Decision to include in joint introduction
The New Therapies Council decides whether a medicine or a new indication should be included in the joint national introduction. A decision on national joint introduction will lead to a recommendation from the New Therapies Council to the regions on how to implement the medicine.
New therapies are presented to the New Therapies Council based on the early assessment reports from the horizon scanning process. The regions have also been asked whether they wish the medicine to be handled through national joint introduction or not, guided by the following general criteria:
- If equal use across the country is important
- High to very high severity of the condition
- Expected large resource impact
- Ethically or politically challenging
One region can nominate a medicine for recommendation by the New Therapies Council. They can also nominate older pharmaceutical therapies to the New Therapies Council, for example when an older pharmaceutical receives a new indication that may have an impact on the healthcare system.
The New Therapies Council's assessment is guided by the criteria set out above. The Council's decision can have two outcomes:
- The medicine/indication is included in the process of joint introduction
- The medicine/indication is not included in the process of joint introduction
When the New Therapies Council has made a decision, they notify the affected pharmaceutical company and all regions. The medicine or indication is also published as a pending case on this website.
Decisions about joint introduction are often made before the pharmaceutical has been approved by the European Medicines Agency (EMA). If and when the medicine receives marketing authorisation, the New Therapies Council generally recommends the regions to delay the introduction of the treatment until the New Therapies Council has access to enough information to issue a recommendation.
Prescription medicines are generally not included
Prescription medicines are generally not included in the joint introduction through the New Therapies Council, as they are handled through the Dental and Pharmaceutical Benefits Agency, TLV. However, the New Therapies Council can make recommendations regarding prescription medicines in any of the following cases:
- If new prescription and requisition medicines are in the same therapy area, and there is a need for a coherent therapy area recommendation to support the regions’ introduction process.
- If the medicine's role in the therapy has to be clarified, because it is important to have equal use nationally and/or because the medicine is expected to have a large impact on resources.
- If the regions need to wait for a formal benefits decision from TLV, for example because the medicine has a large impact on resources, because there is a risk of unequal care or because the medicine is already included in the benefits for another indication. The recommendation to wait is archived (and thus invalidated) when TLV has issued its decision.
The regions cooperate in a designated working group with so-called tripartite negotiations for certain medicines that are the subject to benefit applications at TLV. The New Therapies Council has no role in this.
When a medicine is not included in joint introduction
The New Therapies Council can decide for a medicine or indication NOT to be covered by national joint introduction for several reasons, for example:
- The budget impact is deemed to be so small that a health economic evaluation is not necessary.
- There are other processes that can ensure equal drug use.
- The use of the medicine is not expected to be marginal, or can be handled through a benefit application with TLV.
In cases where the New Therapies Council assesses that a medicine should not be covered by national joint introduction, it is up to care program groups, medicine committees and the regions to handle the introduction according to their regular routines.
A decision to not include a medicine in the national joint introduction process is not a dissuasion from using the medicine, it merely entails that the New Therapies Council will not issue a recommendation for the regions on how to implement the medicine.
A list of medicines that are NOT included in joint introduction, and thus are handled regionally, is presented on this website.