National framework for reviewing codependent technologies (personalised medicines)
This framework helps decide whether to fund personalized medicine treatments and their associated tests in Australia. It looks at how well the treatment works for people with certain genetic markers, whether the test improves outcomes, and if the combined cost is worth the benefit.
At a glance
Use when
Evaluating reimbursement for personalized medicine interventions involving a biomarker test and a targeted therapy, especially when their clinical and economic value is interdependent.
Avoid when
Assessing non-personalized, standalone drugs or tests without a biomarker link, or when evidence on biomarker-drug interaction is insufficient or absent.
Inputs
Clinical trial data, biomarker validation studies, economic models, regulatory assessments, real-world evidence, and stakeholder input.
Outputs
Reimbursement recommendations for biomarker tests, targeted drugs, or their combination, based on clinical and cost-effectiveness.
How it works
The framework comprises five components—context, clinical benefit, evidence translation, cost-effectiveness, and financial impact—and includes a 79-item checklist. It supports reimbursement decisions for codependent technologies (e.g., biomarker tests and targeted drugs) by evaluating whether the biomarker acts as a treatment effect modifier or a prognostic factor. It integrates evidence on causality, clinical utility, and economic impact, and was developed using data from Australian reimbursement applications, international guidelines, and expert and public consultation.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Organisational aspects
- Assumptions
- The biomarker has a biologically plausible link to the drug response; valid and reliable tests are available; and combined evaluation of test and drug provides more accurate value assessment than evaluating either alone.
- Strengths
- Comprehensive structure with explicit consideration of causality and evidence linkage; developed with policy maker, technical expert, and public input; first national framework of its kind, applicable to health systems considering personalized medicine reimbursement.
- Limitations
- May require adaptation for use in health systems with different reimbursement processes; relies on availability of high-quality biomarker and clinical outcome data; complexity may pose implementation challenges in resource-limited settings.
- Also known as
- Assessing Personalized Medicines in Australia, Framework for codependent technologies, Personalized medicine assessment framework
Questions this answers
- › Should a biomarker test, a drug, both, or neither be subsidized?
- › Is the biomarker a treatment effect modifier or a prognostic factor?
- › Does using the biomarker improve clinical outcomes when guiding treatment?
- › Is the combined use of test and drug cost-effective?
- › What is the financial impact of subsidizing codependent technologies?
- › What evidence gaps exist in the evaluation of personalized medicine?
References & sources
Similar by meaning
- Recommendations for reimbursement of personalised medicines
- MSAC evaluation framework for genetic and genomic tests (value-of-knowing / personal utility)
- HEcoPerMed Guidance for Harmonisation and Improvement of Economic Evaluations in Personalised Medicine
- Guidance for good health economic modelling practices in personalised medicines
- SMC Decision Modifiers Framework
Beta record. Generated from the primary source via AI extraction and independent audit, pending final human review.