: https://lnkd.in/gbsKyBxy

Are you prepared for the changes in supply monitoring? 🌍 #MedicineShortages pose a significant global challenge, impacting #healthcare systems and patients alike. To address this, the European Medicines Agency (#EMA) has launched the European Shortages Monitoring Platform (#ESMP), a groundbreaking tool to enhance transparency and response capabilities across the #EU and #EEA. 📆 By February 2025, the ESMP will fully integrate mandatory reporting, enabling stakeholders to monitor #supply and #demand dynamics during both routine operations and crises. This proactive measure aims to strengthen healthcare resilience and ensure consistent access to essential medicines across the EU and EEA regions. Follow DUE Pharm and stay up to date on the latest changes in the industry. #DUEPharm #PlatformLaunch #PatientCare #PublicHealth #PharmaRegulations #HealthcareResilience #MedicineSupply #EMAUpdates #GlobalHealth #CrisisPreparedness #SupplyChainManagement #RegulatoryCompliance #EUHealthcare

Health Technology Assessment Coordination Group & Cooperation with European Medicines Agency (#EMA). The public consultation on the new implenting act on the cooperation of the two bodies has been completed. The new #HTAR takes into consideration the assessment of #medicines, #medicaldevices and #invitrodiagnostics. All comments performed by european regulators, patient grous, consultansies etc are available in the link below. In a few months the new regulation will be voted and clarify all issues commented. The exchange of information of the two bodies involves the following: i) planning and forecast of the Joint Clinical Assessment (JCA) & Joint Scientific Consultations (JSC). ii) identifications of patients, clinical experts and other relevant experts to be involved in the procedure iii) general scientific and technical matters for #JCA & #JSC iv) security of sharing and protection of confidential information exchanged between #EMA, HTA secretariat and coordination group. Will keep you posted on the progress of the #HTAR and the relevant info. https://lnkd.in/d8g9qy7U

📢 Medicines and Healthcare products Regulatory Agency Update: The #UK will be the first country in the world to introduce a tailored framework for the regulation of innovative products manufactured at or close to the location where a patient receives care. A Statutory Instrument (SI) laid in Parliament today, 21 October, will provide a new regulatory framework meaning that medicines with a very short shelf life and highly personalised medicines can more easily be made in or near a hospital setting and can get to the patients who need them safely and much more quickly. The regulation will also allow for manufacture of innovative medicines in small, portable units that can be set up close to patients who may be too sick to travel or whose reduced immunity precludes travel or where rapid medicine availability is best served. Ian Rees, Point of Care lead at the MHRA, said: “This totally new framework, the first of its kind in the world, supports the MHRA’s drive to deliver for patients; making it possible to safely manufacture breakthrough medicines closer to where care is delivered and increasing the attractiveness of the UK as a destination to market new life-saving medicines.” Find out more here ➡️ https://bit.ly/3Nvb4n4