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Single-arm designs, wrong comparator, and missing economic models are MSAC's most common basis for a Not Recommended or Deferred device decision.

Claiming a higher Evidence Standards Framework tier than the evidence supports, or an economic model outside the NICE reference case, drives most negative appraisals.

Absent Māori/Pacific equity evidence and no budget impact analysis are recurring gaps under PHARMAC's Factors for Consideration for device funding.

No Coverage with Evidence Development plan, no site-of-service/team requirements, or relying on FDA clearance alone are recurring gaps in real CMS coverage decisions. Largest US public payer, not the only one — Medicaid and private payers aren't covered.

A different question from the three above (market approval, not funding) — shown here as reference material. Not part of the Evidence Gap Analysis score.