Five Years of Cancer Drug Approvals

Mailankody, Sham; Prasad, Vinay

doi:10.1001/jamaoncol.2015.0373

Cited by 262 publications

(133 citation statements)

References 4 publications

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“…Most new drugs offer little new besides higher cost,2675152535455 while firms often extend market exclusivity through trivial modifications and secondary patenting 5657…”

Section: Preclinical Drug Developmentmentioning

confidence: 99%

“…Yet the pharmaceutical systems of the United States and Canada are mired in dysfunction. The industry’s pricing practices—charging whatever the market will bear, especially in the US—strain budgets and put vital medicines out of reach for many patients 1234. Despite some notable advances, the industry’s overall rate of real innovation remains incommensurate with our vast drug spending; many new drugs are marketed each year but few represent substantial clinical improvements 567.…”

mentioning

confidence: 99%

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Healing an ailing pharmaceutical system: prescription for reform for United States and Canada

Gaffney

Lexchin

2018

BMJ

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“…Most new drugs offer little new besides higher cost,2675152535455 while firms often extend market exclusivity through trivial modifications and secondary patenting 5657…”

Section: Preclinical Drug Developmentmentioning

confidence: 99%

mentioning

confidence: 99%

Healing an ailing pharmaceutical system: prescription for reform for United States and Canada

Gaffney

Lexchin

2018

BMJ

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“…They mainly have narrow indications in relation with the expression of the target in a particular type of cancer (often a rare or an orphan indication) and regarding enzyme inhibitors they are mostly used orally as a single agent-therapy. Targeted therapies are very expensive (around 120000$/year in the United States) [6] when compared with previous agents or medications of others therapeutic classes and according to the country, their access to patients may be hindered by funding difficulties or partial covering.…”

Section: Targeted Therapiesmentioning

confidence: 99%

Off-label use of targeted therapies in oncology

Levêque

2016

WJCO

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Off-label use is defined by the prescription of a marketed drug outside the conditions described in the summary of product characteristics. In oncology, off-label prescribing of targeted therapies may occur in patients with other tumor types expressing the same target. Agents associated to phenotypic approaches such as therapies against the tumoral vasculature (anti-angiogenic drugs) and new immunotherapies (checkpoint inhibitors) also carry the potential of alternative indications or combinations. Off-label use of targeted therapies is little documented and appears to be in the same range than that regarding older drugs with wide variations among agents. When compared with older agents, off-label use of targeted therapies is probably more rational through tumoral genotyping but is faced with a limited clinical support, reimbursement challenges related to the very high pricing and the cost of genotyping or molecular profiling, when applicable. Core tip: Off-label use is defined by the prescription of a marketed drug outside the conditions described in the summary of product characteristics. This review is the first one focussing on the off-label use of targeted therapies in oncology. When compared with older agents, off-label use of targeted therapies is probably more rational through tumoral genotyping but is faced with a limited clinical support, reimbursement challenges related to the very high pricing and the cost of genotyping or molecular profiling, when applicable.Levêque D. Off-label use of targeted therapies in oncology.

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“…In analysing 51 cancer drug approvals in the US between 2009 and 2013, Mailankody and Prasad [36] have suggested that initial and on-going pricing is not based upon the costs associated with the research and development of these novel medicines, but is instead a reflection of free market economics, i.e. the willingness to pay.…”

Section: Cost Pricing and Value: A Triple-edged Swordmentioning

confidence: 99%

Shooting for the Moon or Flying Too Near the Sun? Crossing the Value Rubicon in Precision Cancer Care

Lawler¹,

French

Henderson³

et al. 2016

Public Health Genomics

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In his last two State of the Union addresses, President Barack Obama has focused on the need to deliver innovative solutions to improve human health, through the Precision Medicine Initiative in 2015 and the recently announced Cancer Moonshot in 2016. Precision cancer care has delivered clear patient benefit, but even for high-impact medicines such as imatinib mesylate (Glivec) in chronic myeloid leukaemia, the excitement at the success of this practice-changing clinical intervention has been somewhat tempered by the escalating price of this ‘poster child' for precision cancer medicine (PCM). Recent studies on the costs of cancer drugs have revealed significant price differentials, which are a major causative factor behind disparities in the access to new generations of immunological and molecularly targeted agents. In this perspective, we will discuss the benefits of PCM to modern cancer control, but also emphasise how increasing costs are rendering the current approaches to integrating the paradigm of PCM unsustainable. Despite the ever increasing pressure on cancer and health care budgets, innovation will and must continue. Value-based frameworks offer one of the most rational approaches for policymakers committed to improving cancer outcomes through a public health approach.

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Five Years of Cancer Drug Approvals

Cited by 262 publications

References 4 publications

Healing an ailing pharmaceutical system: prescription for reform for United States and Canada

Healing an ailing pharmaceutical system: prescription for reform for United States and Canada

Off-label use of targeted therapies in oncology

Shooting for the Moon or Flying Too Near the Sun? Crossing the Value Rubicon in Precision Cancer Care

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