Pharma Value’s Post

🚀 Advancing the Health Technology Assessment framework  📢 As announced by the European Commission, a new implementing regulation under the Health Technology Assessment (#HTA) Regulation has been adopted, setting the stage for joint scientific consultations on medicinal products for human use. 💡 These consultations also foster collaboration between health technology developers, HTA bodies, and the European Medicines Agency (#EMA), ensuring development plans meet clinical assessment needs. A significant step towards transparent and innovative healthcare for better patient outcomes! 👉 Learn more here (in Portuguese): https://lnkd.in/gwEUas3V #HealthTechnologyAssessment #EUHealthcare #InnovationInHealthcare #Infarmed

Achieve your 2025 goals with the support of Salutem Insights. From Irish market access strategies to HTA submissions and health economic modelling, we offer the expertise and flexibility to enhance your in-house capabilities. Let us help you navigate the complexities and drive success. Connect with us to explore how we can support your team. #MarketAccess #HTASupport #HealthEconomics #SalutemInsights #Pharma

The draft Implementing Act (IA) on Joint Clinical Assessment (JCA) for medicinal products has just been published! This is a major milestone in the journey to the new era of European Health Technology Assessment (EU HTA). What does this mean for you as you prepare a product launch for 2025? Explore the details of the Implementing Act on JCA to learn what changes have occurred, what issues remain unaddressed, and how to prepare for the upcoming final implementation of EU #HTA in 2025. https://bit.ly/3xXEnKs

🌍 Ready to master the #EUHTA era? The landscape of EU Health Technology Assessment (HTA) is shifting fast, and the key to success lies in how well you adapt. Whether you're navigating joint clinical assessments, optimising PICOs, or participating in joint scientific consultations, having the right guidance is crucial. In the snippet below, managing directors Graham and Paul discuss the importance of communicating value at the European level. If you missed the live session, don't worry—we've got you covered. Watch our webinar on demand and learn how to seamlessly integrate EU HTA considerations into your long-term strategies, ensuring your organisation stays ahead of the curve 🛣 📽️ Watch the webinar now: https://lnkd.in/ewYuC4s8 #MarketAccess #HEOR #HealthcareStrategy #PICO #JointClinicalAssessments #JointScientificConsultations #HTA #Pharma

🎱 EU HTA UPDATE - WEBINAR FOR HTDs 🎱 Details here ☛ https://lnkd.in/e7eNqiaW "In this webinar, Chairs and Co-chairs of the Member State Coordination Group on Health Technology Assessment and its subgroups will explain the process for joint clinical assessments and joint scientific consultations. The webinar is targeted at representatives of health technology developers of medicinal products."

The Health and International Relations Monitor project, supported by the Health Foundation, has released a new report on the future of health after Brexit. The report highlights that global medicine shortages are being felt particularly acutely in the UK, and the country's reliance on migration as a source of health and social care staff is intensifying. As the relationship with Europe continues to evolve, it is crucial for the UK to evaluate the impact on the delivery of health and care services. The full report is below. #pharma #medtech #devices

The EU’s co-funded joint actions on HTA (EUnetHTA Joint Actions) have identified nine domains by reference to which health technologies are assessed. 🔎 🖱️ Swipe left to read a quick overview of these 9 clinical and non-clinical domains of Health Technology Assessment by Prof. Dr. Lieven Annemans, CELforPharma faculty member and eminent HTA expert. Successfully planning for HTAs in Europe is an ever more complex undertaking, considering the detailed analyses required for each of these 9 domains and especially the varying approaches adopted by different countries. 😵 To navigate these complexities 🗺️, everyone involved in the process must develop a thorough understanding of the expected changes and issues related to both the clinical and the non-clinical domains. -------- ☝️ I am Inge 🔥 My mission: Helping Pharma managers acquire business-critical competencies to make better decisions Liked this post? Want to see more? 🔔 Ring the bell on my Profile to get notified 🔝 Connect with me  #neverstoplearning #pharma #healthtechnology #assessment

🔥 Report on Global Regulatory Best Practices Analysis: A scoping review of HTA and Regulatory RWD/RWE policy documents 🎬 The IDERHA project (Integration of heterogenous Data and Evidence towards Regulatory and HTA Acceptance), funded under the Innovative Health Initiative (IHI) , aims to integrate, analyze, and use heterogenous health data, including real-world data to better support doctors, researchers, and patients with insights that can improve the treatment and management of disease and allow for more personalized care. 🔎 The review explores 🔹 what current policies cover 🔹 where there is consensus on best practice policy for broader adoption 🔹 where there are policy gaps for the use of RWD and RWE in decision making 🔹 where additional foundational work and/or consensus development is needed - Regulatory bodies tend to focus more on the scientific #validity and regulatory compliance aspects, while HTA agencies and third parties may emphasize practical considerations for data use in healthcare decision making. #digitalhealth #healthdata #HTA #RWD #RWE #medicaldevices #medicines #realworldoutcomes #patientjourney #medicalaffairs #realworlddata #outcomesresearch #artificialintelligence #EMA #clinicaltrials #realworlddata #dataquality #outcomes #patientoutcomes #heor #healtheconomics #adherence #PASS #drugsafety #efficacy #reimbursement #regulatoryaffairs #regulatory #generalizability #DIA DIA

Learning Episode- 4 #ESCMIDGlobal2024 ♦️With increasing number of medicinal products on the market how should health care providers know which product is better for their patients? ♦️ Randomized controlled trials( RCTs) are a must in order to determine the performance of a medicinal product ♦️Observational studies which are these days referred to as real world evidence( RWE) can only be supportive of RCTs. These observational studies are prone to bias and can be misleading, they should be interpreted carefully

📌 NEWS - Navigating the New Regulation on Health Technology Assessment (HTA) ▶ As of January 12th, 2025, Regulation (EU) 2021/2282 on health technology assessment has come into effect! This landmark #legislation enhances #cooperation among #EUMemberStates, creating a unified approach to evaluating #healthtechnologies, including medicines, #medicaldevices, and other interventions. ▶ The #HTA Regulation establishes a Joint Clinical Assessment process, focusing on the #clinical aspects of #newtechnologies. By fostering collaboration across the EU, it aims to eliminate duplication of efforts, optimize resources, and ensure faster access to innovative healthcare solutions for patients. To sum up: ✔️ Pool resources at the #EU level by introducing a single submission file for #JointClinicalAssessments. ✔️ Establish faster #procedures, enabling quicker access to essential #medicines for patients. ✔️ Keep #patients at the center, with their input being consulted throughout the process. ▶ As a first step, these new rules apply to new #cancermedicines and #advancedtherapymedicinalproducts. By 2028, they will extend to #orphanmedicines and eventually cover all new medicinal products.