Written by Beth McCormick, Senior Analyst
France’s cost-effectiveness body, CEESP, currently reviews manufacturer’s economic analyses and determines the potential budget impact on health insurance expenditure. However, a report by France’s National Audit Office has recommended CEESP transforms into an organization which conducts independent cost-effectiveness analyses, like England’s National Institute for Health and Care Excellence (NICE) [1].
The impetus behind this transformation:
Oncology therapies have shown significant therapeutic progress in the past decade, but now pose long-term financial challenges for the healthcare insurance scheme. To combat rapidly increasing costs of cancer drugs, France’s National Audit Office recommends adopting a cost-effectiveness model similar to NICE for new drug evaluations. It is currently unclear if this recommendation would impact all drugs or be limited to drugs with oncology indications.
France’s authorities do not currently have ring-fenced budgets for oncology therapies; while these are well established in England, including the Cancer Drugs Fund and the Innovative Medicines Fund [7]. Without these types of budgets, patient access to the growing number of high-cost, innovative oncology therapies could be impacted in France.
In England, NICE conducts cost-effectiveness analyses on new drugs by calculating the incremental cost-effectiveness ratio (ICER), which estimates the cost per quality-adjusted life year (QALY) gained. The ICER is then compared to established thresholds, typically £20,000 to £30,000 per QALY for standard treatments, with some flexibility for severe or rare diseases, to determine whether a treatment is considered cost-effective and recommended for NHS funding [2].
France’s National Audit Office points towards the limited quality of economic analyses submitted by manufacturers to CEESP. Between 2017 and 2022, CEESP was unable to determine the cost-effectiveness of submitted therapies in 39% of cases due to inadequate submissions [1].
The impact of the joint EUHTA:
With the imminent introduction of the joint EUHTA, independent economic assessments by CEESP would provide an additional step to maintain decision-making autonomy in France. While clinical assessments will occur at the EU level, member states will retain price and reimbursement negotiation powers with manufacturers based on individual criteria and economic evaluations [3].
Across Europe, several HTA bodies are increasingly incorporating cost-effectiveness models into their evaluation processes to ensure new drug prices reflect a therapy’s true value. In 2019, Spain introduced cost-effectiveness analyses for new therapies following NICE’s methodologies [4].
Executing this transition:
The execution of independent cost-effectiveness analyses by CEESP will certainly increase the negotiating power of the Economic Committee for Health Products (CEPS) in pricing negotiations. However significant organizational transformation of CEESP is necessary to implement a policy change to conduct more rigorous, independent analyses.
CEESP currently provides advice and input to CEPS on economic evaluations, which are typically only requested for drugs which achieve an ASMR III or above, alongside a high expected budget impact. However in the majority of assessments, the clinical benefit of the product versus the standard of care is the main driver of reimbursement, and cost effectiveness evaluations are not required. Therefore, CEESP is composed of only 31 members due to the limited use of cost-effectiveness in French assessments [5].
On the other hand, NICE is responsible for conducting rigorous cost-effectiveness analyses for all new therapies in England. NICE has a vastly different workforce compared to CEESP, currently employing around 700 full-time experts [6].
Key considerations for manufacturers:
Historically, lower prices are achieved in cost-effectiveness markets due to the methodological calculation of the ICER, strict thresholds, and confidential price negotiations. While cost-effectiveness is not a new concept in France, the addition of independently conducted cost-effectiveness analysis to the clinical-benefit assessment completed by HAS may extend the assessment and negotiation timelines for new therapies in France.
The prospective implementation of more rigorous cost-effectiveness analysis in France, potentially for a wider range of drugs, will require additional planning and investment by manufacturers. Manufacturers would be required to provide additional evidence to input into cost-effectiveness analyses, which could include direct and indirect healthcare costs of the therapy versus current treatment practices in France. If this transition is implemented, manufacturers should engage with CEESP to understand which drugs are more likely to be subject to a cost-effectiveness analysis to enable adequate preparations to be made. Manufacturers should also seek to understand the potential implications on price potential for new therapies in France.
At P4A, we have extensive experience in supporting our clients navigate the complex market access landscape of Europe through our tailored market entry approaches. We remain vigilant in tracking the dynamic European access environment to provide our clients with expert advice on determining their worldwide launch strategies.
Sources:
[1] https://www.ccomptes.fr/sites/default/files/2024-05/20240529-RALFSS-2024.pdf
[4] https://partners4access.com/blogs/is-spain-becoming-a-cost-effectiveness-market-for-biopharma/
[5] https://www.has-sante.fr/jcms/c_2036304/en/economic-and-public-health-evaluation-committee
[6] https://www.inahta.org/members/nice/
[7] https://www.abpi.org.uk/value-and-access/innovative-medicines-fund-imf/
