Horizon scanning involves collecting and evaluating information about new pharmaceutical treatments before they are approved for marketing authorisation. The regions then get better foresight in the work of preparing for the introduction of new medicines.
The Horizon Scanning working group continuously maps which new medicines and indications are expected to be approved within the EU and launched on the Swedish market in the foreseeable future.
The horizon scan takes place in three stages:
- Data is collected to map medicines on their way to the Swedish market, approximately one to two years before approval. This is done partly by monitoring various sources and databases, and partly through regular pipeline meetings with the pharmaceutical companies.
- Collected data is filtered and condensed into a list of medicines that are deemed to have an impact on the healthcare system. The selection takes place according to criteria described below. The list is forwarded to the regions.
- For these pharmaceuticals, the Horizon Scanning working group writes an early assessment report that describes the current scientific evidence about the treatment and the consequences it may have for the healthcare system. The aim is to release this report around six months before the pharmaceutical is approved within the EU.
Criteria for selection
In order to be selected in the horizon scan, and thus proposed for national coordinated introduction, the substance or indication must meet at least one of the criteria below:
- Large patient population
- Significant morbidity associated with the condition
- Potential to clinically improve patient outcomes
- Innovative method of treatment
- Potential cost implications
- May require reorganisation of the health care system
- Potential to influence treatment guidelines and other recommendations
- Potential safety issues needing consideration
- Potentially high media/public interest
- Non-optimal introduction rate following marketing authorisation
- Potentially interesting from a legal, ethical or political perspective
Consideration is also given to the substance/indication if it:
- Belongs to a growing class of medicines or therapy area.
- Represents a new form of treatment or a new class of medicines
- Is relevant to Swedish conditions.
- Is in late phase clinical trials (Phase II or Phase III) or has been submitted to regulatory agencies for approval.
The Horizon Scanning working group first makes an internal assessment of which substances/indications that are of interest. In complicated cases, the group seeks advice from the regions' expert groups. The experts' opinions are then weighed in.
Early assessment reports
The early assessment reports are forwarded to the pharmaceutical companies concerned, the regions and the New Therapies Council. The Horizon Scanning working group also communicates directly with appointed contact persons in the regions.
A list of current early assessment reports are presented on this website.