The New Therapies Council has the regions' mandate to issue recommendations on the use of medicines that are subject to national joint introduction. The aim is to achieve equal access to new medicines through efficient use of our common resources.
The New Therapies Council's recommendations to the regions must be based on the same principles, regardless of pharmaceutical or medical condition.
Ethical platform for prioritization
The recommendations are based on the assessment of a medicine's value at patient group level and are based on the ethical platform for prioritization adopted by the Swedish Parliament in 1997. The ethical platform has three principles in hierarchical order, but must be handled as a whole:
- Human value: The health care system must respect the equal value of all people.
- Needs and solidarity: More of the healthcare resources should be allocated to those who have the greatest needs, the most severe illnesses and the poorest quality of life.
- Cost-effectiveness: A reasonable relationship between costs and benefits, measured in improved health and increased quality of life, must be pursued.
This means that the New Therapies Council sometimes needs to say no to a medicine, for instance if the price is so high that there is a risk of displacing other care for patients with equal or greater needs. The recommendations are formulated as a Yes or No To Use.
Assessment of willingness to pay
The New Therapies Council has a policy for assessing society's willingness to pay.
The recommendations are based on an assessment of the value of a new medicine, compared to the best current treatment for each medical condition. In its assessment, the New Therapies Council considers the severity of the disease, the efficacy of the treatment, the reliability of the scientific data and the size of the patient population.
These factors are put in relation to the cost per quality-adjusted life year (QALY) gained, which is estimated in the health economic evaluation from the TLV. The pharmaceutical company provides TLV with the basis for this assessment, and can thus contribute to increasing the reliability of the scientific data.
When the recommendation is ready
When the New Therapies Council issues a new recommendation, it is published on the web. The New Therapies Council also communicates directly with the regions' contact persons for pharmaceuticals and notifies the relevant patient organisations and the pharmaceutical company concerned.
Period of validity
The New Therapies Council reassesses its recommendations within two years of its first issue. The recommendation remains if it is still deemed to fulfil a function to ensure equal use. If the New Therapies Council considers that the medicine has been fully introduced in the regions according to the issued recommendation, the national joint introduction process is finalised and the regions are informed that the medicine henceforth is handled by the regional pharmaceutical committees.
If the recommendation is out of date, it may need to be revised. This can happen if, for example, the medicine has been approved for other indications, has another reimbursement limitation, new agreements have been added or other competing medicines have been introduced for the same indication.