In Malta, the reimbursement of rare disease treatments is managed by the national health authority, the Malta Medicines Authority (MMA). The MMA is responsible for assessing and approving the reimbursement of drugs and other medical products, including those used to treat rare diseases.
The process for reimbursement of rare disease treatments in Malta involves an application from the pharmaceutical company, which is reviewed by the MMA’s pricing and reimbursement committee. The committee evaluates the clinical and cost-effectiveness of the product, as well as the impact on the national health budget. The committee also considers the availability of alternative treatments and the level of unmet medical need for the specific rare disease.
Once the committee has reviewed the application, they make a recommendation to the MMA’s board, which makes the final decision on reimbursement. If the product is approved for reimbursement, it will be added to the Malta National Formulary, which is the list of reimbursed drugs and medical products available to patients.