This Wednesday (14th) the Ministry of Health signed an settlement with the pharmaceutical firm Novartis to purchase Zolgensma, one of the crucial costly medicine in the world, and provide it without spending a dime in the SUS (Unified Health System). There is just one dose of the drug, which will value SUS BRL 5.7 million and will be used to deal with sufferers with spinal muscular atrophy (AME). The illness causes muscle paralysis and additionally impacts respiration.
The innovation is that SUS will pay the complete quantity of the drug provided that the therapy is efficient. The first installment, 20%, is paid whereas making use of a single dose. The cost of one other 4 installments, additionally 20%, is linked to the effectiveness of the therapy.
How the therapy works
- AME is a uncommon, incurable and very costly illness to deal with. It is brought on by a genetic change that forestalls muscular tissues from growing correctly.
- It causes muscle atrophy and paralysis, affecting the power to breathe, swallow, converse and stroll. It impacts 1 in 10,000 youngsters.
- The drug prices BRL 6.4 million per dose and will be offered to SUS for BRL 5.7 million. Novartis additionally provided a 3% low cost on the worth of every dose, about R$ 170,000, which is used to display youngsters with AME.
- Repayment will be remodeled 5 years, with installments totaling 20% per yr.
- The firm will solely get a full installment if the kid reaches sure developmental milestones — akin to holding their head up and sitting up — and if they’re maintained after just a few years.
- The settlement supplies for the acquisition of a most of 250 doses in the primary two years and provision of an extra 40 therapies by the corporate for free of charge if required.
We are reinventing the way in which medicines are integrated into public well being in Brazil. We need to be a part of the answer.
Renato Carvalho, president of Novartis in Brazil
How the treatment was granted
- The total course of from approval of buy by SUS took about two years between 2020 and 2022.
- Novartis appealed the primary value set by the federal government, BRL 2.9 million, and managed to succeed in BRL 6.4 million. On sale to SUS, the worth of the drug will be R$ 5.7 million.
- After this part, Novartis, in May this yr, introduced a file for inclusion of the drug in the SUS. After seven months, the approval was obtained.
- The course of consists of an preliminary assembly to current the case, a public session and the presentation of the Commission’s closing opinion.
- The fee requested the laboratory for extra particulars, so a call was taken after the third assembly.
It was a journey, we had been the primary gene remedy [tratamento que introduz genes saudáveis no organismo] Approved by SUS.
Zolgensma has been available on the market since 2019 and is used in public well being methods in different nations akin to England, Italy, Canada, the United States, Spain and Portugal, in accordance with Novartis. SUS will be the most important public system for utilizing medicine. Why is medicine so costly?
The drug in opposition to AME was till just lately the costliest in the world. Today, this submit belongs to Hemgenix, a drug used in the therapy of hemophilia and priced at US$ 3.5 million in the United States, is equal to about R$ 18 million at present costs.
what occurs now
- Zolgensma is utilized in a single dose and should be administered till the second yr of the affected person’s life.
- SUS will solely give the drug to sufferers who stay for six months, together with these with SMA kind I (essentially the most extreme) and those that spend greater than 16 hours a day with out utilizing invasive air flow strategies.
- According to the corporate, the earlier the drug is run, the larger the probabilities of life returning to regular.
- According to Carvalho, Novartis is in contact with well being plans to attempt to make complementary well being therapies attainable.
- When included in the SUS, the drug therapy is entered into the ANS (National Supplementary Health Agency) listing inside 60 days.