MAP Patient Access Limited’s Post

Balancing Act for Spanish HTA The new Spanish Health Technology Assessment (HTA) process has been designed to align with European Union regulations while retaining autonomy and flexibility. By integrating the Joint Clinical Assessment (JCA) framework into its national HTA process, Spain hopes to ensure timely and transparent evaluations. Read more about this balanced approach in this article (https://lnkd.in/eCdKjjRH) which explores how Spain's HTA process reflects a cautious yet collaborative attitude toward JCA regulation. #JCA #Lifesciencenews #HEOR #HTA

MPE provided detailed feedback on the second implementing act of the EU health technology assessment (HTA) regulation (EU HTAR) focusing on procedural rules for assessing and managing conflicts of interest (CoI) for representatives and individual experts (including patient experts). MPE believes that the current overly strict approach to CoI might lead to patient experts with the best available knowledge being left out of HTA assessments. Thus, MPE recommends a more flexible and pragmatic approach towards the CoI, one that balances the need to ensure transparency, impartiality and independence with the realities of patient expertise. https://lnkd.in/dqscBXhd

AOTMiT & EU HTA Discover the agenda for the Final Info Day on the Implementation of the New #EUHTA Regulation 📜 🗓️ Date and time: Tuesday, 5 November 2024, 9:00 – 12:30 This event offers an opportunity to discuss: ✅Gain in-depth insights into the key components of the new #EUHTA Regulation ✅Explore the challenges and opportunities in the implementation process ✅Involve stakeholders in #EU HTA implementation 🔗 Info & Registration: https://lnkd.in/dPKETvic The Health Technology Assessment Regulation (#HTAR) aims to establish a robust and collaborative approach to HTA within the #EU Member States🤝. #HTAR (JCA/JSC) will be gradually enforced from 2025. Building a transparent & efficient collaboration for the #EU #HTA #AOTMiT

🔍🔬 As experts with over a decade of experience in HTA services, we've delved deep into the recently published draft 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗶𝗻𝗴 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗽𝘂𝗿𝘀𝘂𝗮𝗻𝘁 𝘁𝗼 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 (𝗘𝗨) 𝟮𝟬𝟮𝟭/𝟮𝟮𝟴𝟮 on health technology assessment. We had our say and published our comments. 📣 Our 𝗸𝗲𝘆 𝗺𝗲𝘀𝘀𝗮𝗴𝗲𝘀 summarised for you: 1). We welcome the introduction of an Assessment Scope Explanation Meeting, but see a need for earlier HTD involvement in PICO scoping to ensure high quality submission dossiers and Joint Clinical Assessment (JCA) reports. 2). We appreciate the flexibility of the submission dossier, yet advocate for clearer specifications on some methodological requirements to ensure efficient processing. 3). It is now clear that in the event of a late change in therapeutic indication, the JCA may either continue or start anew, but questions regarding the timelines and potential misalignment with EMA procedures remain open. Our detailed commentary reflects our commitment to enhance the efficiency and transparency of the EU HTA system. 📝 Read our 𝗳𝘂𝗹𝗹 𝗰𝗼𝗺𝗺𝗲𝗻𝘁𝗮𝗿𝘆 [𝘭𝘪𝘯𝘬 𝘪𝘯 𝘤𝘰𝘮𝘮𝘦𝘯𝘵] and let us know what you think of the draft Implementing Regulation. ☎️ 📧 Want to learn more about EU HTA? Reach out to us at 𝗛𝗧𝗔-𝗧𝗲𝗮𝗺@𝗮𝗺𝘀-𝗲𝘂𝗿𝗼𝗽𝗲.𝗰𝗼𝗺. At 𝘼𝙈𝙎, we're prepared to navigate the complexities of JCAs. #HealthTech #EUHTA #HealthcareInnovation #JCA #HTA #PublicConsultation

📄 On the 19th September, the European Commission published a guidance document on the validity of clinical studies for joint clinical assessments under the EU Health Technology Assessment (HTA) Regulation, developed by the Member State Coordination Group on HTA.   We particularly welcome the acknowledgement of Real-World Data (RWD), Real-World Evidence (RWE), and Clinical Registries into this document as methodological topics of particular relevance for HTAs. 🤩   This inclusion symbolises a growing understanding of the role that these sources can play in supporting clinical research and generating data for HTAs. The document outlines the requirements for reporting and proposes methods for mitigating the weaknesses which may naturally arise with RWD. By addressing potential limitations heads-on, the guidance helps promote the generation of robust and reliable RWE.    Interested to find out more? Make sure to read the document below. 👇 #HTA #HealthTechnologyAssessment #RWD #RWE #ClinicalRegistries

🚀 Promoting Excellence in European Health Technology Assessments by ensuring that the best expertise is included 🚀 The vfa fully supports the EU Regulation 2021/2282's commitment to high-quality, transparent, and independent Health Technology Assessments (HTA). However, we are concerned that the proposed strict conflict of interest rules in the European commission’s draft implementing regulation might exclude crucial experts, potentially compromising scientific quality. 🔍 Our Recommendation: Adopt a pragmatic approach that ensures the best expertise is included, with transparent documentation of declared interests, case-by-case evaluation and diverse expert panels. This way, we can uphold both integrity and quality in joint HTA work. Let’s find the right balance and achieve excellence in European Health Technology Assessment! For more information, please visit the vfa comment. https://lnkd.in/ewAmZbmy #HealthTech #Innovation #Quality #Transparency #Independence #vfa #EURegulation #HTA #Expertise #ScientificIntegrity #conflictofinterest

Great to attend this insightful event last week. Patient Language Summaries to support Patient Expert Input to HTA: Lessons and Guidance for Patient Organisations, HTA Bodies and Industry. The collective aim being to improve the availability of Plain Language Summary Information to support the timely, structured, and meaningful integration of patients' insights into Health Technology Assessment (HTA) evaluations. To meaningfully contribute to the HTA process, patient experts need a baseline of timely, clear & accessible information on the treatment being assessed. The quality and relevance of written & verbal submissions to HTA bodies are likely to improve if patient experts are better informed. To support this. a standard template to gather Plain Language Information has been developed based on the Summary Information for Patients (SIP) template originated by the Scottish Medicines Consortium. #HTAI:PatientAndCitizenInvolvementInterestGroup #HTAI:HealthTechnologyAssessmentInternational #SMC:ScottishMedicinesConsortium #NICE:NationalInstituteForHealthAndCareExcellence #EPF #CancerPatientsEurope #OpenedDoorConsultancy #BMSAustralia

Spotlight on Spain's New HTA Regulations: The Spanish Ministry of Health has released a groundbreaking Draft Royal Decree aimed at regulating Health Technology Assessments (HTAs). This decree sets a new governance framework, including the formation of a Governance Council and specialized evaluation offices. In our latest thought leadership piece, our experts explore the implications of this new framework and how it aligns with European standards. Find out more by visiting our website: https://buff.ly/3MBhzUI #LumanityPerspectives #EUHTARegulation #HEOR #HTA

📢 You can now watch the recording of the @Acute Leukaemia Advocates Network (ALAN) and Myeloma Patients Europe (MPE) webinar on the new EU Health Technology Assessment (HTA) regulation. 🎥 Learn how the new EU HTA regulation impacts patients and patient organisations with Béla Dajka, policy officer at the European Commission. https://lnkd.in/dXkc3_QV #EUHealth #HTARegulation #PatientAdvocacy 

“To build a sustainable and resilient Healthcare System we should invest in the better use of data from the Health Technology Assessment (HTA) process. Therapeutic protocols based on clinical benefits, economic cost and social impact can improve everyday clinical practice. But to achieve that, we need a National Plan for the collection and utilization of Real-World Data. The recent political agreement for the European Health Data Space paves the way to the use of RWD to a more resilient HTA process”, Antonis Karokis, External Affairs Director, MSD Greece mentioned during his speech at the HTA Annual Conference held on the 23rd of April in Athens.