The Working Group on Intellectual Property (GTPI), which the State of São Paulo Forum on NGO/AIDS is member, took part at the 11th Conitec (SUS National Committee on Technologies Incorporation) Public Consultation, that updates the Clinical Protocol and Guidelines on Hepatitis C and Confection” (PCDT).
Concluded last March 5, this update addresses treatment to all hepatitis C infected person, regardless their fibrosis stage. At the 2017 update, the main decisions were the treatment to fibrosis stage 2 (F2) patients and the introduction of new medicines.
In the 2018 PCDT update they are included the drugs sofosbuvir (400 mg) + ledipasvir (90 mg) in addiction to elbasvir (50 mg) + gazoprevir (100 mg), to treat the genotypes 1ª, 1b and 4, raising the options to treat the different stages of the disease (no cirrhosis, cirrhosis Child-Pugh A, cirrhosis Child-Pug B or C). There were no updates for the genotypes 2, 3, 5 and 6.
The GTPI contribution
The Clinical Protocol and Therapeutic Guidelines on Hepatitis C and Confection was updated in 2017. The changes represents a large step in treatment advances and new drugs availability, mainly because of the inclusion of the drug Metavir on the treatment of the patients suffering fibrosis 2. In the Protocol proposed by the Public Consultation n° 11/2018, the treatment begins to be addressed to every Hepatitis C infected patient, that is a great advance right to the universal treatment, as the civil society organizations demand since 2013.
Nevertheless, it is necessary to highlight that efforts are still necessary to bring a real universal coverage. The discrepancy between the estimated prevalence and real hepatitis C diagnoses keeps huge. Therefore, the changes can not be announced as universality guarantee, that only might be reached with more efficient strategies on diagnosis, including more specific approach at the most vulnerable population.
It was included two new drugs in the mentioned protocol, sofosbuvir (400 mg) + ledipasvir (90 mg) and elbasvir (50 mg) + grazoprevir (100 mg). Amplifying the treatment options to fit the different patient demands is a positive attitude. Anyway, there are also concerns about de new range of options, so that means no Ministry of Health protocol at the treatment prescription, but the doctors prescription, according to their preference. It is necessary a guideline on prescriptions from the Ministry of Health to make clear which options are indicated to te different situations according to scientific evidences, the most common genotypes in Brazil, more tolerable and cost-effective dosage regimens. Without a protocol that standardize prescriptions, the treatment will no longer be guided by Ministry of Health, but by individual prescriptions. The use of standard protocols contributes for proper follow-up of cure and the efficacy of the treatment, as well as with futures Ministry of Health Pharmaceutical Assistance’ s purchases.
There is also a question concerning on the link between this PCDT and that “new purchase model”, which proposes “buying the cure, not the medicine”, as affirmed by the Ministry of Health at the World Hepatitis Summit, held in São Paulo, in November 2017. The model has not opened to civil society consultation, furthermore, there is motion of rejection moved by the final plenary at the XII NGOs National Meeting on Viral Hepatitis and Liver Transplantation. We demand that the Conitec explains how this purchase model is linked the new PCDT and evaluates elements as cost-efficacy of this new procedure and its impact on the cure monitoring and the confidentiality of the patients information.