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Estimating the effects of reforms in advance is an important part of evidence-based and transparent legislative processes. The aim of this study was to describe a microsimulation method created to produce ex ante estimates of pharmaceutical pricing and reimbursement policy reforms. As a case example, the estimates for the 2016 pharmaceutical reimbursement scheme reform, including, e.g., the introduction of a €50 annual deductible, are presented. A static microsimulation model was developed based on the reimbursed purchases of 380,931 individuals drawn at random (10% sample) from the prescription register. The 2016 reform was projected to create savings of €44 million/year for the National Health Insurance (NHI). For patients, the median annual out-of-pocket costs increased from €78 to €96 (by +€18). For 97%, the estimated change was less than €50/year. The majority of patients whose out-of-pocket costs increased had relatively low prior costs. However, >€50/year increases predominantly affected patients entitled to higher reimbursements based on chronic or severe illnesses, among whom older and lower-income individuals were overrepresented. Increases of >€100 were rare (0.003%) and derived from exceptional circumstances. The microsimulation produced prompt but versatile estimates of the effects of legislative reforms by factoring in the entire spectrum of individual situations among affected patients.

Estimating the effects of reforms in advance is an important part of evidence-based and transparent legislative processes. The aim of this study was to describe a microsimulation method created to produce ex ante estimates of pharmaceutical pricing and reimbursement policy reforms. As a case example, the estimates for the 2016 pharmaceutical reimbursement scheme reform, including, e.g., the introduction of a €50 annual deductible, are presented. A static microsimulation model was developed based on the reimbursed purchases of 380,931 individuals drawn at random (10% sample) from the prescription register. The 2016 reform was projected to create savings of €44 million/year for the National Health Insurance (NHI). For patients, the median annual out-of-pocket costs increased from €78 to €96 (by +€18). For 97%, the estimated change was less than €50/year. The majority of patients whose out-of-pocket costs increased had relatively low prior costs. However, >€50/year increases predominantly affected patients entitled to higher reimbursements based on chronic or severe illnesses, among whom older and lower-income individuals were overrepresented. Increases of >€100 were rare (0.003%) and derived from exceptional circumstances. The microsimulation produced prompt but versatile estimates of the effects of legislative reforms by factoring in the entire spectrum of individual situations among affected patients.

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80–90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 – €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries. ; peer-reviewed