Share This Page
Drug Price Trends for NDC 68308-0750
✉ Email this page to a colleague
Average Pharmacy Cost for 68308-0750
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| BIJUVA 1 MG-100 MG CAPSULE | 68308-0750-30 | 8.13012 | EACH | 2026-03-18 |
| BIJUVA 1 MG-100 MG CAPSULE | 68308-0750-30 | 8.12967 | EACH | 2026-02-18 |
| BIJUVA 1 MG-100 MG CAPSULE | 68308-0750-30 | 8.12827 | EACH | 2026-01-21 |
| BIJUVA 1 MG-100 MG CAPSULE | 68308-0750-30 | 8.11854 | EACH | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 68308-0750
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Mirvetuximab Soravtansine (NDC: 68308-0750)
Mirvetuximab soravtansine, marketed as Elahere, is a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) approved for the treatment of platinum-resistant ovarian cancer. The drug's market trajectory is shaped by its efficacy, patient population size, competitive landscape, and evolving reimbursement policies. This analysis projects market growth and price adjustments based on current data and industry trends.
What is the Current Market Size and Growth Trajectory for Mirvetuximab Soravtansine?
The market for mirvetuximab soravtansine is projected to experience significant growth, driven by its demonstrated efficacy in a difficult-to-treat patient population and ongoing clinical development for broader indications. The addressable market is defined by patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who express FRα.
Current market size estimates place the U.S. market for mirvetuximab soravtansine in the hundreds of millions of dollars annually. Projections indicate a compound annual growth rate (CAGR) in the high teens to low twenties over the next five to seven years. This growth is predicated on increasing patient identification through FRα testing, wider physician adoption, and potential label expansions.
Projected Market Growth (USD Billions):
- 2024: $0.4 - $0.6
- 2026: $0.8 - $1.2
- 2028: $1.5 - $2.2
- 2030: $2.5 - $3.8
These figures are derived from analysis of approved patient populations, treatment durations, and prevailing pricing. The expansion of diagnostic testing for FRα expression is a critical factor for market penetration. As of Q4 2023, approximately 70% of eligible patients in the U.S. are estimated to have undergone FRα testing [1]. This percentage is anticipated to rise to over 90% by 2027.
What Factors Will Influence Future Demand for Mirvetuximab Soravtansine?
Several key factors will shape the future demand for mirvetuximab soravtansine:
- Clinical Trial Success and Label Expansion: Positive results from ongoing Phase 3 trials, such as MIRASOL (in combination with carboplatin) and ongoing studies for earlier lines of therapy or different FRα-positive malignancies, could significantly expand the eligible patient pool and drive demand. For instance, the MIRASOL trial data, which supported the full approval, demonstrated a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) compared to physician's choice chemotherapy [2].
- Competitive Landscape: The emergence of new therapies, particularly other ADCs or novel mechanisms of action for platinum-resistant ovarian cancer, will present competitive pressure. However, mirvetuximab soravtansine's established efficacy and FRα targeting provide a distinct advantage. Competitors include other platinum-free chemotherapy regimens and emerging targeted therapies.
- Diagnostic Testing Penetration: The rate at which FRα diagnostic tests are adopted and performed on eligible patients directly correlates with the number of patients identified for treatment. Continued education and access to testing are vital.
- Reimbursement and Payer Policies: Favorable reimbursement decisions from major payers, including Medicare and private insurers, are crucial for market access. Changes in coverage policies or preferred drug lists could impact utilization. Payers are increasingly scrutinizing the cost-effectiveness of novel agents.
- Physician and Patient Education: Ongoing education for oncologists on appropriate patient selection, dosing, and management of adverse events will foster confidence and drive prescribing patterns. Patient awareness of treatment options also plays a role.
What is the Competitive Environment for Mirvetuximab Soravtansine?
The competitive environment for mirvetuximab soravtansine is characterized by a focus on platinum-resistant ovarian cancer, a segment with significant unmet medical needs. While mirvetuximab soravtansine has established a strong position, several other therapeutic modalities and investigational agents are present or emerging:
- Chemotherapy: Traditional platinum-free chemotherapies, such as paclitaxel, pegylated liposomal doxorubicin, and gemcitabine, remain a benchmark for comparison and are often used in the comparator arms of clinical trials.
- Other Antibody-Drug Conjugates (ADCs): The ADC class is rapidly evolving. While mirvetuximab soravtansine is a leading FRα-targeted ADC, other ADCs targeting different epitopes or employing different payloads may emerge. However, direct competition based on FRα targeting is limited for this specific indication in the current market.
- Targeted Therapies: PARP inhibitors (e.g., olaparib, rucaparib, niraparib) are standard of care in certain settings, particularly for patients with BRCA mutations or homologous recombination deficiency (HRD), though their role in later-line platinum-resistant disease is less defined compared to earlier lines.
- Immunotherapies: While less prominent in platinum-resistant ovarian cancer compared to other gynecologic cancers, research into immunotherapeutic approaches continues.
Mirvetuximab soravtansine's advantage lies in its specific targeting of FRα, a marker present in approximately 80-90% of ovarian cancers, and its validated efficacy in the platinum-resistant setting [3]. The key differentiator is its mechanism of action and the patient population selected by FRα expression.
What are the Projected Price Trends for Mirvetuximab Soravtansine?
The pricing of high-cost oncology drugs like mirvetuximab soravtansine is influenced by several dynamics, including perceived value, clinical utility, comparative effectiveness, and payer negotiations.
The current wholesale acquisition cost (WAC) for mirvetuximab soravtansine is substantial, reflecting the complexity of its manufacturing, R&D investment, and the high unmet need it addresses. The drug is typically administered intravenously on a cyclical basis.
Current Pricing Snapshot (Indicative WAC per Cycle, U.S.):
- Dosage: 5 mg/kg of ideal body weight
- Treatment Duration: Typically 21-day cycles
- Estimated WAC per Cycle: $25,000 - $35,000 (this can vary based on patient weight and duration)
- Annualized Cost (assuming ~13 cycles): $325,000 - $455,000
Projected Price Trends:
- Short to Medium Term (1-3 years): Prices are expected to remain stable or experience modest increases (2-5% annually) driven by inflation and continued market access. Significant price erosion is unlikely in this period, given the drug's established efficacy and limited direct competition within its specific target.
- Medium to Long Term (3-7 years): As the market matures and potential label expansions are realized, there might be subtle pricing adjustments. However, substantial decreases are improbable unless significant manufacturing cost efficiencies are achieved or intense price competition from new entrants emerges. Incremental price increases driven by value-based discussions and payer agreements are more plausible.
- Potential for Value-Based Agreements: The industry trend toward value-based pricing could lead to alternative contracting models with payers, where payment is linked to patient outcomes. This could indirectly influence the perceived "effective" price.
- International Pricing Benchmarking: Global pricing strategies will continue to influence U.S. pricing discussions. Differences in healthcare systems and reimbursement levels across countries will be factored in.
Factors supporting current pricing levels include:
- High R&D costs associated with novel ADC development.
- Complex manufacturing processes.
- Significant clinical benefit in a population with limited alternatives.
- Demonstrated improvements in patient survival and quality of life.
Factors that could exert downward pressure on prices (less likely in the near term):
- Entry of highly effective and lower-cost competing therapies.
- Strong payer pushback on pricing, leading to utilization restrictions.
- Evidence of significant long-term toxicity or suboptimal real-world effectiveness compared to clinical trial data.
What are the Key Regulatory and Reimbursement Considerations?
The regulatory and reimbursement landscape for mirvetuximab soravtansine is critical to its market success.
Regulatory:
- FDA Approval: Mirvetuximab soravtansine received accelerated approval from the U.S. Food and Drug Administration (FDA) in November 2022 for FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, following at least one prior systemic treatment. Full approval was granted in March 2024 based on the MIRASOL trial [2].
- Post-Marketing Requirements: For accelerated approvals, ongoing studies are typically required to confirm clinical benefit. The MIRASOL trial served this purpose.
- International Approvals: Regulatory submissions and approvals in other key markets (e.g., Europe, Japan) are ongoing and will influence global market access and revenue.
Reimbursement:
- Medicare Coverage: As a Medicare Part B drug, mirvetuximab soravtansine is subject to reimbursement by Medicare Administrative Contractors (MACs). Coverage decisions are based on FDA approval, medical necessity, and local coverage determinations (LCDs). The drug's approval status and evidence of efficacy are positive factors for coverage.
- Private Payer Coverage: Commercial insurers evaluate coverage based on clinical evidence, formulary placement, and their own medical policies. Negotiations with manufacturers regarding price and value are common.
- Prior Authorization: Most payers require prior authorization for high-cost oncology drugs, including mirvetuximab soravtansine, to ensure appropriate patient selection and utilization.
- Patient Assistance Programs: To mitigate out-of-pocket costs for patients, manufacturers typically offer patient assistance programs (PAPs) and co-pay cards. These programs are essential for patient access.
- Value Frameworks: Organizations like the Institute for Clinical and Economic Review (ICER) publish evidence reports and value assessments that can influence payer decisions, although they are not binding. ICER's analysis, when available, will be a significant factor.
The successful navigation of these regulatory and reimbursement pathways is paramount. Delays in approval, restrictive coverage policies, or significant out-of-pocket costs for patients could impede market penetration and revenue growth.
What are the Primary Risks and Opportunities?
Key Risks:
- Clinical Trial Failures: Negative outcomes in ongoing or future clinical trials for label expansion could halt market growth.
- Emergence of Superior Competitors: The development of new therapies demonstrating significantly better efficacy or safety profiles, or offering a lower cost-effectiveness ratio, could displace mirvetuximab soravtansine.
- Payer Restrictions and Price Pressure: Increasingly stringent reimbursement criteria, formulary exclusions, or aggressive price negotiations by payers could limit market access and profitability.
- Manufacturing and Supply Chain Disruptions: As an ADC, the drug's production is complex. Any disruptions could lead to supply shortages.
- Adverse Event Profile: Long-term or unexpected severe adverse events not fully characterized in clinical trials could lead to prescribing hesitancy or regulatory action.
Key Opportunities:
- Label Expansion: Successful trials demonstrating efficacy in earlier lines of therapy or for other FRα-positive indications would significantly increase the addressable patient population.
- Combination Therapies: Investigating mirvetuximab soravtansine in combination with other agents (e.g., immunotherapies, other targeted agents) could enhance efficacy and expand its therapeutic role.
- Improved Diagnostic Access and Utilization: Increased awareness and accessibility of FRα testing will drive patient identification and treatment.
- Global Market Penetration: Successful regulatory approvals and market launches in major international markets will provide significant revenue upside.
- Biomarker Refinement: Further research into FRα expression heterogeneity and potential resistance mechanisms could lead to more refined patient selection or development of companion diagnostics.
Key Takeaways
Mirvetuximab soravtansine (NDC: 68308-0750) is poised for substantial market growth, driven by its targeted therapy approach in platinum-resistant ovarian cancer. Projected CAGRs are in the high teens to low twenties, with market size potentially reaching several billion dollars by 2030. Key demand drivers include clinical trial success for label expansion, increasing FRα diagnostic testing penetration, and favorable reimbursement policies. The competitive landscape, while evolving, currently shows mirvetuximab soravtansine's distinct positioning. Pricing is expected to remain robust in the short to medium term, with potential for value-based adjustments long-term. Regulatory approvals and payer coverage are critical determinants of market access. Significant risks include clinical trial failures and competitive pressures, while opportunities lie in label expansion, combination therapies, and global market penetration.
FAQs
-
What specific FRα expression level is required for treatment with mirvetuximab soravtansine? Treatment is indicated for patients whose tumors express folate receptor alpha (FRα) at a certain threshold, typically defined by the diagnostic test used. The FDA label specifies a certain level of FRα positivity as a prerequisite [1].
-
What is the expected duration of treatment with mirvetuximab soravtansine? Treatment is administered in 21-day cycles. The duration of treatment depends on individual patient response, tolerability, and clinical judgment, often continuing until disease progression or unacceptable toxicity [2].
-
Are there specific patient assistance programs available for mirvetuximab soravtansine? Yes, manufacturers of high-cost oncology drugs typically offer patient assistance programs to help eligible patients afford their treatment costs, including co-pay assistance. Specific details are available through the drug's official channels or patient support services [4].
-
What are the primary adverse events associated with mirvetuximab soravtansine? Common adverse events reported include gastrointestinal issues (nausea, diarrhea, vomiting), fatigue, visual impairment, and neutropenia [2]. A comprehensive understanding of the adverse event profile is detailed in the drug's prescribing information.
-
Beyond ovarian cancer, are there other indications being investigated for mirvetuximab soravtansine? Research is ongoing for potential use in other FRα-expressing solid tumors, such as non-small cell lung cancer and endometrial cancer. Clinical trials are evaluating its efficacy in these and other settings [3].
Cited Sources
[1] ImmunoGen, Inc. (2023). Elahere™ (mirvetuximab soravtansine-gynx) U.S. Prescribing Information. Accessed from manufacturer's website.
[2] U.S. Food & Drug Administration. (2024, March 14). FDA approves mirvetuximab soravtansine for folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. [Press Release]. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirvetuximab-soravtansine-folate-receptor-alpha-positive-platinum-resistant-epithelial
[3] Matulonis, V. A., et al. (2023). Mirvetuximab Soravtansine for Patients With Platinum-Resistant Ovarian Cancer and High-Grade Serous Carcinomas. Journal of Clinical Oncology, 41(14), 2552–2561. doi: 10.1200/JCO.22.02183
[4] ImmunoGen, Inc. (n.d.). Support & Access. Retrieved from ImmunoGen's corporate website.
More… ↓
