Severe Weather Warning – Shaping a market access strategy to navigate choppy local waters

For many pharma companies, the level of local country uptake of global market access tools is remarkably low. Yet there are ways to increase the probability of local market engagement and thereby increase return on investment.  Answering six essential questions can help shape your global market access development and deployment strategy.

1) Why is there such disconnect between global and local market access in pharma?

Market access is ultimately about packaging data and information in the right way, for the right customer at the right time. Global pharma teams generally support their local affiliates with this process through the creation of market access toolkits; but the uptake of global tools at a local level is remarkably low. 

Why is this?  Common objections from local markets include late delivery, over-complexity, and – most importantly of all – the fact that global tools do not align with the local market access needs.  

It can also depend on the country, says Dr Etienne Régulier, Associate Director, Global Market Access and Pricing in a biopharmaceutical company. “In well-developed affiliates, such as France, Germany or Spain, fully dedicated teams are in place – including marketing, medical, commercial and market access– in these countries, the need for global tools and documents is perceived as quite low due to local expertise."

Is that such a problem? Given that affiliates know their own healthcare environment best, shouldn’t they drive their own local access programme?

“We try to avoid this as we don’t want affiliates to produce documents and tools that are not aligned with global strategy,” said Dr Régulier. “We have a global strategy to launch a new product and the documents are aligned with medical, commercial and marketing. They are cross-checked and reviewed by all the functions; so it is credible data that we know can be published and validated.”

2) What value can global bring?

The current payer landscape is moving increasingly towards demonstrating ‘value’ and ‘outcomes’ for new products. 

It is a challenging landscape and global can be more than just providers of template tools to affiliates.  They can work closely with local teams to coordinate and aggregate information, cherry-picking best practice to produce an overall plan to help implement local strategy. There are a variety of tools that the global team can produce within this, including the core value dossier, budget impact models, cost-effectiveness models and managed entry agreements.

These documents can be produced earlier by global teams than local teams (due to resource availability) and contain all the evidence of the clinical, economic, and human value of a new product as well as data on the global burden of illness for that particular therapeutic area. Importantly they help to define how the product delivers value.

The ultimate goal should be the harmonisation of tools across products and business units.  This necessitates market access team collaboration throughout the business and across worldwide markets.

3) How can local uptake be improved?

If we accept that global does have an important role to play, how can we begin to improve the uptake of tools at a local level?  First we need to look at the specific barriers throughout the five stages of market access tool development and deployment:

I. Design
II. Build
III. Deploy
IV. Use
V. Maintain & evolve

There are many factors which impact affiliate implementation of global tools throughout these five stages, ranging from the local team set-up to the existence of a long-term sustainability plan.

These factors can be mapped out by stage and prioritised based on their impact on local uptake of global tools [see Fig. 1]. 

Fig 1: Factors affecting local uptake of global market access tools

Stage: Design

Time from launch: -12 months

Key factors:

• Early affiliate involvement
• Harmonisation of tool logic and structure across disease areas
• Involvement of end customers in tool design

Stage: Build

Time from launch: -8 months

Key factors:

• Cross-functional collaboration at global level
• On-going validation with representative affiliates

Stage: Localise and deploy

Time from launch: -4 months

Key factors: 

• Cross-functional collaboration at global level
• On-going validation with representative affiliates

Stage: Use

Time of Launch

Key factors:

• Evolution of local KPIs and incentives to focus on value creation
• Evolution of affiliate customer facing team set-up
• Support of affiliate capability development

Stage: Maintain & evolve

On-going

Key factors:

• Continuity of global tool ownership
• On-going tool improvement

4) What is best practice in the “design” and “build” phases?

Global teams should not develop tools in a silo.  Acceptance and engagement of global materials will improve if target audiences are involved in their development.  

For example, involving a number of affiliates in the production and validation of a master framework and key documents such as the value dossier, will engender buy-in to the end result, and should ensure materials are useful and easily adaptable. 

Ideally, the end-customers (e.g. payers) should also be involved.  Through initial one-on-one consultations, global teams can prioritise the messages / data that resonate well and uncover the unmet needs at the forefront of payers’ minds. 

Engagement should be done at an early stage to be effective, says Dr Régulier. “We have committed to developing tools and models very early in conjunction with affiliates. We’ve had some very positive feedback from local affiliates as a result.”

However, Dr Régulier points out that challenges do exist around internal alignment with medical and clinical to obtain the relevant data early enough to be able to incorporate it into the document.   In addition, there is the need to plan post-hoc analysis well in advance, and while the early involvement of biostat teams is important, they are usually very busy in preparing data for regulatory approval.  Another challenge is that country level resources are usually focussed on achieving plans for the shorter term, and there are limited country-level resources allocated for pipeline products.

Working with third party suppliers and putting processes in place for sharing best practices can help, encouraging affiliates to publish lessons learned and share developed documents such as adapted models, local HTA dossiers, and case studies.

5) What is best practice in the “deploy” and “use” phases?

Deployment is too often an afterthought for global teams.  The perceived goal is the development, approval and distribution of the tool, but that is not where the role of global ends; what immediately follows is possibly the most critical stage of all, and where global can add significant value to contribute to local capabilities.

At a minimum, global should provide a guidance document to inform local teams on how the tools are best used.  Ideally this guidance should be provided in person, via meetings, workshops, role-playing, to really sell the value and help local teams become quickly acquainted with global strategy, messaging, data and proposed roll-out.   

From Dr Regulier's perspective, the answer lies in local country workshops. “We have organised workshops with the countries at a very early stage. We do this to ensure we understand their needs and that they understand what we can develop for them,” he said. Such workshops can also provide advanced training for affiliates to become familiar with the new tools and how to use them, and provide useful insights on what their local needs will be for market access. 

There are also steps global teams can take to make deployment of global tools more incentivised, for example ensuring market access discussions reflecting the global strategy are in-built into personal and team objectives.

6) What is best practice in the “maintain & evolve” phase?

Another aspect of improving the adoption is improving the long-term sustainability of market access tools.  There needs to be a process or platform in place to facilitate consistent check-ins to help overcome any issues around local staff turnover, and to be able to adapt and evolve the tool (if required) in the journey towards launch.

Tools are often too static; a one-off hit provided during a particular point in time.  They can lose their relevance or accuracy alarmingly quickly.

Global support of local market access must be seen as an ongoing journey.  Messaging will evolve as new data is available, as competitors enter the market, as market dynamics change – and there needs to be an ongoing process and associated resources to support this evolution. 

Therefore global teams should not think about ‘tool development’ per se but rather ‘programme development.  And appropriate time and budget must be built in during the initial planning stage to ensure this can be supported.

A local role for global teams

There is no doubt that global teams have a significant role to play in local market access.  Improvements need to be made in the development and deployment of market access tools to avoid the large-scale waste occurring today.  There are methods to help assess which barriers to local usage global teams should focus on, and for designing and deploying market access tools that are more likely to be adopted by affiliates.  Even in the relative short-term, this could represent a significant increase in return on investment.