Brazil's health technology assessment body CONITEC has issued negative reimbursement decisions for Pfizer (US)'s Somavert (pegvisomant) and Merck KGaA (Germany)'s Erbitux (cetuximab).
IHS Life Sciences perspective | |
Significance | Brazil's CONITEC denied reimbursement to Pfizer (US)'s Somavert (pegvisomant) and Merck KGaA (Germany)'s Erbitux (cetuximab). |
Implications | The Brazilian agency has become increasingly careful when choosing technologies to be introduced into the national health system. Both of the negative funding decisions were based on cost-effectiveness and budget impact considerations. |
Outlook | Although there is still opportunity for manufacturers to re-submit their innovative products for CONITEC's assessment, these two negative funding recommendations are likely to affect sales of the respective products in the Brazilian market. |
Brazil's health technology assessment (HTA) body CONITEC has issued negative funding recommendations for the public financing of new drugs through the reimbursement list in the Brazilian Unified Health System (SUS). The negative decisions were for Pfizer (US)'s Somavert (pegvisomant) and Merck KGaA (Germany)'s Erbitux (cetuximab).
Somavert received marketing authorisation by the Brazilian Health Surveillance Agency (Anvisa) in 2005. Somavert is a growth hormone receptor antagonist used in the treatment of acromegaly in patients that present an inadequate response to treatment with surgery or radiotherapy and for those patients whose medical response to treatment with somatostatin analogues did not normalise IGF-I concentration or were not tolerated. The funding recommendation requested by Pfizer was whether Somavert is more efficient to treat acromegaly than the somatostatin analogue that is already included in the SUS. In relation to the scientific analysis, according to the evidence presented, CONITEC considers that Somavert has not proved to be more efficacious than what is already included in the SUS for the same indication due to Somavert's effects on patients being very heterogeneous and not increasing patients' quality of life in terms of symptoms and side effects. Regarding the economic evaluation, CONITEC has found some limitations in the Markov model used for the requesters to assess Somavert costs, mainly in relation to the target population and the structure of the model.
Therefore, CONITEC has decided not to recommend the public funding of Somavert as treatment for acromegaly in Brazil's SUS. CONITEC's decision can be accessed here in Portuguese.
In view of similar budget impact considerations and clinical assessments, CONITEC decided to not recommend funding for Merck KGaA (Germany)'s Erbitux (cetuximab) in the treatment of recurrent or metastatic head and neck cancer (R/M HNSCC). The funding recommendation request from Merck KGaA and Bionovis was whether the use of Erbitux with platinum-based chemotherapy for the treatment of R/M HNSCC is more effective and safe than only platinum-based chemotherapy or chemotherapy plus placebo. CONITEC has decided not to incorporate Erbitux in combination with platinum-based chemotherapy into the SUS's reimbursement list under the consideration that the cost of treatment would be higher than the drugs already available in the SUS for the same indication. Additionally, CONITEC found that the clinical studies show that there is no scientific superiority efficacy of Erbitux (overall survival) for the treatment of R/M HNSCC in stabilising disease progression and marginal benefit in the progression-free survival endpoint.
CONITEC's decision can be accessed here, in Portuguese.
Outlook and implications
These two negative funding recommendations from Brazil's HTA body are mainly linked to cost-effectiveness. Although the Brazilian government under the leadership of President Dilma Rousseff is aiming to provide citizens with the best possible service and supply of drugs through the public healthcare system, the intention is for it to be done in a sustainable way by purchasing and including cost-effective treatments that will fit Brazil's annual public healthcare budget. However, the negative decisions may come as a blow to multinational manufacturers wishing to sell chronic disease drugs on a large scale in the large Brazilian pharma market.
Although these two funding recommendations were negative, it is important to highlight that the Ministry of Health reported last year a considerable increase in the number of innovative medicines incorporated into the reimbursement list, with 114 medicines gaining approval since 2012 (see Brazil: 9 December 2014: Brazil reports USD4.8-bil. investment in medicines in 2014 and announces details of price-adjustment methodology for 2015). However, several negative decisions based on high budget impact demonstrate the strict cost-effectiveness assessment carried out by the HTA agency.
Although there is still opportunity for manufacturers to re-submit their innovative products for CONITEC's assessments, these two negative funding recommendations are likely to affect sales of the respective products from Pfizer and Merck KGaA in the Brazilian market.