RESUMEN
OBJECTIVE: In Malaysia, there is now a dearth of recommendations pertaining to the priority of biologic treatments for the effective management of psoriasis, given the multitude of available therapeutic alternatives. Present analysis reports results of a cost-effectiveness model that determines the most optimal arrangement of biologic treatments, with a particular focus of adding biosimilars to the existing treatment pathway for psoriasis in Malaysia. METHODS: A Markov model was developed to compare the cost effectiveness of various biologic sequential treatments in a hypothetical cohort of moderate to severe psoriasis patient in Malaysia over a lifetime horizon. The model simulated the progression of patients through three lines of active biologic therapy, before transitioning to best supportive care. Costs and effects were discounted annually at a rate of 3%. RESULTS: First line secukinumab has produced lowest incremental cost effectiveness ratios (ICERs) when compared to first line systemic [ICERs value; US$152,474 (first set analysis) and US$110,572 (second set analysis)] and first line phototherapy [ICERs value; US$147,057 (first set analysis) and US$107,616 (second set analysis)]. However, these values were slightly higher than the Malaysian based threshold of three times gross domestic product per capita, US$104,337. A 40% reduction in the unit costs of reference biologics renders most of the evaluated treatment sequences cost-effective. CONCLUSION: Adding biosimilar to the current treatment sequence could achieve cost savings ranging from 4.3% to 10.8% without significant loss of effectiveness. Given the significant impact of comorbidities and the resulting decline in quality of life among individuals with psoriasis, it may be justifiable to establish a threshold of up to US$184,000 per quality-adjusted life year (QALY) for the provision of therapies in the context of Malaysia.
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Análisis Costo-Beneficio , Psoriasis , Psoriasis/tratamiento farmacológico , Psoriasis/economía , Humanos , Malasia , Cadenas de Markov , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/economía , Años de Vida Ajustados por Calidad de Vida , Biosimilares Farmacéuticos/economía , Biosimilares Farmacéuticos/uso terapéutico , Masculino , Índice de Severidad de la Enfermedad , Atención a la Salud/economía , Productos Biológicos/uso terapéutico , Productos Biológicos/economía , Análisis de Costo-EfectividadAsunto(s)
Productos Biológicos , Hidradenitis Supurativa , Cobertura del Seguro , Medicaid , Humanos , Hidradenitis Supurativa/tratamiento farmacológico , Hidradenitis Supurativa/economía , Estados Unidos , Productos Biológicos/uso terapéutico , Productos Biológicos/economía , Medicaid/economía , Medicaid/estadística & datos numéricos , Cobertura del Seguro/economía , Cobertura del Seguro/estadística & datos numéricosAsunto(s)
Productos Biológicos , Enfermedad Pulmonar Obstructiva Crónica , Cese del Hábito de Fumar , Humanos , Enfermedad Pulmonar Obstructiva Crónica/rehabilitación , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Productos Biológicos/uso terapéutico , Productos Biológicos/economíaAsunto(s)
Artritis Reumatoide , Productos Biológicos , Disparidades en Atención de Salud , Humanos , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/economía , Productos Biológicos/uso terapéutico , Productos Biológicos/economía , Disparidades en Atención de Salud/economía , Persona de Mediana Edad , Femenino , Masculino , Antirreumáticos/uso terapéutico , Antirreumáticos/economía , Anciano , Adulto , Pautas de la Práctica en Medicina/economíaRESUMEN
AIMS: Suboptimal treatment indicators, including treatment switch, are common among patients with Crohn's disease (CD), but little is known about their associated healthcare resource utilization (HRU) and costs. This study assessed the impact of suboptimal treatment indicators on HRU and costs among adults with CD newly treated with a first-line biologic. METHODS: Adult patients with CD were identified in the IBM MarketScan Commercial Subset (10/01/2015-03/31/2020). The index date was defined as initiation of the first-line biologic, and the study period was defined as the 12 months following the index date. Patients were classified into Suboptimal Treatment and Optimal Treatment cohorts based on observed indicators of suboptimal treatment during the study period. Patients in the Suboptimal Treatment Cohort with a treatment switch were classified into the Treatment Switch Cohort and compared to patients with no treatment switch. All-cause HRU and costs were measured during the study period and assessed for patients with suboptimal vs optimal treatment and patients with vs without a treatment switch. RESULTS: The study included 4,006 patients (Suboptimal Treatment: 2,091, Optimal Treatment: 1,915). Treatment switch was a common indicator of suboptimal treatment (Treatment Switch: 640, No Treatment Switch: 3,366). HRU and costs were significantly higher among patients with suboptimal treatment than those with optimal treatment (annual costs: $92,043 vs $73,764; p < 0.01), and among those with a treatment switch than those with no treatment switch (annual costs: $95,689 vs $81,027; p < 0.01). Increases in the number of suboptimal treatment indicators were associated with increased costs. LIMITATIONS: Claims data were used to identify suboptimal treatment indicators based on observed treatment patterns; reasons for treatment decisions could not be assessed. CONCLUSION: This study demonstrates that patients with suboptimal treatment indicators, including treatment switch, incur substantially higher HRU and costs compared to patients receiving optimal treatment and those that do not switch treatments.
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Enfermedad de Crohn , Revisión de Utilización de Seguros , Humanos , Masculino , Enfermedad de Crohn/tratamiento farmacológico , Enfermedad de Crohn/economía , Femenino , Adulto , Estudios Retrospectivos , Persona de Mediana Edad , Estados Unidos , Productos Biológicos/uso terapéutico , Productos Biológicos/economía , Aceptación de la Atención de Salud/estadística & datos numéricos , Adulto Joven , Gastos en Salud/estadística & datos numéricos , Recursos en Salud/estadística & datos numéricos , Recursos en Salud/economía , AdolescenteRESUMEN
Aim: The objective of this study was to compare adverse event (AE) management costs for fruquintinib, regorafenib, trifluridine/tipiracil (T/T) and trifluridine/tipiracil+bevacizumab (T/T+bev) for patients with metastatic colorectal cancer (mCRC) previously treated with at least two prior lines of therapy from the US commercial and Medicare payer perspectives. Materials & methods: A cost-consequence model was developed to calculate the per-patient and per-patient-per-month (PPPM) AE costs using rates of grade 3/4 AEs with incidence ≥5% in clinical trials, event-specific management costs and duration treatment. Anchored comparisons of AE costs were calculated using a difference-in-differences approach with best supportive care (BSC) as a common reference. AE rates and treatment duration were obtained from clinical trials: FRESCO and FRESCO-2 (fruquintinib), RECOURSE (T/T), CORRECT (regorafenib) and SUNLIGHT (T/T, T/T+bev). AE management costs for the commercial and Medicare perspectives were obtained from publicly available sources. Results: From the commercial perspective, the AE costs (presented as per-patient, PPPM) were: $4015, $1091 for fruquintinib (FRESCO); $4253, $1390 for fruquintinib (FRESCO-2); $17,110, $11,104 for T/T (RECOURSE); $9851, $4691 for T/T (SUNLIGHT); $8199, $4823 for regorafenib; and $11,620, $2324 for T/T+bev. These results were consistent in anchored comparisons: the difference-in-difference for fruquintinib based on FRESCO was -$1929 versus regorafenib and -$11,427 versus T/T; for fruquintinib based on FRESCO-2 was -$2257 versus regorafenib and -$11,756 versus T/T. Across all analyses, results were consistent from the Medicare perspective. Conclusion: Fruquintinib was associated with lower AE management costs compared with regorafenib, T/T and T/T+bev for patients with previously treated mCRC. This evidence has direct implications for treatment, formulary and pathways decision-making in this patient population.
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Protocolos de Quimioterapia Combinada Antineoplásica , Benzofuranos , Bevacizumab , Neoplasias Colorrectales , Compuestos de Fenilurea , Piridinas , Timina , Trifluridina , Humanos , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/economía , Estados Unidos , Piridinas/economía , Piridinas/uso terapéutico , Piridinas/efectos adversos , Timina/uso terapéutico , Trifluridina/uso terapéutico , Trifluridina/economía , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Bevacizumab/economía , Bevacizumab/uso terapéutico , Bevacizumab/efectos adversos , Compuestos de Fenilurea/uso terapéutico , Compuestos de Fenilurea/economía , Compuestos de Fenilurea/efectos adversos , Benzofuranos/economía , Benzofuranos/uso terapéutico , Benzofuranos/efectos adversos , Irinotecán/uso terapéutico , Irinotecán/economía , Combinación de Medicamentos , Pirrolidinas/uso terapéutico , Pirrolidinas/economía , Oxaliplatino/economía , Oxaliplatino/uso terapéutico , Oxaliplatino/efectos adversos , Medicare/economía , Camptotecina/análogos & derivados , Camptotecina/uso terapéutico , Camptotecina/economía , Camptotecina/efectos adversos , Quinazolinas/economía , Quinazolinas/uso terapéutico , Quinazolinas/efectos adversos , Compuestos Organoplatinos/economía , Compuestos Organoplatinos/uso terapéutico , Compuestos Organoplatinos/efectos adversos , Uracilo/análogos & derivados , Uracilo/uso terapéutico , Uracilo/economía , Uracilo/efectos adversos , Fluorouracilo/uso terapéutico , Fluorouracilo/economía , Fluorouracilo/efectos adversos , Modelos Económicos , Productos Biológicos/economíaRESUMEN
INTRODUCTION: Biological disease-modifying antirheumatic drugs (bDMARDs) have revolutionised the treatment of inflammatory arthritis (IA). However, many people with IA still require planned orthopaedic surgery to reduce pain and improve function. Currently, bDMARDs are withheld during the perioperative period due to potential infection risk. However, this predisposes patients to IA flares and loss of disease control. The question of whether to stop or continue bDMARDs in the perioperative period has not been adequately addressed in a randomised controlled trial (RCT). METHODS AND ANALYSIS: PERISCOPE is a multicentre, superiority, pragmatic RCT investigating the stoppage or continuation of bDMARDs. Participants will be assigned 1:1 to either stop or continue their bDMARDs during the perioperative period. We aim to recruit 394 adult participants with IA. Potential participants will be identified in secondary care hospitals in the UK, screened by a delegated clinician. If eligible and consenting, baseline data will be collected and randomisation completed. The primary outcome will be the self-reported PROMIS-29 (Patient Reported Outcome Measurement Information System) over the first 12 weeks postsurgery. Secondary outcome measures are as follows: PROMIS - Health Assessment Questionnaire (PROMIS-HAQ), EQ-5D-5L, Disease activity: generic global Numeric Rating Scale (patient and clinician), Self-Administered Patient Satisfaction scale, Health care resource use and costs, Medication use, Surgical site infection, delayed wound healing, Adverse events (including systemic infections) and disease-specific outcomes (according to IA diagnosis). The costs associated with stopping and continuing bDMARDs will be assessed. A qualitative study will explore the patients' and clinicians' acceptability and experience of continuation/stoppage of bDMARDs in the perioperative period and the impact postoperatively. ETHICS AND DISSEMINATION: Ethical approval for this study was received from the West of Scotland Research Ethics Committee on 25 April 2023 (REC Ref: 23/WS/0049). The findings from PERISCOPE will be submitted to peer-reviewed journals and feed directly into practice guidelines for the use of bDMARDs in the perioperative period. TRIAL REGISTRATION NUMBER: ISRCTN17691638.
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Antirreumáticos , Procedimientos Ortopédicos , Ensayos Clínicos Pragmáticos como Asunto , Humanos , Reino Unido , Antirreumáticos/uso terapéutico , Antirreumáticos/economía , Atención Perioperativa/métodos , Atención Perioperativa/economía , Investigación Cualitativa , Estudios Multicéntricos como Asunto , Proyectos Piloto , Análisis Costo-Beneficio , Productos Biológicos/uso terapéutico , Productos Biológicos/economíaRESUMEN
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.
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Análisis Costo-Beneficio , Psoriasis , Índice de Severidad de la Enfermedad , Talidomida , Humanos , Psoriasis/tratamiento farmacológico , Psoriasis/economía , Estados Unidos , Talidomida/análogos & derivados , Talidomida/economía , Talidomida/uso terapéutico , Productos Biológicos/economía , Productos Biológicos/uso terapéutico , Resultado del Tratamiento , Costos de los Medicamentos , Masculino , FemeninoRESUMEN
OBJECTIVE: To evaluate the impact of the entry of biosimilars on the pricing of eight biologic products in 57 countries and regions. METHODS: We utilized an interrupted time series design and IQVIA MIDAS® data to analyze the annual sales data of eight biologic products (adalimumab, bevacizumab, epoetin, etanercept, filgrastim, infliximab, pegfilgrastim, and trastuzumab) across 57 countries and regions from January 1, 2012, to December 31, 2019. We examined the immediate and long-term changes in biologics ex-manufacturer pricing following the entry of biosimilars to the market. RESULTS: Following the entry of biosimilars, the average price per dose of biologic product was immediately reduced by $438 for trastuzumab, $112 for infliximab, and $110 for bevacizumab. The persistent effect of biosimilars' market entry led to further reductions in price per dose every year: by $49 for adalimumab, $290 for filgrastim, $21 for infliximab, and $189 for trastuzumab. Similarly, we analyzed the impact of biosimilars on four biologics' prices in the US, where the prices of three biologics significantly decreased every year, with filgrastim, pegfilgrastim, and infliximab decreasing by $955, $753, and $104, respectively. CONCLUSIONS: The introduction of biosimilars has significantly reduced the prices of biologics both globally and in the US. These findings not only demonstrate the economic benefits of increasing biosimilar utilization, but also emphasize the importance of biosimilars in controlling healthcare costs. Policies should aim to expand the availability of biosimilars to counteract the exponential growth of medical spending caused by the use of biologics.
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Biosimilares Farmacéuticos , Infliximab , Biosimilares Farmacéuticos/economía , Biosimilares Farmacéuticos/uso terapéutico , Humanos , Infliximab/economía , Infliximab/uso terapéutico , Filgrastim/economía , Filgrastim/uso terapéutico , Productos Biológicos/economía , Productos Biológicos/uso terapéutico , Costos de los Medicamentos , Adalimumab/economía , Adalimumab/uso terapéutico , Etanercept/economía , Etanercept/uso terapéutico , Trastuzumab/economía , Trastuzumab/uso terapéutico , Costos y Análisis de Costo , PolietilenglicolesRESUMEN
Although biotherapeutic drugs have the potential of transforming the management of many life-threatening diseases, their affordability and accessibility remain an issue. This study offers an overview of the global affordability of biotherapeutic products. For this, prices for 10 representative biotherapeutic products were examined in 40 countries, including high-income countries (HICs), upper middle-income countries (UMICs), lower middle-income countries (LMICs), and low-income countries (LICs). The affordability of these biotherapeutics was calculated based on the World Health Organization/Health Action International (WHO/HAI) method. As expected, affordability was found to be better in HICs, followed by UMICs, LMICs, and finally, LICs. Furthermore, based on the trend of per capita income, we predict that in UMICs and LMICs, the affordability of high molecular weight biologics will worsen by 1.5× and 2× by 2030, respectively, and further by 4× and 6× by 2040. On the other hand, affordability will stay nearly the same for people living in HICs in the coming decades. Our analysis suggests that it is imperative that measures be taken to make this class of products more affordable and accessible. Governments can contribute by creating conducive policies. Global institutions like the WHO can play a significant role as well. Finally, manufacturers need to invest in and implement manufacturing innovations.
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Productos Biológicos , Países en Desarrollo , Humanos , Productos Biológicos/economía , Productos Biológicos/uso terapéutico , Países en Desarrollo/economía , Costos de los Medicamentos/tendencias , Salud Global/economía , Accesibilidad a los Servicios de Salud/economía , Accesibilidad a los Servicios de Salud/tendencias , Organización Mundial de la SaludRESUMEN
Introduction: Novel therapies for 3L+ relapsed/refractory (r/r) follicular lymphoma (FL) have been approved recently by the US Food and Drug Administration including anti-CD19 CAR-T therapies such as axicabtagene ciloleucel (axi-cel) and CD20 × CD3 T-cell-engaging bispecific monoclonal antibodies such as mosunetuzumab (mosun). The objective of this study was to assess the cost-effectiveness of axi-cel compared to mosun in 3L+ r/r FL patients from a US third-party payer perspective. Methods: A three-state (progression-free, progressed disease, and death) partitioned-survival model was used to compare two treatments over a lifetime horizon in a hypothetical cohort of US adults (age ≥18) receiving 3L+ treatment for r/r FL. ZUMA-5 and GO29781 trial data were used to inform progression-free survival (PFS) and overall survival (OS). Mosun survival was modeled via hazard ratios (HRs) applied to axi-cel survival curves. The PFS HR value was estimated via a matching-adjusted indirect comparison (MAIC) based on mosun pseudo-individual patient data and adjusted axi-cel data to account for trial populations differences. One-way sensitivity analysis (OWSA) and probabilistic sensitivity analyses (PSA) were conducted. Scenario analyses included: 1) the mosun HRs were applied to the weighted (adjusted) ZUMA-5 24-month data to most exactly reflect the MAIC, 2) mosun HR values were applied to axi-cel 48-month follow-up data, and 3) recent axi-cel health state utility values in diffuse large B-cell lymphoma patients. Results: The analysis estimated increases of 1.82 LY and 1.89 QALY for axi-cel compared to mosun. PFS for axi-cel patients was 6.42 LY vs. 1.60 LY for mosun. Increase of $257,113 in the progression-free state was driven by one-time axi-cel treatment costs. Total incremental costs for axi-cel were $204,377, resulting in an ICER of $108,307/QALY gained. The OWSA led to ICERs ranging from $240,255 to $75,624, with all but two parameters falling below $150,000/QALY. In the PSA, axi-cel had an 64% probability of being cost-effective across 5,000 iterations using a $150,000 willingness-to-pay threshold. Scenarios one and two resulted in ICERs of $105,353 and $102,695, respectively. Discussion: This study finds that axi-cel is cost-effective compared to mosun at the commonly cited $150,000/QALY US willingness-to-pay threshold, with robust results across a range of sensitivity analyses accounting for parameter uncertainty.
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Productos Biológicos , Análisis Costo-Beneficio , Linfoma Folicular , Humanos , Linfoma Folicular/tratamiento farmacológico , Linfoma Folicular/economía , Linfoma Folicular/mortalidad , Estados Unidos , Productos Biológicos/uso terapéutico , Productos Biológicos/economía , Masculino , Anticuerpos Biespecíficos/uso terapéutico , Anticuerpos Biespecíficos/economía , Femenino , Inmunoterapia Adoptiva/economía , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/economía , Persona de Mediana Edad , Antineoplásicos Inmunológicos/uso terapéutico , Antineoplásicos Inmunológicos/economía , Adulto , Años de Vida Ajustados por Calidad de Vida , Recurrencia Local de Neoplasia/tratamiento farmacológico , AncianoRESUMEN
Aim: Cost-effectiveness analysis (CEA) was performed to compare axicabtagene ciloleucel (axi-cel) with tisagenlecleucel (tisa-cel) and lisocabtagene (liso-cel) for treatment of relapsed or refractory large B-cell lymphoma in adult patients after ≥2 lines of therapy in Japan. Materials & methods: Cost-effectiveness analysis was conducted using the partition survival mixture cure model based on the ZUMA-1 trial and adjusted to the JULIET and TRANSCEND trials using matching-adjusted indirect comparisons. Results & conclusion: Axi-cel was associated with greater incremental life years (3.13 and 2.85) and incremental quality-adjusted life-years (2.65 and 2.24), thus generated lower incremental direct medical costs (-$976.29 [-¥137,657] and -$242.00 [-¥34,122]), compared with tisa-cel and liso-cel. Axi-cel was cost-effective option compared with tisa-cel and liso-cel from a Japanese payer's perspective.
[Box: see text].
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Análisis Costo-Beneficio , Años de Vida Ajustados por Calidad de Vida , Humanos , Japón/epidemiología , Masculino , Femenino , Linfoma de Células B Grandes Difuso/tratamiento farmacológico , Linfoma de Células B Grandes Difuso/economía , Linfoma de Células B Grandes Difuso/mortalidad , Antígenos CD19/economía , Antígenos CD19/inmunología , Antígenos CD19/uso terapéutico , Receptores de Antígenos de Linfocitos T/uso terapéutico , Inmunoterapia Adoptiva/economía , Inmunoterapia Adoptiva/métodos , Persona de Mediana Edad , Adulto , Vacunas contra el Cáncer/economía , Vacunas contra el Cáncer/administración & dosificación , Anciano , Productos Biológicos/economía , Productos Biológicos/uso terapéutico , Análisis de Costo-EfectividadRESUMEN
OBJECTIVES: The results of a recent single-arm trial (ZUMA-5) of axicabtagene ciloleucel (axi-cel) for relapsed/refractory (r/r) follicular lymphoma (FL) demonstrated high rates of durable response and tolerable toxicity among treated patients. To quantify the value of axi-cel compared with standard of care (SOC) to manage r/r FL patients who have had at least 2 prior lines of systemic therapy (3L+), a cost-effectiveness model was developed from a US third-party payer perspective. METHODS: A 3-state partitioned-survival cost-effectiveness model was developed with a lifetime horizon. Patient-level analyses of the 36-month ZUMA-5 (axi-cel) and SCHOLAR-5 (SOC) studies were used to extrapolate progression-free and overall survivals. After 5 years of survival, an estimated 40% of the modeled population was assumed to experience long-term remission based on literature. Results include the incremental cost-effectiveness ratio (ICER) measured as incremental cost per quality-adjusted life year (QALY) gained. One-way sensitivity analysis, probabilistic sensitivity analysis, and scenario analyses were performed. All outcomes were discounted 3% per year. RESULTS: Axi-cel led to an increase of 4.28 life-years, 3.64 QALYs, and a total cost increase of $321 192 relative to SOC, resulting in an ICER of $88 300 per QALY. Across all parameters varied in the one-way sensitivity analysis, the ICER varied between $133 030 and $67 277. In the probabilistic sensitivity analysis, axi-cel had a 99% probability of being cost-effective across 5000 iterations using a $150 000 willingness-to-pay threshold. CONCLUSIONS: Given the robustness of the model results and sensitivity analyses, axi-cel is expected to be a cost-effective treatment in 3L+ r/r FL.
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Análisis Costo-Beneficio , Linfoma Folicular , Años de Vida Ajustados por Calidad de Vida , Humanos , Linfoma Folicular/tratamiento farmacológico , Linfoma Folicular/economía , Linfoma Folicular/mortalidad , Estados Unidos , Productos Biológicos/economía , Productos Biológicos/uso terapéutico , Adulto , Vacunas contra el Cáncer/economía , Vacunas contra el Cáncer/uso terapéutico , Persona de Mediana Edad , Modelos Económicos , Masculino , Femenino , Antígenos CD19/economía , Antígenos CD19/uso terapéuticoRESUMEN
KEY POINTS: In 2021, Medicare spending on biologics was $926 million in Part B (FFS) and $1.3 billion in Part D (FFS/MA). Between 2017 and 2021, annual Medicare spending on biologics increased by approximately 200%. Between 2023 and 2025, Medicare Part D OOP costs for biologics will decrease by an estimated 50%-60%.
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Asma , Productos Biológicos , Pólipos Nasales , Rinitis , Sinusitis , Humanos , Estados Unidos , Sinusitis/economía , Sinusitis/tratamiento farmacológico , Enfermedad Crónica/economía , Asma/economía , Asma/tratamiento farmacológico , Asma/terapia , Pólipos Nasales/economía , Pólipos Nasales/tratamiento farmacológico , Pólipos Nasales/terapia , Rinitis/economía , Rinitis/tratamiento farmacológico , Rinitis/terapia , Productos Biológicos/uso terapéutico , Productos Biológicos/economía , Medicare/economía , Terapia Biológica/economía , Medicare Part D/economía , Gastos en Salud , RinosinusitisRESUMEN
OBJECTIVE(S): Biologics for chronic rhinosinusitis with nasal polyposis (CRSwNP) are an evolving therapeutic option, but there are limited data on physician experiences in prescribing them. The goal of this study was to gain a better understanding of these experiences including prescribing practices, patient factors which guide prescriber decision, and physician and patient-reported issues which might limit cost-effectiveness of these therapies. METHODS: A survey was distributed to attending otolaryngologists using the Canadian Society of Otolaryngology (CSOHNS) email distribution and eSurvey program. Responses were tabulated for the entire cohort and compared between rhinologists and non-rhinologists where appropriate. Frequencies and proportions were expressed as a percentage of total respondents. Fisher's exact test was used for statistical analysis between groups. RESULTS: Seventy-nine total survey responses were recorded representing a response rate of 43%. Significantly more rhinologists reported prescribing biologic medications on their own (100% vs. 50%; p < 0.001) and a higher proportion (1 to 10% vs. <1%) of their patients were on biologics compared with non-rhinologists (p = 0.023). Rhinologists were more likely to consider poor response to medical therapies, need for rescue steroids, and comorbid type 2 conditions in their decision to pursue biologics than non-rhinologists, but they also experienced poorer assistance from patient support programs and less availability to medications. CONCLUSION: Rhinologists are more comfortable with prescribing and managing biologics for CRSwNP compared with non-rhinologist colleagues. Clinicians prescribing biologic medications for CRSwNP should be familiar with guidelines, indications, and potential adverse events. LEVEL OF EVIDENCE: N/A Laryngoscope, 134:3493-3498, 2024.
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Productos Biológicos , Otorrinolaringólogos , Pautas de la Práctica en Medicina , Rinitis , Sinusitis , Humanos , Sinusitis/tratamiento farmacológico , Enfermedad Crónica , Pautas de la Práctica en Medicina/estadística & datos numéricos , Rinitis/tratamiento farmacológico , Productos Biológicos/uso terapéutico , Productos Biológicos/economía , Otorrinolaringólogos/estadística & datos numéricos , Otorrinolaringólogos/economía , Canadá , Encuestas y Cuestionarios , Masculino , Femenino , Otolaringología/estadística & datos numéricos , Pólipos Nasales/tratamiento farmacológico , Pólipos Nasales/complicaciones , RinosinusitisRESUMEN
INTRODUCTION: By reducing treatment costs, biosimilars provide an opportunity to improve accessibility to highly effective drugs. OBJECTIVES: This study aimed to evaluate access to biologic disease-modifying antirheumatic drugs (bDMARDs) and Janus kinase inhibitors (JAKis) among patients with rheumatic musculoskeletal diseases within a 10 year timeframe in Poland. PATIENTS AND METHODS: We performed a retrospective analysis using a nationwide public payer database. RESULTS: By 2022, 11 102, 6602, and 4400 patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) were treated with bDMARDs or JAKis. Peak drug utilization was observed for adalimumab, followed by etanercept and tocilizumab. Within the study timeframe, the estimated access to innovative drugs increased from 0.8%, 1.4%, and 0.8% to 3.2%, 8.7%, and 3.5% for RA, PsA, and axSpA patients, respectively. Affordable tumor necrosis factor inhibitors (TNFis) still predominate among innovative therapeutics, but their market share declined from 87% to 46%. The number of patients treated with other bDMARDs/JAKis almost doubled within the prespecified timeframe. Overall, the average annual treatment cost per patient decreased by 60%, from 7315 EUR to 2886 EUR. Despite recent safety warnings, JAKis appear to be increasingly utilized. Additional analyses regarding the COVID19 pandemic showed impaired access to intravenous therapies, but not subcutaneous or oral formulations. CONCLUSIONS: In Poland, biosimilarsrelated savings improved availability of higherpriced innovative drugs rather than less costly TNFis. Datadriven resource allocation and dedicated policy solutions facilitating access to affordable biologics are recommended.
Asunto(s)
Antirreumáticos , Biosimilares Farmacéuticos , Inhibidores de las Cinasas Janus , Enfermedades Reumáticas , Humanos , Polonia , Biosimilares Farmacéuticos/uso terapéutico , Biosimilares Farmacéuticos/economía , Estudios Retrospectivos , Antirreumáticos/uso terapéutico , Antirreumáticos/economía , Inhibidores de las Cinasas Janus/uso terapéutico , Enfermedades Reumáticas/tratamiento farmacológico , Masculino , Femenino , Persona de Mediana Edad , Productos Biológicos/uso terapéutico , Productos Biológicos/economía , Adulto , Artritis Psoriásica/tratamiento farmacológico , Artritis Reumatoide/tratamiento farmacológico , Etanercept/uso terapéutico , Etanercept/economíaRESUMEN
The new biologics have great potential to help patients with hitherto uncurable diseases. But their exorbitant costs challenges the basis of health care systems based on equity.
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Productos Biológicos , Costos de los Medicamentos , Humanos , Productos Biológicos/economíaRESUMEN
In this work, process models were developed to capture the impact of biomanufacturing costs on a commercial scale and emphasize the way in which facility design and operation must balance meeting product demand while minimizing production costs. Using a scenario-based modeling approach, several facility design strategies were evaluated, including a traditional large stainless-steel facility and a small footprint, portable-on-demand (POD)-based facility. Bioprocessing platforms were compared by estimating their total production costs across different facility types and specifically illustrating how continuous bioprocessing has gained in popularity as a novel and cost-effective approach to manufacture high-quality biopharmaceuticals. The analysis showed how fluctuations in market demand have a dramatic effect on manufacturing costs and plant utilization, with far-reaching implications on the total cost to patients.
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Productos Biológicos , Industria Farmacéutica , Productos Biológicos/economía , Industria Farmacéutica/economíaRESUMEN
Background: Omalizumab has been demonstrated to be effective in treating chronic spontaneous urticaria (CSU) and was FDA approved for this indication in 2014. Previous work has shown that access to injectable biologics varies across US counties. In the present study we evaluate geographic and temporal trends in the utilization of omalizumab in the Medicare population by dermatologists, with its use by allergists and pulmonologists as comparators. Methods: We analyzed year-over-year trends in omalizumab utilization across geographic regions using the Medicare Provider Utilization and Payment Data: Part D files. Results: Utilization of omalizumab by dermatologists increased rapidly after its FDA approval, from 0.08 claims/100,000 enrollees totaling $209/100,000 enrollees in 2014 to 1.45 claims/100,000 enrollees totaling $3115/100,000 enrollees in 2017. Nonetheless, prescribing dermatologists were present in only 2.8% (95% Confidence Interval (CI): 2.0%-3.9%) and 0.2% (95% CI: 0.0%-0.5%) of metropolitan and non-metropolitan counties, respectively, in 2017, demonstrating limited availability, especially in non-metropolitan counties. Similarly, prescribers of any specialty were available in 32.9% (95% CI: 30.2%-35.6%) and 3.8% (95% CI: 3.1%-4.8%) of metropolitan and non-metropolitan counties, respectively, in 2017. Conclusions: Our data suggest that despite increasing omalizumab utilization, there remains a lack of access across many counties, particularly in non-metropolitan regions. Efforts to expand omalizumab prescriber accessibility in these counties may improve outcomes for patients with CSU.
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Productos Biológicos , Costos de los Medicamentos , Omalizumab , Anciano , Productos Biológicos/economía , Productos Biológicos/uso terapéutico , Humanos , Medicare , Omalizumab/economía , Omalizumab/uso terapéutico , Estados Unidos , Urticaria/tratamiento farmacológicoRESUMEN
AIMS: This study evaluated from a US payer perspective the cost-effectiveness of two chimeric antigen receptor T (CAR T) cell therapies, axicabtagene ciloleucel (axi-cel) versus lisocabtagene maraleucel (liso-cel), for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) following two or more systemic therapy lines. METHODS: We developed a 3-state (i.e., pre-progression, post-progression, death) partitioned survival model to estimate patients' lifetime outcomes. Mixture cure models were used for survival extrapolation to account for long-term remission. Survival inputs were based on a matching-adjusted indirect comparison (MAIC) that reweighted the ZUMA-1 population (receiving axi-cel) to match patient characteristics in TRANSCEND-NHL-001 (assessing liso-cel). Costs included apheresis, drug acquisition, and administration for conditioning chemotherapy and CAR T therapies, monitoring, transplant, hospitalization, adverse events, routine care, and terminal care, per published literature and databases. Utilities were derived from ZUMA-1 and literature. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: In the base case, axi-cel was associated with more QALYs (7.76 vs. 5.94) and greater costs overall ($611,440 vs. $597,174) than liso-cel, at $7,843/QALY gained. The incremental costs (+$14,266) were largely driven by higher routine care costs (+$18,596) due to longer survival and hospitalization (+$10,993) but partially offset by reduced costs of CAR T acquisition (â$11,300) and terminal care (â$4,025). Sensitivity analyses consistently suggested robustness of base-case results. LIMITATIONS: This study relied on an MAIC in which trial design differences and unobserved confounders could not be accounted for. Future real-world studies for recently approved CAR T are warranted to validate our results. Due to a lack of data, we assumed equivalent use of transplants and treatment for B-cell aplasia between the two therapies based on clinicians' opinions. CONCLUSIONS: In the US, axi-cel is a potentially cost-effective treatment option compared with liso-cel for adult patients with r/r LBCL after two or more systemic therapy lines.