Market Access Professionals: Your Definitive HTA Checklist for a Smooth P&R Journey
Use this checklist as a self-assessment tool to ensure your dossier covers all critical evidence domains. Simply run through each item, ticking the box as you confirm it’s addressed – helping you anticipate payer questions and fast-track pricing & reimbursement decisions.
The 10 Essential HTA Domains for P&R Success
Clinical Effectiveness
Design and launch real-world evidence cohorts alongside pivotal trials to reinforce adherence, safety and effectiveness in practice.
Health-Related Quality of Life
Embed patient-reported outcome instruments (EQ-5D or disease-specific) in all trial phases – and ensure high completion rates.
Cost-Effectiveness
Engage early with health-economic modelers to build transparent ICER analyses and stress-test scenarios against local willingness-to-pay thresholds.
Safety & Tolerability
Implement comprehensive safety-follow-up programs that capture both trial and real-world adverse-event data to head off payer concerns.
Comparator Selection
Map comparator strategy to each market – align control arms with local standard-of-care or, when needed, build robust indirect comparisons.
Patient Population
Align inclusion/exclusion criteria to real-world epidemiology; pre-specify key subgroup analyses to demonstrate broad applicability.
Care Pathway Integration
Partner with clinical operations teams early – outline training, monitoring and infrastructure needs to present a turnkey adoption plan.
Resource Use & Budget Impact
Perform early budget-impact analyses using local cost data – highlight net savings from avoided hospital stays or procedures.
Evidence Quality & Robustness
Ensure pivotal trials are randomized, controlled and adequately powered; pre-define all endpoints and minimize risk of bias.
Uncertainty & Sensitivity
Integrate comprehensive sensitivity analyses into your dossier – highlight stable base-case results and plan follow-up data to address unknowns.
See Your Edge
Tick every box, and you’ll dramatically reduce data requests, accelerate reviews and strengthen your negotiation position.
Do you know how your program stacks up?
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