The challenge of successful market access

Mark Holliday

Capgemini consulting

What must pharmaceutical companies do to get products to market in a fast changing, increasingly demanding environment?

Market access has been, and continues to be, at the top of most pharmaceutical companies’ agendas. Economic pressures, the need for product differentiation and cost containment requirements are creating some conflicts. In particular, we are seeing a rise in healthcare costs, due to growing prevalence of chronic diseases, an aging population and the higher prices associated with new therapies. Also evident is a challenging pricing and reimbursement environment, with increasingly frequent reimbursement rejections by payers, and growing use of pricing and reimbursement tools like reference pricing, generic substitution and price controls in order 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, in order 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 it 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.

Pharmaceutical 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 stakeholder landscape and the need for mapping

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 are now having 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.

"This fragmentation of the stakeholder landscape means that a broader range of stakeholders can influence market access."

Furthermore, access to reliable healthcare information on the internet is helping patients become more informed. They are also footing a growing proportion of the drug bill and want cures, not just treatments. To satisfy them, pharmaceutical companies need to transition from selling drugs to selling integrated concepts, such as holistic solutions for health delivery and health 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.

This fragmentation of the stakeholder landscape means that a broader range of stakeholders can influence market access. Companies must identify the groups and individuals who influence prescribing in each of their markets. They must understand what drives them, 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&amp,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 one another’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 their behaviour, and hence open up market access for products.

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

Stakeholder mapping

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 which are 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.

"A stakeholder evaluation is a critical input into the development of a new therapeutic strategy…"

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 what the individuals’ role is 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 committee 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 interaction with them and will help companies to target the right stakeholders with the right product arguments.

How companies need to change internally

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 “pharmaco-economic” 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 which responds to stakeholders’ needs for efficiency, added value and so on, and is consistently communicated 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 which 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 who have a strong influence on market access, such as hospital drug evaluation committees.

"…market access must become the business of everyone in the company."

New skills will be needed in areas like networking and public relations.

Companies will need people with a grounding in government and pharmaco-economics, 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.

Conclusion

Getting to grips with market access is a complex challenge, particularly in view of today’s dynamic environment, with far-reaching 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 continually adapt their approaches to the needs of new stakeholders.

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. But for those that rise to the challenge, competitive advantage lies ahead.

About the author:

Mark Holliday is Managing Consultant in Capgemini Consulting’s Life Sciences Practice. Capgemini is a leading global provider of management consulting, technology and outsourcing services to the pharmaceutical, biotechnology, and medical devices industries. Established in 1993, the team globally includes 200 strategy and transformation experts who concentrate on this industry, plus an affiliated network of 2,500 consultants with significant experience.

For more information please visit www.capgemini.com/services-and-solutions/by-industry/life-sciences/overview/ or contact Mark Holliday on +44 (0)870 904 5815 – mark.holliday@capgemini.com

How do you secure market access in this changing environment?