by the Brazil Agency
The Ministry of Health introduced this Wednesday (07), the inclusion of the world’s most expensive drug Zolgensma in the Unified Health System (SUS). It is utilized by kids as much as six months. The announcement comes 5 days after the National Commission for the Incorporation of New Technologies in Health (CONITECH) expressed itself in favor of distribution of the drug by way of public networks.
Used in the remedy of kids affected by spinal muscular atrophy (SMA) kind 1, the drug – also called onasemnogeno abeparvovac – should be accessible in the public well being community inside 180 days – a interval set by the Ministry in an ordinance printed as we speak (7), at Official Diary of the Union??
According to the Ministry of Health, an adjustment interval is required for the authorities to organize a tenet protocol on the use of the product, in addition to negotiate the buy worth and supply time with the manufacturing laboratory, Novartis.
On Twitter, the Minister of Health, Marcelo Quiroga, highlighted that the drug ought to solely be utilized to kids as much as six months who’re being handled for the results of spinal muscular atrophy with out the use of invasive air flow for greater than 16 hours a day. Prescription follows the preliminary protocol established by the Ministry.
Quiroga additionally introduced that, as established by Law 14,307 of March of this 12 months, the drug also needs to be included in the record of the National Supplementary Health Agency, which obliges well being plans to cowl the remedy when prescribed to their shoppers.
“Health plans should supply remedy to their beneficiaries inside a most of 60 days, as regulated by Law no. [federal] and permitted by the President [da República] Jair Bolsonaro,” Quiroga wrote.
AME is a uncommon, degenerative illness, handed from mother and father to kids, that interferes with the physique’s capability to supply proteins important for the survival of motor neurons (accountable for easy very important voluntary physique actions, comparable to respiration, swallowing and motion).
It varies from kind 0 (earlier than start) to kind 4 (second or third decade of life), relying on the diploma of muscle impairment and the age at which the first signs seem.
Major indicators of the illness embrace loss of muscle management and energy and lack of ability and/or problem with motion and motion; to swallow; Keep your head up and breathe.
According to the Ministry of Health, other than the technical analysis in the SUS by the National Commission for the Incorporation of Technology, the inclusion of Zolgensma in the SUS was the topic of a public session that obtained ideas/contributions from over 1,200 folks. .
In addition to Zolgensma, two different drugs that have an effect on the motor neurons of the spinal wire are already included in the SUS: Nucinersena and Risdiplum, each for steady use.