United States
US payer strategy across every tier.
US market access runs through several layers: CMS, the major commercial payers, pharmacy benefit managers, and the hospital Value Analysis Committees that decide whether to actually buy. We build evidence packs that work at every tier.
The US payer landscape.
ICER is an independent non-profit that publishes value assessments. ICER reports are non-binding but heavily referenced. An unfavourable assessment can constrain pricing and coverage discussions across the entire commercial channel.
AMCP Format 4.1 is the canonical dossier template private payers and PBMs request for new product reviews. Most P&T committees expect AMCP-format evidence packs as the starting point.
CMS / Medicare uses National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and, under the IRA, direct price negotiation for a phased list of drugs starting 2026. Medicaid varies by state but operates under a federal best-price floor; states layer prior authorisation, preferred drug lists, and supplemental rebates on top.
340B hospital pricing, Medicare Part D redesign, and state-level transparency laws are the live operational backdrop. A US payer strategy that ignores them is missing the point.
Value Analysis Committees sit one layer below payer coverage. Every hospital with any purchasing sophistication runs a VAC (also called Clinical Value Analysis or Technology Assessment Committee) that reviews evidence and decides whether to actually buy. Group Purchasing Organisations (Vizient, Premier, HealthTrust) and Integrated Delivery Networks layer on contracting requirements. For medtech, diagnostics, and facility-administered products, a VAC-ready evidence pack matters as much as the payer policy that preceded it.
Where HEC fits in the pathway.
ICER engagement
Scoping document review, evidence submission to ICER, comment periods, post-report response. The earlier the engagement, the more leverage on the report's framing.
AMCP Format 4.1 dossier
Canonical template build covering Sections 1-7: clinical evidence, economic model, budget impact, and product-specific value frames. Distributed to commercial payer P&T committees.
Private payer / PBM submissions
Tailored evidence packs for specific commercial reviewers: managed care organisations, PBMs, integrated delivery networks. Customised probabilistic sensitivity analysis (PSA) and budget-impact lenses.
Medicare coverage analyses
NCD and LCD evidence packs, CMS coverage gap analyses, IRA price-negotiation modelling for drugs entering the eligibility window.
State Medicaid strategy
PA criteria preparation, preferred drug list strategy, supplemental rebate scenarios. Focused on the high-priority states for the product.
Value-based contracting
Outcomes-based agreement modelling, contract structure scoping, real-world evidence collection design to support post-launch evidence generation.
Hospital procurement evidence
Value Analysis Committee dossiers, cost-per-case models calibrated to specific institutions, and budget impact analyses for IDN supply chain teams. A separate evidence layer from the AMCP Format payer dossier.
Common questions on US payer strategy.
Does the US have an HTA agency like NICE?
No single national agency. ICER produces influential independent value assessments. Commercial payers and PBMs run their own reviews using the AMCP Format. Medicare and Medicaid have their own coverage processes.
What is the AMCP Format dossier?
The canonical template (Format 4.1) US private payers and PBMs expect: clinical, economic, and budget impact evidence in a payer-friendly structure.
How influential is ICER?
Non-binding but heavily referenced by private payers, PBMs, and increasingly Medicare and state Medicaid. Engagement during scoping is high-leverage.
What about Medicare and Medicaid?
Medicare via NCDs / LCDs; IRA price negotiation kicks in for selected drugs from 2026. Medicaid varies by state: federal best price + state PA + supplemental rebates.
Planning US market entry?
30 minutes to scope the US strategy across ICER, AMCP, private payers, Medicare, and IRA, and decide where an agreement adds value.
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