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Case Study– How PRISMA Compliance Secured HTA Acceptance

In evidence synthesis, it’s not just what you find — it’s how you show you found it.

A mid-sized biotech company discovered this when preparing an HTA submission for its new immunology therapy.

They had commissioned a literature review to support the clinical effectiveness section and economic model inputs. But when the draft landed, the issues were obvious:

  • No flow diagram of screened vs excluded records
     

  • Vague search strategies with incomplete database documentation
     

  • No rationale for inclusion/exclusion decisions
     

  • Tables that looked busy but lacked traceability
     

⚠️ The risk? NICE or CADTH reviewers could flag the review as biased or incomplete, potentially leading to a resubmission — and 3–6 months of lost time-to-market.

 

Our Approach: Retrofitting PRISMA, Fast


We rebuilt the review under PRISMA 2020 guidelines without derailing timelines:

🔹 Defined clear objectives using PICO and set upfront criteria
🔹 Re-ran searches across Medline, Embase, CENTRAL, grey literature — fully documented with Boolean logic and filters
🔹 Dual screening + PRISMA flow diagram to show transparent study selection
🔹 Critical appraisal with GRADE & NICE checklists, documented in a methodological annex
🔹 Narrative synthesis that highlighted both consistent evidence and uncertainty, directly linking back to included studies

 

The Results


✨ The HTA submission passed with no methodology-related objections
✨ Reviewers praised the transparency of the evidence package
✨ Internal teams gained confidence using the outputs in payer boards & advisory decks
✨ The same review was repurposed for a GVD annex, a peer-reviewed manuscript, and payer slides — multiplying ROI
✨ Most importantly: avoided 3–6 months of resubmission delays

 

The Insight


PRISMA is not just a reporting standard — it’s a trust-building tool.

For HTA agencies, transparency is non-negotiable. A PRISMA-compliant review isn’t just compliant — it’s credible, auditable, and future-proof.

👉 Lesson Learned: Reviews built on PRISMA principles don’t just inform a single submission — they become strategic assets across regulatory, market access, and publication needs.

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