-
[show abstract]
[hide abstract]
ABSTRACT: BACKGROUND: To estimate the costs (paid amounts) of palliative radiation episodes of care (REOCs) to the bone for patients with bone metastases secondary to breast or prostate cancer. METHODS: Claims-linked medical records from patients at 98 cancer treatment centers in 16 US states were analyzed. Inclusion criteria included a primary neoplasm of breast or prostate cancer with a secondary neoplasm of bone metastases; >=2 visits to >=1 radiation center during the study period (1 July 2008 through 31 December 2009) on or after the metastatic cancer diagnosis date; radiation therapy to >=1 bone site; and >=1 complete REOC as evidenced by a >30-day gap pre- and post-radiation therapy. RESULTS: The total number of REOCs was 220 for 207 breast cancer patients and 233 for 213 prostate cancer patients. In the main analysis (which excluded records with unpopulated costs) the median number of fractions per a REOC for treatment of metastases was 10. Mean total radiation costs (i.e., radiation direct cost + cost of radiation-related procedures and visits) per REOC were $7457 for patients with breast cancer and $7553 for patients with prostate cancer. Results were consistent in sensitivity analyses excluding patients with unpopulated costs. CONCLUSIONS: In the US, current use of radiation therapy for bone metastases is relatively costly and the use of multi-fraction schedules remains prevalent.
Radiation Oncology 10/2012; 7(1):168. · 2.32 Impact Factor
-
Charles S Cleeland,
Jean-Jacques Body,
Alison Stopeck,
Roger von Moos,
Lesley Fallowfield,
Susan D Mathias,
Donald L Patrick,
Mark Clemons,
Katia Tonkin,
Norikazu Masuda,
Allan Lipton,
Richard de Boer,
Stefania Salvagni,
Celia Tosello Oliveira,
Yi Qian,
Qi Jiang,
Roger Dansey,
Ada Braun, Karen Chung
[show abstract]
[hide abstract]
ABSTRACT: BACKGROUND: In this study, the authors evaluated the effect of denosumab versus zoledronic acid (ZA) on pain in patients with advanced breast cancer and bone metastases. METHODS: The prevention of pain, reduction in pain interference with daily life activities, and the proportion of patients requiring strong opioid analgesics were assessed in a randomized, double-blind, double-dummy phase 3 study comparing denosumab with ZA for preventing skeletal-related events in 2046 patients who had breast cancer and bone metastases. Patients completed the Brief Pain Inventory-Short Form at baseline and monthly thereafter. RESULTS: Fewer patients who received denosumab reported a clinically meaningful worsening of pain severity (≥2-point increase) from baseline compared with patients who received ZA, and a trend was observed toward delayed time to pain worsening with denosumab versus ZA (denosumab, 8.5 months; ZA, 7.4 months; P = .08). In patients who had no/mild pain at baseline, a 4-month delay in progression to moderate/severe pain was observed with denosumab compared with ZA (9.7 months vs 5.8 months; P = .002). Denosumab delayed the time to increased pain interference by approximately 1 month compared with ZA (denosumab, 16.0 months; ZA, 14.9 months; P = .09). The time to pain improvement (P = .72) and the time to decreased pain interference (P = .92) were similar between the groups. Fewer denosumab-treated patients reported increased analgesic use from no/low use at baseline to strong opioid use. CONCLUSIONS: Denosumab demonstrated improved pain prevention and comparable pain palliation compared with ZA. In addition, fewer denosumab-treated patients shifted to strong opioid analgesic use. Cancer 2012. © 2012 American Cancer Society.
Cancer 09/2012; · 4.77 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: To evaluate a cohort of United States-based urology practices for patterns related to screening, diagnosis, and treatment of bone metastases in men with castration-resistant prostate cancer.
Chart audits at 15 community-based urology group practices were conducted in the United States. Patient charts were eligible for study inclusion and review if they had documented bone metastasis secondary to castration-resistant prostate cancer. Data abstracted include site and patient demographics, diagnosis patterns, and bone metastases treatment between July 2006 and July 2009. A sample of approximately 10 charts per practice was used, starting with the most recent patient who met eligibility requirements.
Eligible patients (n = 147) from 15 practices had a mean (SD) age of 67.8 (9.3) years at prostate cancer diagnosis and 72.5 (8.6) years at diagnosis of bone metastasis. Bone metastasis occurred 31.3 months (median) after cancer diagnosis. Seventy-three percent (n = 108) of patients had multiple bone metastases, and 82% (n = 120) had bone metastases in weight-bearing bones at last follow-up. Intravenous bisphosphonates were administered to 49% (72/147) of patients, with 97% (70/72) receiving zoledronic acid.
Among patients with castration-resistant prostate cancer and documented bone metastases, approximately one half received intravenous zoledronic acid. This suggests that the other half of patients with bone metastases from prostate cancer remained undertreated for the prevention of skeletal complications based on National Comprehensive Cancer Network guidelines during the study time period.
Urology 06/2012; 80(2):293-8. · 2.43 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: With increasing healthcare resource constraints, it has become important to understand the incremental cost-effectiveness of new medicines. Subcutaneous denosumab is superior to intravenous zoledronic acid (ZA) for the prevention of skeletal-related events (SREs) in patients with advanced solid tumors and bone metastases. This study sought to determine the lifetime cost-effectiveness of denosumab vs ZA in this setting, from a US managed-care perspective.
A lifetime Markov model was developed, with relative rate reductions in SREs for denosumab vs ZA derived from three pivotal Phase 3 trials involving patients with castration-resistant prostate cancer (CRPC), breast cancer, and non-small-cell lung cancer (NSCLC), and bone metastases. The real-world SRE rates in ZA-treated patients were derived from a large commercial database. SRE and treatment administration quality-adjusted life year (QALY) decrements were estimated with time-trade-off studies. SRE costs were estimated from a nationally representative commercial claims database. Drug, drug administration, and renal monitoring costs were included. Costs and QALYs were discounted at 3% annually. One-way and probabilistic sensitivity analyses were conducted.
Across tumor types, denosumab was associated with a reduced number of SREs, increased QALYs, and increased lifetime total costs vs ZA. The costs per QALY gained for denosumab vs ZA in CRPC, breast cancer, and NSCLC were $49,405, $78,915, and $67,931, respectively, commonly considered good value in the US. Costs per SRE avoided were $8567, $13,557, and $10,513, respectively. Results were sensitive to drug costs and SRE rates.
Differences in pain severity and analgesic use favoring denosumab over ZA were not captured. Mortality was extrapolated from fitted generalized gamma function beyond the trial duration.
Denosumab is a cost-effective treatment option for the prevention of SREs in patients with advanced solid tumors and bone metastases compared to ZA. The overall value of denosumab is based on superior efficacy, favorable safety, and more efficient administration.
Journal of Medical Economics 03/2012; 15(4):712-23.
-
[show abstract]
[hide abstract]
ABSTRACT: Intravenous (IV) zoledronic acid (ZA) is commonly used to delay skeletal complications secondary to bone metastases. However, the time associated with ZA administration may represent a significant burden to healthcare providers and patients. This study assessed the time associated with IV ZA infusion in patients with bone metastases secondary to breast or prostate cancer (BC or PC) in the clinic setting.
Eligible BC or PC patients with bone metastases scheduled to receive IV ZA were observed at seven US-based oncology clinics. Trained observers recorded the time for preinfusion tasks, ZA drug preparation, intravenous infusion, and follow-up activities.
Data are reported for 39 patients (BC: 24; PC: 15). Mean administration time was 69 (standard deviation [SD] 42) minutes for all patients combined, 72 (SD 47) minutes for BC, and 65 (SD 33) minutes for PC. Activity times were comparable between tumor types. Mean time for preinfusion tasks (eg, assessment of vital signs, blood draw) and ZA preparation were 12 (SD 20) minutes and 2 (SD 1) minutes, respectively. Mean time required for intravenous infusion (ZA infusion and hydration, when provided) and follow-up activities were 54 (SD 31) minutes and 2 (SD 1) minutes, respectively.
Infusion time was the greatest time commitment associated with IV ZA administration, representing 78% of the total time on average. Time for preinfusion activities varied substantially. Overall, the mean time for ZA administration represents a notable time burden for healthcare providers and patients.
Cancer Management and Research 01/2012; 4:55-60.
-
[show abstract]
[hide abstract]
ABSTRACT: Background: Although cost utility models are often used to estimate the value of treatments for metastatic cancer, limited information is available on the utility of common treatment modalities. Bisphosphonate treatment for bone metastases (BM) is frequently administered via intravenous (IV) infusion, while a recently approved treatment to prevent skeletal-related events (SREs) of BM is administered as a subcutaneous (SC) injection. This study estimated the impact of these treatment modalities on health state (HS) preference. Methods: Participants from the UK general population completed time trade-off interviews to assess the utility of HS vignettes. Respondents first rated a HS representing cancer with BM. Subsequent HSs added descriptions of treatment modalities (ie, injection or infusion) to this basic HS. To represent a range of possible treatment experiences, the two treatment modalities were presented with and without chemotherapy (chemotx), and infusion characteristics were varied by duration (30 minutes or 2 hours) and renal monitoring. Results: A total of 121 participants completed the interviews (47.9% male, 76.9% white). Cancer with BM had a mean utility of 0.40 on a standard utility scale (1 = full health; 0 = death). Adding an injection resulted in a mean utility decrease (ie, disutility) of -0.004. The 30 minute and 2 hour infusions had mean disutilities of -0.02 and -0.04, respectively. Mean disutility of the 30 minute infusion was greater with renal monitoring (-0.05 with same-day blood draw; -0.07 with blood draw 2 days prior). Chemotx was associated with substantial disutility (-0.17). For the HS of BM with chemotx, the mean disutilities of injection, 30 minute infusion, and 2 hour infusion, were -0.02, -0.03, and -0.04, respectively. Disutility associated with injection was significantly smaller than the disutility of both the 30 minute and 2 hour infusions (p < 0.05), regardless of chemotx status. Conclusions: Respondents perceived an inconvenience with each type of BM treatment, but injections were preferred over infusions. The resulting utilities may be used in cost utility models examining the value of treatments for the prevention of SREs in patients with BM.
ASCO; 01/2012
-
[show abstract]
[hide abstract]
ABSTRACT: Patients with bone metastasis secondary to prostate or breast cancer or multiple myeloma are predisposed to skeletal-related events (SREs), such as surgery or radiation to the bone, pathologic fracture, and spinal cord compression. Inpatient costs of these and other SREs represent an estimated 49%-59% of total costs related to SREs. However, information on payer costs for hospitalizations associated with SREs is limited, especially for costs associated with specific SREs by tumor type.
To examine costs from a payer perspective for SRE-associated hospitalizations among patients with multiple myeloma or bone metastasis secondary to prostate or breast cancer.
Patients with SRE hospitalizations were selected from the MarketScan commercial and Medicare databases (January 1, 2003, through June 30, 2009). Sampled patients had at least 2 medical claims with primary or secondary ICD-9-CM diagnosis codes for prostate cancer, breast cancer, or multiple myeloma and at least 1 subsequent hospitalization with principal diagnosis or procedure codes indicating bone surgery, pathologic fracture, or spinal cord compression. For patients with prostate cancer or breast cancer, a diagnosis code for bone metastasis was also required. If secondary diagnoses or procedure codes for SREs were present in the claim, they were used to more precisely identify the type of SRE for which the patient was treated, resulting in 3 mutually exclusive categories: spinal cord compression with or without pathologic fracture and/or surgery to the bone; pathologic fracture with or without surgery to the bone; and only surgery to the bone. Related readmissions within 30 days of a previous SRE-associated hospitalization date of discharge were excluded to minimize the risk of underestimating costs. Mean health plan payments per hospitalization, measured as net reimbursed amounts paid by the health plan to a hospital after subtracting patient copayments and deductibles, were analyzed by cancer type and type of SRE.
A total of 555 patients contributed 572 hospitalizations that met the study criteria for prostate cancer, 1,413 patients contributed 1,542 hospitalizations for breast cancer, and 1,361 patients contributed 1,495 hospitalizations for multiple myeloma. The mean age range was 61 to 72 years, and the mean length of stay per admission was 5.9 to 11.6 days across the 3 tumor types. The ranges of mean health plan payment per hospital admission across tumor types were $43,691-$59,854 for spinal cord compression, with or without pathologic fracture and/or surgery to the bone; $22,390-$26,936 for pathologic fracture without spinal cord compression, with or without surgery to the bone; and $31,016-$42,094 for surgery to the bone without pathologic fracture or spinal cord compression.
The inpatient costs associated with treating SREs are significant from a payer perspective. Our study used a systematic process for patient selection and mutually exclusive categorization by SRE type and provides a per episode estimate of the inpatient financial impact of cancer related SREs assessed in this study from a third-party payer perspective.
Journal of managed care pharmacy: JMCP 11/2010; 16(9):693-702. · 2.25 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: The Brief Pain Inventory-Short Form (BPI-SF) is widely used for assessing pain in clinical and research studies. The worst pain rating is often the primary outcome of interest; yet, no published data are available on its minimally important difference (MID). Breast cancer patients with bone metastases enrolled in a randomized, double-blind, phase III study comparing denosumab with zoledronic acid for preventing skeletal related events and completed the BPI-SF, FACT-B, and EQ-5 Datbaseline, week 5, and monthly through the end of the study. Anchor-and distribution-based MID estimates were computed. Data from 1,564 patients were available. Spearman correlation coefficients for anchors ranged from 0.33-0.65. Mean change scores for worst pain ratings corresponding to one-category improvement in each anchor were 0.26-1.04 for BPI-SF current pain, -1.40 to -2.42 for EQ-5D Index score, 1.71-1.98 for EQ-5D Pain item, -2.22 to -0.51 for FACT-BTOI, -1.61 to -0.16 for FACT-G Physical, and -1.31 to -0.12 for FACT-G total. Distribution-based results were ISEM = 1.6, 0.5 effect size = 1.4, and Guyatt's statistic = 1.4. Combining anchor-and distribution-based results yielded a two-point MID estimate. An MID estimate of two points is useful for interpreting how much change in worst pain is considered clinically meaningful.
The journal of supportive oncology 9(2):72-8.
