Specialty Pharmacy Channels
Regulated development and commercialization journeys where clinical, quality, and market access align.
Inside this journey
-
Pre-Discovery
Align the room on outcomes, decision process, and constraints before deeper discovery.
-
Stakeholder Alignment
Confirm decision roles, timelines, success metrics, and constraints around limited distribution, payer rules, and manufacturer requirements.
Alignment Questions
Getting Oriented Together
- Who are you representing in this initiative and in one sentence what outcome do you need from a specialty pharmacy partner?
- Which therapeutic areas or product launches are highest priority for this engagement?
- Which internal teams will need visibility or integration with our service (pick all that apply)?
- How have previous specialty pharmacy relationships performed against your expectations—brief example of a win or a failure?
- What is your ideal decision timeframe for selecting a partner?
Why Does Prior Authorization Still Add Weeks?
- Why are prior authorizations still adding weeks — not days — to therapy starts at your organization?
- Where in your PA workflow do cases most commonly stall?
- On average, how long does a typical PA take from submission to approval today?
- What percentage of PAs require an appeal or step therapy override?
- When PA delays occur, what internal escalation paths do you use and who gets visibly accountable?
Who's Really Calling the Shots?
- If you map the last 10 specialty approvals, whose decision or influence changed the outcome most often?
- Which decision roles must be aligned before you’ll sign a contract (select all that apply)?
- What timelines and constraints are non-negotiable from your side (e.g., reporting cadence, SLA hours, handling of LDN requirements)?
- Which single metric would make leadership say this partnership was clearly successful?
- Who typically signs off on acceptance criteria for pilots and how many review cycles are normal?
Where Patients Most Often Fall Off the Rails
- Which single step in the patient pathway is currently losing the most patients to abandonment?
- Which factors drive patient abandonment most in your population (select all that apply)?
- What percentage of newly prescribed specialty patients do not receive their first dose within 30 days?
- Tell us about a recent patient who dropped out — what happened and how did it feel to your team?
- How do you currently measure and report adherence and persistence for specialty therapies?
Cold Chain: The Quiet Risk No One Talks About
- How many times in the past 12 months has a cold-chain breach impacted patient therapy or required dose replacement?
- Which cold-chain capabilities are must-haves for you (select all that apply)?
- Describe a recent logistics failure (if any) and how it affected patient experience or cost?
- What maximum temperature excursion or time-out-of-range is acceptable before a dose is considered compromised?
- Which vendors or couriers do you currently trust to handle biologics reliably?
Limited Distribution & Manufacturer Rules: Where Flexibility Dies
- When manufacturer distribution rules change overnight, how quickly can your patients be re-routed without delay — and what usually breaks when that happens?
- Which manufacturers or products in your portfolio require limited distribution today?
- How long does onboarding into a new LDN typically take for you?
- What documentation, accreditation, or security controls do manufacturers demand from partners in your experience?
- Has an LDN restriction ever caused a patient to delay or stop therapy? Tell us what happened.
If We Succeed, What Must Change?
- If your CFO asked for a one-line measurable outcome for this program, what would you give them?
- Which of these success signals will you prioritize (pick up to three)?
- For the primary signal you picked, what is your target benchmark and by when?
- How do you prefer to receive outcome reporting (select all that apply)?
- Who will be accountable on your side for monitoring and signing off on these outcomes?
If We Move Forward, What Would Kill the Deal?
- What are the top three deal-breakers that would cause you to stop a pilot before completion?
- What integrations or data access must be in place before launch?
- What accreditation, audit, or compliance evidence will your organization require from a partner prior to go-live?
- Realistically, what is the earliest date you could start a small pilot if prerequisites were met?
- What support from us would make your stakeholders say yes faster (e.g., short technical demo, sample SLA, reference call)?
-
Current State Mapping
Document existing PA workflows, benefits coverage gaps, patient abandonment drivers, cold-chain capabilities, and integration points.
Current State
Getting Comfortable — Who You Are and What You Carry
- Tell us briefly about your organization and the patient populations you most commonly manage (therapeutic areas / conditions / volume).
- Which stakeholders are typically involved when specialty prescriptions move from prescriber to patient (select all that apply)?
- Roughly how many new specialty patients per month do you handle (or expect to handle) across the therapies we’re discussing?
- Who is the primary operational contact we should map with for workflow details (role and email or phone)?
- What existing performance metrics do you track today that reflect access and start-of-therapy success (e.g., time-to-first-fill, PA approval rate, abandonment %, enrollment in assistance)?
What If Prior Authorizations Never Pushed Back a Start Date?
- How often do prior authorizations delay therapy initiation in your population—more often than you expect, about as expected, or less frequently?
- When a PA causes a delay or denial, where in your current workflow does it most commonly get stuck (clinician submission, payer review, missing documentation, appeals, patient follow-up)?
- What are the top three reasons payers are denying or placing barriers on approvals today? Please provide examples or recent denial language if available.
- How long is the average round-trip time from initial prescription to PA decision today (in calendar days)?
- Who owns escalation when a PA is urgent—your team, the prescriber, the manufacturer, or the payer—and how comfortable are you with that handoff?
- Describe a recent PA that took significantly longer than expected—what happened, and how did it impact the patient and budget?
Where Patients Drop Out — And Why It Hurts
- When you think about patient abandonment, what feels most unfair or avoidable about how those patients are lost?
- At what point in the patient journey do most abandonments occur for your therapies (prescription not picked up, PA denied, copay sticker shock, waiting for financial assistance, side effects during induction)?
- How do you currently capture why a patient stopped the process—do you have a structured reason code, frontline notes, or mostly anecdotal tracking?
- What percentage of patients who receive a prescription never start therapy today (best estimate)?
- Which of the following interventions have you tried to reduce abandonment, and which felt most effective?
- Share a short story of a patient who nearly abandoned therapy but was retained—what changed and who made the difference?
Unseen Coverage Holes That Keep Coming Back
- If a single payer policy could be rewritten to remove your biggest barrier to coverage, what would you change and why?
- Which benefit design features most frequently block access for your therapies (select all that apply)?
- How consistent are coverage rules across the payers you work with—mostly uniform, some variation, or highly inconsistent?
- Do you receive real-time benefit verification (RTBV) or are you relying on manual eligibility checks? If manual, how often does benefit info prove inaccurate?
- How frequently do patients face retroactive denials or recoupments after therapy has started, and how is that handled operationally?
- Where do coverage exceptions or appeals tend to succeed or fail—who are the people/processes that win exceptions for your patients?
Cold Chain: Is Your Drug Truly Protected End-to-End?
- When a therapy requires cold-chain handling, what keeps you up at night about its journey from dispenser to patient?
- Which elements of your cold-chain are owned internally versus outsourced (select all that apply)?
- How often do you experience temperature excursions or delivery failures, and what is your current escalation path when that happens?
- Do you require chain-of-custody documentation and temperature proofs for each shipment today, and how is that information stored or shared?
- Are there geographic areas or patient settings where cold-chain delivery consistently fails (rural addresses, home freezers, LTC facilities)? Please describe.
- What SLA do you currently promise for cold-chain deliveries, and how often do you meet it?
Systems That Should Talk — But Don’t
- Imagine real-time visibility into every specialty patient’s status—what decisions would that allow you to make that you can’t make today?
- Which systems do you currently use that must integrate with a specialty pharmacy partner (select all that apply)?
- Do you have existing APIs, SFTP feeds, or HL7/FHIR endpoints available for us to connect to, and what is the expected timeline/IT resource availability for integration?
- Where do handoffs fail between your systems and external partners today (e.g., lost messages, duplicate records, delayed reporting)?
- What reporting cadence and format do you need (real-time dashboard, daily batch, weekly summary, event-driven alerts)?
- Who is your technical point of contact for integrations and what firewall/whitelisting requirements do they typically require?
If You Could Snap Your Fingers — The One Fix That Changes Everything
- If one single operational change could cut time‑to‑therapy in half tomorrow, what would it be and why would it matter most to your stakeholders?
- Which of the following outcomes would signal success to you in the first 90 days of a new partnership (select top 2)?
- What constraints must we respect if we were to implement that change (limited distribution rules, budget caps, contract terms, accreditation requirements)?
- How would you prioritize trade-offs between speed, cost, and patient experience for this therapy—put them in order (1 = most important)
- Who needs to sign off internally for us to pilot a focused improvement (roles and ideal timeline)?
- What would success look like at 30, 90, and 180 days—please list one measurable metric for each timeframe.
-
-
Outcome Discovery
Define target outcomes, measurable success signals (PA speed, adherence, financial assistance enrollment, LDN participation), and cost impact expectations.
Discovery Questions
Starting Point: Which outcome matters most right now?
- Which single outcome are you most focused on improving in the next 12 months?
- Tell us the story behind that choice—why is this outcome the top priority for your team?
- How do you currently define and measure this outcome (primary metric and data source)?
- Who in your organization is accountable for that metric (role/title)?
- If we could change one thing about how that metric moves today, what would it be and why?
If We Do Nothing: The Real Cost
- How would continuing with your current approach cost you in patient outcomes, dollars, or reputation over the next year?
- Estimate the annualized budgetary impact of current delays or failures (choose a range).
- Which source accounts for the largest portion of that cost?
- How many patients per month do you estimate abandon therapy before first fill?
- When you present these costs internally, what reactions or actions typically follow?
What’s Truly Blocking Better Outcomes?
- If faster approvals and enrollments are the goal, what single structural blocker would you remove first—and why?
- What is your average time from prescription to PA submission and then to approval (select closest)?
- Describe the most common failure mode in your PA workflow (e.g., missing clinical info, payer denials, field delays).
- Which payer rules or manufacturer LDN mandates cause the most workflow friction for you?
- How predictable are approval outcomes across therapeutic areas you manage?
Signals That Make Us Say 'This Works'
- What combination of measurable signals would make you confidently say a specialty pharmacy partnership is delivering value?
- For the signals you picked, what target threshold would you consider a success (give specific % or time goals)?
- How frequently do you need these signals reported to feel in control?
- Who on your team must have direct access to these reports (roles)?
- What level of variance or error in these metrics would be tolerable (e.g., ±5%, ±10%)?
Money, Models, and What 'Worth It' Means
- If a partnership could reduce total cost of care by X%, what minimum X would make you move forward?
- Which cost buckets matter most when evaluating ROI?
- Which commercial models are you most open to exploring?
- Describe a past commercial structure that felt fair—or one that failed—and why.
- How long does your procurement/contracting process typically take from term-sheet to signature?
The Patient Story: What Success Looks Like for Them
- If a patient could describe the ideal first 30 days on therapy, what three words would you hope they'd use?
- Where do most patients fall out of the care pathway—what moment causes the biggest emotional or logistical drop-off?
- Which interventions have demonstrably reduced abandonment or increased adherence in your population?
- How much do caregiver or provider touchpoints influence adherence versus automated/digital approaches?
- What patient-reported outcomes or experiences would you like to capture that you currently don’t?
Can We Operationalize This? Reality Check
- If we promised faster time-to-therapy but it required changes to your workflows, which compromise would you be most reluctant to make?
- Which systems must integrate to make outcomes visible and actionable (pick all that apply)?
- What regulatory, credentialing, or limited distribution requirements would prevent a go-live?
- What SLAs are non-negotiable for you (e.g., PA turnaround, dispensing windows, cold-chain delivery windows)?
- What internal resources (FTEs, clinical staff, IT) are you willing to allocate to a pilot or initial deployment?
Decision Gravity: Are We Ready to Change?
- What single proof or deliverable in the next 90 days would make you move from evaluation to commitment?
- Who are the decision-makers and approvers we need to engage (roles/titles)?
- What risks or events in the next 30–60 days would most likely derail a deal?
- If we proposed a focused 90-day pilot, what would success look like and what internal commitments would you provide?
- Anything else—hidden constraints, politics, or past experiences—we should know before designing the outcome plan?
-
Solution Experience
Walk through how dispensing, clinical management, and logistics deliver the agreed outcomes using real patient and payer scenarios.
Experience Meetings
- Current State & Consequence Alignment
- Dispensing Flow — Patient & Payer Scenario Walkthrough
- Clinical Management Scenario Walkthrough (Enrollment, Adherence, Side-Effect Management)
- Logistics, Cold-Chain & Limited Distribution Execution Walkthrough
- Integrated End-to-End Validation & Acceptance Criteria
- Agree on exception SLAs and the reporting required for audit and clinical teams.
- Seller: Produce a redlined end-to-end process map for each scenario showing current-state vs. proposed timings.
- Customer: Approve or modify the chosen scenarios and confirm any additional payer contacts needed for LDN cases.
- Seller: Draft proposed dispensing SLAs and the dashboard fields that will surface status to the customer.
- Preconditions Check & Clinical Objectives
- Prove how clinical workflows materially reduce abandonment and improve adherence for the supplied patient cases.
- Agree on the clinical escalation rules and the measurement set that will demonstrate outcomes.
- Confirm integration points and data feeds needed to populate clinical dashboards.
- Seller: Provide a sample clinical touchpoint schedule and the expected adherence improvement baseline estimates.
- Customer: Confirm patient privacy and data-sharing approvals required for the clinical interventions.
- Seller: List required EHR/portal integration fields to support real-time clinical status updates.
- Preconditions & KPIs
- Demonstrate reliable cold-chain handling and measurable controls that meet regulatory and manufacturer expectations.
- Confirm LDN workflows do not add unacceptable delay and that manufacturer controls are respected.
- Introductions & Objectives
- Seller: Share standard operating procedures and temperature-monitoring specs for cold-chain shipments.
- Customer: Provide manufacturer LDN contact points and any contract constraints for inclusion in the LDN playbook.
- Seller: Draft example exception report and remediation timeline to be used in acceptance testing.
- Recap of Agreed Current & Future State
- Finalize measurable acceptance criteria that directly map to the earlier quantified consequences.
- Assign owners and timelines for acceptance testing and secure agreement on the formal signoff process.
- Create a clear handover plan to Deployment with defined artifacts and responsibilities.
- Seller: Produce a formal Acceptance Criteria document with KPI targets and test scripts within 3 business days.
- Customer: Nominate test owners and provide availability for acceptance test windows.
- Seller & Customer: Schedule the first end-to-end acceptance test and set the reporting cadence for progress updates.
- Agree on an explicit, one-sentence current state that the customer recognizes as accurate.
- Surface and quantify the tangible consequences (financial, clinical, timing) of the current state.
- Define a one-sentence future state and measurable success signals to be proven in scenario walkthroughs.
- Confirm decision owners, constraints (LDN, payer rules), and required prework for subsequent sessions.
- Customer: Deliver confirmed one-sentence current state and metrics dataset (PA times, abandonment, cold-chain exceptions) within 3 business days.
- Seller: Draft candidate one-sentence future state and initial list of success signals to share before the next meeting.
- Seller: Identify owners for each constraint (LDN, payer rule contacts) to invite to relevant walkthroughs.
- Preconditions Check
- Validate that the dispensing flow demonstrably shortens time-to-initiation and reduces manual rework for the provided scenarios.
- Confirm how limited distribution requirements are handled without adding cycle time.
- Align on SLA targets and the reporting fields required to prove success to payers and prescribers.
- State Statement Confirmation
- Scenario Walkthrough — Enrollment & Initial Counseling
- Scenario 1 — Standard Specialty Prescription
- End-to-End Synthesized Scenario Run
- End-to-End Cold-Chain Scenario
- LDN Onboarding & Manufacturer Controls
- Adherence & Monitoring Workflow
- Scenario 2 — LDN + Complex Payer Rules
- Acceptance Tests & KPI Table
- Consequence Quantification
- Signoff Process & Owners
- Side-Effect/Triage & Escalation Path
- Constraints & Stakeholder Roles
- Proof Points & Controls
- Exception Management & Escalation
- Visibility & Reporting
- Next Steps & Deployment Handover
- SLA & Reporting Touchpoints
- Measurement & Proof
- Define Future-State Sentence & Success Signals
- Validation & Agreement
- Validation Check
- Validation & Acceptance Criteria
- Validation Checkpoint
-
Solution Scope
Define included modules (dispense, PA management, financial assistance, adherence outreach, cold-chain delivery), responsibilities, SLAs, and reporting metrics.
Scope Configuration
- Prior Authorization Submission and Follow‑Up
- Benefits Investigation and Coverage Confirmation
- Patient Financial Assistance Enrollment (PAP/TAP)
- Limited Distribution Network Fulfillment
- Cold Chain Storage and Temperature‑Controlled Delivery
- Specialty Medication Dispensing and Labeling
- Pharmacist‑Led Medication Counseling Sessions
- Ongoing Adherence Monitoring with Proactive Outreach
- Clinical Monitoring and Side‑Effect Management
- Refill Coordination and Synchronization
- Real‑Time Patient Status Reporting via Clinical Portal
- Outcomes and Utilization Reporting (clinical and financial)
Scope Questions
Prior Authorization Submission and Follow‑Up
- Do you require the partner to perform full prior authorization (PA) preparation and submission?
- Which payer types require PA handling by the partner?
- Average monthly PA volume (per 1,000 covered lives or absolute)
- What SLA do you expect for initial PA submission and acknowledgement?
- Do you require appeals and denials management (including drafting appeals and tracking outcomes)?
- What integration method do you prefer for receiving PA status updates (select all that apply)?
- Are standardized clinical templates (physician letters, supporting lab/result attachments) required?
Benefits Investigation and Coverage Confirmation
- Should the partner perform benefits verification for new prescriptions, refills, or both?
- Which information must be returned on coverage confirmation?
- Do you require eligibility checks at point of prescribing (EHR/CDS) or at dispense?
- How frequently should benefits be re‑verified for pending prescriptions?
- Are coverage gap or step therapy enrollments tracked and escalated for clinical review?
- Do you require automated patient cost estimates and OOP calculators integrated into reports?
- Please list any payer-specific rules, formularies, or exception processes that must be supported (free text).
Patient Financial Assistance Enrollment (PAP/TAP)
- Do you want the partner to manage foundation PAP, manufacturer TAP, and/or copay assistance?
- What level of ownership is expected for financial assistance cases?
- Typical monthly assistance cases to manage (per program)
- Do you require benefit coordination to minimize patient OOP using assistance programs?
- What SLA do you expect for enrollment submissions and patient follow‑up?
- Are consent forms, income documentation, or attestation collection required as part of enrollment?
- Describe any reporting or reconciliation needs for assistance programs (payments, denials, residual balances).
Limited Distribution Network Fulfillment
- Does the therapy require participation in a manufacturer LDN (limited distribution network)?
- Which LDN partners or manufacturer portals must be integrated or accessed?
- Do you require management of site-of-care restrictions, accreditation verification, or special onboarding for LDN participation?
- Are there special packaging, labeling, or tracking requirements imposed by the manufacturer?
- What SLA is expected for order acceptance and shipment for LDN products?
- Who is responsible for handling manufacturer recalls, buybacks, or inventory credits?
- Please list any contract terms, accreditation, or audit requirements from the manufacturer (free text).
Cold Chain Storage and Temperature‑Controlled Delivery
- Which temperature ranges must be supported (select all that apply)?
- Do you require validated temperature‑controlled packaging and chain‑of‑custody documentation?
- What delivery SLA is required for temperature‑sensitive shipments (e.g., next‑day, 48h)?
- Are specific carriers or cold‑chain providers mandated by the manufacturer or payer?
- Do you require continuous temperature telemetry with exception alerts during transit?
- Is on‑site refrigerated/ultra‑cold storage needed at dispensing locations?
- Please describe any regulatory, cold‑chain validation, or documentation requirements (e.g., GDP, chain‑of‑custody).
Specialty Medication Dispensing and Labeling
- Do you require kitted or therapy‑specific packaging (e.g., multi‑product kits, starter packs)?
- Are there special labeling or patient instruction requirements (language, pictograms, REMS materials)?
- What dispensing frequencies are needed (initial supply, maintenance fills, multi‑month supply)?
- Do you require serialized tracking, lot/expiry capture, or returns handling workflows?
- Will the partner handle patient pickup, home delivery, or clinic/specialty site deliveries?
- What dispensing accreditation or labeling compliance standards must be met (URAC, ACHC, FDA REMS)?
- Please describe any hazardous handling, cold‑chain packaging, or disposal requirements for labeled products.
Pharmacist‑Led Medication Counseling Sessions
- At which touchpoints do you want pharmacist counseling (initiation, first fill, adverse event, ongoing)?
- Do counseling sessions need to be synchronous (phone/video) or asynchronous (recorded/portal messages)?
- What clinical topics must be covered in counseling (adherence, side effects, administration technique)?
- Are documentation and clinical note templates required for each counseling interaction?
- Do you require multilingual counseling or interpreter services?
- What KPIs will measure counseling effectiveness (e.g., adherence lift, satisfaction scores)?
- Should counseling be scheduled proactively or offered on demand by patients/providers?
Ongoing Adherence Monitoring with Proactive Outreach
- Which adherence signals should trigger outreach (missed refill, gap in therapy, abnormal lab)?
- What outreach channels should be used (phone, SMS, email, portal)?
- What frequency and cadence of outreach do you expect for nonadherence?
- Do you require integration of adherence data into EHRs or payer systems?
- What adherence thresholds define escalation to clinical review or case management?
- Are patient incentives or behavioral nudges part of the adherence program?
- Please describe required reporting metrics for adherence (e.g., PDC, MPR, persistence) and cadence.
Clinical Monitoring and Side‑Effect Management
- What clinical parameters must be monitored (labs, vitals, symptom scales)?
- Do you require protocolized monitoring pathways and escalation rules?
- Who should receive clinical alerts and within what SLA (prescriber, care manager, pharmacist)?
- Is telehealth/remote monitoring (e.g., patient‑reported outcomes) required as part of clinical follow‑up?
-
Mutual Commit
Finalize commercial terms, accreditation expectations, limited distribution participation, SLAs, and acceptance criteria.
Agreement Modules
- Statement of Work (SOW)
- Master Services Agreement (MSA)
- Service Level Agreement (SLA)
- Commercial Terms & Pricing Schedule
- Limited Distribution Network (LDN) Participation Agreement
- Accreditation & Compliance Attestation
- Business Associate Agreement (BAA) / Data Processing Agreement (DPA)
- Integration & Data Access Agreement
- Acceptance Criteria & Go-Live Checklist
- Transition & Implementation Plan
- Financial Assistance & Patient Support Terms
- Change Order & Amendment Process
- Reporting & Performance Review Schedule
- Renewal, Exit & Termination Terms
-
Deployment
Operationalize rollout with readiness checks, enablement, and outcome validation.
-
Pre-Deployment Readiness
Confirm data access, integrations, staffing, credentials, and regulatory controls are in place for launch.
Readiness Questions
Quick Grounding — Who Are We Launching With?
- Tell us your role and the best contact for launch coordination (name, title, email/phone).
- Which type of organization are you representing today?
- Roughly how many specialty prescriptions per month would touch this partnership at steady state?
- What is your target go-live window for initial patients?
- Which therapeutic areas will be in scope for launch (select all that apply)?
- What single outcome matters most to you in the first 90 days (e.g., faster PA approvals, baseline adherence, zero cold-chain failures)?
If Launching Today Felt Risky, Where Would You Blame?
- What is the single biggest launch risk you worry will stop patients from getting therapy on time?
- Tell a recent story where a similar risk actually happened—what went wrong and who felt the impact?
- How do you typically detect these failures today—manual checks, exception reports, or frontline patient complaints?
- Who in your organization is ultimately accountable for resolving that type of issue (title/department)?
- When that risk occurs, how quickly do you need it resolved to avoid patient harm or financial exposure?
Are Your Systems Actually Ready to Talk to Ours?
- Which integrations must be fully functional before we can launch (pick all that apply)?
- Which EHR / EMR systems and versions are in scope for prescriptions and clinical status feeds?
- How will we exchange protected data—what technical methods are allowed on your side?
- Are there specific security or penetration-testing requirements we must pass before data connections are approved? If so, list them and target dates.
- Do you have a technical sandbox or test environment we can use, and when can we access it?
Where Do Real-World Workflows Tend to Break Down?
- Which step in the patient journey currently causes the most delay or drop-off for your patients?
- What is your current median time from prescription to first fill for these therapies (choose range)?
- Where do handoffs between your teams and external partners most often create friction (describe role-to-role handoff and frequency)?
- What percentage of patients abandon therapy before first fill, and do you track top reasons?
- If you had to rank the top three operational chokepoints for this launch, what would they be (ranked list)?
Who’s on the Launch Team — and Are They Empowered?
- Do you already have a named launch lead and cross-functional core team for this program?
- List the primary internal stakeholders who will need training or access (roles only: e.g., pharmacy ops manager, payer clinical lead).
- How much dedicated FTE (or percent of FTE) can your organization commit to launch activities over the first 90 days?
- Which training formats work best for your teams (select all that apply)?
- What common organizational barriers have blocked past launches—political, budgetary, operational, or otherwise?
Show Me the Evidence — How Will We Measure Early Wins?
- Which success signals must we demonstrate in the first 30–90 days to call the launch a success?
- Please provide or summarize current baseline metrics for the top 3 signals you selected above (numbers, timeframes).
- How often do you want operational performance reports during ramp—daily, weekly, monthly?
- Who will be the formal acceptance authority for launch KPI signoff (title/role)?
- Are there financial or contract milestones tied to these metrics (bonuses, penalties, holdbacks)? If so, summarize.
What Could Stop Us at the Threshold — Regulatory, Privacy, Credentials?
- Are there any non-negotiable regulatory or accreditation requirements we must show before launch?
- Do you require vendor background checks, SSAE/SOC reports, or other formal attestations before data sharing?
- What is the current status of Data Use Agreements or Business Associate Agreements (BAAs) with our organization?
- Are there patient consent or authorization workflows we must support differently (e.g., special consent for cold-chain monitoring or text messages)? Describe.
- What is your expected timeline to complete all credentialing and compliance checks required for go-live?
I’m Imagining Launch Day — What Keeps You Up at Night?
- On day one, what single failure scenario would be most damaging—what exactly would happen and to whom?
- What contingency plans do you already have in place for that scenario?
- Who will be the 24/7 escalation contact from your side and what is their preferred communication channel?
- What acceptance test must pass on day zero (describe one critical end-to-end scenario we should run together)?
- On a scale from 1–10, how confident are you that the program is operationally ready for launch today? (1 = not ready, 10 = fully ready)
Agreeing Next Steps — Who Does What, When?
- What are the top three actions you want our team to take in the next 7 days to move readiness forward?
- Which deliverables do you need from us to unblock legal, technical, or operational approval (pick all that apply)?
- Who on your side will own each of these items—please list name, role, and target completion date.
- When should we schedule the next checkpoint meeting to review readiness (select preferred cadence)?
- What would a reasonable minimum-viable launch look like for you (scope/features we must include vs. what can come later)?
-
Deployment Enablement
Schedule tasks, train operational teams, activate LDN connections, and execute cold-chain logistics with clear owners.
-
Validation Checklist
Verify end-to-end prescriptions, PA approvals, patient onboarding, cold-chain delivery tests, and reporting feeds meet acceptance criteria.
Validation Questions
Tell Us About Your World
- How many patients on specialty therapies does your organization manage each year?
- Which therapeutic areas currently drive the majority of your specialty spend?
- Who owns specialty pharmacy strategy and vendor relationships inside your organization?
- Briefly describe your current relationship(s) with specialty pharmacy vendors—what works well and what doesn’t.
- What is the primary objective you are trying to achieve with specialty pharmacy partners right now?
- Tell us about a recent initiative related to specialty care you’re proud of or that changed how you work.
Are You Losing Patients Before Therapy Starts?
- How often do patients never start a prescribed specialty therapy—and why does that still happen in your experience?
- What is your estimated patient abandonment rate between prescription and first fill?
- Which of the following most commonly causes patients to abandon therapy before first dose?
- Share a recent patient story where abandonment occurred—what were the key moments and decisions?
- How do you currently measure the downstream cost or clinical impact of patients who fail to start therapy?
- Who on your team is responsible for initiatives to reduce abandonment and what resources do they have?
When Prior Authorization Becomes the Bottleneck
- If prior authorization approval times were cut in half tomorrow, what would be different for patients and your organization?
- What is your average time from prescription to PA approval today?
- Approximately what percentage of PAs are approved on the first submission?
- Which teams or vendors submit and manage PAs for your patients?
- What are the top three reasons submissions get kicked back, delayed, or denied?
- Do you currently use electronic prior authorization (ePA), rules engines, or payer portals; if so, which and how reliable are they?
If Limited Distribution Rules Could Be Different…
- How have limited distribution network (LDN) policies forced compromises in care or access for your patients?
- About how many products that matter to your population are in LDN today?
- Which manufacturer requirements create the biggest operational burden (select all that apply)?
- How often does LDN availability or manufacturer routing change unexpectedly and disrupt patients?
- Describe a specific instance where LDN constraints led to delayed therapy or administrative escalation.
- If a partner could guarantee manufacturer acceptance and LDN compliance, would you consider consolidating LDN management?
What Would Success Feel Like for Patients and Your Team?
- If the end-to-end journey (PA → first dose → active adherence at 6 months) were consistently reliable, what new opportunities would that create for your organization?
- Which metrics matter most to you right now? Pick up to three.
- What target thresholds would you set for your top metrics (give specific numbers or ranges)?
- How often do you need reports or live dashboards to feel confident in performance?
- Who needs view or edit access to patient status and outcomes dashboards (roles, not names)?
Where the Logistics Break Down (And Who Bears the Fallout)
- When a temperature excursion or failed cold-chain delivery happens, how long does it typically take to resolve and what are the consequences?
- How many cold-chain shipments do you coordinate monthly for your specialty population?
- Have you experienced product loss, delayed dosing, or clinical compromise due to cold-chain failure in the last 24 months?
- Which partners or vendors currently manage last-mile delivery and temperature telemetry for you?
- What visibility and controls would you require on chain-of-custody, telemetry data, and exception alerts before go-live?
- List the acceptance tests (for example: temp excursion simulation, chain-of-custody audit, KPI thresholds) you'd want completed in a pilot.
Money, Incentives, and Access—What Keeps You Up at Night?
- Which single financial barrier—benefit design, copay burden, or administrative delay—causes the largest drop-off in access, and why hasn’t it been solved?
- Approximately what share of patients require financial assistance to initiate therapy?
- Do you operate an in‑house financial assistance team, rely on manufacturer PAPs, or partner with third-party foundations?
- On average, how long does it take from referral to confirmed patient financial clearance?
- What documentation or controls do payers and manufacturers require to verify financial assistance and how burdensome is that process?
- Would shortened financial clearance change prescribing patterns or formulary decisions in your organization?
If We Took This On—What Would You Need From Us First?
- What's the one thing a specialty pharmacy partner must deliver on day one to earn your trust?
- What is your decision timeline for selecting a dispensing and clinical partner?
- Which contractual or procurement constraints will most shape any agreement (pick all that apply)?
- Would you require a time‑bound pilot before broad deployment, and if so, how long would be acceptable?
- Which technical integrations are must-haves (EMR, claims, lab results, HIE, manufacturer portals)?
- Who are the internal signatories or decision roles for commercial terms and clinical acceptance?
Commitments, Risks, and Small Wins to Start
- What is the smallest, clearly measurable pilot that would reduce your biggest operational risk within 90 days?
- What acceptance criteria and KPIs would you require the pilot to meet to consider a full roll‑out? Please be specific.
- Which internal teams must be actively engaged during a pilot to make it successful?
- What reporting cadence and level of detail do you expect during a pilot (examples: real‑time exceptions, weekly KPI scorecard, root cause analysis)?
- If the pilot succeeds, what would be the earliest acceptable timeline to transition to a broader contract or operational handoff?
- Is there anything else—hidden constraints, political dynamics, or stakeholder sensitivities—we should know before proposing next steps?
-
-
Success
Review outcomes versus success signals, capture learnings, and maintain a shared channel for issues and enhancements.
Success Reviews
- Outcome Review Workshop
- Lessons Learned & Continuous Improvement Session
- Operational Issue Triage & Escalation Meeting
- Quarterly Business Review — Outcomes & Value Realization
- Shared Channel Setup & Governance Kickoff
Issues & Enhancements
- Agree on KPIs and cadence for ongoing performance reporting.
- Distribute detailed metric deck and raw data extracts to attendees within 48 hours.
- Welcome & Objectives
- Assign pilot owners, start dates, and success criteria for the top pilots.
- Update SOPs and training materials for any immediate low-effort changes.
- Active Issue Queue Review
- Ensure all high-severity operational issues have concrete remediation plans and owners.
- Reduce time-to-resolution for critical incidents through clear escalation and contingency steps.
- Prevent recurrence by assigning root-cause owners for long-term fixes.
- Open/assign remediation tickets in the shared tracking tool with SLAs for each critical issue.
- Notify affected prescribers/payers when patient-impacting incidents are identified, per communication protocol.
- Prepare a short report for executive escalation if any incident remains open past the agreed threshold.
- Executive Summary
- Confirm program delivered agreed value and quantify financial/clinical impact.
- Obtain executive endorsement for any contract or scope changes informed by results.
- Assign remediation owners and schedule follow-up actions with deadlines.
- Produce the formal QBR report including appendices of raw metrics and distribute to executive stakeholders.
- If required, draft contract amendment language reflecting agreed scope or SLA changes.
- Schedule the next QBR and interim checkpoint dates for high-priority remediation items.
- Stand up a shared collaboration channel with clear ownership and access.
- Purpose, Scope & Participants
- Agree and document response SLAs, severity definitions, and escalation rules.
- Define the recurring cadence for operational triage and backlog reviews tied to the channel.
- Create the CustomerNode workspace and invite primary and backup contacts from all parties.
- Configure integrations and set up automated metric alerts to the channel.
- Publish thechannel governance document and circulate access/how-to instructions.
- Confirm which success signals were met, partially met, or unmet with evidence.
- Identify top 3 outcome gaps with agreed root causes and estimated consequence.
- Create remediation tickets for each top-3 gap with owners and proposed target dates.
- Schedule the follow-up verification meeting to confirm remediation effectiveness.
- Win Highlights
- Capture a validated list of lessons learned across clinical, ops, and payer dimensions.
- Agree on 2–3 prioritized pilots to address highest-impact problems.
- Define measurement criteria and go/no-go rules for each pilot.
- Create an improvement backlog with estimated impact/effort scores for each idea.
- Triage & Root Cause Assignment
- Failure Modes & Consequence Mapping
- Tooling & Integrations
- Financial Impact & ROI
- Recap of Success Signals & Targets
- Metric Review — Quantitative Results
- Improvement Options Brainstorm
- Immediate Remediation Plans
- Clinical Outcomes & Patient Impact
- Channel Rules & Communication Protocols
- SLA & Contract Performance Review
- Governance, RACI & Escalation Paths
- Prioritization & Pilot Plan
- Representative Patient & Payer Case Walkthroughs
- Risk Mitigation & Contingency
- Escalation Confirmation & SLA Adjustments
- Onboarding, Access & Cadence
- Gap Analysis & Root Causes
- Strategic Recommendations & Renewal Considerations
- Governance & Measurement
- Customer Validation & Alignment
- Decisions & Executive Actions
- Decisions & Next Steps