ANS includes Zolgensma in the coverage of health plans

Zolgensma, which won the informal title of “the most expensive medicine in the world”, was included by the National Supplementary Agency (ANS) in the list of medicines that must have mandatory coverage by health plans in Brazil. The value of this medicine can reach approximately R$ 11 million. It is used in the treatment of patients with Spinal Muscular Atrophy (SMA).

The ANS, however, approved the incorporation with rules that restrict its use to “pediatric patients up to 6 months of age with Spinal Muscular Atrophy (SMA) type I who are not on invasive mechanical ventilation for more than 16 hours a day”. The merger was defined at the agency’s meeting on Monday (6) and will still be published in the Official Gazette (DOU).

ANS reported that Zolgensma is the first advanced therapy to be included in the list of mandatory coverage by health plan operators, whose incorporation into the list takes place in compliance with paragraph 10 of Law 14,307, of March 2022.

According to the legal website jot, Anvisa had given the endorsement, in 2020, so that babies up to 2 years old could receive the medicine. But the Ministry of Health had expressed itself in the sense that the effectiveness of the medicine was greater in younger children.

In a note sent to jot, the National Federation of Supplementary Health (FenaSaúde) said it will comply with the decision of the ANS, but defended the revision of the price of Zolgensma. “The entity defends the need to discuss risk-sharing models between health plans and the pharmaceutical industry, as well as the review of the price of the medicine, with the objective of achieving comparable values ​​between SUS and supplementary health”, he said. to FenaSaúde.

In the Unified Health System (SUS), the incorporation was approved in December 2022. The medication will also be intended for children up to six months old with AME.

The deadline for SUS to start offering the drug is 180 days. In the case of health plans, the law provides for a period of 60 days for the remedy to be made available.

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Spinal Muscular Atrophy (AME) is a rare, degenerative disease, transmitted from parents to children and that interferes with the body’s ability to produce an essential protein for the survival of motor neurons (responsible for simple voluntary body gestures, such as breathing, swallow and move), according to the Brazil Agency.

The disease ranges from type 0 (before birth) to type 4 (second or third decade of life), depending on the degree of muscle impairment and the age at which the first symptoms appear. Still according to Brazil Agency, the main signs of the disease include loss of control and muscle strength and incapacity and/or difficulty in movement and locomotion; to swallow; keep your head up and breathe.