Unlocking oncology access: What the OECD findings mean for market access in 2025

As oncology innovation accelerates, ensuring timely and equitable patient access is a shared priority for healthcare product manufacturers, healthcare policymakers, and payers. The OECD’s 2024 report on Access to oncology medicines in EU and OECD countries highlighted challenges in delivering equitable patient access.[i] One year on, these findings remain highly relevant, particularly considering new policies shaping the market access landscape, such as the introduction of the EU HTA for oncology medicines.

This article explores what these findings mean today and how key stakeholders can collaborate to overcome these access barriers.

Key challenges in oncology access

The OECD report highlighted a rapid rise in oncology drug approvals, from four medicines annually between 2004-2011 to 17 and 15 medicines in 2021 and 2022, respectively.¹ Despite this, inequalities remain across every stage of the regulatory, access, and commercialisation life cycle, including clinical uptake and real-world utilisation.

Five challenges identified by the OECD that particularly impact market access are explored further in this article, where we also aim to discuss how stakeholders can mitigate these access barriers:

1. Delays from regulatory approval to HTA and reimbursement
2. Immature evidence for oncology medicines seeking reimbursement
3. Growing affordability and budget impact concerns
4. Lack of coupling of the reimbursement of diagnostics and medicines
5. Slow uptake and utilisation of medicines into clinical practice

Tackling these barriers to access is not only a concern for healthcare systems, but also product manufacturers, as delays impact both patient outcomes and a company’s return on investment potential.

Accelerating reimbursement timelines

Delays between regulatory approval and reimbursement remain a barrier to timely access. The OECD examined timelines for a sample of breast and lung cancer medicines that had received EMA authorisation in January 2016 and had high European Society for Medical Oncology’s Magnitude of Clinical Benefit Scale (ESMO-MCBS) scores. By April 2023, reimbursement rates varied widely, from 100% in Germany and 92% in the Netherlands, to 31% in Cyprus and Latvia, and 0% in Malta. Time from marketing authorisation to reimbursement were similarly variable, ranging from under 100 days of less in Germany and Sweden, to over three years in Cyprus, Latvia, and Lithuania.¹

Based on the OECD report, two key factors can be identified as contributors to these delays. First is the timing of the manufacturer’s reimbursement application. The OECD report noted a trend towards longer delays to reimbursement application in countries with lower GDP per capita.¹ This could be reflective of manufacturer launch strategies, with lower GDP countries being deprioritised for launch. The second aspect is how long the HTA process takes, which can vary depending on HTA body capacity, process complexity, and resourcing.

Manufacturer market access teams may mitigate these delays by including lower-income countries within their first-wave launch markets, resulting in earlier filing of reimbursement applications in lower-income markets. This could be of particular value in countries where HTA pathways are predictable. Meanwhile, the joint EU HTA for oncology medicines offers potential for streamlining clinical assessments,[ii] reducing duplication and improving efficiency in countries with limited HTA capacity. Earlier planning for country-specific reimbursement processes that includes a wider range of markets covering a broad spectrum of low to high income countries could therefore help manufacturers accelerate equitable access to oncology medicines whilst optimising launch performance.

Navigating evidence expectations

Oncology medicines commonly gain regulatory approval with limited clinical data from early phase trials, which results in uncertainty for payers. Manufacturers should consider outside the box access agreements with payers that help to manage this uncertainty. Analysis highlighted by the OECD report showed that 80% of EMA approvals (between 2010 to 2019) were supported by at least one randomised controlled trial (RCT),¹ although it was noted that there was wide variability in study design, i.e., blinded vs unblinded, and overall survival as a primary endpoint vs other surrogates as the primary endpoint.^1,[iii]

Managed entry agreements (MEAs) are commonly used to address clinical data uncertainty, with 86% of countries in the OECD report using financial MEAs, such as rebates/discounts, price-volume agreements, or expenditure caps. Meanwhile, 67% of countries used performance-based MEAs (such as reimbursement on the condition of additional evidence development and payment-by-result type approaches), and 33% of countries used post-marketing studies.¹ Challenges to using performance-based MEAs include lack of infrastructure, including administrative capacity, adequate IT systems to report on outcomes that can then be linked to financial agreements, and defining relevant disease outcomes to measure performance.

Payers, regulators, and manufacturers should consider early collaborative discussions to align on trial design, endpoints, and evidence expectations prior to market entry. This may include co-developing protocols for patient-relevant outcomes with key stakeholders, including patients, and establishing robust data infrastructure for reporting.

Planning for budget impact

With rising pressure on healthcare budgets, affordability considerations must be built into pricing and access strategies early. In the 2024 OECD report, 79% of countries felt budget impact was of increasing importance in coverage and reimbursement decisions, with reasons such as high prices of new medicines, increasing numbers of new medicines, and increasing numbers of cancer patients cited as key considerations. Even in countries that were not reporting an increase in the importance of budget impact, the OECD report suggests this could be because budget impact was already a central factor in decision-making in these countries. For example, this may well be the case for countries such as Estonia and Iceland.¹

Manufacturers should consider strategies to anticipate and manage budget impact early in development, including integrating budget modelling earlier in development and pressure-testing launch plans against different uptake scenarios. Innovative contracting models, such as budget caps with risk-sharing and indication-based pricing could also be explored. For manufacturers with multi-product oncology portfolios, cross-portfolio negotiations could be considered to balance pricing flexibility with access. In addition, the growing interest in value-based pricing (VBP) highlights the importance of aligning clinical and economic value narratives from the outset, including support from real-world evidence to reinforce the value proposition of therapies over time.

Integrating diagnostics strategy

Personalised treatment in oncology depends not only on novel targeted therapies, but also on timely access to companion diagnostics that identify relevant biomarkers in a patient’s tumour.[iv]ECD report highlighted that reimbursement of the companion diagnostic is not automatically coupled to reimbursement of the medicine in most countries, but that 47% of EMA approvals for solid tumours were based on biomarkers.^1,[v] This can lead to situations where payers may reimburse a cancer medicine, but not the required diagnostic, leaving patients to pay out of pocket or rely on manufacturer support programmes.^1,[vi]

The EU HTA Regulation introduced joint clinical assessment (JCA) for certain new oncology medicines from January 2025,[vii]^,[viii] creating a shared clinical evidence base intended to streamline clinical value assessment while pricing and reimbursement decisions remain the decision of individual member states. There is no explicit requirement in the JCA to submit companion diagnostic data as a separate element. However, the dossier submitted for the assessment is the same as that used for regulatory approval,⁸ implying that any biomarker requirements listed in the summary of product characteristics would be visible to national HTA bodies. In parallel, the joint scientific consultations (JSC) now allow developers to seek coordinated advice on medicines and related diagnostics.[ix] This creates an opportunity to align evidence generation and strengthen the case for coordinated reimbursement strategies, as well as highlight potential gaps in access to diagnostics for national decision making.

For manufacturers, this increases the importance of integrating diagnostic strategy into early clinical and market access planning, something that can be optimally achieved through partnerships between medicine and diagnostic manufacturers. This approach could strengthen the link between therapy and diagnostics in future HTA processes, creating a clearer pathway for coordinated access once EU and national assessments are complete. In addition, both medicine and diagnostic manufacturers should consider how they can help to integrate diagnostics into the care pathway and help build infrastructure where the lack of infrastructure is a clear barrier.

Driving real-world uptake and equity

The 2024 OECD analysis showed that, even after cancer drugs are funded, real-world uptake can be slow. This may be due to hospital testing infrastructure limitations, outdated clinical guidelines and protocols, lack of staff training, and high patient co-payments restricting patient affordability.¹

Patient access to clinical trials and early access schemes varies widely. Although clinical trial participation can give early access to new oncology medicines, the numbers of oncology trials range from under two per 100,000 people in Romania and Croatia, to over 10 per 100,000 people in Denmark and Belgium, with trial sites often concentrated in wealthier regions.^1,[x]

In OECD countries, named-patient schemes remain the primary route for early access. These individual, case-by-case programmes are administratively burdensome and benefit fewer than 10% of clinically eligible patients, tending to favour well-informed patients or those treated by certain clinicians.¹ To address these disparities, the OECD suggests shifting to population-based schemes,^1,[xi] which operate under central protocols with predefined eligibility, monitoring, and oversight, thereby enabling broader reach and systematic data capture. However, these programmes require upfront governance, diagnostic capacity, and data infrastructure. According to 2023 survey data, seven OECD countries appear to have such schemes.¹

Addressing gaps in real-world uptake and equity offers both commercial and patient benefit. Manufacturers may help accelerated uptake by providing support such as supporting establishment of testing infrastructure and providing staff training. Digital tools like shared patient registries and virtual tumour boards of healthcare professionals might improve patient identification and enable the sharing of best practices. Regional pilots could be used to build payer confidence and encourage equitable uptake.

Closing gaps in access to oncology medicines

Ensuring timely and equitable access to oncology medicines requires a co-ordinated approach across the medicine life cycle from evidence generation and market access to diagnostic integration and real-world uptake. One year on, the OECD’s findings on barriers to access to oncology medicines remain important. Whilst the EU HTA for oncology medicines could offer an opportunity to streamline some aspects of access delays and inequalities, this will still require collaboration between stakeholders, and we are yet to see if such schemes do have a material impact on improving equitable and timely access.

For manufacturers, early market access planning is critical and should include aligning launch strategies in light of the EU HTA, engaging early with payers and regulators on evidence requirements, and integrating considerations on how to manage payers’ budget impact concerns into access strategy and planning. Innovative contracting models, value-based pricing, and coordinated reimbursement of diagnostics and treatments could help overcome access and affordability challenges. Finally, supporting real-world uptake of new oncology medicines by investing in diagnostic infrastructure, staff training, digital tools to improve patient identification and share best practices, and regional pilots for new treatments could further improve access and equity.

Manufacturers, healthcare policymakers, and payers should work closely to address access and uptake delays and variability. Early collaboration between these stakeholders could help reduce disparities in patient access and improve predictability of market access, overall aiming to improve patient outcomes.

References

[i] Hofmarcher T, Berchet C, Dedet G. Access to oncology medicines in EU and OECD countries. OECD Health Working Papers No. 170. Paris: OECD Publishing; 2024.

[ii] Hwang TJ, Vokinger KN. New EU regulation on health technology assessment of cancer medicines. Lancet Oncol. 2022 Feb. doi: 10.1016/S1470-2045(22)00008-0.

[iii] Farina A, Moro F, Fasslrinner F, Sedghi A, Bromley M, Siepmann T. Strength of clinical evidence leading to approval of novel cancer medicines in Europe: a systematic review and data synthesis. Pharmacol Res Perspect. 2021;9(6): e00816. doi: 10.1002/prp2.816.

[iv] European Society for Medical Oncology. Personalised cancer medicine: fact sheet. 

[v] Falcone R, Lombardi P, Filetti M, Duranti S, Pietragalla A, Fabi A, et al. Oncologic drugs approval in Europe for solid tumors: overview of the last 6 years. Cancers (Basel). 2022;14(4):889. doi: 10.3390/cancers14040889.

[vi] Normanno N, Apostolidis K, Wolf A, Al Dieri R, Deans Z, Fairley J, et al. Access and quality of biomarker testing for precision oncology in Europe. Eur J Cancer. 2022; 176:70-7. doi: 10.1016/j.ejca.2022.09.005.

[vii] European Commission. Joint clinical assessments. 

[viii] European Commission. Joint clinical assessment for medicinal products. Luxembourg: Publications Office of the European Union; 2024. ISBN 978-92-68-21595-1. doi: 10.2875/3592258. 

[ix] European Commission. Joint scientific consultations. 

[x] Carneiro A, Amaral TMS, Brandao M, Scheffler M, Bol K, Ferrara R, et al. LBA66_PR disparities in access to oncology clinical trials in Europe in the period 2009–2019. Ann Oncol. 2020;31(Suppl 4): S1196. doi: 10.1016/j.annonc.2020.08.2301.

[xi] Rex M, Allen N. Expanded access programs (EAPs) in Europe: are they right for your therapy? Partners4Access; n.d. 

About the authors

Dr Jasim Uddin is a principal and global market access lead in LCP’s Health Analytics team, with over 20 years of experience in healthcare product development. As a seasoned consultant, Dr Uddin has significant experience in navigating client market access challenges, with a track record of delivery on a range of global market access strategy, value communication, and cross-collaborative projects. Dr Uddin’s experience spans a diverse range of therapy areas and a wide range of healthcare product types, including pharmaceuticals, medical devices, diagnostics, and digital prescription therapeutics. He has a specific interest in payer value communications, particularly how to optimally translate evidence into meaningful communications and tools that aim to facilitate optimal patient access. Dr Uddin has held senior leadership roles in several consultancies and also has a wealth of experience working in industry, across roles spanning medical writing, pharmacovigilance, clinical research, medical ethics, medical affairs, market access, and expert engagement. Dr Uddin holds a BSc in Pharmacology with Toxicology from King’s College London and was awarded a PhD in Investigative Medicine from Imperial College London, where his doctoral research focused on investigating the neuro-immune mechanisms associated with bacterial and parasitic infections.

Dr Alice Beattie is a consultant in LCP’s Health Analytics team, with experience in supporting clients with diverse needs across market access and evidence generation. Dr Beattie combines clinical experience with analytical expertise to deliver impactful insights, drawing on her background as a medical doctor in the NHS in England. Dr Beattie’s clinical specialties including acute medicine, general surgery, and primary care experiences, which Dr Beattie now applies in analytical and strategic contexts in consulting projects to support clients in the health and life sciences sector. Dr Beattie originally studied Natural Sciences at the University of Cambridge before completing a medical degree at the University of Southampton. In addition, she was awarded a Master’s in Data Science for Health and Social Care from the University of Edinburgh.

Anukriti Banerjee is an analyst in LCP’s Health Analytics team, where she supports clients in navigating complex market access challenges through strategic research and evidence-based insights. Her work focuses on understanding how healthcare systems operate, how value is assessed and communicated, and how policy landscapes shape access decisions across markets. Banerjee has built experience across the life sciences space, from global health policy to cross-market research, and is drawn to the grey areas in access strategy, the questions that cut across commercial and public health priorities, and finding practical ways to move things forward in systems that are rarely straightforward. Banerjee brings a mixed-methods background to the table, combining qualitative research, policy analysis, and systems thinking. She works on making evidence clear, relevant, and usable for the people who need to act on it, whether that's healthcare providers (HCPs), payers, policymakers, or patients. Banerjee holds an MSc in Health Policy from the London School of Economics and a Bachelor of Social Science from the National University of Singapore. She is a member of Health Systems Global and enjoys staying plugged into new ideas from across the health policy world.