Brazil's health technology assessment body CONITEC has issued new positive reimbursement decisions for the incorporation of seven new drugs on the national healthcare system's list of free medicines.
IHS Global Insight perspective | |
Significance | Brazil's health technology assessment (HTA) body CONITEC has recently published positive reimbursement decisions for sildenafil, naproxen, clobetasol, biotin, tacrolimus, immunoglobulin and cancer antigen CA 125 on the national healthcare system (SUS)'s basic list of medicines. After final deliberations these drugs have been granted funding after undergoing the new HTA process, including the public consultation phase. |
Implications | The set of new drugs incorporated into the SUS are for a variety of symptoms and diseases, ranging from treatment of Raynaud's syndrome to post-treatment of malignant epithelial ovarian tumours. |
Outlook | Following on from other recent positive reimbursement decisions for drugs incorporated into the SUS, the latest positive decisions further move towards more transparency in the Brazilian HTA decision process, as well as benefiting the generic manufacturers of such drugs and expanding the domestic generics industry. |
The drugs incorporated into the Brazilian public healthcare system, the SUS, are for a variety of symptoms and diseases, ranging from sildenafil for the treatment of Raynaud's syndrome, naproxen for the treatment of spondylitis arthritis, clobetasol for the treatment of psoriasis, biotin for the treatment of biotinidase deficiency, tacrolimus for the treatment of primary nephritic syndrome, immunoglobulin for the treatment of acute rejection in renal transplant, and the cancer antigen CA 125 for the post-treatment of malignant epithelial ovarian tumours.
The decision to incorporate sildenafil in the SUS basic list of drugs as a treatment for Reynaud's syndrome comes as a simplified reimbursement procedure (not undergoing public consultation) as sildenafil was already part of the SUS basic list of drugs for the treatment of pulmonary arterial hypertension, and its indication has now been expanded to Raynaud's syndrome, a vasospastic disorder causing the discoloration of fingers, toes, and occasionally other areas.
The decision to incorporate naproxen for the treatment of spondylitis arthritis comes as part of the decision to introduce the use of a non-steroidal anti-inflammatory products (AINE) that includes the use of sulfasalazine, metrotexate, glucocorticoids, and tumour necrosis factor alpha-blocking agents. According to CONITEC's evaluation, the use of naproxen proved to produce less cardiovascular risks that other AINE treatment.
Clobetasol, in formulation of 0.05% 30g cream, received a positive reimbursement decision for the treatment of psoriasis, eczemas, lupus erythematosus, and other dermatitis when the patient is non-responsive to less aggressive steroidal treatments.
The use of biotine (vitamin H) for the treatment of biotinidase deficiency was approved for administration in capsules or liquid solution 10mg/mL once a day. The use of biotine had already been approved by Brazil's health surveillance agency Anvisa, but only in association with other multivitamin complexes.
Immunoglobulin for the treatment of acute rejection in renal transplant was recommended following a series of tests carried out by CONITEC, and after careful cost-assessment evaluation of the specific incidence of rejection in renal transplant in the country and subsequent cost of surgeries creating a financial strain on the government.
Lastly, although the use of the cancer antigen CA 125 has been long established in Brazil and approved by Anvisa, CONITEC deliberated on the inclusion of the antigen for the post-treatment of malignant epithelial ovarian tumours following positive testing carried.
More information on the deliberations can be found here.
Outlook and implications
Following on from other recent positive reimbursement decisions for drugs on the SUS, the latest positive decision to incorporate the new drugs is a further move towards more transparency in the Brazilian assessment decision process, as well as benefiting the generic manufacturers of such drugs and expanding the domestic generics industry (see Brazil: 19 September 2012: Five New Arthritis Treatments to Be Incorporated Into List of Basic Medicines in Brazil and Brazil: 27 September 2012: New COPD Treatments to Be Available via Brazi's SUS in Six Months). Further to the positive decisions, the technical department at the Ministry of Health will have a maximum timeframe of 180 days to outline the drug proposal to the SUS. Although some negative reimbursement decisions have also recently been made, the publications of the reports detailing the rationale of CONITEC – including a review of the public consultation phase – is to be seen as a major leap forward for transparency in the Brazilian assessment decision-making process (see Brazil: 24 September 2012: Brazil's CONITEC Rejects Incorporation of Four Drugs into SUS).
Part of the Ministry of Health (MoH), CONITEC was created in December 2011 via Decree 7.646, with the aim of ensuring transparency and speeding up the process of incorporation of drugs into the SUS. The agency is increasingly playing a crucial role in ensuring the MoH makes efficient use of its pharmaceutical budget. Since President Dilma Rousseff came to power, there has been a focus on enhancing funding for the SUS and its overall drug expenditure. In a further effort to create a strongly transparent HTA environment, the most solid created in Latin America so far, the MoH has created a new Department of Management and Incorporations of Health Technologies, within the Secretary for Science and Technology that effectively is responsible for helping CONITEC to carry out its duties. The creation of the new department was detailed in Article 31 of Decree 7797 2012 published in August 2012.