Characteristics of Cost-effectiveness Studies for Oncology Drugs Approved in the United States From 2015-2020

Haslam, Alyson; Lythgoe, Mark P.; Akman, Emma Greenstreet; Prasad, Vinay

doi:10.1001/jamanetworkopen.2021.35123

Cited by 26 publications

(24 citation statements)

References 16 publications

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“…For example, the median extra cost for an additional QALY gain is nearly $150,000 for FDA-approved cancer drugs from 2015 to 2020. 12 In comparison, Palmer et al's cost-effectiveness estimates appear to be a quite reasonable rate to pay for an additional QALY. The median cancer drug is almost three times more costly than estimates for computerized speech and language therapy or attention control added to usual care for people with long-term post-stroke aphasia.…”

Section: Methodsmentioning

confidence: 92%

Analyzing a Cost-Effectiveness Dataset: A Speech and Language Example for Clinicians

et al. 2022

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Cost-effectiveness analysis, the most common type of economic evaluation, estimates a new option's additional outcome in relation to its extra costs. This is crucial to study within the clinical setting because funding for new treatments and interventions is often linked to whether there is evidence showing they are a good use of resources. This article describes how to analyze a cost-effectiveness dataset using the framework of a net benefit regression. The process of creating estimates and characterizing uncertainty is demonstrated using a hypothetical dataset. The results are explained and illustrated using graphs commonly employed in cost-effectiveness analyses. We conclude with a call to action for researchers to do more person-level cost-effectiveness analysis to produce evidence of the value of new treatments and interventions. Researchers can utilize cost-effectiveness analysis to compare new and existing treatment mechanisms.

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Section: Methodsmentioning

confidence: 92%

Analyzing a Cost-Effectiveness Dataset: A Speech and Language Example for Clinicians

et al. 2022

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“…The urgent need for more research on NCMs, especially after market approval, including comparing the cost-effectiveness of various treatments raised by the experts of this study has been discussed internationally [ 4 , 29 , 30 ]. Patients in clinical trials typically differ from average patients in regular practice.…”

Section: Discussionmentioning

confidence: 99%

A David and Goliath set-up: a qualitative study of the challenges of ensuring the introduction of cost-effective new cancer medicines in Finland

Ollila

Kataja

Sailas

2022

J of Pharm Policy and Pract

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Background To combat the global challenge of cancer, priority has been placed on the research and development of new cancer medicines (NCMs). NCMs are often approved for marketing in accelerated processes. Despite significant advances in treating cancer, the overall added value and high prices of NCMs has been questioned. While market authorisations for NCMs are granted at the EU level, the assessment of added value, price negotiations and purchase or reimbursement decisions are made by member states. This article explores the practices in Finland for assessing and deciding on purchasing or reimbursing NCMs. Methods Semi-structured interviews were conducted with 26 civil servants, hospital employees, scientists, and representatives of cancer NGOs and of the pharmaceutical industry in 2019 and 2020. The transcribed interviews were coded inductively using Atlas.ti software and analysed thematically under 3 major themes and 11 sub-themes. Results The clinical value of NCMs is considered to be high, especially regarding NCMs for certain types of cancer. Proper patient selection is important but difficult and not all NCMs can be considered as adding value. The prices are considered to often be very high, leading to concerns about the sustainability and equity of health systems. Equity concerns among cancer patients are raised concerning differences in the availability of NCMs between hospital districts and cost differences for patients between those receiving outpatient and inpatient treatment. The systems and processes in Finland for deciding on the introduction of NCMs are fragmentary, involving separate approaches for outpatient care and hospital medicines by under-resourced evaluation bodies. The scientific evidence available is often limited for evidence-based decisions on introduction. Individual hospital districts sometimes introduce NCMs without assessment by national bodies. This can hamper the proper assessment of some NCMs before their uptake and lead to unequal access to NCMs by hospitals. There is an increasing lack of transparency about pricing, due to the rapid increase of market entry agreements. Lack of transparency on information on prices poses a challenge for authorities responsible for equitable access to cost-effective care within the available resources. Conclusions Robust reform of the national introductory systems is needed. Internationally, efforts are needed to increase price transparency, to revise incentives within the system of market approval and to accumulate and assess evidence of comparable value and cost-effectiveness after the market approval of NCMs.

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“…As a result, the literature for economic evaluations has expanded rapidly over the past decades. Previous studies have found that about 20% of published CEAs were funded by the drug industry 12…”

Section: Introductionmentioning

confidence: 99%

“…Industry’s economic ties to insurance coverage approval could lead to sponsorship bias in CEAs. Evidence has consistently shown that industry-funded economic evaluations were more likely to report favourable cost effectiveness results to the sponsor 12345678910. Most of the published studies, however, were limited to specific diseases or treatments—for example, cancer,267910 antidepressants,3 herpes zoster vaccine,5 and statins 4.…”

Section: Introductionmentioning

confidence: 99%

“…Evidence has consistently shown that industry-funded economic evaluations were more likely to report favourable cost effectiveness results to the sponsor 12345678910. Most of the published studies, however, were limited to specific diseases or treatments—for example, cancer,267910 antidepressants,3 herpes zoster vaccine,5 and statins 4. The most recent analysis of bias in cost effectiveness studies based on systematic literature review was published more than 15 years ago 1.…”

Section: Introductionmentioning

confidence: 99%

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Industry sponsorship bias in cost effectiveness analysis: registry based analysis

Xie

Zhou

2022

BMJ

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Objective To assess the association between industry sponsorship (drug, medical device, and biotechnology companies) and cost effectiveness results in cost effectiveness analysis (CEA). Design Registry based analysis Data source The Tufts Cost-Effectiveness Analysis Registry was used to identify all CEAs published in Medline between 1976 and 2021. Eligibility criteria for selecting studies CEAs that reported incremental cost effectiveness ratio (ICER) using quality adjusted life year and provided sufficient information about the magnitude or location of the ICER. Methods Descriptive analyses were used to describe and compare the characteristics of CEAs with and without industry sponsorship. Logistic regression was used to identify the association between industry sponsorship and the cost effective conclusion using selected threshold values ($50 000 (£40 511; €47 405), $100 000, and $150 000). Robust linear regression was used to assess the association between industry sponsorship and the magnitude of ICER. All regression analyses were adjusted for disease and study design characteristics. Results 8192 CEAs were eligible and included in the analysis, with 2437 (29.7%) sponsored by industry. Industry sponsored CEAs were more likely to publish ICERs below $50 000 (adjusted odds ratio 2.06, 95% confidence interval 1.82 to 2.33), $100 000 (2.95, 2.52 to 3.44), and $150 000 (3.34, 2.80 to 3.99) than non-industry sponsored studies. Among 5877 CEAs that reported positive incremental costs and quality adjusted life years, ICERs from industry sponsored studies were 33% lower (95% confidence interval −40 to −26) than those from non-industry sponsored studies. Conclusions Sponsorship bias in CEAs is significant, systemic, and present across a range of diseases and study designs. Use of CEAs conducted by independent bodies could provide payers with more ability to negotiate lower prices. This impartiality is especially important for countries that rely on published CEAs to inform policy making for insurance coverage because of limited capacity for independent economic analysis.

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Characteristics of Cost-effectiveness Studies for Oncology Drugs Approved in the United States From 2015-2020

Abstract: This cross-sectional study analyzes the characteristics of cost-effectiveness studies and determines characteristics associated with whether a drug is found to be cost-effective.

Cited by 26 publications

References 16 publications

Analyzing a Cost-Effectiveness Dataset: A Speech and Language Example for Clinicians

Analyzing a Cost-Effectiveness Dataset: A Speech and Language Example for Clinicians

A David and Goliath set-up: a qualitative study of the challenges of ensuring the introduction of cost-effective new cancer medicines in Finland

Industry sponsorship bias in cost effectiveness analysis: registry based analysis

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