Last updated: March 1, 2026
What is NDC 66689-0038?
NDC 66689-0038 is a specific drug identified within the National Drug Code (NDC) system. This code corresponds to Risdiplam (marketed as Evrysdi), a spinal muscular atrophy (SMA) treatment. Approved by the FDA in August 2020, Risdiplam is a small molecule agent that modulates SMN2 gene splicing, increasing survival motor neuron (SMN) protein levels.
Market Overview
Indication and Market Size
- Primary indication: SMA across all ages, including infants, children, and adults.
- Prevalence estimates:
- Global SMA prevalence: roughly 1 in 10,000 live births.
- US SMA population:
- Approximately 10,000 to 15,000 diagnosed individuals.
- Infantile SMA (Type 1): around 60% of cases.
- Market penetration:
- Earlier treatments included nusinersen (Spinraza) and onasemnogene abeparvovec (Zolgensma).
- Risdiplam’s oral administration offers convenience, expanding its share among SMA therapies.
Competitive Landscape
| Drug |
Type |
Approval Year |
Administration |
Market Share (2022) |
Pricing (per year) |
| Spinraza |
Antisense oligonucleotide |
2016 |
Intrathecal |
~50% |
$750,000 (initial); ~$125,000/year (maintenance) |
| Zolgensma |
Gene therapy |
2019 |
Single infusion |
~25% |
~$2.1 million per dose |
| Evrysdi |
Small molecule |
2020 |
Oral |
~20% |
$340,000/year |
Note: Exact market share varies by region and source.
Adoption Trends
- Risdiplam's oral route reduces procedural barriers associated with injection-based therapies.
- Increased adoption among adult SMA patients.
- Expanded reimbursement coverage following favorable health technology assessments.
Price Projections
Current Pricing Benchmarks
- Evrysdi: list price approximates $340,000 annually.
- Pricing sources: CMS and private insurer data indicate net prices including discounts may be 20-30% lower than list prices.
Market Dynamics Impacting Pricing
- Generics and biosimilars: Currently, no biosimilar exists for Risdiplam. Entry anticipated in 5–8 years, potentially reducing prices.
- Reimbursement policies: CMS and private plans heavily influence net prices. Moves towards value-based pricing could pressure list prices downward.
- Innovation pressure: Development of next-generation SMA therapies may drive price competition.
Future Price Trends (2023-2028)
| Year |
Expected List Price |
Notes |
| 2023 |
$340,000 |
Stable; no biosimilars yet |
| 2024 |
$330,000 |
Slight decline due to negotiations |
| 2025 |
$310,000 |
Anticipated biosimilar entry in niche markets |
| 2026 |
$290,000 |
Biosimilar activity increases |
| 2027 |
$270,000 |
Deeper price competition expected |
| 2028 |
$250,000 |
Potential biosimilar or alternative therapies impact pricing |
Revenue Projections
- US market revenue (2023-2028): $1.2 billion initial, decreasing to ~$780 million as prices decline and biosimilars enter.
- Global market expansion: Additional $500 million by 2028, primarily in Europe and emerging markets.
Policy and Regulatory Impacts
- Insurance coverage limits will influence net prices.
- Price negotiations by the US Medicare program may set a precedent.
- International pricing controls, especially in Europe, pressurize list prices.
Key Competitor Price Trends
| Drug |
Price Range (2022) |
Expected Trend |
Notes |
| Spinraza |
$750,000/year |
Stable |
Intrathecal delivery increases cost |
| Zolgensma |
~$2.1 million per dose |
Stable |
One-time therapy |
| Evrysdi |
$340,000/year |
Slight decline |
Oral administration enhances adoption |
Key Takeaways
- The current annual list price for Risdiplam is approximately $340,000.
- The therapy holds about 20% of the SMA treatment market share.
- Market share is influenced by administration convenience and evolving reimbursement policies.
- Price declines projected: 10-25% over the next five years, mainly driven by biosimilar activity and policy adjustments.
- Revenue growth depends on market penetration, pricing strategies, and competitive dynamics.
FAQs
1. What factors could accelerate Risdiplam price reductions?
Introduction of biosimilars, improvements in reimbursement negotiations, and new competing therapies.
2. How does Risdiplam’s oral administration influence its market share?
It facilitates easier administration, especially for adult patients and outpatient settings, increasing adoption.
3. Will biosimilars impact Risdiplam’s pricing?
Yes, biosimilar entry typically drives prices downward due to competition and market sharing.
4. What regions are most relevant for global Risdiplam sales?
North America, Europe, and Japan lead sales; emerging markets are growing but face price controls.
5. How do historical pricing trends for SMA therapies inform future projections?
Pricing tends to stabilize post-approval, then decline gradually as biosimilars emerge and competition intensifies.
References
-
Food and Drug Administration. (2020). FDA approves Evrysdi to treat spinal muscular atrophy. https://www.fda.gov/news-events/press-announcements/fda-approves-evrysdi-treat-spinal-muscular-atrophy
-
IQVIA. (2022). Global Market Insights: SMA therapies.
-
SSR Health. (2022). Estimated net prices for SMA drugs.
-
Centers for Medicare & Medicaid Services (CMS). (2022). Pricing and reimbursement policy analysis.
-
EvaluatePharma. (2023). 2023 Drug Market Outlook.
