# Dental and Pharmaceutical Benefits Agency (TLV)

Source: https://onco.cc/institutions/tlv-sweden/  
OnCo record `tlv-sweden` (Institution). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The Swedish state agency that decides which prescription medicines are subsidised and at what price, and that writes the health-economic assessments the regions use for cancer drugs given in hospital. It pays more for a treatment the more severe the disease.

## Summary

Tandvårds- och läkemedelsförmånsverket decides, through its expert board Nämnden för läkemedelsförmåner, whether a medicine enters the pharmaceutical benefits, the scheme that caps what a patient pays at the pharmacy, and at what price. The company must apply and must show the medicine meets the law (2002:160); the ordinance (2002:687) requires a decision within 180 days of a complete application.

TLV's assessments rest on the ethical platform Sweden's parliament set for health-care priorities: human dignity, need and solidarity, and cost-effectiveness. Severity is graded on a four-step scale, low, moderate, high and very high, and the agency states that the more severe the condition, the higher the cost per quality-adjusted life year it is reasonable to pay; for particularly rare conditions of very high severity it may accept more. It publishes no fixed threshold, so the figures appear case by case: for erdafitinib in previously treated urothelial cancer, a condition TLV graded very high in severity, it estimated about 950,000 kronor per QALY against vinflunine and judged most of its sensitivity analyses below what it normally accepts at that severity.

For drugs given in hospital, which the regions buy rather than the pharmacy benefit, TLV produces health-economic assessments on request from the regions' NT council and takes no decision itself. Where regions and a company agree, TLV hosts three-party talks that can end in a side agreement under which the company repays part of the cost to the regions. TLV also works in the Joint Nordic HTA-Bodies, begun as FINOSE with Finland and Norway in 2018, and in the EU joint clinical assessments under Regulation 2021/2282, which began on 12 January 2025 with cancer medicines and advanced therapies; the health-economic judgement stays national.

## Fields

- Kind: Institution
- Last checked: 2026-11-03
- Also known as: TLV; Tandvårds- och läkemedelsförmånsverket; Nämnden för läkemedelsförmåner
- City: Stockholm, SE
- Type: government
- Website: https://www.tlv.se/

## Sources

- TLV: hälsoekonomi (severity scale and the ethical platform): https://www.tlv.se/lakemedelsforetag/halsoekonomi.html
- TLV: trepartsöverläggningar: https://www.tlv.se/lakemedelsforetag/trepartsoverlaggningar-mellan-foretag-och-regionerna.html
- Förordning (2002:687) om läkemedelsförmåner, section 9 (180 days): https://www.riksdagen.se/sv/dokument-och-lagar/dokument/svensk-forfattningssamling/forordning-2002687-om-lakemedelsformaner-mm_sfs-2002-687/
- TLV decision basis, Balversa (erdafitinib), Dnr 3644/2024 (PDF): https://www.tlv.se/download/18.1a66d8be196f12a54922e940/1748270301976/bes250522_balversa_3644-2024_underlag.pdf

## Connected records

- institutions: [NT Council (Rådet för nya terapier)](https://onco.cc/institutions/nt-radet/)
- bottlenecks: [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/)

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