Cost-utility of tafenoquine vs. primaquine for the radical cure (prevention of relapse) of Plasmodium vivax malaria.

The aim of this study was to compare cost-utility of tafenoquine (TQ) and primaquine (PQ) for a radical cure (prevention of relapse) of Plasmodium vivax (PV) malaria in Serbia using A five-state, 1-month cycle Markov model. The perspective of Republic Health Insurance Fund was chosen, and the time horizon was 10 years. The model results were obtained after Monte Carlo microsimulation of a sample with 1000 virtual patients. After base case analysis PQ was dominated by TQ, as the net monetary benefit was positive (20,713.84 ± 7,167.46 RSD (99% CI) (174.95 ± 60.54 €)) and incremental cost-effectiveness ratio was below the willingness-to-pay line of 1 Serbian gross national product per capita per quality-adjusted life year gained. Multiple one-way sensitivity analysis and probabilistic sensitivity analysis confirmed the results of the base case simulation. In conclusion, TQ was cost-effective in comparison to PQ for radical cure of PV malaria in socio-economic settings of a South-Eastern European country.

Provider and household costs of Plasmodium vivax malaria episodes: a multicountry comparative analysis of primary trial data.

OBJECTIVE: To determine household and health-care provider costs associated with Plasmodium vivax infection across a range of endemic settings. METHODS: We collected cost data alongside three multicentre clinical trials of P. vivax treatment in Afghanistan, Brazil, Colombia, Ethiopia, Indonesia, Philippines, Peru, Thailand and Viet Nam conducted between April 2014 to December 2017. We derived household costs from trial participant surveys administered at enrolment and again 2 weeks later to determine the costs of treatment and transportation, and the number of days that patients and their household caregivers were unable to undertake their usual activities. We determined costs of routine care by health-care providers by micro-costing the resources used to diagnose and treat P. vivax at the study sites. FINDINGS: The mean total household costs ranged from 8.7 United States dollars (US$; standard deviation, SD: 4.3) in Afghanistan to US$ 254.7 (SD: 148.4) in Colombia. Across all countries, productivity losses were the largest household cost component, resulting in mean indirect costs ranging from US$ 5.3 (SD: 3.0) to US$ 220.8 (SD: 158.40). The range of health-care provider costs for routine care was US$ 3.6-6.6. The cost of administering a glucose-6-phosphate-dehydrogenase rapid diagnostic test, ranged from US$ 0.9 to 13.5, consistently lower than the costs of the widely-used fluorescent spot test (US$ 6.3 to 17.4). CONCLUSION: An episode of P. vivax malaria results in high costs to households. The costs of diagnosing and treating P. vivax are important inputs for future cost-effectiveness analyses to ensure optimal allocation of resources for malaria elimination.

Cost-efficacy analysis of 3% diclofenac sodium, ingenol mebutate, and 3.75% imiquimod in the treatment of actinic keratosis.

Actinic keratosis (AK) is a clinical condition characterized by keratinocytic dysplastic lesions of the epidermis, affecting individuals chronically exposed to sunlight. Topical therapies allow the treatment of a whole area of affected skin and currently include diclofenac sodium gel, 5-fluorouracil cream, 5-fluorouracil and acetylsalicylic acid solution, imiquimod cream, and ingenol mebutate gel. Due to the comparable efficacy of 3% diclofenac, ingenol mebutate, and 3.75% imiquimod in treating AK multiple lesions, a pharmacoeconomic evaluation of cost-effectiveness of the three treatments was needed. A cost-efficacy analysis comparing 3% diclofenac sodium with ingenol mebutate and 3.75% imiquimod was performed. In this analysis, efficacy data were combined with quality-of-life measurement derived from previous studies as well as the costs associated with the management of these lesions in Italy. Patients' demographics and clinical characteristics were assumed to reflect those from the clinical studies considered.

Cost-effectiveness of Ingenol Mebutate Gel for the Treatment of Actinic Keratosis in Greece.

PURPOSE: The present study aimed to perform a cost-effectiveness analysis of ingenol mebutate (IM) versus other topical alternatives for the treatment of actinic keratosis (AK). METHODS: The analysis used a decision tree to calculate the clinical effects and costs of AK first-line treatments, IM (2-3 days), diclofenac 3% (for 8 or 12 weeks), imiquimod 5% (for 4 or 8 weeks), during a 24-month horizon, using discrete intervals of 6 months. A hypothetical cohort of immunocompetent adult patients with clinically confirmed AK on the face and scalp or trunk and extremities was considered. Clinical data on the relative efficacy were obtained from a network meta-analysis. Inputs concerning resource use derived from an expert panel. All costs were calculated from a Greek third-party payer perspective. FINDINGS: IM 0.015% and 0.05% were both cost-effective compared with diclofenac and below a willingness-to-pay threshold of €30,000 per quality-adjusted life-year (QALY) (€199 and €167 per QALY, respectively). Comparing IM on the face and scalp AK lesions for 3 days versus imiquimod for 4 weeks resulted in an incremental cost-effectiveness ratio of €10,868 per QALY. IM was dominant during the 8-week imiquimod period. IM use on the trunk and extremities compared with diclofenac (8 or 12 weeks) led to incremental cost-effectiveness ratios estimated at €1584 and €1316 per QALY accordingly. Results remained robust to deterministic and probabilistic sensitivity analyses. IMPLICATIONS: From a social insurance perspective in Greece, IM 0.015% and IM 0.05% could be the most cost-effective first-line topical field treatment options in all cases for AK treatment.

Cost-Effectiveness and Cost-Utility Analysis of Ingenol Mebutate Versus Diclofenac 3% and Imiquimod 5% in the Treatment of Actinic Keratosis in Spain. / Análisis de coste-efectividad y coste-utilidad de ingenol mebutato versus diclofenaco 3% e imiquimod 5% en el tratamiento de la queratosis actínica en España.

OBJECTIVE: To perform a cost-effectiveness and cost-utility analysis of ingenol mebutate in the treatment of actinic keratosis in Spain. METHODS: We used an adapted Markov model to simulate outcomes in a cohort of patients (mean age, 73 years) with actinic keratosis over a 5-year period. The comparators were diclofenac 3% and imiquimod 5%. The analysis was performed from the perspective of the Spanish National Health System based on direct costs (2015 retail price plus value added tax less the mandatory discount). A panel of experts estimated resources, taking unit costs from national databases. An annual discount rate of 3% was applied. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: The effectiveness of ingenol mebutate-with 0.192 and 0.129 more clearances gained in treatments for face and scalp lesions and trunk and extremity lesions, respectively-was superior to diclofenac's. The total costs of treatment with ingenol mebutate were lower at € 551.50 (face and scalp) and € 622.27 (trunk and extremities) than the respective costs with diclofenac (€ 849.11 and € 844.93). The incremental cost-effectiveness and cost-utility ratios showed that ingenol mebutate was a dominant strategy vs diclofenac. Ingenol mebutate also proved to be more effective than imiquimod, based on 0.535 and 0.503 additional clearances, and total costs of € 551.50 and € 527.89 for the two drugs, respectively. The resulting incremental cost-effectiveness ratio was € 728.64 per clearance gained with ingenol mebutate vs imiquimod. CONCLUSIONS: Ingenol mebutate was a dominant treatment option vs diclofenac and was efficient vs imiquimod (i.e., more effective at a higher cost, achieving an incremental cost-utility ratio of<€30000/quality-adjusted life-years).

Real-life Data on Patient Characteristics, Cost and Effectiveness of Field-directed Treatment for Actinic Keratoses: An Observational Study.

Actinic keratoses (AK) occur frequently; however, real-life clinical data on personalized treatment choice and costs are scarce. This multicentre one-year observational study investigated patient-characteristics, cost and effectiveness of methylaminolaevulinate photodynamic therapy (MAL-PDT), imiquimod (IMI) and 5-fluorour-acil (5-FU) in patients with AKs on the face/scalp. A total of 104 patients preferred MAL-PDT, 106 preferred IMI and 110 preferred 5-FU. At baseline, significant differences between treatment groups were found; most patients were severely affected (mean 32.5 AK in PDT-group, 20.2 in IMI-group, 22.8 in 5-FU-group). A mean reduction in lesions of 81% after MAL-PDT, 82% after IMI and 88% after 5-FU was found after one year. Annual costs were €1,950 for MAL-PDT, €877 for IMI and €738 for 5-FU. These results show that, compared with clinical trials, in the real-life clinical setting AK patients are usually more severely affected and treatment costs are much higher. Furthermore, patient characteristics are important factors in treatment choice.

Topical and intralesional treatment of nonmelanoma skin cancer: efficacy and cost comparisons.

BACKGROUND: Topical chemotherapy, topical immunomodulators, or intralesional chemotherapy may be used to treat nonmelanoma skin cancer (NMSC). OBJECTIVES: To review the cost and efficacy of topical and intralesional therapies for NMSC. METHODS: Literature search assessing the efficacy of NMSC treatment with topical imiquimod, topical 5-fluorouracil (5FU) intralesional 5FU, methotrexate, bleomycin, and interferon (IFN). Single-lesion case reports were excluded. Aggregate cure rates and the estimated cost of treatment (including excision and repair of recurrent lesions) for a sample 1-cm lesion on an extremity were calculated. RESULTS: Cure rates ranged from 65% to 100% for topical imiquimod and 61% to 92% for 5FU. For intralesional agents, cure rates varied considerably according to medication used and NMSC subtype treated. Keratoacanthomas had high cure rates with intralesional agents: 98% for 5FU, 91% for methotrexate, 100% for bleomycin, 100% for IFN alpha (α)-2, 83% for IFN α-2a, and 100% for IFN α-2b. Estimated costs (excluding medication cost) ranged from $205 (intralesional methotrexate for keratoacanthoma) to $1,174 (IFN α-2a for superficial basal cell carcinoma). CONCLUSION: Nonsurgical management of NMSC remains a viable and relatively cost effective treatment option in select cases. Providers should consider the relative efficacy and cost of each medication when using nonsurgical modalities.

What determines patient preferences for treating low risk basal cell carcinoma when comparing surgery vs imiquimod? A discrete choice experiment survey from the SINS trial.

BACKGROUND: The SINS trial (Controlled Clinical Trials ISRCTN48755084; Eudract No. 2004-004506-24) is a randomised controlled trial evaluating long term success of excisional surgery vs. imiquimod 5% cream for low risk nodular and superficial basal cell carcinoma (BCC). The trial included a discrete choice experiment questionnaire to explore patient preferences of a cream versus surgery for the treatment of their skin cancer. METHODS: The self-completed questionnaire was administered at baseline to 183 participants, measuring patients' strength of preferences when choosing either alternative 'surgery' or 'imiquimod cream' instead of a fixed 'current situation' option (of surgical excision as standard practice in UK). The treatments were described according to: cost, chance of complete clearance, side effects and appearance. Participants had to choose between various scenarios. Analysis was performed using a mixed logit model, which took into account the impact of previous BCC treatment and sample preference variability. RESULTS: The analysis showed that respondents preferred 'imiquimod cream' to their 'current situation' or 'surgery', regardless of previous experience of BCC symptoms and treatment. Respondents were more likely to be worried about their cosmetic outcomes and side effects they might experience over and above their chance of clearance and cost. Those with no experience of surgery (compared with experience) valued more the choice of 'imiquimod cream' (£1013 vs £781). All treatment characteristics were significant determinants of treatment choice, and there was significant variability in the population preferences for all of them. CONCLUSIONS: Patients with BCC valued more 'imiquimod cream' than alternative 'surgery' options, and all treatment characteristics were important for their choice of care. Understanding how people with a BCC value alternative interventions may better inform the development of health care interventions.

Cost effectiveness of imiquimod 5% cream compared with methyl aminolevulinate-based photodynamic therapy in the treatment of non-hyperkeratotic, non-hypertrophic actinic (solar) keratoses: a decision tree model.

BACKGROUND: Actinic keratosis (AK) is caused by chronic exposure to UV radiation (sunlight). First-line treatments are cryosurgery, topical 5-fluorouracil (5-FU) and topical diclofenac. Where these are contraindicated or less appropriate, alternatives are imiquimod and photodynamic therapy (PDT). OBJECTIVE: To compare the cost effectiveness of imiquimod and methyl aminolevulinate-based PDT (MAL-PDT) from the perspective of the UK NHS. METHODS: A decision tree model was populated with data from a literature review and used to estimate costs and QALYs gained and incremental cost effectiveness over 1 year. The model simulated patients who were in secondary care, who had four to nine AK lesions, and for whom cryosurgery, 5-FU and diclofenac were contraindicated or considered less appropriate. RESULTS: Over 1 year, imiquimod cost £174 less than MAL-PDT (year 2006 values) but resulted in 0.005 fewer QALYs gained. The incremental cost-effectiveness ratio (ICER) of MAL-PDT over imiquimod was £34,576. In the probabilistic sensitivity analysis, there was a 75% probability that imiquimod was cost effective compared with MAL-PDT at a threshold of £20,000 per QALY gained, falling to 73% at £30,000. CONCLUSIONS: Imiquimod may be the more cost-effective treatment at conventional cost-effectiveness thresholds. A direct head-to-head study of MAL-PDT versus imiquimod is required to reduce uncertainty.

Cost-effectiveness analysis of topical treatments for actinic keratosis in the perspective of the Italian health care system.

Actinic keratosis (AK) is the most common cutaneous malignant neoplasm and its prevalence continues to increase. According to the most recent findings, AK is currently considered the initial stage, in situ, of squamous cell carcinoma. Field-directed therapies for AKs are the preferred treatment since they have the advantage to clear the clinically visible lesions and also subclinical lesions within the cancerous field. We assessed the cost-effectiveness of topical treatments for AKs including 3% diclofenac in 2.5% hyaluronic acid (HA) gel, imiquimod 5% cream and photodynamic therapy with methyl aminolevulinate (MAL-PDT) in the perspective of the Italian Health Care System (SSN). We used a decision tree analytical approach and efficacy data were drawn from published clinical trials. Cost was evaluated from the SSN perspective during a time horizon of 3 months. A responder was defined as a patient with all lesions clinically cleared and showing an excellent cosmetic result. Based on the applied model, the cost per complete responder was calculated. Diclofenac 3% in HA was less expensive (Euro 256) than MAL-PDT (Euro 320) and imiquimod (Euro 342). Effectiveness was similar and better for diclofenac 3% in HA and MAL-PDT (0.813%) in comparison to 0.734% of imiquimod, respectively. The one-way and probabilistic sensitivity analyses confirmed the results of base case scenario. Based on this cost-effectiveness model, diclofenac 3% in HA can be considered the treatment of choice for AK lesions and surrounding field under a pharmacoeconomic point of view.

A cost analysis of photodynamic therapy with methyl aminolevulinate and imiquimod compared with conventional surgery for the treatment of superficial basal cell carcinoma and Bowen's disease of the lower extremities.

BACKGROUND: Superficial basal cell carcinoma (sBCC) and Bowen's disease (BD) are usually slow-growing, low-grade malignancies that mainly affect older persons. Surgery is often the first choice of treatment and the modality with the lowest failure rate. However, non-invasive procedures, such as topical methyl aminolevulinate photodynamic therapy (MAL-PDT) and imiquimod, are increasingly demanded by dermatologists and patients, because of their generally favourable efficacy and adverse effects profile and their excellent cosmetic outcome. OBJECTIVE: To assess the cost of MAL-PDT and of treatment with imiquimod for primary non-melanoma superficial cutaneous carcinomas compared with conventional surgery, thereby calculating the total medical cost, and the direct and indirect costs. SETTING: We collected data on 67 patients with 86 tumours (32 sBCC, 54 BD). Patients were treated between May 2006 and April 2007 at the Dermatology Department of the Costa del Sol Hospital in Marbella, Spain. The mean cost and mean cost per complete clinical response were calculated for each therapeutic option. RESULTS: After 2 years of follow-up, a complete response was observed in 89.5% of the MAL-PDT group, 87.5% of the imiquimod group and 97.5% of the surgery group. The difference in costs when compared with the surgery group was a mean saving per lesion treated of 307 euros for the imiquimod group, and 322 euros for the MAL-PDT group. CONCLUSIONS: Although surgery proved to be more effective treatment, our results suggest that its average cost is greater than that of non-invasive therapy for the treatment of non-melanoma superficial cutaneous carcinomas on the lower limbs, at least after the first 2 years of follow-up.

The SINS trial: a randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma.

BACKGROUND: Basal cell carcinoma is the commonest human cancer. Despite increasing incidence it remains poorly researched. While not life threatening it can cause significant cosmetic disfigurement. Imiquimod, a cream which enhances the body's immune response, may help deal with the number of cases that occur in low-risk sites, especially when good cosmetic results and home use without surgery are needed.This study aims 1. To compare excisional surgery with imiquimod cream for nodular or superficial basal cell carcinoma in low risk sites, with respect to 3 year clinical clearance, cost-effectiveness and cosmetic results. 2. To ascertain if certain phenotypic features and gene polymorphisms predict tumour responsiveness to treatment. METHODS/DESIGN: Five hundred participants with low risk nodular or superficial basal cell carcinoma will be recruited from hospitals to this multi-centre, randomised, parallel group, controlled phase III trial. Treatment in the imiquimod group is for 6 weeks for superficial basal cell carcinoma and 12 weeks for nodular basal cell carcinoma. Both treatment groups are followed up in clinic for 3 years. Primary outcome variable: the proportion of participants with clinical evidence of success (no recurrence) at 3 years. The primary outcome will be compared between the two treatment groups. Secondary outcomes include: i) clinical success at 1, 2 and 5 years, ii) time to first recurrence, iii) cosmetic appearance of lesion site after treatment, iv) level of pain, and v) cost-effectiveness. Safety and tolerability data will also be reported. DISCUSSION: This study protocol describes a pragmatic randomised controlled trial which it is hoped will address the above uncertainties. Three-year results will be available towards the end of 2010. TRIAL REGISTRATION: Meta-register: NCT00066872, Eudract No. 2004-004506-24, ISRCTN48755084.

Comparative study on the efficacy, safety, and acceptability of imiquimod 5% cream versus cryotherapy for molluscum contagiosum in children.

To compare the efficacy, safety and acceptability of imiquimod (IMQ) 5% cream with cryotherapy for the treatment of molluscum contagiosum (MC) in children. Prospective, randomized, comparative, observer blinded study. A total of 74 children, with MC were divided randomly to receive treatment with either IMQ 5% cream (group A) 5 days a week or cryotherapy (group B) once a week until clinical cure or up to a maximum of 16 weeks. All the patients were followed up weekly during active treatment. The patients were followed-up for 6 months after clinical cure to look for recurrence. In the IMQ group (group A), the overall complete cure rate was 91.8% (34 of 37), 22 of the 37 patients cleared by the end of 6 weeks and 12 more patients cleared by the end of 12 weeks, while the remaining three patients (8.1%) did not clear even after 16 weeks. Whereas, in the cryotherapy group, all 37 patients achieved complete cure, 26 of 37 (70.27%) patients cleared after 3 weeks, and the remaining 11 (29.72%) cleared by the end of 6 weeks. No statistically significant difference was found between the overall complete cure rate in both groups at the end of maximum treatment period (16 weeks). Pain, bullae formation, pigmentary changes, and superficial scarring were more significantly common in the cryotherapy group compared with the IMQ group. Imiqimod 5% cream seems to be slow acting but an effective agent for the treatment of MC in children. IMQ appears to be practically painless and more cosmetically accepted treatment when compared with cryotherapy, and may be the preferred treatment of MC in children especially with numerous small lesions. Cryotherapy has the advantage of being rapidly effective, and is less expensive than IMQ and may be the preferred treatment for large solitary or few lesions.

A cost-effectiveness analysis of sinecatechins in the treatment of external genital warts.

OBJECTIVE: To evaluate the cost-effectiveness and treatment-cost impact of sinecatechins (Veregen) as first-line therapy against its principal comparator, imiquimod (Aldara), in the treatment of external genital warts (EGWs). METHOD: A two-stage decision model is proposed to compare sinecatechins with its principal comparator, imiquimod, as a first-line topical therapy in the treatment of EGWs. The model utilizes estimates of sustained clearance from two pivotal sinecatechins trials and from a systematic literature review for imiquimod. Resource inputs are: (1) trial-based estimates of average drug utilization and (2) CPT (Current Procedural Terminology) codes describing anticipated office visits and utilization of second-line ablative procedures. The analysis considers: (1) comparative costs of achieving a successful outcome with sinecatechins versus imiquimod, and (2) comparative cost-consequences of sinecatechins versus imiquimod. As a modeled approach to evaluating comparative product effectiveness, the claims made reflect the structure of the model, which focuses on topical products as first-line therapy in EGW interventions and in its reliance on estimates of sustained clearance from pivotal randomized clinical trials (RCTs). Sustained clearance in this context being defined as the proportion of patients who report initial wart clearance over the RCT period corrected for subsequent recurrence. RESULTS: As first-line therapy, sinecatechins dominates imiquimod as a lower cost treatment with a higher sustained clearance rate (51.9 vs. 40.6%). First-line average cost of treatment with sinecatechins is $774 compared to imiquimod at $930. Cost per successful outcome with sinecatechins is $1,492, which is lower than $2,289 for imiquimod. Taking account of patients failing first-line therapy moving to a second-line ablative therapy yields an average cost of treatment for patients initiated to sinecatechins of $943 and $1,138 for those initiated to imiquimod. A sensitivity assessment confirmed the position of sinecatechins within the decision-model framework. CONCLUSION: Sinecatechins yields a lower cost of treatment compared to imiquimod in the treatment of EGW. It also offers cost savings to healthcare systems. This conclusion should be qualified by the limitations of the decision framework within which the assessment has been made. The model focuses on topical preparations as first-line therapies, with estimates of sustained clearance taken from pivotal RCTs. Treatment cost estimates are generated independently, but reflect current product and ancillary costs.

A relative value unit-based cost comparison of treatment modalities for nonmelanoma skin cancer: effect of the loss of the Mohs multiple surgery reduction exemption.

BACKGROUND: The incidence of skin cancer has increased dramatically, with as many as 2.8 million skin cancers treated in 2005. In an era of decreasing reimbursement, insurer policy changes, and increasing pressure to deliver cost effective care, physicians should understand the total cost of different skin cancer treatment modalities in order to determine which yields the best value for patients. OBJECTIVE: To estimate the costs of treating nonmelanoma skin cancers by multiple modalities based on their assigned relative value unit (RVU) values. METHODS: The cost analysis was performed for the treatment of two skin cancer examples, a basal cell carcinoma (BCC) on the central cheek and a squamous cell carcinoma (SCC) on the forearm of varying sizes. The estimated costs of treatment of each of the skin cancers was calculated for treatment with electrodessication and curettage (EDC), imiquimod immunotherapy, Mohs micrographic surgery, traditional surgical excision with permanent section margin evaluation in an office setting (with immediate repair or with repair delayed until clear margins are confirmed), surgical excision with frozen section margin control in both an ambulatory surgery center and hospital-based setting, and radiation therapy. The effect of the loss of exemption from multiple surgery reduction on the cost of Mohs surgery is also examined. RESULTS: Our estimation of costs for each of the treatment modalities reveals that EDC is the least expensive option, with average costs of $471 (BCC cheek) and $392 (SCC arm). Imiquimod treatment and office-based excision with immediate repair of the surgical defect have similar total average costs of $959 (BCC cheek) and $931 (SCC arm) and $1006 (BCC cheek) and $907 (SCC arm), respectively. If repair of the defect is delayed until negative surgical margins are confirmed by permanent section, the cost of excision increases to $1170 and $1041. The average cost of Mohs micrographic surgery is $1263 (BCC cheek) and $1131 (SCC arm). Mohs surgery's recent loss of multiple surgery reduction exemption has decreased the cost of Mohs surgery by 9% to 25%. Excision with frozen section margin control in an ambulatory surgery center results in costs of $2334 (BCC cheek) and $2200 (SCC arm). However, if the excision is performed in a hospital operating room, the procedure is substantially more expensive, at $3085 and $2680. The cost of radiation therapy treatment is $2591 to $3460 for the BCC of the cheek and $2559 to $3431 for the SCC of the arm, depending on the fractional dose used. LIMITATIONS: These are cost estimates based on literature examples and 2008 RVU values; variations related to individual practices and procedure valuations by private insurers are expected. CONCLUSION: Tumor destruction by EDC or imiquimod and office-based procedures, such as traditional surgical excision or Mohs surgery, are the lowest cost options for treatment of nonmelanoma skin cancer.

An economic evaluation of topical treatments for actinic keratosis.

Actinic keratoses (AK) commonly occur as lesions, in sun-exposed areas. Various treatment modalities exist for their removal. We assessed the cost-effectiveness in 2007 of topical treatments (5-fluorouracil, imiquimod) and photodynamic therapy with methyl aminolevulinate (MAL-PDT) for AK under the perspective of the UK National Health Service (NHS) in England and Wales over two lines of treatment. We used a decision tree analytical approach. Efficacy data were taken from published trial literature for two investigator-assessed outcomes: 'complete clinical response' and 'excellent cosmetic outcome'. MAL-PDT at first line followed by various second-line treatments provided the greatest probability of complete clinical response (91.7%), but MAL-PDT at first line followed by further MAL-PDT as the second-line treatment provided the greatest probability of excellent cosmetic outcome (73.6%). The cost of MAL-PDT was 437 pounds sterling after two lines of treatment if MAL-PDT was that second-line treatment or 418 pounds sterling if various treatments were offered at second line. The probabilistic analysis produced consistent results. Based on this model, the costs and effectiveness of MAL-PDT in the UK NHS compare well with other treatments for AK.

Imiquimod: a review of basal cell carcinoma treatments.

Basal cell carcinoma (BCC) is regarded as the most prevalent malignant skin tumor in whites. A variety of surgical and nonsurgical interventions are available to treat BCC. In recent years, an immune response modifier drug, imiquimod, has been approved in treating superficial BCC (sBCC). The objective of the authors was to review the published literature to evaluate outcomes such as efficacy, safety, and quality of life associated with imiquimod treatment among patients with sBCC. A MEDLINE search of the literature was performed to identify studies published between January 1, 1995 and March 31, 2008 that evaluated imiquimod efficacy, safety, and quality of life in treating BCC. Overall, imiquimod 5% cream was associated with increased clinical and histologic clearance among patients with sBCC as compared to placebo. The findings from short-term cost effectiveness studies suggest that use of imiquimod 5% cream can be more cost-effective than surgical interventions such as excision surgery among patients with superficial BCC. Future studies evaluating long term cost effectiveness of imiquimod treatment are warranted.

Pharmacoeconomic analysis of the treatment of multiple actinic keratoses.

Actinic keratosis (AK) is common and lesions may progress to squamous cell carcinoma. The choice of therapy depends mainly on 2 factors: the efficacy of therapeutic options and the number of lesions present. Cryotherapy alone is suitable for treating a few lesions, whereas topical medications, photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA), or either in combination with cryotherapy are appropriate for treating multiple (>15) lesions. When combinations are necessary, the total cost to treat multiple AKs to 100% clearance becomes important. This report provides a simple pharmacoeconomic analysis of 4 FDA-cleared therapies (imiquimod, diclofenac, 5-fluorouacil [5-FU], and ALA PDT) for AK given in combination with cryotherapy. This analysis assumes standard costs of procedures and office visits (based on April 2007 reimbursement data) and 2 treatment courses (medications: imiquimod, diclofenac, 5-FU) or sessions (ALA PDT) of each modality followed by cryotherapy to 100% clearance. The total cost of each combination is $725.17 for ALA PDT, $845.07 for diclofenac, $942.13 for 5-FU, and $1,473.39 for imiquimod. When phase III trial efficacies of the 4 modalities are considered, the actual cost of using imiquimod or diclofenac increases because additional treatments may be required. Among these 4 FDA-cleared therapies for multiple AK lesions, ALA PDT is the least expensive treatment and imiquimod is the most expensive treatment under the stated assumptions.