Opening: Who Are You, and What's Pushing This Now?

• Tell us your role and the three people on your team who will be most involved in market access decisions for this program.
• What stage is your program in today (select the best match)? Options: Phase 2 safety/efficacy readouts pending, Phase 3 ongoing, Regulatory submission planned, Regulatory filing in progress, Post-approval preparations
• What immediate trigger prompted you to start this access work now (pick up to two)? Options: Phase 3 timing, Early payer advisory feedback, Competitor activity, Pricing committee request, Budget review, Other
• If you had to name the single biggest fear about launch-day access in one sentence, what would it be?
• Who in your organization will judge whether our engagement was successful—title(s) and their top success metric?

Who Really Pulls the Trigger? The People Behind the Decisions

• Who do you think holds the most informal influence over payer strategy decisions—and why might that differ from who has formal sign-off?
• List the internal and external stakeholder groups that will be involved in access decisions (choose all that apply). Options: Head of Market Access, VP/Head of Commercial, Chief Medical Officer, HEOR Director, Pricing Committee, Legal/Compliance, Finance, External Advisory Board, Key KOLs, Payor-facing account leads
• For each of the top three stakeholders you listed, what is their primary decision criterion (e.g., budget impact, clinical differentiation, reputational risk)?
• How aligned are those stakeholders today on (a) willingness to accept higher price for better access and (b) tolerance for innovative contracting? Options: Both well aligned, Aligned on price but not contracting, Aligned on contracting but not price, Mostly misaligned, Unsure
• Give an example of a past internal disagreement over pricing or access—what happened and how long did it take to resolve?

Money Talks: Budgets, Approval Paths, and Tradeoffs

• If budget constraints were removed, would your team change the access ambition for launch—why or why not?
• Which best describes how launch access budgets are set in your organization? Options: Centralized annual budget, Business unit-run with ad hoc approvals, Cross-functional pooled budget, No formal budget yet
• Select the budget/ARR range that best matches the allocation you expect to make for payer engagement and contracting over the next 12 months. Options: <$250k, $250k–$750k, $750k–$2M, $2M–$5M, >$5M, Undecided
• Who has final commercial sign-off on contracting terms and discounts (title or team)?
• How open is leadership to using value-based or outcomes-based payment models to secure access (pick one)? Options: Very open — already piloting, Open with constraints, Skeptical but negotiable, Not open
• If asked to prioritize, would leadership trade price concessions for broader formulary placement, or prefer a higher price with narrower coverage? Options: Trade price for broader access, Prefer price over breadth, Case-by-case, Undecided

What 'Good Access' Actually Looks Like (Stop Saying ‘Coverage’)

• Imagine we reopen this conversation 12 months after launch and you call it a success—what three concrete payer outcomes would need to be true?
• Pick the top measurable access targets you care about for launch (select up to three). Options: Formulary tier 1–2 placement, No step therapy, Low prior authorization rate (<10%), Preferred specialty network access, Contracting with top 5 PBMs, Inclusion in major ACO formularies, Positive ICER/reimbursement outcome
• What is an acceptable prior authorization or utilization management outcome that still feels like commercial success? Options: <10% PA rate, 10–25% PA rate, 25–40% PA rate, >40% PA rate, Unsure
• Which payer segments are highest priority to hit those targets (rank top 3)? Options: National commercial plans, Regional commercial plans, Large PBMs, Managed Medicaid, Medicare Part D, Integrated delivery networks (IDNs), Employer coalitions
• How important is speed of access vs. breadth of access to your commercial plan (choose one)? Options: Speed is paramount, Breadth is paramount, Equal importance, Depends on market/indication

Hidden Payer Roadblocks: What Keeps You Awake at Night?

• If a payer could pick one reason to delay or deny access, what do you suspect they'd use against your product? Options: Comparator not convincingly superior, Insufficient real-world outcomes, Unfavorable cost-effectiveness, Safety/long-term data gaps, Budget impact concerns, Other
• Which failure modes have you experienced before that could repeat here (select all that apply)? Options: Formulary exclusion, Harsh step therapy, Medicaid Preferred Drug List denial, Negative ICER assessment, Contract collapse late in negotiations, PBM carve-outs
• Describe a recent payer interaction that surprised you—what did you learn and how quickly did you act on it?
• How mature is your competitor/landscape monitoring—do you have rapid alerts for policy or formulary shifts? Options: Real-time monitoring, Quarterly reviews, Ad hoc/manual tracking, None
• Which external stakeholder could create an access blocker that is currently underestimated internally (e.g., PBM, large ACO, state Medicaid director)? Options: PBMs, State Medicaid, ICER/HTA groups, Large payers/regional plans, Employer coalitions, Other

Evidence & Storytelling: What Would Make Payers Say Yes?

• If payers only read one piece of evidence, which single asset would you want it to be and why?
• Which evidence assets do you already have (select all that apply)? Options: Phase 3 clinical data package, Health economic model, Real-world evidence plan, Value dossier, Advisory board findings, Budget impact model
• Where are the clearest evidence gaps that could trigger payer rejection (pick up to three)? Options: Long-term effectiveness, Comparative effectiveness vs. standard care, Subgroup benefit data, Real-world safety, Economic model assumptions, Patient-reported outcomes
• Who owns HEOR and evidence generation internally, and how accessible are they to a joint payer-facing program?
• Would you be open to running payer advisory boards or targeted real-world pilots to close acceptance gaps—what would stop you from doing that? Options: Yes, already planned, Yes, with funding, Maybe — concerns about time/data, No — not a priority

Timelines, Gates, and the Dates That Can't Move

• Which single date if missed would cause the biggest commercial or operational problem (launch week, payer contracting deadline, regulatory milestone, etc.)?
• List the hard and soft milestones you must hit over the next 12 months (select types that apply). Options: Regulatory submission/approval, PEP/ICER review window, PBM contracting cycle, Formulary committee meetings, Manufacturing/commercial supply readiness, Reimbursement policy changes
• How fixed are your internal decision gates (e.g., pricing committee, board sign-off) — are they date-driven or outcome-driven? Options: Date-driven and fixed, Mostly date-driven with some flexibility, Outcome-driven and flexible, Undetermined
• If one critical milestone slips, what contingency would you prefer: accelerate payer engagement, lower price, or delay launch? Options: Accelerate engagement, Lower price, Delay launch, Other/combination
• How much runway do you need for payer engagement before your key formulary decision dates (select one)? Options: <3 months, 3–6 months, 6–12 months, >12 months

Stakeholder Sentiment: Politics, Trust, and Hidden Agendas

• Who internally is quietly skeptical about the access plan, and what would they need to see to become an ally?
• How do the commercial and clinical teams view each other with respect to risk appetite and speed—aligned, mildly misaligned, or sharply divided? Options: Well aligned, Some friction but workable, Significant misalignment, Open conflict
• Has the company previously lost access because of internal politics or timing? What happened and what was the cost?
• On a scale from 1–10, how confident are you that people who need to agree will be in the room and able to make decisions when needed? Options: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
• What communication or governance cadence would reduce friction—weekly stand-ups, milestone approvals, or executive decision gates? Options: Weekly stand-ups, Bi-weekly reviews, Milestone approval meetings, Executive decision gates, Ad hoc as needed

If We Had 30 Days: Priorities, Deliverables, and Low-Noise Support

• If we could only deliver one high-impact thing in the next 30 days that would materially change your access odds, what should it be?
• Which deliverables would you prefer to see first (pick up to three)? Options: Rapid payer segmentation, Gap analysis of evidence vs. payer needs, Draft formulary value story, Priority payer outreach list, Contract term playbook, Milestone-based project plan
• What governance cadence do you want from a consulting partner (select one)? Options: Weekly tactical calls + monthly exec updates, Bi-weekly cross-functional meetings, Milestone-only check-ins, Embedded daily support
• Are milestone-based payment triggers acceptable to you, and if so, which milestones feel reasonable to tie to payments? Options: Yes — payer engagement milestones, Yes — evidence deliverable milestones, Yes — commercial readiness milestones, No — prefer time-based invoicing
• What would make you say 'this partner understood our business' after the first 30 days—list 2–3 specific signs.

Final Check: Risks We Must Mitigate Together

• What are the top three risks (operational, political, clinical, or payer-driven) that would cause you to pause or stop the program?
• For each risk you named, how severe would the impact be (select one for each): minor, moderate, or critical? Options: Minor, Moderate, Critical
• What existing mitigations do you already have in place for those risks, and where are the gaps?
• Which internal sponsor would you want us to brief monthly about progress and issues (title or team)?
• Finally, what would be a fair first milestone for us to commit to—one that delivers clear value but stays realistic? Options: 30-day payer priority list + gap map, Draft value dossier outline, Initial payer advisory board plan, Formulary modeling of 3 target payers

Starting Point: A Quick Snapshot

• Briefly describe the product (generic/brand name), therapeutic area, and current development stage (e.g., pre-BLA, rolling submission, commercial).
• What is your target launch geography for initial payer access? Options: U.S. commercial plans, Medicare Part B, Medicare Part D, Medicaid (state-by-state), Global markets (specify), Other
• Which of these best describes your current internal urgency around payer access? Options: Immediate — outreach needed now, High — within 3–6 months, Moderate — 6–12 months, Planning stage — >12 months, Unsure
• Who are the primary internal owners for commercial access (names/roles), and who will be the single point of contact for coordinating evidence and payer outreach?
• How would you describe your existing relationship strength with payers overall? Options: Strong (trusted partner), Transactional (known but limited), Weak (limited contact), Adversarial/unknown

If Payers Were the Jury, What Would They Say?

• Which payers, PBMs, or IDNs do you believe will be most decisive for your launch access? (list top 5).
• Which payer types are highest priority for early wins? Options: National commercial MCOs, Regional commercial MCOs, National PBMs, Regional PBMs, Integrated Delivery Networks (IDNs), Specialty pharmacy chains, Medicaid MCOs, Other
• How would you categorize each top payer’s stance today: supportive, neutral, skeptical, or opposed? (please map payer → stance) Options: Supportive, Neutral, Skeptical, Opposed, Unknown
• For payers where relationships already exist, what tangible assets or contacts do you hold (e.g., named medical directors, contracting leads, account teams)?
• What has been the single most effective tactic with payers in prior launches (advisory boards, KOL letters, economic models, contracting pilots, other)? Options: Payer advisory boards, Local KOL engagement, Real-world evidence packages, Budget impact models, Indicator-based contracting, Pilot agreements, Other

Evidence: What’s Truly Persuasive (and What’s Missing)?

• If a skeptical payer asked for proof that your therapy changes clinical practice, what three pieces of evidence would you hand them first?
• Which evidence assets do you currently have complete and shareable? Options: Phase 3 primary endpoint results, Subgroup analyses, Health economic model (BU/BIA), Cost-effectiveness model (CEA), Real-world evidence (claims/EMR), Burden-of-illness data, Patient-reported outcomes, Value dossier, None of the above
• Which ongoing or planned studies could meaningfully change payer perception in the next 12 months?
• Where are your biggest evidence gaps relative to payer expectations (e.g., long-term outcomes, comparative effectiveness, subgroup data, adherence, safety in comorbid populations)?
• How confident are you that your current HEOR and real-world evidence strategies would survive a tough ICER-style review? Options: Very confident, Somewhat confident, Not confident, Not sure

Pricing & Negotiations: Where Have We Won or Lost?

• When pricing discussions occurred internally or externally, what argument or data point repeatedly failed to land with payers?
• What is your proposed list price or WAC band, and how flexible is it (% discount or range you are willing to consider)?
• Which contracting mechanisms have you used or are open to (select all that apply)? Options: Flat discount/rebate, Indication-based pricing, Outcomes-based contracts, Risk-sharing (cost per outcome), Volume guarantees, Time-limited access programs, Other
• Have you historically accepted formulary placement trade-offs (tier movement vs. net price) and how were those decisions made? Options: Yes — routinely, Occasionally — case-by-case, Rarely, Never
• Which competitor pricing or reimbursement actions pose the biggest threat to your commercial assumptions?

What’s Killed Access Before? Failure Modes We Can’t Ignore

• If you had to name the single most likely failure mode on launch day, what would it be (e.g., blanket formulary exclusion, PA criteria too restrictive, supply/logistics issues)?
• Which of these past failure modes have you experienced on other products? Options: Formulary exclusion, Overly restrictive PA/step edits, Negative HTA/ICER assessment, Coding & billing issues, Insufficient economic evidence, Contracting delays, Supply disruptions, Other
• For a recent failure you experienced, what root cause did you identify and how long did remediation take?
• Which internal or external dependencies most commonly amplify these failure modes (e.g., legal approvals, data sharing limitations, PBM contracting cycles)?
• Who in your organization owns failure-mode mitigation today, and do they have clear authority and budget to act? Options: Commercial/Access lead, HEOR lead, Legal/Compliance, Market Access team, Cross-functional governance, Not assigned

Who Moves the Needle? The Decision Ecosystem

• If you had to pick one person or role at payers whose support would unlock broad access, who is it—and what would convince them?
• Which internal stakeholders will be critical for payer conversations and what does 'good access' look like to each (e.g., formulary tier, PA rules, contracting terms)?
• Are there known payer champions (individuals or offices) willing to speak on behalf of the product? If so, please name and describe the relationship.
• Which external influencers (KOLs, patient groups, disease foundations) do payers respect in this therapeutic area?
• How aligned or misaligned are commercial, clinical, and HEOR teams internally on the access strategy? Options: Fully aligned, Mostly aligned with exceptions, Significant misalignment, Unclear

Operational Readiness: Could We Start Outreach Tomorrow?

• If outreach began next week, which of the following would you be able to share immediately with payers? Options: Clinical trial results summary, Value dossier, Budget impact model, Economic model, Patient materials, None of the above
• Which data sources and model versions are finalized and auditable (claims datasets, EMR, CEA/BIA versions)?
• What payer contact lists and CRM workflows exist to support targeted outreach? Options: Comprehensive payer contact list, Partial lists by region, No formal list — ad hoc contacts, Rely on external network/consultants
• Are there legal/compliance or data use constraints that would prevent sharing certain evidence or contracting pilots with payers? Options: Yes — major constraints, Some constraints but manageable, No constraints known, Unsure
• What are the three biggest operational risks that would break a payer meeting or a contracting negotiation?

Access Scenarios & Success Signals: What Counts as Winning?

• What minimum formulary outcome would make the launch commercially viable (e.g., preferred tier, open without PA, limited PA with step-down)? Options: Preferred tier (no PA), Preferred tier with simple PA, Non-preferred with manageable PA, Specialty carve-out, Other
• Which quantitative KPIs will you track to judge access success in the first 12 months? Options: Formulary tier placements, Prior authorization approval rate, Script volume vs. target, Net realized price, Patient continuation/adherence, Other
• What timing window (months before launch) do you believe is the last point to materially influence payer decisions? Options: >12 months, 9–12 months, 6–9 months, 3–6 months, <3 months
• Which payer segments would you prioritize for pilots or early contracting to create momentum? Options: Regional commercial MCOs, National PBMs, IDNs, Top 5 payers by membership, Medicare Part D plans, Medicaid MCOs
• What would be a credible early success (a small win) that changes internal confidence in the launch?

Timing & Milestones: The Dates That Can Make or Break Us

• Which upcoming external milestones could shift payer positions (ICER timelines, competitor readouts, guideline updates, regulatory decisions)? Please list dates where known.
• Are there internal milestones or decision gates (pricing committee, board approvals, budget cycles) that constrain our ability to negotiate?
• Which contractual or procurement cycles at payers (e.g., formulary review windows, PBM contracting periods) do we need to align with?
• If we could only attend one external forum or advisory in the next 6 months, which would it be and why?
• Which single missed date would have the largest negative impact on launch access?

Commitment & Next Steps: What Would It Take To Move Forward?

• What would cause you to cancel an external market access partnership within the first 90 days?
• What governance cadence do you prefer for an access engagement (weekly touchpoint, biweekly steering, monthly executive reviews)? Options: Weekly working sessions, Biweekly project reviews, Monthly executive steering, Ad hoc as-needed
• What level of data-sharing and transparency are you willing to provide to a partner (full datasets, aggregate only, no raw data)? Options: Full datasets under DUA, Aggregate summaries only, Selective sharing by request, No raw data
• What are your budgetary guardrails or procurement constraints for vendor engagements of this type?
• What immediate next step would be most helpful: a rapid payer landscape memo, an evidence gap assessment, a mock formulary model, or a pricing sensitivity run? Options: Rapid payer landscape memo, Evidence gap assessment, Mock formulary/modeling run, Pricing sensitivity analysis, Other

Quick introductions — who’s in the room?

• Who on your team will be our primary day-to-day contact for launch access activities (name, role, email)?
• Which internal functions are formally committed to launch access (select all that apply)? Options: Commercial/Launch, HEOR/Outcomes, Medical Affairs, Regulatory, Legal/Compliance, Market Access, Pricing, Other
• What is your target commercial launch window (month/quarter and year)? Options: Within 3 months, 3–6 months, 6–12 months, 12–18 months, 18+ months, Unsure
• Tell us briefly: what previous launch experience (if any) on your team informs expectations here?
• Which outcome from this engagement would make your leadership say “this was worth it”? Options: Preferred formulary tier, Reduced PA burden, Favorable contracting, Clear pricing strategy, Convincing HEOR narrative, Other

What keeps you up at night about launch access?

• If launch day went poorly, what single payer action would cause the biggest strategic pain for you? Options: Formulary exclusion, Restrictive prior authorization, Unfavorable tiering, Low net reimbursement from contracting, Negative ICER review, Supply stranded
• Which payer segments are you most worried about right now (pick up to three)? Options: National PBMs, Regional PBMs, Integrated delivery networks (IDNs), Commercial plans, Medicaid programs, Medicare Part D plans, Specialty pharmacies
• How much commercial inventory (weeks of supply) could be stranded if access delays occur? Options: None, 1–4 weeks, 1–3 months, 3+ months, Unsure
• Describe a prior launch or access challenge you've faced and what you learned from it (specific example).
• How does the potential access risk feel to you and your team—manageable, alarming, or somewhere in between? Options: Very alarming, Somewhat concerning, Manageable with support, Not a concern

Where the evidence meets reality — what do payers actually need?

• What are the top three evidence gaps you’ve heard from payers or advisors? Options: Comparative effectiveness vs. SOC, Long-term durability/survival, Real-world safety, Economic burden data, Health-related quality of life, Adherence and persistence, Other
• Which existing evidence assets are ready to share with payers today (select all that apply)? Options: Phase 3 clinical data, Indirect treatment comparisons, Economic model drafts, Value dossier, RWE/claims analyses, Advisory board summaries, None
• What data sources do you have access to for modeling and payer conversations (choose all that apply)? Options: Clinical trial datasets, Claims databases, EHR datasets, Patient registries, Commercial market data, Proprietary surveys, None/limited
• Do you have a finalized economic model version and a formal version-control process in place? Options: Yes — model ready and versioned, Model exists but needs version control, Draft model only, No model yet, Unsure
• Who on your team owns HEOR/model sign-off, and what is their availability for iterative review?

Who actually opens the doors — mapping the decision influencers

• If you had to name the three payer roles whose buy-in frees access fastest, who are they?
• Do you have up-to-date contact lists for payer decision-makers and PBM formulary leads? Options: Comprehensive and verified, Partial and needs updating, Minimal contacts available, No contacts
• Which external relationships currently give you the most leverage (select up to two)? Options: Existing PBM champions, KOLs with payer credibility, IDN pharmacy directors, Contracting intermediaries, Patient advocacy groups, None
• Who will be the designated outreach owner for payer engagement (internal vs. our team)? Options: Client-owned, Consultant-owned, Joint ownership, Undecided
• How comfortable are you with sharing draft dossiers/models with external payers at this stage? Options: Very comfortable, Comfortable with NDA, Prefer to wait until later, Not comfortable

If we were going to fail before deployment — what would be the reason?

• Which operational gap most often causes last-minute derailment for launches you’ve seen? Options: Missing payer contacts, Unvalidated economic model, No clear owner for sequencing, Governance delays, Legal/compliance bottlenecks, Data access problems
• Do you have a documented governance cadence and decision gates tied to launch milestones? Options: Yes — documented and active, Draft governance, Verbal plan only, No governance structure
• What third-party dependencies (vendors, specialty pharmacies, data partners) pose the biggest execution risk?
• How quickly can your team resolve discrepancies between model outputs and clinical team expectations? Options: Within days, 1–2 weeks, Several weeks, Depends on issue, Unsure
• What legal, compliance, or contracting constraints could limit what we present to payers? Options: Medical claims use limitations, GDPR/PHI constraints, Manufacturer contracting restrictions, Government price reporting concerns, None known, Other

What would launch-day confidence look and feel like?

• Which success metrics should we use to judge pre-deployment readiness (choose all that apply)? Options: Validated economic model, Verified payer contact list, Dossier completed, Advisory board conducted, Defined contracting strategy, Clear launch milestone plan
• What thresholds would make you comfortable to begin payer outreach (e.g., % of model features validated, dossier completion percent)?
• How will you measure early outreach effectiveness (select primary metric)? Options: Rate of payer engagement, Favorable formulary feedback, Reduction in PA requirements, Speed to contracting conversations, Qualitative payer sentiment
• If we achieved an ideal state before outreach, what would your leadership want to see in a 1-page readiness snapshot?
• How much runway (in weeks) do you need between readiness sign-off and first external outreach? Options: Immediate (0–2 weeks), 2–4 weeks, 1–2 months, 2+ months, Undecided

Ready, set, who does what — aligning owners and next steps

• If we agree on a pre-deployment checklist today, who will own completing each item on your side? Options: Commercial lead, HEOR lead, Medical affairs, Legal/Compliance, Data/Analytics, Dedicated program manager
• Which of the following should be our first joint milestone before outreach? Options: Finalize economic model version, Complete value dossier draft, Run payer advisory board, Assemble payer contact list, Agree on contracting approach
• What risks should we immediately mitigate before sending materials to payers, and what is your preferred mitigation for each?
• How would you prefer we handle model updates during outreach—centralized version control or localized tailored variants per payer? Options: Centralized single source, Tailored payer variants, Hybrid approach, Undecided
• Realistically, when can we commit to a date for the first outreach (week/month)? Options: Within 2 weeks, 2–4 weeks, 1–2 months, 2+ months, TBD
• Any immediate blockers that would prevent your team from signing off on a readiness checklist this quarter? Options: Data access gaps, Internal alignment unresolved, Budget constraints, Regulatory timing, None, Other

Setting the Table: Quick Snapshot

• In one sentence, what is the single biggest access risk you’re losing sleep over for this launch?
• Which launch milestone are you currently preparing for? Options: Pre-Phase 3 / planning, Phase 3 readout, Regulatory submission, Pre-launch (6–18 months out), Launch imminent (0–6 months)
• Select the payer segments that are most important to your launch success Options: National commercial plans, Regional / Blues plans, PBMs, Integrated delivery networks (IDNs), Medicaid (state programs), Medicare Part D, Specialty pharmacies, Other
• Who is our primary counterpart on your team for payer strategy and execution? Options: VP Market Access, Head of HEOR, Commercial Launch Lead, Director of Payer Strategy, Other
• Roughly how many payer engagements or advisory boards have you completed in the last 12 months? Options: None, 1–2, 3–5, 6–10, 10+
• Which evidence assets do you currently have ready or in near-complete form? Options: Value dossier, Budget impact model, Cost-effectiveness model, Real-world evidence study, Advisory board summaries, Comparative clinical data, None of the above

If We Don’t Fix This, Who Gets Hurt?

• Why do you think payers might deny or delay access for this product—what’s the unspoken reason they’d give?
• Which of these payer objections have you already heard in advisory boards, calls, or informal feedback? Options: Formulary exclusion, Step therapy preference, Cost-effectiveness concerns, ICER or HTA exposure, Insufficient real-world evidence, Safety/tolerability concerns, Other
• How quickly would an unfavorable formulary decision affect your commercial forecast? Options: Immediately (launch inventory stranded), Within 3 months, 3–6 months, 6–12 months, Minimal impact
• Tell me about a past launch where payer resistance surprised you—what broke down and why?
• How do these potential access failures make your team feel—frustrated, resigned, anxious, or something else? Options: Anxious, Frustrated, Resigned, Motivated to act, Other

Are Our Evidence Assets Persuasive—or Just Pretty?

• If a skeptical payer looked at your dossier and models, which single piece of evidence would they call out as weakest?
• Which evidence types are you relying on most to make the value case? Options: Randomized controlled trials, Indirect comparisons / network meta-analysis, Real-world evidence, Budget impact analyses, Cost-effectiveness models, Patient-reported outcomes, Other
• How confident are you that your economic model assumptions match payer decision-making realities (e.g., comparator mix, target population, resource use)? Options: Very confident, Somewhat confident, Neutral, Somewhat doubtful, Not at all confident
• Which payer-facing evidence have you stress-tested with an external advisory board or payer reviewers? Options: Full dossier, Key slides / executive summary, Model outputs, Budget scenarios only, We haven’t stress-tested externally
• Describe a specific evidence gap a payer could seize on and how that would change the access outcome.

Are We Modeling Reality—or Hope?

• What’s the one assumption in your economic or budget model that, if wrong, destroys your access case?
• Which model inputs are underpinned by hard data versus expert opinion? Options: Clinical inputs (trial data), Resource utilization estimates, Adherence / persistence, Price and discounting assumptions, Market share uptake, None are fully data-driven
• How many distinct model versions do you currently maintain and how do you control versioning? Options: Single master version, 2–3 versions, Multiple parallel versions (4+), No formal version control process
• When assumptions are challenged by payers, who on your team is empowered to update the model and re-run scenarios in real time? Options: HEOR lead, Modelling analyst, Market access lead, External consultant, No one currently assigned
• Walk me through a worst-case sensitivity test you’ve run—what did you learn and how did it change strategy?

What Would a Payer Say at Their Worst Moment?

• If a payer wanted to exclude your product, what three talking points would they use in negotiation or a committee memo?
• Which negotiation levers are you prepared to deploy (price, outcomes contracts, restrictions, step therapy) and which are off the table? Options: Price discounting, Outcomes-based contracting, Volume-based rebates, Prior authorization with criteria, Step therapy protocols, Exclusion (no contract)
• How quickly could your commercial team approve a deal term a payer requests in a meeting—days, weeks, or months? Options: Same day, 1–3 days, Within 1–2 weeks, Several weeks, Requires multiple governance approvals
• Who is the single escalation contact that can greenlight a concession that materially changes access outcomes? Options: CEO / C-suite, VP Market Access, Head of Commercial, Finance Lead, No single contact / committee
• What would you walk away from—what’s an absolute red line in payer negotiations for this product?

Behind Closed Doors: Internal Alignment Under Pressure

• If payers push back hard at launch, who internally must be aligned before you change pricing or contracting strategy? Options: Commercial leadership, Finance, Legal / Compliance, Medical / HEOR, Board / Investors, Regulatory
• How do you currently document and approve launch acceptance criteria (e.g., minimum formulary tier, maximum PA rate)? Options: Formal scorecard with thresholds, Informal email approvals, Governance committee, Not documented
• When a proposed change conflicts with clinical labeling or regulatory commitments, who adjudicates the trade-off? Options: Regulatory counsel, Medical affairs, Legal, Commercial leadership, Cross-functional committee
• How emotionally prepared is your executive team to accept a less-than-ideal access outcome at launch? Options: Ready to accept trade-offs, Reluctant but realistic, Resistant and optimistic, Not prepared
• Describe a scenario where internal misalignment previously derailed a rapid response to payer feedback—what could have prevented it?

Have We Given Payers What They Actually Need?

• Which payer evidence formats have you validated for acceptability (e.g., ICER-style submissions, real-world analyses, budget impact one-pagers)? Options: Full dossier, Executive summary one-pager, Budget impact model file, Technical appendix for models, Patient-level RWE, None validated with payers
• How do payers prefer to receive model inputs—live model, static slides, or interactive calculators? Options: Live model with user access, Static model output tables, Interactive web calculator, Slide-based summaries, Depends on payer
• Have you mapped payer evidence needs to specific committee decision criteria (e.g., comparative effectiveness for Pharmacy & Therapeutics, budget impact for finance)? Options: Yes, fully mapped, Partially mapped, Not mapped yet
• Which external reviewers or payers would you trust to pilot-test your dossier and why?
• If a payer asked for one additional analysis tomorrow, what would it be and how long would it take to deliver?

Go / No-Go: How Do We Know We’re Ready?

• What are the top three measurable acceptance criteria that must be met before you initiate payer outreach?
• Which of these launch signals would automatically pause outreach or trigger a revised strategy? Options: Negative ICER draft, Major comparator label change, Material safety signal, Unresolved model uncertainty, Investor/board directive
• How will you objectively measure success during the first 6 months post-launch (select primary metrics)? Options: Formulary tiering, Prior authorization denial rate, Time to contract, Patient starts / prescription volume, Market share vs. plan targets, Other
• Who signs the launch readiness certificate and what is the cadence for re-checking acceptance criteria? Options: VP Market Access, Commercial lead, Joint sign-off: Access+Finance, Governance committee sign-off, No formal sign-off
• If early outcomes fall short of targets, what is the first three-step escalation plan you would enact?

So What’s Next—Concrete Steps and Ownership

• Which of the following immediate actions would move you from ‘risky’ to ‘ready’ in the next 30 days? Options: Finalize dossier and executive summary, Complete sensitivity analyses, Run payer advisory board feedback, Establish negotiation playbook, Secure internal governance sign-off
• Who on your team will own each of these deliverables (name and role)?
• What single outside resource or capability would change the trajectory of your launch access probability? Options: Payer advisory board facilitation, Advanced formulary modeling tool, Outcomes contracting expertise, RWE generation partner, Pricing strategy specialist, Other
• How urgent is this need on a scale from 1–5, and what deadline should we target together? Options: 1 — Low urgency, 2, 3 — Moderate, 4, 5 — Critical / Immediate
• Finally, describe one fear and one hope you have for this launch that we should keep front and center during validation.