Rewarding Value Creation to Promote Innovation in Oncology: The Importance of Considering the Global Product Life Cycle

Garrison, Louis P.

doi:10.1634/theoncologist.2010-s1-49

Cited by 27 publications

(15 citation statements)

References 22 publications

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“…This has resulted in an Increased in cost-sharing (i.e. the portion of a drug price paid by the patient) to 20-25%, resulting and an increased price sensitivity from patients and oncologists (Light & Kantarjian 2013;Garrison 2010). Brock (2010) and Danzon & Taylor (2010) warn of the possible financial risks of such measures for patients, when products are costly, coupled with lower access to appropriate therapies.…”

Section: Insurance Ethics Shortages and Counterfeitsmentioning

confidence: 99%

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Emerging product-process archetypes in oncology: informing the sustainable provision of next-generation medicines

Harrington

Srai

Najim

2018

IJHTM

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The emergence of more targeted molecular therapies has contributed to accelerated growth within the oncology market. Projected to become the leading therapeutic area by 2017, forecast spends are expected to be in the range of $74-84 billion. Coupled with its many specificities around pricing, insurance implications, and ethics, we argue that the oncology segment may best inform future pharmaceutical value network design characteristics-in supporting the sustainable manufacture and supply of next-generation medicines. Through exploration of future state scenarios and opportunities areas, driven by the adoption of emerging process and digital technologies, a base framework is extended to enable a systematic assessment of a series of candidates representative of the wider oncology market. These include niche, low volume drugs on-patent with high QALYs (quality-adjusted life years), through to higher volume generics with a history of supply shortages. A series of emerging product-process 'archetypes' in oncology are proposed-classified as 'New Niche', 'Old Niche' and 'Established Generics'-with associated models for reconfiguration, based on the clustering of potential supply benefits. A key application of this systems approach is the potential of informing economies of drug 'repurposing', through its extension from commercial to drug discovery, development and clinical trial contexts, and in matching emerging process capabilities to future adaptive supply requirements-for the sustainable provision of next-generation medicines.

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Section: Insurance Ethics Shortages and Counterfeitsmentioning

confidence: 99%

“…This results in many ethical issues, which ultimately lead to the development and refinement of a set of methods broadly known as "Cost-Effectiveness Analysis" (Garrison 2010), which involves e.g.…”

Section: Insurance Ethics Shortages and Counterfeitsmentioning

confidence: 99%

Emerging product-process archetypes in oncology: informing the sustainable provision of next-generation medicines

Harrington

Srai

Najim

2018

IJHTM

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“…The primary measurement tool in cost effectiveness is the "incremental cost-effectiveness ratio" (ICER) -the ratio of incremental cost of a new intervention versus the standard of care (the numerator) over the incremental health benefits (the denominator). (Garrison, 2010, Sullivan et al, 2011. The denominator is measured by the "quality-adjusted" life-year (QALY) or "utility.…”

Section: Cost Effectiveness and Cermentioning

confidence: 99%

“…Garrison Jr, (2010) stresses the need to develop new approaches and tools that take in to consideration the entire product life cycle on a global basis.…”

Section: Cost Effectiveness and Cermentioning

confidence: 99%

Restraining High and Rising Cancer Drug Prices: Need for Accelerating R&D Productivity and Aligning Prices with Value

Bhardwaj¹

2015

PCBR

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“…Thus, there is a connection -albeit a complex one -between the costs and incentives for producing new knowledge in the form of medicines and how we finance R&D through patents and country-specific reimbursement schemes. [4] The FCC on CER provided the following definition in its 2009 report: [1] ''Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in 'real world' settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.''…”

Section: Comparative Effectiveness Research (Cer) and Benefit-risk Asmentioning

confidence: 99%

Regulatory Benefit-Risk Assessment and Comparative Effectiveness Research

Garrison

2010

PharmacoEconomics

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Over the past 5 years, we have witnessed growing interest in both comparative effectiveness research (CER) and regulatory benefit-risk assessment (BRA). Both deal with benefits and harms, although at different stages of the product lifecycle. There are growing pressures for a more systematic and quantitative approach to regulatory BRA. However, there is also a need for CER - beyond the evidence that can reasonably be generated during pre-launch product development. Important regulatory and policy questions include the following: What would be a level playing field across disease areas and companies? Who should bear the costs of these studies? What role can benefit-risk modelling play? What is the value of research and how is it related to the prevalence of disease? What is the relationship between uncertainty and the value of evidence? We need to recognize the lifecycle nature of evidence generation, moving from the regulatory setting to the real world and affecting potentially hundreds of thousands, or even millions, of patients worldwide. We need to emphasize not only the public goods nature of information embedded in innovations, but also that it is global. Finally, we need to more systematically explore the benefits and costs of gathering further information - the value of research - recognizing that doing this requires a model or methodology, which we have, for systematically appraising our current state of knowledge and what could be gained from further research. All said, it would seem that BRA and CER should be neither strangers nor strange bedfellows, but may need to be coaxed into being bedfellows.

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Rewarding Value Creation to Promote Innovation in Oncology: The Importance of Considering the Global Product Life Cycle

Abstract: This discussion highlights the linkage between the concept of economic value in cancer care and the incentives for innovation from a global perspective. The key point is that value is also dynamic, changing over the product life cycle.

Cited by 27 publications

References 22 publications

Emerging product-process archetypes in oncology: informing the sustainable provision of next-generation medicines

Emerging product-process archetypes in oncology: informing the sustainable provision of next-generation medicines

Restraining High and Rising Cancer Drug Prices: Need for Accelerating R&D Productivity and Aligning Prices with Value

Regulatory Benefit-Risk Assessment and Comparative Effectiveness Research

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