SUS patients are left without access to effective remedies against Covid

Almost two years after the beginning of the pandemic, the first generation of effective drugs against Covid-19 are available or about to enter Brazil, including medications that act as a true early treatment – preventing mild and moderate cases from evolving into the severe form. These drugs, however, are only found in private services and are not expected to reach the SUS.

The high cost charged by the pharmaceutical companies and the slowness of the Ministry of Health in evaluating the treatments are pointed out as obstacles to the offer in the public network, according to doctors and specialists heard by the Reporter Brazil.

“We are super late in the incorporation of medications into the SUS. With such a huge public health problem, the Ministry of Health was supposed to be negotiating with pharmaceutical companies, but they are still thinking about chloroquine”, criticizes infectologist José David Urbaez, from the Brazilian Society of Infectology in the Federal District.

The government’s sluggishness exacerbates the inequality of access among the Brazilian population. On the one hand, patients who can afford drugs such as regkirona, baricitinib and rendesivir (see list at the end of the report) gain a new chance to beat Covid. On the other hand, SUS users who do not have any options.

The Ministry of Health told the Reporter Brazil that there is still no open negotiation with pharmaceutical companies and that this can only happen after Conitec (National Commission for the Incorporation of Technologies in the SUS) approves the inclusion of drugs in the SUS. He also said that he has been speeding up Conitec’s analysis and that he is in contact with pharmaceutical companies to expedite requests to the commission.

Of eight pharmaceutical companies consulted, only MSD and Pfizer told the report that they are talking to the government about acquisitions, however, their products await approval from Anvisa (National Health Surveillance Agency).

Instead of accelerating the evaluation of treatments, the government is striving to keep the Covid kit, composed of chloroquine, ivermectin and other proven ineffective drugs, in force. This is what happened in January, when the government disapproved of the new guidelines for the SUS, which brought suggestions based on scientific evidence and vetoed the drugs defended by President Jair Bolsonaro (PL).

This new protocol, prepared by a group of doctors and scientists, was barred by the then secretary of Science, Technology and Strategic Inputs at the ministry, Hélio Angotti Neto, a defender of Bolsonarist ideas.

Angotti’s veto prevented SUS patients from having access to tocilizumab, indicated for rheumatoid arthritis, but used for months in private hospitals for Covid. This drug works in the severe phase of the disease and has been recommended since July by the WHO (World Health Organization).

The national guidelines, which considered tocilizumab for patients “in clear clinical deterioration”, were approved in June by Conitec, which advises the ministry on these decisions. Angotti and the Minister of Health, Marcelo Queiroga, spent six months without touching the subject, until the document was rejected this year. Queiroga will have the final word, but no one knows when.

This slowness impairs the entry of other even more effective drugs into the SUS. “In the last six months, new drugs for the hospital phase have already appeared with better levels of evidence”, says Alexandre Naime Barbosa, vice president of the Brazilian Society of Infectious Diseases and professor at Unesp.

A member of the scientific group, he says it is necessary to update the recommendations. What is not known, however, is whether the government is interested. “We don’t know if the minister wants us to continue doing science,” he says.

One of the options mentioned by him is baricitinib., anti-inflammatory drug that in January became strongly recommended by the WHO for severe Covid. The drug is also being used in the private network and outside the SUS. Manufacturer Lilly asked in January for Conitec to evaluate its incorporation. The analysis begins this Thursday (10).

early treatment

In addition to drugs for severe cases, there are others for the initial phase, when the virus is in the airways. “If the virus is blocked at this stage, we can prevent the case from evolving into a severe form”, says Barbosa.

There are at least six drugs: the antivirals rendesivir (Gilead), paxlovid (Pfizer) and molnupiravir (MSD), which prevent the virus from replicating, in addition to the monoclonal antibodies sotrovimab (GSK), regkirona (Celltrion Healthcare) and evusheld (Astrazeneca), that attack the virus. Only the last three are released in Brazil as initial treatment. Rendesivir is authorized only for the severe phase, while Pfizer and MSD await approval from Anvisa.

In the US and the UK public network, initial treatment is only offered to high-risk patients. That’s what Barbosa does in his private practice, but using regkirona, “the only option” in Brazil, he says. “True early treatment”.

“I’m applying it to a patient with Covid who has rheumatoid arthritis and a greater risk of evolving into a severe case. It’s a single infusion of four ampoules. It has no side effect and reduces the risk of death by up to 90%”, says the doctor, who has already indicated therapy for at least 40 patients. At a cost of R$2,800 per ampoule, the treatment costs R$11,200.

Despite the price, the doctor says that the medication could be adopted in the SUS for elderly people over 70 and immunosuppressed. As these groups have a less efficient response to vaccines, anti-Covid drugs could reduce hospitalizations and deaths. “For this group it is worth investing”.

Despite this, the analysis of incorporation of regkirona was not carried out, as the manufacturer did not present the necessary documentation, according to the ministry.

High cost

Anti-Covid drugs are expensive and price is a central element in deciding whether to include them in the SUS. Rendesivir, for example, would have an impact of R$ 28 billion in the first five years, according to Conitec’s assessment in August, when it rejected the incorporation for considering the uncertain benefits before the high cost.

But if a drug really works, it must be incorporated, says researcher Jorge Bermudez, from Fiocruz, a specialist in access to medicines. Which does not mean paying billions in treatments, but making their prices affordable, with the manufacture of generics. “An immunosuppressed person who goes to a public hospital should receive the medication, not just those who are treated at Einstein”, says the researcher.

Baricitinib, for example, does not have a generic version in Brazil. In India, the 14-day generic treatment costs a total of US$5.50 (R$28), but Lilly’s proposed price for the US is above US$2,300 (R$11,700), according to the Doctors Without Borders (MSF). In Brazil, the treatment would cost R$ 2,750, according to private market values.

To make the production of generics viable, it would be necessary to suspend pharmaceutical patents, a matter dear to pharmaceutical companies and the countries where the companies are based. Since October 2020, a proposal has been dragging on at the World Trade Organization that would allow this suspension in the pandemic. But the discussion “is being fought by the rich countries”, according to Bermudez.

anti-covid drugs

Name and manufacturer: Rendesivir (Gilead)

Way of use: intravenously administered antiviral

Treatment type:

• Initial treatment: yea
• Severe phase: yea

Availability in Brazil:

• Registration with Anvisa (allows use in the country): Yes. Definitive registration for the severe phase
• Analysis by Conitec and the Ministry of Health (give approval to enter the SUS): rejected for use in the severe phase due to uncertainty about benefit. Company plans new order

Who recommends? UK and USA

Name and manufacturer: REGN-COV2 / casirivimab + indevimab (Regeneron and Roche)

Way of use: monoclonal antibody therapy given intravenously

Treatment type:

• Initial treatment: yea
• Severe phase: no

Availability in Brazil:

• Registration with Anvisa (allows use in the country): Yes. Emergency use record. No proven effectiveness against the micron
• Analysis by Conitec and the Ministry of Health (give approval to enter the SUS): rejected by Conitec due to uncertainties about effectiveness against variants

Who recommends? WHO

Name and manufacturer: Regkirona / regdanvimab (Celttrion Healthcare)

Way of use: monoclonal antibody therapy given intravenously

Treatment type:

• Initial treatment: yea
• Severe phase: no

Availability in Brazil:

• Registration with Anvisa (allows use in the country): Yes. Emergency use record
• Analysis by Conitec and the Ministry of Health (give approval to enter the SUS): Analysis was canceled due to lack of documents

Who recommends? –

Name and manufacturer: sotrovimab (GSK)

Way of use: monoclonal antibody therapy given intravenously

Treatment type:

• Initial treatment: yea
• Severe phase: no

Availability in Brazil:

• Registration with Anvisa (allows use in the country): Yes. Emergency use record
• Analysis by Conitec and the Ministry of Health (give approval to enter the SUS): no order forecast

who recommendThe? WHO, UK and US

Name and manufacturer: baricitinib (Lilly)

Way of use: oral pill

Treatment type:

• Initial treatment: no
• Severe phase: yea

Availability in Brazil:

• Registration with Anvisa (allows use in the country): Yes. Original registration is for rheumatoid arthritis, but Anvisa has already approved the inclusion of Covid in the package insert
• Analysis by Conitec and the Ministry of Health (give approval to enter the SUS): request for analysis made in January 2022

Who recommends? WHO and USA

Name and manufacturer: paxlovid (Pfizer)

Way of use: oral pill

Treatment type:

• Initial treatment: yea
• Severe phase: no

Availability in Brazil:

• Registration with Anvisa (allows use in the country): do not. Order placed in February 2022
• Analysis by Conitec and the Ministry of Health (give approval to enter the SUS): without prediction

Who recommends? UK and USA

Name and manufacturer: molnupiravir (MSD)

Way of use: oral pill

Treatment type:

• Initial treatment: yea
• Severe phase: no

Availability in Brazil:

• Registration with Anvisa (allows use in the country): do not. Order placed in November 2021
• Analysis by Conitec and the Ministry of Health (give approval to enter the SUS): without prediction

Who recommends? WHO, UK and US

Name and manufacturer: Evusheld (Astrazeneca)

Way of use: monoclonal antibody therapy given intravenously

Treatment type:

• Initial treatment: yes (also acts as a preventative)
• Severe phase: no

Availability in Brazil:

• Registration with Anvisa (allows use in the country): Yes. Emergency use record
• Analysis by Conitec and the Ministry of Health (give approval to enter the SUS): without prediction

Who recommends? –​

Name and manufacturer: tocilizumab (Roche)

Way of use: monoclonal antibody therapy given intravenously

Treatment type:

• Initial treatment: no
• Severe phase: yea

Availability in Brazil:

• Registration with Anvisa (allows use in the country): do not. The medication is registered for rheumatoid arthritis, but the company has already requested approval for its use for Covid
• Analysis by Conitec and the Ministry of Health (give approval to enter the SUS): without prediction

Who recommends? WHO and USA

_{Sources: José David Urbaez, Alexandre Naime Barbosa, Anvisa, Ministry of Health, WHO, NIH (US), NHS (UK) and pharmaceutical companies cited (information updated March 9, 2022)}