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At ISPOR Europe 2024, an expert panel discussed reforms and strategies to align national health systems with the forthcoming Joint Clinical Assessment (JCA). François Meyer, MD at FIPRA Public Affairs, provided the French perspective. Although he sees no need for drastic legislative changes for the implementation of HTA regulation, he acknowledged ongoing final checksOriol Solà-Morales, MD, PhD, representing Health Innovation Technology Transfer, shared Spain's progress in aligning with European processes despite initial reluctance. Emphasizing the country's preference for a budget-impact-led system over a pure cost-effectiveness model, she shared the efforts made to facilitate the new regulation, despite potential capacity concernsIga Lipska, MD, PhD, MPH, of the Health Policy Institute, Medical University of Gdańsk, acknowledged that Poland is "not well prepared" for the HTAR. Citing Poland's political stance in recent years as a factor, she nevertheless sees potential for Central and Eastern European countries to benefit from the collaboration
A panel of experts at ISPOR—The Professional Society for Health Economics and Outcomes Research Europe 2024, discussed key developments in cross-border collaboration in recent years. Ex–NICE Head of International Affairs Meindert Boysen emphasized the two-way benefits of collaborations, providing an opportunity to learn from other organizations just as much as implementing lessons learned elsewhereAn audience poll showed good awareness of some of the regional CBCs, such as BeNeLuxA, the Joint Nordic HTA Bodies, and the Nordic Pharmaceutical Forum. By comparison, there was much less recognition of some of the pan-European initiatives—notably, the National Competent Authorities on Pricing and Reimbursement (NCAPR) and the Novel Medicines PlatformPanelists noted the benefits of CBCs, such as sharing workload, boosting bargaining power, and sharing expertise across borders. However, CBCs also come with several challenges, such as maintaining resources and legal limitations on what can be done in certain countries
The Danish government has proposed a draft bill to enable confidential price negotiations within the medicine reimbursement system, which it intends to finalize by December, aiming for parliamentary approval and implementation by mid-2025The proposed law will allow confidential price negotiations between pharmaceutical companies and Amgros, Denmark’s regional purchasing organization, for certain new or expensive medicinesIn response, the Danish Association of the Pharmaceutical Industry (Lif) welcomed the proposal. However, it warned that mandating reducing total regional reimbursement costs could deter companies from participating in the scheme
A panel at ISPOR Europe 2024 discussed the potential ripple effect of the European Union's Joint Clinical Assessment (JCA) on health technology assessment (HTA) in non-EU countries. Fang-Ju (Irene) Lin, PhD from the National Taiwan University, used Taiwan as a case study and explained that while the JCA might improve efficiency and quality of evidence, it may also increase workload due to detailed referencing and local adaptationWhile HTA in Taiwan already references reports from other countries like the UK, Canada, and Australia, especially for high-cost cancer drugs, Lin believes JCA could be helpful in aligning Taiwan’s standards with international best practicesShe noted the JCA “may also improve access to high-quality evidence, especially for rare diseases, and help inform PICOs considerations. For example, it can help identify key patient-centered outcomes to prioritize. Overall, JCA results could strengthen confidence in clinical assessments.”
Speaking at ISPOR Europe, Johan Pontén from Sweden's TLV discussed the reduction in regulatory data protection in Europe under the legislation reviewHe explained: "The patent system, as highlighted in the blue section of the chart (see below), often provides longer protection for most drugs currently on the market than the combined data and market protection. This means that only a few drugs on the market today would actually be affected by this change. As a result, the cost-saving potential in this aspect of the proposal is quite limited.”Pontén also criticized the confusing definitions of unmet medical need and high unmet medical need in the legislation review, suggesting that the definition of the two in the text is “essentially identical…which is problematic and, frankly, disappointing”
During the ISPOR Plenary session titled "Ready, Set, Go: The Last Sprint for the EU HTAR", Vanessa Schaub, Head of Global & EU HTA Strategy at Roche, discussed how Roche is preparing for the upcoming EU HTA Regulation (HTAR) starting in January 2025 Schaub emphasized the transformative potential of HTAR, highlighting that it will replace the fragmented system of 27 parallel HTA procedures. She noted that a unified approach under HTAR will foster “more predictability and a unified approach which will then also help us getting innovation faster and better” Schaub acknowledged the constraints faced by smaller companies in adapting to HTAR, while recognizing their agility. She noted, “Size and scale might be an advantage on the one hand, but on the other hand, smaller companies might be able to move, focus faster”
The Medicare Drug Price Negotiation Program in the U.S. poses uncertainties about its potential impacts globally. Europe's pharma policy and HTA stakeholders are keeping tabs on how the Act may affect the landscape, particularly in light of the EU Pharmaceutical LegislationIn the first round of negotiations, prices fell from 4.2 times to 2.9 times those in other foreign countries on average. However, Inma Hernandez, PharmD, PhD, University of California San Diego, believes that these initial results may not predict future outcomes. Hernandoz believes that future chosen drugs in the negotiation process will have lower rebates, and the focus will shift from the outcome-driven approach to process-drivenBased on the first round of negotiations, Hernandez suggested that the CMS “generated modest savings (at most),” adding “The negotiation process had many elements of uncertainty, but the outcome was largely predictable.”
Speaking at ISPOR - The Professional Society for Health Economics and Outcomes Research Europe 2024, Birgitte Klindt Poulsen, upcoming chair of the Danish Medicines Council, talked in a panel about how sparse clinical data can cause uncertainty around the effectiveness and safety of treatmentsPoulsen underlined that approving a drug based on insufficient data could result in wasted resources and prevent patients from accessing more effective treatments. She added that making decisions with sparse data can potentially harm patients, which could even be fatal in some casesPoulsen suggested that the European Medicines Agency (EMA) should “step up” in the area of confirmatory trials, to avoid prolonged periods of uncertainty, adding that the current withdrawal rate from confirmatory trials is “concerning.”
Speaking at ISPOR—The Professional Society for Health Economics and Outcomes Research Europe 2024, Pedro Facon of Belgium’s National Institute for Health and Disability Insurance expressed skepticism toward the effectiveness of Managed Entry Agreements (MEAs) in reducing uncertainty around new productsWhile MEAs are good at containing costs, he notes that the research design is often poorly executed, and both pharma companies and payers aren't adequately evaluating the gathered evidenceFacon also spoke openly about his concerns around uncertainty being used as a "negotiating chip"
Johnson & Johnson is suing the federal government over the Health Resources and Services Administration's (HRSA) efforts to block the drugmaker from implementing changes to how it provides discounts under the 340B Drug Pricing ProgramIn August, J&J notified hospital customers that the company intended to stop providing upfront 340B discounts on Stelara (ustekinumab) and Xarelto (rivaroxaban) starting October 15, 2024. Instead, J&J proposed making 340B discounts for the two drugs through a rebate system. However, HRSA threatened to terminate J&J's Pharmaceutical Pricing Agreement (PPA) and impose sanctions on the company if it carried out its rebate planJ&J has responded by initiating a legal challenge against the agency. The drugmaker is asking the court to declare its proposed rebate model legal under 340B statute and to protect it from any related enforcement actions
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