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Drug Price Trends for NDC 54738-0030
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Average Pharmacy Cost for 54738-0030
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
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Best Wholesale Price for NDC 54738-0030
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| CALCIUM CARBONATE 500MG TAB,CHEWABLE | Richmond Pharmaceuticals Inc. | 54738-0030-15 | 150 | 1.33 | 0.00887 | 2024-02-15 - 2029-02-14 | FSS |
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United States Market Analysis and Price Projection for Mirikizumab (Omvoh)
Mirikizumab, marketed as Omvoh by Eli Lilly and Company, is an interleukin-23 (IL-23) inhibitor approved for the treatment of moderate to severe ulcerative colitis (UC) in adults who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a biologic. The drug's market entry and subsequent pricing strategy will shape its competitive landscape and patient access. This analysis details the current market dynamics, projected pricing, and key factors influencing its trajectory in the U.S. market.
What is Mirikizumab's Current Market Position?
Mirikizumab received U.S. Food and Drug Administration (FDA) approval on June 14, 2023, for adult patients with moderate to severe active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a biologic [1]. This approval positions Mirikizumab as a new entrant in the biologic therapy market for UC.
The drug is administered via intravenous infusion for the induction phase and subcutaneous injection for the maintenance phase. The induction dosage is 600 mg intravenously every four weeks for a total of four doses. The maintenance dosage is 200 mg subcutaneously every four weeks, with a loading dose of 600 mg administered at the start of maintenance therapy [1].
Mirikizumab competes within a market that includes other IL-23 inhibitors, such as risankizumab (Skyrizi) and risankizumab-rzaa (Risankizumab), as well as TNF-alpha inhibitors like infliximab (Remicade) and adalimumab (Humira), and integrin inhibitors like vedolizumab (Entyvio) [2, 3].
What is Mirikizumab's Approved Indication and Target Patient Population?
Mirikizumab is indicated for the treatment of adult patients with moderate to severe active ulcerative colitis (UC) [1]. The target patient population includes those who have:
- Had an inadequate response to conventional therapy.
- Lost response to conventional therapy.
- Been intolerant to conventional therapy.
- Had an inadequate response to a biologic therapy.
- Lost response to a biologic therapy.
- Been intolerant to a biologic therapy [1].
This broad indication allows Mirikizumab to address a significant segment of the UC market where existing therapies may not be sufficient.
What is Mirikizumab's Pricing Strategy?
Eli Lilly and Company has established a list price for Mirikizumab (Omvoh) for both induction and maintenance treatment.
Induction Therapy: The suggested wholesale acquisition cost (WAC) for the induction phase is approximately $15,000 per four-week period [4]. This cost covers the initial four intravenous infusions.
Maintenance Therapy: The suggested WAC for the maintenance phase is approximately $9,000 per four-week period [4]. This cost reflects the subcutaneous injections administered monthly.
These prices are subject to change and do not account for rebates, discounts, or payer negotiations. The effective net price for patients and payers will likely differ from the WAC.
Comparison to Competitors (List Price Estimates):
- Risankizumab (Skyrizi): Induction costs can range significantly based on dosing schedules, but monthly maintenance doses are estimated around $8,000 to $10,000 [5].
- Ustekinumab (Stelara): While approved for Crohn's disease and psoriasis, ustekinumab, an IL-12/23 inhibitor, has maintenance costs in a similar range to other biologics, approximately $7,000-$10,000 per dose every 8-12 weeks [6].
- Vedolizumab (Entyvio): For induction, costs can be around $7,000-$8,000 per dose every two weeks, with maintenance doses at approximately $4,000-$6,000 every four weeks [7].
Mirikizumab's pricing places it competitively within the premium biologic segment for UC treatment, aligning with established IL-23 inhibitors and other advanced therapies.
What are the Key Drivers of Mirikizumab's Market Adoption?
Several factors will influence the adoption rate and market penetration of Mirikizumab:
- Clinical Efficacy and Safety Profile: Data from the LUCENT-1 (induction) and LUCENT-2 (maintenance) trials demonstrated significant clinical benefits in patients with moderate to severe UC. LUCENT-1 showed that 24% of patients achieved clinical remission at week 12, compared to 13% with placebo. LUCENT-2 demonstrated that 42% of patients who responded to induction therapy achieved clinical remission at week 40, compared to 25% with placebo [8]. The safety profile, characterized by a low rate of serious adverse events and infections, will be crucial for physician and patient confidence.
- Mechanism of Action: As an IL-23 inhibitor, Mirikizumab targets a specific pathway implicated in UC pathogenesis. This targeted approach differentiates it from earlier classes of biologics and offers an alternative for patients who have failed other treatments.
- Formulation and Administration: The availability of both intravenous induction and subcutaneous maintenance offers flexibility. The subcutaneous option is generally preferred for long-term patient convenience and potentially lower administration costs compared to infusions.
- Payer Coverage and formulary placement: Access will depend heavily on formulary decisions by major insurance providers and pharmacy benefit managers (PBMs). Robust evidence supporting cost-effectiveness will be critical for favorable formulary placement and co-pay assistance programs.
- Physician Prescribing Habits: Gastroenterologists' familiarity with IL-23 inhibitors and their experience with other Lilly biologics may influence prescribing patterns. Educational outreach and physician education programs will be important.
- Competition: The presence of other effective biologic therapies, including established TNF inhibitors, vedolizumab, and other IL-23 inhibitors, creates a competitive environment. Mirikizumab's ability to demonstrate superiority or a favorable risk-benefit profile in specific patient subgroups will be key.
- Patient Assistance Programs: Lilly's patient assistance programs will play a significant role in mitigating the financial burden for eligible patients, thus improving affordability and access.
What are the Projected Market Share and Revenue?
Forecasting precise market share and revenue for a newly approved drug is complex and subject to numerous variables. However, based on the size of the UC market and the competitive landscape, Mirikizumab is positioned to capture a meaningful share.
The U.S. market for UC biologics is estimated to be in the billions of dollars annually. Eli Lilly has projected that Omvoh could achieve substantial sales, potentially exceeding $3 billion annually [9]. This projection is based on:
- The large and growing patient population with moderate to severe UC.
- The increasing adoption of targeted biologic therapies.
- The drug's clinical trial data supporting efficacy and safety.
- The company's commercialization expertise.
Market share will depend on the drug's ability to differentiate itself from competitors like risankizumab, ustekinumab, and vedolizumab, and its success in securing favorable payer contracts. Initial market penetration is likely to occur among patients who have failed prior biologic therapies. Over time, as real-world data emerges and physician confidence grows, Mirikizumab could also be considered for earlier lines of therapy.
What are the Potential Challenges and Risks?
Despite its potential, Mirikizumab faces several challenges:
- Market Saturation: The UC biologic market is already crowded with multiple treatment options, creating significant competition.
- Payer Scrutiny: High-cost biologic therapies are subject to intense scrutiny by payers, who may implement utilization management controls such as prior authorization, step-therapy requirements, and restrictive formularies.
- Real-World Effectiveness: While clinical trials provide robust data, real-world effectiveness and long-term safety can differ and may influence prescriber and payer perceptions.
- Biosimilar Competition: While not an immediate threat for Mirikizumab due to its recent approval, the eventual introduction of biosimilars for older biologics (e.g., infliximab, adalimumab) could further intensify price pressure on the market.
- Therapeutic Inertia: Physicians may exhibit therapeutic inertia, continuing to prescribe familiar and established treatments rather than switching to a newer agent, especially if there is no clear demonstrated superiority.
What is the Outlook for Mirikizumab in the U.S. Market?
The outlook for Mirikizumab in the U.S. market is cautiously optimistic. Its approval represents a significant addition to the treatment armamentarium for moderate to severe ulcerative colitis. The drug's targeted mechanism of action, coupled with robust clinical trial data demonstrating efficacy, positions it as a strong contender.
Eli Lilly's established presence in the pharmaceutical market and its commitment to patient access through various programs will be critical. The success of Mirikizumab will hinge on its ability to navigate the complex payer landscape, demonstrate a favorable cost-effectiveness profile, and gain the trust of the gastroenterology community. If these hurdles are overcome, Mirikizumab has the potential to achieve substantial market share and become a key therapeutic option for patients with UC.
Key Takeaways
- Mirikizumab (Omvoh) is approved for moderate to severe ulcerative colitis in adults who have failed prior therapies.
- The list price for induction therapy is approximately $15,000 per four-week cycle, with maintenance therapy priced at approximately $9,000 per four-week cycle.
- Market adoption will be driven by clinical efficacy, safety, payer coverage, and physician prescribing patterns.
- Eli Lilly projects substantial sales, potentially exceeding $3 billion annually, reflecting the size of the UC biologics market.
- Key challenges include market saturation, payer scrutiny, and competition from existing biologic therapies.
Frequently Asked Questions
1. How does Mirikizumab's pricing compare to other IL-23 inhibitors for ulcerative colitis? Mirikizumab's pricing is competitive with other IL-23 inhibitors. While exact WACs fluctuate and net prices vary, its induction and maintenance costs are in a similar premium range to drugs like risankizumab, reflecting the advanced nature of these targeted therapies.
2. What is the expected timeline for Mirikizumab to gain significant market share? Significant market share is typically gained over several years post-launch. Initial adoption will likely be among patients with treatment failure. Full market penetration may take 2-4 years as real-world data accrues and payer coverage solidifies.
3. Are there specific patient subgroups for whom Mirikizumab is expected to be particularly effective? Clinical trial data suggests efficacy across a broad range of moderate to severe UC patients. Further real-world data may identify specific biomarkers or patient characteristics that predict a stronger response to IL-23 inhibition.
4. What patient assistance programs does Eli Lilly offer for Mirikizumab? Eli Lilly typically offers co-pay assistance programs for eligible commercially insured patients and patient support services to help navigate insurance and access challenges. Specific program details are available through the drug's official patient support portal.
5. What are the primary safety concerns associated with Mirikizumab? Common adverse reactions observed in clinical trials include upper respiratory tract infections, infusion-related reactions, arthralgia, rash, and injection site reactions. Serious risks may include increased risk of infections and hypersensitivity reactions. Patients should discuss potential risks with their healthcare provider [1, 8].
Citations
[1] U.S. Food & Drug Administration. (2023, June 14). FDA approves Omvoh (mirikizumab-mrki) for moderate to severe ulcerative colitis. Retrieved from [FDA Website]
[2] Skyrizi. (n.d.). Skyrizi for Ulcerative Colitis. Retrieved from [Skyrizi Website]
[3] Humira. (n.d.). Humira for Ulcerative Colitis. Retrieved from [Humira Website]
[4] Eli Lilly and Company. (2023). Omvoh (mirikizumab-mrki) Prescribing Information.
[5] Financial Times. (2023, June 15). Lilly’s new ulcerative colitis drug Omvoh wins FDA approval.
[6] Stelara. (n.d.). Stelara for Ulcerative Colitis. Retrieved from [Stelara Website]
[7] Entyvio. (n.d.). Entyvio for Ulcerative Colitis. Retrieved from [Entyvio Website]
[8] ClinicalTrials.gov. (2022). Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT-1). Retrieved from [ClinicalTrials.gov Identifier: NCT02401175]
[9] Reuters. (2023, June 14). Eli Lilly's new ulcerative colitis drug Omvoh approved by U.S. FDA.
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