The Jair Bolsonaro government (no party) has not included in the SUS any of the six drug treatments for Covid-19 approved by Anvisa (National Health Surveillance Agency).
To avoid a serious blow to the president’s denial banner, the Ministry of Health is still trying to prevent the overthrow of guidelines pro-“kit Covid”.
The debates are focused on Conitec (National Commission for the Incorporation of Technologies in the Unified Health System), the ministry’s advisory body for the analysis of new therapies and definition of protocols for the public network.
On the 21st, the collegiate had a tie in voting on the opinion that contraindicates the use of hydroxychloroquine, among other drugs without efficacy for Covid, in outpatient treatment.
At previous meetings, Conitec refused the inclusion of three of Covid’s new treatments in the SUS: rendesivir and the associations of casirivimab with imdevimab (Regen-Cov 2) and banlanivimab with etesevimab.
The effects of these medications are limited and the drugs are expensive. Therefore, SUS managers and specialists are divided on the benefit of including products in the public network.
Outside the SUS, at least three of the new drugs are used in Brazil by patients with health plans and in private hospitals.
The first drug use authorization for Covid was given by the agency in March 2021 to Rendesivir. The antiviral, which gained definitive registration from Anvisa, can shorten the patient’s recovery.
Conitec estimated a budget impact between R$ 27.6 billion and R$ 50 billion in five years with the product in SUS. The manufacturer Gilead, on the other hand, calculated savings to the government of BRL 339 million to BRL 645 million with the use of rendesivir.
Other products have been granted emergency use. In a note, Anvisa says that this type of authorization is “preferably for use in public health programs of the Ministry of Health”.
For Adriano Massuda, physician, professor at the Getulio Vargas Foundation (FGV) and former executive secretary of Health, it is “logical and natural” for the government to seek a way to introduce new treatments for Covid-19 into the SUS.
He recalled that Saúde achieved a strong reduction in the prices of hepatitis C treatments after negotiating with the industry. The price of one of the drugs used for this disease, sofosbuvir, fell from R$252 to R$32 per unit between 2015 and 2019.
“If you have technology that can reduce these numbers of the pandemic, without a doubt, a form of incorporation must be sought”, says Massuda.
The physician and vice president of Abrasco (Brazilian Association of Collective Health), Reinaldo Guimarães, assesses that there are still no drugs for Covid-19 approved in Brazil with therapeutic power and cost-effectiveness that justify their incorporation into the SUS.
“The strategy is centered on the vaccine, which is correct”, says Guimarães. He was head of the SCTIE (Secretary of Science, Technology, Innovation and Strategic Health Inputs).
One of the ways to facilitate the entry of products into the SUS is to establish a partnership between public and private laboratories.
Fiocruz (Oswaldo Cruz Foundation) is negotiating to produce the antiviral molnupiravir, developed by the pharmaceutical company MSD and used in the first days of symptoms. The product is not yet guaranteed by Anvisa.
For Massuda, the Ministry of Health has abandoned the leadership of these negotiations with the industry and is dysfunctional.
“To build policies with the industry, to reduce prices, it is necessary to have a degree of confidence in the Brazilian State, and the dismantling of institutions undermines this credibility”, says the researcher.
Conitec’s discussions gained prominence due to attempts by the Bolsonaro government to boycott the appearance that contraindicates the “Covid kit”.
The commission has already approved barring this treatment to hospitalized patients. The opinion has been ready since June, but so far the Ministry of Health has not published the standard in the Official Gazette.
The recommendation against drugs without efficacy in mild cases has more resistance in the committee. Five of the seven representatives of the ministry in the body voted not to approve the opinion on the 21st, in a meeting that ended in a draw.
“These drugs, used alone or the association of hydroxychloroquine with azithromycin, did not benefit patients. Therefore, we do not recommend their use in the pre-hospital phase based on scientific studies carried out in various parts of the world”, says Carlos Carvalho, physician and coordinator of the group of specialists who prepared Conitec’s opinions on Covid’s treatment.
Carvalho says that he has already asked the Minister of Health, Marcelo Queiroga, for the publication of the protocol on hospital treatment of the pandemic, which has already been approved by the commission.
“He was supposed to talk to Hélio Angotti [secretário de Ciência, Tecnologia, Inovação e Insumos Estratégicos] about the publication. And he said it would be done,” says the doctor.
Sought, the ministry says that the guidelines on outpatient treatment of Covid will be taken for public consultation. The paste did not comment on the other treatments.
Covid’s CPI approved, in the final opinion, to trigger the TCU (Court of Accounts of the Union) to annul the meeting that ended in a tie. It also asks the agency to inspect Conitec “with the objective of verifying the performance of this commission and the undue political influence”.
It is among the functions of Conitec to approve recommendations on PCDTs (Clinical Protocols and Therapeutic Guidelines) to the SUS, which may or may not be accepted by the ministry.
The document also marks the public purchases and inspection bodies. In other words, a PCDT that bars the use of the “Covid kit” would give rise to questioning managers who still invest in these drugs.
In May 2020, Health issued a note encouraging the use of the “Covid kit”, but the document is not a SUS protocol. For public network managers, the measure was a way, at the time, to promote ineffective treatment without having to go through Conitec.
Still outside the SUS, some of the drugs already approved by Anvisa for Covid are in use in the private network. Regdanvimab was used in patients in São Paulo, Minas Gerais, Rio Grande do Sul and the Federal District, according to the manufacturer Celltrion Healthcare.
Part of the patients paid for the treatment out of their own pocket. In other cases, plans assess coverage. Each ampoule of this product costs R$ 3,500 in Brazil. A person weighing about 70 kg would use 3 ampoules.
Rendesivir is available in 103 private hospitals across the country. Reimbursement of rendesivir in the private market is ensured by the ANS (National Agency for Supplementary Health), according to the manufacturer Gilead.
“Most patients will take a five-day course of treatment with rendesivir. In developed countries, the government price for a five-day course of treatment is $2,340,” Gilead said.
The Regen-Cov2 is not being used in the country, says the manufacturer Roche. In the United States it costs US$ 2,000, around R$ 11,850.
The Eli Lilly laboratory is responsible for two drugs approved by Anvisa: the combination of the monoclonal antibodies bamlanivimab and etesevimab, and also baricitinib. Only the last one is used in Brazil.
GSK claims that Sotrovimabe is also not in use in Brazil, despite the approval of Anvisa.
MEDICINES APPROVED BY ANVISA FOR COVID
Agency approved the use of 6 treatments against Covid in Brazil; outside the SUS, part of the drugs is used in the private network
Rendesevir
Injectable antiviral that prevents virus replication, slowing the infection process. May shorten patient recovery. Indicated for hospital use in people aged 12 years or older who have pneumonia and need oxygen support, but who are not under artificial ventilation. Product gained definitive registration from Anvisa
Casirivimabe e imdevimabe (Regen-Cov 2)
Combination of monoclonal antibodies, given as a single dose by intravenous infusion that must be done in hospital, in people over 12 years of age or older. It can help the body overcome viral infection by preventing the virus from entering and infecting the cell. Used in mild and moderate conditions of people who are at high risk of progressing to the severe form of the disease, such as the elderly or patients with chronic diseases. There is no endorsement for use in hospitalized patients or those in need of respiratory support. Product has emergency use authorization
Banlanivimabe e etesevimab
Combination of monoclonal antibodies, administered as a single dose by intravenous infusion that must be done in hospital, in people over 12 years of age. Drugs try to neutralize foreign molecules in the body. Indicated for mild to moderate forms for patients who are at high risk of disease progression. There is no endorsement for use in hospitalized patients or those who need breathing support. Product has emergency use authorization
Regkirona (regdanvimabe)
Monoclonal antibody indicated for adults who do not use oxygen supplementation. This product can be injected and applied in hospitals, it can help the body to resist infection by the virus and prevent the disease from getting worse. The drug prevents the virus from entering human cells. Product has emergency use authorization
Sotrovimabe
Monoclonal antibody indicated for mild to moderate cases in adult and adolescent patients aged 12 years and over, who are at risk of progression to the severe stage of the disease. It works against the spike protein of Sars-CoV-2 and is designed to block the virus from binding and entering human cells. Product has emergency use authorization
baricitinibe
Medicine already used for rheumatoid arthritis and moderate to severe atopic dermatitis. Indicated for adult patients hospitalized with Covid’s severe condition, who require oxygen support by mask, nasal catheter or mechanical ventilation. Anvisa approved a change in the drug’s registration to include the indication for Covid in the package insert
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