A²I™ Device Class
In vitro diagnostics, companion diagnostics, lab-based assays
26 rejection patterns apply to this device class across MSAC, NICE, and PHARMAC.
MSAC consistently rejects clinical utility claims based on single-arm studies. Comparative evidence against current Australian standard of care is required. Single-arm studies are only accepted for safety and feasibility claims, not for clinical utility or cost-effectiveness.
The comparator must reflect current Australian clinical practice — not placebo, historical control, or international standard of care unless explicitly justified. MSAC has deferred multiple applications where the comparator was not the Australian standard of care.
MSAC requires patient-relevant outcomes — survival, quality of life, functional status, or validated intermediate endpoints with demonstrated linkage to patient outcomes. Diagnostic accuracy alone is insufficient without evidence of downstream patient benefit.
Studies conducted entirely in non-Australian populations require explicit bridging justification. MSAC has rejected or deferred applications where prevalence, treatment pathway, or clinical setting differed materially from Australian practice.
MSAC requires a full health economic model for all MBS listing applications, using Australian costs and epidemiology, presenting cost per QALY or cost per clinical outcome. Absence of an economic model is an automatic rejection driver.
MSAC has deferred applications where follow-up was insufficient to capture clinically meaningful outcomes. Implantable devices require a minimum 12 months; chronic condition devices require follow-up commensurate with the disease course.
MSAC requires explicit consideration of access for Aboriginal and Torres Strait Islander peoples and rural/remote populations. Applications that do not address equity of access are flagged, weighted heavily where the condition has disproportionate burden in these populations.
MSAC separates assessment of safety, effectiveness, and cost-effectiveness. A device shown to be safe and to perform as claimed has not thereby shown clinical utility — it must show it changes clinical management in a way that improves patient outcomes.
MSAC has rejected applications where sample sizes were insufficient to detect a clinically meaningful difference. Studies powered for regulatory clearance are frequently underpowered for MSAC's comparative-effectiveness purposes.
Post-hoc endpoint selection or composite endpoints without pre-specification are a recurring MSAC concern. The primary endpoint must be pre-specified, clinically relevant, and powered accordingly.
NICE requires a cost-utility analysis using QALYs, reference case threshold £20,000–£30,000/QALY (higher for end-of-life criteria: survival under 24 months, QALY gain ≥3 months). Applications without a QALY model are rejected at assessment stage.
Evidence from non-UK populations must be explicitly bridged to UK NHS clinical practice, addressing differences in care pathways, disease prevalence, and treatment standards. US evidence in particular frequently requires substantial bridging.
NICE requires validated surrogate endpoints — evidence that the surrogate reliably predicts the patient-relevant outcome. Unvalidated surrogates lead to high uncertainty ratings and typically a not-recommended or research-only outcome.
Under the Equality Act 2010, NICE requires applicants to demonstrate consideration of impact on protected characteristics (age, sex, disability, ethnicity, etc). Missing equality impact assessments are a compliance gap that delays or blocks appraisal.
NICE's reference case specifies perspective (NHS and personal social services), time horizon (lifetime), discount rate (3.5% costs and outcomes), and utility measurement (EQ-5D). Deviations without justification result in model rejection.
Where cost-effectiveness is uncertain or the ICER exceeds threshold, NICE expects a Patient Access Scheme proposal. Absence of a PAS when the base case ICER is above £30,000 is a negative signal.
PHARMAC's Factors for Consideration require comparison against the current funded alternative (an existing Schedule device or standard hospital practice), not an unfunded or international comparator, unless a case is made for a first-in-class listing.
PHARMAC's investment approach weighs health need, health benefit, cost, and suitability within a fixed device/pharmaceutical budget. Applications without a budget impact analysis and cost-utility case are difficult to prioritise against competing investments.
Under Te Tiriti o Waitangi obligations, PHARMAC requires explicit consideration of equity impact for Māori and Pacific peoples. Absent equity evidence can block funded access or generate binding conditions, consistent with the pattern seen across PHARMAC's pharmaceutical decisions.
Evidence generated entirely offshore (commonly US, European, or Australian trials) requires bridging to the New Zealand health system, clinical pathway, and population profile before PHARMAC will treat it as directly applicable.
PHARMAC's Factors for Consideration weigh the health need of the population against the strength and directness of clinical benefit evidence. Surrogate-only or indirect evidence weakens the case relative to devices with direct, patient-relevant outcome data.