Prescribing Patterns of Oral Antineoplastic Therapies Observed in the Treatment of Patients With Advanced Prostate Cancer Between 2012 and 2014: Results of an Oncology EMR Analysis

Malangone-Monaco, Elisabetta; Foley, Kathleen A.; Varker, Helen; Wilson, Kathleen; McKenzie, Scott; Ellis, Lorie

doi:10.1016/j.clinthera.2016.07.004

Cited by 14 publications

(11 citation statements)

References 14 publications

(15 reference statements)

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“…4,5 AA is currently the most widely prescribed first-line medication for CRPC. 6 In 1 year, there were over 70,000 claims through Medicare Part D alone, 7 and according to the manufacturer, over 100,000 prescriptions for AA have been written in the first 5 years of availability, 8 at a wholesale acquisition cost of approximately $8,000 to $11,000 per month. 9,10…”

Section: Introductionmentioning

confidence: 99%

Prospective International Randomized Phase II Study of Low-Dose Abiraterone With Food Versus Standard Dose Abiraterone In Castration-Resistant Prostate Cancer

Szmulewitz

Peer

Ibraheem

et al. 2018

JCO

151

116

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Purpose Abiraterone acetate (AA) is a standard of care for metastatic castration-resistant prostate cancer (CRPC). Despite a large food effect, AA was administered under fasting conditions in its pivotal trials. We sought to test the hypothesis that low-dose AA (LOW; 250 mg with a low-fat meal) would have comparable activity to standard AA (STD; 1,000 mg fasting) in patients with CRPC. Patients and Methods Patients (n = 72) with progressive CRPC from seven institutions in the United States and Singapore were randomly assigned to STD or LOW. Both arms received prednisone 5 mg twice daily. Prostate-specific antigen (PSA) was assessed monthly, and testosterone/dehydroepiandrosterone sulfate were assessed every 12 weeks with disease burden radiographic assessments. Plasma was collected for drug concentrations. Log change in PSA, as a pharmacodynamic biomarker for efficacy, was the primary end point, using a noninferiority design. Progression-free survival (PFS), PSA response (≥ 50% reduction), change in androgen levels, and pharmacokinetics were secondary end points. Results Thirty-six patients were accrued to both arms. At 12 weeks, there was a greater effect on PSA in the LOW arm (mean log change, -1.59) compared with STD (-1.19), and noninferiority of LOW was established according to predefined criteria. The PSA response rate was 58% in LOW and 50% in STD, and the median PFS was approximately 9 months in both groups. Androgen levels decreased similarly in both arms. Although there was no difference in PSA response or PFS, abiraterone concentrations were higher in STD. Conclusion Low-dose AA (with low-fat breakfast) is noninferior to standard dosing with respect to PSA metrics. Given the pharmacoeconomic implications, these data warrant consideration by prescribers, payers, and patients. Additional studies are indicated to assess the long-term efficacy of this approach.

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Section: Introductionmentioning

confidence: 99%

Prospective International Randomized Phase II Study of Low-Dose Abiraterone With Food Versus Standard Dose Abiraterone In Castration-Resistant Prostate Cancer

Szmulewitz

Peer

Ibraheem

et al. 2018

JCO

151

116

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“…2,5 For the drugs that are in the MPD but are missing in EHR (18%), there is concern regarding the completeness of utilization patterns that are generated based on EHR. 6 A data linkage between EHR and administrative claims would potentially improve the capture of exposures and outcomes and thus produce better quality data that could be used in regulatory decision-making.…”

Section: Discussionmentioning

confidence: 99%

Concordance Between Electronic Health Record Data and Medicare Part D Claims Data for Oral Anticancer Drug Use

et al. 2020

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“…In the sipuleucel-T phase III trial almost 50% of patients chose to forego docetaxel therapy after progressing [3] . A recent study following patients taking enzulutamide or abiraterone as first-line therapy for mCRPC noted less than 20% of patients who progressed took the other drug and less than 10% were treated with docetaxel [29] . Patterns like these would reduce total costs, though have no impact on enhanced survival.…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness analysis of treatments for metastatic castration resistant prostate cancer

Pollard

Moskowitz

Diefenbach

et al. 2017

Asian Journal of Urology

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ObjectiveTreatment options for metastatic castration resistant prostate cancer (mCRPC) have expanded rapidly in recent years. Given the significant economic burden, we sought perform a cost-effectiveness analysis (CEA) of the contemporary treatment paradigm for mCRPC.MethodsWe devised a treatment protocol consisting of sipuleucel-T, enzalutamide, abiraterone, docetaxel, radium-223, and cabazitaxel. We estimated number and length of treatments for each therapy using dosing schedules or progression free survival data from published clinical trials. We estimated treatment cost using billing data and Medicare reimbursement values and performed a CEA. Our analysis assumed US$100,000 per life year saved (LYS) as the threshold societal willingness to pay.ResultsIncremental cost-effectiveness ratios (ICER) for strategies incorporating sipuleucel-T that were not eliminated by extended dominance exceeded the societal threshold willingness-to-pay of US$100,000 per LYS, the lowest of which was sipuleucel-T + enzalutamide + abiraterone + docetaxel at US$207,714 per LYS. Enzalutamide + abiraterone + docetaxel exhibited the most favorable ICER among strategies without sipuleucel-T at US$165,460 per LYS.ConclusionBased on the available survival data and current costs of treatment, all treatment strategies greatly exceed a commonly assumed societal willingness-to-pay threshold of US$100,000 per LYS. Improvements in this regard can only come with a reduction in pricing, better tailoring of treatment or significant enhancements in survival with clinical use of treatment combinations or sequences.

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Prescribing Patterns of Oral Antineoplastic Therapies Observed in the Treatment of Patients With Advanced Prostate Cancer Between 2012 and 2014: Results of an Oncology EMR Analysis

Abstract: This EMR study is among the first to present evidence of US physician practice prescribing patterns regarding initiation of oral antineoplastic agents and use of subsequent therapies in patients with advanced prostate cancer.

Cited by 14 publications

References 14 publications

Prospective International Randomized Phase II Study of Low-Dose Abiraterone With Food Versus Standard Dose Abiraterone In Castration-Resistant Prostate Cancer

Prospective International Randomized Phase II Study of Low-Dose Abiraterone With Food Versus Standard Dose Abiraterone In Castration-Resistant Prostate Cancer

Concordance Between Electronic Health Record Data and Medicare Part D Claims Data for Oral Anticancer Drug Use

Cost-effectiveness analysis of treatments for metastatic castration resistant prostate cancer

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