The Effect on BSA of Proactive Management versus Reactive Management of Psoriasis With Fixed-Dose Cal/BD Foam in the PSO-LONG Study.

Reduction of psoriasis body surface area (BSA) is associated with improved patient quality of life. Post-hoc analyses of the PSO-LONG study compared impact on BSA of proactive management versus reactive management strategies using calcipotriol/betamethasone dipropionate (Cal/BD) foam. Mean BSA values, as well as normalized area under the curves (AUCs) for patient BSA were assessed. Analyses found that after the PSO-LONG study’s four-week open-label lead-in phase, when all patients received once-daily Cal/BD foam, mean BSA was significantly reduced. Thereafter, mean BSA remained at lower levels in patients on proactive management compared to reactive management. This was reflected in AUC BSA, which was consistently lower in the proactive management arm. Treatment-related differences were statistically significant when analyzing the full analysis set (FAS) population, as well as when restricting the analysis to study completers. Additional analyses restricted the dataset to include only observations from psoriasis remission periods, or periods of disease relapse. Treatment-related differences in AUC were statistically significant in observations during remission, but not during relapse. This could be expected given the trial’s design, wherein all patients who relapsed were offered the same rescue therapy with once daily Cal/BD foam. Similarly, for patients who dropped out, there was no treatment-related difference in mean BSA during the two weeks preceding dropout, likely due to the common occurrence of relapse in these patients. This paper found that proactive management, in addition to preventing more relapses as previously shown, also maintained BSA at a lower level during remission than reactive management. J Drugs Dermatol. 20(5):567-570. doi:10.36849/JDD.5870.

A three-year national follow-up study on the development of community-level cancer rehabilitation in Denmark.

Aims: Scandinavian cancer care policies emphasise community-level rehabilitation services, but little is known about changes in service provision over time. This follow-up study explores development in these services in Danish municipalities, focusing on availability, utilisation and organisation of services, including existing opportunities and challenges. Methods: A national survey among all 98 Danish municipalities was conducted in 2013 (baseline) and repeated in 2016 (follow-up). The electronic questionnaire comprised closed- and open-ended questions. Data were analysed using descriptive statistics and content analysis. Results: A total of 93 municipalities responded (95% response rate) and the services offered primarily comprised group physical activity, dietary advice, smoking cessation and individual counselling on physical activity. The number of patients enrolled was below the estimated number needing rehabilitation in Denmark. Inequality in utilisation by ethnicity, age and gender was reported. Key challenges for the delivery of services were: inadequate referral and recruitment procedures; lack of needs assessment tools; obstacles to ensuring collaboration and referral of patients between hospitals and municipalities; and inadequate evidence on the rehabilitation's effect. Key recommendations include ensuring collaboration between municipalities; provision of diagnosis-specific group-based activities; services focusing on physical activity; and gender-specific activities directed particularly at men. Conclusions: This study, which highlights improvements in the provision of community-level cancer rehabilitation, recommends that more effort be made to ensure equality in utilisation across patient groups, improved integration of municipal-level services into cancer care trajectories, more uniform documentation of service delivery and the enforcement of patient outcomes to gradually build a more robust evidence base for community-level cancer rehabilitation.

Diversity in cancer care: exploring social categories in encounters between healthcare professionals and breast cancer patients.

BACKGROUND: The burden of breast cancer is a key challenge for women's health globally. Rehabilitation needs and strategies for living with long-term consequences of breast cancer and its treatment cannot be isolated from the social contexts of patients, including relationships with relatives and healthcare professionals. AIM: This study explores how healthcare professionals' categorisations engage with breast cancer patients' social identities in encounters about rehabilitation before hospital discharge. METHOD: We conducted a multiperspective case-based qualitative study at a Danish department of breast surgery, including participant observations and interviews with twelve patients and eight nurses. Data were analysed thematically using theories of categorisation and clinical encounters. Ethical considerations: The Danish Data Protection Agency approved the study (journal number 2012-41-0701). RESULTS: Interactions in clinical encounters are shaped by categorisations of patients' social identities in terms of social resources and ethnicity, and by the resource-constrained organisational context, with impact on the assessments of the patient's rehabilitation needs. CONCLUSIONS: There is a need for a greater focus on improving encounters between breast cancer patients and healthcare professionals to ensure that rehabilitation needs are accommodated for among diverse patient groups.

Cost per responder of biologic drugs used in the treatment of moderate-to-severe plaque psoriasis in France and Germany.

OBJECTIVE: The treatment of moderate-to-severe plaque psoriasis has seen significant improvements in recent years with the advent of biologic drugs. The aim of this study was to assess the cost-effectiveness of anti-IL17 drugs and other biologic therapies used to treat moderate-to-severe plaque psoriasis in France and Germany over a one-year time horizon. METHODS: We developed a cost per responder model for biologic drugs used in psoriasis treatment. The model included anti-IL17s (brodalumab, secukinumab, ixekizumab and bimekizumab), anti-TNFs (adalimumab, etanercept, certolizumab and infliximab), an anti-IL12/23 (ustekinumab), and anti-IL23s (risankizumab, guselkumab and tildrakizumab). Efficacy estimates were collected through a systematic literature review of network meta-analyses on long-term Psoriasis Area and Severity Index (PASI) measures. Dose recommendations and country-specific prices were used to calculate drug costs. Biosimilar drug prices were used when available as a substitute for the originator drugs. RESULTS: After one year, brodalumab had the lowest cost per PASI100-responder in both France (€20,220) and Germany (€26,807) across all available biologic treatments. Among the anti-IL17s, brodalumab had a 23% lower cost per PASI100-responder vs. the nearest comparator in France (bimekizumab, €26,369), and 30% lower vs. nearest comparator in Germany (ixekizumab, €38,027). Brodalumab also had the lowest cost per PASI75- and PASI90-responder among the anti-IL17s in both France and Germany after one year. Adalimumab had the lowest cost per PASI100-responder among the anti-TNFs in both France (€23,418) and Germany (€38,264). Among the anti-IL-23s, risankizumab had the lowest cost per PASI100-responder in both France (€20,969) and Germany (€26,994). CONCLUSION: Driven by its lower costs and high response rates, brodalumab was the most cost-effective treatment option for moderate-to-severe plaque psoriasis over a one-year time-horizon within the anti-IL17 class and when compared to all other biologics in France and Germany.

The Cost-Effectiveness of Anti-IL17 Biologic Therapies for Moderate-to-Severe Plaque Psoriasis Treatment in Italy and Germany: A Sequential Treatment Analysis.

Objective: The objective of this study was to optimise the cost-effectiveness of different anti-IL17 treatment sequences used in the treatment of moderate-to-severe plaque psoriasis in Italy and Germany over a five-year time horizon. Methods: We adjusted a previously published treatment sequence model for biologic drugs used in psoriasis treatment to an Italian and German setting, respectively. The model included all anti-IL17 biologics currently available in the treatment of moderate-to-severe plaque psoriasis in the markets of scope (secukinumab, ixekizumab, brodalumab and bimekizumab). Real-world discontinuation rates were used to model switches between the four anti-IL17 biologics included in the study. The treatment costs were based on label dosing recommendations for each drug, including induction and maintenance therapy, and the manufacturer prices of each drug in Italy and Germany, respectively. We used long-term Psoriasis Area and Severity Index 100 (PASI100) measures to inform the model on the efficacy for each treatment. The cost-effectiveness in the analysis was evaluated based on the cost per PASI100-responder. Results: We found that the most cost-effective treatment sequence was achieved by using brodalumab as first-line treatment, bimekizumab as second-line treatment, ixekizumab as third-line treatment and secukinumab as fourth-line treatment in both Italy and Germany, which resulted in a total cost per responder of €128,200 and €138,212, respectively, over a five-year period. Several scenario analyses were also conducted and ensured that the results were robust to changes in key input parameters. Conclusion: Our study showed that using brodalumab as a first-line therapy to treat moderate-to-severe psoriasis in both Italy and Germany leads to the most cost-effective treatment sequence, when compared to all possible combinations of anti-IL17s over a five-year time horizon. In addition, we found that treatment discontinuation and switching are important factors when assessing the cost-effectiveness of biologic therapies.

Clinical, patient and estimated cost benefits of proactive management versus reactive management with calcipotriol/betamethasone dipropionate foam for the treatment of plaque psoriasis in Finland.

BACKGROUND: Proactive management of plaque psoriasis with twice-weekly topical calcipotriol/betamethasone dipropionate (Cal/BD) foam has a demonstrated clinical benefit in preventing disease relapse compared to reactive management, where Cal/BD foam is only given as rescue therapy once-daily for four weeks after relapse. The impact of proactive management with Cal/BD foam on a wider range of clinical responses is not yet known, nor is its potential cost-effectiveness in the healthcare system of Finland. METHODS: This study involved a post-hoc analysis exploring the clinical and patient-reported benefits of proactive versus reactive management with Cal/BD foam observed in the PSO-LONG trial (NCT02899962). A range of response criteria based on modified psoriasis area and severity index (mPASI) and dermatology life quality index (DLQI) were analyzed, and the cost-effectiveness of proactive versus reactive management was estimated in a Finnish healthcare setting. RESULTS AND CONCLUSION: The analysis found a consistent clinical benefit of proactive management compared to reactive management on all response criteria, and a markedly lower cost-per-responder for the response criteria of mPASI 75, mPASI ≤ 2 and DLQ1 ≤ 1. The analysis was robust to sensitivity analyses on key inputs and demonstrates the cost and clinical benefits of proactive over reactive management of plaque psoriasis with Cal/BD foam in the Finnish healthcare setting.

Effectiveness comparison and incremental cost-per-responder analysis of calcipotriene 0.005%/betamethasone dipropionate 0.064% foam vs. halobetasol 0.01%/tazarotene 0.045% lotion for plaque psoriasis: a matching-adjusted indirect comparative analysis.

Background: The fixed-dose combination foam formulation of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) has demonstrated efficacy and a favorable safety profile for the treatment of plaque psoriasis. Recently, a topical lotion of the combination of halobetasol 0.01% plus tazarotene 0.045% (HP/TAZ) was approved for treating adult plaque psoriasis. Currently, no head-to-head studies have compared Cal/BD foam with HP/TAZ lotion.Objective: Compare the effectiveness and drug incremental cost per responder (ICPR) of Cal/BD foam vs. HP/TAZ lotion in moderate-to-severe plaque psoriasis.Methods: An anchor-based, matching-adjusted indirect comparison was conducted for PGA treatment success (Physician's Global Assessment of "clear" or "almost clear," [PGA 0/1] with at least a 2-point improvement) using individual patient data from 3 randomized clinical studies of Cal/BD foam and published data from 2 randomized, Phase 3 clinical studies of HP/TAZ lotion. The number needed to treat and ICPR were also calculated.Results: After reweighting of patients in the Cal/BD foam studies to match summary baseline characteristics of the HP/TAZ lotion study patients and anchoring to vehicle effect, 4 weeks of Cal/BD foam produced a significantly greater rate of treatment success than 8 weeks of HP/TAZ lotion treatment (51.4 vs. 30.7%; treatment difference = 20.7%, p < .001). The number needed to treat with Cal/BD foam was also less than HP/TAZ lotion (1.9 vs. 3.3). Using US wholesale acquisition costs and equal weekly consumption rates, the incremental cost per PGA 0/1 responder relative to vehicle for Cal/BD foam was $3,988 and was 37% lower compared with HP/TAZ lotion ($6,294).Conclusions: The indirect comparison analyses showed that Cal/BD foam was associated with a greater rate of treatment success, lower ICPR, and quicker treatment response than HP/TAZ lotion in adult patients with moderate-to-severe plaque psoriasis.