Brazil's health technology assessment body CONITEC has issued negative decisions on seven drugs for the national healthcare system's basic list of free medicines.
IHS Global Insight perspective | |
Significance | Brazil's health technology assessment (HTA) body CONITEC has recently published its decision to not place the treatments infliximab, etanercept, adalimumab, Daivobet (calcipotrol + betamethasone dipropionate), and ustekinumab for psoriasis; roflumilast for chronic obstructive pulmonary disease; and botulinum toxin type A for the treatment of overactive bladder on the national healthcare system's basic list of drugs. 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. The newly formed agency is clearly not prepared to fund medicines it finds to have dubious supporting evidence. |
Outlook | The negative decisions, which follows another set of negative decisions for arthritis drugs earlier this year, may well be seen as a blow to the manufacturers, but is offset by a recent wave of positive reimbursement decisions for seven drugs. Furthermore, the actual publication 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 published its decision to not place the treatments infliximab, etanecerpt, adalimumab, Daivobet (calcipotrol + betamethasone dipropionate), and ustekinumab for psoriasis; roflumilast for chronic obstructive pulmonary disease (COPD), and botulinum toxin type A for the overactive bladder on the national healthcare system (SUS)'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.
Although it is currently not possible to access governmental decisions linked to the rejection of biological treatments infliximab, etanercept, adalimumab, and ustekinumab for the treatment of moderate-to-severe psoriasis in adults, the decision is expected to rest on cost assessment and lack of efficacy and safety evidence.
According to CONITEC, COPD treatment roflumilast has been rejected following weak cost-effectiveness results, as the drug is more costly than other COPD therapies currently in use throughout the SUS, and has also shown weak efficacy and safety evidence that led the drug to be restricted from incorporation into national healthcare services in England, Canada, and Ireland.
CONITEC rejected the incorporation of the botulinum toxin type A into the SUS for the treatment of overactive bladder as the botulinum treatment is considered effective only for patients who have previously failed to react to less complex and aggressive treatments for overactive bladder, such as the use of classic anti-cholergenic therapies. Furthermore, CONITEC rejects the introduction of such therapies on the grounds of the fact that more studies should be carried out to find out the exact dosage of botulinum toxin type A to be administered for the specified treatment.
Daivobet (Leo Pharma, Denmark; calcipotrol + betamethasone dipropionate) was rejected on the grounds of a lack of evidence of the efficacy of treatment of moderate psoriasis as a single treatment and not in conjunction with any other treatment. Furthermore, in a cost-effectiveness analysis, one of the treatment's ingredients, calcipotrol, had been found to have already been incorporated into the SUS basic list of drugs for the treatment of psoriasis in November 2011.
Outlook and implications
The set of negative decisions, which follows another recent set of negative decisions for arthritis drugs, may be seen as a blow to the manufacturers, but is offset by this week's wave of positive reimbursement decisions for seven drugs by CONITEC (see Brazil: 24 September 2012: Brazil's CONITEC Rejects Incorporation of Four Drugs into SUS and Brazil: 10 October 2012: CONITEC publishes seven positive reimbursement decisions for Brazil's basic list of drugs). Furthermore, 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.
The recent reimbursement denials of the drugs that cover a range of different therapies is a consequence of a variety of factors, including the lack of cost effectiveness and weak evidence on efficacy and safety submitted by the manufacturer. Most decisions were largely due to the absence or quality of data available 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.
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