Drugs, cancer and end-of-life care: A case study of pharmaceuticalization?

Davis, Courtney

doi:10.1016/j.socscimed.2014.12.007

Cited by 55 publications

(63 citation statements)

References 88 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The expansion of systemic therapy in this context is a product of complex upstream factors, including patient and provider expectations 29 , and the resulting rising expenditures on systemic therapy drugs is increasing the pressure on public and private providers alike to control costs 18 . However, the implications of the trends with respect to patient outcomes and quality of care are not clear.…”

Section: Discussionmentioning

confidence: 99%

Population-Based Trends in Systemic Therapy Use and Cost for Cancer Patients in the Last Year of Life

et al. 2016

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 99%

Population-Based Trends in Systemic Therapy Use and Cost for Cancer Patients in the Last Year of Life

et al. 2016

View full text Add to dashboard Cite

show abstract

“…These endpoints show that an agent has biological activity, but they are not reliable surrogates for improved survival4 5 6 7 8 9 10 11 or quality of life4 6 11 12 13 in all settings, and two recent systematic reviews suggest that the strength of association between surrogates in cancer clinical trials and life extension is generally low 814 Moreover, there is growing concern that the benefits offered by many new treatments for cancer—often discussed and promoted as “breakthroughs”15 16 17 18—are marginal and might not be clinically meaningful to patients, despite rapidly escalating costs 1920 21 22 23 Consequently, there have been calls to raise the evidence bar for market authorisation of new cancer drugs 15…”

Section: Introductionmentioning

confidence: 99%

“…14 Moreover, there is growing concern that the benefits offered by many new treatments for cancer—often discussed and promoted as “breakthroughs”15 16 17 18—are marginal and might not be clinically meaningful to patients, despite rapidly escalating costs 1920 21 22 23 Consequently, there have been calls to raise the evidence bar for market authorisation of new cancer drugs 1521 23 24 25 26 …”

Section: Introductionmentioning

confidence: 99%

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13

Davis

Naci

Gurpinar

et al. 2017

BMJ

Self Cite

478

415

View full text Add to dashboard Cite

Objective To determine the availability of data on overall survival and quality of life benefits of cancer drugs approved in Europe. Design Retrospective cohort study. Setting Publicly accessible regulatory and scientific reports on cancer approvals by the European Medicines Agency (EMA) from 2009 to 2013. Main outcome measures Pivotal and postmarketing trials of cancer drugs according to their design features (randomisation, crossover, blinding), comparators, and endpoints. Availability and magnitude of benefit on overall survival or quality of life determined at time of approval and after market entry. Validated European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) used to assess the clinical value of the reported gains in published studies of cancer drugs. Results From 2009 to 2013, the EMA approved the use of 48 cancer drugs for 68 indications. Of these, eight indications (12%) were approved on the basis of a single arm study. At the time of market approval, there was significant prolongation of survival in 24 of the 68 (35%). The magnitude of the benefit on overall survival ranged from 1.0 to 5.8 months (median 2.7 months). At the time of market approval, there was an improvement in quality of life in seven of 68 indications (10%). Out of 44 indications for which there was no evidence of a survival gain at the time of market authorisation, in the subsequent postmarketing period there was evidence for extension of life in three (7%) and reported benefit on quality of life in five (11%). Of the 68 cancer indications with EMA approval, and with a median of 5.4 years’ follow-up (minimum 3.3 years, maximum 8.1 years), only 35 (51%) had shown a significant improvement in survival or quality of life, while 33 (49%) remained uncertain. Of 23 indications associated with a survival benefit that could be scored with the ESMO-MCBS tool, the benefit was judged to be clinically meaningful in less than half (11/23, 48%). Conclusions This systematic evaluation of oncology approvals by the EMA in 2009-13 shows that most drugs entered the market without evidence of benefit on survival or quality of life. At a minimum of 3.3 years after market entry, there was still no conclusive evidence that these drugs either extended or improved life for most cancer indications. When there were survival gains over existing treatment options or placebo, they were often marginal.

show abstract

“…surgery or radiotherapy) have been shown to contribute more to relevant outcomes than anti-cancer drug therapy (30), then some of the opportunity costs to which the fund gives rise fall on cancer patients receiving non-drug therapies (31).…”

Section: Evaluation Of Methods For Cost-effectiveness and Prioritisatmentioning

confidence: 99%

“…The pre-eminence of survival may bias cancer treatment, and industry priorities for development, towards drug therapies that extend life by small margins at high cost (32), and away from cancer prevention, early diagnosis, management, and palliative care (31).…”

Section: Evaluation Of Methods For Cost-effectiveness and Prioritisatmentioning

confidence: 99%

Did It Matter That the Cancer Drugs Fund Was Not NICE? A Retrospective Review

2016

View full text Add to dashboard Cite

General rightsThis document is made available in accordance with publisher policies. Please cite only the published version using the reference above. Full terms of use are available: http://www.bristol.ac.uk/pure/about/ebr-terms October 2010 and the introduction of reforms to its structure and operations in July 2016. There has been much more debate about the existence of the fund than about how it spent its substantial budget. It is important to undertake a retrospective examination of "where the money went" in light of the substantial reforms that will be introduced in 2016.Objective: We review the means by which the CDF made recent funding decisions for cancer drugs in order to provide an assessment of the merits of the CDF "model" as a basis for allocation decisions. We assess the extent to which proposed reforms could overcome defects in the original CDF model of prioritisation, and lessons for other countries. Methods:We provide a narrative commentary on the CDF's methods and processes since 2014. We evaluate methods against best practice in cost-effectiveness analysis, and processes against the "accountability for reasonableness" framework.We comment on reforms to the fund.Results: There are no grounds for concluding that the opportunity costs imposed on cancer patients were well evidenced, or the product of legitimate deliberative processes. We note that some of these issues will be addressed in the proposed next incarnation of the fund, but the rationale for the fund's existence remains unconvincing.

show abstract

Drugs, cancer and end-of-life care: A case study of pharmaceuticalization?

Cited by 55 publications

References 88 publications

Population-Based Trends in Systemic Therapy Use and Cost for Cancer Patients in the Last Year of Life

Population-Based Trends in Systemic Therapy Use and Cost for Cancer Patients in the Last Year of Life

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13

Did It Matter That the Cancer Drugs Fund Was Not NICE? A Retrospective Review

Contact Info

Product

Resources

About