TLV submissions and market access in Sweden.

How the Swedish system works

Outpatient medicines: The Dental and Pharmaceutical Benefits Agency (TLV) decides whether a prescription medicine is included in the pharmaceutical benefits scheme and at what price. The decision is taken by the Pharmaceutical Benefits Board (Nämnden för läkemedelsförmåner), whose members are appointed by the government and which meets once a month.

TLV must decide within 180 days of receiving a complete application. It often starts work earlier, but the clock runs only once the file is complete, and completeness requires a marketing authorisation from the Swedish Medical Products Agency or the European Commission. When TLV asks for supplementary material it usually allows five working days, and that time counts within the 180 days. The company receives the decision basis about two weeks before the board meeting and has three working days to correct factual errors.^[1]

Hospital medicines: For medicines used in hospital care (klinikläkemedel), the NT council (NT-rådet), an expert group within the Swedish Association of Local Authorities and Regions, asks TLV for a health economic assessment. TLV then asks the company whether it will submit documentation. The finished assessment goes to the NT council and the company and is published, and the NT council uses it in its recommendation to the regions. TLV makes no reimbursement decision in this route, publishes no fixed deadline, and prioritises its work by urgency, societal impact and the date the documentation arrived.^[2]

The two routes side by side

Evidence and methods requirements

TLV's general guidance on economic evaluations (TLVAR 2017:1) sets the reference case:^[4]

• Perspective: societal, including all relevant costs and effects regardless of who bears them, with inputs that reflect Swedish conditions.
• Comparator: the most cost-effective of the clinically relevant treatments available in Sweden. No treatment is acceptable only where no relevant, cost-effective alternative exists.
• Relative effect: direct comparisons first. Indirect comparisons can be accepted where direct evidence is missing or limited, preferably adjusted methods, with assumptions reported.
• Outcome: cost-utility analysis with QALYs. Where survival is affected, life-years gained are reported too. A cost-minimisation analysis may be enough if effects match the comparator.
• Time horizon: long enough to capture the main costs and effects, and lifetime for treatments that affect survival.
• Discounting: 3% for costs and effects, with 0% and 5% in sensitivity analysis and a scenario with costs at 3% and effects at 0%.

The model goes to TLV electronically with its assumptions clearly explained. The application form and the SmPC must be in Swedish; other documents may be in Swedish or English. See health economic modelling.

Severity, cost per QALY and side agreements

TLV applies an ethical platform of three principles: human dignity, need and solidarity, and cost-effectiveness. Severity is graded on a four-level scale (low, moderate, high and very high), assessed at group level and in relation to all other conditions. A higher cost per QALY can be accepted when severity is high, and in some cases for very severe and rare conditions. TLV's guidance sets no fixed threshold for each level: it judges whether the cost per QALY is reasonable in the individual case.

The regions or the company can ask for three-party talks (trepartsöverläggningar) during TLV's handling of a case. TLV is not a party to any resulting agreement, which can cover price, limits on the subsidy or follow-up, and under which the company refunds part of the cost to the regions. While talks are under way, TLV treats the application as complete only once it knows whether an agreement will be signed. If no agreement follows, TLV decides on the documentation already submitted.

How the EU JCA interacts with TLV

For medicines within the scope of the JCA (phase-in dates in our HTA requirements comparison):

• A price and reimbursement application is complete only once the JCA report is published, so the 180 days cannot start before then.
• A TLV health economic assessment of a hospital medicine also requires the published JCA report.
• TLV gives due consideration to the JCA report, attaches it to its own report and does not ask for information already submitted at EU level.
• Sweden reports to the HTA Coordination Group on how the JCA report was used nationally, as Article 13 requires.

Sweden is also the entry point for joint Nordic assessments (see Nordic HTA). For EU-level work, see EU JCA dossiers.

What we deliver

• Route and timing plan for outpatient reimbursement or a hospital assessment, aligned with the JCA timeline
• TLV reimbursement applications and documentation for health economic assessments requested by the NT council
• Cost-utility and cost-minimisation models to TLVAR 2017:1, with Swedish costs and transparent assumptions
• Comparator analysis grounded in Swedish practice, and indirect treatment comparisons where head-to-head data are missing
• Severity arguments and scenario analyses that show where the cost per QALY sits and why
• Analysis to support three-party talks and side agreements
• Responses to TLV's supplementary questions within short deadlines

What TLV assessors look for

• The right comparator: TLV expects the most cost-effective relevant alternative, not the most convenient one in the trial.
• A complete file on day one: The clock does not start without it, and a five-day response window leaves little room to rebuild analyses.
• Extrapolation that holds up: Lifetime horizons put weight on survival curves and treatment-effect assumptions.
• A clear severity case: The grade drives what cost per QALY is reasonable, so the evidence behind it matters.
• Consistency with the JCA: Differences between the national analysis and the JCA PICO need explaining.

Why Evidaxia

Our EU-level work, covering EU JCA dossiers, PICO scoping, indirect comparisons and network meta-analyses, and global model adaptation, is built to feed national processes such as TLV's, and we bring that experience to Swedish submissions. Our founder also worked on the assessor's side at NICE as an HTA Technical Lead and Analyst, so we prepare files with the reviewer's questions in mind.

References

1. Tandvårds- och läkemedelsförmånsverket (TLV). Handling of applications for price and reimbursement [Internet]. Stockholm: Tandvårds- och läkemedelsförmånsverket (TLV); [date unknown] [cited 2026 Oct]. Available from: https://www.tlv.se/lakemedel/ansok-om-pris-och-subvention/handlaggning.html
2. Tandvårds- och läkemedelsförmånsverket (TLV). Health economic assessments of hospital medicines [Internet]. Stockholm: Tandvårds- och läkemedelsförmånsverket (TLV); [date unknown] [cited 2026 Oct]. Available from: https://www.tlv.se/lakemedelsforetag/halsoekonomiska-bedomningar-och-rapporter-kliniklakemedel.html
3. Tandvårds- och läkemedelsförmånsverket (TLV). The JCA report in TLV processes [Internet]. Stockholm: Tandvårds- och läkemedelsförmånsverket (TLV); [date unknown] [cited 2026 Oct]. Available from: https://www.tlv.se/lakemedelsforetag/hta-forordningen/jca-rapporten-i-tlvs-processer.html
4. Tandvårds- och läkemedelsförmånsverket (TLV). Tandvårds- och läkemedelsförmånsverkets allmänna råd om ekonomiska utvärderingar (TLVAR 2017:1) [Internet]. Stockholm: TLV; 2017 [cited 2026 Oct]. Available from: https://www.tlv.se/download/18.467926b615d084471ac3230c/1510316374332/TLVAR_2017_1.pdf

Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.