Function

The aim of market access activities for a TB vaccine is to secure the introduction of the vaccine into national immunisation programmes (accessibility) together with subsequent funding (affordability) from national and/or supranational sources as close as possible to market authorisation, to ensure timely and impactful vaccination coverage of the targeted population and therefore meet the vaccination programmes objectives.

This guidance presents the main steps of a comprehensive market access process independent of the company or institution that will perform them. It should help vaccine developers to understand the full approach including the steps that should be initiated in early development stages that could also contribute to a better understanding of the value of the product candidate for potential partners.

Stage 
E
Perform, First-in-human/Ph1
Gate 
E
Progress to Ph2
Main Activities
  • Based on TPP identify potential list of targeted countries (early, middle and late adopter countries) and considering income (low, average, high)
  • Collect epidemiological, burden of disease data and market data in targeted countries for a preliminary market assessment
CRITERIA REQUIRED
  • Initial list of targeted countries established, with rationale
  • Preliminary market assessments & business strategy available for targeted countries
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Guidance

With the decision to move the candidate(s) into clinical development, a formal market assessment should be performed at this stage. It will include the medical need (from epidemiology data, including incidence and disease burden), market characteristics and dynamics (demand, market size, competition, procurement and delivery processes), and positioning of the vaccine (versus Standard of Care, niche indications, competitive advantages, match between product and demand). A market strategy and communication plan should be drafted and be part of the PDP. Target countries for vaccination implementation should also be re-evaluated and defined. A comprehensive review of recent literature would be a relevant way to gather these data (see for example Tu et al., 2012).

Stage 
F
Perform Ph2 (including Pre-POC) studies
Gate 
F
Progress to Ph2b Efficacy
Main Activities
  • Establish a multidisciplinary market access team
  • Based upon business strategy, develop understanding of all relevant international stakeholder’s requirements (WHO, GAVI, UNICEF, etc.) and develop mapping
  • Prepare international and national stakeholders mapping, including civil society and TB-affected communities
  • Start to analyse healthcare systems and requirements of countries for integration in National Immunization Program (NIP) and funding
CRITERIA REQUIRED
  • Capacity and expertise to support market access activities available
  • Processes and requirements of international stakeholders understood
  • Map of stakeholders available and engagement underway
  • Countries healthcare systems and requirements analysed
  • Initial identification of early, mid- and late adopters available
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Guidance

A multidisciplinary market access team should be constituted at this Stage. The team is comprised of all functions that are necessary to support the process from initiation until completion of a market access plan. This includes, though is not restricted to, Epidemiology, Clinical Operations, Regulatory, Health Economics and Business. Vaccines Europe is currently reviewing market access best practices focusing on European countries and comparing to non-European countries. The market access approach for novel TB vaccines should be aligned with those practices. However, since TB is a global disease with significant burden in low and middle income countries and in poor populations, the market access strategy may differ from a European-focused strategy on a case-by-case basis (vaccineseurope.eu). A dedicated project management tool would facilitate the process of establishing a market access plan.

The major purpose of the activities at this stage and according to the business strategy is to identify important international (WHO, GAVI, UNICEF) and national (Ministry of Health, Ministry of Finance) stakeholders, including civil society, that will influence the vaccine implementation decision-making processes. The aim is to understand their requirements in terms of data, studies, assessments, including for example Health Economic elements. In addition to desk research, external ad-hoc studies may be worth conducting at this stage such as qualitative interviews with international and/ or national leaders in the TB field. The outcome of this analysis should be a specific mapping of all relevant stakeholders that will also contribute to identify the early versus late countries adopters.

Stage 
G
Perform Ph2b Efficacy
Gate 
G
Progress to Ph3
Main Activities
  • Identify data gaps and options to close them in early (middle, late) adopter countries, aiming to build evidence and meet requirements from stakeholders
  • Identify complementary studies and/or protocol evolution (Phase 3) to close data gaps in early (mid, and late) adopters
  • Define Health Economics, Outcomes Research (HEOR) activities to support health economics (HE) rationale (cost-effectiveness, health and budget impacts, etc.) in early (middle and late) adopters
  • Initiate interactions with major stakeholders (countries, Global Fund, GAVI, UNICEF etc.)
  • Draft market access strategy
CRITERIA REQUIRED
  • Data gaps and options to close them identified
  • Complementary studies and/or protocols evolution (Ph3) to close data gaps identified
  • HEOR activities defined
  • Interactions with major stakeholders initiated
  • Market access strategy drafted
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Guidance

The Market Access team needs to identify the gaps between data available and evidence required by the different stakeholders. A second step is to define in a dedicated plan how to address existing gaps during clinical Phase 3 development or beyond with the objective to quantify both clinical and economical outcomes of the use of the novel vaccine.

In order to build a gap analysis plan, Health Economic-Outcome Research (HEOR) activities should identify either trials or trial protocol adaptations and/ or modelling approaches to demonstrate the public health value of vaccination and satisfy the perspective of the ultimate customer in terms of cost effectiveness and budget impact (Knight et al 2014, Bellini et al., 2016). The gap analysis plan will also provide the opportunity to prioritise among countries (feasibility/ cost approach) and draft an initial market access strategy. Interactions with major stakeholders are key to understand their requirements and the relevance of the gap analysis plan.

Stage 
H
Perform Ph3
Gate 
H
Progress to licensure
Main Activities
  • Develop pricing strategy as per HE outcomes
  • Consult and engage national and international stakeholders
  • Draft a market access plan
  • SSSSS
CRITERIA REQUIRED
  • Draft core value dossier available for international stakeholders and early (priority), mid and late (option) adopters
  • Pricing strategy defined
  • National and international stakeholders engaged
  • Market access plan draft available
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Guidance

The objective is to implement as part of or in parallel to Phase 3 the HEOR activities that will enable gathering of key data and the elements to subsequently develop the value dossier to support the medical and economic rationale of the vaccination programme.

A draft of this value dossier should be developed during stage H and contain a summary of the clinical, economic and societal value, and supporting evidence (studies) for the new TB vaccine as well as background and information on TB (i.e., burden of illness, epidemiology, etc.). The core dossier is developed as an evolving document that can serve as a template for customising submissions to local, national and/ or supranational customers and other stakeholders at a later stage.

At this stage, the initial pricing strategy should be drafted and developed. The strategy is supported by a value-based approach documented by the HEOR rationale and data. It will need to encompass an international vision, taking into account for example specificities of high, middle and low income countries, (multi-tiered pricing strategy). The planning and prioritisation in gathering relevant data to support this value-based approach is crucial because of   the timing and costs of these activities.

Regular consultations with stakeholders that were identified in earlier stages are crucial to prepare regulatory submissions, WHO pre-qualification, policy recommendation, implementation studies, financing and product launch.

A draft of the market access plan should be available at this Stage H.