Quick orientation: your launch at a glance

• Tell me briefly about the launch you are planning and the patient population you expect to treat.
• How many target payers and integrated delivery networks do you expect to prioritize in the first 12 months? Options: 1-3, 4-7, 8-12, More than 12
• Which clinical endpoints and real world evidence pieces do you already have that payers ask for in this therapeutic area? Options: Primary endpoint data, Subgroup analyses, Real world claims data, Patient reported outcomes, No payer-grade evidence yet
• When was the last time a payer advisory board raised a reimbursement concern about this mechanism or indication? Options: Within last 3 months, 3-6 months ago, 6-12 months ago, More than 12 months ago, Never
• Who on your team currently owns payer strategy and who would be our day to day counterpart?
• Describe the revenue and inventory exposure you would face if your therapy received a restricted formulary placement at launch.

Where access could break, and what that would actually cost you

• If a top national payer required step therapy or excluded your product on day one, what operational or financial impact would force you to change course?
• Why do you think prior authorization or step edits are most likely to be used against this therapy?
• How often have launches in this class seen utilization drop more than 30 percent because of coverage restrictions? Options: Almost every launch, Several times in recent launches, Rarely, Never observed
• What regulatory or reference pricing decisions outside your control could derail access in major markets?
• Which internal silos have caused delays on past launches, and how long did those delays typically last? Options: Clinical/Medical Affairs, Commercial/Market Access, Legal/Compliance, Data/Analytics, Other
• Can you name a recent payer negotiation that turned on HEOR assumptions rather than clinical endpoints? Options: Yes, within 6 months, Yes, 6-12 months, Yes, more than 12 months ago, No
• Is there a single threshold of ICER or budget impact that would make your commercial team walk away from this pricing plan? Options: Yes - specific ICER threshold, Yes - specific budget impact threshold, No single threshold, Not sure

Evidence and narrative gaps nobody admits but payers notice

• What specific evidence gap do payers bring up most often when you discuss clinical benefit in this indication? Options: Comparative effectiveness vs standard of care, Durability of response, Real world safety profile, Patient reported outcomes, Long term cost offsets
• Tell me about the last time a payer asked for a head to head comparison you did not have, what happened next?
• How many comparative effectiveness analyses and budget impact models do you currently have ready for submission? Options: None, 1, 2-3, 4 or more
• When you try to make the economic case internally, which assumptions do finance and commercial challenge most aggressively? Options: Population size, Duration of effect, List to net price assumptions, Adherence estimates, Other
• Who within your clinical team tends to push back on HEOR narratives and why?
• In your view, which payer decision criterion is least visible in your current dossier and how could we prove it?
• If we could close one specific evidence gap in 12 weeks, which gap would accelerate formulary uptake enough to aim for a preferred placement? Options: Comparative effectiveness, Real world utilization patterns, Budget impact short term, Patient reported outcomes, Other

The other options on the table

• List the external firms, consultancies, and internal alternatives you are weighing right now.
• Would you prefer an internal solution, an external specialist, or a hybrid approach if it required no incremental budget? Options: Internal, External specialist, Hybrid, Undecided
• Describe the conditions under which the incumbent approach would be good enough to keep, rather than change partners.
• Can you say whether anyone internally is proposing to solve this without an outside partner and who would be responsible? Options: Yes - a single function proposed it, Yes - a cross functional team proposed it, No one has proposed internal solution, Unsure
• Name the evidence, timeline, and cost thresholds that would keep you with the current approach instead of switching vendors.
• On a scale from 1 to 5, how important is vendor continuity versus faster payer engagement for your leadership? Options: 1 - continuity much more important, 2, 3 - balanced, 4, 5 - speed much more important

Can we actually move at your pace, or will practical constraints stop us?

• Could your team provide the billing, patient, and claims data we would need to build models within 6 weeks? Options: Yes, full access and contact identified, Partial access, will take longer, No, data not available, Not sure
• Identify the person or team that owns claims and real world data and whether they can authorize sharing under your governance rules.
• How clean and accessible is your historical utilization and prior authorization data for the target indications? Options: Clean and queryable, Partially cleaned, Raw and fragmented, Unavailable
• Does your legal or compliance group require review cycles longer than 4 weeks for HEOR and payer-facing deliverables? Options: Yes, always longer than 4 weeks, Sometimes longer, depends on content, No, typically under 4 weeks, Not sure
• List the third party systems we must integrate with and note whether APIs exist for automated pulls.
• Can your commercial team commit headcount to attend weekly payer engagement calls through the negotiation phase? Options: Yes, dedicated attendees identified, Yes, but shared resources, No, limited availability, Unsure
• Name the single constraint that would terminate the engagement if it cannot be resolved and explain why.

Who's in the room, who signs, and how decisions actually get made

• Identify the executive sponsor for this work and the final decision maker for contracts.
• Walk me through how cross functional governance runs for launches at your company, from forecasting to formulary submissions.
• How often does your leadership re-evaluate launch strategy as new competitive intelligence arrives? Options: Weekly, Monthly, Quarterly, Ad hoc
• Would a disagreement between commercial and medical affairs over label interpretation stop the project, and who would arbitrate?
• Explain the escalation path when payers demand evidence outside the agreed scope and name who can authorize additional spend.
• Provide the acceptance criteria that would allow your team to sign within two weeks after we deliver the payer-ready dossier and contract templates.

How we measure launch victory and what speeds a yes

• Assuming launch day access is weaker than planned, name the metric shortfall that would force you to reprice or pull allocation and why.
• Provide the top three KPIs you will use to determine launch success and their target thresholds.
• Would you accept a 10 percent net price improvement at the cost of a 3 month access delay, and who has authority to make that tradeoff? Options: Yes, commercial lead, Yes, executive sponsor, No, prefer access, Decision requires cross functional approval
• Specify the reporting cadence and owners who will keep us aligned during negotiations and the stakeholders who must receive weekly updates. Options: Weekly sync + executive summary, Biweekly sync, Monthly review only, Ad hoc as issues arise
• How soon after contract execution do you expect to see formulary placement shifts or prior authorization changes? Options: Immediately (0-30 days), 1-3 months, 3-6 months, 6+ months
• Please indicate the milestone in your timeline that you will use as the billing trigger and why.
• Outline the decision point that would accelerate full roll out within 90 days and the signer required to proceed.

• Payer Barrier Discovery and Stakeholder Map
• Clinical Evidence Gap Validation
• Economic Evidence and Model Inputs Workshop
• Payer Messaging and Objection Response Workshop
• Evidence Prioritization and Implementation Roadmap

• Produce the finalized one-page payer narratives and share in the workspace.
• Data sourcing plan with owners and deadlines to populate the model.
• Produce the model input spreadsheet with agreed base-case values and ranges.
• Identify and retrieve primary data sources for each missing input.
• Schedule model run and sensitivity analysis timelines aligned to payer engagement dates.
• Identify and prioritize payer objections from barrier list
• Finalized one-page payer value narratives for each key payer segment.
• Objection-response matrix for the top payer objections with linked evidence references.
• List of messaging elements requiring additional evidence or tighter language before payer meetings.
• Confirm scope, payer types, and success criteria
• Populate the objection-response matrix with exact evidence citations and page/slide refs.
• Prepare a short slide pack using the narratives for upcoming payer advisory or negotiation meetings.
• Review consolidated gap, model, and messaging dependencies
• Prioritized evidence roadmap with 90- and 180-day milestones and owners.
• Acceptance criteria documented for each deliverable that will be used to confirm readiness for payer engagement.
• Agreed governance model and meeting cadence to manage execution and risk.
• Publish the prioritized evidence roadmap with milestones, owners, and acceptance criteria.
• Schedule recurring status syncs and a decision checkpoint before the first payer outreach.
• Initiate data collection and analysis tasks for the top 90-day deliverable.
• Documented and prioritized list of payer barriers by payer type that will drive evidence priorities.
• Stakeholder map with named payer roles and expected decision timelines for each payer segment.
• Calendar of follow-up evidence workshops and agreed owners for scheduling.
• Distribute the prioritized payer barrier list and stakeholder map for asynchronous review.
• Gather and share source payer documents and advisory outputs referenced during the session.
• Schedule the clinical evidence gap validation workshop and reserve required attendees.
• Recap prioritized payer barriers that depend on clinical evidence
• Validated evidence gap matrix with severity and estimated time to close for each gap.
• List of candidate data sources and initial owner assignments for each high and critical gap.
• Decision on which gaps require new analyses or studies versus reinterpretation of existing data.
• Compile and share the evidence gap matrix with referenced source documents and severity ratings.
• Prepare data extraction tasks for each high-priority gap with target completion dates.
• Draft protocols or analysis plans for any new retrospective analyses or RWE studies identified.
• Recap clinical gaps that affect economic modeling
• Documented set of core model inputs and preferred comparators for payer economic submissions.
• Prioritized list of sensitivity analyses and thresholds that will be used to test payer responses.
• Review existing payer signals and advisory findings
• Prioritize evidence tasks by impact and time to deliver
• Confirm target payer metrics and comparator choices
• Review current clinical dataset and label-relevant evidence
• Draft one-page payer value narratives
• Develop evidence-backed responses for top objections
• Review proposed model structure and draft inputs
• Assign owners, timelines, and acceptance criteria
• Identify evidence gaps against payer requirements
• Structured exercise to surface payer barriers
• Test messages against payer decision criteria and refine
• Map stakeholders and decision timelines
• Rate gaps by decision impact and time to address
• Set governance and communication cadence
• Prioritize sensitivity analyses and threshold scenarios
• Agree immediate next steps and workshop schedule
• Assign owners for evidence retrieval or generation
• Agree data needs and timing to populate the model

• Build Cost-Effectiveness Model
• Create Budget Impact Model
• Draft Value Dossier for Payer Submission
• Prepare Formulary Submission Package
• Facilitate Payer Advisory Board Meetings
• Produce Real-World Evidence Analysis
• Draft Prior Authorization and Step-Therapy Templates
• Prepare Managed Care Contract Templates and Playbooks
• Execute Payer Meetings and Field Support
• Model Formulary Tiering and Rebate Scenarios
• Generate ICER-Style Value Brief and Rebuttal Materials
• Train Commercial Teams on Payer Value Messaging

Build Cost-Effectiveness Model

• Do you have an agreed primary comparator and the trial or real-world efficacy inputs for the cost-effectiveness model? Options: Yes, comparator and inputs finalized, Comparator agreed but inputs incomplete, No, need support selecting comparator
• Which payer perspective(s) should the model adopt (for example commercial managed care, Medicare Part D, Medicaid fee-for-service)? Options: Commercial Managed Care, Medicare Part D, Medicaid fee-for-service, Multiple perspectives
• How many modeled time horizons do you require for the economic evaluation (for example 1-year budget impact plus lifetime QALY horizon)? Options: 1 year, 5 years, Lifetime, Custom
• Provide the primary sources for resource use and cost inputs you want included (pharmacy claims, medical claims, chart review, internal list/net price assumptions). Options: Pharmacy claims (NDC-level), Medical claims (ICD/CPT-level), Chart review / registry, Assumptions / forecast
• Identify any subgroup analyses required (for example biologic-naive, prior-failure population, biomarker-positive) and the exact subgroup definitions.
• What acceptance criteria will confirm the cost-effectiveness model is deliverable (for example reproducible model code, deterministic check dataset, and a one-page executive summary aligned to agreed comparators)?

Create Budget Impact Model

• Which payer segments require individual budget-impact outputs (commercial MCO, self-insured employer, Medicare Part D, Medicaid)? Options: Commercial MCO, Self-insured employer, Medicare Part D, Medicaid fee-for-service, Multiple segments
• Do you have target population estimates by line of therapy, incidence and prevalence that should be used for the budget-impact model? Options: Yes - population estimates ready, Partial - need validation, No - require modeling
• Specify the list price and net price assumptions to include (for example WAC, estimated net after rebates, or channel-specific net prices). Options: Wholesale acquisition cost (WAC), Estimated net price after rebates, Channel-specific net prices, Custom input
• List the formulary restriction scenarios to model (preferred with prior authorization, non-preferred with step therapy, specialty tier with limited distribution). Options: Preferred without PA, Preferred with PA, Non-preferred with step therapy, Specialty tier limited distribution, Other
• Estimate the expected uptake profile to model for year 1 and year 3 (for example slow <5% year1, moderate 5-20%, aggressive >20%). Options: Slow uptake (<5% year1), Moderate (5-20%), Aggressive (>20%), Custom
• How will you validate the budget-impact model outputs internally (for example reconciliation with your commercial forecasting model and sign-off by your head of commercial)?

Draft Value Dossier for Payer Submission

• Are there payer-specific clinical endpoints or surrogate endpoints you expect the dossier to emphasize (for example sustained response at 12 months, reduction in hospitalizations)? Options: Yes - list available, No - use standard trial endpoints, Need payer input
• Indicate which real-world evidence sources should be cited in the dossier (claims-based treatment patterns, disease registries, EHR cohorts). Options: Pharmacy claims, Medical claims, Disease registry, EHR cohort, No RWE
• Estimate how many distinct payer audiences the dossier should be tailored for with customized cover letters (for example national PBMs, regional MCOs, state Medicaid programs). Options: 1-3, 4-10, 10+
• Specify any regional or state Medicaid policy variations we must address in the dossier (for example supplemental rebate expectations or preferred drug list constraints).
• Identify required appendices for the dossier (for example full economic model files, patient-level trial listings, safety tables) and whether they are ready to include. Options: Economic model files available, Patient-level listings available, Safety tables ready, Appendices need preparation
• What defines acceptance for the dossier draft (for example payer-ready executive summary, appendix with model inputs, and sign-off by your medical lead)?

Prepare Formulary Submission Package

• Select the target formulary tier and coverage intent the submission should seek (preferred brand tier, non-preferred, specialty tier, step-therapy allowed). Options: Preferred brand tier, Non-preferred tier, Specialty tier, Step-therapy approach
• Confirm whether you have a standard Pharmacy and Therapeutics committee submission template we must align to. Options: Yes - will provide template, No - use standard market template, Need us to request payer template
• List the clinical evidence and safety materials you require in the package (for example label, key randomized controlled trials, meta-analyses, REMS documents).
• Provide NDC-level dosing, administration setting (clinic vs home), and expected site-of-care mix to include in budget and utilization tables.
• Indicate target submission dates or P&T meeting cycles we should align with to hit payer review windows. Options: Next 30 days, 30-90 days, >90 days, Flexible
• Confirm whether you require a payer-facing one-page talking points sheet with the formulary rationale. Options: Yes - one-page talking points, No, Maybe - discuss scope

Facilitate Payer Advisory Board Meetings

• State how many advisory board sessions you want and the geography for recruitment (national, regional, state Medicaid). Options: 1, 2-3, 4+
• Name the specialist mix and payer roles to recruit (for example medical directors, pharmacy directors, formulary pharmacists, case managers). Options: Medical directors, Pharmacy directors, Formulary pharmacists, Case managers, Other
• Choose the preferred meeting format and timing (virtual 60-90 minutes, in-person half day, hybrid) for advisory board sessions. Options: Virtual 60-90 minutes, In-person half day, Hybrid
• Outline the key discussion objectives you want validated during the advisory board (for example payer evidence gaps, acceptable comparators, likely utilization management criteria).
• Will you require non-disclosure agreements and honoraria management to be handled by us for advisory board participants? Options: Yes - include in scope, No - you will manage, Need discussion
• Attach any existing slide decks or briefing materials you want reviewed prior to the advisory board (upload or link).

Produce Real-World Evidence Analysis

• State which claims or electronic health record datasets are available or preferred for the RWE analysis (pharmacy claims, medical claims, registry data). Options: Pharmacy claims, Medical claims, Disease registry, EHR cohort, None available
• Does the work require a new cohort definition for claims-based treatment episodes (line-of-therapy rules, washout periods, ICD/CPT code lists)? Options: Yes - code lists provided, Partial - need mapping, No - use trial-based cohort
• Select the outcomes to measure in RWE (for example hospitalization rates, treatment persistence, adherence measured by days supply). Options: Hospitalization rates, Treatment persistence, Medication adherence (days supply), Healthcare resource utilization, Other
• Quantify the minimum sample size or number of index patients needed for stable estimates in the RWE analysis. Options: <500, 500-2,000, >2,000, Custom
• When do you need a feasibility report before full RWE analysis (for example a 2-3 week feasibility check)? Options: 2 weeks, 4 weeks, 6+ weeks
• Are there data use agreements or institutional review board requirements we must factor into the RWE timeline? Options: Yes - DUA/IRB required, No, Uncertain

Draft Prior Authorization and Step-Therapy Templates

• Describe the clinical criteria that should drive prior authorization decisions (for example lab thresholds, prior therapy failure, biomarker positivity).
• Will step-therapy require failure of a generic alternative or a branded alternative before access to the product? Options: Generic alternative required first, Branded alternative required first, No step-therapy expected, Need evaluation
• Outline allowable exceptions and clinical rationales for prior authorization overrides (for example rapid disease progression, contraindications).
• Choose the expected documentation burden for prescribers (for example diagnosis and basic labs vs detailed chart abstraction) that you will accept. Options: Minimal (diagnosis and basic labs), Moderate (supporting notes), High (detailed chart abstraction), Custom
• Who is the final approver for the prior authorization and step-therapy templates within your team (name and role)?
• Name the payers or channels that must accept the PA template before deployment and indicate the integration points to support (payer portal, electronic prior authorization, fax, specialty pharmacy portal). Options: Payer portals, Electronic prior authorization (ePA), Fax, Specialty pharmacy portal, Other

Prepare Managed Care Contract Templates and Playbooks

• Enumerate which contract types the templates should cover (national rebate agreements, value-based contracts, indication-based pricing, outcomes guarantees). Options: National rebate agreements, Value-based contracts, Indication-based pricing, Outcomes guarantees
• Explain whether baseline commercial terms are already agreed (for example target net price floor, rebate cap, reporting cadence) that must be reflected in templates. Options: Yes - provide terms, No - need to draft standard terms, Partial - need negotiation support
• Describe the performance metrics you are willing to include in outcomes-based contracts (for example hospitalization reduction, readmission rates, medication persistence).
• Clarify the data sources and reporting frequency required for contract measurement (for example claims with 90-day adjudication lag, monthly extracts, quarterly reconciliation). Options: Claims with 90-day lag, Monthly EHR extracts, Quarterly reconciliation, Annual audit
• Who will own negotiations and have signature authority on your side for managed care contracts (name and role)?
• Would you like playbooks for field teams that include objection handling scripts and payer-specific negotiation points? Options: Yes - full playbook, Yes - high-level talking points, No

Execute Payer Meetings and Field Support

• Project how many payer meetings you expect us to lead per quarter during execution. Options: 1-2, 3-5, >5
• Prioritize which payer audiences should be engaged first in the field (national PBMs, regional MCO medical directors, integrated delivery networks). Options: National PBMs, Regional MCO medical directors, Integrated delivery networks, Specialty pharmacies
• Detail your preferred attendee mix for payer meetings (for example clinical lead, HEOR lead, contracting lead, commercial lead). Options: Clinical lead, HEOR lead, Contracting lead, Commercial lead, Other
• Require live support during payer Q&A for meetings (for example HEOR expert on call, clinical expert present)? Options: Yes - HEOR and clinical, Yes - HEOR only, No
• Explain any geographic travel requirements or constraints for in-person payer meetings. Options: No travel, US domestic travel ok, International travel required, Hybrid
• Define the success metrics for payer engagement fieldwork (for example meetings secured, formal feedback received, provisional formulary commitments). Options: Meetings held, Documented payer feedback, Conditional formulary commitment, Other

Model Formulary Tiering and Rebate Scenarios

• Model which net price scenarios (for example list price only, list minus standard rebate, deep net with supplemental rebate) for tiering analysis? Options: List price only, List minus standard rebate, Deep net with supplemental rebate, Custom scenarios
• Have you defined target formulary tier objectives by payer that the modeling should reflect? Options: Yes - list by payer, No - need recommendation, Partial
• Declare competitor branded and generic availability timelines that will affect tiering assumptions and model inputs.
• Ask whether you require sensitivity analysis of tiering outcomes to utilization management intensity (for example PA vs step therapy vs none). Options: Yes - sensitivity required, No - not required
• Designate who will approve the final recommended rebate range or tiering proposal on your side (name and role).
• Quantify the minimum acceptable net price or formulary position threshold that you will accept (provide numeric net price target or tier target).

• Non-Disclosure Agreement (NDA)
• Master Services Agreement (MSA)
• Statement of Work (SOW)
• Payment Schedule Agreement
• Governance & Steering Committee Charter
• Data Processing Agreement (DPA) & HIPAA Business Associate Addendum (BAA) (conditional)
• Data Access & Security Addendum
• Acceptance Criteria & Delivery Sign-off
• Change Order Agreement
• Subcontracting & Third-Party Services Addendum

• Go-live health check (weeks 1-4 post-launch)
• First measurement review (weeks 4-10)
• 90-day realization review (around day 90)
• Monthly access operations stand-up
• Quarterly strategic access review

• Update the shared blocker log with revised owners and deadlines for any items discussed.
• Log prioritized enhancement and evidence requests into the shared backlog with acceptance criteria.
• Publish a schedule of monthly operational reviews and the quarterly strategic review dates.
• Review monthly formulary placement and PA trend
• Ensure top operational blockers are closed or on-track with new resolution dates.
• Demonstrate month-over-month movement in formulary placement or PA approval rate or document why not.
• Confirm the short list of enhancements to be delivered before the next stand-up.
• Re-confirm success criteria and owners
• Submit any expedited evidence updates or PA form adjustments to targeted payers.
• Publish the monthly access metrics snapshot in the shared channel for asynchronous review.
• Add mitigation tasks for top policy risks to the enhancement backlog with target dates.
• Schedule the next monthly and quarterly reviews and publish the execution plan to the shared channel.
• Quarterly trend analysis vs Engagement Scope targets
• Align on whether quarter-over-quarter progress meets the trajectory required by Engagement Scope targets.
• Identify and document top policy or competitive risks with mitigation actions.
• Agree and schedule the priority enhancements and payer engagements for the next quarter.
• Produce the quarterly access report summarizing metrics, risks, and the prioritized roadmap.
• Confirm all launch artifacts required by Engagement Scope were delivered and received by payers.
• Establish the shared issue-tracking channel and confirm access for all named owners.
• Produce a short remediation list with owners and deadlines for critical blockers.
• Distribute the deployment status report summarizing submissions and payer receipts to the shared channel.
• Open remediation tickets for each critical blocker with target resolution dates.
• Confirm and document contact points for urgent payer escalations in the shared channel.
• Present first measurement data vs Engagement Scope targets
• Determine whether formulary placement, PA approval rate, and coverage commitments are trending to the Engagement Scope targets.
• Document root causes for each major variance and commit to specific corrective actions with dates.
• Confirm the short list of payers requiring targeted follow-up and the timeline for that work.
• Publish the measurement dashboard snapshot and variance analysis in the shared channel.
• Submit targeted supplemental evidence or appeals to the top 3 payers driving the largest gaps.
• Schedule focused payer engagement calls for the identified gap payers within the agreed timeline.
• Present 90-day outcomes vs Engagement Scope targets
• Document final 90-day status for each named metric against Engagement Scope targets and record any remediation required.
• Agree concrete remediation tasks and timelines for any metric not meeting target, with clear criteria for closure.
• Prioritize the enhancement backlog items that impact access in the next 90 days.
• Deliver a remediation plan listing actions, owners, and dates for each underperforming metric.
• Root cause diagnosis for variances
• Deployment and artifact validation
• Policy and competitive risk review
• Decide remediation path for failed or underperforming metrics
• Blocker triage and burn-down
• Enhancement roadmap and prioritization
• Early signals and acknowledgements
• Payer commitments and contract updates
• Capture enhancement and evidence requests
• Agree corrective actions and owners
• Confirm ongoing monitoring cadence and reporting
• Open issues and immediate blockers
• Confirm next quarter execution plan
• Confirm timeline to next milestone
• Short-term enhancement prioritization
• Agree immediate remediation actions