Horizon scanning

The national process of introducing new medicines starts with horizon scanning. The aim of the work is to gather, document and validate information on new medicines or indications before these are granted marketing authorisation. This facilitates the county councils’ long-term planning, with the possibility of preparing the health care sector for the introduction of new medicines. Horizon scanning also provides the county councils and the New Therapies Council (NT-rådet) with a basis for decisions on whether a new medicine should be included in the national process for managed introduction.
The Horizon scanning collaboration has been carried out since 2009 by the four largest county councils: the Region of Västra Götaland, the Region of Östergötland, Stockholm County Council and the Region of Skåne.

Methods

The horizon scanning working group continuously identifies new medicines and indications expected to be granted marketing authorisation within a foreseeable time in three steps as described below:

1. Data collection, monitoring sources
2. Filtration and condensation of collected data – about 1–2- years before expected marketing authorisation. This results in a list of early assessment reports (i.e. a more thorough literature examination) to come, which is communicated to the county councils.
3. Comprising an early assessment report which describes the current state of knowledge. The report is provided to the county councils about 6 months before market authorisation.

Criteria for selection

The filtration of data is carried out in two steps. The first step is within the working group. The medicines/indications which are assessed as interesting or that are difficult to decide on, are referred to the county councils’ clinical experts. The second step is deciding which early assessment reports to write; this is based on the experts’ opinions.
In the filtration process, several criteria are taken into consideration. These criteria are listed below.

• Size of patient population
• Severity of the disease
• Potential to clinically improve patient outcomes
• Innovative way of treating the disease
• Potential to affect treatment costs
• May require reorganisation of the health care system
• Potential to influence treatment guidelines
• Potential safety issues needing consideration
• Potentially high media/public interest
• Non-optimal introduction rate following marketing authorisation
• Potentially legally, ethically or politically interesting

It is also taken into consideration whether the medicine/indication:

• 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 is submitted to regulatory agencies

Communication

The medicines or indications selected for assessment are listed on the web site for national managed introduction of new medicines. The Horizon Scanning Working Group also communicate directly with contacts in each of the county councils.