The ANS (National Supplementary Health Agency) approved this Monday (6) the incorporation of four technologies to the List of Procedures and Events in Health, which must be followed by health plan operators.
The main novelty is the presence of the medicine Zolgensma (onasemnogeno abeparvoveque), from Novartis Biosciences SA, for the treatment of children up to six months old diagnosed with AME (Spinal Muscular Atrophy) type 1, considered the most serious.
The medicine, a single-dose infusion that is among the first in a new class of cutting-edge gene therapies — it holds great promise for people with life-threatening or debilitating conditions — had already been incorporated into the SUS (Sistema Único de Saúde) early on. last December, after evaluation by Conitec (National Commission for the Incorporation of Technology in the SUS) and undergoing public consultation.
The recommendation is that it be used in patients who are not on non-invasive ventilation for more than 16 hours a day.
SMA affects the spinal motor neuron and is caused by a change in the gene responsible for coding the protein necessary for proper muscle development. Rare and incurable, the disease causes weakness, hypotonia, atrophy and progressive muscle paralysis affecting breathing, swallowing, speech and the ability to walk. Type 1 affects 45% to 60% of all patients with SMA and can lead to death.
Zolgensma counteracts the effects of AME in babies. Therapy reduces the need for artificial ventilation to breathe and improves movement and muscle strength – in practice, the child can sit, support the head and crawl, for example.
The maximum price stipulated by the Medicines Market Regulation Chamber, the inter-ministerial body responsible for defining the maximum prices for the sale of medicines in the country, is R$ 6.4 million for the treatment. The government, however, has agreed to pay the equivalent of around $1 million (R$5.14 million) for treatment — far less than what some other governments are paying.
The agreement with Novartis provides that Brazil divides the payment for each treatment into five equal installments over four years. If a patient dies, needs to be permanently ventilated, or is unable to maintain certain motor functions two years after receiving treatment, the government will not be required to make subsequent payments.
After incorporation into SUS, Zolgensma had already become mandatory coverage by health plans when prescribed by the attending physician for administration in hospitalization, in hospital segmentation plans (with or without obstetrics) and reference plans. Now on the ANS list, it must also be offered by plans for outpatient prescriptions.
The technology will be offered to users of health plans after publication in the Official Gazette, which should take place this week.
Sought, the Abramge (Brazilian Association of Health Plans) states that “the operators follow the rules of the National Supplementary Health Agency, as well as its guidelines”.
The other three drugs included in the ANS list are: Dupilumab, for the treatment of adult patients with severe atopic dermatitis with indication for systemic treatment and who present failure, intolerance or contraindication to cyclosporine; Zanubrutinib, for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy; and Romosozumab, for the treatment of postmenopausal women with osteoporosis, from the age of 70, who have failed drug treatment.
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