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Negotiation and Procurement

The regions act jointly to develop terms, including pricing, for medicines subject to national joint introduction. The regions and the Dental and Pharmaceutical Benefits Agency (TLV) often collaborate on prescribed medicines as well as medicines purchased by the regions for hospital care.

Negotiation and procurement of hospital pharmaceuticals

The health economic evaluation from TLV often concludes that the cost of a new medicine exceeds the regions' willingness to pay. For requisition medicines that are covered by national joint introduction, the New Therapies Council can then initiate negotiations with the company.

The assignment to negotiate is handled via the joint functions Market and Negotiation. The goal for the regions is to obtain terms for cost-effectiveness. This is often achieved via a reimbursement agreement, which means that the companies subsequently pay back part of the cost of a medicine to the regions.

A negotiation group with representatives from the regions is established by the Market and Negotiation functions. Medical expertise is also often included in the group.

If the results of the negotiation with the company are acceptable based on the regions' willingness to pay, the New Therapies Council can issue a recommendation to the regions to use the pharmaceutical for hospital care. All regions who wish to can then sign agreements with the company according to the negotiated terms. The refund received according to the agreement is usually covered by confidentiality at the company's request.

If the outcome of the negotiation does not reach the level of cost-effectiveness, the New Therapies Council issues a recommendation to the regions to refrain from using the medicine.

Sometimes the regions collaborate in joint procurements of medicines used in hospital care. Usually, one region is then authorized to carry out the procurement on behalf of all regions.

Negotiation of prescription pharmaceuticals

In connection with TLV's handling of applications for subsidies for prescription drugs, the regions, TLV and the company can carry out so-called tripartite deliberations.

The deliberations can result in an agreement between the company and regions, which reduces costs for the regions and can contribute to reduced uncertainty in TLV's assessments of cost effectiveness. In this way, the agreement can contribute to the medicine being eligible for reimbursement status and included in the high-cost threshold.

All regions have appointed a person with power of attorney to, among other things, represent their region in the decisions that the regions take in tripartite deliberations. Sometimes medicines covered by tripartite deliberations are subject to national joint introduction via the New Therapies Council and after a decision by TLV's board, the New Therapies Council will take a position on a recommendation.

Criteria for tripartite negotiations

The regions believe that the majority of new pharmaceuticals should be able to be included in the reimbursement system without special efforts from the regions. Tripartite negotiation is also not seen as a general solution for new medicines with excessively high prices to be included in the national benefits system.

The regions assess the degree of urgency on a case-by-case basis. Factors that are taken into account include:

  • Documents from TLV including preliminary assessments
  • ICER based on the company's baseline scenario
  • If the pharmaceutical is included in the joint process for introduction by the NT Council
  • Obtained opinions from clinical expertise
  • Equal treatment – ​​between competing or other pharmaceuticals

None of the factors that are evaluated are individually decisive, but are included in an overall evaluation.

If it is confidential that the benefit application has been submitted to TLV, tripartite negotiations cannot be initiated.

Implementation of tripartite negotiations

In cases where a tripartite negotiation is carried out, it applies to all regions. When the regions have agreed to a tripartite consultation, it also means they are ready to sign a possible agreement that reduces the cost of the pharmaceutical. It also requires that the company lifts any confidentiality regarding having applied to TLV for the medicine to be included in the national reimbursement system. In order for an agreement to be valid, it is required that the medicine is covered by The Swedish Pharmaceutical Insurance or the equivalent.

Individual regions' positions regarding contract terms are not reported separately. Only a collective, common response is given from the regions to TLV and to the company. For all positions at least half of the regions, corresponding to at least 75% of the population, must agree for the contract to be valid.