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Country/JA: France flag France
Action type: Policy initiative

Problem: With many innovative therapies continually emerging, the potential clinical impact on therapeutic strategies and organizational impacts on health systems are substantive. It is therefore important to anticipate the arrival on the market of new drugs. Innovative medicines in oncology require specific considerations, including the variety of drugs, the preliminary status of clinical trials data, their non-comparativeness and the dynamics of this therapeutic area.

Objective: The French National Cancer Institute (INCa) aimed to implement a horizon scanning system (HSS), a process that allows decision-makers to anticipate clinical, economic and organizational impacts of innovative therapies and prioritize new and emerging anticancer drugs (including extension of indications) and their associated biomarkers. This included an explicit scoring method in order to help prioritize clinically impactful drugs.

Implementation status: Implementation is complete and the programme is ongoing

Key Contextual Factors

  • The principle of HSS applied to medicines is to identify emerging drugs before their marketing authorization and to anticipate their clinical, organizational and economic impacts.
  • In 2014, EuroScan developed a toolkit for the identification and assessment of new and emerging health technologies.
  • INCa is one of 11 European Union organizations performing HSS.
  • INCa is the preeminent health and science agency in charge of cancer control in France and reports to the Ministries for Health and for Research.

Key Components/Steps

  • Public procurement for development of the HSS was initiated in December 2017, with the vendor selected and initiating work by September 2018    
  • First version of the database was delivered in March 2019 with first results and prioritization of emerging drugs by the end of 2019
  • INCa developed a scoring method, integrating several indicators to prioritize clinical developments.  First, a score is attributed for six categories: (1) added therapeutic value; (2) availability of specific early access programme (ATU or RTU); (3) regulatory innovation; (4) pediatric population; (5) disease incurability; and (6) population size. Second, a list of filtered clinical trials is generated and sent to all relevant French stakeholders who attribute a score between 0 and 100 based on their assessment of the degree of innovation. Third, a final score is calculated based on the mean of the first two scores and the result is a list of prioritized medicines published on the INCa website.
  • In 2019, 78 developments of anticancer drugs were scored and prioritized.
  • Staff resources at INCa: 0.75 FTE staff involved with additional support from the IT team
  • Budget: 500 000€ for the 2 first years of the project

Main Impacts/Added Value

HSS is a standardized process to provides an overview of the landscape of upcoming innovative anti-cancer drugs, supporting the proper introduction and diffusion of innovative drugs on the territory. Having a methodology specifically developed for medicines in the field of oncology is very helpful to better anticipate challenges related to these innovative therapies.

Lessons Learned

  • Using a scoring system involving the key scientific societies and stakeholders is highly valuable for the prioritization of clinically impactful medicines.
  • Having a HSS in place with a structured database is a strong support to answer potential additional requests or to prepare thematic reports.

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