Delay in access to new therapies, after completing the technical and clinical development program and approval by EMA and/or FDA, is undesirable, especially in areas of unmet medical need. Causes for such delays are national and/or regional reimbursement procedures prior to deciding on the implementation of new therapies in the national or regional health care system. Health authorities control the access of new therapies by requiring additional evaluations on top of the regulatory approval, such as evaluation of the added value and cost-effectiveness of the new therapy versus the available, often less expensive, standard of care. New therapies, therefore, have become budgetary competitors to current standard of care. Reimbursement procedures may differ largely per country and region in terms of extensiveness and complexity of reimbursement criteria, time needed and involved stakeholders necessary for decision making. Though physicians facilitated reimbursement procedures by providing consensus statements about the position of the new therapy in the treatment algorithm and therewith determining how ‘to treat the right patient with the right therapy’, this did not always result in a positive reimbursement decision.
To comply with the increased demand of health authorities and health insurers for control of the extent of the treated population and therewith budget control, we worked on a complementary approach called ‘a consensus-based implementation framework’ that facilitates the reimbursement and implementation process with minimal delays.
This framework consists of a six-step approach covering assessment of added value, efficiency of the new therapy and its position in the treatment algorithm combined with determination of the organizational structure of the care in daily practice, establishing registries for outcomes and quality control measures.
This approach has been successful for implementation of autologous chondrocyte implantation for the knee in the Netherlands, which has an advanced reimbursement system, often serving as an example for other countries.