Impact of a Restrictive Reimbursement Policy on Access, Costs and Quality & Safety of treatment: Analysis of a Dutch reimbursement case regarding GLP-1 therapy

Summary Background: In response to the high and growing costs of health care, governments introduce restrictive drug reimbursement policies on drugs. These policies aim to contain costs without denying patients’ access to good quality health care. In the Netherlands, the balance between these competing aspect of healthcare (access, costs and quality of treatment) are safeguarded by the Minister of Health who is authorized to decide which drugs are reimbursed and under which conditions. Additionally, insurers are responsible for an effective application of the reimbursed drugs by having the authorization to apply additional reimbursement conditions. In the reimbursement case of drugs from the GLP-1 receptor agonist class for Diabetes Mellitus Type 2 patients, the ‘Zorgverzekeraars Nederland (ZN)’ (representing Dutch health insurers) decided that the first prescription must be prescribed by a medical specialist in order to be reimbursed for patients. Objective: Several concerns regarding a disturbance in the balance between the three societal values were raised after the introduction of ZN’s additional reimbursement condition. However, limited scientific data is available on how ZN’s additional reimbursement condition affects the three competing societal values. Therefore, this study’s objective is to evaluate the impact of ZN’s reimbursement condition on access, costs and quality of treatment in order to identify whether the reimbursement condition must be removed. Methods: Qualitative research was performed to identify the impact of the additional reimbursement condition. First, relevant literature and documentation were studied during a 6-month internship at the pharmaceutical company Eli Lilly. Subsequently, thirteen semi-structured interviews were conducted with stakeholders with different perspectives, i.e. patient, physician, health insurance and societal perspective. The stakeholders were asked to compare the ‘current’ situation (with ZN’s reimbursement condition) compared to a ‘fictive’ situation (without ZN’s reimbursement condition). Results: Three barriers for GPs to refer patients (i.e. financial, cultural and professional) were identified that suggest a limited access for patients to GLP-1 therapy. This suggestion is strengthened by stakeholders’ expectation of an absolute volume increase of GLP-1 therapy in the fictive situation. Evaluating the impact on costs both cost increasing and decreasing factors were expected in the fictive situation. This thesis, however, suggests that the expected increase in drug cost would only be partially offset by a reduction in costs related to consults, productivity, co-morbidity and a decreased number of glucose test strips. Finally, evaluating the impact on quality and safety of treatment, both improvements and deterioration associated with characteristics of GPs and 2nd line physician care were expected in the fictive situation. However, due to the absence of GLP-1 therapy in the treatment guidelines for 1st line physicians (NHG), this thesis suggests that quality and safety of treatment cannot be guaranteed in the fictive situation. Conclusion: First, this study demonstrated that the balance between access, costs, quality and safety is currently disturbed due to ZN’s reimbursement condition. Focusing mainly on the impact on access, one could suggest that the reimbursement condition should be removed since it would be highly improper that patients are currently hindered in access to treatment that might be beneficial to them. However, looking beyond the impact on access, our suggestions regarding the impact on costs and quality/safety indicated that the reimbursement condition should not be removed. In addition, this study’s most consideration in deciding not to remove ZN’s reimbursement condition is that from our opinion the limited access to GLP-1 therapy is not necessarily caused by the reimbursement condition. We believe that a poor collaboration between 1st and 2nd line physicians, together with a lack of solid agreements regarding referral criteria, are the fundamental reasons for 1st line physicians’ referral barriers, which, in turn induce the limited patients’ access to GLP-1 therapy. Therefore, additional research on the cooperation between 1st and 2nd line physician is recommended in order to dissolve the referral barriers, which, in turn would increases patients’ access to GLP-1 therapy without the need of removing ZN’s reimbursement condition.