gms | German Medical Science

Horizon scanning means early systematic collecting, documenting, and assessing information about new pharmaceuticals that are expected to be approved within the EU and launched on the Swedish market in the foreseeable future. Collected data is filtered to identify pharmaceuticals that are deemed to have an impact on the healthcare system. Since 2009, Sweden has carried out a national structured horizon scanning as a first, basic, part in a joint national process for the introduction of new medicines. In Sweden, the healthcare organization is decentralized in regions. With the network-based joint national process for the introduction, the regions then get better foresight in the work of preparing for the introduction of new medicines. The aim of the process is to achieve an equal, cost-effective, and appropriate use of new medicines for all patients in the country, all regions.

As part of the work with horizon scanning, the healthcare regional organizations of clinical experts are involved in early comments on priority findings, e.g., level on innovation and unmet medical need. Later in the process, the clinical experts contribute through a more detailed comment in an early assessment report (may also be called high impact report) that describes the current scientific evidence on the treatment and the consequences it may have on the healthcare system. Early assessment reports are the final products of the horizon scanning process for prioritized new indications for already approved medicinal products and new pharmaceuticals.

A future including more individualized and highly specialized medicines including ATMP (Advanced Therapy Medicinal Product) will entail both organizational and major financial challenges. New legislations, e.g., the new EU HTA regulation (Regulation on Health Technology Assessment) and the proposed reform to the EU human medicines legislation, may entail opportunities but also challenges. For example, current clinical experts may become involved in more and other projects. In the proposed reform to the EU human medicines legislation, earlier approval for medicinal products is addressed, which may mean less evidence as basis for early assessment reports. This, in turn, can mean greater challenges during the latter part of the national process, e.g., for adequate decisions. A new database with horizon scanning data for the members of the IHSI (International Horizon Scanning Initiative), with associated high impact reports, means new opportunities and will require adjustment of the present national process for horizon scanning.