The Costs of Caring: Who Pays? Who Profits? Who Panders?

Fleck, Leonard M.

doi:10.1353/hcr.2006.0040

Cited by 50 publications

(29 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Blood samples for PK analysis were taken on days 1 (predose then 1.5, 3, 6 and 12 h after infusion start), 2 (24 h after infusion start), 3,5,8,15,22,29,50 and 71. Noncompartmental trastuzumab serum PK parameters were b Safety population: all randomised subjects who received a complete or partial dose of either CT-P6 or reference trastuzumab.…”

Section: Primary Endpointsmentioning

confidence: 99%

“…The use of biological therapies has advanced cancer treatment but also significantly increased treatment costs, with, for example, one course of reference trastuzumab costing approximately US $70,000 [22]. When considered alongside increasing cancer prevalence, particularly in developing nations, and a growing and ageing global population, this financial burden to healthcare systems may soon reach unsustainable levels [23,24].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab

Esteva¹,

Stebbing

Wood-Horrall³

et al. 2018

Cancer Chemother Pharmacol

View full text Add to dashboard Cite

Purpose Access to trastuzumab, a valuable anti-cancer treatment, can be limited by cost. The primary aim of this study was to evaluate and compare the PK profiles of CT-P6, a biosimilar of trastuzumab, and US-licensed reference trastuzumab (Herceptin ® ) in healthy subjects. Secondary study aims included comparison of the safety and immunogenicity of CT-P6 and reference trastuzumab in these subjects. Methods We performed a single-dose, randomised, double-blind, parallel group study (NCT02665637) comparing CT-P6 with reference trastuzumab (6 mg/kg, 90 min intravenous infusion) in 70 healthy adult males. Pharmacokinetics, safety and immunogenicity were evaluated up to 10 weeks post-dose. Primary endpoints were area under the serum concentration-time curve (AUC) from time 0 to infinity (AUC inf ); AUC from time 0 to last quantifiable concentration (AUC last ); and observed maximum serum concentration (C max ). The pre-determined equivalence criterion was a 90% confidence interval of 80-125% for ratios of geometric least squares (LS) means. Results Equivalence of CT-P6 and reference trastuzumab was demonstrated. Ratios (CT-P6/reference trastuzumab) of geometric LS means (90% confidence interval) were: AUC inf 99.05 (93.00, 105.51); AUC last 99.30 (92.85, 106.20); C max 96.58 (90.93, 102.59). Safety profiles were similar; treatment-emergent adverse events occurred in ten subjects (28.6%) in the CT-P6 group and 11 (31.4%) in the reference trastuzumab group. No serious adverse events or deaths occurred. No subjects tested positive for anti-drug antibodies. Conclusions These data add to the totality of evidence required to demonstrate biosimilarity. A phase III study of CT-P6-in which equivalent neoadjuvant efficacy to reference trastuzumab has been demonstrated-is ongoing.

show abstract

Section: Primary Endpointsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab

Esteva¹,

Stebbing

Wood-Horrall³

et al. 2018

Cancer Chemother Pharmacol

View full text Add to dashboard Cite

show abstract

“…This discrimination by diagnosis raises important issues of distributive justice. Social justice is also challenged by policies that enable for-profit hemodialysis vendors to cherry pick patients to maximize profits from public funds (77). With bundling of care, previous incentives to offer hemodialysis to as many patients as possible will be replaced with a disincentive to dialyze high-risk patients.…”

Section: Justice Challenges During Times Of Changementioning

confidence: 99%

The Ethics of Chronic Dialysis for the Older Patient

Thorsteinsdottir

Swetz

Albright³

2015

Clinical Journal of the American Society of Nephrology

View full text Add to dashboard Cite

Recent research highlights the potential burdens of hemodialysis for older patients with significant comorbidities, for whom there is clinical equipoise regarding the net benefits. With the advent of accountable care and bundled payment, previous incentives to offer hemodialysis to as many patients as possible are being replaced with a disincentive to dialyze high-risk patients. While this may offset the harm of overtreatment for some elderly patients, some voice concerns that the pendulum will swing too far back, with a return to ageist rationing of hemodialysis. Nephrologists should ensure that the patient's rights to be informed about the potential benefits and burdens of hemodialysis are respected, particularly because age, functional status, nutritional status, and comorbidities affect the net balance between benefits and burdens. Nephrologists are also called on to help patients make a decision, for which the patient's goals of care guide determination of potential benefit from hemodialysis. This article addresses concerns about present overtreatment and future risk of undertreatment of older adults with ESRD. It also discusses ways in which providers can ethically approach the question of initiation of hemodialysis in the elderly patient by including patient-specific estimates of prognosis, shared decision-making, and the use of specialist palliative care clinicians or ethics consultants for complex cases.

show abstract

“…Therefore, all potential patients for treatment with trastuzumab, but especially those with prior anthracycline and cyclophosphamide exposure, should undergo baseline cardiac assessment and a careful risk-benefit assessment should be made before deciding to treat with trastuzumab [23]. At last, significantly high annual costs for trastuzumab treatment which could reach up to 70,000 USD, should be taken into consideration [24].…”

Section: Trastuzumabmentioning

confidence: 99%

Targeted therapy and its availability in Serbia

Kovacevic¹,

Rančić²,

Tarabar³

et al. 2014

Hosp Pharm Int Multi J

View full text Add to dashboard Cite

SUMMARYTargeted therapy has made a significant breakthrough for the treatment of different kind of severe diseases, mostly oncological and autoimmune ones. Biological or biotech products, as well as small synthetic molecules, like family of tyrosine kinase inhibitors, have already expressed their efficacy in several important indications. Their availability on the market and reimbursement possibility is of great importance, especially for the patients needed to be on lifelong therapies. Targeted therapy enhanced progression free and overall survival in many conditions, but also a number of these therapies produced important and severe side effects. Considering the fact that targeted therapy is on the global market relatively shortly, there is necessity for prolonged therapy monitoring: for further effectiveness assessment, for safety profile and long term health consequences establishment. Reimbursed targeted therapy proved its benefits that overweight risks, but still remains extremely high costs problem for its application. For an upper middle income country like Serbia, with significantly lower health care expenditures per capita than in other well developed countries, the availability of this expensive therapy is not yet gratifying.

show abstract

The Costs of Caring: Who Pays? Who Profits? Who Panders?

Cited by 50 publications

References 17 publications

A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab

A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab

The Ethics of Chronic Dialysis for the Older Patient

Targeted therapy and its availability in Serbia

Contact Info

Product

Resources

About