Country: BRAZIL | Region: SOUTH AMERICA | Type: Pricing & Reimbursement | Keywords:#anvisa #cellandgenetherapy #cmed #maximumsellingprices #novartis
- At the 6th Extraordinary Meeting of the Medicines Market Regulation Chamber’s (CMED) Technical-Executive Committee, the agency authorized maximum selling prices for Novartis’ gene therapies, Zolgensma (onasemnogene abeparvovec) and Luxturna (voretigene neparvovec)—however, the prices have not been announced yet
- CMED’s decision to set the price for these gene therapies, Brazil’s first two ever, was called “unprecedented” by Brazil’s National Sanitary Surveillance Agency (ANVISA), and Novartis still has time to appeal
- In August, Luxturna was approved for the treatment of vision loss due to hereditary retinal dystrophy and Zolgensma for the treatment of pediatric patients up to two years old diagnosed with type 1 SMA with biallelic mutations in the SMN1 gene or up to three copies of another gene known as SMN2
THE DETAILS
BRASILIA, Brazil – At the 6th Extraordinary Meeting of the Medicines Market Regulation Chamber’s (CMED) Technical-Executive Committee, the agency authorized maximum selling prices for Novartis’ gene therapies, Zolgensma (onasemnogene abeparvovec) and Luxturna (voretigene neparvovec).
Now, Zolgensma can be made available for spinal muscular atrophy (SMA) patients aged two years and under and Luxturna for the treatment of vision loss due to hereditary retinal dystrophy.
CMED’s decision to set the price for these gene therapies, Brazil’s first two ever, was called “unprecedented” by Brazil’s National Sanitary Surveillance Agency (ANVISA). Novartis still has the possibility to appeal to CMED regarding the prices it set.
The prices for these two gene therapies have not yet been announced.
August of this year saw Brazil approve its first gene therapy, Luxturna, however, its commercialization remained dependent on ANVISA assessment of its therapeutic capacity and subsequent approval. All in all, it took 232 business days from submission until ANVISA said yes to Luxturna.
Shortly after Luxturna secured approval, ANVISA announced it approved Zolgensma for the treatment of pediatric patients up to two years old diagnosed with type 1 SMA with biallelic mutations in the SMN1 gene or up to three copies of another gene known as SMN2.
Prior to ANVISA’s final decision, both Luxturna and Zolgensma collected nods from the Brazilian Technical Commission of Biosafety (CTNBio), the body responsible for evaluating biosafety of Genetically Modified Organisms (GMOs) in Brazil.
With Zolgensma, ANVISA concluded its benefits outweighed any risks, however, because it is an innovative gene therapy, an exceptional record was approved, meaning that additional studies must be carried out by the company to confirm its long-term effectiveness and safety.
Brazilian President Jair Bolsonaro moved import tax rates to zero for Zolgensma before it secured ANVISA approval. Without zero import tax, Zolgensma would have been subject to a 4% tax rate—or, an additional USD 80,000, according to the Brazil Report.
At the time, former directors of ANVISA and the Ministry of Health warned against Bolsonaro’s decision, as it could set a negative precedent for the future of these drugs, which are still very new to the Brazilian market.
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