Early Health Technology Assessments in Pharmacogenomics: A Case Example in Cardiovascular Drugs

Geenen, Joost W; Baranova, Ekaterina; Asselbergs, Folkert W.; Boer, Anthonius de; Vreman, Rick A; Palmer, Colin N.A.; Zee, Anke‐Hilse Maitland‐van der; Hövels, Anke M.

doi:10.2217/pgs-2017-0063

Cited by 5 publications

(3 citation statements)

References 30 publications

(31 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…[80] The cost-effectiveness of PGx testing for some patients has not been demonstrated [81] or in some cases, testing may only be cost-effective in high-risk patient populations. [82,83] Federal regulatory oversight of PGx testing may also impact reimbursement decisions.…”

Section: Barriers To Test Utilizationmentioning

confidence: 99%

Integrating pharmacogenetic testing into primary care

Haga

2017

Expert Review of Precision Medicine and Drug Development

View full text Add to dashboard Cite

Introduction Pharmacogenetic (PGx) testing has greatly expanded due to enhanced understanding of the role of genes in drug response and advances in DNA-based testing technology development. As many primary care visits result in a prescription, the use of PGx testing may be particularly beneficial in this setting. However, integration of PGx testing may be limited as no uniform approach to delivery of tests has been established and providers are ill-prepared to integrate PGx testing into routine care. Areas covered In this paper, the readiness of primary care practitioners are reviewed as well as strategies to address these barriers based on published research and ongoing activities on education and implementation of PGx testing. Expert Commentary Widespread integration of PGx testing will warrant continued education and point-of-care decisional support. Primary care providers may also benefit from consultation services or team-based care with laboratory medicine specialists, pharmacists, and genetic counselors.

show abstract

Section: Barriers To Test Utilizationmentioning

confidence: 99%

Integrating pharmacogenetic testing into primary care

Haga

2017

Expert Review of Precision Medicine and Drug Development

View full text Add to dashboard Cite

show abstract

“…One method is the use of early cost-utility analyses, which can clarify the relative impact of the parameters that drive cost effectiveness. Early cost-utility analyses allow decision makers and manufacturers to streamline clinical development and reimbursement processes [15–18].…”

Section: Introductionmentioning

confidence: 99%

Phase I/II Clinical Trial-Based Early Economic Evaluation of Acalabrutinib for Relapsed Chronic Lymphocytic Leukaemia

Vreman

Geenen

Hövels

et al. 2019

Appl Health Econ Health Policy

View full text Add to dashboard Cite

ObjectivesThe objective of this study was to construct an early economic evaluation for acalabrutinib for relapsed chronic lymphocytic leukaemia (CLL) to assist early reimbursement decision making. Scenarios were assessed to find the relative impact of critical parameters on incremental costs and quality-adjusted life-years (QALYs).MethodsA partitioned survival model was constructed comparing acalabrutinib and ibrutinib from a UK national health service perspective. This model included states for progression-free survival (PFS), post-progression survival (PPS) and death. PFS and overall survival (OS) were parametrically extrapolated from ibrutinib publications and a preliminary hazard ratio based on phase I/II data was applied for acalabrutinib. Deterministic and probabilistic sensitivity analyses were performed, and 1296 scenarios were assessed.ResultsThe base-case incremental cost-effectiveness ratio (ICER) was £61,941/QALY, with 3.44 incremental QALYs and incremental costs of £213,339. Deterministic sensitivity analysis indicated that survival estimates, utilities and treatment costs of ibrutinib and acalabrutinib and resource use during PFS have the greatest influence on the ICER. Probabilistic results under different development scenarios indicated that greater efficacy of acalabrutinib would decrease the likelihood of cost effectiveness (from 63% at no effect to 2% at maximum efficacy). Scenario analyses showed that a reduction in PFS did not lead to great QALY differences (− 8 to − 14% incremental QALYs) although it did greatly affect costs (− 47 to − 122% incremental pounds). For OS, the opposite was true (− 89 to − 93% QALYs and − 7 to − 39% pounds).ConclusionsAcalabrutinib is not likely to be cost effective compared with ibrutinib under current development scenarios. The conflicting effects of OS, PFS, drug costs and utility during PFS show that determining the cost effectiveness of acalabrutinib without insight into all parameters complicates health technology assessment decision making. Early assessment of the cost effectiveness of new products can support development choices and reimbursement processes through effective early dialogues between stakeholders.Electronic supplementary materialThe online version of this article (10.1007/s40258-019-00496-1) contains supplementary material, which is available to authorized users.

show abstract

“…What is the price of the test, and what are the costs per quality adjusted life year? Only if these costs are under a certain threshold, genetic testing will be implemented in standard clinical care [9]. Furthermore, a proper infrastructure is one of the other key conditions that is required to implement pharmacogenetics into clinical practice.…”

mentioning

confidence: 99%