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Pharmaceutical companies must take a wider look to enable them to bring their products into this fast changing, increasingly demanding market

An owl's face against a blue backgroundMarket access has been, and continues to be, at the top of most pharmaceutical companies' agendas. This article develops on 'Building strength' - a stakeholder management article written by Capgemini for the May 2010 edition of Pharmaceutical Marketing - by taking a broader look at the area of market access.

Health economics constraints and cost containment requirements are creating conflicts: in particular, a rise in healthcare costs due to growing prevalence of chronic diseases, an ageing population and the higher prices associated with new therapies. The pricing and reimbursement environment is also challenging, with increasingly frequent reimbursement rejections by payers; the use of pricing and reimbursement tools like reference pricing, generic substitution and price controls is growing in an attempt to bring down healthcare costs.

For pharma companies, product differentiation is vital to securing market access in this new environment. It is a question of packaging the right data in the right way, for the right customer and at the right time, to prove that the product brings economic value in terms of lower product costs, lower overall treatment costs and/or reduction in additional potential costs. It is crucial that the product embodies innovation; this can be demonstrated through a head-to-head proof of superiority and through outcome studies.

It is also necessary to prove that the product offers value-added services: for example, that it helps patients access and stay on therapy.

Alternatively, a product may answer unfulfilled needs of key stakeholders along the care delivery chain, perhaps by providing support for clinicians' prescribing decisions or payers' funding decisions.

Pharma companies must address the need for product differentiation, and for market access in general, at each phase of the product development process. Apart from building evidence to prove they offer differentiated products, companies can differentiate their offering through complementary pharmacoeconomic strategies, such as risk sharing and discounted pricing.

The new landscape
Another major change affecting market access is the transformation of the stakeholder landscape. Traditionally, market access depended largely on the views of prescribers, Key Opinion Leaders (KOLs) and regulatory agencies.

However, the focus is now shifting dramatically, with new non-clinical stakeholders influencing the uptake of drugs. For instance, payers now have an increased influence on physicians' prescriptions.

They scrutinise drugs on the basis of health technology assessments (HTAs), creating a strong requirement for cost effectiveness in addition to safety, efficacy and manufacturing quality. They also play a role in the establishment of treatment protocols, and are increasingly influencing physician prescribing. In some countries, patients are increasingly bearing the additional costs of high-priced drugs through co-payment schemes.

Furthermore, access to reliable healthcare information on the internet is helping patients become more informed. They are footing a growing proportion of the drug bill and want cures, not just treatments. To satisfy them, pharma companies need to transition from selling drugs to selling integrated concepts, such as holistic solutions for health delivery and management. We can expect to see a much more collaborative relationship between pharmaceutical organisations on the one hand and patients and patient associations on the other: adherence programmes, patient education, drug administration and diagnostic services will characterise this new relationship.

Mapping the new landscape
This fragmentation of the stakeholder landscape means that a broader range of stakeholders can influence market access. Companies must identify the groups and individuals that influence prescribing in each of their markets.

They must understand what drives these influencers, what their operating environment is and how they are measured and rewarded.

In our experience, this exercise often identifies a significant gap in the organisation's understanding of its stakeholders and their key requirements.

The evaluation may also highlight a lack of alignment with major stakeholder groups. As well as hampering external relationships, this misalignment can affect working relations between internal groups such as access, marketing, sales and R&D, and also between the local and global parts of the organisation.

For example, affiliates typically gain understanding of the access requirements for a new drug through building a good relationship with the relevant local authorities. If this relationship is weak, the understanding will be lacking, and the affiliates will not be able to provide the right input for the outcome studies that need to be performed at global level.

A stakeholder evaluation is a critical input into the development of a new therapeutic strategy, because it ensures a good understanding of market access, pricing, assessment procedures, publication and medical guideline requirements. It is also important when there have been major changes to legislation or other aspects of the healthcare environment.

The various stakeholder groups can affect each other's decisions, so pharmaceutical companies not only need to identify the key stakeholders and their needs but also must understand how the stakeholders interact with one another.

Once they have gained this understanding, the companies can segment stakeholders with a view to communicating with each group in ways that will influence its behaviour, and hence open up market access for products.

The relevant analysis and decisions will often have to be tackled at regional level.

Understanding stakeholders
Stakeholder mapping is a key technique for developing an understanding of the decision-making landscape. It helps companies to analyse complex decision processes which vary between therapy areas and geographical areas; identify stakeholders who have influence, whether direct or indirect, and the key decision makers under each influencer, and target the key point of contact so as to influence the decision maker within the policy framework.

There are many different techniques for stakeholder mapping. However one of the most important factors during the stakeholder mapping process is categorising each stakeholder. This will enable them to be grouped and their key characteristics and drivers assessed. Some of the key characteristics used in the mapping process include autonomy, power, reach of influence, degree of decision-making ability and attitude.

It can also be useful to group stakeholders into levels or tiers, each one with a different degree of influence from direct to indirect.

Once the stakeholders have been profiled they need to be mapped using a formal structure. In essence, stakeholder mapping is the technique and process of building a picture of the individual's role within the organisation.

Although the individual stakeholder is critically important in this process, the dynamics have changed over recent years. Historically, individuals such as the traditional consultant KOLs had a direct influence. Nowadays, the influence is much more by committees and the organisations they represent. Therefore, organisational mapping needs to be considered in the stakeholder mapping process.

In short, stakeholder mapping will provide a clear view of the target audience landscape in terms of the most effective ways of interacting with it. It will also help companies to target the right stakeholders with the right product arguments.

Companies need internal change
We have outlined some of the changes that are affecting market access, and the responses that companies need to make to assure the success of their products. To produce a really effective response, however, the companies will need to evolve their own culture, organisation, skills, data and tools.

In terms of culture, pharmaceutical companies need to plan a cultural shift to a marketing-oriented model.

This will entail: the adoption of a pharmacoeconomic mindset; the development of a culture of collaboration, with teams from different functions working together towards common objectives, and the creation of an 'argument' or business case for each new product – one that responds to stakeholders' needs for efficiency, added value and so on, and is communicated consistently internally.

Change to the organisation is also needed: market access must become the business of everyone in the company.

Companies need to promote an integrated approach to stakeholder management that must be reflected in the organisational hierarchy, as well as becoming part of the culture.

Changes will typically include the implementation of a department dedicated to market access, and/or a field-based team dedicated to relationship management for key stakeholders. It will also be necessary to break down silos and encourage internal collaboration, interaction and consistency between relevant teams at both country and corporate levels.

Another change will usually involve the introduction of a key account management function to coordinate and optimise activity directed at stakeholders that have a strong influence on market access, such as hospital drug evaluation committees. New skills will be needed in areas like networking and public relations.
Companies will need people with a grounding in Government and pharmacoeconomics, along with scientific and medical knowledge.

Strong data analysis competencies will also be necessary, because data and tools must evolve to support a multichannel, 360-degree view of stakeholders.

Pharmaceutical companies need a detailed, up-to-date picture of their stakeholders, integrating data from all channels and all stakeholder-facing functions. Only with comprehensive knowledge like this can companies identify the stakeholders who have the greatest ability to influence market access, and then optimise their strategies to promote long-lasting relationships with them.

The tools chosen will have to be flexible enough to keep up with the constant evolution of the healthcare system and consequent changes to the stakeholder landscape. The information could be delivered through a CRM system (which might have the advantage of fostering cross-functional collaboration) or otherwise.

Moving forward
Getting to grips with market access is a complex challenge, particularly in view of today's dynamic environment, with farreaching health reforms planned in the US, UK and elsewhere. The strategies we have described above, such as mapping the stakeholder landscape and differentiating products, will always be relevant, but pharma companies must adapt their approaches to the needs of new stakeholders constantly.

To succeed in the long run, companies will need, as we have seen, to change just about every aspect of themselves – culture, organisation, skills, data and tools – and they must ensure that their change management capabilities are adequate.

The Author
Mark Holliday is a managing consultant in Capgemini's life sciences team.

To comment on this article, email pm@pmlive.com

6th January 2011

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