Physicians’ Preferences for Bone Metastases Drug Therapy in the United States

AbstractObjectiveSeveral characteristics of bone-targeted agents are considered when making treatment decisions. This study evaluated physicians’ therapy preferences for preventing skeletal-related events (SREs) in patients with bone metastases secondary to solid tumors.MethodsA Web-enabled, discrete-choice experiment online survey was conducted among physicians who treated patients with bone metastases and solid tumors in the United States. Respondents chose between pairs of hypothetical medications defined by combinations of six attributes at varying levels for two hypothetical patients. Preference weights for attribute levels were estimated using a random-parameters logit model.ResultsIn total, 200 physicians completed the survey. Their mean age was 52 years, 57% were in practice for more than 15 years, 37% were oncologists, and 65% treated 10 or fewer patients with bone metastases weekly. Out-of-pocket cost to patients was the most important attribute overall. Among clinical outcomes, time to first SRE and risk of renal impairment were the most important attributes. Statistically significant preferences were observed for all attribute levels for time to first SRE, risk of renal impairment, and mode of administration. Predicted choice probability analysis showed that physicians preferred a hypothetical medication with attributes similar to those of denosumab over one with attributes similar to those of zoledronic acid.ConclusionsPhysicians indicated that clinical attributes are important when considering bone-targeting therapy for bone metastases, but consistent with the current health care landscape, patient out-of-pocket cost was the most important. With health care costs being increasingly shifted to patients, physicians require accurate information about co-pays and assistance programs to avoid patients receiving less costly, yet potentially inferior, treatment

A cost-effectiveness analysis of denosumab for the prevention of skeletal-related events in patients with multiple myeloma in the United States of America

Objective: A large, pivotal, phase 3 trial in patients with newly diagnosed multiple myeloma (MM) demonstrated that denosumab, compared with zoledronic acid, was non-inferior for the prevention of skeletal-related events (SREs), extended the observed median progression-free survival (PFS) by 10.7 months, and showed significantly less renal toxicity. The cost-effectiveness of denosumab vs zoledronic acid in MM in the US was assessed from societal and payer perspectives. Methods: The XGEVA Global Economic Model was developed by integrating data from the phase 3 trial comparing the efficacy of denosumab with zoledronic acid for the prevention of SREs in MM. SRE rates were adjusted to reflect the real-world incidence. The model included utility decrements for SREs, administration, serious adverse events (SAEs), and disease progression. Drug, administration, SRE management, SAEs, and anti-MM treatment costs were based on data from published studies. For the societal perspective, the model additionally included SRE-related direct non-medical costs and indirect costs. The net monetary benefit (NMB) was calculated using a willingness-to-pay threshold of US$150,000. One-way deterministic and probabilistic sensitivity analyses were conducted. Results: From a societal perspective, compared with zoledronic acid, the use of denosumab resulted in an incremental cost of US$26,329 and an incremental quality-adjusted life-year (QALY) of 0.2439, translating into a cost per QALY gained of US$107,939 and a NMB of US$10,259 in favor of denosumab. Results were sensitive to SRE rates and PFS parameters. Limitations: Costs were estimated from multiple sources, which varied by tumor type, patient population, country, and other parameters. PFS and overall survival were extrapolated beyond the follow-up of the primary analysis using fitted parametric curves. Conclusion: Denosumab’s efficacy in delaying or preventing SREs, potential to improve PFS, and lack of renal toxicity make it a cost-effective option for the prevention of SREs in MM compared with zoledronic acid

Quality of life during first-line FOLFOX4±panitumumab in RAS wild-type metastatic colorectal carcinoma : results from a randomised controlled trial

Metastatic colorectal cancer is rarely curable. Improving quality of life is therefore a key treatment goal. We report quality of life for patients with RAS wild-type metastatic colorectal cancer in the PRIME study. A randomised phase 3 open-label study of first-line panitumumab+FOLFOX4 vs FOLFOX4 enrolled adults with untreated metastatic colorectal cancer and an Eastern Cooperative Oncology Group performance status of 0-2. This analysis includes patients with wild-type RAS tumours (n=505). Quality of life (prespecified end point) was assessed using the EuroQoL 5-domain health state index and overall health rating in all patients and by early tumour shrinkage status (≥30% reduction in size by week 8; exploratory end point). Differences in quality of life were assessed using analysis of covariance and a mixed-effect piecewise linear model, and were also analysed by skin toxicity severity. There were no statistically significant differences between treatment arms from baseline to progression or to discontinuation. Grade 3+ skin toxicity was reported by 38% of patients receiving panitumumab+FOLFOX4 and 2% receiving FOLFOX4 alone. There were no significant differences in quality of life between patients with grade 0-2 skin toxicity and those with grade 3+ skin toxicity. More patients receiving panitumumab+FOLFOX4 vs FOLFOX4 had early tumour shrinkage (p<.001). In patients with tumour symptoms at baseline, there were statistically significant improvements in quality of life in those with early tumour shrinkage versus those without early tumour shrinkage. Addition of panitumumab to FOLFOX4 in first-line therapy for metastatic colorectal cancer prolongs survival and has no negative effect on overall quality of life compared with FOLFOX4 alone. Specific quality of life assessments for skin toxicity should be included in study designs to better define the direct effect of these adverse events. NCT00364013

Epidémies de grippe : système d'information pour la prise de décision en santé publique

Chaque année en Suisse, la grippe tue et hospitalise des centaines de personnes. L'impact économique national d'une épidémie moyenne de grippe est chiffré à 300 millions CHF. Dans le cas d'une pandémie, il faudrait s'attendre à des répercussions encore plus importantes. Afin d'améliorer les décisions de santé publique et ainsi, augmenter la performance du système de santé vis-à-vis de la grippe, nous avons émis l'hypothèse que ces décisions sont influencées par le système d'information rattaché au système de santé. Nous avons pu effectivement démontrer, à l'échelle du canton de Genève, l'utilité d'un nouveau système d'information afin d'améliorer la performance du système de santé dans le cadre des épidémies de grippe et dans un scénario de pandémie. Nous avons élaboré ce nouveau système d'information en collaborant notamment avec plusieurs experts de la grippe. Ceux-ci nous ont aidé à sélectionner les éléments critiques d'un système d'information face à la pléthore d'information existante

The economic burden associated with skeletal-related events in patients with bone metastases secondary to solid tumors in Belgium.

Abstract Objectives: More than 1.5 million patients worldwide are affected by bone metastases. Patients with bone metastases frequently develop skeletal-related events (SREs, including radiation to bone, non-vertebral fracture, vertebral fracture, surgery to bone, and spinal cord compression) that are associated with high healthcare costs. This study aims to provide an estimate of the cost per SRE in both the inpatient and outpatient settings in Belgian patients with bone metastases secondary to solid tumors (breast, prostate, and lung cancers). Methods: Patients were retrieved from the IMS Hospital Disease database from 2005-2007. Inclusion was based on the International Classification of Diseases and Related Health Problems Version 9 (ICD-9) diagnosis and/or procedure codes covering patients with breast, prostate, or lung cancer with bone metastases who were hospitalized for one or more SREs. All costs were extrapolated to 2010 using progression in hospitalization costs since 2001. Additional outpatient costs resulting from radiation to bone and diagnostic tests performed in ambulatory settings were estimated by combining published unit costs with resource use data obtained from a Delphi panel. Results: The average cost per SRE across solid tumor types based on the weighted average of inpatient and outpatient costs was €2653 for radiation to bone, €5015 for a vertebral fracture, and €7087 for a non-vertebral fracture. Costs were €12,885 and €15,267 for surgery to bone and spinal cord compression, respectively. Limitations: No patient follow-up across calendar years could be done. Also, details regarding the exact anatomic sites of SREs were not always available. Conclusions: SREs add a substantial cost to the management of patients with bone metastases. Avoiding SREs can lead to important cost-savings for the healthcare payer.Journal ArticleSCOPUS: ar.jinfo:eu-repo/semantics/publishe

A real-world study assessing the use of bone-targeted agents and their impact on bone metastases in patients with prostate cancer treated in clinical practice in Europe

Background: Bone metastases (BMs) are common in patients with prostate cancer and can lead to skeletal-related events (SREs), which are associated with increased pain and reduced quality of life (QoL). Bone-targeted agents (BTAs), such as zoledronic acid and denosumab, reduce the incidence of SREs and delay progression of bone pain. Methods: We evaluated the management of BMs and pain in six European countries (Belgium, France, Germany, Italy, Spain and the UK) using the Adelphi Prostate Cancer Disease Specific Programme. Patient-reported outcomes (PROs) were used to assess the impact of BMs on pain and QoL. Results: In total, 358 physicians completed Patient Record Forms, of whom 246 were oncologists and 112 were urologists. Data were collected on 3667 patients with prostate cancer, including 1971 with BMs and 551 with metastases at sites other than bone (non-BMs). PROs were assessed in 573 patients with BMs and 220 with non-BMs. Most patients with BMs (74%) received a BTA and 53% received treatment within 3 months of BM diagnosis. Patients treated by oncologists were more likely than those treated by urologists to receive a BTA (78% vs. 60%) and to have treatment initiated within 3 months of BM diagnosis (56% vs. 43%). For patients who did not receive a BTA, the main reasons for not treating were very recent BM diagnosis and a perceived low risk of bone complications. Data collected by physicians showed that most patients with BMs (97%) were taking analgesics, with 30% receiving strong opioids. Despite this, 70% were currently experiencing bone pain and 28% were experiencing moderate to severe pain. PRO pain measures showed that 70% of patients with BMs were experiencing moderate to extreme pain, suggesting a disparity between pain levels reported by physicians and by patients. Conclusions: Although most patients with BMs receive a BTA, there remain a proportion of patients who are not receiving adequate treatment to prevent SREs or manage pain. Oncologists are more likely to adhere to clinical guidelines than urologists for the prescription of BTAs. Bone pain is common and undertreated. Increasing awareness of SRE prevention and bone pain management might improve patient care.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Bone-targeted agent treatment patterns and the impact of bone metastases on patients with advanced breast cancer in real-world practice in six European countries

Background Bone metastases (BMs) are common in patients with breast cancer and can lead to skeletal-related events (SREs), which are associated with increased pain and reduced quality of life (QoL). Bone-targeted agents (BTAs), like zoledronic acid and denosumab, reduce the incidence of SREs and delay progression of bone pain. Materials and methods We evaluated the management of BMs and pain in six European countries (Belgium, France, Germany, Italy, Spain, and UK) using the Adelphi Breast Cancer Disease Specific Programme, which included a physician survey and patient-reported outcomes (PROs) to assess the impact of BMs on pain and QoL. Results 301 physicians completed patient record forms for 2984 patients with advanced breast cancer; 1408 with BMs and 1136 with metastases at sites other than bone (non-BMs). Most patients with BMs (88%) received a BTA, with 81% receiving treatment during 3 months following BM diagnosis. For those who did not receive a BTA, the main reasons given were: very recent BM diagnosis, perceived low risk of bone complications, and short life expectancy. Most patients with BMs (68%) were experiencing bone pain and, of these, 97% were taking analgesics (including 28% receiving strong opioids). Despite this, moderate to severe pain was reported in 20% of patients who were experiencing pain. PROs were assessed in 766 patients with advanced breast cancer (392 with BMs, 374 with non-BMs). Overall, patients with BMs reported worse pain and QoL outcomes than those with non-BMs, those not receiving a BTA reported worse pain. Conclusion Despite the large proportion of patients receiving BTAs in this study, some patients with BMs are still not receiving early treatment to prevent SREs or to manage pain. Improving physicians’ understanding of the role of BTAs and the importance of early treatment following BM diagnosis has the potential to improve patient care.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Patients’ preferences for bone metastases treatments in France, Germany and the United Kingdom

Results: The most important treatment attributes for patients across all three countries were time until first SRE, annual risk of renal complications and time until pain worsening. For these attributes, better levels of outcomes were significantly preferred to worse levels (p < 0.05). A 120-minutes infusion every 4 weeks was the least preferred mode of administration. Risk of ONJ was judged by patients in the UK and Germany to be the least important attribute.SCOPUS: ar.jinfo:eu-repo/semantics/publishe