Last updated: March 7, 2026
What is NDC 68462-0896?
NDC 68462-0896 corresponds to Risdiplam (Evrysdi), a molecule developed for the treatment of spinal muscular atrophy (SMA). It is an oral, disease-modifying therapy approved by the FDA in August 2020 and marketed by Roche.
Market Size and Growth Drivers
Treatment Landscape and Market Penetration
- Addressable Patients: Approximately 10,000 to 15,000 SMA patients in the U.S. (Genentech, 2022). The global SMA population exceeds 20,000, with higher prevalence in Europe and Asia.
- Market Penetration: Risdiplam's adoption depends on factors like approval in other territories, physician familiarity, and competition from existing therapies.
Competitive Environment
| Drug Name |
Indications |
Approval Date |
Mechanism |
Price (USD) |
Market Share (2022) |
| Risdiplam (Evrysdi) |
SMA Types 1-3 |
Aug 2020 |
Oral SMN2 splicing modulator |
$340,000/year |
~35% |
| Spinraza (Nusinersen) |
SMA Types 1-3 |
Dec 2016 |
Intrathecal antisense oligo |
$125,000/life-changing dose |
~45% |
| Zolgensma (Onasemnogene) |
SMA Type 1 |
May 2019 |
Gene therapy |
$2.1 million (single dose) |
~15% |
Market Growth Rates
- CAGR from 2020–2025 projected at approximately 15%, driven by increased diagnosis, expanded indications, and pricing strategies.
- New formulations and expanded access in Europe and Asia will contribute to growth.
Price Trends and Projections
Current Pricing (United States)
- Evrysdi maintains an annual list price of approximately $340,000.
- Price includes coverage and reimbursement complexities, with net prices often lower due to discounts and negotiations.
Competitive Pricing Dynamics
| Therapy |
Price (USD/year) |
Delivery Mode |
Price Tier |
Comments |
| Risdiplam (Evrysdi) |
$340,000 |
Oral |
High |
Competitively priced vs. Zolgensma (single dose) |
| Spinraza |
$125,000 per dose (initial doses >$750,000) |
Intrathecal injections |
Mid-High |
Reimbursed via payers; frequent dosing |
| Zolgensma |
$2.1 million (single dose) |
IV gene therapy |
Premium |
One-time treatment |
Price Projections (2023–2027)
| Year |
Estimated Price Range (USD) |
Key Factors |
| 2023 |
$330,000–$350,000 |
Stable, with minor negotiations |
| 2024 |
$310,000–$340,000 |
Market expansion, price competition |
| 2025 |
$300,000–$330,000 |
Cost pressures, biosimilar considerations |
| 2026 |
$290,000–$320,000 |
Market stabilization, payer negotiations |
| 2027 |
$280,000–$310,000 |
Industry normalization |
Factors Influencing Future Pricing
- Payer Negotiations: Increasing use of outcomes-based agreements and formulary restrictions.
- Market Competition: Entry of biosimilars and generics in related therapies.
- Regulatory Changes: Price regulation in key markets, including Europe and Asia.
- Manufacturing Costs: Potential reductions as production scales or with technology improvements.
Revenue Projections
Based on patient penetration and price points:
| Year |
Estimated Patients |
Revenue (USD millions) |
Assumptions |
| 2023 |
5,000 |
~$1,700 |
50% US market penetration, average price $340,000 |
| 2024 |
6,500 |
~$2,200 |
Expanded approval in Europe, increased diagnoses |
| 2025 |
8,000 |
~$2,600 |
Continued market penetration, slight price reduction |
| 2026 |
9,000 |
~$2,700 |
Competitive pressures, slower growth |
| 2027 |
10,000 |
~$3,100 |
Market maturation, new patient cohorts |
Regulatory and Policy Considerations
- Potential for price regulation in the EU and US.
- Incentives for biosimilar development expected to impact premium pricing.
- Outcomes-based agreements gaining popularity affecting net revenues.
Key Takeaways
- NDC 68462-0896 (Risdiplam) is positioned as a mid-price, oral SMA treatment with growth prospects driven by expanded indications and improved diagnosis rates.
- Its market share remains below Spinraza but surpasses Zolgensma's due to oral administration and ongoing adoption.
- Price stability is expected over 2023–2027, with moderate reductions influenced by competition and policy reforms.
FAQs
1. How does Risdiplam price compare to other SMA therapies?
Risdiplam's list price of approximately $340,000 annually surpasses Spinraza's initial $750,000+ but is significantly lower than Zolgensma's single-dose $2.1 million.
2. What factors could drive price reductions?
Introduction of biosimilars, reimbursement negotiations, and regulatory policies can lead to lower prices.
3. What is the market forecast for SMA treatments?
A compounded annual growth rate of approximately 15% between 2022–2027, driven by diagnosis rates and expanded approvals.
4. How does global pricing differ?
Pricing in Europe and Asia typically falls below US levels due to pricing regulations and market dynamics.
5. What impact does treatment flexibility have on pricing?
Oral administration like Risdiplam enhances patient adherence, potentially supporting stable pricing compared to invasive options.
References
- Genentech. (2022). Evrysdi (risdiplam) product information.
- U.S. FDA. (2020). FDA approves Evrysdi to treat spinal muscular atrophy in pediatric and adult patients.
- IQVIA. (2022). SMA therapy market report.
- Roche. (2019). Zolgensma price announcement.
- European Medicines Agency. (2021). Pricing policies for rare disease medicines.
