Policy, Advocacy, and Economy Abstacts

April 2014, Vol 5, No 3

Cost Considerations for New Oral Therapies for Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated with Docetaxel
Lorie A. Ellis1, R. Scott McKenzie1, Mekre Senbetta1
1Janssen Scientific Affairs, LLC, Horsham, PA

Objective: Abiraterone acetate (AA) and enzalutamide (EN) are two novel oral agents approved for use in docetaxel-treated mCRPC patients. Phase 3 studies in docetaxel-treated mCRPC populations showed median treatment duration of 8 months for AA+prednisone (AA+P)1 and 8.3 months for EN.2 The budgetary impact of these products to payers depends upon real world treatment duration, adherence, and the proportion of patients utilizing each product. This research modeled expected pharmacy costs of AA+P or EN in docetaxel-treated mCRPC patients.

Methods: Pharmacy costs for a 30-day supply of the recommended dosage of AA+P1 ($6,846.36) and EN2 ($7,889.55) were calculated using the following drug wholesale acquisition costs3: AA - $6,836.59 (10/15/13); P- 5mg tablet (West-Ward Inc, $16.28 per 100 units (9/25/13); or $9.77 for a 60 unit, 30-day supply); and EN - $7,889.55 (9/4/13). Costs of 8 or 12 treatment months per patient and for an estimated number of treated patients were modeled. Docetaxel-treated mCRPC population estimates were derived from a dynamic progression model.4

Results: In a 1,000,000 member plan, the model estimated 57 docetaxel-treated mCRPC patients. For a 240 day (approximately 8 month) treatment duration, estimated AA+P cost was $54,770.88 per patient and $63,116.40 per patient for EN, a difference of $8,345.52 per patient. The modeled cost for 360 days of therapy (approximately 12 months) was $82,156.32 per patient for AA+P and $94,674.60 per patient for EN, or a difference of $12,518.28 per patient. The expected budget impact of approximately 8 treatment months in a 1,000,000 member plan with 25% (14) of the estimated 57 docetaxel-treated mCRPC patients receiving AA+P and 25% (14) receiving EN was $766,792.32 (AA+P) or $883,629.60 (EN), a difference of $116,837.28. Based on similar assumptions, the expected budget impact of approximately 12 treatment months was $1,150,188.48 (AA+P) and $1,325,444.40 (EN), a difference of $175,255.92.

Conclusions: In this cost model, treatment of post-docetaxel mCRPC patients with AA+P was less costly than EN when treatment duration, adherence, and number of treated patients were held constant. EN therapy resulted in an additional $116,848.28 and $175,255.92 in plan spending for an 8 or 12 month course of therapy, respectively.


  1. Zytiga® Prescribing Information; Janssen Biotech Inc (2013).
  2. Xtandi® Prescribing Information; Astellas Pharma US, Inc (2012).
  3. Analysource/First Data Bank.
  4. Solo K, et al. Presented at ASCO Annual Meeting, 2011.

Healthcare Resource Utilization (HRU) in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia
Chris Kozma1, Terra Slaton1, Scott McKenzie2, Lorie Ellis2, Brad Schenkel2
1CK Consulting, 2Janssen Scientific Affairs, LLC

Objective: There is a paucity of data regarding healthcare resource utilization (HRU) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). This observational study investigated patient demographics, CLL treatment patterns, and HRU during the six months following treatment initiation for relapsed/refractory CLL.

Methods: This observational analysis was conducted using commercially available U.S. administrative claims data. Inclusion criteria were age ?18 years, relapsed (chemotherapy claims following a 90 day treatment gap after initial therapy) or refractory (claims for additional agents to initial therapy) CLL, and six months eligibility following the first relapsed/refractory chemotherapy date. Exclusion criteria included patients with claims for pregnancy or non-CLL chemotherapies. CLL chemotherapies of interest included alemtuzumab, bendamustine, chlorambucil, cyclophosphamide, cytarabine, doxorubicin, etoposide, fludarabine, lenalidomide, ofatumumab, oxaliplatin, pentostatin, rituximab, vincristine, or combinations. Demographics, CLL chemotherapy treatment patterns and HRU data were summarized using descriptive statistics. HRU patterns based on initial claims from 2005-2012 were analyzed for the six months following relapsed/refractory CLL therapy.

Results: This analysis identified 486 patients with a mean age of 70 (SD 11) years and 62% male. Initial therapy varied; however, 72% of relapsed/refractory CLL therapies consisted of one of the following regimens: rituximab monotherapy, chlorambucil monotherapy, cyclophosphamide-fludarabine-rituximab, and fludarabine-rituximab. Chemotherapy claims were observed during a mean of 2.3 (SD 1.5) months in the six months of follow-up. The HRU analysis identified 17% with claims for white blood cell colony stimulating factors, 12% with claims for red blood cell growth factors, 5% with claims for red blood cell transfusion, and 1% with claims for stem cell transplantation. The mean number of hospitalizations (including patients with no hospitalizations as zeros) was 0.2 (SD 0.5)/patient incurring a mean of 1.3 (SD 4.0) hospital days. In the 85 patients hospitalized, the mean hospital length of stay was 7.7 (SD 6.5) days.

Conclusions: This observational study of 486 CLL patients with relapsed/refractory CLL reported significant HRU in the six months following initiation of therapy for relapsed or refractory disease. These results provide an indicator of CLL disease burden and allow stakeholders to estimate HRU in the six months following therapy initiation for relapsed/refractory disease.

Ibrutinib Therapy for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia: A Budget Impact Analysis from a US Payer Perspective
Senbetta M1, Dandappanavar A2, Schenkel B1, O’Day K2
1Janssen Scientific Affairs, LLC, Horsham, PA
2Xcenda, Palm Harbor, FL

Objective: In 2013, an estimated 15,680 new cases of chronic lymphocytic leukemia (CLL) were diagnosed, and 4,580 attributable deaths occurred in the US.1 Despite improvements in first-line therapy for CLL, a majority of patients eventually develop relapsed/refractory (R/R) disease and are faced with limited therapeutic options.2 Ibrutinib is FDA-approved for the treatment of CLL patients who have received at least one prior therapy. Due to increased health care costs, health plans are interested in the budget impact of new treatments. The purpose of this study was to estimate the budget impact of adding ibrutinib for R/R CLL to a US health plan formulary over a 1-year time horizon.

Methods: A model was developed to evaluate the budget impact of ibrutinib in a hypothetical 1-million member US health plan. Comparators included NCCN-recommended, commonly prescribed regimens for R/R CLL patients, including ofatumumab and lenalidomide monotherapies, and combinations of bendamustine + rituximab, lenalidomide + rituximab, and fludarabine + cyclophosphamide + rituximab. Dosing, administration, mean duration of therapy (DOT), and adverse event (AE) rates were based on package inserts for approved drugs and published literature for other regimens. Drug, administration, and AE costs were considered. The estimated treatment-eligible population was based on epidemiologic data and a database analysis. Market share was estimated for each treatment with and without ibrutinib. The incremental per-treated-member-per-month (PTMPM) and per-member-per-month (PMPM) costs were calculated. One-way sensitivity analysis was performed.

Results: The model estimated a treatment-eligible population of 112 R/R CLL patients in a 1-million member health plan. Based on the comparators and assumptions listed above, the incremental budget impact of adopting ibrutinib for R/R CLL patients for a duration of 12 months is estimated to be $69.00 PTMPM and $0.01 PMPM. The model results were most sensitive to ibrutinib DOT, followed by number of previously treated CLL patients, and proportion of the health plan population ?65 years of age.

Conclusions: The model results indicate that reimbursement of ibrutinib for eligible R/R CLL patients may have a minimal impact on a US health plan budget despite a longer DOT relative to the comparators in the model. This is relevant considering the efficacy and safety benefits of ibrutinib for this orphan disease with high unmet need.


  1. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013;63(1):11-30.
  2. Veliz M, Pinilla-Ibarz J. Treatment of relapsed or refractory chronic lymphocytic leukemia. Cancer Control. 2012;19(1):37-53.

Out-of-Pocket Costs Among Women with Metastatic Breast Cancer
Jacqueline Hall, MSPH1; Marco daCosta DiBonaventura, PhD2; Ronda Copher, PhD1; Claudio Faria, PharmD, MPH1; Rose Lorenzo, BA2
1 Eisai, Inc. Woodcliff Lake, NJ.
2 Kantar Health. New York, NY.

Objectives: Metastatic breast cancer (mBC) accounts for about 4% of all incident breast cancer cases annually. Although a growing number of treatment options are available, many are expensive and can place an out-of-pocket (OOP) cost burden on the patient. The aim of this study was to provide current estimates of the OOP cost burden reported by women with mBC and how these costs vary by demographic factors.

Methods: Data were collected through a cross-sectional Internet survey of 181 women diagnosed with mBC who had prior experience with either a taxane, paclitaxel, or docetaxel. Patients provided demographic, health history, and monthly OOP cost information. Monthly OOP costs were stratified by various demographic factors; ANOVA tests were used to examine significant differences across these variables.

Results: Women had a mean age of 52.24 years (SD=9.11) and 93.92% were non-Hispanic white. Nearly half (47.51%) had annual household incomes greater or equal to $75K; 71.82% were college-educated and 89.50% had private insurance. Mean overall OOP costs in the past month were $302 (SD=$785) for breast cancer treatments, $107 (SD=$200) for physician visits, $27 (SD=$51) for non-breast cancer treatments, and $12 (SD=$27) for non-breast cancer physician visits. There was a significant association between region and monthly OOP breast cancer treatment costs; specifically, women in the Midwest reported the highest costs ($587) compared with costs in other regions (South = $190 to Northeast = $198; p<.05). Although not significant, there was a trend toward higher breast cancer treatment costs among those with a college education ($322 vs. $254), higher incomes ($120 for those with an annual income of <$25K vs. $389 for those with $75K or more), and with private insurance ($317 vs. $244).

Discussion: Breast cancer-related treatment costs comprised the largest share of OOP costs for women with mBC, nearly triple that of breast cancer-related physician visits. Although the overall sample was generally affluent, OOP costs increased as socioeconomic indicator variables increased (e.g., education, income, insurance), potentially suggesting a greater ability and willingness to pay OOP costs among these subgroups.

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