In mid-November 2016 the government issued directives to review the pricing and reimbursement system and the national financing system for medicinal products. The government declared that the existing system is complex and complicated and must be improved in order to operate a modern healthcare system.
Among other things, the review seeks to find a clear division of responsibilities between the national government and local county councils and regions and to establish foreseeable processes for stakeholders.
The report from the review will be presented to the government on December 1 2018.
Pricing and reimbursement system
The pricing and reimbursement system is generally aimed at medicinal products sold and dispensed at retail pharmacies. For medicinal products ordered and used within the hospital system, pricing is free and the hospital access to such medicinal products is normally established through public procurements. Pricing is also free for prescription medicinal products sold and dispensed at retail pharmacies which have not been granted reimbursement.
The current pricing and reimbursement system was implemented in 2002 and requires that a product pass a health technology assessment to be granted reimbursement. The medicinal product applying for reimbursement is compared to one or more alternative medicinal products used within the healthcare system in order to assess its cost effectiveness. The evaluations may, for instance, describe whether a new treatment that is more effective than an existing treatment is also cost effective. The result is often presented as a cost per quality adjusted life year (QALY) gained. If the cost per QALY gained is below a certain threshold value, the new medicinal product is deemed cost effective.
The current system is product based, not indication based (ie, unless the TLV specifically limits the reimbursement due to certain indications not having been deemed cost effective, all indications under the marketing authorisation are reimbursed).
Review Under the current pricing and reimbursement system, medicinal products aimed at smaller patient groups (eg, orphan drugs) will have difficulty proving cost effectiveness within QALY thresholds used by the TLV, due to high research and development costs and a very high price per patient ratio. The effectiveness of such a medicinal product is also often uncertain due to difficulties in conducting conclusive clinical trials on the severe and chronic conditions for which they are indicated.
Advanced therapy medicinal products (eg, gene therapy, which is predicted to increase in the future) are problematic to handle under the pricing and reimbursement system – including whether they should be classified as medicinal products that can apply for reimbursement or treatment methods within the healthcare system.
Pricing and reimbursement for medicinal products under adaptive licensing or other types of licensing (eg, accelerated assessments of marketing authorisations) make up another topic which the government believes should be covered in the review, since there is a clear benefit for certain patients getting early access to new effective medicinal produtcts, while simultaneously patient risk is increased.
The review will compare a product-based pricing and reimbursement system with an indication-based pricing and reimbursement system. The review will also address the fact that Sweden is one of the few countries not using international reference pricing. As a result, pharmaceutical companies have an incentive to try to maintain high prices for medicinal products within the Swedish reimbursement system.
Finally, the TLV’s so-called ‘Trialogue Project’ – which concerns negotiations between pharmaceutical companies, the TLV and the county councils on risk-sharing or discount agreements – will be reviewed to ensure that the process is clear, predictable and transparent.
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Source: Lexology – Advokatfirman Lindahl – Jonas Löfgren, Annie Kabala