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

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

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

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

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

Is Spain interested in joint procurement of medicines with the rest of the EU? Recent comments by César Hernández, the Director General of the Common Portfolio of SNS and Pharmacy Services (DGCCSF), hint at that possibility. The Minister of Health, Mónica García, has also spoken about her aspirations for drug procurement.   Speaking at the Post-ISPOR Conference—which had the theme “Towards a sustainable future: impact of changes in HTA regulation”—Hernández expressed the view that Spain must move from a supply-driven model dictated by manufacturers to one that is driven by demand and the needs of healthcare systems. He called for the creation of “buying clubs” that value a European market of 450 million people, as opposed to the Spanish market of 47 million people.   Spain has been a member of the Valletta Declaration Group—an alliance of ten countries with a combined population of more than 160 million—since May 2017. Its intended activities include horizon scanning, HTA and joint pricing negotiation, but it has not announced any concrete results to date.   According to Hernández, Spain spends 2% of its GDP on health technologies—a much larger share than the European average of 1.3%. Moreover, although pricing and reimbursement may be slower than in some other European countries, uptake thereafter of innovative medicines is usually relatively fast. He wants the pharmaceutical industry to recognise Spain’s access peculiarities to build “a balanced and predictable system, based on our realities and adapted to our needs.”   Hernández also revealed that the long-awaited Royal Decree on Health Technology Assessment has been delayed by the need for input from the autonomous communities, various ministries and the Red Española de Agencias de Evaluación de Tecnologías Sanitarias Y Prestaciones del Sistema Nacional de Salud (RedETS; Spanish Network of Agencies for the Evaluation of Health Technologies and Services in the National Health System). The draft should, however, be published before the summer to allow for feedback in the second half of the year. The drafts of the Royal Decree on Pricing and Reimbursement, as well as the Law on Guarantees, could be published by the end of the year.   Meanwhile, Health Minister García spoke at the 77th World Health Assembly in Geneva. She said: “We need an entrepreneurial state that promotes research, puts health at the centre of policies and adds value to the well-being economy with indicators that go beyond GDP. We continue to push for a world that puts people at the centre” (tinyurl.com/ytsanutz).   García’s priorities include structuring public-private collaboration to limit profiteering, strategically exploiting public procurement to shape markets aligned with health objectives and valuing health in the economy through a panel of metrics that goes beyond GDP. #Spain #jointprocurement #crossbordercollaboration #HTA #drugpricing

What role will pharmaceutical market access play in the future of European competitiveness—and what changes are needed? Mario Draghi, the former President of the European Central Bank, offers proposals in a report of nearly 400 pages that identifies pharma as one of ten key sectors for the region’s future competitiveness (tinyurl.com/wau9bxrj).   The accompanying table summarises Draghi’s nine broad proposals for pharma. His recommendations on market access and HTA are particularly interesting. He sees a need to “co-operate on pricing and reimbursement as well as procurement.”   The report calls on the European Commission to “streamline guidance to industry on unmet medical needs, the design of clinical trials and the use of real-world evidence across national medicine agencies, national bodies for HTAs as well as pricing and reimbursement authorities. In general, interaction between national medicine agencies and other relevant national actors should be stepped up in a structured way. This matters all the more, as decisions on the location of R&D activities, such as phase III clinical trials with chronic (repeat use) treatments, may in part be governed by the likelihood of the subsequent coverage of medicines by local public payers. Overall, there is a trend towards growing integration of the entire value chain, starting with R&D.”   Draghi believes “Member States should adhere more closely to pricing principles as previously established under the EURIPID collaboration and step up cross-country initiatives for joint pricing (and reimbursement) negotiations for specific medicines.” It may be advantageous to expand EU joint procurement beyond treatments for cross-border health threats. He notes “trade-offs at play between stimulating innovation, fiscal sustainability and affordable access for patients. Actions can build on experience and expertise gained in the Network of Competent Authorities for Pricing and Reimbursement (NCAPR), as well as cross-country collaborative approaches (such as Beneluxa).”   The European Commission could also “use award criteria in public tenders such as security of supply and production in the EU/EEA or in countries with which the EU has concluded an agreement on government #procurement to foster EU competitiveness.”   The report urges the Commission to “rapidly and fully implement the #HTA regulation and ensure the required resources are allocated to ensure the delivery of joint clinical assessments as of 2025, with the aim of establishing an #EU agency in the long term.” It suggests that “sufficient expert staff from national HTA bodies and Commission services as well as commensurate funding at EU level for HTA bodies should be freed up to ensure the successful implementation of Joint Clinical Assessments.” The cost of EU-level HTA activities could be recovered through industry fees.   The findings of the report will contribute to a new Commission plan for sustainable prosperity and #competitiveness. #drugpricing

For many years, Stratenym has been supporting clients with market access strategy in a way that closely follows the key suggestions outlined in Mario Draghi's report. We have found that aligning with EU regulations and optimising evidence strategies for our clients results in positive recommendations as payers increasingly adopt a holistic view of the value chain, following the trend highlighted by Mario Draghi. #MarketAccess

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

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.