For decades, the free market model of the US healthcare system has been very attractive for biotech manufacturers, especially for revolutionary and blockbuster worthy therapies enjoying long-lived exclusivity periods. Recent developments in the US regarding the payer and PBM landscape and multiple attempts at pricing restrictions imposed by the last three administrations will likely force manufacturers to reconsider their launch and ongoing commercial strategies, both in the US and overseas. This article will discuss factors that require consideration for a successful EU or UK launch.
Evolving US Price Controls, and the Need for the EU and UK to Be on the Radar as Early as Possible
In recent years, the US pharmaceutical market is attempting a complex price control overhaul. In 2022, the Biden administration’s Inflation Reduction Act enacted the Medicare Drug Price Negotiation Program. This unprecedented legislation aims to reduce drug spending by the federal government and lower prescription drug costs for those covered by Medicare1. For the first time, the government is required to negotiate prices with manufacturers for publicly funded healthcare programs. Undoubtedly, these measures will have an impact on treatments widely utilised by the older and impoverished populations – including but not limited to costly oncology, immunological, and metabolic products. More recently, as part of Trump’s ‘Most Favoured Nation’ executive order, manufacturers are being pushed to match the lowest price for a product in selected countries abroad when selling to US consumers2. As these countries typically have price control mechanisms established, a manufacturer’s asset may have a significant discount imposed for access in the US. The introduction of these laws, therefore, has led to an understandable level of uncertainty for manufacturers. Now more than ever, US manufacturers must keep other markets – including EU and UK, in their decision-making processes.
There are three key factors that US manufacturers must consider in the EU to secure an optimal launch. These include:
- HTA Submission and Expectations of European HTA Bodies
- Impact of the Joint Clinical Assessment
- How Business Development Assessments Can Mitigate Launch Risk
HTA Submission and Expectations Differ Across European HTA Bodies
Manufacturers should begin developing and enacting their HTA strategy early, at least 2-3 years before EU or UK launch, to enable optimal access. An important factor in this strategy should be considering the different expectations held by national HTA bodies across Europe. Without planning for these specificities, access within specific nations may be impacted. For example:
In The UK, NICE requires that manufacturers principally demonstrate value by linking outcomes to QoL and cost-effectiveness benefits laying out specified QALY ranges for products to meet 3.
In Germany and France, the primary focus is on comparative evidence and patient outcomes. In Germany, a product must undergo an early benefit assessment to determine the additional benefit of a product4. The demonstration of additional benefit through clinical evidence and the identification of the appropriate comparators is key to reimbursement, as this is considered in pricing negotiations to determine the level of reimbursement. In France, manufacturers must demonstrate the clinical benefit (SMR) and added clinical value (ASMR) of a product5. The SMR will be linked to the reimbursement rate, whilst the ASMR will determine the price level achievable in negotiation by the manufacturer. As such, manufacturers must focus on the demonstration of worthwhile clinical benefit over existing therapies with clinical and economic data.
In Italy and Spain, the primary focus goes back to budget impact. In Italy, the added therapeutic value of a drug and level of innovation will be assessed against available standard treatments6. Pharmacoeconomic analysis is also required, including cost-effectiveness or cost-utility analysis, to enable price negotiation. In Spain, a manufacturer submits a value dossier which will lead to the development of a therapeutic positioning report which examines a drug’s clinical value, place in therapy, comparison to alternatives, and degree of innovation7. This, alongside the demonstration of cost-effectiveness and acceptable budget impact, will inform reimbursement decision-making.
Whilst each of these markets share aspects of their reimbursement decision-making processes, the specific requirements in the EU4 and UK markets differ from each other and from other smaller EU markets, leading to the necessity of early planning prior to navigating these expectations. US manufacturers should ensure they conduct a thorough assessment of HTA in priority markets for the asset and may also consider undertaking scientific advice processes in priority markets to gain advice backed by official HTA bodies to ensure the best likelihood of access.
Impact of the Joint Clinical Assessment
The Joint Clinical Assessment (JCA) is set to reshape the Premarket approval (PMA) landscape across the EU – covering all new medicines by 2030. Historically, manufacturers have submitted bespoke clinical dossiers separately to each Member State; the JCA is designed to replace that duplication with a single EU-level clinical evaluation, reducing administrative burden and facilitating earlier patient access8. Significant procedural uncertainties remain, however. A key concern involves Population, Intervention, Comparator, and Outcomes scoping (PICO) within the JCA. Member States propose consolidating PICO measures by the JCA co-assessors, thus giving manufacturers limited opportunity to influence the final list. A key concern is that there will be an overwhelming number of PICO measures proposed, and the 100-day deadline for evidence submission evidence may prove unrealistic9.
Moreover, although the JCA may harmonise clinical evidence assessment, economic evaluations will continue to be conducted nationally. Companies must therefore engage with HTA bodies and negotiate prices by country, each applying its own framework. Because most Member States have not yet published detailed guidance on how they will embed JCA outputs into local processes, manufacturers still face considerable uncertainty about the practicalities of this “harmonisation.”
US manufacturers, particularly those with limited experience navigating the EU HTA landscape, will need to invest in comprehensive forward planning to mitigate potential risks and fully capitalise on the opportunities presented by the JCA. Early engagement and resource allocation will be key to success, and manufacturers should consider allocating dedicated resources to evidence generation and internal coordination well ahead of EMA filing, potentially establishing specialised teams to manage the JCA process. Manufacturers should also ensure strong cross-functional collaboration, with close alignment between market access, clinical development, and commercial teams to optimise EU HTA strategy. This includes adapting early trial designs to meet anticipated evidence requirements, assessing the impact of the JCA on launch sequencing, and preparing for country-specific HTA follow-up. Furthermore, manufacturers should conduct robust PICO mapping ahead of finalising clinical trial design to ensure the most critical PICOs can be addressed to support a successful JCA evaluation. Finally, although eligibility criteria are stringent, manufacturers should assess the feasibility of seeking early scientific advice through the Joint Scientific Consultation (JSC) process. Engaging with the JSC at an early stage can provide critical guidance to optimise clinical development in line with EU-level HTA expectations.
How Business Development Assessments Can Mitigate Launch Risk
A key strategic consideration linked to HTA expectations and the impact of the JCA is the need for manufacturers to undertake launch sequence modelling as part of early planning for EU and UK market entry. This early strategic planning is critical to ensuring optimal patient access and maximum commercial success.
Launch sequence modelling enables manufacturers to systematically evaluate and prioritise key markets, accounting for a range of factors which may carry inherent uncertainty. These include market prioritisation, regulatory and HTA timelines, pricing strategy, and broader commercial considerations. While regulatory approval in the EU is centralised via the EMA, in the UK marketing authorisation is granted by the MHRA. In addition, early access pathways such as the EMA’s PRIME scheme must be incorporated into strategic planning to align timelines and facilitate early dialogue with regulators and HTA bodies. Misalignment between regulatory approval, HTA submission, and national reimbursement timelines can lead to delays in patient access and lost commercial opportunity.
As discussed previously, PMA strategies vary across the EU. Key variables such as pricing flexibility at launch and international reference pricing rules must be considered to prevent unintended price erosion or access delays. Manufacturers must also account for additional factors such as target list and net prices, patent life and market exclusivity, and country-specific healthcare system structures in their early strategy. To navigate these complexities, manufacturers should initiate launch sequence modelling early in the asset’s development programme, to allow sufficient time to align clinical development, regulatory filings, value evidence generation, and market access planning.
Conclusion
Given the continually evolving pharmaceutical landscape across the EU and UK, US manufacturers must adopt a proactive, structured approach to strategic planning to secure optimal market access. Initiating this process ideally at least 2-3 years prior to launch is essential to navigate the complexities of regulatory, HTA, and pricing requirements across the EU and UK. Key components of early strategic planning should include:
- In-depth analysis of HTA processes in priority EU and UK markets to understand country-specific evidence expectations and decision drivers
- Assessment of opportunities for early scientific advice with national HTA bodies to align clinical and economic evidence generation strategies
- Comprehensive understanding of PICO mapping and price comparators in each country to anticipate outcomes and expectations within the JCA
- Evaluation of feasibility for the JSC to receive consolidated EU-level guidance on clinical development planning
- Early-stage launch sequence modelling and BD assessment planning
Remap Consulting offers end-to-end support to US manufacturers as trusted external advisors. This includes strategic input across the product lifecycle—from early planning to post-launch value optimisation. Our services cover the development of HTA evidence dossiers, PICO mapping for JCA readiness, and bespoke launch sequence modelling. Through close collaboration, we ensure that US manufacturers are equipped with the right insights and tools to execute a successful EU and UK launch strategy. For more information, reach out to Jessica Riggs Ivy at jessica.riggsivy@remapconsulting.com.
References
- FAQs about the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. KKF. https://www.kff.org/medicare/issue-brief/faqs-about-the-inflation-reduction-acts-medicare-drug-price-negotiation-program/. Accessed 22nd July 2025.
- Trump signs an order to reduce drug prices, but it’s unclear how it would work. NPR. https://www.npr.org/sections/shots-health-news/2025/05/12/nx-s1-5395625/trump-lower-drug-prices. Accessed 22nd July 2025.
- The guidelines manual. NICE. https://www.nice.org.uk/process/pmg6/chapter/assessing-cost-effectiveness. Accessed 22nd July 2025.
- The benefit assessment of medicinal products in accordance with the German Social Code, Book Five (SGB V), section 35a. G-BA. https://www.g-ba.de/english/benefitassessment/. Accessed 22nd July 2025.
- Pricing & Reimbursement of drugs and HTA policies in France. HAS. https://www.has-sante.fr/upload/docs/application/pdf/2014-03/pricing_reimbursement_of_drugs_and_hta_policies_in_france.pdf. Accessed 22nd July 2025.
- Innovative medicinal products. AIFA. https://www.aifa.gov.it/en/web/guest/farmaci-innovativi. Accessed 22nd July 2025.
- Informes de posicionamiento terapéutico. AEMPS. https://www.aemps.gob.es/medicamentos-de-uso-humano/informes-de-posicionamiento-terapeutico/?lang=en. Accessed 22nd July 2025.
- Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance). European Union. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282. Accessed 22nd July 2025.
- Are pharmaceutical companies ready for EU JCA. Simon Kucher. https://www.simon-kucher.com/en/insights/simon-kucher-industry-insights-are-pharmaceutical-companies-ready-eu-jca. Accessed 22nd July 2025.