Last updated: March 12, 2026
What is the drug associated with NDC 84635-0570?
NDC 84635-0570 is the National Drug Code for Nusinersen (brand name Spinraza), an antisense oligonucleotide used to treat spinal muscular atrophy (SMA). Approved by the FDA in December 2016, it is marketed by Biogen.
Market Landscape
Market Size and Demand
- Prevalence of SMA: An estimated 1 in 10,000 live births. Approximately 400 to 600 new cases annually in the U.S.
- Patient Population: About 7,000 to 10,000 living patients in the U.S., with a wider global market.
- Treatment Eligibility: All SMA subtypes, starting early for maximum efficacy.
Competitive Environment
- Current Treatments: Spinraza is the first approved drug for SMA; newer options include Zolgensma (AAV9 gene therapy) and Evrysdi (risdiplam).
- Market Share: Spinraza's market dominance initially high, but Zolgensma and Evrysdi gained ground since 2019.
Market Trends
- Increase in SMA diagnosis due to improved screening methods.
- Evolving standard of care toward early intervention.
- Growing acceptance for gene therapies and oral treatments, pressuring Spinraza's market share.
Price Analysis
Current Pricing
- U.S. List Price: Approximately $125,000 per dose.
- Dosing Schedule: Four doses in the first year, then three doses annually.
- Annual Cost Estimate: About $750,000 per patient.
Cost Breakdown and Reimbursement
- Per-Patient Cost: Around $750,000 - $1 million annually.
- Reimbursement: Insurance coverage varies; patient assistance programs mitigate out-of-pocket costs.
Price Trends and Factors
- Pricing Stability: Maintained since approval, with minimal reductions.
- Market Competition: Introduction of Zolgensma (single-dose gene therapy priced around $2.1 million) has impacted perception of value.
- Policy Influences: Price negotiations with Medicare and Medicaid could influence future pricing strategies.
Projections and Factors Impacting Future Price
| Year |
Expected Price Range |
Key Influencing Factors |
| 2023 |
$125,000 per dose |
Steady demand; no major price changes |
| 2024-2025 |
$120,000 - $125,000 |
Potential negotiations; biosimilar or competitor entry impacts |
| 2026+ |
Possible decrease to $100,000 |
Increased competition from Evrysdi and Zolgensma; biosimilar developments |
Potential Price Drivers
- Market competition: New therapies could reduce Spinraza’s pricing power.
- Regulatory changes: Price regulations and value-based assessments may reduce list prices.
- Reimbursement policies: Shifts toward outcome-based contracts could alter effective prices.
Summary
Spinraza (NDC 84635-0570) remains a high-cost, high-demand treatment for SMA with a current list price of approximately $125,000 per dose. Market dynamics, competitive therapies, and policy climate will influence future pricing, with a trend toward stabilization or modest reductions over the next few years.
Key Takeaways
- Nusinersen dominates SMA treatment but faces increasing competition.
- Current annual per-patient cost exceeds $750,000.
- Price stability has persisted since launch, but future trends include potential declines driven by new therapies.
- Market growth hinges on early diagnosis and therapy accessibility.
- Regulatory and reimbursement policy shifts could significantly influence pricing strategies.
FAQs
1. How does Spinraza compare to Zolgensma in price and efficacy?
Zolgensma is a one-time gene therapy priced around $2.1 million, offering a different treatment paradigm. Efficacy varies by patient age and disease severity; both are approved for SMA but differ in dosing and long-term outcomes.
2. Are there biosimilars or generics for Spinraza?
As of 2023, no biosimilars or generics are approved for Spinraza, given its biological nature and patent protections.
3. How does the price of Spinraza influence healthcare costs?
It significantly impacts insurance payouts and healthcare budgets, especially considering the high per-patient annual cost.
4. What is the outlook for patient access to Spinraza?
Access depends on insurance coverage and patient financial assistance programs. FDA and payor policies could either streamline or complicate broad access.
5. Will the price of Spinraza decrease with increased competition?
Likely, if new therapies capture market share or biosimilars emerge, leading to price negotiations and potential discounts.
References
[1] Food and Drug Administration. (2016). FDA approves Spinraza to treat spinal muscular atrophy.
[2] Biogen. (2023). Spinraza (nusinersen) prescribing information.
[3] IQVIA. (2023). Global Drug Pricing Data.
[4] EvaluatePharma. (2023). World Preview of Biopharmaceutical Markets.
[5] Centers for Disease Control and Prevention. (2022). Data on SMA prevalence.
