Linking the Price of Cancer Drug Treatments to Their Clinical Value

Gozzo, Lucia; Navarria, Andrea; Drago, Valentina; Longo, Laura; Mansueto, Silvana; Pignataro, Giacomo; Cicchetti, Americo; Salomone, Salvatore; Drago, Filippo

doi:10.1007/s40261-016-0403-1

Cited by 7 publications

(10 citation statements)

References 34 publications

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“…Over the last decade, health systems were increasingly burdened with fast growing expenditures on oncology drugs, with a total expenditure in Europe from 7.6 billion in 2005 to 19.1 billion in 2014 (Jönsson et al, 2016). Uncertain benefit-risk ratios put the high prices for oncology drugs under debate (Garattini and Bertele, 2002; Fojo and Grady, 2009; Abboud et al, 2013; Pauwels et al, 2014; Fojo and Lo, 2016; Gozzo et al, 2016). …”

Section: Introductionmentioning

confidence: 99%

Managed Entry Agreements for Oncology Drugs: Lessons from the European Experience to Inform the Future

et al. 2017

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Objectives: The aim of this study is to conduct an analysis on the regulation and application of managed entry agreements (MEA) for oncology drugs across different European countries.Methods: Literature search and document analysis were performed between September 2015 and June 2016 to collect information on the regulatory framework and practice of MEA in Belgium, The Netherlands, Scotland, England and Wales, Sweden, Italy, Czech Republic and France. An overview of the content and typology of MEA applied for oncology drugs between 2008 and 2015 was generated based on publically available sources and contributions by national health authorities. Semi-structured interviews were conducted with representatives of national health authorities involved in the management or negotiation of MEA.Results: The application of MEA differs across countries and across different indications for the same drug. Financial based agreements are prevailing due to their simplicity compared to performance-based agreements. Performance-based agreements are less commonly applied in the European countries except for Italy. In the Netherlands, application of performance-based agreements was stopped due to their inability to deal with dynamics in the market, which is highly relevant for oncology drugs.Conclusions: MEA constitute a common policy tool that public payers in European countries use to ensure early access to highly priced oncology drugs. In light of strengths and weaknesses observed for MEA and the expected developments in the oncology area, the importance of MEA is likely to grow in the future.

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Section: Introductionmentioning

confidence: 99%

Managed Entry Agreements for Oncology Drugs: Lessons from the European Experience to Inform the Future

et al. 2017

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“…This evidence is central to recent debates around the affordability of cancer drugs and the sustainability of high drug prices. 1 – 3 The tension between effective management of health care budgets and the provision of optimal care to cancer patients highlights the need for decision makers to assess the true value of cancer treatments using the most rigorous and robust methods. 4 , 5 …”

Section: Introductionmentioning

confidence: 99%

“…Comparing treatment effect can be complex; this is particularly true given the numerous surrogate endpoints often used in clinical trials which may, or may not, be predictive of a true OS benefit. 1 , 6 In the evaluation of new treatments, a balance between disease progression and treatment-related toxicities is key to determining clinically meaningful outcomes for patients. To improve cross product and disease area comparisons, the European Society for Medical Oncology (ESMO) has developed a reproducible tool which can be applied to new anticancer treatments to assess the magnitude of clinical benefit (ESMO Magnitude of Clinical Benefit Scale).…”

Section: Introductionmentioning

confidence: 99%

Modeling the economic outcomes of immuno-oncology drugs: alternative model frameworks to capture clinical outcomes

Gibson¹,

Begum²,

Koblbauer³

et al. 2018

CEOR

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BackgroundEconomic models in oncology are commonly based on the three-state partitioned survival model (PSM) distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O) suggests that new approaches may be appropriate to reflect disease dynamics meaningfully.Materials and methodsThis study explored the impact of incorporating immune-specific health states into economic models of I-O therapy. Two variants of the PSM and a Markov model were populated with data from one clinical trial in metastatic melanoma patients. Short-term modeled outcomes were benchmarked to the clinical trial data and a lifetime model horizon provided estimates of life years and quality adjusted life years (QALYs).ResultsThe PSM-based models produced short-term outcomes closely matching the trial outcomes. Adding health states generated increased QALYs while providing a more granular representation of outcomes for decision making. The Markov model gave the greatest level of detail on outcomes but gave short-term results which diverged from those of the trial (overstating year 1 progression-free survival by around 60%).ConclusionIncreased sophistication in the representation of disease dynamics in economic models is desirable when attempting to model treatment response in I-O. However, the assumptions underlying different model structures and the availability of data for health state mapping may be important limiting factors.

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“…None of the drugs evaluated (abiraterone, afatinib, aflibercept, bevacizumab, dabrafenib, and ipilimumab) achieved a final score of 75 (corresponding to adequate pricing), with afatinib achieving the highest score of 55 points. 29 The absolute cost to society will become increasingly unaffordable if every drug with statistically significant, but clinically unimportant, benefit is approved and will be prescribed/reimbursed. 30 For all new medicines, in addition to efficacy and safety, there should be a focus on value, with measured outcomes.…”

Section: High Drug Costs Should Only Be Considered Acceptable If Imprmentioning

confidence: 99%

“…27 Several studies have demonstrated a weak correlation between the price of a drug and its benefit for the individual patient in terms of prolonged survival, degree of tumour shrinkage, or improved quality of life (QoL). 23,28,29 However, the nature of the disease and the seriousness of a diagnosis of cancer also means that physicians and patients are often willing to pay a high price for treatments, even those associated with only marginal improvements in outcome. 30 Recent research suggests that market exclusivity for most approved tyrosine kinase inhibitors is more than a decade, averaging around 14−15 years.…”

mentioning

confidence: 99%

Can we Continue to Afford Access to Cancer Treatment?

Wilking¹,

Lopes²,

Meier³

et al. 2017

European Oncology &Amp; Haematology

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O ncology is facing a crisis of affordability that is not sustainable. The economic burden of cancer is growing, as a result of the rising cancer incidence and increased survival, alongside growing investment in disease prevention, diagnosis and treatment. The prices of new cancer drugs continue to increase, placing growing pressure on many healthcare systems. The aim of this article is to explore the reasons why the cost of cancer care is increasing, and why this increase may become unsustainable unless changes are made. There are only limited options for future health spending. Finding ways to improve the allocation of existing resources to achieve the best outcomes for patients will be key to achieving sustainability, whilst safeguarding the continued development of new, effective cancer treatments. Currently, too many cancer drugs are approved without robust evidence of value, and spending more on treatments does not necessarily translate to improvements in health. For all new drugs, in addition to efficacy and safety, there should be a focus on value, with measured outcomes and pricing that ensures these drugs are affordable. Fundamental changes to healthcare systems and industry are needed to sustain cancer care and allow continued access to effective and safe treatments for all patients.

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Linking the Price of Cancer Drug Treatments to Their Clinical Value

Abstract: This method may be considered a tool for the evaluation of appropriateness of price proposed at negotiation and could represent a reliable resource for decision-making. Furthermore, this analysis suggests that most recently approved cancer drugs in Italy do not fulfill price adequacy.

Cited by 7 publications

References 34 publications

Managed Entry Agreements for Oncology Drugs: Lessons from the European Experience to Inform the Future

Managed Entry Agreements for Oncology Drugs: Lessons from the European Experience to Inform the Future

Modeling the economic outcomes of immuno-oncology drugs: alternative model frameworks to capture clinical outcomes

Can we Continue to Afford Access to Cancer Treatment?

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