Market
Access &
Reimbursement

Leaders in Payer & HTA Strategy

Why Access Matters

Approval Gets You to Market. Reimbursement Decides Whether It Was Worth Going.

Regulators ask whether a product is safe and effective. Payers ask a harder question: whether it is worth paying for, at your price, instead of what they cover today. That case is built from evidence, and the window to generate it is during development, not after launch. We build access strategy alongside the regulatory program: the payer evidence plan, the price and its defense, the HTA submissions, and for devices, the coding, coverage, and payment pathway that turns clearance into revenue.

Launch date set but no payer evidence plan? The HTA clock starts before approval does.

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Capabilities

From Evidence Plan to Paid Claim.

We cover the full access arc: planning the payer evidence during development, setting and defending the price, winning the HTA and payer reviews, and for devices, securing the codes and coverage that make adoption possible.

Access Strategy & Evidence Planning

Integrated evidence plans that put payer requirements into the development program while the trials can still carry them.
Pricing & Reimbursement Strategy

Global pricing corridors, launch sequencing against reference pricing, and mock negotiations run by former payers.
HTA & JCA Submissions

EU Joint Clinical Assessment readiness plus national submissions: NICE, G-BA (AMNOG), HAS, and the other major HTA bodies.
Value Dossiers & Communication

Global value dossiers, AMCP Format dossiers, and payer materials that survive the committee meeting you're not in.
HEOR & Economic Modeling

Cost-effectiveness and budget impact models, PRO strategy, and real-world evidence built to withstand the payer's own analysts.
Device Coding, Coverage & Payment

CPT and HCPCS strategy, CMS and commercial coverage campaigns, and payment pathways from NTAP to TCET.
Access Strategy & Evidence Planning

Access Is Designed Into the Program, or Bolted On Too Late.

The most common access failure is a Phase 3 program that answers the regulator's question and leaves the payer's unanswered: wrong comparator, missing quality-of-life endpoint, no economic data collection. We bring payer requirements into the development plan while protocols can still carry them, so the same trials that win approval also fund the value story. One evidence plan, both audiences.

What We Plan

  • Integrated evidence plans spanning regulatory and payer requirements
  • Payer and HTA advisory boards during development
  • Access-informed target product profile and value criteria
  • Comparator and endpoint selection with HTA review in mind
  • Evidence gap analysis against target payer archetypes
  • Access risk assessment for pipeline and licensing decisions
  • Launch readiness roadmaps by market and payer channel
Pricing & Reimbursement Strategy

Price Is Set Once, Defended Everywhere, and Referenced Forever.

A launch price is not one decision; it is the anchor for every negotiation that follows it, in every market that references the markets before it. We build pricing strategy that survives that chain: corridors grounded in payer research, launch sequences that protect the reference price, and negotiation preparation run by people who used to sit on the payer's side of the table.

How We Price and Defend

  • Global pricing strategy and price corridor development
  • International reference pricing modeling and launch sequencing
  • Payer research: willingness-to-pay and value driver testing
  • Mock negotiations with former payers and HTA committee members
  • Value-based and outcome-based agreement design
  • US gross-to-net, rebate, and contracting strategy
  • Price erosion and loss-of-exclusivity scenario planning
HTA & JCA Submissions

The HTA Body Is Your Second Regulator. Prepare for It Like One.

Under the EU HTA Regulation, the Joint Clinical Assessment runs in parallel with the EMA review, and its PICO scoping can demand comparisons your trials never made. National bodies then layer their own methods on top: NICE's cost-effectiveness thresholds, AMNOG's added-benefit categories, HAS's ASMR ratings. We plan for these assessments from scoping onward and author submissions that anticipate the assessor's methods instead of discovering them in the report.

Submissions We Support

  • EU Joint Clinical Assessment readiness under HTA Regulation 2021/2282
  • PICO scoping anticipation and evidence mapping
  • NICE, SMC, and AWTTC submissions (UK)
  • G-BA benefit dossiers under AMNOG (Germany)
  • HAS, AIFA, and other national HTA submissions
  • Indirect treatment comparisons and network meta-analyses
  • Joint scientific consultations and parallel EMA/HTA advice
  • Responses to assessment reports and appraisal committees

First JCA cycle or AMNOG dossier ahead? The evidence you can still generate shrinks every quarter.

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Value Dossiers & Communication

Your Value Story Gets Retold in Rooms You'll Never Enter.

The decisive conversation about your product happens inside the payer's own committee, retold by a reviewer working from your dossier. That document has to argue for itself: claims linked to evidence, objections answered before they are raised, and a structure the committee's process can digest. We build the global value dossier once, then localize it so every market argues from the same facts.

What We Build

  • Global value dossiers (GVD) with linked evidence libraries
  • AMCP Format dossiers for US formulary review
  • Core value messages with objection-handling appendices
  • Payer presentation decks and negotiation leave-behinds
  • Affiliate localization kits for national submissions
  • Formulary and P&T committee submission support
  • Field market access team training materials
HEOR & Economic Modeling

Evidence That Survives the Payer's Own Analysts.

Every serious payer and HTA body will rebuild your model, rerun your comparisons, and stress-test your assumptions. Economic evidence only helps if it holds up under that treatment: transparent structure, defensible inputs, and sensitivity analyses that show you already asked the hard questions. Our health economists build models and evidence syntheses designed to be taken apart, because they will be.

Evidence We Generate

  • Cost-effectiveness and cost-utility models built to national methods guides
  • Budget impact models for national and plan-level audiences
  • Systematic literature reviews, meta-analyses, and indirect comparisons
  • Patient-reported outcome strategy and instrument selection
  • Real-world evidence studies: registries, claims, and chart reviews
  • Local model adaptations for affiliate submissions
  • Publication planning and peer-reviewed manuscript support
Device Coding, Coverage & Payment

For Devices, Access Means Coding, Coverage, and Payment. You Need All Three.

A cleared device without a code cannot be billed; a coded device without coverage will not be ordered; a covered device paid below cost will not be stocked. We run the three tracks as one campaign: the code applications, the coverage evidence and payer engagement, and the payment benchmarks that make the economics work for the provider who has to choose your product.

What We Secure

  • CPT and HCPCS code strategy, applications, and committee presentations
  • DRG and APC mapping with site-of-care payment analysis
  • Medicare coverage strategy: NCD and LCD engagement
  • New-technology pathways: NTAP, TPT, and TCET evaluation
  • Commercial payer coverage campaigns and medical policy dossiers
  • Hospital value-analysis committee economic tools
  • Provider economics models and reimbursement launch playbooks
Adjacent Capabilities

Before the Launch, and When Access Breaks.

Two engagements extend the core work: leading the market access function before you can justify the full-time hire, and rebuilding access when a rejection or restriction has already landed.

Fractional Market Access Leadership

A Head of Market Access, for the Years Before You Can Hire One.

Access decisions start years before launch, but most companies hire their market access lead months before it. Our senior consultants act as your head of market access in the interim: owning the evidence plan, briefing the board on pricing risk, standing up the payer engagement program, and building the function the permanent hire will inherit.

Included Capabilities

  • Acting VP or Head of Market Access engagements
  • Access function design, hiring plans, and team mentoring
  • Board and investor communication on access and pricing risk
  • Payer engagement program design and governance
  • Vendor selection and oversight for HEOR and RWE partners
  • Transition and handover to permanent leadership
Access Rescue & Resubmission

A Rejection Is a Position, Not a Verdict.

A negative HTA recommendation, a restrictive coverage policy, or an AMNOG price below expectations is the start of a negotiation, not the end of one. We diagnose why the assessment went wrong, decide whether the fix is new evidence, a new comparison, or a new price, and run the resubmission, appeal, or managed-entry negotiation that follows.

Included Capabilities

  • Rejection and restriction root-cause analysis
  • Resubmission strategy and evidence gap closure plans
  • Appeals and reconsideration processes at HTA bodies
  • Managed entry and coverage-with-evidence agreements
  • Price renegotiation preparation and support
  • Indication and population re-scoping for access
Who You're Working With

People Who Have Sat on the Payer's Side of the Table.

Access advice is only as good as its realism about how payers decide. Our teams combine former payer and HTA committee members, health economists who build to national methods guides, and market access leaders who have carried launches from evidence plan to reimbursement.

Former Payers and HTA Assessors

Consultants who have voted on formulary committees and written HTA assessments. They know which arguments move a committee and which ones get skimmed.

Regulatory and Access, Integrated

Because we run regulatory strategy too, the access plan and the regulatory plan are built from the same evidence, not negotiated between two vendors after the fact.

Health Economists and Modelers

Modelers who build to NICE, IQWiG, and CADTH methods expectations, with the documentation discipline that lets a payer's analyst walk the model without a guide.

Pharma and Device Breadth

Drugs, biologics, cell & gene therapies, devices, and diagnostics, across payer systems in North America, Europe, and Asia-Pacific.

Work With Us

The Payer Conversation Starts Long Before Launch. Start It Now.

Tell us where the program stands: evidence in hand, markets in scope, and the access questions keeping the plan honest. We'll match you with a senior market access lead and respond within one business day. All inquiries are strictly confidential.

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Insights & News

Thought Leadership on Access and Value.

Our team's perspectives on payer strategy, HTA methods, and what actually decides coverage: coming soon. In the meantime, reach out directly with a question you'd like to see addressed.

Coming Soon

The First JCA Cycles: What Sponsors Learned

Early lessons from joint clinical assessment, and what they mean for your PICO.

Coming Soon

Pricing a First-in-Class Asset Without Comparators

Anchoring value when there is nothing on the market to reference.

Coming Soon

Device Coverage Without an RCT

The evidence packages payers actually accept, and the ones they only say they want.