Pharma Value’s Post

𝗔 𝗛𝗶𝘀𝘁𝗼𝗿𝗶𝗰 𝗗𝗮𝘆 𝗳𝗼𝗿 𝗛𝗧𝗔 𝗶𝗻 𝗘𝘂𝗿𝗼𝗽𝗲! 💥 💥 💥 For those of us working in Health Technology Assessment, today marks a historic milestone. The new 🇪🇺 𝗘𝗨 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗼𝗻 𝗛𝗧𝗔 has officially entered into force, ushering in a new era of healthcare innovation across Europe. This landmark legislation will transform how we assess and introduce innovative health technologies, such as medicines and medical devices, by accelerating patient access, improving decision-making, and prioritizing patient voices. This is a major step forward in ensuring equitable access to the most advanced and effective healthcare solutions for all Europeans. With over 10 years of experience in the HTA field and having directly participated in the 𝗘𝗨𝗻𝗲𝘁𝗛𝗧𝗔 project since the Joint Action 1, I am excited to share my enthusiasm for this transformative revolution in healthcare. #HTA #HealthcareInnovation #PatientAccess #EuropeanUnion

YHEC recently worked with Prova Health to co-develop a white paper on generating economic evidence for digital solutions. Economic evidence is arguably the most crucial type of evidence for digital health innovators. This evidence is vital for decision makers to determine whether a digital health solution can be funded through investment, adopted by patients and clinicians, and reimbursed by payers. This white paper delves into the importance of economic evidence in digital health and the challenges in generating it. It highlights the differences in health economic evaluations for digital health solutions, medical devices and pharmaceuticals, offering insights into how to effectively generate economic evidence for digital health innovations. You can read more here: https://lnkd.in/d57-AEcm #DigitalHealthSolutions

EU Health Technology Assessment: Draft Regulation Open for Feedback! 🇪🇺🏥 The European Commission has released a draft regulation on joint scientific consultations for medical devices as part of the EU-wide Health Technology Assessment (HTA) coordination efforts. This regulation aims to harmonize HTA processes across the EU, and 𝘀𝘁𝗮𝗸𝗲𝗵𝗼𝗹𝗱𝗲𝗿𝘀 𝗵𝗮𝘃𝗲 𝘂𝗻𝘁𝗶𝗹 𝟮𝟲 𝗡𝗼𝘃𝗲𝗺𝗯𝗲𝗿 𝟮𝟬𝟮𝟰 𝘁𝗼 𝗽𝗿𝗼𝘃𝗶𝗱𝗲 𝘁𝗵𝗲𝗶𝗿 𝗶𝗻𝗽𝘂𝘁 through the "Have your say" portal. Key aspects of the draft regulation include: 1️⃣ 𝗦𝘁𝗮𝗸𝗲𝗵𝗼𝗹𝗱𝗲𝗿 𝗶𝗻𝘃𝗼𝗹𝘃𝗲𝗺𝗲𝗻𝘁: The regulation emphasizes including patients, healthcare professionals, and clinical experts in the consultation process, addressing a major concern raised by many stakeholders. 2️⃣ 𝗧𝗶𝗺𝗲𝗹𝗶𝗻𝗲𝘀 𝗮𝗻𝗱 𝗮𝗱𝗺𝗶𝗻𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝘃𝗲 𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗲𝘀: Specific timelines for submission and consultation are proposed. While this provides structure, there are concerns about potential administrative burdens, especially for smaller companies. 3️⃣ 𝗘𝘅𝗽𝗲𝗿𝘁 𝘀𝗲𝗹𝗲𝗰𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗰𝗲𝘀𝘀: A process for selecting and involving individual experts is outlined, aiming to consider diverse perspectives and address concerns about potential bias. 4️⃣ 𝗖𝗼𝗻𝗳𝗶𝗱𝗲𝗻𝘁𝗶𝗮𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝘁𝗿𝗮𝗻𝘀𝗽𝗮𝗿𝗲𝗻𝗰𝘆: The regulation addresses the balance between protecting sensitive commercial data and ensuring transparency, though some stakeholders feel this area may need further refinement. 5️⃣ 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗵𝗮𝗿𝗺𝗼𝗻𝗶𝘇𝗮𝘁𝗶𝗼𝗻: While the regulation provides a framework for joint consultations, questions remain about how this will be implemented across member states and harmonized with existing national HTA processes. While the draft regulation represents progress in EU healthcare policy harmonization, stakeholders should review the document carefully to assess its potential impacts. Your feedback can contribute to shaping the future of health technology assessment in the EU. To review the document and provide your input, visit: https://lnkd.in/ev5Mja7i #HealthTechnologyAssessment #EUHealthcare #MedicalInnovation

European Health Technology Assessment (HTA) Regulation entering into force: Evolution or Revolution? To me, a (limited) evolution. Member states might have a same medical evaluation but, pricing and reimbursement, remains their competence. And as long as you have the power to pay ... or not 🙂↕️. But happy to read other's opinion. #HealthTech #HTA #Regulation2025 #Innovation #Strategy #Europeentry #biotech #medtech

On Sunday, 12 January, the Regulation on Health Technology Assessment (HTA) will become applicable, bringing a significant improvement in ensuring that innovative and effective health technologies are available to patients across the EU. The new rules create an EU framework for the assessment of health technologies, such as medicines and medical devices, by fostering collaboration and coordination between EU Member States. This will help national authorities to make more timely and informed decisions on the pricing and reimbursement of health technologies and streamline the procedure for health technology developers. This will contribute to faster and wider access to new and more effective innovative products for patients. The rules will apply to companies seeking marketing authorisation for their products by introducing a new and permanent EU framework for Health Technology Assessment, including through: - introducing a single EU-level submission file for joint clinical assessments in order to ensure pooling of resources at the EU level and strengthening the scientific quality of HTA across the EU whileavoiding duplication of assessments at national level. - establishing faster procedures requiring Joint Clinical Assessments to be completed within 30 days after the authorisation of the medicine; the systematic consultation of patients and clinicians during the preparation of the assessments as well as the involvement and consultation of the HTA stakeholders. As a first step, starting on 12 January, these new rules will apply to marketing authorisation applications for a new cancer medicine or an advanced therapy medicinal product (ATMP). The rules will be extended to orphan medicines in January 2028 and will as of 2030 cover all new medicinal products. Selected high-risk medical devices will also be assessed as of 2026. The new EU framework replaces the long standing EU-funded project-based cooperation between Member States on health technology assessment, while fully respecting Member States' responsibility for the management of their health services as their national context requires.

💸 Demonstrating the value of digital health solutions can be more challenging than for conventional drugs, not least as digital solutions can provide unique combinations of advantages that go beyond clinical outcomes. 📑 This is the case especially for generating economic evidence, as the complexity of digital health solutions creates challenges in identifying common evaluation principles that may be used in other healthcare settings. ❓ What exactly are these challenges? Challenge 2️⃣: Identifying comparators and standards of care across regions and practices Digital solutions often involve a combination of alternative treatment options, including both digital and non-digital comparators, with differences in pathways across regional and local healthcare practices. Determining what the appropriate comparators are for digital solutions can be challenging. Unlike pharmaceuticals with well-defined placebos or competing drugs, digital solutions often replace or complement existing technology or pathways, which is highly variable. To learn more about generating economic evidence for digital health solutions, read the latest Prova Health white paper, developed in collaboration with York Health Economics Consortium and leading health economics experts: https://lnkd.in/d57-AEcm If you’re looking for support in generating economic evidence for your digital health solution, get in touch! #healtheconomics #digitalhealth #medtech

Of interest to folks in HTA, HEOR, and Market Access. The EU Health Technology Assessment Regulation has recently published a few key guidance documents that are essential for health technology developers. These documents will help prepare the appropriate analyses and information required for submission to the assessment process.   1. Scientific specifications for medicinal products undergoing joint clinical assessments. [https://lnkd.in/gc6cpzV4] 2. Guidance on outcomes for joint clinical assessments. [https://lnkd.in/gN-Y2eNQ] 3. Guidance on reporting requirements for multiplicity issues, subgroup analyses, sensitivity analyses, and post hoc analyses in joint clinical assessments [https://lnkd.in/gbtMRFVj]   #HealthTech #EURegulations #ClinicalAssessments #HTA

How to improve the implementation of innovative methods in health technology assessment practice? To make sure that the methods used to determine whether new forms of health care should be reimbursed or not, are future-proof and well-suited to the forms of health care being assessed. That is the goal of the European SUSTAIN-HTA project, in which fifteen partners, both from academia and the assessment practice, will be collaborating over the next four years. The project, led by Utrecht University, covers all kinds of healthcare but focuses on medicines and medical devices. It is made possible by a Horizon Europe grant of five million euros. The evolving landscape of healthcare has prompted questions about whether the evaluation methods used by assessment organizations remain aligned with current and future practices. Wim Goettsch, professor of Health Technology Assessment of #Pharmaceuticals at Utrecht University and project leader of SUSTAIN-HTA, explains: "For instance, in the past, the focus for medicines was primarily on treatments prescribed to large groups of people. Assessing effectiveness involved examining their impact on the average patient. However, contemporary healthcare uses more personalized approaches, with medicines designed for smaller, more specific patient populations. The question arises whether the existing methods are equipped to address these developments?" More information: https://lnkd.in/d9jDtgK4 #UUScience #HorizonEU #Healthcare #ClinicalPharmacology

What should the comparator be when evaluating my digital health solution? How will this impact my economic business case? Read more in our latest white paper below.

Thrilled to share the newest publication by the LCP Health Analytics team: "Health Technology Assessment in the US—A Word of Caution"! Together with my colleagues Sreeram Ramagopalan and Alex M., we provide a cautious perspective on the implementation of health technology assessment (HTA) processes in the US. 💊🇺🇲 Key takeaways: 🔹️ Countries with formal HTA bodies have substantially fewer available drugs than the US. Manufacturers often choose not to submit their products to countries with rigid HTA frameworks and this trend has been increasing in recent years. 🔹️ Even when a drug is available, reimbursement restrictions for specific populations can further limit patient access. 🔹️ HTA agencies can provide divergent opinions on the value of the same product, highlighting the need for a more transparent decision-making process. Access the full paper to learn more about why a formal HTA process in the US may not be entirely favorable to patient access to medicines.🔍📖 Link to publication: https://lnkd.in/dK-bwDXS #HTA #marketaccess #US #healthcare #patientaccess