scholarly journals Willingness-to-pay to access Ingenol Mebutate Gel for Actinic Keratosis Treatment in the U.S. Setting

10.36469/9879 ◽  
2014 ◽  
Vol 2 (1) ◽  
pp. 1-14
Author(s):  
Michael Willis ◽  
Sandra Erntoft ◽  
Sofie Persson ◽  
Jenny M. Norlin ◽  
Ulf Persson

Background: Currently available topical treatments for actinic keratosis (AK) adversely affect patients’ quality of life because of long treatment durations and long-lasting local skin reactions (LSRs), which may result in poor treatment adherence and patient outcomes. Ingenol mebutate gel, a recently introduced treatment for AK, is administered for 2 or 3 days, and LSR’s are predicable in onset and duration. Objectives: The objective of the study was to estimate the value of ingenol mebutate gel’s shorter treatment duration and tolerability profile to potential patients, versus existing topical treatments (imiquimod 3.75%, imiquimod 5% and diclofenac 3%) in the United States. Methods: The open-ended Contingent Valuation (CV) approach was used to estimate incremental willingness-to-pay (WTP) for ingenol mebutate gel rather than treatment with imiquimod 5%, imiquimod 3.75% and diclofenac 3%. Profiles for each therapy differed in regards to treatment duration, time-to-LSR resolution, and price. Subjects were asked to state their maximum out-of-pocket WTP to receive ingenol mebutate gel instead of each of the three alternatives. Results: 103 subjects provided usable answers. Between 48% and 63% of subjects were willing to pay extra to gain access to treatment with the ingenol mebutate gel profile instead of the comparators, and the mean incremental WTP ranged from $475 to $518. Subjects with experience of topical treatment stated higher WTP for accessing ingenol mebutate gel. Subjects whose most bothersome AK area was the full scalp or forehead also claimed higher WTP for ingenol mebutate gel. Conclusions: Patients diagnosed with AK indicated an unmet need for fast-acting topical treatment with shorter LSR resolution time.

2014 ◽  
Vol 30 (2) ◽  
pp. 320-321 ◽  
Author(s):  
C. Longo ◽  
L. Neri ◽  
G. Argenziano ◽  
S. Calvieri ◽  
P.G. Calzavara-Pinton ◽  
...  

2020 ◽  
Vol 4 (5) ◽  
pp. s65
Author(s):  
Scott Freeman ◽  
Miriam Bettencourt ◽  
Meg Corliss ◽  
Nikeshia Dunkelly-Allen ◽  
Karen A Veverka

Abstract not available.


2017 ◽  
Vol 23 (9) ◽  
Author(s):  
Alberto Conde-Taboada ◽  
Bárbara Mercado ◽  
Beatriz Aranegui ◽  
Elena González-Guerra ◽  
Eduardo López-Bran

2001 ◽  
Vol 20 (3_suppl) ◽  
pp. 1-6 ◽  

Acid Violet 43 is an anthraquinone color that may be used as a colorant in cosmetic formulations that are hair dyes, colors, and coloring rinses. Batches of Acid Violet 43 that are certified to meet the United States Food and Drug Administration (U.S. FDA) specifications are termed Ext. D & C Violet No. 2. Hair dyes and colors containing Acid Violet 43 are considered coal tar ingredients and, as such, routinely bear a caution statement regarding potential skin irritation and instructions for determining whether the product causes skin irritation in any given individual. Expected concentrations of use are less than or equal to 1%. Impurities include anthracenedione derivatives, p-toluidine, and p-toluidine sulfonic acid, as well as heavy metals. Based on extensive safety test data, the U.S. FDA has established specifications (including limits on impurities) for Ext. D & C Violet No. 2 that allow its use in any cosmetic. It is the certified color (Ext. D & C Violet No. 2) that has been evaluated in the following safety tests. Oral toxicity tests do not demonstrate significant acute toxicity. In a short-term dermal toxicity study using guinea pigs and a subchronic dermal toxicity study using rabbits, no signs of systemic toxicity and no significant local skin reactions were noted. This ingredient was not genotoxic in bacterial assays, nor was it carcinogenic when applied to mouse skin at a 1% concentration. Accordingly, Acid Violet 43 was determined to be safe for use in hair dye formulations, when impurities are limited as follows: ≤ 18% volatile matter (at 135° C) and chlorides and sulfates (calculated as sodium salts); ≤ 0.4% water-insoluble matter; ≤ 0.2% 1-hydroxy-9,10-anthracenedione; ≤ 0.2% 1,4-dihydroxy-9,10-anthracenedione; ≤ 0.1% p-toluidine; ≤ 0.2% p-toluidine sulfonic acids, sodium salts; ≤ 1% subsidiary colors; ≤ 20 ppm lead (as Pb); ≤ 3 ppm arsenic (as As); ≤ 1 ppm mercury (as Hg); and with ≤ 80% total color.


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