OBJECTIVES

Since 2015 the Dental and Pharmaceutical Benefits Agency (TLV) together with the administrative regions in Sweden have offered risk-sharing agreements (known as three-party agreements) to market authorization holders of new innovative drugs both in oncology and other disease areas. The risk-option to enter a risk-sharing agreement was initially put in place to offset or share the uncertainty associated with the evaluation of the cost-effectiveness of new and expensive treatments. The uncertainty is usually due to immature clinical data.

METHODS

In this study we reviewed all three-party agreements between 2015 and 2019 in oncology to understand how the risk-sharing agreements have been implemented. The associated risk was extracted together with any restriction to the reimbursement, follow-up requirements, national recommendation of use, average treatment cost per patient, and when available the willingness to pay (ICER at acceptance).

RESULTS

Eleven oncology products where identified and the associated risk was found to be treatment effect and/or the duration of treatment. Three of the eleven products received a restricted reimbursement compared to their indication. Three of the eleven products received follow-up requirements, two to follow the use in clinical practice and one to update the health-economic analysis with more mature clinical data. Of the eleven products only three received national recommendations of use. Treatment costs (prior to discounts) ranged from EUR 3000 to 5500 per patient per month and the willingness to pay (post discounts) was EUR 60 000 – 90 000.

CONCLUSIONS

Risk-sharing agreements in Sweden have increased rapidly since its introduction in 2015. Willingness to pay has not increased and post-discount ICERs indicate that ICERs have been considered larger than the willingness to pay. Few of the included oncology products are subject to restrictions and follow-up.