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10 Steps to Market Access Success

In Quintiles' experience, there are ten essential market access activities that are fundamental to success, regardless of how a company decides to approach launch. For small to medium sized companies going it alone, these 10 steps will help prepare a company for successful pricing, reimbursement and health technology assessment (HTA) submissions across Europe.

The first steps should take place well before anticipated launch, in order to ensure that products can be prescribed (and revenue established) as soon as possible following marketing authorization. These early steps develop the value story and core support materials. Once the value platform is established, the final steps build it out in preparation of value dissemination to local stakeholders.

VALUE ARGUMENT ARTICULATION:

Core tasks that should be completed one year before launch

  1. Identify key decision-makers in each market that will have an influence on whether a product is made available for patients and at what price
  2. Identify any gaps in evidence supporting the value of the medicine in relation to unmet need and known stakeholder priorities for the specific therapy area
  3. Focus on key markets, notably the UK, Germany and France, which are large individual markets and are most frequently referenced by other countries in Europe when evaluating at new products

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  1. Build core models aligned to the value proposition for cost effectiveness and budget impact for use in the core value dossier and, eventually, in interactions with payers and prescribers
  2. Test value messages with payers and key opinion leaders (KOLs) to understand the extent to which they find them compelling and whether the supporting evidence is sufficiently robust

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  1. Develop insight into comparative treatment paradigms through a systematic review of available literature, taking into account the standard of care in each market
  2. Adapt and refine value messages according to findings and any opportunities identified to address unmet need

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  1. Conduct a comparison of the product against the appropriate comparators as considered by the different decision-makers, using either a meta-analysis or a mixed treatment comparison
  2. Ensure data on different comparators, which may be from multiple sources, is assessed robustly, to ensure results can be adapted to different country requirements

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  1. Package the evidence-based value propositions in a compelling global value dossier (GVD) that effectively communicates the benefits of the product to payers, HTA agencies and other stakeholders, remembering to take into account the need to accommodate country-specific data requirements

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  1. Develop a core health economic model that assesses all costs and relevant outcomes
  2. Model additional scenarios in order to meet the standards required by HTA authorities in France, Germany and the UK
  3. Adapt this core model into health economic technical reports for each country, addressing the specific needs of local decision-makers in each country

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Launch minus 12 months

VALUE DISSEMINATION:

Local adaptation during the year before launch and delivery through the
launch phase

  1. Determine the revenue and profit optimising price for your product through assessment of supporting evidence, any pricing thresholds that exist, and likelihood of premium pricing being secured due to the product addressing an area of unmet need or priority therapy areas
  2. Determine launch country priorities

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  1. Develop customised, local language pricing and reimbursement submission dossiers for each country, based on understanding of the HTA agency’s processes and priorities
  2. Create all required ancillary documents (for example cost effectiveness analyses, literature reviews, budget impact models) by adapting global documentation for local markets

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  1. Submit country dossier packages and negotiate with national payers based on their established procedure for assessing the value a new product brings

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  1. Continue to engage with health authorities on a local basis, negotiating as needed to enhance formulary uptake on a regional or hospital level
  2. Ensure ongoing collection of evidence to demonstrate the long term value of the product through local Budget Impact Models (BIMs) and other methods of demonstrating outcomes

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Regulatory approval / Launch