Rare Disease Drug Price Slashed by 99%: Expert Submission in Kerala HC

Drastic drug price reduction was made possible by bypassing patent protections and facilitating local manufacturing
Increased financial assistance and digital crowdfunding platform launched (Representational Image: Unsplash)
Increased financial assistance and digital crowdfunding platform launched (Representational Image: Unsplash)
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A groundbreaking revelation has emerged in the Kerala High Court, where a 24-year-old Spinal Muscular Atrophy (SMA) patient has filed an affidavit stating that a life-changing drug, risdiplam, can be produced locally for a staggering Rs 3,000 per year, contrary to its current market price of Rs 72 lakh per year. This drastic drug price reduction is made possible by bypassing patent protections and facilitating local manufacturing.

Key Takeaways:

  • Risdiplam's Current Price: Rs 72 lakh per year

  • Proposed Local Production Cost: Rs 3,000 per year

  • Preferred Treatment: Risdiplam is the preferred SMA treatment due to ease of administration and cost-effectiveness

  • Manufacturing Feasibility: Production in small volumes is feasible and cost-effective

  • Government Initiatives: Increased financial assistance and digital crowdfunding platform launched, but with limited success

Dr. Melissa Barber, a renowned expert from Yale University, conducted a cost analysis that supports this claim. Her findings indicate that even with a 1,000% markup, the production cost would still result in a 99% decrease compared to current US prices. This is largely due to risdiplam being a small-molecule medicine with relatively simple manufacturing processes.

other SMA treatments that require invasive procedures, risdiplam can be orally administered (Representational Image: Unsplash)
other SMA treatments that require invasive procedures, risdiplam can be orally administered (Representational Image: Unsplash)

Risdiplam is the preferred treatment for SMA in many healthcare contexts, owing to its ease of administration and cost-effectiveness. This development has the potential to revolutionize access to life-changing treatments for SMA patients in India. Unlike other SMA treatments that require invasive procedures, risdiplam can be orally administered by family members.

Even a markup of 1,000% (unit price $12.83 per 60mg/80mL vial) would result in a 99% decrease relative to current prices in the United States ($11,170 per vial)
Dr Melissa Barber, Expert from Yale University
Spinal Muscular Atrophy (SMA) patient has filed an affidavit stating that a life-changing drug, risdiplam (Representational Image: Unsplash)
Spinal Muscular Atrophy (SMA) patient has filed an affidavit stating that a life-changing drug, risdiplam (Representational Image: Unsplash)

The health ministry has increased financial assistance for rare disease patients from Rs 20 lakh to Rs 50 lakh. However, the petitioner argues that this is insufficient without indigenous production.

A digital crowdfunding platform has been launched, but it has collected a mere Rs 3.5 lakh despite 2,340 patients registering.

The National Rare Diseases Committee aims to procure and indigenize drugs, but the petitioner's affidavit criticizes the lack of concrete steps toward creating an environment conducive to affordable local production. The committee's short-term goal is drug procurement, while its mid-term objective is indigenization.

(Input From Various Sources)

(Rehash/Neha Kamble)

Increased financial assistance and digital crowdfunding platform launched (Representational Image: Unsplash)
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