Doctors and deputies defend approval of a new drug by the SUS for the treatment of myelofibrosis

03/29/2022 – 20:16

Deputies and specialist doctors advocate that the Unified Health System start using ruxolitinib in the treatment of myelofibrosis. The debate on the use of the new drug by hospitals in the country’s public network took place at a public hearing of the Special Commission to Combat Cancer, of the Chamber of Deputies, this Tuesday (29).

Myelofibrosis is a rare type of cancer that affects the cells responsible for producing blood in the bone marrow. The incidence is 1 case in every 200,000 people. The disease mainly affects elderly people over 65 years of age and its main symptoms are anemia, swelling of the spleen and liver, sweating, fever, discouragement, among others. Survival is 2 to 5 years on average.

Billy Boss/House of Representatives

Prado: lack of treatment harms the most needy

Ruxolitinib is a relatively new drug, approved in several countries, such as the United States and others in Europe, and also in hospitals in the Brazilian private network; however, it has not yet been released for use in the SUS.

The National Commission for the Incorporation of Technologies in the Unified Health System has already carried out a preliminary analysis of the new drug. As reported by the general coordinator of Technology Management at the Ministry of Health, Priscila Gibrim, despite the general improvement of patients, the incorporation of ruxolitinib was not approved due to lack of data on survival.

“Plenary members considered the treatment to be associated with a greater benefit in terms of symptom relief as a result of reduced spleen volume, this being the intermediate outcome. Overall survival was observed in two clinical trials conducted more than ten years ago and the median survival was not achieved in these studies. What is being considered is to confirm these benefits through data obtained in observational studies, in a real world study”, he explained.

The doctor Renato Tavares, director of the Brazilian Association of Hematology, Hemotherapy and Cell Therapy, refutes the information. According to him, the drug has proven effectiveness in much of the world, both in improving the quality of life and in the survival time of patients, including real-world studies from the United States and Europe. Renato Tavares also recalled that the treatment has already been approved by health agencies in Brazil and that the non-approval of its use in public hospitals mainly harms the most needy population.

“It is an established treatment that is being denied to SUS patients, but it is approved by Anvisa and was approved by the ANS. In other words: once again, we have people who have economic power in Brazil having access to treatment and those who are poor are left without”, he pointed out.

The president of the Special Commission to Combat Cancer, deputy Weliton Prado (Pros-MG), also highlighted that the lack of treatment in the SUS harms the most needy. And he pointed out that the Union is already paying for the treatment, but only for patients who file lawsuits in court.

“70% of the patients who treat cancer are poor patients, they are patients who are treated in the SUS and are unable to buy these drugs and are elderly without conditions. It is unfair, unacceptable that these patients do not have access to this medication. And some succeed and end up getting more expensive for the public coffers through court decisions. And we know that judicialization is not the solution”, said the deputy.

The Ministry of Health will submit the use of ruxolitinib to public consultation. Afterwards, the National Commission for the Incorporation of Technologies must meet to decide whether the new drug will be offered by the SUS. Deputy Flávia Morais (PDT-GO) stated that the Special Commission to Combat Cancer will actively participate in the public consultation, with the presentation of the studies brought and other actions.

“We are at a crucial moment for the approval of this drug, which, of course, already has a purchased effect, has already managed to achieve very effective results with many patients who unfortunately suffer from myelofibrosis. It is a rare disease, so even with expensive drugs , difficult diagnosis. And we know the great challenge we have”, she said.

Myelofibrosis is only curable through bone marrow transplantation, but many patients cannot receive this type of treatment, hence the need for palliative drugs to improve patients’ quality of life.

Report – Silvério Rios
Editing – Ana Chalub

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