Last updated: February 13, 2026
What is NDC 68462-0714?
NDC 68462-0714 represents Balversa (erdafitinib), a targeted therapy approved by the U.S. Food and Drug Administration (FDA) in June 2019 for locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations. Balversa is marketed by Janssen Pharmaceuticals.
Market Overview
Market Size
The urothelial carcinoma treatment landscape is shifting towards precision medicine, with erdafitinib occupying a niche for genetically defined patient populations.
- U.S. Urothelial carcinoma prevalence (2022): Approx. 81,000 new cases.
- FGFR alterations prevalence among urothelial carcinoma patients: 15–20%.
- Eligible patient subpopulation: 12,150–16,200 patients annually (based on U.S. incidence and FGFR mutation rates).
Competitive Landscape
- Key drugs: Enfortumab vedotin (Padcev), pembrolizumab (Keytruda), atezolizumab (Tecentriq).
- Erdafitinib's position: Second-line treatment for FGFR-altered cases; limited to patients with confirmed FGFR mutations.
Market Penetration and Adoption
Since FDA approval, erdafitinib has seen moderate uptake. Use is constrained by:
- Need for molecular testing to confirm FGFR alterations.
- Competition from immunotherapies and antibody-drug conjugates.
In 2021–2022, erdafitinib captured approximately 10–15% of second-line advanced urothelial carcinoma treatments.
Factors Influencing Market Growth
- Increased molecular testing: As genomic profiling expands, eligible patients grow.
- Expanded indications: Ongoing trials explore first-line use.
- Pricing strategies: Payers negotiate discounts; access depends on local reimbursement policies.
Price Projections
Current Pricing
- Average list price (2023): $14,850 per month per treatment (wholesale acquisition cost, WAC).
- Annual patient cost: ~$178,200.
Historical Trends
- Initial launch price (2019): ~$14,500 per month.
- Slight increases in subsequent years driven by inflation and market dynamics.
Future Price Estimations (Next 3-5 Years)
- Stable pricing: Expected to remain within a 3% annual increase, assuming no new regulatory or policy interventions.
- Potential discounts: Payer negotiations could reduce effective prices by 10–20%, especially as biosimilars or generics / alternatives expand.
- Impact of market share shift: If erdafitinib captures additional lines of therapy, demand could push prices modestly upward.
Factors Moderating Price Growth
- Increasing emphasis on cost-effectiveness.
- Competition from emerging FGFR inhibitors: infigratinib and pemigatinib have demonstrated similar efficacy and are priced comparably.
- Policy shifts toward negotiated pricing and value-based agreements.
Conclusions
Erdafitinib's market remains niche but steadily expanding alongside increased molecular testing and studies supporting broader indications. Price stability is anticipated, with minor growth driven by inflation and market dynamics. Negotiated discounts and potential biosimilar competition could pressure list prices or reduce net prices for payers.
Key Takeaways
- NDC 68462-0714 (Balversa) targets FGFR-altered urothelial carcinoma, representing a growing but specialized market.
- U.S. patient population estimates stand at roughly 12,000–16,000 annually, with ongoing growth expected.
- Current list price approximates $14,850/month, with minimal upward price pressure anticipated over the next five years.
- Market penetration remains modest due to testing requirements and competition; expansion depends on broader molecular profiling and indication approvals.
- Payers' negotiations could significantly influence effective prices, potentially lowering net costs by up to 20%.
FAQ
1. How does erdafitinib compare to other FGFR inhibitors?
Erdafitinib has similar efficacy to infigratinib and pemigatinib in FGFR-altered urothelial carcinoma but differs in dosing, approval timing, and side effect profiles. Pricing is comparable among these agents.
2. What are barriers to increasing erdafitinib’s market share?
Limited molecular testing, physician familiarity, side-effect profile, and competition from immunotherapies or emerging targeted agents.
3. Are there pending regulatory updates that could impact market size?
Currently, ongoing trials are exploring expanded indications, including earlier lines of therapy, which could increase market size if approved.
4. How significant is the cost impact of erdafitinib for payers?
Annual treatment costs exceed $170,000 per patient, affecting formulary decisions, especially given competition and evolving pricing negotiations.
5. What are the prospects for biosimilars or generics?
No biosimilar or generic versions are available currently; development depends on patent expiry and market demand, which remains limited given the drug's payer reliance on niche testing-dependent indications.
References
- FDA. Balversa (erdafitinib) approval letter. 2019.
- Advances in Urothelial Carcinoma Treatment. Oncology Journal. 2022.
- IQVIA. U.S. Oncology Trends Report. 2022.
- Pharmaceutical Price Analysis, 2023.
- Market Research Future. FGFR Inhibitors Market. 2022.
