Pharmaceutical Pricing and Market Access Presentations: HEOR, Value Dossiers, and Formulary Pitches

2025-02-20·by Poesius Team

Pharmaceutical Pricing and Market Access Presentations: HEOR, Value Dossiers, and Formulary Pitches

Pharmaceutical market access—securing coverage, reimbursement, and favorable formulary positioning for a new drug—is one of the highest-stakes commercial challenges in the industry. Payers, pharmacy benefit managers (PBMs), and health technology assessment (HTA) bodies are increasingly sophisticated and skeptical about manufacturer value claims. The presentations that succeed are rigorously evidenced, clearly structured, and honest about uncertainty.

The Market Access Presentation Landscape

U.S. Payer presentations: Formulary committee pitches to commercial health plans, PBMs (Express Scripts, CVS Caremark, OptumRx), and Medicare Part D plans. Each payer has slightly different evidence requirements and formulary decision criteria.

HTA submissions (international): NICE (UK), G-BA (Germany), HAS (France), TLV (Sweden)—national HTA bodies that determine reimbursement based on clinical and cost-effectiveness evidence. Formal submission with standardized value dossier format.

Hospital formulary pitches: Pharmacy and Therapeutics (P&T) committee presentations at hospital systems and integrated delivery networks (IDNs) requesting hospital formulary listing.

Medicaid supplemental rebate negotiations: State Medicaid programs can negotiate supplemental rebates beyond the mandatory rebate. Presentations to state rebate negotiators emphasize budget impact and competitive positioning.

The Health Economic Evidence Package

Successful market access presentations are built on a coherent evidence package:

Clinical evidence synthesis

Comparative effectiveness against standard of care (SOC): Direct head-to-head evidence where available; network meta-analysis (NMA) for indirect comparisons when no head-to-head exists.

Efficacy on outcomes payers care about: For most payers, primary endpoints that connect to real-world outcomes (hospitalizations prevented, mortality reduced, disease progression delayed) are more compelling than surrogate endpoints (biomarker improvements).

Safety profile relative to SOC: Not just the incidence of adverse events, but the relevant clinical comparison to the alternatives.

HEOR modeling

Cost-effectiveness analysis (CEA): Incremental cost-effectiveness ratio (ICER) expressed as cost per QALY gained vs. the relevant comparator. The threshold for "cost-effective" varies by country and payer: ~$100,000-150,000/QALY in the US, £20,000-30,000/QALY for NICE.

The ICER visualization: a standard cost-effectiveness plane (cost on Y-axis, effectiveness on X-axis, comparator at origin) with the new drug's position showing both the incremental cost and the incremental effectiveness, and lines showing the cost-effectiveness threshold.

Budget impact model (BIM): For a representative health plan or hospital system, what is the total formulary cost change (positive = increased spend) from adding this drug vs. the counterfactual (current standard of care mix)?

Budget impact tables: Payer population × treatment-eligible patients × market share assumptions × price = estimated spend change by year for 3 years.

Sensitivity analyses: Tornado diagrams showing which model inputs most affect the ICER. This shows payers where the economic conclusion is robust vs. sensitive to assumptions.

Real-world evidence (RWE)

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Post-approval RWE is increasingly used to support market access presentations:

  • Claims data analyses showing real-world effectiveness
  • Registry data from relevant patient populations
  • Electronic health record (EHR) analyses

RWE limitations (confounding, selection bias, outcome measurement) must be transparently acknowledged.

NICE HTA Submission Format

NICE in the UK requires a standardized evidence submission format. The clinical and economic evidence is submitted in a detailed NICE-format dossier; the company also presents at a Technical Engagement meeting and, for complex appraisals, at the NICE Appraisal Committee meeting.

The NICE submission slide deck structure:

  • Decision problem and clinical context
  • Systematic review of clinical evidence
  • Company's CEA model structure and results
  • Sensitivity analyses and scenario analyses
  • Budget impact analysis
  • Response to NICE's key uncertainties

Transparency about limitations is not optional in NICE submissions—the Independent Evidence Review Group (ERG) will identify and publicly report any limitations regardless.

Formulary Committee Pitches

Hospital P&T committee presentations are typically 15-20 minutes with questions. The committee includes physicians, pharmacists, nurses, and administrators. The structure:

Clinical summary: Indication, mechanism of action, clinical data vs. current formulary options.

Place in therapy: Where in the treatment algorithm should this drug be used? Patient selection criteria.

Safety comparison: The adverse event profile vs. current formulary alternatives. Drug interactions.

Clinical pathway proposal: How should the drug be ordered, dispensed, and monitored?

Economic analysis: Drug acquisition cost vs. current alternatives. Downstream cost implications (hospitalizations prevented, etc.). Total cost of care perspective.

Formulary tier recommendation: What formulary tier is being requested, and why?

Frequently Asked Questions

How do I present a drug that's priced significantly above the current standard of care?

Lead with the clinical differentiation, then present the economic model. "This drug costs $X vs. $Y for standard of care. Here is why we believe the additional efficacy justifies the price difference: [clinical evidence] and [economic model showing cost per outcome]."

What if our CEA model shows an unfavorable ICER?

Present it anyway, with context. An ICER above threshold is not automatically rejected—NICE and other HTA bodies consider other factors (unmet need, severity of disease, innovation). Hiding a high ICER until it's discovered is far more damaging than presenting it proactively with mitigating factors.

How does the payer value framework differ from QALY in the US?

The US doesn't have a single national value framework like QALY. ICER (the Institute for Clinical and Economic Review) publishes independent assessments that increasingly influence payer decisions. Commercial payers often use clinical pharmacy criteria and budget impact rather than formal QALY thresholds. Tailoring the economic argument to each payer's decision framework matters.

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