Last updated: February 27, 2026
What is the drug with NDC 31722-0317?
The National Drug Code (NDC) 31722-0317 corresponds to Dabrafenib and Trametinib (Combination). It is approved by the FDA for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations.
Market size and patient population
The global market for melanoma therapies, especially targeted treatments like Dabrafenib and Trametinib, grows with increased diagnosis rates and genetic testing.
- Estimated diagnosed cases globally in 2022: 324,635 (source: GLOBOCAN)
- 40-60% of melanoma cases harbor BRAF mutations; extrapolating to 130,000–200,000 potential U.S. patients annually.
- In the U.S., the array of treatment options limits market penetration initially but is expected to grow.
Competitive landscape
Major competitors include:
- Vemurafenib (BRAF inhibitor)
- Encorafenib (BRAF inhibitor)
- Cotellic (Cobimetinib) (MEK inhibitor)
- Binimetinib (MEK inhibitor)
Dabrafenib plus Trametinib benefits from FDA approval dating back to 2018, with expanded uses for additional melanoma stages and BRAF V600 mutations.
Market dynamics
- Market growth rate: CAGR of approximately 7% for melanoma targeted therapies (2022–2028).
- Sales figures (2022): Estimated at $800 million for the combination class; Dabrafenib and Trametinib represent a significant share due to broader indications and optimized dosing.
Pricing overview
Current list prices:
- Dabrafenib (Tafinlar): Approximately $7,600 per 112-capsule pack ($67 per capsule).
- Trametinib (Mekinist): Approximately $8,600 per 56-tablet pack ($154 per tablet).
Combination therapy involves daily dosing of both drugs, roughly totaling $14,000–$16,000/month per patient.
Price projections (2023–2028)
| Year |
Estimated Wholesale Price per Patient |
Notes |
| 2023 |
$14,500 |
Current state |
| 2024 |
$14,500–$15,000 |
Minor adjustments |
| 2025 |
$15,000 |
Potential discounts, rebates |
| 2026 |
$15,000–$15,500 |
Market stabilization |
| 2027 |
$15,500 |
Inflated by inflation rates |
| 2028 |
$16,000 |
Peak pricing anticipated |
Price trends are anchored in historical drug inflation, payer negotiations, and demand growth. Future discounts, patent protections, and biosimilar entrances could impact actual sales prices.
Key factors influencing market and prices
- Patent protection: Patents expire around 2030, risking biosimilar entry.
- Biosimilar competition: Expected in late 2020s, potentially reducing prices by 20–40%.
- Regulatory changes: Expanded indications or new combination approvals could increase market size.
- Reimbursement policies: Coverage decisions by CMS and private insurers influence net prices.
- Market penetration: Off-label uses and combination with immunotherapies expand demand.
Regulatory and policy considerations
- The FDA approved Dabrafenib + Trametinib for melanoma in 2018 and expanded approval for other BRAF V600 mutation-positive solid tumors.
- CMS coverage policies generally favor FDA-approved, label-consistent therapies.
- Price negotiations under Medicare Part D and private plans may influence actual transaction prices.
Conclusions
- The global melanoma targeted therapy market is expected to reach over $2 billion by 2028.
- The specific combination of Dabrafenib and Trametinib maintains premium pricing, though imminent patent expirations may pressure prices.
- The US market constitutes approximately 50% of revenue with continued growth driven by genetic testing and treatment accessibility.
Key Takeaways
- NDC 31722-0317, representing Dabrafenib and Trametinib, remains a high-value targeted treatment.
- Market size driven by BRAF mutation prevalence, with high unmet needs in metastatic melanoma.
- Price projections suggest stability with slight inflation until patent expiration and biosimilar competition.
- Market growth governed by regulatory approvals, pricing trends, and competitive dynamics.
- Biosimilar entry from late 2020s could significantly alter pricing landscape.
FAQs
Q1: What factors could lead to a significant price decrease for this drug?
Patent expiration, biosimilar competition, and payer negotiations are primary drivers. Biosimilar patents typically expire 12–15 years post-approval.
Q2: How many patients are eligible for this therapy annually?
Approximately 130,000–200,000 U.S. patients with BRAF V600 mutations; globally, the number is higher depending on regional testing rates.
Q3: What is the expected impact of biosimilars on prices?
Biosimilars could reduce prices by 20–40%, affecting overall market revenues.
Q4: Are there any upcoming regulatory changes that could influence market size?
Yes, expanded indications for related BRAF/MEK inhibitors and combination strategies could increase eligible patient populations.
Q5: How does the pricing compare to other melanoma treatments?
Pricing for Dabrafenib and Trametinib is similar to other targeted therapies but remains among the highest in the class due to combination and indication breadth.
References
[1] GLOBOCAN 2022. International Agency for Research on Cancer.
[2] FDA. (2018). FDA approves combination of dabrafenib and trametinib for BRAF V600E mutation-positive melanoma.
[3] IQVIA. (2022). Market Intelligence Reports on Oncology Drugs.
