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OBJECTIVE: To compare health care resource utilization and treatment patterns between patients with actinic keratosis (AK) treated with ingenol mebutate gel (IngMeb) and those treated with other field-directed AK therapies. METHODS: A retrospective, propensity-score-matched, cohort study compared refill/repeat and adding-on/switching patterns and outpatient visits and prescriptions (health care resource utilization) over 6 months in patients receiving IngMeb versus those receiving imiquimod, 5-fluorouracil, diclofenac sodium, and methyl aminolevulinate or aminolevulinic acid photodynamic therapy (MAL/ALA-PDT). RESULTS: The final sample analyzed included four matched treatment cohort pairs (IngMeb and comparator; n = 790-971 per treatment arm). Refill rates were similar except for imiquimod (15% vs. 9% for imiquimod and IngMeb, respectively; P < 0.05). MAL/ALA-PDT treatment repetition rates were higher than IngMeb refill rates (20% vs. 10%; P < 0.05). Topical agent add-on/switch rates were comparable. PDT had higher switch rates than did IngMeb (5% vs. 2%; P < 0.05). The IngMeb cohort had a significantly lower proportion of patients with at least one AK-related outpatient visit during the 6-month follow-up than did any other cohort: versus imiquimod (50% vs. 66%; P < 0.0001), versus 5-fluorouracil (50% vs. 69%; P < 0.0001), versus diclofenac sodium (51% vs. 56%; P = 0.034), and versus MAL/ALA-PDT (50% vs. 100%; P < 0.0001). There were significantly fewer AK-related prescriptions among patients receiving IngMeb than among patients in other cohorts. CONCLUSIONS: Results based on the first 6 months after treatment initiation suggested that most field-directed AK therapies had clinically comparable treatment patterns except imiquimod, which was associated with higher refill rates, and PDT, which was associated with significantly more frequent treatment sessions and higher switching rates. IngMeb was also associated with significantly fewer outpatient visits than were other field-directed therapies.
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Fármacos Dermatológicos/uso terapéutico , Diterpenos/uso terapéutico , Recursos en Salud/tendencias , Queratosis Actínica/tratamiento farmacológico , Pautas de la Práctica en Medicina/tendencias , Anciano , Atención Ambulatoria/tendencias , Terapia Combinada , Fármacos Dermatológicos/economía , Diterpenos/economía , Costos de los Medicamentos , Prescripciones de Medicamentos , Sustitución de Medicamentos/tendencias , Quimioterapia Combinada , Femenino , Recursos en Salud/economía , Recursos en Salud/estadística & datos numéricos , Humanos , Estimación de Kaplan-Meier , Queratosis Actínica/diagnóstico , Queratosis Actínica/economía , Masculino , Persona de Mediana Edad , Pautas de la Práctica en Medicina/economía , Puntaje de Propensión , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
BACKGROUND: Psoriasis is a chronic, immune-mediated dermatological disease associated with substantial economic, clinical, and humanistic burden. OBJECTIVE: The aim of this study was to understand the disutility of patients with psoriasis vulgaris, using mean baseline EuroQoL five dimensions (EQ-5D) index scores reported in the published literature, and to compare this to patients with other chronic diseases. METHODS: Two systematic literature searches were conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Searches were conducted in ten databases including Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials (CENTRAL). The first search (December 2013) used search terms psoria* AND (EQ5D OR EQ OR EUROQoL). Only publications of original research, which reported baseline EQ-5D scores for mild/moderate/severe psoriasis, were included. The second search (March 2014) used the terms (systematic review) AND (EQ5D OR EQ 5D OR EuroQoL). Titles were screened by two independent reviewers. Four independent reviewers reviewed titles and full-length papers. EQ-5D scores for psoriasis patients were qualitatively compared with scores from patients with other chronic diseases identified through the literature search. RESULTS: Of 133 publications on psoriasis, 12 met the inclusion criteria. The mean EQ-5D index scores for psoriasis (all severities) ranged from 0.52 (standard deviation: 0.39) to 0.9 (standard deviation: 0.1). Of the 48 results from the second search, six met the inclusion criteria. The reported EQ-5D lower limit for other diseases ranged from 0.20 (Type 2 diabetes mellitus) to 0.66 (liver diseases). The highest EQ-5D estimates for other diseases ranged from 0.79 (liver diseases) to 0.93 (cancer patients). Both lower and upper EQ-5D estimates in psoriasis patients were within the range of those reported for other chronic diseases. CONCLUSION: Comparative studies of morbidity are relevant in health care studies and patient advocacy. This systematic review demonstrates that the ranges of disutility among psoriasis patients are within the ranges of other chronic diseases (cardiovascular diseases, diabetes, end-stage renal diseases, liver diseases, cancer, and visual disorders).
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BACKGROUND: Topical therapy is important in the treatment of actinic keratosis, but guidance for improving adherence/persistence during topical therapy is still lacking. OBJECTIVES: To utilize expert consensus to generate a list of recommendations to improve real-world efficacy when prescribing topical therapy for actinic keratosis. METHODS: An expert panel of eight dermatologists was convened to generate recommendations based on facilitated discussion and consensus generation using a modified Delphi session. The recommendations were ratified with the expert panel. RESULTS: Facilitated discussion generated 31 issues within five themes, which were prioritized using expert voting. Consensus was achieved on the importance of short and simple treatment regimens for maximizing patient compliance, physician awareness of the progression of actinic keratosis to squamous cell carcinoma, provision of appropriate patient information, and the use of effective communication strategies to educate physicians about actinic keratosis. Based on these key findings, eight recommendations were generated. CONCLUSIONS: The recommendations will assist physicians when prescribing topical actinic keratosis therapy. Further research should focus on the types of patient outcomes that are influenced by the characteristics of topical field therapy.
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Queratosis Actínica/tratamiento farmacológico , Cooperación del Paciente , Administración Tópica , Humanos , Guías de Práctica Clínica como AsuntoRESUMEN
After having practicing and researching health economics for nearly 15 years now, it has become clear to me that the use of cost-effectiveness data in priority setting decisions is rather a rare than a common practice. The Eckard et al. article though, describes a wonderful exception to this rule and a very good example of how it can be used when the conditions are right. However, do we fully understand what these conditions are? In this commentary article I will address some of the institutional and cultural conditions that need to be fulfilled in order for cost-effectiveness data to actually be used in priority setting decisions.
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BACKGROUND: Actinic keratosis therapy can elicit unsightly and painful local skin responses; assessment of treatment satisfaction and health-related quality of life (QoL) is important. Ingenol mebutate gel is a novel topical field therapy for actinic keratosis. OBJECTIVE: Post-hoc analyses were performed based on patient-reported outcomes from phase-III trials (n = 1005) to assess the effects of ingenol mebutate on QoL and the relationship between both QoL and treatment satisfaction, and degree of lesion clearance. METHODS: Patients received ingenol mebutate or vehicle for self-application to a 25-cm(2) contiguous area: 0.015% once daily for 3 consecutive days (face/scalp) or 0.05% once daily for 2 consecutive days (trunk/extremities). QoL (Skindex-16) and Treatment Satisfaction Questionnaire for Medication data were recorded. RESULTS: Significant, positive associations between Treatment Satisfaction Questionnaire for Medication score and degree of clearance were identified for patients in the face/scalp (effectiveness P < .0001 and global satisfaction P = .0002) and trunk/extremities (P < .0001 and P = .0014, respectively) groups. There was a significant association between Skindex-16 score and clearance for patients in the face/scalp group for change in symptoms (P = .0218), emotions (P = .0002), and overall Skindex-16 score (P = .0006) from baseline. LIMITATIONS: Clinical trial population findings may not be generalizable to clinical practice. CONCLUSION: Ingenol mebutate significantly improved patients' QoL and treatment satisfaction. Improvements were associated with higher degrees of actinic keratosis lesion clearance.
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Diterpenos/uso terapéutico , Queratosis Actínica/tratamiento farmacológico , Satisfacción del Paciente , Calidad de Vida , Administración Tópica , Diterpenos/administración & dosificación , Diterpenos/metabolismo , Esquema de Medicación , Geles , Humanos , Vehículos Farmacéuticos , Autoadministración , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
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.
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OBJECTIVES: To investigate which factors and criteria are used in priority setting of pharmaceuticals, in what contexts health economic evaluations are used, and barriers to the use of health economic evaluations at micro, meso, and macro health-care levels. METHODS: The search for empirical articles was based on the MeSH index (Medical Substance Heading), including the search terms "economic evaluation," "cost-effectiveness analysis," "cost-utility analysis," "cost-benefit analysis," "pharmacoeconomic," AND "drug cost(s)," AND "eligibility determination," AND "decision-making," AND "rationing," AND formulary. The following databases were searched: PubMed, EconLit, Cochrane, Web of Science, CINAHL, and PsycINFO. More than 3100 studies were identified, 31 of which were included in this review. RESULTS: The use of health economic evaluations at all three health-care levels was investigated in three countries (United States [US], United Kingdom [UK], and Sweden). Postal and telephone survey methods dominated (n = 17) followed by interviews (n = 13), document analysis (n = 10), and observations of group deliberations (n = 9). The cost-effectiveness criterion was most important at the macro level. A number of contextual uses of health economic evaluations were identified, including importantly the legitimizing of decisions, structuring the priority-setting process, and requesting additional budgets to finance expensive pharmaceuticals. CONCLUSION: Factors that seem to support the increased use of health economic evaluations are well-developed frameworks for evaluations, the presence of health economic skills, and an explicit priority-setting process. Differences in how economic evaluations are used at macro, meso, and micro levels are attributed to differences in the preconditions at each level.