Brazil's health technology assessment body CONITEC has issued positive funding recommendations for hepatitis C virus drugs Sovaldi (sofosbuvir; Gilead Sciences, US); Daklinza (daclatasvir; Bristol-Myers Squibb, US); and Olysio (simeprevir; Janssen-Cilag, subsidiary of US firm Johnson & Johnson), with conditions.
IHS Life Sciences perspective | |
Significance | Brazil's health technology assessment body CONITEC has issued funding recommendations for hepatitis C virus drugs Sovaldi (sofosbuvir; Gilead Sciences, US); Daklinza (daclatasvir; Bristol-Myers Squibb, US); and Olysio (simeprevir; Janssen-Cilag, subsidiary of US firm Johnson & Johnson). |
Implications | CONITEC has decided unanimously to recommend the incorporation of the treatments for chronic hepatitis C, but with six conditions. |
Outlook | Among the several conditions, the reduction in prices could be an issue due to negotiations that could take a couple of months because of the high cost of the medicines delaying the final funding recommendation by the Ministry of Health. |
Brazil's health technology assessment body CONITEC has issued positive conditional funding recommendations for the public financing of new drugs through the reimbursement list of the Brazilian Unified Health System (SUS). The positive decisions were for hepatitis C virus (HCV) drugs Sovaldi (sofosbuvir; Gilead Sciences, US); Daklinza (daclatasvir; Bristol-Myers Squibb, US); and Olysio (simeprevir; Janssen-Cilag, subsidiary of US firm Johnson & Johnson).
The funding recommendation requested by the Department of STDs, AIDS and Viral Hepatitis of the Ministry of Health related to whether these three direct-acting anti-virals are more effective and safe to treat HCV than current treatments. CONITEC's decision can be accessed here, in Portuguese.
Scientific analysis
CONITEC has made positive recommendations for the use of Daklinza, Olysio, and Sovaldi in HCV patients with genotypes 1 (including 1ae and 1b subtypes), 2, 3, and 4 in patients with advanced fibrosis (Metavir F3 or F4), and co-infected by HIV-1 irrespective of the degree of fibrosis.
After analysing several clinical studies, CONITEC has concluded that Daklinza, Olysio, and Sovaldi have a high cure rate in the range of 80–100% for a 12–24-week treatment and results in fewer side effects than other HCV treatments. Studies have also shown a 80% cure rate in patients with cirrhosis that have been previously treated.
According to CONITEC, there is evidence that in genotype 1 patients, including subtypes 1a and 1b, the use of associations between Sovaldi and Olysio or Daclatasvir resulted in 95–100% response rates. In patients with genotype 2, using Sovaldi in association with ribavirin for 12 weeks resulted in standard variable rates of 90–97% from individuals without cirrhosis and 80–88% with cirrhosis. In patients with genotype 3, the use of Daclatasvir in association with Sovaldi for 12 weeks resulted in higher standard variable rates of 90% in treatment-naïve and 86% in treated individuals.
Additionally, the three direct-acting anti-virals are capable of reducing treatment time from 72 weeks to 12 or 24 weeks. The studies did not report on the reduction or regression of impaired liver function, the need for transplants or death.
Budget impact assessment
Regarding the economic evaluation, CONITEC has assessed that the budgetary impact of including these three treatments in the SUS will be BRL467 million (USD145 million) to BRL666 million for the annual treatment of 15,000 individuals infected with different genotypes.
Conditional decision
CONITEC decided unanimously to recommend the incorporation of Daklinza, Olysio, and Sovaldi for the treatment of chronic hepatitis C, but under six conditions:
- the revision of the Clinical Protocol and Therapeutic Guidelines (PCDT) of HCV;
- prioritisation of patients with advanced fibrosis (METAVIR F3 or F4);
- improvements in patient access to information on the prevention and treatment goals, and expected benefits and risks;
- the reduction of prices from the initial proposals submitted by the manufacturers due to these proposal only considering minimum purchase volumes;
- attempting to negotiate with producer payment-by-result agreements; and
- exclusion of evir and telaprevir bocepr drugs, guaranteeing that patients already using these drugs will have their treatments secured by the criteria of the current PCDT.
Outlook and implications
The conditional recommendation is a positive step for HCV patients that have been waiting several months for the incorporation of these medicines into the SUS (see Brazil: 5 December 2014: Protesting Brazilian patients call for approval of innovative HCV treatments). However, the several conditions that CONITEC has introduced before the funding of the medicines are likely to considerably delay patient access to these medicines.
Although progress has been made by the Brazilian health authorities to have these innovative HCV treatments made available to the public, among the several conditions the reduction in prices could be an issue due to negotiations that could take a couple of months because of the high cost of the medicines. Indeed, US company Gilead Sciences announced recently that it has entered pricing negotiations with the Brazilian government on Sovaldi (see Brazil: 18 June 2015: Gilead Sciences enters into pricing negotiations with Brazilian government for HCV drug Sovaldi).
However, once the conditions are fulfilled, the incorporation of Daklinza, Olysio, and Sovaldi is likely to boost the respective manufacturers' profits in the Brazilian market. According to the Ministry of Health and CONITEC, 15,000 people are likely to receive these hepatitis C treatments through the SUS, and the prevalence of hepatitis C among the population is approximately at 1.4–1.7%, which brings a positive outlook to this market.