Immunomodulator adherence in multiple myeloma patients with lower socioeconomic status: a retrospective study.

OBJECTIVE: Poor adherence to oral chemotherapy adversely impacts clinical outcomes and escalates overall healthcare costs. Despite barriers to medication adherence, a significant gap remains in assessing adherence to oral chemotherapy among multiple myeloma (MM) patients with lower socioeconomic status. Hence, our study aims to evaluate immunomodulator adherence in MM patients at a county hospital, primarily serving underrepresented and indigent individuals with low socioeconomic status across the greater Houston area. METHODS: Inclusion criteria composed of patients diagnosed with MM, aged at least 18 years, and treated with lenalidomide or pomalidomide-two widely used immunomodulators-for a minimum of 2 months or having two or more records of dispensation between May 2019 and May 2021. Adherence was gauged using an adjusted version of the medication possession ratio (MPR). RESULTS: Sixty-two patients were enrolled, yielding a mean MPR value of 88% (SD, ± 18.9). Of these, 43 patients (69.3%) demonstrated adherence with an MPR of ≥ 0.90. A significant difference was found in treatment duration between the adherent (mean 8.8 months; SD, ± 7.2) and non-adherent (mean 13.4 months; SD, ± 7.9) groups (p = 0.027). Notably, race/ethnicity demonstrated a significant difference (p = 0.048), driven by disparities in African American and Hispanic representation across adherence levels. CONCLUSION: In summary, our findings highlight race and treatment duration to be predictors of immunomodulator adherence among MM patients with lower socioeconomic status. Further research is imperative to devise and test innovative interventions aimed at enhancing medication adherence, thereby contributing to improved survival and healthcare quality in this population.

Cost per response analysis of deucravacitinib versus apremilast and first-line biologics among patients with moderate to severe plaque psoriasis in the United States.

BACKGROUND: Understanding the economic value of deucravacitinib and apremilast could assist treatment decision-making for patients with moderate to severe plaque psoriasis. OBJECTIVE: This study compared the cost per response (CPR) for US patients initiating deucravacitinib versus apremilast for moderate to severe plaque psoriasis. METHODS: A CPR model using pharmacy and administration costs was developed from a US payer perspective. Response was defined as a 75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) at weeks 16 and 24. Long-term response was defined as the cumulative benefit over 52 weeks, measured as area under the curve; subsequent treatment was included. Scenario analyses explored varying the efficacy measure or choices of subsequent treatments and limiting discontinuation. RESULTS: The CPR for deucravacitinib versus apremilast was lower at 16 weeks (difference: -$3796 [95% confidence interval (CI): -$6140 to -$1659]) and 24 weeks (difference: -$12,784 [95% CI: -$16,674 to -$9369]). At 52 weeks, the cost per cumulative benefit was lower for patients who initiated deucravacitinib, regardless of initial treatment period duration (16 or 24 weeks). CONCLUSIONS: Scenario analyses found mainly consistent results. This study showed that the CPR is lower when initiating deucravacitinib versus apremilast in moderate to severe plaque psoriasis.

Cost-Effectiveness of Novel Agent Regimens for Transplant-Eligible Newly Diagnosed Multiple Myeloma Patients in India.

BACKGROUND: Survival outcomes for multiple myeloma have improved dramatically since the introduction of novel therapeutic agents. While these drugs are highly effective in improving survival outcomes and quality of life in patients with multiple myeloma, they come at a significant cost. We assessed the cost-effectiveness of bortezomib-based triplet or quadruplet drug regimens in isolation and followed by autologous hematopoietic stem cell transplantation (AHSCT) for the treatment of newly diagnosed multiple myeloma (NDMM) in the Indian context. METHODS: A Markov model was developed to assess the health and economic outcomes of novel drug regimens with and without AHSCT for the treatment of NDMM in India. We estimated the lifetime quality-adjusted life-years (QALYs) and costs in each scenario. The incremental cost-effectiveness ratios (ICERs) were computed and compared against the current willingness-to-pay threshold of a one-time per capita gross domestic product of ₹146,890 (US$1,927.70) for India. Parameter uncertainty was assessed through Monte Carlo probabilistic sensitivity analysis. RESULTS: Among seven treatment sequences, the VCd (bortezomib, cyclophosphamide, dexamethasone) alone arm has the lowest cost and health benefits as compared to four treatment sequences, namely VTd (bortezomib, thalidomide, dexamethasone) alone, VRd (bortezomib, lenalidomide, dexamethasone) alone, VRd plus AHSCT and DVRd (Daratumumab, bortezomib, lenalidomide, dexamethasone) plus AHSCT. It was found that VTd plus AHSCT and VCd plus AHSCT arms were extendedly dominated (ED) by combination of two alternative treatments. Among the five non-dominated strategies, VRd has a lowest incremental cost of ₹ 2,20,093 (US$2,888) per QALY gained compared to VTd alone followed by VRd plus AHSCT [₹3,14,530 (US$4,128) per QALY gained] in comparison to VRd alone. None of the novel treatment sequences were found to be cost-effective at the current WTP threshold of ₹1,46,890 (US$1,927.7). CONCLUSION: At the current WTP threshold of one-time per capita GDP (₹ 146,890) of India, VRd alone and VRd plus AHSCT has 38.1% and 6.9% probability to be cost-effective, respectively. Reduction in current reimbursement rates of novel drugs, namely VRd, lenalidomide, and pomalidomide plus dexamethasone under national insurance program and societal cost of transplant by 50%, would make VRd plus AHSCT and VTd plus AHSCT cost-effective at an incremental cost of ₹40,671 (US$34) and ₹97,639 (US$1,281) per QALY gained, respectively.

Survival outcomes among patients with multiple myeloma in the era of novel agents: exploratory assessment using an electronic medical record database in Japan.

Despite recent advances in the range of therapies available for the treatment of multiple myeloma (MM), there are limited data surrounding survival outcomes and baseline characteristics influencing survival in general clinical practice in Japan. The aim of this study was to use electronic medical records (EMRs) to examine overall survival (OS) and prognostic factors in Japanese patients with MM. We extracted EMRs in the Real World Data (RWD) database of patients with a confirmed diagnosis of MM and treatment history with bortezomib, thalidomide, and/or lenalidomide. OS and prognostic factors for OS were analyzed using a univariate analysis and decision tree model. Of the 6509 patients in the database with a diagnosis of MM, 1565 were eligible. Patients had a median (range) age of 72 (23-92) years, a median OS of 53.5 months, and a 5-year OS rate of 45.6%. In alignment with previous studies, International Staging System stage and age were prognostic of OS. In addition, platelet and erythrocyte counts, chloride, total protein, C-reactive protein, and lactate dehydrogenase levels were identified as important prognostic factors for OS and were used to pilot a simple prognostic tool. In conclusion, we found that the survival outcomes extracted from EMRs in the RWD of Japanese patients with MM aligned with a previous retrospective study from Japan. Baseline laboratory parameters prognostic for OS were explored with additional factors to International Staging System and age identified. These might be used to optimize treatment selection, although further investigation using additional data sources is required.

Real-world assessment of treatment patterns and outcomes in patients with relapsed-refractory multiple myeloma in an Italian haematological tertiary care centre.

Despite significant improvements in therapeutic options, multiple myeloma (MM) patients experience a series of remissions and relapses requiring further lines of therapy (LOTs). We analysed treatment pathways, attrition rates (ARs) and refractoriness patterns across LOTs in 413 MM patients treated from 2011 and 2021. Across LOT-2 to LOT-5 ARs were 26%, 27%, 34% and 37.5%, being 50% for subsequent LOTs. In univariate analysis age over 65 years, international staging system (ISS) II/III, more than two comorbidities, no transplant and no maintenance therapy were significantly associated with AR but regression analysis selected only age over 65 years and more than 2 comorbidities. Median progression-free survival (PFS) was 40.5, 19.5, 10.3, 6 and 4.7 months from LOT-1 to LOT-5. Lenalidomide-refractory patients, among those relapsed after LOT-1, were 26% and 64.5% respectively, in patients starting therapy before 2019 versus in or after 2021. In the two cohorts, 57.5% and 85.5% of patients relapsed after LOT-2 were lenalidomide-refractory. Among patients not relapsed from LOT-1, 80% are receiving continuous lenalidomide and could become lenalidomide-refractory, whereas 91% and 51.5% of patients in LOT-2 could become potential lenalidomide- and daratumumab-refractory respectively. In our analysis the rate of patients reaching subsequent LOTs was higher than previously reported and the increase in early refractoriness would require faster and more efficient treatment licensing processes.

Daratumumab in first-line therapy is cost-effective in transplant-eligible patients with newly diagnosed myeloma.

Triplet regimens, such as lenalidomide, bortezomib, and dexamethasone (RVd) or thalidomide, bortezomib, and dexamethasone (VTd), are standard induction therapies for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). The addition of daratumumab to RVd and VTd has been investigated in the GRIFFIN and CASSIOPEIA trials, respectively, resulting in improvement in the rate of minimal residual disease (MRD) negativity. In this study, we conducted a cost-effectiveness analysis with a 10-year time horizon to compare first-line and second-line use of daratumumab for transplant-eligible patients with NDMM. Because long-term follow-up data for these clinical trials are not yet available, we developed a Markov model that uses MRD status to predict progression-free survival. Daratumumab was used either in the first-line setting in combination with RVd or VTd or in the second-line setting with carfilzomib plus dexamethasone (Kd). Quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios were calculated from a Japanese and US payer perspective. In the Japanese analysis, D-RVd showed higher QALYs (5.43 vs 5.18) and lower costs (¥64 479,793 vs ¥71 287 569) compared with RVd, and D-VTd showed higher QALYs (5.67 vs 5.42) and lower costs (¥43 600 310 vs ¥49 471,941) compared with VTd. Similarly, the US analysis demonstrated dominance of a strategy incorporating daratumumab in first-line treatment regimens. Given that overall costs are reduced and outcomes are improved when daratumumab is used as part of a first-line regimen, the economic analysis indicates that addition of daratumumab to first-line RVd and VTd regimens is a dominant strategy compared with reserving its use for the second-line setting.

Cuidado clínico farmacêutico e estratégia para o uso racional e adesão ao tratamento em pacientes com hanseníase numa Policlínica do Recife / Pharmaceutical clinical care and strategy to rational use and adhesion to treatment in Hansen's disease patients at a policlinic from Recife

Introdução: a hanseníase é uma doença de fácil diagnóstico, possuindo tratamento e cura. Quando diagnosticada tardiamente, pode trazer graves consequências para os portadores e seus familiares. Uma vez que o tratamento da hanseníase está inserido no componente estratégico da assistência farmacêutica, são exigidos cuidados e orientação. Há necessidade de intervenção clínica farmacêutica, com objetivo de acompanhar prescrições medicamentosas, analisando a adesão dos pacientes ao tratamento com a promoção de ações de educação em saúde, além de minimizar a ocorrência de eventos adversos relacionados aos fármacos do tratamento com possível redução de custos associados aos agravos. Objetivo: realizar o monitoramento para identificar e tratar as possíveis intercorrências que estão comumente presentes no tratamento de hanseníase. Metodologia: a realização do estudo deu-se com o acompanhamento dos pacientes atendidos no serviço de referência a partir da aplicação de questionários em consultas periódic as, vis to que a adesão ao tratamento, reduç ão dos eventos adver sos e controle dos comunic antes são de suma impor tância para o controle epidemiológico. Resultados: os principais sintomas dos indivíduos acometidos foram dormência e eritema nodoso hansênico. A maioria utilizava como tratamento o esquema multibacilar e talidomida. O acometimento relatado dos pacientes foi em nível moderado. Os pacientes possuíam comorbidades como hipertensão, artrose e diabetes. O acompanhamento clínico foi relatado como positivo pela maioria dos entrevistados. Conclusão: o desfecho do estudo mostra que a adesão do paciente é crucial para o êxito do tratamento e o acompanhamento do farmacêutico clínico constitui um pilar positivo, contribuindo para a prevenção de agravos e conscientização da comunidade.

Introduction: Hansen's disease is an easily diagnosed disease, with treatment and cure available. When diagnosed late, it can bring serious consequences for patients and their families. Since the treatment of Hansen's disease is part of the strategic component of pharmaceutical assistance, care and guidance are required. There is a need for clinical pharmaceutical intervention, aiming to monitor drug prescriptions, analyze patients' adherence to treatment while promoting health education actions, in addition to minimizing the occurrence of adverse events related to treatment drugs with possible reduction in costs associated to grievances. Objective:thus, the present study aimed to monitor, identify, and treat possible complications commonly present in the treatment of Hansen's disease. Methodology: The study was carried out with the follow-up of patients seen at the reference service, through the application of questionnaires in periodic appointments, since adherence to treatment, reduction of adverse events and control of communicants are of short importance for epidemiological control. Results:The main symptoms of Hansen's disease patients were numbness and leprosy nodosum erythema. Most used the multibacillary scheme and thalidomide as treatment. The reported involvement of patients was at a moderate level. Patients had other comorbidities such as hypertension, arthrosis and diabetes. The clinical assistance was reported as positive by most interviewees. Conclusion: The outcome of the study shows that patient's compliance is crucial for the success of treatment and the clinical pharmacist's accompaniment is a positive pillar, contributing to the prevention of complications and community awareness.

Lenalidomida para pacientes com mieloma múltiplo inelegíveis ao transplante de células-tronco hematopoiéticas / Lenalidomide for patients with multiple myeloma ineligible for stem cell transplant hematopoietic

INTRODUÇÃO: O mieloma múltiplo é uma neoplasia de plasmócitos com incidência anual no Brasil de 1,24 casos a cada 100.000 habitantes. Apesar de avanços no tratamento da doença, o mieloma múltiplo é considerado incurável e o objetivo da terapia é induzir a remissão e prolongar a sobrevida do paciente preservando sua qualidade de vida. Um dos principais tratamentos é o TCTH. No entanto, uma parcela significativa dos pacientes não é elegível ao TCTH podendo ser apenas submetida a medicamentos. A lenalidomida é um imunomodulador que pode ser utilizado na terapia de indução e manutenção nesses pacientes. Desta forma, o objetivo deste Relatório é comparar eficácia, segurança, custo-efetividade e impacto orçamentário da lenalidomida em relação à talidomida, imunomodulador disponível no SUS, em pacientes com mieloma múltiplo inelegíveis ao TCTH. TECNOLOGIA: Lenalidomida. PERGUNTA: A lenalidomida é mais eficaz, segura e custo-efetiva em esquemas com dois ou três medicamentos comparada à talidomida em esquemas terapêuticos com dois ou três medicamentos para o t

Cost minimization analysis of mainstay treatments in cutaneous lupus erythematous.

Cutaneous lupus erythematosus (CLE) can be treated with multiple oral immunosuppressants but cost analyses of these treatments are lacking. We aimed to assess the relative cost difference between various oral medications for CLE using a cost-minimization analysis. Annual direct costs for 10 oral medications used in CLE were calculated including cost of medications and patient monitoring, which include office visits, laboratory and radiological studies, and procedures. Medication costs were taken from the National Average Drug Acquisition Cost calculated by the Centers of Medicare and Medicaid Services or the Average Wholesale Price. Monitoring guidelines were obtained from expert consensus and FDA-approved recommendations. Methotrexate had the lowest total direct cost ($899.31), followed by hydroxychloroquine ($1007.38), mycophenolate mofetil ($1162.12), azathioprine ($1193.71), chloroquine ($2525.01), dapsone ($2750.68), cyclosporine ($2976.32), thalidomide ($75,831.44), and lenalidomide ($316,104.03). For medications used for CLE patients, the medication cost contributes the most to differences between direct costs. Limitations include insufficient patient outcome data to ascertain medication efficacy, exclusion of cost of medication-related adverse events and hospitalizations, and medication cost data not reflecting all payers. Clinicians can use this data to help discern which medication to prescribe CLE patients with financial constraints and reduce healthcare spending.

Switch rates and total cost associated with apremilast and biologics in biologic-naive patients with psoriatic arthritis.

Aim: Real-world treatment data for psoriatic arthritis are limited. We evaluated switch rates, adherence, and costs for patients initiating apremilast versus tumor necrosis factor inhibitor (TNFi) and interleukin inhibitor (ILi) among biologic-naive psoriatic arthritis patients. Materials & methods: This retrospective analysis used IBM MarketScan claims data to assess treatment switches, adherence and costs. Results: Twelve-month switch rates were significantly lower for apremilast versus TNFi (15.5% vs 26.6%; p < 0.0001) and similar to ILi (15.5% vs 14.0%; p = 0.71). Apremilast initiators had lower total costs versus TNFi and ILi (US$39,854 vs US$57,243 and US$65,687; p < 0.05) and adherence was slightly lower versus TNFi and higher versus ILi. Conclusion: Biologic-naive apremilast initiators had lower switch rates versus TNFi initiators and lower total costs versus TNFi or ILi initiators.

Survival, health care resource utilization and expenditures of first-line treatments for multiple myeloma patients ineligible for transplant in Taiwan.

BACKGROUND: We aimed to provide real-world information on survival, health care resource utilization (HCRU), and expenditures related to various first lines of therapy (1LOTs) in newly diagnosed multiple myeloma (NDMM) patients who were transplant ineligible (TI). PATIENTS AND METHODS: From the Taiwan National Health Insurance Database (2008-2016), we identified 1,511 NDMM-TI patients who had received 1LOT since June 2012. We categorized 1LOT regimens into four groups: bortezomib (V)+thalidomide (T), V, T, and non-V/T. Patients' characteristics were collected. The overall survival (OS), event-free survival (EFS), frequencies of HCRU (hospitalization, visiting outpatient and emergency departments), and related expenditures within one year after commencement of the 1LOT were evaluated and compared. RESULTS: The mean age of the included patients was 71.3 (SD 10.7) years, and 40.4% of patients had a CCI score ≥3. Most patients (747; 49.4%) were in the V+T group and, after adjusting for covariates, had a significantly longer OS (median, 22.2 months) and EFS (9.1 months) than those in the T group (12.6 and 4.5 months, respectively) and the non-V/T group (12.2 and 3.2 months, respectively), but they were mostly comparable with patients in the V group (23.8 and 6.6 months, respectively). Compared to those in the V+T group, patients in the T and non-V/T groups had 29% and 39% fewer outpatient visits and 15% and 24% lower total expenditure, respectively. CONCLUSION: Our real-world data consolidate evidence for the effectiveness of bortezomib-containing regimens as the 1LOT in NDMM-TI patients at the expense of more outpatient visits and higher total costs.

Clinical effectiveness of DNA methyltransferase inhibitors and lenalidomide in older patients with refractory anemia with ring sideroblasts: a population-based study in the United States.

Existing studies regarding the role of DNA methyltransferase inhibitors (DNMTi) and lenalidomide in refractory anemia with ring sideroblasts (RARS) are limited. Using the surveillance, epidemiology, and end results-medicare database, we assembled a population-based cohort of older adults diagnosed with non-del(5q) lower-risk myelodysplastic syndromes during 2007-2015. Of 2167 patients, 30% had RARS. About 16% of RARS and non- ring sideroblasts (RS) patients received DNMTi. RARS patients were more likely to receive lenalidomide (11.1% vs. 7.1%, p < 0.01). Among patients who were transfusion-dependent at treatment initiation, 55.6% of those treated with DNMTi only and 42.5% treated with lenalidomide only achieved red blood cell transfusion independence (RBC-TI) for a median duration of 21 and 12 weeks, respectively. RS status did not impact rate of RBC-TI. RARS patients had a significantly better survival, and the median survival of RARS patients varied by treatment group. In this population-based study of older RARS patients, DNMTi and lenalidomide were clinically active.

Lessons Learned Treating Patients with Multiple Myeloma in Resource-Constrained Settings.

PURPOSE OF REVIEW: Based on personal experiences, recommendations for physicians treating patients with multiple myeloma (MM) in low- and middle-income countries (LMICs) are proposed. RECOMMENDATIONS: (1) Implement strategies to keep the patient in the best possible condition for the longest time, in addition to focusing on ways to avoid financial toxicity; (2) if lenalidomide is unavailable, start treatment with thalidomide and dexamethasone, include, if possible, bortezomib; (3) conduct an outpatient-based autologous stem cell transplantation (ASCT) in all eligible patients; (4) use thalidomide as post-ASCT maintenance treatment if lenalidomide is unavailable for the standard risk patients; (5) monitor monoclonal proteins with serum protein electrophoresis and free light chain measurements; (6) employ novel drugs in cases of relapsed or refractory disease; and (7) do not forget supportive therapy. The therapeutic recommendations to treat patients with MM are somewhat different for physicians working in LMICs, compared with those treating patients in high-income countries. These are relevant since more than 50% of the inhabitants of the world live in LMICs, thus indicating that the vast majority of patients with MM are being treated in resource-constrained settings. As time goes by, physicians may acquire the ability to analyze and express their feelings and experiences about topics in the practice of medicine in which they could have learned lessons (1). Since 1980, we have been treating patients with multiple myeloma (MM); to date, we have been personally involved in the study and treatment of more than 300 patients with this disease (2). Having gained experience dealing with MM patients in underprivileged circumstances, such as those prevailing in our country: México, having explored different ideas, treatments, and methods, and being aware of the financial implications which may impact our selection of therapeutic strategies and recommendations, we felt that it was appropriate to share in this article some of these ideas with practitioners around the world who are involved in the treatment of patients with MM in low- and middle-income countries (LMICs).

Real-world treatment patterns, healthcare use and costs in triple-class exposed relapsed and refractory multiple myeloma patients in the USA.

Aim: To estimate treatment patterns and healthcare costs among triple-class exposed relapsed and refractory multiple myeloma (RRMM) patients. Materials & methods: Eligible patients had ≥1 line of therapy (LOT) each of proteasome inhibitors, immunomodulatory drugs and daratumumab in December 2015-September 2018 and received a new LOT. Results: A total of 154 patients were included with a median follow-up of 6.2 months. Median time from diagnosis to new LOT was 41.0 months. Kaplan-Meier estimate of median time to therapy discontinuation was 4.2 months. Mean per-patient, per-month MM-related costs were USD 35,657. Most frequently observed regimens were lenalidomide or pomalidomide + daratumumab (18.2%), lenalidomide or pomalidomide + proteasome inhibitors (15.6%) and lenalidomide or pomalidomide monotherapy (11.0%). Conclusion: Triple-class exposed RRMM patients receive heterogeneous treatments for a short duration with high healthcare resource utilization and costs.

Real-world biologic and apremilast treatment patterns and healthcare costs in moderate-to-severe plaque psoriasis.

Plaque psoriasis is a chronic disease requiring long-term therapy. However, long-term real-world treatment patterns and costs are not well characterized. This study examined treatment patterns and healthcare costs among patients newly initiating a biologic or apremilast for moderate-to-severe plaque psoriasis. Included patients had ?1 prescription for secukinumab, ixekizumab, adalimumab, ustekinumab, etanercept, or apremilast between 01/01/2015 and 08/31/2018, no prior use of the index medication, and continuous enrolment 12 months pre-index and 24 months post-index. Treatment adherence, non-persistence, discontinuation, switching, use of combination therapy, and re-initiation were assessed at 12, 18, and 24 -months post-index. In addition, total and psoriasis-related healthcare costs were evaluated at 24 months. A total of 7,773 patients with 24-month follow-up were included. Overall, adherence was low (21.3%-33.5%) and non-persistence was high (58.4%-86.5%) over 24 months. Discontinuation (38.4%-51.3%), switching (29.7%-52.6%), combination therapy (27.6%-42.9%), and re-initiation of the index medication (19.3%-44.5%) were common. Healthcare costs were high and mostly contributed by psoriasis treatment. Therefore, maintaining disease control on long-term therapy is still challenging for many patients.

Real-world treatment patterns and healthcare costs of biologics and apremilast among patients with moderate-to-severe plaque psoriasis by metabolic condition status.

OBJECTIVES: To compare treatment patterns and costs among psoriasis patients with and without metabolic conditions newly initiating a biologic or apremilast. METHODS: Adult patients included had ≥1 prescription for secukinumab, adalimumab, ustekinumab, etanercept, or apremilast between 01/01/2015 and 08/31/2018 (date of first prescription was index date) and no index drug use in the 12-months pre-index, and continuous enrollment in the 12-month pre-index and 24-month post-index periods. Patients were divided into mutually exclusive treatment cohorts and stratified by their pre-index metabolic condition status. Treatment patterns (adherence, non-persistence, switching, discontinuation, use of combination therapy, and re-initiation) and healthcare costs were compared. RESULTS: Overall, 7773 patients were included; 47.5-56.7% had a metabolic condition. Except for the apremilast group, patients with metabolic conditions had higher discontinuation (secukinumab: 50.6% vs. 43.7%; adalimumab*: 53.9% vs. 48.7%; ustekinumab*: 41.9% vs. 35.1%; etanercept: 42.8% vs. 41.2%; apremilast: 43.1% vs. 46.1%) and switching (secukinumab: 48.1% vs. 41.2%; adalimumab*: 47.8% vs. 41.9%; ustekinumab*: 34.5% vs. 25.3%; etanercept*: 53.6% vs. 51.5%; apremilast: 45.8% vs. 44.6%) than patients without (*p < .05). Patients with metabolic conditions incurred significantly higher costs. CONCLUSION: Many psoriasis patients initiating biologics or apremilast had metabolic conditions. These patients had higher discontinuation and switching, and significantly higher healthcare costs.

Real-world switch patterns and healthcare costs in biologic-naive psoriasis patients initiating apremilast or biologics.

Aim: Treatment switching and healthcare costs were compared among biologic-naive psoriasis patients initiating apremilast or biologics with ≥12 months pre-/post-index continuous enrollment in Optum Clinformatics™ Data Mart. Methods: After propensity score matching, switch rates (new therapy post-index) and days between index and switch were assessed. Total and per-patient per-month costs by service type were assessed. Results: Apremilast initiators (n = 533) were matched and compared with biologic initiators (n = 955). Twelve-month cumulative switch rates and days to switch were similar. Apremilast initiators had significantly lower total healthcare costs than biologic initiators; apremilast switchers and nonswitchers had significantly lower per-patient per-month costs than biologic switchers and nonswitchers, driven mainly by reduced outpatient pharmacy costs. Conclusion: Apremilast initiators had lower healthcare costs even with treatment switching.

Real-World Experience With Apremilast in the Treatment of Adults With Moderate to Severe Plaque Psoriasis in Québec: A Claims-Based Analysis of Drug Utilization and Healthcare Resource Utilization.

BACKGROUND: In Québec, targeted biologic therapies for moderate to severe plaque psoriasis are restricted to patients who have not responded to phototherapy or conventional systemic treatment, primarily due to high drug costs. Apremilast, an oral treatment for plaque psoriasis, was added to the Québec provincial health insurance plan (Régie de l'assurance maladie du Québec; RAMQ) formulary in 2015, making this the only province in Canada with public drug plan reimbursement for apremilast. OBJECTIVES: The aim of this study is to describe patients' characteristics, treatment patterns, healthcare resource utilization (HCRU), and associated costs and to measure real-world budget impact of using apremilast before biologics in plaque psoriasis. METHODS: This study was performed using RAMQ drug claims and medical services data. Patients diagnosed with psoriasis between January 2015 and December 2017 were identified. Medical services and prescription claims were categorized as all-cause and psoriasis-related. Using RAMQ database estimates, a 3-year budget impact analysis was developed comparing treatment cost with and without the addition of apremilast to the formulary. RESULTS: In all, 540 patients were identified (apremilast: n = 92; biologics: n = 448). Comorbidity burden and treatment persistence and adherence were comparable between apremilast and biologic users. The year following the index date, all-cause HCRU was lower for apremilast versus biologic users (CAN$19 763 vs CAN$28 025; P < .01), mainly driven by drug cost. Using apremilast before biologics resulted in an estimated RAMQ net savings of CAN$49 290 (2015), CAN$746 856 (2016), and CAN$1 216 512 (2017), and a total savings of CAN$2 012 658 since apremilast's addition to the formulary. CONCLUSION: Adding apremilast to the drug formulary of other Canadian provinces could result in significant healthcare savings.

Informe diário de evidências COVID-19: busca realizada em 5 de junho de 2020 / COVID-19 daily evidence report: search conducted on June 5, 2020

O Informe Diário de Evidências é uma produção do Ministério da Saúde que tem como objetivo acompanhar diariamente as publicações científicas sobre tratamento farmacológico e vacinas para a COVID-19. Dessa forma, são realizadas buscas estruturadas em bases de dados biomédicas, referente ao dia anterior desse informe. Não são incluídos estudos pré-clínicos (in vitro, in vivo, in silico). A frequência dos estudos é demonstrada de acordo com a sua classificação metodológica (revisões sistemáticas, ensaios clínicos randomizados, coortes, entre outros). Para cada estudo é apresentado um resumo com avaliação da qualidade metodológica. Essa avaliação tem por finalidade identificar o grau de certeza/confiança ou o risco de viés de cada estudo. Para tal, são utilizadas ferramentas já validadas e consagradas na literatura científica, na área de saúde baseada em evidências. Cabe ressaltar que o documento tem caráter informativo e não representa uma recomendação oficial do Ministério da Saúde sobre a temática. Foram encontrados 11 artigos e 7 protocolos.

Treatment Switch Patterns and Healthcare Costs in Biologic-Naive Patients with Psoriatic Arthritis.

INTRODUCTION: We compared treatment switch patterns and healthcare costs among biologic-naive patients with psoriatic arthritis (PsA) who initiated apremilast or biologics. METHODS: A 1:2 propensity score match was used to adjust administrative claims data for adults initiating apremilast or biologics from January 1, 2014, to September 30, 2016, for possible selection bias. Patients had at least 12 months of pre- and post-index continuous enrollment in the Optum Clinformatics™ Data Mart database. Outcomes included switch frequency, days to switch, adherence on index treatment, and healthcare costs (total and per patient per month). Switch rate was defined as the proportion of patients who switched to a new treatment after initiation of the index treatment, and days to switch was calculated as the days between initiation of the index treatment and initiation of the new treatment. Adherence was calculated using the proportion of days covered and the medication possession ratio. The t test and chi-square, Kaplan-Meier, and Wilcoxon rank-sum tests were used to evaluate differences between the cohorts. RESULTS: Patient characteristics and switch rates were similar between the matched apremilast (n = 170) and biologic (n = 327) cohorts. After matching, patient characteristics were similar between the matched cohorts. The 12-month switch rates were similar for patients initiating apremilast versus those on biologics (17.7% vs. 25.1%, P = 0.06). This trend was similar at 6 months (7.7% vs. 13.2%, P = 0.07) and 18 months (24.4% vs. 29.3%, P = 0.33). Regardless of treatment switching, 12-month total healthcare costs were lower with apremilast versus biologics (all: $28,423 vs. $41,178, P < 0.0001; switched: $39,803 vs. $51,517, P = 0.0040; did not switch: $25,984 vs. $37,717, P < 0.0001). CONCLUSIONS: Biologic-naive patients with PsA who initiated apremilast had switch rates similar to biologic users and significantly lower healthcare costs, regardless of treatment switching.

Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects an estimated 30% of psoriasis patients who use systemic therapy. Symptoms of PsA, such as joint swelling and tenderness, can be painful and disabling and may worsen quality of life. PsA can also impart a substantial economic burden. Treatment for moderate to severe PsA often involves the use of systemic oral medications (e.g., conventional systemic treatments such as methotrexate or targeted systemic treatments such as apremilast) or biologic therapy given by injection or infusion. Because PsA symptoms and responses to treatment can vary, patients may switch treatments over time. More research is needed to better understand how switching treatments affects healthcare costs among patients starting treatment with apremilast or a biologic for PsA. This study compared treatment switching and healthcare costs among patients with PsA who had never been treated with a biologic and who started treatment with apremilast or a biologic for PsA. Rates of treatment switching at 12 months were similar for patients starting treatment with apremilast versus those starting a biologic. Patients starting treatment with apremilast had significantly lower total healthcare costs compared with those starting a biologic, even if they later switched to a biologic. Healthcare costs calculated per patient per month (PPPM) were also lower with apremilast versus biologics, driven by lower PPPM pharmacy costs. These findings suggest that starting treatment with apremilast may be an effective and cost-effective strategy for managing PsA, even for patients who later switch to a biologic.