title: Budgetary Impact of Cabazitaxel Use After Docetaxel Treatment for Metastatic Castration-Resistant Prostate Cancer.
abstract: BACKGROUND
  With the approval of several new treatments for metastatic castration-resistant prostate cancer (mCRPC), budgetary impact is a concern for health plan decision makers. Budget impact models (BIMs) are becoming a requirement in many countries as part of formulary approval or reimbursement decisions. Cabazitaxel is a second-generation taxane developed to overcome resistance to docetaxel and is approved for the treatment of patients with mCRPC previously treated with a docetaxel-containing regimen.
  
  
  OBJECTIVE
  To estimate a 1-year projected budget impact of varying utilization rates of cabazitaxel as a second-line treatment for mCRPC following docetaxel, using a hypothetical U.S. private managed care plan with 1 million members.
  
  
  METHODS
  A BIM was developed to evaluate costs for currently available treatment options for patients with mCRPC previously treated with docetaxel. Treatments included in the model were cabazitaxel, abiraterone acetate, enzalutamide, and radium-223, with utilization rates derived from market research data. Medication costs were calculated according to published pricing benchmarks factored by dosing and duration of therapy as stated in the prescribing information for each agent. Published rates and costs of grade 3-4 adverse events were also factored into the model. In addition, the model reports budget impact under 2 scenarios. In the first base-case scenario, patient out-of-pocket costs were subtracted from the total cost of treatment. In the second scenario, all treatment costs were assumed to be paid by the plan.
  
  
  RESULTS
  In a hypothetical 1 million-member health plan population, 100 patients were estimated to receive second-line treatment for mCRPC after treatment with docetaxel. Using current utilization rates for the 4 agents of interest, the base-case scenario estimated the cost of second-line treatment after docetaxel to be $6,331,704, or $0.528 per member per month (PMPM). In a scenario where cabazitaxel use increases from the base-rate case of 24% to a hypothetical rate of 33%, the PMPM cost would decrease to $0.524, reflecting a cost saving of $0.004 PMPM and equating to incremental savings of $49,546, or $497 per patient per year (PPPY). In the second scenario, when out-of-pocket costs were not considered, the cost of second-line treatment after docetaxel was estimated as $6,733,594, or $0.561 PMPM. With a hypothetical increase in cabazitaxel use (24%-33%), the PMPM cost would decrease to $0.554, reflecting savings of $0.007 PMPM and equating to incremental savings of $86,136, or $864 PPPY. The primary driver of cost savings with increased cabazitaxel use was lower acquisition cost. One-way sensitivity analyses revealed that the model results were robust over a wide range of input values (utilization, prevalence, and population parameters).
  
  
  CONCLUSIONS
  In the presented BIM, an increase in cabazitaxel use is expected to result in modest cost savings to the health plan. Patient coinsurance savings may also be realized based on applicable Medicare Part B and Part D calculations. This BIM presents an objective, comprehensive, robust, and user-adaptable tool that health plans and medical decision makers may use to evaluate potential economic impact of formulary and reimbursement decisions.
  
  
  BACKGROUND
  Research and analysis were funded by Sanofi US. The sponsor had the opportunity to review the final draft; however, the authors were responsible for all content and editorial decisions. Flannery, Drea, Hudspeth, and Miao are employees of Sanofi. Miao is an owner of stock in Sanofi. Corman, Gao, and Xue are employees of Pharmerit International and served as consultants to Sanofi during this study. All authors contributed to study design and data collection and analysis. The manuscript was written by Flannery, along with the other authors, and revised by all the authors.
authors.affiliation: 1 North America Medical Affairs, Evidence Based Medicine Division, Sanofi US, Bridgewater, New Jersey.
authors.forename: Kyle
authors.initials: K
authors.lastname: Flannery
authors.affiliation: 1 North America Medical Affairs, Evidence Based Medicine Division, Sanofi US, Bridgewater, New Jersey.
authors.forename: Ed
authors.initials: E
authors.lastname: Drea
authors.affiliation: 1 North America Medical Affairs, Evidence Based Medicine Division, Sanofi US, Bridgewater, New Jersey.
authors.forename: Louis
authors.initials: L
authors.lastname: Hudspeth
authors.affiliation: 2 Pharmerit International, Bethesda, Maryland.
authors.forename: Shelby
authors.initials: S
authors.lastname: Corman
authors.affiliation: 2 Pharmerit International, Bethesda, Maryland.
authors.forename: Xin
authors.initials: X
authors.lastname: Gao
authors.affiliation: 2 Pharmerit International, Bethesda, Maryland.
authors.forename: Mei
authors.initials: M
authors.lastname: Xue
authors.affiliation: 1 North America Medical Affairs, Evidence Based Medicine Division, Sanofi US, Bridgewater, New Jersey.
authors.forename: Raymond
authors.initials: R
authors.lastname: Miao
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use; D002017:Budgets; D003198:Computer Simulation; D017046:Cost Savings; D000077143:Docetaxel; D016527:Drug Costs; D064420:Drug-Related Side Effects and Adverse Reactions / Q000191:economics; D017048:Health Care Costs; D006801:Humans; D008297:Male; D008329:Managed Care Programs / Q000191:economics; D018803:Models, Economic; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy / Q000191:economics*; D043823:Taxoids / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; C552428:cabazitaxel