Need for leaders as Value & Access plays increasing role in pharma

At the forthcoming Pharmaccess Leaders Forum Spring conference, Ana Céspedes, senior vice president of global marketing and strategy at EMD Serono, a business of Merck KGaA, Darmstadt, Germany will give a presentation outlining the evolution of the Value & Access function. Pharmaphorum spoke to her ahead of the conference, in London on April 17-18, to get her thoughts on the latest developments.

Céspedes has been working in this field for the last 18 years at country, regional and global levels. During the last five years, she built the Global Market Access and Pricing function at Merck KGaA and recently transitioned to marketing and strategy.

Ana Céspedes

She speaks about Market Access from her experience on the payer and policy side, as a consultant, inside the market access teams and, now, from the outside.

As the pharma industry, and the way it interacts with payers, has evolved, the Value & Access function has also changed and become increasingly important.

She says that, as pharma’s approach to pricing has become more nuanced and complex, the different skills required in the Value & Access function have also increased.

Successful Value & Access teams can help to contribute throughout the product cycle, from the research stage, through product registration and through the drug’s market life cycle.

She believes that pharma companies need Value & Access teams that are capable of contributing across different functions in a company, with a range of skills.

The teams must also be able to interact with external stakeholders, including payers and health technology assessment bodies.

With the different skills required, Value & Access teams may become quite differentiated, with some individuals focusing on health economics, pricing and contracting, or evidence generation, and others specialising in policy, for example.

But across Value & Access there is one skill that she says is vital: leadership.

“We need leaders and sometimes we forget this,” she points out.

“It is challenging to find someone with all those skills; Value & Access is one of the most cross-functional jobs in pharma.”

Increasingly, pharma companies are turning to innovative pricing arrangements to ensure access to new drugs.

This is made possible by a wealth of new data that is becoming available that goes above and beyond that gathered from clinical trials.

Patient-reported outcomes, matched with insights gained from sources such as patient registries, can be used – but it is important to ensure this information is available at the time the drug receives regulatory approval.

Céspedes continues: “We need to power trials so they are access-orientated. If you don’t consider access straight after proof-of-concept and from early development, you are missing an opportunity.”

Pharma-payer partnerships

Céspedes cites the recent agreements announced by NICE for a multiple sclerosis drug and a breast cancer drug as examples of the kind of approach that companies must take.

At the FT Global Pharma and Biotech conference in London, NHS chief executive Simon Stephens described the agreements as “precedent setting” as they involved sharing risks between the NHS and pharma.

Céspedes explains: “In the case of the UK affiliate of Merck KGaA, it was joint work by the medical, commercial and market access functions, with strong leadership of the General Manager. This is the example to follow.”

Centres of excellence

Those deals are examples of Céspedes’ vision of how the Value & Access teams should operate – rather than just being a business support function, it helps to contribute to strategy, to ensure that drugs are accessible in the market and meet the needs of patients.

Training the Value & Access professionals of today and tomorrow is therefore crucial and Céspedes speaks with passion about one of her last projects at Merck KGaA last year, where the company joined 12 other pharma companies and the London School of Economics to create a ‘Market Access Academy’.

The initiative involves a five-day training programme in London and combines speakers, case studies, group work, social events and networking opportunities to help attendees hone their skills and improve their knowledge.

Topics covered at the academy held last September included drivers and barriers to access and how to produce evidence packages.

Céspedes describes this initiative as “a great step forward”.

Individuals within teams should be given the training and the opportunity to play to their strengths – whether it is health economics, advocacy and communication, or the technical knowledge that can be applied, to ensure trials generate data that can be useful during the health technology assessment (HTA) process.

“You are looking at superman or superwoman. You need people who have potential and we need to help them to grow,” Céspedes states.

Patients

Aside from working with payers and governments, Value & Access must never lose sight of the needs of patients.

As HTA bodies are also keen to strike up a dialogue with patients, Value & Access professionals need to have the communication skills to ensure they can adequately explain the overall value of the medicine to society, which encompasses benefits to patients, caregivers, payers, health care systems, and the wider economy.

Insights from patient groups could be key at any point in the drug lifecycle – during R&D, during the regulatory process as bodies such as the FDA look to prioritise badly-needed drugs, during pricing negotiations, and once the drug is on the market.

These insights can be fed into the rest of the company’s work – for instance the trial design, finding information to support an HTA dossier.

“This is a continuous process,” Céspedes concludes.