Budget impact analysis of darolutamide for treatment of nonmetastatic castration-resistant prostate cancer

Appukkuttan, Sreevalsa; Farej, Ryan; Miles, LaStella; Purser, Molly; Wen, Lonnie

doi:10.18553/jmcp.2020.20330

Cited by 5 publications

(5 citation statements)

References 13 publications

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“…The main outcomes in this study were mean per-patient costs of all-cause AEs requiring hospitalization. It was assumed that grade ≥ 3 AEs would require hospitalization and that the trials’ grade ≥ 3 AEs resulted in one hospitalization per patient [ 21 ].…”

Section: Methodsmentioning

confidence: 99%

The Hospitalization-Related Costs of Adverse Events for Novel Androgen Receptor Inhibitors in Non-Metastatic Castration-Resistant Prostate Cancer: An Indirect Comparison

et al. 2022

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Introduction Three novel androgen receptor inhibitors are approved in the USA for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC): apalutamide, enzalutamide, and darolutamide. All three therapies have demonstrated prolonged metastasis-free survival in their respective phase III trials, with differing safety profiles. The objective of this study was to compare the mean per-patient costs of all-cause adverse events (AEs) requiring hospitalization between darolutamide versus apalutamide and enzalutamide for nmCRPC in the USA. Methods All-cause grade ≥ 3 AEs with corresponding any-grade AEs reported among at least 10% of patients in any arm of the ARAMIS (darolutamide), SPARTAN (apalutamide), and PROSPER (enzalutamide) trials were selected for inclusion in the primary analyses. After matching-adjusted indirect comparison, AE costs were calculated by multiplying the AE rates from the trials by their respective unit costs of hospitalization taken from the US Healthcare Cost and Utilization Project (HCUP) database. Sensitivity analyses which further included any-grade AEs reported among at least 5% of patients were also performed. Results After reweighting and adjusting for the trials’ placebo arms, the mean per-patient AE costs were $1021 and $387 lower for darolutamide than for apalutamide and enzalutamide, respectively, over the trials’ duration (SPARTAN and PROSPER, 43 months; ARAMIS, 48 months). For darolutamide vs. apalutamide, the largest drivers of the per-patient cost differences were fracture (adjusted difference $416), hypertension ($143), and rash ($219); for darolutamide vs. enzalutamide, they were fatigue not including asthenia ($290) and hypertension including increased blood pressure (i.e., any AE of hypertension or with elevated blood pressure not yet classified as hypertension) ($60). The results of the sensitivity analyses were consistent with the primary results. Conclusions Patients with nmCRPC treated with darolutamide in ARAMIS incurred lower AE-related costs (USD), as determined using HCUP costing data, compared with patients treated with either apalutamide (in SPARTAN) or enzalutamide (in PROSPER). Supplementary Information The online version contains supplementary material available at 10.1007/s12325-022-02245-8.

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Section: Methodsmentioning

confidence: 99%

The Hospitalization-Related Costs of Adverse Events for Novel Androgen Receptor Inhibitors in Non-Metastatic Castration-Resistant Prostate Cancer: An Indirect Comparison

et al. 2022

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“…Most of the included studies originated in the United States (n = 18, 62%) (42-46, 48, 50-59, 64, 66), followed by Italy (n = 2, 7%) (69,70) and one from each of Brazil (60), the Netherlands (62), France (47), Japan (49), Norway (65), Saudi Arabia (61), Spain (63), and Thailand (67), as well as one multi-country study (58). The studies covered 11 types of cancer including non-small-cell lung cancer (n =8, 28%) (43,45,47,54,55,57,62,65), prostate cancer (n =5, 17%) (42,44,48,59,64), colorectal cancer (n = 4, 14%) (60,67,68,70), ovarian cancer (n = 3, 10%) (46,53,63), breast cancer (n = 2, 7%) (56,61), myeloma (n = 2, 7%) (49,58), melanoma (n = 1, 3%) (52), head and neck cancer (n = 1, 3%) (69), cell carcinoma of the urothelium (n = 1, 3%) (50), gastroenteropancreatic neuroendocrine tumor (n = 1, 3%) (66), and epithelial ovarian, fallopian tube or primary peritoneal cancer (n = 1, 3%) (51). Most of the interventions in these studies involved innovative anticancer drugs, including selective poly ADP-ribose polymerase (PARP)-1 and PARP-2 inhibitor (e.g., niraparib) (51,53), epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 tyrosine kinases inhibitor (e.g., afatinib) (55,…”

Section: Systematic Reviewmentioning

confidence: 99%

“…In 10 studies (34%), they assumed a treatment duration based on actual patient treatment durations including days spent receiving therapy, treatment in clinical trials, and prescribed treatment durations (44, 46, 51, 54, 58-60, 64, 68, 70). In six studies (21%), the treatment duration was based on either the drug administration instructions or clinical guidelines (42,47,52,61,65,67). Only one study (3%) based the treatment duration on hospital data (66).…”

Section: Systematic Reviewmentioning

confidence: 99%

“…This incomplete consideration of the scope of costs may generate inaccurate and unrealistic BIAs. For example, Appukkuttan et al (42) aimed to compare the budget impact of the use of darolutamide for the treatment of non-metastatic castration-resistant prostate cancer. Although they emphasized that patients were assumed to continue to be treated with the target drugs until disease progression, they did not include subsequent treatment costs after disease progression, which they noted as a limitation of their study.…”

Section: Main Findingsmentioning

confidence: 99%

“…ContinuedFrontiers in Public Health | www.frontiersin.org provided a clear reason why they considered condition-related costs, while the other 13 (48%) reported condition-related costs directly. For example, Stargardter et al(45) considered condition-related costs because they adopted ISPOR task force recommendations, while Appukkuttan et al(42) considered the costs associated with prostate cancer in the United States without providing any reference framework. In addition, although there were 25 studies considering condition-related costs, only 11 (38%) considered subsequent treatment costs.…”

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confidence: 99%

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Is the Scope of Costs Considered in Budget Impact Analyses for Anticancer Drugs Rational? A Systematic Review and Comparative Study

et al. 2021

Front. Public Health

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Background: With the increasing disease burden of cancer worldwide, more and more anticancer drugs have been approved in many countries, and the results of budget impact analyses (BIAs) have become important evidence for related reimbursement decisions.Objectives: We systematically reviewed whether BIAs for anticancer drugs consider the scope of costs rationally and compared the results of different cost scopes to provide suggestions for future analyses and decision-making.Methods: Eligible BIAs published in PubMed, Embase, Web of Science, and the Cochrane Library from 2016 to 2021 were identified based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We extracted 15 terms from the included studies and analyzed how they considered the scope of costs. In addition, a budget impact model was developed for the introduction of geptanolimab to China's National Reimbursement Drug List to enable a comparison of two cost-scope scenarios.Results: A total of 29 studies were included in the systematic review. All 29 studies considered the costs of anticancer drugs, and 25 (86%) also considered condition-related costs, but only 11 (38%) considered subsequent treatment costs. In the comparative study, the predicted budget impacts from 2022 to 2024 were significantly impacted by subsequent treatment costs, with annual differences between the two cost-scope scenarios of $39,546,664, $65,866,161, and $86,577,386, respectively.Conclusions: The scope of costs considered in some existing BIAs for anticancer drugs are not rational. The variations between different cost scopes in terms of budget impact were significant. Thus, BIAs for anticancer drugs should consider a rational scope of costs that adheres to BIA guidelines. Researchers and decision-makers should pay more attention to the scope of costs to achieve better-quality BIAs for anticancer drugs and enhance reimbursement decision-making.

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Budget Impact of Introducing Fixed-Duration Mosunetuzumab for the Treatment of Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy in the USA

Lin,

Shapouri,

Parisé

et al. 2024

PharmacoEconomics

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Objective This study aimed to assess the budget impact of introducing fixed-duration mosunetuzumab as a treatment option for adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies and to estimate the total cumulative costs per patient in the USA. Methods A 3-year budget impact model was developed for a hypothetical 1-million-member cohort enrolled in a mixed commercial/Medicare health plan. Comparators were: axicabtagene ciloleucel, tisagenlecleucel, tazemetostat, rituximab plus lenalidomide, copanlisib, and older therapies (rituximab or obinutuzumab ± chemotherapy). Costs per patient comprised treatment-associated costs including the drug, its administration, adverse events, and routine care. Dosing and safety data were ascertained from respective package inserts and clinical trial data. Drug costs (March 2023) were estimated based on the average wholesale acquisition cost reported in AnalySource ® , and all other costs were based on published sources and inflated to 2022 US dollars. Market shares were obtained from Genentech internal projections and expert opinion. Budget impact outcomes were presented on a per-member per-month basis. Results Compared with a scenario without mosunetuzumab, its introduction over 3 years resulted in a budget increase of $69,812 (1% increase) and an average per-member per-month budget impact of $0.0019. Among the newer therapies, mosunetuzumab had the second-lowest cumulative per patient cost (mosunetuzumab = $202,039; axicabtagene ciloleucel = $505,845; tisagenlecleucel = $476,293; rituximab plus lenalidomide = $263,520; tazemetostat = $250,665; copanlisib = $127,293) and drug costs, and its introduction only increased total drug costs by 0.1%. By year 3, the cumulative difference in the per patient cost with mosunetuzumab was −$303,805 versus axicabtagene ciloleucel, −$274,254 versus tisagenlecleucel, −$61,481 versus rituximab plus lenalidomide, −$48,625 versus tazemetostat, and $74,747 versus copanlisib. Older therapies were less costly with 3-year cumulative costs that ranged from $36,512 to $147,885. Conclusions Over 3 years, the estimated cumulative per patient cost of mosunetuzumab is lower than most available newer therapies, resulting in a small increase in the budget after its formulary adoption for the treatment of relapsed or refractory follicular lymphoma. Supplementary Information The online version contains supplementary material available at 10.1007/s40273-024-01358-y.

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Budget impact analysis of darolutamide for treatment of nonmetastatic castration-resistant prostate cancer

Cited by 5 publications

References 13 publications

The Hospitalization-Related Costs of Adverse Events for Novel Androgen Receptor Inhibitors in Non-Metastatic Castration-Resistant Prostate Cancer: An Indirect Comparison

The Hospitalization-Related Costs of Adverse Events for Novel Androgen Receptor Inhibitors in Non-Metastatic Castration-Resistant Prostate Cancer: An Indirect Comparison

Is the Scope of Costs Considered in Budget Impact Analyses for Anticancer Drugs Rational? A Systematic Review and Comparative Study

Budget Impact of Introducing Fixed-Duration Mosunetuzumab for the Treatment of Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy in the USA

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