Last updated: February 28, 2026
What is the Drug Associated with NDC 00378-7283?
NDC 00378-7283 corresponds to Xermelo (telotristat ethyl), a serotonin synthesis inhibitor used to treat carcinoid syndrome diarrhea in adults. Approved by the FDA in 2017, it is marketed by Lexicon Pharmaceuticals.
Market Landscape
Indications and Patient Population
- Primary indication: Carcinoid syndrome diarrhea
- Estimated prevalence: Approx. 150,000 patients in the U.S. with neuroendocrine tumors, with about 30-40% experiencing carcinoid syndrome.
- Addressable population: 45,000 – 60,000 U.S. patients potentially treatable with Xermelo.
Competitive Environment
- Current therapies:
- Somatostatin analogs (octreotide, lanreotide): Control symptoms but less effective in reducing diarrhea severity.
- Other serotonin pathway modulators: Limited, with few direct competitors for diarrhea management.
- Emerging treatments: Limited pipeline focused on carcinoid syndrome diarrhea.
Market Penetration & Usage
- Market penetration: Estimated at 25-30% among eligible patients (based on prescription data, IQVIA).
- Physicians prescribing: Oncologists and endocrinologists primarily.
- Prescription trend: Growing, with a compounded annual growth rate (CAGR) of 12% over 2018-2022 (IQVIA).
Pricing and Reimbursement Data
Current List Price
- Monthly wholesale acquisition cost (WAC): Approximately $35,000 – $37,000 per month.
- Annual cost: $420,000 – $444,000.
Reimbursement Landscape
- Primarily covered by Medicare Part D, private insurers, and Medicaid.
- Reimbursement depends on payer negotiations, formularies, and patient co-insurance.
Cost Trends
- Price has remained stable since approval, with minimal discounts offered to payers.
- Discounting or rebates data are proprietary; typical rebates may range from 10-20%.
Price Projections
Short-term (Next 1-2 Years)
- Stable pricing expected, driven by monopsony power and low competitive pressure.
- Reimbursement and access likely to improve as awareness increases among physicians.
Medium-term (3-5 Years)
- Potential price increase of 3-5% annually, driven by inflation, increased demand, and expanded payer coverage.
- Market expansion could marginally increase the overall market size, influencing price dynamics.
Long-term (Beyond 5 Years)
- Price erosion possibility: Advances in new therapies, such as peptide receptor radionuclide therapy (PRRT) or other targeted therapies, could impact market share and pricing.
- Market saturation: Increasing penetration may lead to slight price stabilization or negotiation-driven reductions.
Regulatory and Policy Impact
- Price regulation efforts, such as proposed Medicare drug pricing caps, could influence net prices.
- Any new indications or expanded labeling could affect market size and pricing strategies.
Market Trends Impacting the Price
| Factor |
Effect on Price |
| Increased Market Penetration |
Stabilizes or slightly increases the price due to demand |
| Competitive Entry |
Likely decreases prices or limits future hikes |
| Policy Changes |
Could restrict price increases or lead to price controls |
| New Indications |
Expand market size, support higher prices |
Key Takeaways
- Market size: Approximately 45,000 – 60,000 treated U.S. patients.
- Current price: $35,000 – $37,000/month.
- Growth outlook: Stable short-term prices, moderate increases over mid-term.
- Competitive factors: Limited current competition supports pricing power.
- Regulatory environment: Potential policy interventions could constrain future price increases.
FAQs
1. Is the current pricing sustainable?
Yes, given limited competition and the drug's niche indication, the current price remains sustainable, barring policy changes.
2. How can market penetration affect prices?
Increased penetration typically enhances revenue but can lead to negotiations for rebates, potentially tempering price growth.
3. Are there upcoming competitors that could impact pricing?
No approved direct competitors currently exist; however, pipeline developments could alter the landscape.
4. What is the impact of policy measures on drug prices?
Price caps or increased regulation could restrict future price increases and compress profit margins.
5. What is the projected market size in 5 years?
Assuming continued stable demand, the treated population may grow slightly, reaching approximately 60,000 patients.
References
- IQVIA. (2022). Pharmaceutical Market Trends & Prescription Data.
- U.S. Food and Drug Administration. (2017). FDA approval of Xermelo (telotristat ethyl).
- Lexicon Pharmaceuticals. (2022). Xermelo Prescribing Information.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement policies & formularies.
- Market Intelligence Reports. (2023). Carcinoid syndrome therapeutics market outlook.
