The Keralam government's initiative to make Spinal Muscular Atrophy (SMA) treatment accessible to more patients has been marred by controversy. SMA is a rare, life-threatening genetic disorder that progressively weakens muscles, severely impairing mobility and respiratory function.
Key Takeaways
- The Keralam government has switched from the branded SMA drug, Evrysdi, to a generic version, Natsmart
- Parents of children living with SMA have raised concerns about the efficacy and safety of the generic drug
- The government needs to address the concerns of parents and advocacy groups, while also ensuring that the generic drug is made available to those who need it
- The Delhi High Court verdict allowing Natco Pharma to market the generic alternative of Risdiplam at a dramatically reduced price has changed the landscape of SMA treatment in India
- The controversy over the SMA drug in Keralam has significant implications for patients and families affected by the disorder
What is Spinal Muscular Atrophy?
SMA is a rare inherited neuromuscular disorder caused by changes in the SMN1 gene, leading to progressive muscle weakness by affecting nerve cells that control voluntary movement.
What is the controversy over the SMA drug in Keralam?
The controversy began when the Keralam government switched from the branded version of the SMA drug, Evrysdi, to a generic version, Natsmart, in October this year. Parents of children living with SMA have been claiming that the branded version is more effective and have urged the government to switch back.
Who is affected by the new slab?
Currently, 109 Type 1 and 2 children with SMA below the age of 12 are being given Risdiplam, the active ingredient in Evrysdi, free of cost through government hospitals in Keralam. The government has allocated โน30 crore in the State budget for this.
By the numbers
- โน6.3 lakh: the cost of a bottle of Evrysdi
- โน4.44 lakhs: the current price of a bottle of Evrysdi
- โน5.4 lakh: the negotiated price of a bottle of Evrysdi
- โน15,900: the price of a bottle of Natsmart, the generic version
- โน60-70 lakh: the annual maintenance cost for a patient on Evrysdi
- โน5 lakh: the annual maintenance cost for a patient on Natsmart
What do doctors say?
Public health experts have hailed the government's decision to switch to the generic drug, saying that arguments challenging the efficacy of the generic formulation are unscientific and baseless. The World Health Organization (WHO) recognises that bioequivalence studies are not required for every generic medicine.
What are the concerns about the generic drug?
Parents and advocacy groups claim that the branded medication, Evrysdi, has a proven track record of safety and efficacy, while the new generic version lacks dedicated human bioequivalence or long-term clinical studies specific to paediatric patients.
How did Keralam begin SMA treatment?
Keralam was the first State to give Risdiplam free of cost through government hospitals in 2022, and an SMA clinic was subsequently opened at SAT hospital. Though initially Risdiplam was given free only to children under 12 years of age, in 2026 the government announced an extension of coverage to genetically confirmed SMA Type 2 patients up to age 25.
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What is the history of SMA treatment in India?
Risdiplam was launched in India in July 2021, making it the first and the only approved drug in the country to manage SMA. But the drugโs astronomical cost made it inaccessible to most families. The Delhi High Court verdict allowing Natco Pharma to market the generic alternative of Risdiplam at a dramatically reduced price has changed the landscape of SMA treatment in India.
What are the implications for patients and families?
The controversy over the SMA drug in Keralam has significant implications for patients and families affected by the disorder. The high cost of the branded drug, Evrysdi, has made it inaccessible to many families, and the switch to the generic version, Natsmart, has raised concerns about efficacy and safety.
What is the way forward for SMA treatment in Keralam?
The Keralam government needs to address the concerns of parents and advocacy groups, while also ensuring that the generic drug is made available to those who need it. The government should consider conducting further studies to establish the efficacy and safety of the generic drug, and provide support to families affected by SMA.
Frequently Asked Questions
What is Spinal Muscular Atrophy?
SMA is a rare inherited neuromuscular disorder caused by changes in the SMN1 gene, leading to progressive muscle weakness by affecting nerve cells that control voluntary movement.
What is the controversy over the SMA drug in Keralam?
The controversy began when the Keralam government switched from the branded version of the SMA drug, Evrysdi, to a generic version, Natsmart, in October this year. Parents of children living with SMA have been claiming that the branded version is more effective and have urged the government to switch back.
What are the implications for patients and families?
The controversy over the SMA drug in Keralam has significant implications for patients and families affected by the disorder. The high cost of the branded drug, Evrysdi, has made it inaccessible to many families, and the switch to the generic version, Natsmart, has raised concerns about efficacy and safety.
