Increased topical generic prices by manufacturers

Bhatt, M.; Bhatt, Birju D.; Dorrian, James T.; McLellan, Beth N.

doi:10.1016/j.jaad.2018.03.004

Cited by 10 publications

(5 citation statements)

References 13 publications

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“…8 One study of drug prices among topical dermatologic generic products showed a low median number of manufacturers among drugs sustaining the greatest price increases, but that study did not examine the association between changes in drug price and variations in manufacturing. 9 In the present study, we use a nationally representative drug pricing database to characterize the association between changes in drug price and the number of distinct FDAapproved manufacturers for the most commonly prescribed topical dermatologic generic products.…”

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confidence: 99%

Association Between Market Competition and Prices of Generic Topical Dermatology Drugs

Joyce

Mostaghimi

2018

JAMA Dermatol

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IMPORTANCE During the last decade, increases in drug prices for commonly prescribed dermatologic medications have outpaced the rate of inflation, national health care growth, and reimbursements. Among nondermatologic medications, studies have shown a role for robust generic market competition in reducing drug prices. The association between competition and the costs of topical dermatologic generic drugs has not been evaluated. OBJECTIVE To characterize the association between changes in drug price and the number of US Food and Drug Administration (FDA)-approved manufacturers among the most commonly used topical dermatologic generic products. DESIGN, SETTING, AND PARTICIPANTS This retrospective cost analysis of the most commonly prescribed topical dermatologic generic drugs used cumulative annual claims data from the Medicare Part D Prescriber Public User File to identify 597 dermatologist-prescribed drugs with more than 10 claims. The number of manufacturers and the price per unit were identified from the FDA Orange Book and the National Average Drug Acquisition Cost (NADAC) database, respectively, for 2013 through 2016. Drugs that were nondermatologic, were not topically administered, were missing NADAC data, were lacking a generic formulation, or had fewer than 400 claims were excluded. MAIN OUTCOMES AND MEASURES Primary outcomes included per-unit drug price and number of FDA-approved manufacturers. Pricing measures were adjusted for inflation and are reported in 2016 dollars. RESULTS The present analysis included 116 topical dermatologic generic formulations, representing 70.5% of the total Medicare Part D dermatologist-coded claims from 2015. Drug formulations with 1 to 2 manufacturers during the study period sustained a median percentage increase in price of 12.7%, whereas those with more than 6 manufacturers had a median percentage decrease in price of 20.5%. Formulations with 1 to 2 manufacturers had a 20.6%, 19.5%, and 33.2% higher percentage increase in price than those with 3 to 4 manufacturers, 5 to 6 manufacturers, and more than 6 manufacturers, respectively. There was a statistically significant inverse association between the percentage change in drug price and median number of manufacturers (Spearman correlation coefficient, −0.26; P = .005). CONCLUSIONS AND RELEVANCE The negative association between the change in drug price and the median number of manufacturers of generic topical dermatologic drugs indicates a role for market competition in controlling the costs of generic drug prices within dermatology. These findings support policies that facilitate robust market competition among topical dermatologic generic drugs produced by a limited number of manufacturers.

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confidence: 99%

Association Between Market Competition and Prices of Generic Topical Dermatology Drugs

Joyce

Mostaghimi

2018

JAMA Dermatol

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“…It is reasonable to assume that the medications soluble in water will be formulated in aqueous topical delivery systems, which include solutions, lotions, and creams, while the medications insoluble in water need to be dissolved in oily ingredients or solubilized in surfactant systems. The accessibility of inexpensive, efficacious, as well as safe topical products is a major barrier to satisfying the two objectives mentioned above. − …”

Section: Patents and Brief Topical Market Overviewmentioning

confidence: 99%

New Insights in Topical Drug Delivery for Skin Disorders: From a Nanotechnological Perspective

et al. 2023

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Skin, the largest organ in humans, is an efficient route for the delivery of drugs as it circumvents several disadvantages of the oral and parenteral routes. These advantages of skin have fascinated researchers in recent decades. Drug delivery via a topical route includes moving the drug from a topical product to a locally targeted region with dermal circulation throughout the body and deeper tissues. Still, due to the skin's barrier function, delivery through the skin can be difficult. Drug delivery to the skin using conventional formulations with micronized active components, for instance, lotions, gels, ointments, and creams, results in poor penetration. The use of nanoparticulate carriers is one of the promising strategies, as it provides efficient delivery of drugs through the skin and overcomes the disadvantage of traditional formulations. Nanoformulations with smaller particle sizes contribute to improved permeability of therapeutic agents, targeting, stability, and retention, making nanoformulations ideal for drug delivery through a topical route. Achieving sustained release and preserving a localized effect utilizing nanocarriers can result in the effective treatment of numerous infections or skin disorders. This article aims to evaluate and discuss the most recent developments of nanocarriers as therapeutic agent vehicles for skin conditions with patent technology and a market overview that will give future directions for research. As topical drug delivery systems have shown great preclinical results for skin problems, for future research directions, we anticipate including in-depth studies of nanocarrier behavior in various customized treatments to take into account the phenotypic variability of the disease.

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“…4 Additionally, a cost analysis performed on a randomized trial comparing imiquimod cream, FC cream, and MAL-PDT for superficial BCC found that FC was the most cost-effective, although both creams were more cost-effective than MAL-PDT. 5 The higher cost of MAL-PDT is attributable to substantial overhead and personnel costs, which are not associated with topical creams or with merely increasing patient awareness of potential AK progression to SCC.…”

Section: Photodynamic Therapy and Medicare Expendituresmentioning

confidence: 99%

“…Additionally, particularly in the US, where the cost of branded topical antineoplastic products as a whole has risen 1240% from 2009 to 2015, the retail and out-of-pocket cost of topical FC can be prohibitively high for some patients. 4,5 Comparatively, PDT is typically covered as an office procedure, leading to substantially lower out-of-pocket costs. 6 Finally, PDT is an effective and relatively inexpensive treatment for squamous cell carcinoma and basal cell carcinoma, among other skin conditions, although it is not approved by the US Food and Drug Administration for these indications.…”

Section: Rachel K Limmentioning

confidence: 99%

“…With respect to expenditures, while PDT may not be the most cost-effective field therapy, it can still prevent the development of invasive carcinomas that necessitate more costly treatments. Additionally, particularly in the US, where the cost of branded topical antineoplastic products as a whole has risen 1240% from 2009 to 2015, the retail and out-of-pocket cost of topical FC can be prohibitively high for some patients . Comparatively, PDT is typically covered as an office procedure, leading to substantially lower out-of-pocket costs …”

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Photodynamic Therapy and Medicare Expenditures—Reply

2021

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pathophysiology of the disease and its connection to the aging immune system. Dupilumab is a fully humanized monoclonal antibody that binds the IL-4 receptor and inhibits type 2 helper T lymphocyte (T H 2) cytokine signaling, especially that mediated by IL-4 and IL-13. These cases suggest the role of T H 2 pathways in Grover disease as a possible manifestation of an aging immune system.The substantial improvement of recalcitrant disease and the associated itch with dupilumab suggests a novel treatment option. Evidence supporting this finding includes the fact that IL-4 infusions may induce Grover disease and that the immunophenotype of the immune cells infiltrating Grover disease demonstrate a T H 2 cytokine phenotype. 3,6 Grover disease as a T H 2 disease is also consistent with known age-related changes of the immune system called immunosenescence. Additional studies are needed to better understand the pathophysiology of Grover disease specifically as a marker for an aging immune system. Dupilumab appears to provide a safe and effective treatment option in this vulnerable population.

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Increased topical generic prices by manufacturers

Cited by 10 publications

References 13 publications

Association Between Market Competition and Prices of Generic Topical Dermatology Drugs

Association Between Market Competition and Prices of Generic Topical Dermatology Drugs

New Insights in Topical Drug Delivery for Skin Disorders: From a Nanotechnological Perspective

Photodynamic Therapy and Medicare Expenditures—Reply

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