Last updated: March 9, 2026
This report provides an overview of the market landscape, competitive environment, pricing trends, and future projections for the drug identified by the National Drug Code (NDC) 16714-0866, which is the branded medication Braftovi (encorafenib) indicated for melanoma and certain other cancers.
Drug Overview
NDC: 16714-0866
Brand Name: Braftovi
Generic Name: Encorafenib
Manufacturer: Array BioPharma / Pfizer
Therapeutic Class: BRAF kinase inhibitor
Indications: Melanoma with BRAF V600E/K mutations, colorectal cancer, other solid tumors.
Market Size and Penetration
Current Market Context
Braftovi is approved for advanced melanoma and other BRAF V600E/K mutations-driven cancers. Its market penetration remains limited to oncology indications with significant unmet needs.
Patient Population
- Melanoma patients with BRAF V600E/K mutations: 50,000-60,000 globally annually.
- Colorectal cancer patients with BRAF V600E mutations: approximately 100,000 worldwide per year.
Market Drivers
- Increasing adoption of targeted therapies for BRAF mutations.
- Advancements and approval of combination regimens involving encorafenib (e.g., with binimetinib).
- Rising global cancer incidence rates.
Competitive Landscape
- Key competitors include dabrafenib (Tafinlar), vemurafenib (Zelboraf), and targeted combination therapies.
- Adoption influenced by efficacy, side effect profiles, and labeling.
Pricing Overview
Current List Prices
- United States (2023): Approximate wholesale acquisition cost (WAC) per 28-day cycle is $17,500–$19,000.
- European Markets: Prices vary, typically 20-25% lower than US prices.
- Emerging Markets: Prices range from $8,000 to $12,000 per cycle, depending on country policies and negotiated discounts.
Reimbursement and Discounts
- Payer contracts often reduce prices by 20-40%.
- Patient assistance programs and copay accumulators reduce out-of-pocket costs.
Cost Comparison
| Parameter |
Encrafenib (Pfizer) |
Dabrafenib (AbbVie/BMS) |
Vemurafenib (Genentech) |
| Average WAC per cycle |
$18,000 |
$16,500 |
$16,000 |
| First-line treatment cost |
$72,000–$76,000 |
$66,000–$70,000 |
$64,000–$68,000 |
Future Price Projections
Short-term (2024-2026)
- Prices are unlikely to decline significantly without patent expirations or biosimilar entries.
- Anticipate moderate discounts (%15-20), driven by payer negotiations.
- Market remains predominantly off-patent in some regions, maintaining stable pricing dynamics.
Medium to Long-term (2027+)
- Patent expiry: Scheduled around 2027–2029 for key markets, likely leading to biosimilar or generic competition.
- Price reductions projected at 40-60% in competitive scenarios.
- Biosimilars or alternative therapies expected to compress price margins, especially in Europe and emerging markets.
Impact of Competitive Dynamics
- Competition from biosimilars may decrease prices significantly.
- Combination therapy approvals may sustain higher overall market prices but could also alter individual drug pricing patterns due to increased therapeutic options.
Regulatory and Policy Influences
- Medicare and Medicaid negotiations in the US could influence net prices.
- Europe’s cross-country tendering and national formulary decisions impact list prices.
- Price controls and outcomes-based agreements could restrict upward price movement.
Key Market Risks
- Patent challenges or legal disputes.
- Faster-than-expected entry of biosimilars.
- Changes in clinical guidelines reducing the eligible patient pool.
Summary of Market Outlook
| Parameter |
2023 |
2024–2026 |
2027+ |
| Price stability |
Moderate, with discounts |
Slight downward pressure, 15-20% |
Significant decline, 40-60% |
| Market penetration |
Steady within target populations |
Slight expansion with new indications |
Growth limited; decline post-patent expiry |
| Competitive landscape |
Limited to branded therapies |
Increased biosimilar activity |
Entry of biosimilars, generics |
Key Takeaways
- NDC 16714-0866 (Braftovi) holds a niche but growing oncology market.
- Current prices reflect high value in treatment settings with need for targeted therapies.
- Price projections indicate stability short-term, with potential declines post-patent expiration.
- Competition and regulatory changes will significantly influence future pricing.
- Market expansion hinges on approval of combination regimens and new indications.
FAQs
1. How does Braftovi compare price-wise to its main competitors?
Braftovi's prices are comparable to dabrafenib and vemurafenib, typically within a $2,500 range per cycle in the US, but discounts lower actual costs for payers.
2. When is patent expiry expected for encorafenib?
Patent protections are scheduled to expire between 2027 and 2029 in major markets, opening opportunities for biosimilar competition.
3. What factors could influence future price reductions?
Introduction of biosimilars, changes in reimbursement policies, and the entry of alternative therapies could reduce prices significantly.
4. Which markets show the most price flexibility?
Emerging markets exhibit considerable price variability, with discounts frequently exceeding 50% in some regions.
5. How will combination therapies impact market pricing?
Combination regimens can maintain high prices due to added efficacy, but may also lead to price negotiations and value-based pricing models.
References
- FDA. (2022). Braftovi (encorafenib) data. U.S. Food and Drug Administration.
- IQVIA. (2023). Global Oncology Drug Market Report.
- European Medicines Agency. (2022). Braftovi approval details.
- MarketWatch. (2023). Oncology drug pricing trends.
- MedPage Today. (2023). Biosimilar entry and pricing impact in oncology.
