Pricing, Access, HEOR, & Value Policy
Building a unified value story across pricing, access, and health economics.
IRA Readiness
First-hand IRA negotiation, readiness, and evidence-generation support — spanning IRA preparation, CMS response strategy, negotiation readiness, evidence generation, and stakeholder communication.
Deep support across IPAY 2026–IPAY 2028 planning and response
Innopiphany brings rare, practical experience supporting teams through IRA readiness, CMS response strategy, evidence development, and negotiation preparation.
Supported 15 engagements and 9 products from IPAY 2026 to IPAY 2028, including team coordination, response strategy, evidence compilation, and ICR drafting.
Seen initial pricing offers for IPAY26 and IPAY27, providing first-hand perspective on CMS’ pricing logic and choice of therapeutic alternatives.
Developed counteroffer responses and strategies, including negotiation tactics and supporting evidence narratives.
Built proprietary IRA modeling approaches to help project how CMS may evaluate key factors based on past performance.
Pioneered IRA readiness exercises and risk mitigation plans for high-value products.
Created IRA-focused RWE strategies, including early ICR development, data gap analysis, prioritization, and implementation planning.
Developed visual aids and communications to activate KOLs, clinicians, patient advocates, and other stakeholders.
Provided rapid updates and in-depth analysis on CMS guidance, ICR formatting, negotiation dynamics, and emerging policy developments.
Preparation
- Product-specific strategies
- CMS response strategy alignment
- IRA negotiation playbook and process support
- Draft ICRs
- Gap analysis and evidence-generation strategy
- Scenario analyses and Part D planning
- Cross-departmental alignment
- Advocacy strategy
- ICER-IRA report readiness
Response
- Medicare-specific value narrative
- ICR development
- Supplemental submissions
- Meeting materials
- Comment letters to CMS on process
- Manufacturer and trade response support
Negotiation
- Meeting preparation
- Speaker talking points
- Analysis of CMS offer
- Counteroffer strategy
- Negotiation tactics and response planning
IRA E(2) Model & Evidence Generation
Built from first-hand learnings reviewing CMS offers, counteroffers, evidence needs, and negotiation dynamics.
IRA Value Model & Grid
Provides a foundational comparative effectiveness estimation of CMS’ approach to evaluating a product against its therapeutic alternatives.
Evidence Generation
Experienced RWE staff with ready access to multiple databases with researcher-level permissions to support timely, targeted evidence development.
ICER Support & Readiness
Strategic ICER support from evidence planning through assessment response — helping organizations prepare for, interpret, and respond to ICER assessments through evidence strategy, scenario planning, value communication, and stakeholder engagement.
ICER Support
ICER Strategy & Value Assessment Support
We support clients across ICER readiness, evidence review, assessment tracking, stakeholder response, and value strategy.
A searchable resource to support assessment tracking, benchmarking, scenario planning, and evidence strategy.
Differentiators
What Makes Innopiphany Different?
Extensive Expertise with ICER
Our deep familiarity with ICER stems from our continuous engagement in this domain since 2015.
Track Record in Class Reviews
Experience across product-specific assessments and broader therapeutic class reviews in various areas such as oncology and inflammation, including evidence and stakeholder strategy.
Speed, Accuracy & Consistency
Structured tools and repeatable processes help teams move quickly while maintaining quality and consistency. We are also privately owned with high staff retention, and thus have cultivated a deep reservoir of institutional knowledge.
First Draft Excellence
Clear, client-ready outputs designed to reduce revision cycles and support rapid decision-making.
Proven Strategic Insight
Support that goes beyond analysis to help clients understand implications for access, evidence, pricing, and communication strategy. We also have significant experience in navigating drugs in assessments with high visibility.
PDAB Support
Helping clients prepare for, respond to, and shape PDAB strategy as Prescription Drug Affordability Boards evolve across states — with practical strategy, evidence planning, stakeholder engagement, and communications support.
Proposed or implemented PDABs being tracked across the U.S.
Potential U.S. lives impacted by existing and proposed MFPs / UPLs, depending on statutory reach.
States actively considering or using IRA MFP dynamics as part of UPL strategy.
Why It Matters
PDABs are creating new pressure points for access, affordability, evidence, and stakeholder strategy.
As states move from legislation to implementation, manufacturers may face compressed timelines, fragmented state processes, reliance on external analyses, and potential risk of inaccurate or incomplete value assessments.
First-hand experience
Directly supported manufacturers through active PDAB drug reviews
Core Capabilities
PDAB readiness, response, and value-defense support
Legislation Response Strategy
- Track where legislation is moving by state
- Build internal consensus on PDAB strategy and positions
- Develop educational materials for legislators and policy stakeholders
Core Process & Readiness
- Develop PDAB playbooks, roles, responsibilities, and timing
- Support cross-functional process and communication strategy
- Identify products that could be subject to PDAB review
Complete PDAB Dossier
- Create cross-state evidence dossiers
- Develop value narratives and state-specific value grids
- Consolidate clinical, safety, PRO/COA, population, cost, and access-impact evidence
Disease Community Engagement
- Map key stakeholders and influence pathways
- Develop engagement strategy
- Support advisory boards, task forces, white papers, and educational materials
PDAB Policy Evidence Readiness
- Develop evidence on access, affordability, pharmacy viability, and patient-care disruption
- Assess potential impacts on utilization management, supply, and care delivery
- Prepare evidence plans to address gaps and support publication or RWE needs
External Analysis Monitoring
- Track external groups and analyses influencing PDAB decision-making
- Monitor ICER, PORTAL, and other state-relevant evidence inputs
- Assess implications for product-specific value, access, and response strategy
What “Good” Looks Like
A proactive PDAB strategy requires more than monitoring.
Proactively engage PDAB members and stakeholders to defend the product’s role in the care continuum.
Put a deployment plan in place before reviews accelerate or external analysis shapes the narrative.
Align sufficient cross-functional resources across policy, access, HEOR, RWE, advocacy, and communications.
Prepare product, patient experience, affordability, access, pharmacy, and payer evidence to demonstrate potential negative impacts of UPLs.
Build sustained engagement with patient advocates, clinicians, KOLs, pharmacists, payers, and policy stakeholders.
Representative Deliverables
Practical tools to support monitoring, response, and stakeholder communication
Monitoring Calendar
Track strategically important PDAB meetings, notices, timelines, and updates across states.
Biweekly Updates
Provide targeted, high-level summaries of upcoming drug reviews, UPL methodologies, and state developments.
Across-State Dossier
Serve as the foundation document for future submissions, response materials, and stakeholder engagement.
RFI Submissions
Support direct communication with PDABs, submissions, and decision-maker-facing materials.
Comment Letters
Develop structured responses to PDAB processes, evidence requests, and proposed methodologies.
White Papers
Amplify the value narrative and build surround sound with broader stakeholder audiences.
HEOR Strategy
Global HEOR strategy, evidence planning, and HTA support — helping clients strengthen value narratives, support evidence generation, prepare for HTA, and communicate product value to payers and stakeholders.
Strategy
- Payer needs and evidence strategy
- Value narrative development
- Identification of relevant endpoints, including COAs
- Burden-of-disease strategy
- Treatment pattern analysis
- Payment mapping
Evidence & HTA Readiness
- Markov modeling
- Budget impact and population health analyses, including SDoH
- Real-world evidence strategy
- Systematic reviews
- Country-based HTA readiness
Communications
- Global value dossiers
- Objection handlers
- Payer communication decks
- Payer message testing
- Stakeholder mapping
HTA Assessment
- Strategic consulting
- HTA strategy, submissions, and responses
- Stakeholder engagement
- Internal and external communications
Value Frameworks
Value narratives that connect evidence, payer needs, and market access strategy — practical frameworks that clarify payer expectations, shape evidence priorities, and support reimbursement strategy across markets.
Current & Future Payer Environment
What do payers need to understand today, and what may they expect in the future?
Understand payer needs
We assess the payer, HTA, reimbursement, and stakeholder landscape to help clients anticipate evolving evidence expectations.
Economic Hypothesis
How can the product’s economic value be clearly articulated?
Frame the value story
We help clients translate clinical and market assumptions into a concise value hypothesis that can guide evidence planning and payer engagement.
Market-Specific Translation
How should the value story be adapted across markets?
Adapt strategy by market
We support market-specific translation of value messages, evidence needs, patient perspectives, and reimbursement considerations.
Product Proof Points
What evidence is needed to support payer and reimbursement decisions?
Define supporting evidence
We help identify the core proof points, data needs, and communication materials required to support value demonstration.