Dominican Republic Approves Full Coverage for 13 High-Cost Medicines

The National Social Security Council (CNSS) has approved the creation of the Fund for High-Cost Medicines, known as FOMAC, which will finance 13 medicines at 100% for eligible members of the country’s Family Health Insurance system (SFS). The measure, adopted unanimously through Resolution 645-16 on October 1, is designed to reduce the financial burden associated with treatments for complex and potentially life-threatening diseases.

The decision covers medicines used in oncology, autoimmune and rheumatological diseases, pediatric cancer, acromegaly and spinal muscular atrophy. The CNSS said the treatments financed directly through FOMAC will be provided without copays or moderating fees, subject to the medical criteria and conditions established under the program.

FOMAC Will Finance 13 Medicines for 16 Diseases

The initial list includes treatments for several forms of cancer. Ribociclib and Palbociclib will be available for eligible patients with advanced or metastatic breast cancer that is hormone-receptor positive and HER2-negative. Pembrolizumab is included for specified cases of triple-negative breast cancer and non-small-cell lung cancer, as well as certain pediatric cases of refractory or relapsed Hodgkin lymphoma.

The program also incorporates six biologic medicines for immune-mediated conditions: Adalimumab, Etanercept, Golimumab, Infliximab, Tocilizumab and Ustekinumab. Their approved uses include conditions such as rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.

Two additional medicines, Blinatumomab and PEG-Asparaginase, are included for the treatment of acute lymphoblastic leukemia. The list is completed by Octreotide for adult patients with acromegaly and Risdiplam for patients with types 1, 2 and 3 spinal muscular atrophy.

Coverage Will Not Begin Immediately

Although the CNSS has approved the coverage, the medicines will not begin to be dispensed immediately. The government says FOMAC will initially undergo a 12-month capitalization and operational preparation period, during which resources will be accumulated and the mechanisms needed to launch coverage will be completed.

The distinction is significant for patients and families: the resolution establishes the financing mechanism and coverage, but the implementation phase must be completed before beneficiaries can begin receiving the medicines through the new fund.

The fund will be managed by the Directorate of Access to High-Cost Medicines (DAMAC) within the Ministry of Public Health and Social Assistance. Its resources will operate through a specialized account administered by the Treasury of Social Security (TSS).

Higher Monthly SFS Contribution Will Finance the Fund

The CNSS also approved an increase of RD$50.64 in the monthly per-capita cost of Family Health Insurance under the Contributory Regime. Of that amount, RD$48.46 will go to the specialized high-cost medical care account, while RD$2.18 will be allocated to Health Risk Administrators for complementary benefits and administrative expenses.

The financing model is intended to pool resources and allow medicines to be purchased jointly, using economies of scale to improve access and continuity of treatment. The CNSS said the fund’s design also includes a financial reserve to respond to extraordinary circumstances such as supply shortages or unexpected increases in demand.

Additional Support for Children With Cancer

FOMAC will go beyond the 13 medicines by incorporating additional services for pediatric cancer patients. These include specialized diagnostic tests, PET-CT studies, screening, biopsies and follow-up evaluations during and after treatment, according to the conditions and coverage percentages established under the Health Services Plan.

The CNSS said the proposal was presented by the Superintendency of Health and Labor Risks (SISALRIL) and was reviewed by the council’s health and budget, finance and investment committees. The evaluation considered technical, actuarial, financial, operational, legal and sustainability factors before the measure was approved.

For patients with complex diseases, the creation of FOMAC establishes a new financing mechanism within the Dominican social security system aimed at limiting direct treatment costs. Its practical impact will depend on the completion of the 12-month preparation period and the subsequent implementation of the medicine procurement and dispensing system.