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Phase 1: Early Pre-Launch
Phase 2: Pre-Launch
Phase 3: Preparing for Launch
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Phase 5: Post-Launch
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Market Access Roadmap
for UK Clients

The HAVAS UK market access roadmap is a strategic framework for market access functions, acting as a blueprint to support launch success and optimise patient access to new treatments. The roadmap can be used by UK market access teams as a guide to supplement thinking, provide ideas and support a smooth and successful launch programme.

While the roadmap provides a best-practice approach for market launch planning, every product launch is different. As a result, not every deliverable within the roadmap will always be necessary and the timings of some deliverables may need to be adapted.

Structure

The roadmap aims to provide the deliverables to enable optimal access across five different timepoints, from 24 months pre-launch to 12 months post-launch. These are:

For each timepoint, the roadmap provides the key deliverables to be considered, the intended audience, an overview of content, purpose, format and the required time to develop. Example outputs and case studies are included, where available.

How to Use

Scroll through the roadmap below or use the buttons at the top to explore each launch phase and deliverable.

Click any card to view further details. Use 'Add to Plan' to save any deliverables you need. When ready, hit 'Create My Plan' to build your custom launch plan.

Get in touch with us for any further information.

Phase 1

Early Pre-Launch

Minus 24 to Minus 18 months

Access Landscape Analysis

Internal

Desk Research to cover environmental, policy, reimbursement, commissioning and treatment guidelines. Primary Research to pressure test key questions and fill gaps.

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Purpose

Provide a clear understanding of the current healthcare landscape and market access barriers/opportunities, informing pre-launch strategy and identifying areas requiring early attention.

Format

Internal report or slide deck summarizing findings, with data visuals and strategic implications.

Time to Develop

~6–8 weeks (including research and internal reviews).

Access Stakeholder Mapping

Internal

National, regional, local key customer roles.

Click for details

Purpose

Highlight who the critical stakeholders are for market access, enabling the team to plan targeted engagement and advocacy efforts well in advance of launch.

Format

Stakeholder map and profile document (e.g. PowerPoint with diagrams or Excel list with roles and influence).

Time to Develop

~4 weeks (gathering insights, verifying roles, creating mapping visuals).

NICE/SMC Advice Service Assessment

External

Enagement with NICE/SMC through Advice Service to understand HTA challenges.

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Purpose

Determine how to align the development program with HTA expectations in the UK (NICE) and Scotland (SMC), reducing risks in the formal appraisal and speeding up patient access.

Format

Consultation meetings with NICE/SMC, followed by an internal summary report with recommendations.

Time to Develop

~8–10 weeks (includes scheduling the advice, preparing briefing materials, and summarizing guidance).

PharmaScan Completion

External

Writing or reviewing input into PharmaScan as this will drive NICE/SMC prioritisation and scoping for HTA review.

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Purpose

Secure early visibility of the product in the NHS system: the purpose is to trigger NICE/SMC prioritization and scoping of the upcoming HTA, so that no delays occur in scheduling the appraisal.

Format

Completed PharmaScan form (online submission) and confirmation report, aligned with internal regulatory and medical input. 

Time to Develop

~3–4 weeks (data gathering, cross-functional review, final submission). 

NICE/MHRA Aligned Pathway Assesment

Internal

Assessment of whether Aligned Pathway for MHRA/NICE is desirable.

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Purpose

Decide if pursuing an aligned regulatory-HTA pathway could expedite patient access. The purpose is to map out requirements and pros/cons of this route, informing the regulatory strategy. 

Format

Internal briefing document outlining the aligned pathway option, with a recommendation on whether or not to proceed (plus rationale).  

Time to Develop

~2–3 weeks (research into pathway criteria, team discussion, and write-up). 

ILAP Pathway Assessment

Internal

Assessment of whether ILAP Pathway approach is desirable.

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Purpose

Determine the strategic value of ILAP for this product. The purpose is to advise whether to apply for ILAP (to potentially shorten time to market) based on the product’s profile and unmet need. 

Format

Internal analysis memo or slide deck summarizing ILAP pros/cons, entry criteria match, and a go/no-go recommendation.  

Time to Develop

~2–3 weeks (evaluate criteria, consult regulatory colleagues, prepare recommendation).  

PIM assessment and dossier assessment

External

Assessment of whether PIM status is desirable and dossier creation.

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Purpose

Explore an early access route: the purpose is twofold – first, to decide if a PIM designation (and subsequent EAMS route) could significantly accelerate UK access, and second, to be ready with a compelling dossier if pursuing this option. 

Format

Internal recommendation document (go/no-go on PIM/EAMS) and, if pursuing, a formal PIM application dossier (Word/PDF format) for MHRA submission.  

Time to Develop

~2–3 weeks for initial viability assessment; ~4–6 weeks for full PIM dossier preparation (if proceeding).  

High Cost Drugs List submission in England

External

For any high cost drug ensure it has been submitted for inclusion on the HCD by NHS England.

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Purpose

Assess the likelihood of requiring listing on the NHS England NHS Payment Scheme High Cost Drugs List, and apply through the online portal according to the criteria for use. Consider whether a PAS will be required and place of prescribing.

Format

Confidential submission to NHS England through the NHSPS HCD list portal. 

Time to Develop

~2–3 weeks for initial viability assessment; ~2–3 weeks for full online submission preparation (if proceeding).  

Phase 2

Pre-Launch

Minus 18 to Minus 12 months

Advanced Budgetary Notification

External

Provides advanced cost implications to budget holders for new medicine.

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Purpose

Inform and prepare NHS organisations early. Provide budget holders (e.g. Integrated Care Boards) with advance notice of financial requirements and service implications.

Format

ABN document (typically a concise Word/PDF report of ~5–10 pages) tailored for NHS budget holders, following ABPI compliance guidelines.

Time to Develop

~6–8 weeks (drafting content, clinical and health-economic validation, internal approval including ABPI Code sign-off).

Payer Value Message Creation

External

Core value story for use with key decision makers who are price sensitive.

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Purpose

Define the product's narrative for payer communications. Ensure consistent, resonant messaging that demonstrates the product's value to NHS payers.

Format

Value messaging document or slide deck listing key messages and supporting evidence, vetted by medical/health economics teams for accuracy and impact.

Time to Develop

~3–4 weeks (message development workshops, drafting, and internal alignment across medical, health economics, and commercial teams).

Payer value message workshop

Internal

Workshop to test the core value story.

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Purpose

Refine and internalize the value story. The purpose is to align the team on the messaging and strengthen it through internal critique, ensuring that all angles are covered and that the messages will resonate with payer audiences. 

Format

Workshop session (half-day) with presentation materials and discussion guides; post-workshop output could be an updated message framework and a summary of action items. 

Time to Develop

~4 weeks (planning the workshop, preparing materials, conducting the session, and capturing refinements to the messaging). 

Payer value message testing (Synthetic and/or real life)

External

Testing of the core value story with key decision maker customers.

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Purpose

Validate and optimize messaging. The purpose is to ensure the value messages truly resonate with payer priorities and language, and to identify any objections or information gaps before broader dissemination. 

Format

Qualitative research (e.g. a small advisory board or one-on-one payer interviews either synthetically or in real life) followed by an internal report analyzing feedback and recommending adjustments to messages. 

Time to Develop

~6–8 weeks (recruiting payers, conducting sessions, analyzing results, and reporting insights for message refinement). 

Advanced Budgetary Notification

External

Provides advanced cost implications to budget holders for new medicine.

Click for details

Purpose

Inform and prepare NHS organisations early. Provide budget holders (e.g. Integrated Care Boards) with advance notice of financial requirements and service implications.

Format

ABN document (typically a concise Word/PDF report of ~5–10 pages) tailored for NHS budget holders, following ABPI compliance guidelines.

Time to Develop

~6–8 weeks (drafting content, clinical and health-economic validation, internal approval including ABPI Code sign-off).

Payer Value Message Creation

External

Core value story for use with key decision makers who are price sensitive.

Click for details

Purpose

Define the product's narrative for payer communications. Ensure consistent, resonant messaging that demonstrates the product's value to NHS payers.

Format

Value messaging document or slide deck listing key messages and supporting evidence, vetted by medical/health economics teams for accuracy and impact.

Time to Develop

~3–4 weeks (message development workshops, drafting, and internal alignment across medical, health economics, and commercial teams).

Payer value message workshop

Internal

Workshop to test the core value story.

Click for details

Purpose

Refine and internalize the value story. The purpose is to align the team on the messaging and strengthen it through internal critique, ensuring that all angles are covered and that the messages will resonate with payer audiences. 

Format

Workshop session (half-day) with presentation materials and discussion guides; post-workshop output could be an updated message framework and a summary of action items. 

Time to Develop

~4 weeks (planning the workshop, preparing materials, conducting the session, and capturing refinements to the messaging). 

EAMS assessment and dossier development

Internal

Assess whether EAMS submission is desirable and dossier development support.

Click for details

Purpose

Accelerate availability for patients pre-approval. The purpose is to potentially secure a positive EAMS Scientific Opinion, which could provide early patient access ~12–18 months before formal approval15. A successful EAMS can also generate real-world data and signal NHS endorsement, but requires robust evidence and a plan to manage risks. 

Format

Internal decision brief on EAMS feasibility; if positive, a formal EAMS dossier (Word/PDF) for submission, following MHRA’s guidelines and including all required modules (clinical data, manufacturing info, pharmacovigilance plan, etc.). 

Time to Develop

~4 weeks for initial assessment. If proceeding, ~8–12 weeks for dossier development and internal approval prior to MHRA submission (timelines may vary depending on data availability and review cycles).  

Phase 3

Preparing for Launch

Minus 12 to Minus 3 months

Advisory Board(s)

External

To review service flows and issues, funding and reimbursement issues.

Click for details

Purpose

Final check and refinement of the launch approach. Pressure-test the launch plan in a real-world context – ensuring seamless product introduction with stakeholder buy-in.

Format

One-day (or half-day) facilitated advisory board meetings (in-person or virtual) with ~8–10 participants. Outputs include summary report and action items.

Time to Develop

~6–8 weeks per advisory board (including planning, participant recruitment, meeting execution, and follow-up reporting).

ABN Deployment

External

Deployment of any ABN developed with those making policy decisions on budgets.

Click for details

Purpose

Inform NHS budgeting and planning processes at the final pre-launch stage. Ensure budget decision-makers have ample notice of the upcoming therapy's financial impact.

Format

Communication outreach (official ABN email or letter to relevant organisations). Webinar or briefing call may supplement written communication.

Time to Develop

~3–4 weeks (coordination of distribution lists, preparation of cover communications or briefing sessions, and execution of outreach).

Advisory Board(s)

External

To review service flows and issues, funding and reimbursement issues.

Click for details

Purpose

Final check and refinement of the launch approach. Pressure-test the launch plan in a real-world context – ensuring seamless product introduction with stakeholder buy-in.

Format

One-day (or half-day) facilitated advisory board meetings (in-person or virtual) with ~8–10 participants. Outputs include summary report and action items.

Time to Develop

~6–8 weeks per advisory board (including planning, participant recruitment, meeting execution, and follow-up reporting).

ABN Deployment

External

Deployment of any ABN developed with those making policy decisions on budgets.

Click for details

Purpose

Inform NHS budgeting and planning processes at the final pre-launch stage. Ensure budget decision-makers have ample notice of the upcoming therapy's financial impact.

Format

Communication outreach (official ABN email or letter to relevant organisations). Webinar or briefing call may supplement written communication.

Time to Develop

~3–4 weeks (coordination of distribution lists, preparation of cover communications or briefing sessions, and execution of outreach).

Advisory Board(s)

External

To review service flows and issues, funding and reimbursement issues.

Click for details

Purpose

Final check and refinement of the launch approach. Pressure-test the launch plan in a real-world context – ensuring seamless product introduction with stakeholder buy-in.

Format

One-day (or half-day) facilitated advisory board meetings (in-person or virtual) with ~8–10 participants. Outputs include summary report and action items.

Time to Develop

~6–8 weeks per advisory board (including planning, participant recruitment, meeting execution, and follow-up reporting).

ABN Deployment

External

Deployment of any ABN developed with those making policy decisions on budgets.

Click for details

Purpose

Inform NHS budgeting and planning processes at the final pre-launch stage. Ensure budget decision-makers have ample notice of the upcoming therapy's financial impact.

Format

Communication outreach (official ABN email or letter to relevant organisations). Webinar or briefing call may supplement written communication.

Time to Develop

~3–4 weeks (coordination of distribution lists, preparation of cover communications or briefing sessions, and execution of outreach).

Advisory Board(s)

External

To review service flows and issues, funding and reimbursement issues.

Click for details

Purpose

Final check and refinement of the launch approach. Pressure-test the launch plan in a real-world context – ensuring seamless product introduction with stakeholder buy-in.

Format

One-day (or half-day) facilitated advisory board meetings (in-person or virtual) with ~8–10 participants. Outputs include summary report and action items.

Time to Develop

~6–8 weeks per advisory board (including planning, participant recruitment, meeting execution, and follow-up reporting).

ABN Deployment

External

Deployment of any ABN developed with those making policy decisions on budgets.

Click for details

Purpose

Inform NHS budgeting and planning processes at the final pre-launch stage. Ensure budget decision-makers have ample notice of the upcoming therapy's financial impact.

Format

Communication outreach (official ABN email or letter to relevant organisations). Webinar or briefing call may supplement written communication.

Time to Develop

~3–4 weeks (coordination of distribution lists, preparation of cover communications or briefing sessions, and execution of outreach).

Advisory Board(s)

External

To review service flows and issues, funding and reimbursement issues.

Click for details

Purpose

Final check and refinement of the launch approach. Pressure-test the launch plan in a real-world context – ensuring seamless product introduction with stakeholder buy-in.

Format

One-day (or half-day) facilitated advisory board meetings (in-person or virtual) with ~8–10 participants. Outputs include summary report and action items.

Time to Develop

~6–8 weeks per advisory board (including planning, participant recruitment, meeting execution, and follow-up reporting).

ABN Deployment

External

Deployment of any ABN developed with those making policy decisions on budgets.

Click for details

Purpose

Inform NHS budgeting and planning processes at the final pre-launch stage. Ensure budget decision-makers have ample notice of the upcoming therapy's financial impact.

Format

Communication outreach (official ABN email or letter to relevant organisations). Webinar or briefing call may supplement written communication.

Time to Develop

~3–4 weeks (coordination of distribution lists, preparation of cover communications or briefing sessions, and execution of outreach).

Advisory Board(s)

External

To review service flows and issues, funding and reimbursement issues.

Click for details

Purpose

Final check and refinement of the launch approach. Pressure-test the launch plan in a real-world context – ensuring seamless product introduction with stakeholder buy-in.

Format

One-day (or half-day) facilitated advisory board meetings (in-person or virtual) with ~8–10 participants. Outputs include summary report and action items.

Time to Develop

~6–8 weeks per advisory board (including planning, participant recruitment, meeting execution, and follow-up reporting).

ABN Deployment

External

Deployment of any ABN developed with those making policy decisions on budgets.

Click for details

Purpose

Inform NHS budgeting and planning processes at the final pre-launch stage. Ensure budget decision-makers have ample notice of the upcoming therapy's financial impact.

Format

Communication outreach (official ABN email or letter to relevant organisations). Webinar or briefing call may supplement written communication.

Time to Develop

~3–4 weeks (coordination of distribution lists, preparation of cover communications or briefing sessions, and execution of outreach).

Phase 4

Launch

Minus 3 to Plus 3 months

Deploy Payer Facing Materials

External

Complete final content requirements across all materials and deploy to the field team for use.

Click for details

Purpose

Ensure the field is equipped for engagement at launch. Arm the field team with every approved resource to engage payers immediately upon launch.

Format

Deployment package delivered to field teams (online repository with all PDFs, slide decks, models). Internal kickoff call often accompanies distribution.

Time to Develop

~2–3 weeks (final content checks and approvals, then rapid distribution; much development is already complete by this stage).

Launch Notification Document

External

Guide for those making policy decisions on budgets to highlight launch and availability of the new medicine.

Click for details

Purpose

Officially notify and inform healthcare organisations. Ensure budget holders and policy decision-makers are promptly informed of the new medicine's availability.

Format

Brief document or letter (2-3 pages max) on company or joint NHS letterhead. Disseminated via email to NHS stakeholders with formal, compliant tone.

Time to Develop

~4 weeks (drafting with medical and regulatory affairs, getting approvals, coordinating distribution around launch date).

Deploy Payer Facing Materials

External

Complete final content requirements across all materials and deploy to the field team for use.

Click for details

Purpose

Ensure the field is equipped for engagement at launch. Arm the field team with every approved resource to engage payers immediately upon launch.

Format

Deployment package delivered to field teams (online repository with all PDFs, slide decks, models). Internal kickoff call often accompanies distribution.

Time to Develop

~2–3 weeks (final content checks and approvals, then rapid distribution; much development is already complete by this stage).

Launch Notification Document

External

Guide for those making policy decisions on budgets to highlight launch and availability of the new medicine.

Click for details

Purpose

Officially notify and inform healthcare organisations. Ensure budget holders and policy decision-makers are promptly informed of the new medicine's availability.

Format

Brief document or letter (2-3 pages max) on company or joint NHS letterhead. Disseminated via email to NHS stakeholders with formal, compliant tone.

Time to Develop

~4 weeks (drafting with medical and regulatory affairs, getting approvals, coordinating distribution around launch date).

Launch Notification Document

External

Guide for those making policy decisions on budgets to highlight launch and availability of the new medicine.

Click for details

Purpose

Officially notify and inform healthcare organisations. Ensure budget holders and policy decision-makers are promptly informed of the new medicine's availability.

Format

Brief document or letter (2-3 pages max) on company or joint NHS letterhead. Disseminated via email to NHS stakeholders with formal, compliant tone.

Time to Develop

~4 weeks (drafting with medical and regulatory affairs, getting approvals, coordinating distribution around launch date).

Launch Notification Document

External

Guide for those making policy decisions on budgets to highlight launch and availability of the new medicine.

Click for details

Purpose

Officially notify and inform healthcare organisations. Ensure budget holders and policy decision-makers are promptly informed of the new medicine's availability.

Format

Brief document or letter (2-3 pages max) on company or joint NHS letterhead. Disseminated via email to NHS stakeholders with formal, compliant tone.

Time to Develop

~4 weeks (drafting with medical and regulatory affairs, getting approvals, coordinating distribution around launch date).

Phase 5

Post-Launch

Plus 3 to Plus 12 months

NICE/SMC Communications

External

Short communication templates of what NICE/SMC decision was and why to support NHS teams update newsletters etc.

Click for details

Purpose

Facilitate clear and consistent messaging of HTA outcomes. Support NHS stakeholders in quickly informing staff about NICE/SMC decision implications.

Format

Template communications such as a one-page bulletin or email text with decision summary, reasons, access conditions, and link to full guidance.

Time to Develop

~4 weeks to draft and get approvals (well ahead of decision dates). Then 1–2 days post-publication to finalize and disseminate.

Service Evolution Toolkits

External

Toolkits to support services evolve as sustainable and efficient patient centric services.

Click for details

Purpose

Sustain and broaden therapy impact. Enable NHS teams to iteratively refine services so patient outcomes improve and efficiencies are gained.

Format

Modular toolkit packages (PDF or PowerPoint per focus area) with step-by-step guidance, worksheets, case study snapshots, and optional video content.

Time to Develop

~8–12 weeks (collecting post-launch insights, developing content for each module, reviewing with clinical experts, producing final materials).

NICE/SMC Communications

External

Short communication templates of what NICE/SMC decision was and why to support NHS teams update newsletters etc.

Click for details

Purpose

Facilitate clear and consistent messaging of HTA outcomes. Support NHS stakeholders in quickly informing staff about NICE/SMC decision implications.

Format

Template communications such as a one-page bulletin or email text with decision summary, reasons, access conditions, and link to full guidance.

Time to Develop

~4 weeks to draft and get approvals (well ahead of decision dates). Then 1–2 days post-publication to finalize and disseminate.

Service Evolution Toolkits

External

Toolkits to support services evolve as sustainable and efficient patient centric services.

Click for details

Purpose

Sustain and broaden therapy impact. Enable NHS teams to iteratively refine services so patient outcomes improve and efficiencies are gained.

Format

Modular toolkit packages (PDF or PowerPoint per focus area) with step-by-step guidance, worksheets, case study snapshots, and optional video content.

Time to Develop

~8–12 weeks (collecting post-launch insights, developing content for each module, reviewing with clinical experts, producing final materials).

Service Evolution Toolkits

External

Toolkits to support services evolve as sustainable and efficient patient centric services.

Click for details

Purpose

Sustain and broaden therapy impact. Enable NHS teams to iteratively refine services so patient outcomes improve and efficiencies are gained.

Format

Modular toolkit packages (PDF or PowerPoint per focus area) with step-by-step guidance, worksheets, case study snapshots, and optional video content.

Time to Develop

~8–12 weeks (collecting post-launch insights, developing content for each module, reviewing with clinical experts, producing final materials).

Service Evolution Toolkits

External

Toolkits to support services evolve as sustainable and efficient patient centric services.

Click for details

Purpose

Sustain and broaden therapy impact. Enable NHS teams to iteratively refine services so patient outcomes improve and efficiencies are gained.

Format

Modular toolkit packages (PDF or PowerPoint per focus area) with step-by-step guidance, worksheets, case study snapshots, and optional video content.

Time to Develop

~8–12 weeks (collecting post-launch insights, developing content for each module, reviewing with clinical experts, producing final materials).

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