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Drug Price Trends for NDC 00536-1311
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Average Pharmacy Cost for 00536-1311
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| CHEST CONGEST RLF 400 MG TAB | 00536-1311-08 | 0.06663 | EACH | 2026-03-18 |
| CHEST CONGEST RLF 400 MG TAB | 00536-1311-08 | 0.06613 | EACH | 2026-02-18 |
| CHEST CONGEST RLF 400 MG TAB | 00536-1311-08 | 0.06691 | EACH | 2026-01-21 |
| CHEST CONGEST RLF 400 MG TAB | 00536-1311-08 | 0.06685 | EACH | 2025-12-17 |
| CHEST CONGEST RLF 400 MG TAB | 00536-1311-08 | 0.06755 | EACH | 2025-11-19 |
| CHEST CONGEST RLF 400 MG TAB | 00536-1311-08 | 0.06776 | EACH | 2025-10-22 |
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Best Wholesale Price for NDC 00536-1311
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| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of NDA 206086: Lutetium-177 Lu 177 vipivotide tetraxetan for Prostate Cancer
Executive Summary
The market for prostate cancer therapeutics is substantial and growing, driven by an aging population and advances in treatment modalities. NDA 206086, Lutetium-177 Lu 177 vipivotide tetraxetan (177Lu-PSMA-617), represents a significant advancement in targeted radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC) patients. Its approval by the U.S. Food and Drug Administration (FDA) on June 18, 2022, offers a new treatment option for a patient population with limited effective therapies. This analysis examines the drug's market potential, pricing, and competitive landscape.
What is the Approved Indication for Lutetium-177 Lu 177 vipivotide tetraxetan?
Lutetium-177 Lu 177 vipivotide tetraxetan is approved for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (mCRPC) who have received prior androgen receptor pathway inhibition and taxane-based chemotherapy. The drug targets PSMA, a protein highly expressed on prostate cancer cells, delivering a cytotoxic radiation dose directly to tumor sites.
What is the Clinical Evidence Supporting Approval?
The FDA approval was based on the pivotal Phase 3 VISION trial. This randomized, open-label, multicenter study enrolled 831 patients with PSMA-positive mCRPC who had progressed on androgen receptor pathway inhibition and had at least one previous taxane-based chemotherapy. Patients were randomized 2:1 to receive either 177Lu-PSMA-617 plus standard of care (SOC) or SOC alone.
Key findings from the VISION trial include:
- Overall Survival (OS): Patients in the 177Lu-PSMA-617 arm experienced a statistically significant improvement in OS compared to the SOC arm. Median OS was 15.3 months in the 177Lu-PSMA-617 group versus 11.3 months in the SOC group (hazard ratio [HR] 0.61; 95% CI, 0.52-0.73; P < 0.001) [1].
- Radiographic Progression-Free Survival (rPFS): The median rPFS was 5.7 months for patients treated with 177Lu-PSMA-617 plus SOC, compared to 3.4 months for patients treated with SOC alone (HR 0.62; 95% CI, 0.53-0.73; P < 0.001) [1].
- Objective Response Rate (ORR): The ORR was 30% in the 177Lu-PSMA-617 arm, including 2.7% complete responses, versus 2.7% in the SOC arm. The overall response rate (ORR) was a key secondary endpoint [1].
- Pain Response: A higher proportion of patients in the 177Lu-PSMA-617 arm reported a clinically meaningful improvement in pain compared to the SOC arm.
What is the Commercial Landscape for 177Lu-PSMA-617?
Lutetium-177 Lu 177 vipivotide tetraxetan is marketed by Novartis as Pluvicto. Its approval addresses a critical unmet need in the treatment of mCRPC, a disease state with historically poor prognoses and limited therapeutic options after standard treatments fail.
Competitive Products
The competitive landscape for 177Lu-PSMA-617 includes other established therapies for mCRPC and emerging treatments. Key competitors and therapeutic classes include:
- Hormonal Therapies:
- Abiraterone acetate (Zytiga)
- Enzalutamide (Xtandi)
- Apalutamide (Erleada)
- Darolutamide (Nubeqa)
- Chemotherapy:
- Docetaxel
- Cabazitaxel (Jevtana)
- Radiopharmaceuticals (Emerging):
- Radium Ra 223 dichloride (Xofigo) - targets bone metastases, different mechanism and target
- Other Investigational Therapies: Numerous agents are in development targeting various pathways and mechanisms in mCRPC.
177Lu-PSMA-617 differentiates itself through its targeted mechanism, delivering radiation directly to PSMA-expressing cancer cells, thereby minimizing damage to healthy tissues compared to traditional systemic therapies. Its indication specifically targets patients who have progressed on prior androgen receptor pathway inhibition and taxane chemotherapy, a distinct patient segment from some earlier lines of therapy for mCRPC.
What is the Pricing and Reimbursement Strategy?
Novartis has set a price for Pluvicto that reflects its innovative nature, clinical benefit, and the complexity of its administration.
- List Price: The U.S. list price for Pluvicto is approximately $21,000 per dose [2].
- Treatment Regimen: A standard treatment course involves up to six doses administered every six weeks [3]. Therefore, a full six-dose treatment course has a list price of approximately $126,000.
The pricing reflects:
- Payer Value Proposition: The value of improved survival and quality of life for patients with advanced mCRPC.
- Manufacturing Complexity: The specialized production, handling, and administration requirements of radiopharmaceuticals.
- Clinical Trial Investment: The significant costs associated with developing and conducting large-scale clinical trials like VISION.
Reimbursement is a critical factor for market access. Novartis has established patient assistance programs and works with payers to ensure access for eligible patients. The reimbursement landscape for radioligand therapies is evolving, with significant payer interest in evidence demonstrating long-term value and cost-effectiveness.
What is the Projected Market Size and Growth?
The global prostate cancer market is substantial and projected to grow. Factors driving this growth include:
- Aging Population: The incidence of prostate cancer increases with age.
- Improved Diagnostics: Earlier and more accurate detection methods.
- Advancements in Treatment: Development of novel therapies, including targeted agents and radioligand therapies.
The addressable market for 177Lu-PSMA-617 is specifically the population of PSMA-positive mCRPC patients who have progressed on prior standard treatments.
Estimated Market Size and Projections:
- Annual Incidence of mCRPC: Globally, millions of men are diagnosed with prostate cancer annually, with a significant proportion progressing to metastatic disease. In the U.S., an estimated 50,000-60,000 men are diagnosed with mCRPC annually [4].
- Patient Population Eligible for 177Lu-PSMA-617: A substantial subset of these patients will be PSMA-positive and have received prior SOC. The VISION trial's eligibility criteria provide a baseline for this population.
- Market Penetration: Initial market penetration will depend on physician adoption, patient access, and ongoing data demonstrating real-world effectiveness and safety.
- Projected Revenue: Analysts project significant revenue for Pluvicto. For instance, some estimates project annual sales potentially exceeding $1 billion to $2 billion within a few years of launch, depending on market uptake and indication expansion [5].
The market for targeted radioligand therapies in oncology is a rapidly developing segment. As more PSMA-targeting agents gain approval and expand their indications, the competitive intensity will increase. However, the established clinical data and first-mover advantage for 177Lu-PSMA-617 in its specific indication provide a strong foundation.
What are the Manufacturing and Supply Chain Considerations?
The production and distribution of radiopharmaceuticals like 177Lu-PSMA-617 are complex and require specialized infrastructure.
- Radioisotope Sourcing: Lutetium-177 (177Lu) is a key component and must be sourced from specialized nuclear facilities. The availability and stability of the 177Lu supply chain are critical.
- Manufacturing Facilities: The drug product is manufactured in sterile, regulated facilities capable of handling radioactive materials. This often involves centralized manufacturing sites with a limited number of production slots.
- Cold Kit: The drug product is typically a "cold kit" that is combined with the radioisotope immediately prior to patient administration. This requires specialized compounding pharmacies or radiopharmacies.
- Distribution: Cold chain logistics are essential for maintaining the integrity and efficacy of the radioactive product during transport to treatment centers.
- Regulatory Oversight: Manufacturing and distribution are subject to stringent regulatory oversight by bodies such as the FDA and the Nuclear Regulatory Commission (NRC) in the U.S.
These factors contribute to the high cost of radiopharmaceuticals and necessitate robust supply chain management to ensure consistent availability for patients.
What are the Future Market Opportunities and Challenges?
Opportunities
- Expanded Indications: Potential for approval in earlier lines of mCRPC or in combination therapies.
- Geographic Expansion: Launching in other major global markets with established regulatory pathways.
- Development of Companion Diagnostics: Further refinement of PSMA imaging to better identify patient populations likely to benefit.
- Combination Therapies: Exploring synergistic effects with other treatment modalities.
Challenges
- Competition: Emergence of new PSMA-targeting agents and other novel therapies.
- Reimbursement Hurdles: Ongoing scrutiny from payers regarding cost-effectiveness and evidence of real-world value.
- Manufacturing Capacity and Supply: Ensuring sufficient global capacity to meet demand, especially as the market grows.
- Physician Education and Training: Widespread adoption requires training for oncologists, nuclear medicine physicians, and pharmacy staff on administration, patient selection, and monitoring.
- Patient Access: Ensuring equitable access for all eligible patients, irrespective of socioeconomic status or geographic location.
Key Takeaways
- Lutetium-177 Lu 177 vipivotide tetraxetan (Pluvicto) offers a significant therapeutic advance for PSMA-positive mCRPC patients who have failed prior standard treatments.
- The drug demonstrated statistically significant improvements in overall survival and radiographic progression-free survival in the Phase 3 VISION trial.
- The U.S. list price is approximately $21,000 per dose, with a full treatment course costing around $126,000.
- The market for targeted radioligand therapies is expanding, with Pluvicto poised to capture a substantial share of the mCRPC market, with potential annual sales in the billions.
- Manufacturing and supply chain complexities are inherent to radiopharmaceuticals and necessitate robust management.
- Future growth hinges on expanded indications, geographic expansion, and overcoming reimbursement and access challenges.
Frequently Asked Questions
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What is the recommended dosage and frequency for Lutetium-177 Lu 177 vipivotide tetraxetan? The recommended dose is 200 MBq (5.4 mCi) administered intravenously every six weeks for up to four doses, or until disease progression or unacceptable toxicity. This is based on the study regimen for the VISION trial, which included up to six doses. The prescribing information should be consulted for the most current dosing guidelines.
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How does Lutetium-177 Lu 177 vipivotide tetraxetan differ from Radium Ra 223 dichloride (Xofigo)? While both are radiopharmaceuticals used in prostate cancer, they differ significantly. Xofigo targets bone metastases by mimicking calcium and is an alpha-emitter, primarily used for symptomatic bone metastases in mCRPC patients with no visceral metastases. 177Lu-PSMA-617 targets PSMA-expressing cancer cells, including those in visceral sites, and is a beta-emitter, delivered via a chelator (PSMA-617) that binds to PSMA.
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What is the role of PSMA PET imaging in patient selection for Lutetium-177 Lu 177 vipivotide tetraxetan? PSMA-positivty, as confirmed by PET imaging (e.g., using 68Ga-PSMA-1007 or 18F-DCFPyL), is a critical eligibility criterion for treatment with 177Lu-PSMA-617. The drug targets PSMA-expressing cells, and imaging confirms the presence and extent of PSMA expression on tumor lesions.
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What are the most common side effects associated with Lutetium-177 Lu 177 vipivotide tetraxetan therapy? Common adverse reactions include fatigue, dry mouth, nausea, anemia, decreased appetite, and diarrhea. Most side effects are manageable. The prescribing information details the full spectrum of adverse events and management strategies.
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Are there any contraindications for Lutetium-177 Lu 177 vipivotide tetraxetan? The drug is contraindicated in patients with hypersensitivity to lutetium Lu 177 vipivotide tetraxetan or any of its components. Specific patient populations may also require careful consideration due to potential risks, such as severe renal or hepatic impairment.
Citations
[1] Sartor, O., de Bono, J., Wyatt, P., Freitag, N. S., Esfahani, K., Smith, M. R., Rahbar, K., Lee, J. T., Steins, M., de la Taille, A., O’Sullivan, J. M., Grozman, R., El-Bouty, R., Tagliabue, A., Mather, K. C., Al-Saeed, R., Marzolo, F., Mears, S., Strosberg, J. R., … Nelson, P. S. (2021). Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. New England Journal of Medicine, 385(12), 1091–1103. https://doi.org/10.1056/NEJMoa2107322
[2] Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Prescribing Information. (2022). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215760s000lbl.pdf
[3] Novartis. (2022, June 21). FDA approves Novartis’ Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) as the first-of-its-kind radioligand therapy for adult patients with PSMA-positive metastatic castration-resistant prostate cancer [Press release]. https://www.novartis.com/news/media-releases/fda-approves-novartis-pluvicto-lutetium-lu-177-vipivotide-tetraxetan-first-kind-radioligand-therapy-adult-patients-psma-positive-metastatic-castration-resistant-prostate-cancer
[4] National Cancer Institute. (2023). Prostate Cancer Treatment (PDQ®)–Health Professional Version. https://www.cancer.gov/types/prostate/hp/prostate-treatment-pdq
[5] FiercePharma. (2022, June 21). Novartis' Pluvicto snags FDA approval for prostate cancer, setting up blockbuster potential. https://www.fiercepharma.com/pharma/novartis-pluvicto-snags-fda-approval-prostate-cancer-setting-blockbuster-potential
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