HEALTHCARE SYSTEM IN SWEDEN

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