Navigating AMCP, CMS, the IRA and MFN — with evidence built for the US payer
US access is being rewritten in real time: Medicare drug price negotiation under the Inflation Reduction Act, Most-Favored-Nation pricing policy, evolving CMS coverage rules and the AMCP Format for formulary submissions. We help access and pricing teams anticipate the policy, quantify the exposure and prepare the evidence before the deadline arrives.
Strategic advisory
Before any deliverable is scoped, our consultants work with your leadership to answer the questions that determine whether the evidence will change a decision.
- IRA Medicare Drug Price Negotiation readiness: selection-risk assessment, timeline mapping and evidence-package strategy for CMS engagement
- Most-Favored-Nation (MFN) and international reference pricing impact modelling across launch-sequence scenarios
- CMS coverage and reimbursement strategy — Medicare Part B/D, NCD/LCD pathways and evidence expectations
- AMCP Format dossier strategy: which evidence to lead with, and how payers will read it
Evidence generation capabilities
AMCP Format Dossiers
Development and updating of AMCP Format (v5.0) dossiers and unsolicited-request responses for US health plans and PBMs.
IRA Negotiation Evidence Packages
Clinical-benefit, unmet-need and comparative-effectiveness evidence aligned to the CMS negotiation factors and submission templates.
MFN & Reference Pricing Analytics
Scenario and revenue-impact models for MFN pricing policies and international reference pricing dynamics.
CMS Policy Monitoring
Continuous tracking of CMS guidance, IRA implementation milestones, rulemaking and demonstration models with implications briefs.
US Payer Value Evidence
Budget-impact models, value propositions and ICER-response evidence tailored to commercial payers, PBMs and IDNs.
Formulary & Access Intelligence
Coverage, tiering and utilisation-management landscape assessments across Medicare, Medicaid and commercial books of business.
AI-assisted strategic analysis
Not every project needs it. For the engagements below, our consultants draw on in-house AI tools to analyse faster and more consistently — and you receive the insight as a strategic report with recommendations.
IRA negotiation readiness assessment
For assets with Medicare negotiation exposure, we structure the evidence against CMS's negotiation factors and quantify where the package is strong, weak or silent.
MFN & reference pricing scenario modelling
For launch-sequence and pricing decisions, we model how MFN and international reference pricing dynamics could move US net price under alternative scenarios.
Questions clients ask about US Market Access & Pricing Policy
US access strategy is usually built on evidence from our HEOR & Global Market Access Strategy, EU HTA & Joint Clinical Assessment and Advanced Analytics capabilities.
How should we prepare for Medicare IRA drug price negotiation?+
Assess selection risk and timelines, then structure clinical-benefit, unmet-need and comparative-effectiveness evidence against the CMS negotiation factors and submission templates before the selection date.
What is an AMCP Format dossier?+
A standardised evidence package (currently v5.0) that US health plans and PBMs use for formulary review — covering clinical, economic and budget-impact evidence for a product.
How could Most-Favored-Nation pricing affect our launch?+
MFN and international reference pricing link US net price to ex-US prices, so launch sequencing and ex-US pricing become US revenue decisions. We model these scenarios so leadership can choose deliberately.
Scope a US Market Access & Pricing Policy engagement
Share your objectives, timelines and target markets. We respond within one business day with next steps.