PROCURE’s Post

The root causes of unavailability and delay in access of innovative medicines The speed of innovation in recent years and the promise of the industry pipeline provide an opportunity to improve outcomes for patients. However, a significant number of medicines are not available across all EU markets. There are patient access inequities within Europe, with significant differences across countries in the number of products available and the time taken prior to national reimbursement. The average time of reimbursement for innovative treatments across EU and European Economic Area has reached 531 days, ranging from 126 days in Germany to 990 days in Turkey. In the EU, once a new treatment has gone through a process of R&D lasting ten years on average, 3 further milestones must be reached before patients have access to it: 1. A European marketing authorization, confirming the quality, safety, and efficacy of the therapy 2. National authorities must secure reimbursement 3. Once reimbursed, innovations need to reach the right patients. The root causes of delays and unavailability of drugs are multifactorial: 1. The speed of the regulatory process 2. Accessibility of medicines before marketing authorization 3. Initiation of the pricing & reimbursement process 4. The speed of national timelines and adherence 5. The value assessment process 6. The right product differentiation 7. Health system constraints and resources (budget) 8. Diagnosis, supporting infrastructure and relevance to patients 9. Multilayer decision-making process. These may be solved only by stakeholders working together. Here´s a series of specific proposals to improve patient access to innovative medicines and reduce inequalities across Europe: • A commitment from the industry to file pricing and reimbursement (P&R) applications no later than 2 years after EU market authorization • The creation of a portal where marketing authorization holders can provide timely information on the timing and processing of P&R applications • A conceptual framework for equity-based tiered pricing (EBTP) to ensure that ability to pay across countries is considered in the prices of innovative medicines, anchored in a principle of solidarity • Novel payment and pricing models that can accelerate patient access • An efficient implementation of Health Technology Assessment (HTA) across Europe. Comparative research of the time length from application to granting of marketing authorization has shown that the European regulatory process is slower than some international processes, particularly that of the US. The approval timelines have generally converged in other regions of the world, whereas times in Europe have remained relatively unchanged. Hence, Europe is lagging. #Pharma #Marketaccess #Marketingauthorization #Pricing #Reimbursement Visit us on https://lnkd.in/d5tuZczF or look for more information on https://lnkd.in/dytEHHne

The upcoming European Commission pharmaceutical legislation aims to level the playing field for medicine access across Europe, but there's concern about its impact on innovation. Proposals to reduce Regulatory Data Protection (RDP) could deter investment, risking a drop in innovation and access to new medicines. A report warns that reducing RDP might cost the EU €2 billion in R&D and lose 50 pipeline products. Legislation that stifles innovation might worsen the health disparities it seeks to mend. Addressing the East-West health gap in Europe is crucial, yet complex. Local issues like economic barriers and national health funding play a significant role. For instance, Romania's National Cancer Plan has taken steps to improve healthcare for uninsured people, boosting access to cancer prevention and treatment. More legislation and regulation could be a risk for Europe, while a reform to streamline innovation through regulatory approvals might save the inefficiencies that will close the East-West gap. https://lnkd.in/ed38yUh5 #EUHealth #PharmaceuticalLegislation #Innovation #HealthcareAccess #EuropeanUnion

The upcoming European Commission pharmaceutical legislation aims to level the playing field for medicine access across Europe, but there's concern about its impact on innovation. Proposals to reduce Regulatory Data Protection (RDP) could deter investment, risking a drop in innovation and access to new medicines. A report warns that reducing RDP might cost the EU €2 billion in R&D and lose 50 pipeline products. Legislation that stifles innovation might worsen the health disparities it seeks to mend. Addressing the East-West health gap in Europe is crucial, yet complex. Local issues like economic barriers and national health funding play a significant role. For instance, Romania's National Cancer Plan has taken steps to improve healthcare for uninsured people, boosting access to cancer prevention and treatment. More legislation and regulation could be a risk for Europe, while a reform to streamline innovation through regulatory approvals might save the inefficiencies that will close the East-West gap. https://lnkd.in/ebiiTrE7 #EUHealth #PharmaceuticalLegislation #Innovation #HealthcareAccess #EuropeanUnion

Yesterday's The Pharmaceutical Managers Institute Market Access Masterclass, proudly sponsored by Salutem Insights, was a fantastic opportunity to delve into the latest industry developments and gain actionable insights. With expert contributions from key industry leaders, the session covered a wide range of topics crucial to understanding the evolving landscape of market access in Ireland. Here are our key takeaways: 🔹 𝗡𝗖𝗣𝗘 𝗨𝗽𝗱𝗮𝘁𝗲: The NCPE has expanded its team with 11 new staff (7 HTA Assessors & 4 Statisticians) to handle the growing volume of submissions in 2023. However, a backlog remains due to the surge in submissions. 🔹 𝗡𝗲𝘄 𝗕𝘂𝗱𝗴𝗲𝘁 𝗜𝗺𝗽𝗮𝗰𝘁 𝗧𝗲𝗺𝗽𝗹𝗮𝘁𝗲: Exciting news from the NCPE – a new Budget Impact Template is set to roll out by October 2024, promising more efficient processes. 🔹 𝗘𝗮𝗿𝗹𝘆 𝗖𝗼𝘀𝘁 𝗘𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲𝗻𝗲𝘀𝘀: Ronan Mahon from University of Galway shared insights on how early cost-effectiveness analysis can help manufacturers assess the value of new medicines during clinical trials, offering critical insights from a health system perspective. 🔹 𝗣𝗮𝘁𝗶𝗲𝗻𝘁 𝗩𝗼𝗶𝗰𝗲 𝗶𝗻 𝗥𝗲𝗶𝗺𝗯𝘂𝗿𝘀𝗲𝗺𝗲𝗻𝘁: Aoife Kirwan from Multiple Sclerosis Ireland Ireland highlighted the importance of integrating the patient perspective in the reimbursement process, especially in telling the "unmet need" story. 🔹 𝗔𝗜 𝗶𝗻 𝗠𝗮𝗿𝗸𝗲𝘁 𝗔𝗰𝗰𝗲𝘀𝘀: EY Ireland gave us a glimpse into the evolving role of AI in market access. While still in its early stages in Market Access, AI is already starting to add value in other areas. 🔹 𝗣𝗮𝘆𝗲𝗿 𝗣𝗲𝗿𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲𝘀 & 𝗧𝗶𝗺𝗲𝗹𝗶𝗻𝗲𝘀: Our MD, Sandra Redmond, shared insights from the Salutem Insights dashboard on what payers are focused on, timelines, and overcoming challenges in the reimbursement process. 🔹𝗩𝗼𝗶𝗰𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆: Leah Russell from Pfizer gave us an overview of the challenges facing the industry including the forthcoming Framework Agreement and time to reimbursement timelines. A big thank you to Fiona Dunphy and the PMI team for organising such a valuable event. We look forward to continuing the discussion and sharing more updates. If you'd like to learn more about these key topics or how Salutem Insights can support your Market Access strategy, get in touch today! #MarketAccess #HealthcareInnovation #HTA #IrishPharma #Reimbursement #HealthcarePolicy #SalutemInsights

National Primary Health Care Development Agency (NPHCDA) has collaborated with the National Institute for Pharmaceutical Research and Development (NIPRD) to improve the implementation of evidence-based innovations in the health sector of Nigeria.

Reflecting on Medicines for Europe Annual Conference which took place last week. We were delighted to bring together industry leaders from across Europe with the aim of enhancing patients' access to essential medicines. It was great to also be joined by key stakeholders from Ireland to further discuss the generic, biosimilar and value added medicines industry. Opening the event, Medicines for Ireland Chairperson Paul Neill emphasised the value that that off-patent medicines industry delivers to patients and healthcare systems across the continent. It is noteworthy that Medicines for Europe members supply an impressive 70% of all medicines in Europe. This statistic represents millions of patients who have received treatment that enables them to lead more fulfilling lives. It also highlights the savings that the State can reinvest in health systems and underscores the untapped potential that further support for our industry could mean for member states across Europe. Over the past decade, Ireland has witnessed significant growth in the adoption of off-patent medicines. Yet, there is still untapped potential. We are thankful to the Irish and European stakeholders who attended and participated in the Conference, MFI will continue to constructively engage with the policymakers, the health service and the regulator to further increase the penetration of generic, biosimilar and value added medicines to realise positive outcomes for both patients and the State. The conference outlined the importance of collaboration across Europe in shaping the future of the industry for the benefit of patients and member states. You can read more about it here ⬇ https://lnkd.in/eXbdzfus #MedsforEU24 #AccessForAll #BreakingBarriers Pinewood Healthcare Consilient Health Teva Pharmaceuticals Accord Healthcare Clonmel Healthcare Fresenius Kabi Celltrion Inc Rowa/Rowex Pharmaceuticals Ltd Sandoz Fannin Ltd DCC Vital Viatris

On January 12, 2025, the European Union's Health Technology Assessment Regulation (HTAR) (Regulation (EU) 2021/2282) will come into effect, marking a significant milestone in streamlining access to cutting-edge health technologies across Member States. Key Highlights: 1. Improved Accessibility: The HTAR facilitates collaboration between regulators and health technology assessment (HTA) bodies, accelerating decisions on the use, pricing, and reimbursement of innovative medicines. 2. Initial Focus: The new framework will initially apply to cancer medicines and advanced therapy medicinal products (ATMPs) before expanding to orphan medicines by 2028 and all centrally authorised products by 2030. 3. Enhanced EU Coordination: EMA will support timely joint clinical assessments (JCAs) to evaluate the effectiveness and safety of new technologies, aiding informed decision-making. 4. Joint Scientific Consultations (JSCs): EMA and the HTA Coordination Group (HTACG) will provide parallel advice to developers, ensuring evidence generation meets both regulatory and HTA requirements. 5. Future Outlook: In 2025, HTACG expects to conduct 17 JCAs for cancer medicines and 8 for ATMPs. The first JSC request period will launch in February 2025, with plans for 5–7 consultations for medicines and 1–3 for medical devices. The HTAR reflects a commitment to fostering cooperation between decision-makers, driving innovation, and ensuring sustainable healthcare systems across the EU. For further details, you can read the full article here - https://lnkd.in/gNaRR5Wb For more updates on healthcare regulations and advancements, follow Global Regulatory Insights. #HealthcareInnovation #HTAR #EMA #HealthTechnologyAssessment #EURegulations #GlobalRegulatoryInsights

What were some of NICE’s key achievements last year, and what changes are planned for the coming year? The institute’s draft corporate business plan for 2024/25 sets out what has been accomplished and #goals for the months ahead.   In 2023/24, NICE made positive recommendations in 86% of completed technology appraisals and 83% of highly specialised technology (HST) guidance. Real-world evidence was considered in around 75% of committee discussions across all technology appraisals and in more than 95% of cost-effectiveness models.   Optimal appraisals for medicines were published in an average of 36 days. For the first time ever, guidance on two new drugs was published within 24 hours of marketing authorisation.   For the 2024-25 financial year, NICE’s board has set the following key goals:   • Collaborate with key partners such as MHRA, the Department of Health and Social Care, and NHS England (NHSE) to improve the #innovation ecosystem, including collaboration on MHRA’s new International Recognition Procedure. • Contribute to NHSE's update to the Commercial Medicines Framework. • Consult with NHSE on an updated #budgetimpact test with an increased threshold of £40mn. • Pilot two new programmes that consider the value, and potentially improve uptake, of products currently in the market. • Pilot the re-evaluation of the cost-effectiveness of medicines as they are integrated into clinical guidelines. • Integrate horizon scanning across NICE and link this with national and international views of the innovation pipeline. • Review routing criteria for Highly Specialised Technology Appraisals. • Encourage the use of RWD to inform safety aspects of guidance. • Incorporate technology appraisals in new and retrospective guidelines (target incorporation rate of 33% by the end of 2024-25). • Review the use of the disease severity modifier in evaluation and identify any necessary remedial actions. • Update the methods for assessing health inequalities in guidance production. • Expand HTA Lab capacity in line with new funding pledged in the 2024 Voluntary Scheme for Branded Medicines Pricing and Access. • Agree an approach for recognising guidance from other organisations in areas where NICE does not produce guidance.   In addition, NICE has revealed that it now has access to the #horizonscanning platform used by some US payers and the Institute for Clinical and Economic Review (ICER). This resource will enable #NICE to identify technologies that are not listed in UK Pharmascan and follow up with companies to acertain whether they plan to launch their drugs in the UK. The institute believes this change will mitigate a key cause of delays to technology appraisals.   A quantitative modifier for health inequalities is in development, but further work is required to understand the displacement implications.   In the future, NICE’s methods could be modified to support the adoption of technologies and interventions that improve workforce and wider NHS productivity.

In commemoration of #WorldPatientSafetyDay, we came together with various industry stakeholders and student associations in Nairobi on September 13th 2024 to engage on how various pharmaceutical professionals can better patient safety in our region, under the theme; Improving Diagnosis for Patient Safety. Improvements in technology have led to an evolution of various sectors, including the pharmaceutical industry, where we have gained better tools and products for our health, such as medicines and various vaccines. In parallel, new types of technology, equipment, and tools have also been developed for the correct and accurate diagnosis of various diseases. Today, in this fast world with a shortage of time in various aspects, such as day to day activities lined up in people's lives, this fast life has made many people want quick solutions when they are sick, many times resulting in the intake of medicines without referring to diagnostic tests or even avoiding the use of more accurate diagnostic tests. Medication errors that result from self diagnosis and treatment by patients are common and very costly to patients and their families. Another underlying problem is that diagnostic methods, tools, and equipment have not had much research and development effort in recent years, due to the large investment that often does not result in a quick return, unlike the development of new drugs that have had an investment that has paid off and has revolutionized the world in terms of human health. Given the vital role diagnostics play in serving as the first step toward an appropriate treatment plan, discussions of diagnostics must be included in the ongoing dialogue on the affordability and accessibility of new drugs. Thanks to Kenya Association of Pharmaceutical Industry (KAPI), PSK - Young Pharmacists Group, KEPhSA Kenya and all the student associations present, for making this day memorable. #WorldPatientSafetyDay #September17TH2024

EU HTA: how to ensure stakeholder alignment on a national level to accelerate broad patient access Read our Deep Dive of this important and popular panel discussion from the World Evidence, Pricing and Access Congress 2024 - sponsored by Cencora.  With the European Health Technology Assessment Regulation in Europe coming into force in January 2025, there is much speculation around its implications for streamlining #marketaccess, as well as the practicalities of implementing such a large-scale initiative across the European Union. The publication of the first draft implementing act, providing the procedural rules, timelines and templates for the coordinated assessment of #medicinalproducts, has offered some insight on the process, but key questions remain about resource allocation, timelines, #methodologies and potential challenges in achieving true harmonization. Moderator: Herbert Altmann (Cencora) Panelists: Mihai Iulian Rotaru (EFPIA - European Federation of Pharmaceutical Industries and Associations), Neil Grubert (Independent Global Market Access Consultant) and Casper Paardekooper (Vintura, Part of Cencora). Read at The Evidence Base® #hta #patientaccess #jca #jointclinicalassessment #stakeholderengagement #healthpolicy