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Holistic solution

To meet market access challenges, pharma must adopt an integrated, streamlined approach

A tower of pebblesDepending on your point of view, the healthcare market  is either undergoing an evolution or a revolution. If you take the Charles Darwin approach, it is time to adapt to meet the challenges of this evolving environment. However, if you sense turbulent times ahead and can already see the barricades going up, then you need a plan to keep your head when all about you may be losing theirs. In either case, standing still is no longer an option.

Market access is fast becoming one of the most widely discussed challenges impacting on our industry's potential. Earlier this year, Uday Bose, European marketing director for GlaxoSmithKline Oncology, told a conference that until pharma companies see market access as an opportunity rather than a burden, the industry will never have the right attitude to take advantage of all the possibilities. Similarly, Dirk Ziegler, head of sales excellence in oncology in emerging gross markets for Novartis, questioned the wisdom of a narrowly physician-focused sales strategy in an increasingly complex pharma market.

So why is market access the subject of so much discussion; what do we mean by it and just what is wrong with the old ways of marketing products anyway?

The traditional marketing approach depended on proving the efficacy of a product and then reaching out to the clinicians - considered the main stakeholder group - generally via key opinion leaders. Now the efficacy of a new product can be seen as the minimum standard and cost-effectiveness is the new marker for market success.

Multiple stakeholders
NHS reforms have transformed the landscape, producing powerful PCTs and a wealth of stakeholders and influencers with responsibilities under public health priorities and service provider frameworks. Many of these influencers are tasked with cost-containment. Where EMEA licensing was once the ticket to market access, now a multitude of stakeholders, the most obvious of which is NICE, are the new gatekeepers who can block or, indeed, open access to a brand. Pounds spent on a successful UK launch may not be recouped if NICE gives the thumbs down.

The last few years have seen the industry landscape littered with battlefield casualties from this process. These include Orencia for rheumatoid arthritis, and Erbitux and Tarceva for cancer. Arguably, the battle is tougher in the UK than it is in the rest of Europe, after all NICE is the only body carrying out health technology assessments worldwide that has rejected cancer therapies.

Rejections have caused consternation among doctor and patient groups, but the situation has also led to a new force in the stakeholder balance of power: patient advocacy. Activism among patient groups is increasing, with third parties becoming a powerful voice in market access dialogue - witness this year's High Court battle over access to Alzheimer drugs where the court ruled that NICE had not been transparent in its decision making process.

It would be tempting to think that this revolution/evolution in market access was the industry's only battle-front, but this is not the case. There is one more powerful stakeholder group that must not be neglected - the shareholders.

Pressure from the city is forcing the industry to restructure many of its commercial activities as billions of pounds worth of drugs are coming off patent in the first two decades of this century.

Lifecycle long strategy
So what do these multiple pressures and stakeholders mean for our industry's ability to meet the market access challenge? It is clear that the old model of marketing, with its separate solutions for each access challenge along the brand life cycle (a medical education approach for key opinion leaders, lobbyists to influence policy, a PR approach for the media and a motivated sales force to go out to the stakeholders) is not delivering the best return on investment. The weight of regulations, competition and economics now includes Medicines and Healthcare products Regulatory Agency (MHRA), NICE, Area Prescribing Committees, Drug and Therapeutics Committees, Healthcare Commission, National Prescribing Centre, National Horizon Scanning Centre, Quality Outcomes Framework, Regional Evaluation Centres, Specialised Commissioning Groups, Scottish Inter-Collegiate Guidelines Network, Scottish Medicines Consortium and Health Commission Wales.

To cope with the sheer number of often conflicting stakeholders, the industry needs a more holistic, streamlined and strategic approach to meet the market access challenge. Only by putting market access at the centre of marketing efforts can pharma companies achieve effective brand management and optimal market access in this time of change. Whether or not your definition of market access, and how to achieve it, is the same as your colleague's at the next desk, your desired outcome is likely to be the same: ensuring physicians have the freedom to prescribe, to ensure the right patient has access to the right therapy at the right time.

As is so often the case, market access can no longer be considered a single job function or as one hurdle in a brand's journey. Instead it is a constant battle where every action by your company should become a step towards optimising market access for a brand. Market access defines a lifecycle long process of commercialising a product, from its first clinical trials right through to generic defence strategies. It is the single overarching strategy that helps define the brand mission; it aligns internal thinking and provides synergy by linking research, medical, marketing and sales efforts.

While market access transcends the lifecycle of a single brand and embraces multiple disciplines, there is an underlying principle that holds all activities together: understand the values and needs of your stakeholder groups, from the clinical trial stage right through to medical education, in-line marketing and generic defence.

Making market access happen
Making market access happen is the key challenge facing pharmaceutical companies and it requires taking a step back to re-focus. This re-focus will give a new perspective and may even mean new ways of thinking within your organisation and new ways of working with others.

It may also mean seeking out partners and suppliers with different skills, or making different demands of your existing medical education, clinical trial support teams and PR advisers.

Finally, it may mean a new commercial model within your organisation with less emphasis on a GP-focused sales team or brand plan; more emphasis on real life health economics and new capabilities in building dialogues and extended relationships with non-clinical stakeholders.

Conclusion
It is clear that only a broad range of disciplines coming together to create truly integrated solutions can overcome the barriers to market. In this way, market access can be thought of as your key commercialisation strategy, because without it you have no access to a market and no sales. As such, it cannot be one person's responsibility - it requires a spectrum of experts working in concert to refine the value of a therapy on multiple levels to multiple stakeholders.

Evolution or revolution to meet the changing healthcare market? It's up to you.


The Authors
Neil McGregor-Paterson
is Managing Director of Brandtectonics Europe, a specialist healthcare consultancy within the Chandler Chicco Companies


Guide to improving market access:

1. Shape the environment

Understanding policy and environmental risks and working to overcome them smoothes a brand's path to acceptance and underpins policy, public affairs and advocacy relations.
Environmental shaping includes mapping all key bodies that influence market access and identifying individuals to approach.
The process needs to give insights into the needs, incentives and economics these bodies operate under. Real life health economics arguments can be built on this knowledge and used in negotiations with decision-makers.

2. Align your stakeholders
The power of key stakeholders in policy, medical and advocacy areas needs to be synergised and directed to maximise brand success. Once stakeholders have been mapped, development programmes can be devised and carried out to build relationships and further brand knowledge.
Stakeholders can then be influential in areas such as the assessment and updating of current guidelines; providing evidence for health technology assessments and supporting public awareness campaigns.
It is also vitally important that internal stakeholders are aligned. An internal audit may produce evidence of gaps in knowledge or inconsistencies in approach that hamper the company-wide push for market access. If so, an internal working party can be set up to develop a training tool based on best practice.

3. Start early - your clinical trials
The aim is to build a 'virtuous circle' of brand communications, which will positively reinforce the product from its first clinical trials until its final brand positioning.
At clinical trial level, focus group research among the desired patient groups will provide information about appropriate language, messages and communication methods to help with patient recruitment and retention.
This research can also translate into training tools to enhance investigator team skills and keep them motivated. 
It is also important to liaise with regulators and health technology appraisal bodies to ensure clinical trials are designed to answer future questions from these bodies.

4. Revisit brand and portfolio strategies often
An important element is to prepare a range of possible strategies today, in preparation for tomorrow's challenges.
The basic tools in the armoury are clear corporate, franchise and brand position statements. These need to be developed early on and re-visited frequently to check for relevance and in order to keep thinking aligned.
Adding new brands to the mix requires careful portfolio management. Generic defence strategies need to include consistent corporate and brand messaging that leverages the wider portfolio to demonstrate value to payers and policy makers.

4th June 2008

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