Brazil's health technology assessment body CONITEC has issued negative decisions on placing four drugs on the national healthcare system's basic list of free medicines, after going through the new evaluation process.
IHS Global Insight Perspective | |
Significance | Brazil's health technology assessment (HTA) body CONITEC has recently published its decision to not place Gilenya, Afinitor, Cimzia, and Volibris on the national healthcare system's basic list of medicines. These final deliberations constitute the first time medicines have been denied funding after undergoing the new HTA process, including the public consultation phase. |
Implications | CONITEC's negative reimbursement decisions that cover a variety of therapy areas are due to a mixture of reasons, particularly a lack of cost effectiveness, as well as weak efficacy and safety evidence. Aside from Volibris, the other deliberations were largely due to the absence or quality of data submitted. The newly formed agency is clearly not prepared to fund medicines it finds to have dubious supporting evidence. |
Outlook | Despite the negative recommendations being a blow to the manufacturers, the actual publications of the reports detailing the rationale of CONITEC—including a review of the public consultation phase—should be seen as a major leap forward for transparency in the Brazilian HTA decision-making process. |
Brazil's health technology assessment (HTA) body CONITEC has not approved the incorporation of four drugs into the national healthcare system's (SUS's) list of fully reimbursed medicines. The medicines are Gilenya (fingolimod; Novartis, Switzerland) for multiple sclerosis (MS), Afinitor (everolimus, Novartis) for the treatment of brain tumours, Cimzia (certolizumab pegol; UCB Pharma, Belgium) for Crohn's disease, and Volibris (ambrisentan; GlaxoSmithKline, United Kingdom) for pulmonary arterial hypertension (PAH). For Cimzia, Vetter Pharma-Fertigung (Germany), the sponsor named in this funding request, is responsible for manufacturing and supplying the prefilled syringes of the medicine under an agreement with UCB and its co-marketing partner in Brazil, AstraZeneca (UK). The full decision is available here.
For Gilenya, Novartis's proposed indication for funding was the first line treatment of patients with remitting-recurring MS. Afinitor was proposed for the treatment of subependymal giant cell astrocytoma (SEGA), a brain tumour associated with genetic condition tuberous sclerosis. The manufacturer's funding request for Cimzia was for inducing clinical response and to maintain the obtained response as well as remission in patients with active Crohn's disease who are not responsive to other conventional treatment.
Lastly, Volibris was proposed for reimbursement to treat PAH, functional classes II and III, to increase the patients' ability to carry out physical exercise.
According to CONITEC, Gilenya was rejected due to safety concerns linked to the adverse cardiovascular side effects of the drug. CONITEC found the studies submitted presented limited safety results when using the 0.5 mg dose of the drug. Furthermore, European and US regulators have recently launched alerts linking deaths to the administration of the drug. The agency believes there is a need to conduct Phase IV or post-commercialisation studies to evaluate the safety of the medicine, particularly the cardiovascular side effects. This would allow a new risk-benefit evaluation to be undertaken.
Afinitor was rejected by CONITEC due to weak current evidence on efficacy for this indication and its benefit being based on a single Phase II study, while not all endpoints were evaluated in the study. Among other recommendations, the final report suggested the realisation of prospective studies to evaluate the benefit of the drug in avoiding or delaying surgical resection. The report highlighted the need for studies evaluating the efficacy of the drug and others in the class in treating other complications as serious as SEGA. Therefore, the agency was wary of funding the drug until further tests are carried out.
Cimzia was not recommended due to a lack of strong clinical evidence of safety in Crohn's disease. CONITEC found the efficacy of Cimzia is similar to existing drugs already covered by the SUS—infliximab and adalimumab—while its safety is difficult to ascertain due to the duration and size of studies available. The agency's own research found a meta-analysis claiming a higher risk associated with Cimzia than the other two competitors. Therefore, CONITEC concluded there is a need for studies of longer duration (greater than 12 months) and including a greater number of patients to ensure the safety analysis of the drug.
The authority decided not to fund the PAH drug as the cost-effectiveness analysis led to the conclusion that 10mg daily of Volibris, which is the nationally recommended maintenance dose, is more costly than already reimbursed drug sildenafil. CONITEC therefore concluded that it would represent additional costs for the SUS.
Outlook and Implications
The reimbursement denials of the four drugs that cover a range of different therapies is a consequence of a range of factors including the lack of cost effectiveness and weak evidence on efficacy and safety submitted by the sponsor. Aside from Volibris, the other decisions were largely due to the absence or quality of data available and/or in the funding submissions to CONITEC. This demonstrates the recently formed agency's reluctance to back funding of medicines found to have weak supporting evidence.
Although there is no direct mention of costs in the majority of these final deliberations, this issue is critical to the budget constraints faced by the SUS. For example, for Gilenya, CONITEC presented concerns over the lack of detailed information to verify whether the economic analysis done by the sponsor was robust.
These deliberations constitute the first time final negative funding decisions have been made public after undergoing the new HTA process that created CONITEC itself. The actual publication of these reports, which includes an analysis of the public consultation phase, constitutes a big step forward for improving the transparency of the Brazilian reimbursement decision-making process.
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 focus on enhancing funding for the SUS and its overall drug expenditure.