Pharmacoeconomic Guidelines: Sweden

Country/Region: Sweden
PE Guidelines
General guidelines for economic evaluations from The Dental and Pharmaceutical Benefits Agency (updated 2017)
PDF in Swedish
PE Guidelines Source:
The Dental and Pharmaceutical Benefits Agency (TLV)
www.tlv.se
Additional Information:

Assessment of Methods in Health Care, The Swedish Agency for Health Technology Assessment and Assessment of Social Services. August 2017.
www.sbu.se/handbook (English version, SBU’s handbook)

http://www.sbu.se/upload/ebm/metodbok/SBUsHandbok.pdf (Swedish version, SBU’s Handbook)

The Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU)
www.sbu.se

Information current as of Wednesday, February 12, 2020

Key Features

Type of Guidelines PE Guidelines
Title and year of the document Ändring i Tandvårds- och läkemedelsförmånsverkets allmänna råd (TLVAR 2003:2) om ekonomiska utvärderingar (2017)
Affiliation of authors The Dental and Pharmaceutical Benefits Agency (TLV)
Purpose of the document Guidelines for the economic evaluations for submissions to TLV.
Standard reporting format included No
Disclosure Yes
Target audience of funding/ author's interests Pharmaceutical and medical device companies. The Dental and Pharmaceutical Benefits Agency (TLV)
Perspective Societal
Indication Yes
Target population Yes
Subgroup analysis Yes, where the treatment can be expected to differ in cost effectiveness (for instance gender, age, severity, risk level)
Choice of comparator The most cost effective of the available and clinically relevant treatment options in Sweden
Time horizon Shall cover the period when the main health effects and costs arise.
Assumptions required Not stated
Preferred analytical technique CUA, CEA, CMA
Costs to be included All relevant costs. Production loss estimated by human capital approach
Source of costs TLV.se for drugs
Modeling Yes, requires details
Systematic review of evidences Basis for indirect comparisons
Preference for effectiveness over efficacy Not stated
Preferred outcome measure QALY. WTP in some special circumstances.
Preferred method to derive utility Standard gamble, time trade-off, EQ-5D.
Equity issues stated Not stated
Discounting costs Base: 3%; SA: 0~5%; 3%
Discounting outcomes Base: 3%; SA: 0~5%; 0%
Sensitivity analysis-parameters and range For central assumptions and parameters
Sensitivity analysis-methods Not specific
Presenting results Methods, assumptions made, and detailed data shall be shown clearly that the different steps in the analysis are easily followed.
Incremental analysis Yes
Total costs vs effectiveness (cost/effectiveness ratio) Not specific
Portability of results (Generalizability) Internal and external validation of modelling results
Financial impact analysis Not stated as part of health economic guidelines. Requested in other parts of the submission.
Mandatory or recommended or voluntary Recommended

Acknowledgement:

Sophie Werkö, PhD, MSc, Project Director, Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) and Vice Chair, International Network of Agencies for Health Technology Assessment (INAHTA), Stockholm, Sweden contributed to the key feature form.
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