Embracing the new paradigm in pharma market access

Pharma needs to change its image from being drug producers to healthcare provider partners

embracing the new paradigm The European market access picture is changing at a dizzying pace. Yet timely and careful strategic planning, combined with positive engagement, can ensure successful submissions with the most influential and stringent watchdogs.

Thanks to recession and the strain on healthcare budgets, prescribing and dispensing models based on cost containment are being applied across Europe. Against this backdrop, there is a cultural shift brought on by a new set of disparate decision makers.

“Many markets have been experimenting with cost control tools for years. What is different is the pace of change, which is much faster, and the challenges created by this economic environment,” says Carsten Edwards, Managing Partner at Ogilvy Healthworld.

“The pharma industry continues to be wedded to an older model that focuses only on commercialisation and promotion budgets. Market access has to be seen as a normal part of the process, requiring a much more integrative and multidisciplinary approach.”

It’s not just about pricing
So why is the industry still struggling with this so-called ‘fourth hurdle’ in market access? Perhaps because of the need to integrate services and go beyond the number crunching, engaging earlier and more efficiently with a wide range of national and regional influencers.

Nick May, Head of Advocacy Relations, at Sudler & Hennessey (EMEA) agrees that the landscape is very complex and fluid, stressing that market access is the single most important item on the agenda for the industry: “Pharma has the responsibility to communicate value, it’s not about selling pills any more, but offering healthcare solutions. This is hard as it involves structural changes and an internal flexibility that some companies lack.”

Sean McGrath, CEO of Succinct, argues that pharma puts too much emphasis on health economics and pricing and loses track of the non-financial side of market access. “The word ‘payers’ to describe decision makers is misleading.

Pharma needs to know what the rules are and at the moment they are all over the place

It should be ‘commissioners’ and there should be true engagement with all stakeholders. It’s these non-prescribing decision makers that pharma tends to forget about.

“In order to get HTA approval, companies fall over themselves to make sure the health economics models are right. But there are other factors to consider, such as delivery, logistics, the impact on the wider market and on health priorities so that new drugs can reach patients.”

This holistic planning should be done at least 18 months prior to drug launch, says McGrath, and apart from physicians, the industry should focus on a much broader group of stakeholders, including representatives of regulatory bodies, managers, policy makers, pharmacists, patient groups. “I emphasise that the issue of not planning in advance for the impact of drug uptake leads to lost sales,” he cautions.

Ruairi O’Donnell, Commercial Director at Abacus International, concurs that early engagement and looking beyond price and health economics are key: “The more forward-thinking companies are preparing for market access early and paying close attention to payer landscapes globally to get ahead of the game.”

Power and influence
Spheres of influence overlap and bodies such as the UK’s National Institute for Health and Clinical Excellence (NICE) and the German Federal Joint Committee (G-BA) are flexing their muscles beyond national borders.

Since NICE was established in 1999, its influence – as a prolific issuer of clinical guidelines adopted internationally – has been felt across Europe and farther afield, with several countries seeking its advice. Its future role, which will be influenced by NHS reforms, will have a tremendous impact on market access.

NICE weakened by politics
Nick May of Sudler says that NICE has greatly improved its methodology, which is being closely followed in other European markets: “It’s immensely influential and has become a lot more robust. I believe NICE will maintain its role as a guidance body. Everywhere HTA bodies are converging, co-operating and becoming stronger.

“Companies can’t afford to work on the assumption that they will get fair prices; they need to be part of the conversation.”

If NICE loses its influence and GP Consortia get the power to decide whether a drug should be funded by the NHS based on its advice, it would no longer be a “gold standard”.

“NICE has been slightly weakened by political interference, such as government blacklisting of approved drugs. With GP commissioning, clinical staff will look at NICE for guidance but there is a lot of uncertainty. It gets tougher for pharma because there will be more points of contact, more ground to cover, with a need to shift investment,” says Ruairi O’Donnell.

G-BA boosted by reforms
Germany’s G-BA was set up in 2004 but its remit has been strengthened with the new Restructuring of the Pharmaceutical Market in Statutory Health Insurance (AMNOG), which came in to force in January 2011. When a product is launched, the manufacturer must prove its added therapeutic efficiency or it will be included in the reference pricing list. Many firms feel that they are not getting a meaningful and fair price assessment, resulting in delays or the cancellation of drug launches, which impact health outcomes.

Fragmentation or integration?
With over 20 pricing and reimbursement systems with distinct assessment criteria and, in some cases, multiple policies co-existing in each country, what is the outlook for market access in Europe?

“Pharma needs to know what the rules are and at the moment they are all over the place. I see less integration and stronger regional bodies. We are already witnessing that with the London Cancer New Drugs Group which can’t agree with NICE,” McGrath points out.

Is it possible that similarities across Europe override the quirks of regional pharma policy? Carsten Edwards thinks so: “European markets are different, requiring different strategies and local adaptations, but there are a lot of similarities. The trend is towards more integration and affordability is the real issue that concerns all policy makers.”

Embracing a new paradigm and seeing market access as an opportunity and not a hurdle will ensure future success for firms currently struggling or fearing the whole process of getting approval and the right price for their new product.

“HTA bodies are converging, getting stronger and demanding value. Pharma companies must change their image from drug producers, classically seen as wanting to secure high prices, to health provider partners, interacting with government services,” May concludes.