with 7 drugs approved, none are yet available in the country’s public network – Agência AIDS

The pandemic has given some respite in recent weeks, but the care of the coronavirus infection cannot calm down and is expected to last for many, many months. Yet the Department of Health ignores drugs, cocktails and antibody combinations that can help with treatment. A year after the approval by the National Health Watch Agency (Anvisa) of the first drug against Covid-19, none is available on the public network.

The file plans to discuss the subject again at an internal meeting on Monday. It is only then that the National Commission for the Integration of Technologies in the Unified Health System (Conitec), responsible for defining the treatments offered by the SUS, can come back to discuss the indication.

Anvisa has already granted emergency use authorization for seven drugs, including monoclonal antibodies and a combination of antibodies. However, it suspended approval of Eli Lilly’s banlanivimab + etesevimab in February after the company failed to provide efficacy data against Ômicron.

In the latest protocol, Conitec assesses that the benefit of these therapies does not justify their indication due to criteria of “high cost, low experience of use, uncertainties about efficacy and their unavailability in the healthcare system”. The appointment may change to new meetings.

“Since it is a small number of patients, it will not burden the government,” says Antônio Condino Neto, professor of immunology at the Institute of Biomedical Sciences of the University of São Paulo (ICB-USP ). “If immunocompromised patients who could not benefit from the vaccine as they should have had access to these drugs, it is clear that deaths could have been prevented.”

In the viewfinder of the government for possible acquisitions, is Evusheld, the most recent approval of Anvisa and developed by AstraZeneca from human antibodies. It is the first treatment that can prevent coronavirus infection. The indication of the laboratory is given to immunocompromised people from the age of 12. For GLOBO, the company confirmed dialogue with the federal government, but did not provide forecasts of quantity and delivery date. The United States, meanwhile, has an agreement for 1.7 million doses.

The doctors heard by GLOBO stress the importance for the country of investing in drugs and therapies for Covid-19. For Julio Croda, professor of medicine at the Federal University of Mato Grosso do Sul (UFMS) and researcher at the Oswaldo Cruz Foundation (Fiocruz), it is “unsuitable” that the ministry has not integrated medicines so far , which goes against the grain. other countries like the United States.

“They are super necessary, especially for those most at risk. If we had drugs distributed free of charge, as the United States offers in pharmacies, we could use them in the general population or in groups at risk, with comorbidities, immunocompromised people and the elderly, ”points out the infectiologist.

Although advances in vaccination have largely contributed to reducing hospitalizations and deaths from Covid-19, specific groups may benefit from one more alternative in the fight against the disease, such as the immunocompromised – cancer patients, of HIV or AIDS and transplanted. , for example — and the elderly, experts point out.

“It would be good for Brazil to incorporate these drugs. Now, we don’t see this debate taking place within the department. Anvisa approves some drugs, but also slowly. This needs to be accelerated, needs to be evaluated at Conitec. We do not have a protocol for the care of patients with Covid-19, for outpatient or hospital care”, criticizes Croda, former director of health monitoring at the ministry.

Interlocutors linked to Conitec told GLOBO that the discussion on the use of antivirals and immunobiologicals should only come back to the table after the Minister of Health, Marcelo Queiroga, has spoken on the previous protocols. In the latter, the committee also contraindicated the use of the “Covid kit” – with drugs that are ineffective against the disease, such as chloroquine, hydroxychloroquine, ivermectin and azithromycin.

The recommendation was banned by then-Secretary for Science, Technology, Innovation and Strategic Inputs (SCTIE), Hélio Angotti Neto. The scientists appealed against the decision, which has already been rejected by the ophthalmologist, who is a declared olavista. The case went all the way to the final instance: Queiroga’s office.

“What is obvious to us citizens is that there are forces within the Ministry of Health for the adoption of drugs like chloroquine and ivermectin, which have proven to be of no benefit to the treatment. It’s a shame, because they don’t work. It’s a waste of money,” argues Condino Neto, who chairs the immunology department of the Brazilian Society of Pediatrics (SBP).

One of the Anvisa-approved drugs, REGN-COV2, formed by Casirivimab and Indevimab, had an opinion from the manufacturer, Roche, in December stating that the product “does not retain neutralizing activity against the Ômicron variant” . As in others, there was no progress in the negotiation with the ministry. Pfizer’s Paxlovid, on the other hand, has been analyzed by Anvisa since last month. According to the laboratory, the objective is to produce 80 to 120 million doses this year.

Solicited by GLOBO, Anvisa indicated that “it is not possible to anticipate future authorizations or cancellations. In addition, we had the application for registration of Remdesivir (it is not for emergency use) and the approval of the new indication of Baracitinib”, specifies the note. This drug is used against rheumatoid arthritis.

In a note, the Ministry of Health said it “has held meetings with the pharmaceutical industries, to guide the submission of technologies” for incorporation into the SUS. So far, according to the filing, six technologies have been analyzed by Conitec.

The ministry pointed out that the final recommendation was not to incorporate remdesivir, indevimab and casirivimab (evaluated twice and, each time, with an unfavorable recommendation), and regdanvimab (due to non-compliance with legal requirements). There was no request for submission of sotrovimab and the case of baricitinib is being analyzed, the ministry said.

Source: The globe

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