How do the BeNeLuxA and FINOSE collaborations compare?

How do the BeNeLuxA and FINOSE collaborations compare?

There are some obvious similarities between the FINOSE collaboration in the Nordic countries and the BeNeLuxA Initiative in terms of market access, but there are also some differences to highlight.

The BeNeLuxA collaboration began in April 2015 with Belgium and the Netherlands as the initial partners, with Luxembourg joining in September 2015, Austria joining in 2016 and Ireland in June 2018. The FINOSE Nordic collaboration was launched in 2017 for an initial period of three years. The collaborating agencies which form FINOSE are Sweden’s Dental and Pharmaceutical Benefits Agency (TLV), the Norwegian Medicines Agency (NoMA) and the Finnish Medicines Agency (Fimea). The BeNeLuxA Initiative and the FINOSE collaboration have both been created to empower the smaller composite countries or organisations and have greater impact collectively than alone. Both collaborations have developed a clear joint market access process by joining forces to improve efficiency and patient access.

Why were FINOSE and BeNeLuxA developed?

The aims of the FINOSE collaboration specifically are:

  •  supporting timely and equal access to medical technologies

  •  gaining additional knowledge about the products

  •  increased efficiency in production of assessment reports

  •  less divergence in health technology assessment (HTA) methodologies and evidence requirements

  •  reduced complexity in industry submissions.

  •  reduced complexity in industry submissions.

    The BeNeLuxA initiative aims to:

  •  create sustainable access to, and appropriate use of, medicines in the participating countries

  •  increase patients’ access to high-quality and affordable treatments.

The BeNeLuxA collaboration works together on horizon scanning, information sharing and policy exchange, HTAs and pricing and reimbursement.

What value do the collaborations add?

Like the BeNeLuxA organisation, the FINOSE collaboration is designed to bring together smaller countries to become a more powerful entity when it comes to market access. In contrast to BeNeLuxA, FINOSE do not undertake horizon scanning, but do undertake a joint HTA process and pricing decisions.

Through the FINOSE and BeNeLuxA collaborations, the HTA process is expected to take 90 days as opposed to upwards of 150 days if submitting via individual collaborating countries, so the benefits to using the schemes are clear in terms of timescale, for pharmaceutical companies and patients alike. The FINOSE approach is similar to that of the BeNeLuxA Initiative, in that when a company applies for joint approval, the processes for all the organisations involved happen in parallel and a decision is provided at the end of the process.

Unlike the BeNeLuxA Initiative, the FINOSE collaboration is still in relative infancy. The FINOSE collaboration was operating as a pilot project until very recently (June 2020) and there are some improvements and refinements to be made, such as clarity over the total timeline for the process and information sharing between the HTA organisations. FINOSE has already agreed to create a common report template as well as a shared communication platform to aid transparency and clarity. However, a Memorandum of Understanding was signed in June 2020 to extend the FINOSE collaboration until at least June 2023.

It is expected that collaborations such as these will continue to be of importance and value when gaining market access. Finding ways to engage with these transnational collaborations is likely to provide benefits to industry by streamlining complex regulatory and HTA processes and will ultimately benefit patients through speeding up access to treatments. MAP BioPharma has been engaged throughout this process and will continue to help our members with our insights and experience.

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Tash Elmore

Associate Consultant, MAP Online

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