Decision Makers and Decision-Making Processes Diagram
Model description and Symbols:
The ultimate decision maker is listed at the top of the model
Boxes: Decision-making bodies
Solid Arrows: Required step in decision-making process
Broken Arrows: May or may not impact decision
Sweden has a population of over 9 million individuals. The Swedish healthcare system is a national health service, financed mainly through proportional taxes levied by county councils (“landsting” or “region”) and municipalities, but also through state subsidies and user charges. Total health spending accounted for 9.1% of GDP in Sweden in 2007, slightly above the OECD average of 8.9%. Sweden also spends more on health per capita than many OECD countries, with spending of 3,323 USD in 2007 (adjusted for purchasing power parity), compared with an OECD average of 2,964 USD. In Sweden, 81.7% of health spending was funded by public sources in 2007.
Overall healthcare goals and policies are decided at a national level; however, provision of care is determined by county councils and, in some cases, municipalities, both of which have considerable flexibility in deciding how to plan and deliver healthcare. Whilst the overall responsibility for healthcare rests with the Ministry of Health and Social Affairs (Socialdepartementet), supervision of the delivery of healthcare is performed by an independent government authority, the National Board of Health and Welfare (Socialstyrelsen).
A county council is a political body whose representatives are elected by the public every four years. Each county council has its own budget and owns and operates most healthcare facilities, including hospitals and primary care centres. Healthcare can be outsourced to contractors and the number of private physicians and primary care centres vary widely between counties. Currently, all Swedish pharmacies are fully owned by the state and managed by the National Corporation of Swedish Pharmacies (Apoteket). In 2009, this state monopoly will be abolished and the market opened to other competitors.
In order for pharmaceuticals to be reimbursed (i.e. included in the Pharmacy Benefit Scheme) they must be approved by the Dental and Pharmaceutical Benefits Board (Tandvårds- och läkemedelsförmånsverket), or TLV. For reimbursed pharmaceuticals TLV sets both the pharmacy purchase price level and the pharmacy margin, thus effectively setting a fixed national pharmacy retail price. Over-the-counter pharmaceuticals and non-reimbursed prescriptions may be priced freely by the manufacturers. Pharmaceuticals used in hospitals are procured directly by the county councils, often leading to discounts.
Generic substitution is mandatory for pharmaceuticals containing the same substance, in the same formulation and deemed comparable by the Medical Products Agency (MPA). The patient can however choose to pay the extra dividend.
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DECISION-MAKERS AND INFLUENCERS
Health Technology Assessment Organization
Statens beredning för medicinsk utvärdering (SBU): Swedish Council on Technology Assessment in Health Care
Organizations who determine the reimbursement
Tandvårds- och läkemedelsförmånsverket (TLV): Dental and Pharmaceutical Benefits Board MPA: Medical Products Agency
The HTA to support reimbursement decisions is conducted by an expert board at TLV with advice from a board from the 18 county councils.
The county councils provide health care, are responsible for the local health care budget and conduct HTA for recommending the drug on local formularies.
Recommendations from the National Board of Health and Welfare, the Swedish Council on Technology Assessment in Health Care (SBU) and the Medical Product Agency and other experts may also be considered.
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The National Corporation of Swedish Pharmacies is the distributor of drugs and provides some public information about the therapeutic use of drugs.
The TLV decision can be appealed by the pharmaceutical company at a public court.
REIMBURSEMENT AND PRICING APPROVAL PROCESS
In Sweden, the key organization involved in Reimbursement and Pricing process is the Dental and Pharmaceutical Benefits Board (Tandvårds- och läkemedelsförmånsverket), or the TLV, formerly the Pharmaceutical Benefits (Läkemedelsförmånsnämnden). TLV is an independent government agency established in 2002 and is most commonly referred to by its previous Swedish acronym LFN.
TLV makes national pricing and reimbursement decisions on which pharmaceutical and health technology products should be covered by the Pharmaceutical Benefit Scheme. The decisions pertain to primary, secondary and out-patient care. Reimbursement decisions made by the TLV at a national level are mandatory and are therefore always adopted at the local level by the county councils. However the degree and rate of adoption may vary between counties due to individual budget planning mechanisms, differing interpretation of TLV recommendations, or variable access to specialist physicians. Budget planning, health economic modeling and cost-effectiveness evidence are therefore important at the local level as well as the national level. However, pharmaceutical companies can chose to seek coverage via local county councils or through the TLV.
In order for a drug to be reimbursed as part of the national Pharmaceutical Benefit Scheme, the TLV must approve its inclusion. However, if TLV rejects a drug at the national level, a county council may still decide to fund it, as long as specific criteria are met (e.g. if a cost-effective drug fulfils an unmet need, in a severe disease, where there are only a few patients who have no other treatment alternatives). Furthermore, patients can opt to pay for drugs privately that are not reimbursed by the national health service.
TLV does not negotiate on the price of drug; the pharmaceutical company has to apply for reimbursement at a proposed price. The decision by TLV is thus a joint reimbursement and price decision.
TLV has a remit to review all newly licensed pharmaceuticals. However, it is currently also conducting a review of the entire list of pharmaceuticals that were eligible for reimbursement when the new Pharmaceutical Benefits Scheme came into force in October 2002. TLV also decides on what dental care ought to be covered by the society, at which cost. If a submission is rejected, the manufacturer may re-submit with a different drug price or with new evidence, however the new submission will enter the process from the beginning, potentially delaying market access. The Swedish government has requested that TLV should aim to announce reimbursement decisions within 120 days of submission.
The Medical Products Agency (Läkemedelsverket) is the Swedish national authority responsible for regulation and surveillance of the development, manufacturing, and sale of pharmaceuticals and other medicinal products. MPA is primarily involved in the regulatory process of some drugs and interventions. In cases where the MPA has been involved in the regulatory decision, they produce a product monograph detailing the effectiveness and safety of the product. MPA has no involvement in the pricing and reimbursement process of a drug, or the use of the drug in practice.
Health Technology Assessment Process
A TLV assessment of a new drug is usually initiated by the drug manufacturer. However, TLV initiates the review process for older drugs that received reimbursement status prior to October 2002. The entire process is a closed system, with just a short summary made publically available at the end of the process. It is probable that the system will become more transparent in the future.
In order for a drug to be assessed, a submission must be made to TLV by the manufacturer. The content of the submission is detailed in a set of general guidelines published by TLV. The submission is made electronically and includes clinical and cost-effectiveness evidence. Cost-effectiveness evidence should be provided in a health economic model. TLV assessors generally review and adapt the submitted health economic model; though if necessary, they will create a new model. TLV takes a wide societal perspective considering all costs and revenues for treatment and ill health including factors such as lost productivity, work loss and time loss for the patient and their relatives.
SBU has a government remit to comprehensively assess healthcare technology from medical, economic, ethical, and social standpoints. The SBU conducts its own research; therefore, no submission from the manufacturer is required. SBU produces guidelines and reports, and disseminates information on new drugs and technologies. SBU publications have no direct mandate for influencing reimbursement of a drug, or its use in practice. A manufacturer need not apply for assessment of a drug by the SBU in order to gain reimbursement and publications by the SBU have no official influence over pricing and reimbursement decisions.
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- Presentation of the Swedish pharmaceutical reimbursement system at the website of TLV http://www.lfn.se/LFNTemplates/Page____389.aspx
- PPRI - Pharmaceutical Pricing and Reimbursement Information http://ppri.oebig.at/Downloads/Results/Sweden_PPRI_2007...pdf
- General guidelines for economic evaluations from the Pharmaceutical Benefits Board (TLV) www.lfn.se/upload/English/ENG_lfnar2003-eng.pdf
- Anell A, Persson U. Reimbursement and clinical guidance for pharmaceuticals in Sweden. Eur J Health Economics 2005;6:274-9. http://www.springerlink.com/content/l622wv6122r264q1/
- Jansson S. Implementing accountability for reasonableness – the cases of pharmaceutical reimbursement in Sweden. Health Economic, Policy and Law 2007;2:153-71. http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=1164720
OECD Health Data 2009. http://www.oecd.org/dataoecd/46/6/38980334.pdf. accessed 10/4/09
AUTHORS & CONTRIBUTORS
Eric Faulkner, Senior Director RTI Health Solutions, Director, Genomics Biotech Institute, Research Triangle Park, NC, USA
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Karl Matuszewski MS, PharmD, Senior Director, Clinical Knowledge Service, University HealthSystem Consortium, Oak Brook, IL, USA
Christie Niziol, Associate Director- Global Services, Abacus International, UK
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