National Healthcare services are the healthcare system in Sweden which is financed by taxes and also from state subsidies and user charges.
National Level
Responsible for framing healthcare goals and policies
Country councils and municipalities
Providing care
Planning and delivering healthcare
Ministry of Health and Social Affairs
Liable for the overall healthcare
National Board of Health and Welfare
Independent body responsible for the delivery of healthcare services
Pharmacies are fully owned by states and managed by National Corporation of Swedish Pharmacies
Reimbursement body
Dental and Pharmaceutical Benefits Board:
The body that approves the reimbursement of pharmaceuticals
TLC sets the price and margin level
HTA body: Statens Beredning for Medicinsk Utvardering
DECISION MAKING
In Sweden, the Medical Product Agency is involved in drug regulatory activities.
In Sweden, there are 18 country councils and 290 municipalities. The country councils are involved in advising the TLV regarding reimbursement. Other bodies that advice TLV are
National Board of Social Health and Welfare
Swedish Council on Technology Assessment in Healthcare
Medical Product Agency
Steps involved in decision making
TLV makes the decision regarding the reimbursement of pharmaceuticals and services that need to be covered under the Pharmaceutical Benefits Scheme.
TLV makes the decision at the national level and is mandatory for local bodies to follow the decisions. However, the rate of adoption might be different because of budget constraints.
Key factors for decision making
Budget planning
Health economic modeling
Cost-effectiveness evidence
Even if TLV doesn’t recommend a service, local bodies may consider reimbursement considering the above criteria.
Out-of-pay is available for drugs which are not recommended.
TLV does the assessment and provides a short summary for the public.
Evidence required for TLV submission are
Clinical evidence
Cost-effectiveness
Statens beredning för medicinsk utvärdering (SBU)
SBU makes its own assessments. The companies need not submit a new request for SBU. However, SBU assessment has no impact on reimbursement decision making
Reference:
1. ISPOR HTA Road maps https://tools.ispor.org/htaroadmaps/Sweden.asp