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Last Updated: April 4, 2026

Drug Price Trends for NDC 16714-0029


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Best Wholesale Price for NDC 16714-0029

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
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Market Analysis and Price Projections for Drug NDC 16714-0029

Last updated: February 17, 2026

Executive Summary

This report analyzes the current market landscape and projects future pricing for the pharmaceutical product identified by National Drug Code (NDC) 16714-0029. The product, a biologic drug for the treatment of moderate to severe plaque psoriasis, faces a competitive market with established therapies and emerging biosimil competition. Pricing is influenced by clinical efficacy, patient access programs, payer negotiations, and the lifecycle stage of the originator product. Projections indicate a gradual price erosion due to biosimilar entry, offset by continued demand for effective psoriasis treatments.

What is NDC 16714-0029?

NDC 16714-0029 refers to Tremfya (guselkumab) 100 mg/mL injection, a human IgG1κ monoclonal antibody. It is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy [1]. The drug targets the p19 subunit of interleukin-23 (IL-23), a cytokine that plays a key role in the pathogenesis of inflammatory diseases, including psoriasis [2]. Tremfya is administered via subcutaneous injection every eight weeks after an initial loading dose schedule.

Current Market Landscape

Competitive Environment

The market for moderate to severe plaque psoriasis treatments is characterized by a range of therapeutic options, including biologics, small molecules, and topical agents. Tremfya competes directly with other IL-23 inhibitors, TNF-alpha inhibitors, IL-17 inhibitors, and IL-12/23 inhibitors.

Key competitors include:

  • IL-23 Inhibitors: Skyrizi (risankizumab) and Ilumya (tildrakizumab). These share a similar mechanism of action by targeting IL-23, offering comparable efficacy profiles and treatment regimens [3].
  • IL-17 Inhibitors: Cosentyx (secukinumab) and Taltz (ixekizumab). These drugs have demonstrated high rates of skin clearance and are widely prescribed for psoriasis [3].
  • TNF-alpha Inhibitors: Humira (adalimumab), Enbrel (etanercept), and Remicade (infliximab). While older, these remain significant players due to established clinical data and market penetration [3].
  • IL-12/23 Inhibitors: Stelara (ustekinumab). This drug targets both IL-12 and IL-23, offering a broad efficacy spectrum.

The market share distribution among these agents is influenced by factors such as efficacy in specific patient subgroups, side effect profiles, dosing convenience, and formulary placement by payers [4].

Market Penetration and Physician Adoption

Tremfya has achieved significant market penetration since its approval in July 2017 [5]. Its efficacy in achieving and maintaining high levels of skin clearance, coupled with an infrequent dosing schedule (every eight weeks), has driven strong physician adoption. Physician preference is often guided by comparative effectiveness data, patient comorbidities, and familiarity with the drug class. Real-world evidence studies continue to emerge, reinforcing Tremfya's position in the treatment algorithm for plaque psoriasis [6].

Payer Landscape and Reimbursement

Payer coverage and reimbursement policies are critical determinants of market access and pricing. Tremfya is generally covered by major commercial payers and Medicare Part D, though often subject to prior authorization, step-therapy requirements, and co-insurance [7]. Payers evaluate drugs based on clinical value, cost-effectiveness, and budget impact. The presence of biosimilar competitors for older biologics can influence payer negotiations for newer agents like Tremfya, potentially leading to increased scrutiny on pricing and value propositions.

Pricing Analysis

Current Pricing and Market Value

The average wholesale price (AWP) for Tremfya (guselkumab) 100 mg/mL injection is approximately $7,100 per 4 mL vial, translating to an annual cost of approximately $63,900 for the recommended dosing regimen [8]. This pricing reflects its status as a novel biologic with demonstrated clinical benefits in a significant patient population.

Table 1: Tremfya (Guselkumab) Pricing Overview

Metric Value Notes
NDC 16714-0029 100 mg/mL injection
Dosage Form Injection Subcutaneous
AWP (per 4mL vial) ~$7,100 As of Q4 2023 [8]
Annual Cost (est.) ~$63,900 Based on 8-week dosing schedule
Indication Plaque Psoriasis Moderate to severe

Note: Actual out-of-pocket costs for patients can vary significantly due to insurance, co-pay assistance programs, and patient assistance programs offered by the manufacturer.

Factors Influencing Pricing

Several factors contribute to the current pricing and will impact future price trajectories:

  • Clinical Efficacy and Differentiation: Tremfya's demonstrated high efficacy rates, rapid onset of action, and sustained skin clearance contribute to its premium pricing. Its favorable safety profile relative to some older agents also supports its market value [6].
  • Dosing Frequency: The every-eight-weeks dosing schedule is a significant convenience factor for patients and providers, justifying a certain price point compared to more frequent administration regimens.
  • Patent Exclusivity: As a patented biologic, Tremfya benefits from market exclusivity. Patent expiry dates are crucial for forecasting long-term pricing trends, particularly the introduction of biosimil competition.
  • Biosimilar Landscape: The upcoming availability of biosimil versions of adalimumab (Humira) and potentially other biologics used for psoriasis is expected to exert downward price pressure across the entire market, even for newer drugs [9].
  • Payer Negotiations and Rebates: Pharmaceutical manufacturers engage in complex negotiations with payers, often involving significant rebates and discounts in exchange for preferred formulary status. These confidential agreements directly affect net prices, which are typically lower than AWP.
  • Patient Assistance Programs: Manufacturer-sponsored patient assistance programs (PAPs) and co-pay assistance programs can mitigate out-of-pocket costs for eligible patients, indirectly influencing market access and perceived value [7].

Price Projections

Short-Term Projections (1-3 Years)

In the short term (1-3 years), Tremfya is expected to maintain its current pricing levels, with potential for modest annual price increases (2-4%) consistent with industry trends for specialty pharmaceuticals. These increases are often driven by inflation and the continued investment in product lifecycle management. The absence of direct biosimilar competition for Tremfya within this timeframe will allow the originator product to retain its pricing power. However, increased competition from other biologics, including newer IL-23 inhibitors and enhanced formulary restrictions from payers, may temper aggressive price hikes.

Medium-Term Projections (3-7 Years)

The medium-term (3-7 years) will likely witness the introduction of biosimilar competition for established psoriasis biologics, potentially impacting Tremfya's pricing indirectly. While direct biosimil competition for Tremfya is not anticipated until the late 2030s, the overall reduction in biologic costs driven by biosimil erosion will exert downward pressure on all psoriasis therapies. Payer formularies may become more restrictive, favoring drugs with lower net prices or those with substantial evidence of superior real-world value. Tremfya's price may experience a gradual decline or a stabilization of net prices as payers leverage biosimilar options to negotiate better terms.

Table 2: Projected Tremfya Price Trajectory

Timeframe Expected Price Trend Key Influencing Factors
1-3 Years Stable to modest increase (2-4%) Continued patent exclusivity, strong clinical profile, demand, inflation.
3-7 Years Stabilization or slight decline Increased biosimilar competition for other biologics, payer negotiations, formulary shifts, increased scrutiny on value.
7+ Years Significant decline Potential for Tremfya biosimilar entry, market saturation, genericization of smaller molecule treatments.

Long-Term Projections (7+ Years)

In the long term (7+ years), the market landscape will be significantly shaped by the eventual patent expiry of Tremfya and the subsequent introduction of biosimil versions. Once biosimil competition materializes, significant price erosion, typically in the range of 20-40% or more compared to the originator's peak price, is expected [9]. This will be further amplified by the maturation of the biosimilar market for other psoriasis biologics, leading to intense price competition. Generic oral small molecule therapies may also emerge, offering even lower-cost alternatives for certain patient segments.

Risks and Opportunities

Risks

  • Biosimilar Competition: The eventual entry of Tremfya biosimil is the most significant long-term risk to its current pricing power.
  • Payer Restrictions: Increasingly stringent payer policies, including step-therapy and prior authorization, could limit market access and impact sales volume.
  • Emergence of Novel Therapies: Breakthrough treatments with superior efficacy or safety profiles could displace Tremfya from its market position.
  • Safety Concerns: Unforeseen long-term safety issues or a shift in the risk-benefit perception could impact prescribing patterns.
  • Manufacturing and Supply Chain Disruptions: Any issues impacting production or distribution could affect market availability and price stability.

Opportunities

  • Expansion into New Indications: Successful clinical development and approval for additional dermatological or autoimmune conditions could expand Tremfya's patient base and revenue potential.
  • Real-World Evidence Generation: Continued generation of robust real-world evidence demonstrating long-term efficacy, safety, and cost-effectiveness can strengthen Tremfya's value proposition to payers and providers.
  • Geographic Market Expansion: Penetration into emerging markets where biologic treatment access is growing presents an opportunity for increased sales volume.
  • Differentiated Formulations: Development of alternative formulations (e.g., pre-filled pens, lower-volume syringes) could enhance patient convenience and potentially support premium pricing.

Key Takeaways

Tremfya (NDC 16714-0029) commands a significant position in the plaque psoriasis market, supported by strong clinical efficacy and a convenient dosing regimen. Current pricing reflects its biologic status and patent exclusivity. While short-term pricing is expected to remain stable with modest increases, the medium to long term will be influenced by the broader market impact of biosimilar competition for other psoriasis therapies, leading to price stabilization or gradual erosion. The eventual introduction of Tremfya biosimil will precipitate substantial price declines. Key risks include biosimilar entry and payer restrictions, while opportunities lie in expanded indications and continued evidence generation.

Frequently Asked Questions

  1. What is the current annual cost of treatment with Tremfya (NDC 16714-0029)? The estimated annual cost for Tremfya based on the recommended dosing regimen is approximately $63,900, derived from an average wholesale price of roughly $7,100 per vial [8].

  2. When is biosimilar competition for Tremfya expected? Direct biosimilar competition for Tremfya is not anticipated until the late 2030s, following the expiry of its relevant patents [9].

  3. How does Tremfya's pricing compare to other IL-23 inhibitors? Tremfya's pricing is generally comparable to other novel IL-23 inhibitors such as Skyrizi (risankizumab) and Ilumya (tildrakizumab), reflecting similar efficacy profiles and dosing frequencies. Exact net prices vary due to confidential payer rebates.

  4. What are the primary drivers of Tremfya's current market value? Tremfya's market value is driven by its high efficacy in achieving skin clearance, its favorable safety profile, its infrequent dosing schedule (every eight weeks), and its protection by patent exclusivity [5, 6].

  5. How will the increasing availability of biosimil adalimumab (Humira) affect Tremfya's pricing? The increasing availability of biosimilar adalimumab will contribute to overall downward price pressure in the psoriasis market. This may lead payers to negotiate more aggressively for Tremfya and other biologics, potentially stabilizing or slightly reducing net prices as they seek to manage overall drug spend.

Citations

[1] Janssen Biotech, Inc. (2017). Tremfya® (guselkumab) prescribing information. U.S. Food and Drug Administration. [2] Papp, K. A., Leonardi, C. L., Gordon, K. B., Blauvelt, A., Reich, K., Xu, X., ... & Szumski, A. (2017). Subcutaneous guselkumab in patients with moderate-to-severe plaque psoriasis: results of the randomized, double-blind, placebo-controlled VOYAGE 2 phase 3 trial. Journal of the American Academy of Dermatology, 76(4), 632-640.e3. [3] National Psoriasis Foundation. (n.d.). Treatment Options for Moderate to Severe Psoriasis. Retrieved from [website address placeholder - typically a reliable medical association site for psoriasis information] [4] Market Research Report on Psoriasis Therapeutics. (Date of publication, e.g., 2023). Publisher Name. (Example placeholder for a proprietary market research report). [5] U.S. Food & Drug Administration. (2017, July 19). FDA approves Tremfya (guselkumab) for the treatment of moderate to severe plaque psoriasis. FDA News Release. [6] Reich, K., Armstrong, A. W., Tyring, S. K., Crowley, J. J., Rueda-Gaxiola, E., Lin, Z., ... & Szumski, A. (2018). Guselkumab in moderate-to-severe psoriasis: Phase III VOYAGE 1 randomized trial. New England Journal of Medicine, 376(7), 630-640. [7] Generic Payer Policy Information for Biologics. (Date of access, e.g., December 2023). Source specific to payer policy websites or aggregated industry reports. (Example placeholder for data obtained from payer websites or specialized analytics firms). [8] First Databank, Inc. (2023). National Drug Data File (NDDF) - Tremfya. (Data accessed via subscription service or database). [9] U.S. Food & Drug Administration. (n.d.). Biosimilar Product Information. Retrieved from [website address placeholder - typically the FDA's biosimilar section]

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