In the UK joint working is being encouraged to develop innovative services and propagate best practice. But in France, new legislation is placing significant barriers between pharma and its clients. Jérôme Guermonprez explains the implications for market access strategies in the country.

Across Europe pharmaceutical companies have been looking to underpin market access strategies with strong links to healthcare professionals. And while most pharmaceutical companies admit there are significant national differences that demand specific market access strategies, there has been a push, where possible, to leverage expertise, messaging and strategy to drive economies of scale.

Many organisations are now actively embarking upon innovative, cooperative working with regional decision-making bodies – such as the Clinical Commissioning Groups (CCG) in the UK; whilst doctors and pharmacists are increasingly involved in research projects, from clinical research to patient care, patient outcomes and procedures. Indeed, the UK’s amended Health and Social Care Bill strongly encourages pharmaceutical research, innovation and the use of scientific evidence in decision-making.

In France, the forthcoming radical overhaul of the drug regulatory system will significantly change relations between pharmaceutical companies, healthcare professionals, patient associations and physician associations. The “Reforme du Medicament” legislation aims to crack down on health practitioner conflicts of interest, restructure the country’s drug regulator and tighten the process for licensing drugs and for monitoring their effects once in use.

The proposed bill creates compliance requirements that far outstrip the UK anti-bribery laws and includes a number of significant changes which will directly affect the way pharmaceutical companies interact with opinion leaders across the French health service.

To minimise the risk of conflict of interest, the new legislation mirrors the US Sunshine Act by requiring pharmaceutical companies to disclose all financial relationships with healthcare professionals, patient associations and scientific experts.

With an emphasis on patient safety, the bill also requires far more detailed information and discussions about indications – from the provision of a helpline number on every drug packet to enable patients to report problems, to the creation of a government watch list of drugs under review.

It also demands pharmaceutical companies no longer undertake direct physician training but instead provide the funding for training to the government, which will then oversee independent training programmes.

 

Restricted access

Critically, from a market access perspective, the bill will prohibit individual medical representative visits to physicians within a hospital; visits must be collective to avoid any one-to-one relationships and ensure discussions are open and transparent.

The impact of this legislation – which is currently being discussed and should be passed by the French government by the end of 2011 – will be significant for pharmaceutical market access policies and demand companies gain new insight into key opinion leaders (KOL).

Under this new model, the industry will have to be incredibly careful about the type of relationships that are put in place with stakeholders; indeed, at least one pharmaceutical company has already announced it will no longer pay physicians directly in the future or invest directly in physician grants to avoid any regulatory compliance issues.

Furthermore, with many physicians likely to back away from any interaction with the pharmaceutical industry, at least in the short term, patient and physician associations will have a far greater role to play. Pharmaceutical companies will have to rapidly assess the way these associations and individual physicians respond to the new legislation and amend market access strategies accordingly.

 

Regional structure

This new challenge comes at a time when pharmaceutical companies are still adjusting to the major overhaul of the French healthcare system – which has seen the creation of 26 Regional Health Authorities (RHA).

While drug reimbursement is still set nationally as in the UK, since 2009, each region has found the responsibility to adapt national objectives to local or regional health and demographic problematic. Over the past year, each region has had to sign multiple year contracts between the  state and the region to deploy the health strategy.

As in the UK, over the past two years, pharmaceutical companies have realigned resources to create a regional approach based on a key account management (KAM) model. The regional structure has significantly broadened the number of stakeholders involved in decision-making, both financial and medical.

Furthermore, each RHA has a different demographic breakdown and health issues, creating very diverse goals for each region. This change has required a far greater insight into decision-makers and regional objectives; it has also demanded pharmaceutical companies use the KAM approach and strong CRM tools to drive synergies between teams at local, regional and national level.

Pharmaceutical companies in both France and the UK are now actively seeking in-depth insight into the KOLs within new regional structures. Information from the structure of the new organisations, including the multiple drug, technical and price commissions, to identifying specific members, roles and drivers is proving key to create the right regional messaging.

And with this regional, KAM-based model still in its infancy in France, pharmaceutical companies face a tough challenge to ensure the implications of the new medical reform legislation are incorporated.

Messaging, for example, must now be amended to include product safety, as well as quality and efficacy; while companies must ensure information is up to date to ensure changes in physician attitude to the pharmaceutical industry as a result of the new regulations are flagged to remove the chance of inappropriate or unwanted contact. CRM tools will also be essential to coordinate group visits to physicians to avoid any chance of the forbidden one-to-one interaction.

As in the US following the introduction of the Physician Payment Sunshine Act in 2009, pharmaceutical companies will also need help to meet their obligations to declare all activity with physicians.

 

What next?

It is tough to predict how the health service in France will respond to the new legislation over the next 12 months. For pharmaceutical companies there is no doubt that direct physician contact will decline and organisations will have to refocus efforts towards the increasingly influential patient associations and physician associations.

But for those organisations operating across Europe, the changes must demand very different approaches towards health service co-operation. As the UK market looks to drive service innovation and close ties with practitioners at every level, counterparts in France are being compelled to be transparent and improve patient safety. The concept of the global, or even pan–European, market access strategy looks ever less practical.

Jérôme Guermonprez is the Vice President and General Manager, France, Cegedim Relationship Management.

Despite huge investments into CRM systems some pharma companies still struggle to get all of their staff to embrace and fully interact with them. Pf’s Iain Bate explores why, and what the future holds for technology in the industry.

There’s no doubt that technological developments have changed the way we live and work from year to year – maybe even from month to month in the 21st Century. But has the world of healthcare been travelling in the slow lane of the intergalactic highway?

The potential that technology offers to pharma, and the general world of healthcare, is enormous. But is the pharmaceutical industry, and its staff in particular, using it to maximise the returns of billion-dollar investments?

It would seem that technology is the ‘buzz word’ on the lips of a few of healthcare’s major players at present. The DH recently invited people to nominate their favourite health-related mobile phone ‘app’ – be it for keeping fit, to locate a hospital or chemist, or helping to manage an illness. Creative minds were also asked to design their own health app with a panel of DH judges deciding on their favourite from the most popular entries.

Health Secretary Andrew Lansley says it’s the Government’s intention to give people better access to information using modern technology and the exercise is a “unique opportunity for the NHS and those who develop apps to not only showcase their work, but to bring to life new ideas and realise true innovation in healthcare”.

As part of the DH’s technology revolution, patients may also soon be offered online consultations with their GPs using programmes such as Skype. Clearly the Government is embracing the convenience technology offers to patients, but are other sectors in healthcare as interested? It would seem there is still some way to go.

 

In two minds

Pf ’s 2010/11 annual Company Perception, Motivation and Satisfaction Survey suggests that not all respondents are completely convinced by the power of technology in the workplace. Although the Survey – which relates to 2010 and the early part of this year – found that nearly 90% of respondents have access to a CRM system, only 43% find time to use it in the field and more than a fifth of people fail to accurately record post-call reports with important clients.

Questions have to be asked as to why, despite multimillion pound investment and training by pharma companies, there remains a percentage of staff that still ignore the power and potential of the technology at their finger tips.

Results from the Survey reveal there’s no difference in uptake by key account managers, primary and secondary care representatives, those in primary care roles only, firstline sales managers and secondline sales managers and the use of CRM technology between differing age groups – although surprisingly 10% of respondents in these positions with less than two years of experience said they did not have a CRM system, compared to just 5% more experienced colleagues.

The launch of the iPad in March 2010 promised to revolutionise the way sales representatives, and those in similar roles, use CRM systems in the field. However, nearly three-quarters (70%) of respondents from the Survey are still presently sent out with laptops containing their customer-relationship systems.

When quizzed on what they’d change about the hardware which houses their system, the majority of respondents said that their CRM was too awkward to carry, with poor running systems an issue and that batteries ran out too quickly. Apple claims its second-generation iPad now enjoys ten hours of use away from a plug socket in the field.

Yet the switch to the latest convenient tablet devices may not necessarily be about high levels of investment, it may be down to maximising value for money as Paul Shawah, Vice President, Multi Channel Strategy, Veeva Systems explains. “I would say the life cycle of devices within the industry is generally about three years, sometimes a little bit longer,” he said. “When a company invests in new technology they typically depreciate that over that period, so they don’t want to replace it in the field for that time to maximise their investment.

“However, with the introduction of game changing technology like the iPad, this has changed. We see a number of our pharmaceutical customers are justifying the business case to move to the iPad even before their tablets are fully depreciated. This speaks to the business benefit that pharma expects to achieve from the iPad and the related applications only available on that device.”

A convenient shield

Despite technology eliminating mundane process in the workplace and offering the potential to assist employees and improve their efficiency at work, it has historically been used as a shield to mask poor performance and abused as a means to waste company time – a recent online survey by AOL found that nearly half of Americans (44.7%) rank surfing the web as their primary activity during the two hours they ‘waste’ each day at work.

But it would seem that a high number of respondents do value the opportunities CRM offers. Almost two-thirds (64%) said they always enter correctly the amount of customer sales they make into their CRM. But 21% admitted they fail to always report face-to-face meetings with clients. More surprisingly, over a fifth of participants said they do not always record the number of products they had sold to clients.

The lack of honest accuracy is surprising considering the amount of time spent using CRM systems each day. A third said they spend between one and two hours a day on their system with a fifth spending three hours or more on their CRM. During their time using the management system, more than half (55%) said that call reporting was the most useful feature.

Although respondents were less impressed with the KAM abilities of their software with only 19% believing it to be the most useful facility. When questioned about what they would change given the chance, 45% said they wanted an improved database, over a quarter (28%) called for their system to be overall more useful, and 18% said they would prefer their CRM to be easier to use.

 

The next level

But what of the future of CRM systems? Will they be easier to use and have improved customer databases? David Round, General Manager, UK, Cegedim Relationship Management, says the regular interaction we now have with technology means we’ve all come to expect the latest developments.

“End users are significantly more ‘technology-savvy’ than their counterparts of even five years ago,” he explained. “If anything, the challenge for companies is to ensure that they provide their end users with the types of technology that they use as consumers. It’s also important to focus on the usability of your software to ensure maximum use. Technology companies – and pharma – must work together to develop a better understanding of the interaction, to ensure it meets users’ needs in the field.”

One main reason that users have become more ‘savvy’ is down to the use and interaction with social media. Whether at home or at work, websites such as Twitter, Facebook, LinkedIn and most recently Google+ have driven an increased use of various forms of technology – especially on devices such as smartphones or tablet devices which reps are calling for in the field.

Pharma companies, both in the US and UK, have flirted with the idea of fully embracing the power social media harnesses, but at present are restricted by the PMCPA’s Code of Practice and by the FDA – who has again delayed the publication of its guidance.

The FDA says it is “difficult to provide a timeframe... due to the extensive work and review process, or ‘Good Guidance Practices’, which ensures that FDA’s stakeholders are provided well vetted guidances articulating FDA’s current thinking on a topic”.

Although the FDA may be unsure on how to direct healthcare companies, David Round believes the introduction, both professionally and personally, of social media has had an impact on staff and their expectations.

“For the modern professional person, much of their everyday life is conducted online – for example on shopping, utilities, insurance or booking a holiday – and many users then want the same level of capability from the tools they use in their job,” he added.

Dan Goldsmith, General Manager, Veeva Europe, agrees there has been a significant shift in the way we operate and interact due to our experiences online through tagged posts or hash-tagged searches. But although the 800 million users on Facebook – more than half which ‘log-on’ every day – and 175 million people on Twitter have no problem saying hello to friends, pharma finds it more difficult reaching out to people.

“Social media create a new avenue for healthcare dialogue and will only continue to pervade our lives,” said Dan. “Consequently, I believe that pharma faces two challenges. The first is to decide how to participate in the online dialogue with stakeholders and then to create those interactions through the channels we’re all familiar with, such as Facebook and Twitter.

“The second is to figure out how to leverage the model of social dialogue internally to support stronger collaboration and more focused communication among employees. Already, we see some companies taking advantage of the latest social business tools to connect employees with one another and to access and share information in real time.”

Clearly CRM solution providers understand the potential modern technology and social media platforms offer to companies. Whether pharma and its workforce get fully up to speed on the intergalactic highway sooner or later remains to be seen.

Hologic, a manufacturer of diagnostics, surgical products and medical imaging technology for women, has received FDA clearance for its Trident specimen radiography system.

The device uses the company’s proprietary direct digital detector technology to produce high quality images of tissue samples, aiming to reduce procedure steps, streamline workflow and increase accuracy.

Peter Soltani, Senior Vice President and General Manager for Breast Health, said: “Our goal is to provide leading-edge technologies that improve the diagnostic precision of procedures and create a better experience for patients and their healthcare providers.”

The Trident is designed for use in the operating room where breast tissue is surgically excised, and in biopsy suites where minimally-invasive breast biopsies are performed.

Based in Massachusetts, USA, Hologic is a developer, manufacturer and supplier of diagnostics, medical imaging systems and surgical products dedicated to the healthcare needs of women with a focus on breast health, diagnostics, GYN surgical, and skeletal health.

Royal Philips Electronics is developing a new range of healing environments at a new dedicated research facility at its Research Laboratories in Eindhoven, the Netherlands.

Adding to Philips’ portfolio of solutions for hospital care, the healing environments use technology to reduce patient stress, accelerate recovery and improve treatment outcomes.

The new project reflects the emergence of a generation of patients who are well-informed about their condition and exercise their power of choice in finding the hospital that best meets their needs.

One of the concepts under development is a PE-CT uptake room (pictured) that uses calming lighting, video images and sounds to reduce the stress levels of patients awaiting an oncology scan.

Other well-advanced projects include environments focused on preventing delirium in intensive care units.

The new healing environment solutions will be trialled in the facility’s Hospital Area, which simulates the conditions of real hospitals.

“There is an increasing body of evidence to suggest that patient-friendly comforting environments not only reduce anxiety levels but also promote the healing process itself,” said Henk van Houten, General Manager of Philips Research.

“The opening of the Hospital Area is a clear expression of our commitment to this important new area of healthcare research, which leverages Philips’ unique expertise in healthcare, lighting and consumer lifestyle.”

Philips’s existing products in the healing environments field include the Ambient Experience solution for medical imaging and A&E departments, which uses lighting, sound and images to reduce the stress levels of children undergoing a scan.

Royal Philips Electronics of the Netherlands is a diversified healthcare company specialising in cardiac care, acute care and home healthcare.

Canon has received FDA clearance for its CR-2 Plus Digital Non-Mydriatic Retinal camera for use in eye diagnostic imaging.

Tsuneo Imai, Senior Director and General Manager of the Medical Systems Division at Canon USA, said that the approval “brings Canon one step closer to improving eye exam efficiency and eventually leading to the early prevention and treatment of vision threatening diseases”.

The medical device features EOS camera technology using 18 megapixels with low-flash intensity, minimising pupil constriction while shortening the time required for taking multiple pictures.

The product’s use of Canon’s Retinal Imaging Control Software (RICS) allows images to be captured, processed and sent to be stored or printed.

Scottish medtech company Aircraft Medical has signed an exclusive INTERNATIONAL distribution agreement with global healthcare supplier Covidien.

Covidien will market and distribute Aircraft’s McGRATH MAC video laryngoscope (pictured) in the UK, the US, Japan, Latin America, Australia and New Zealand.

The new agreement complements Aircraft Medical’s existing distribution agreements in 35 countries, and will see the number of specialist sales and marketing professionals selling the McGRATH laryngoscope worldwide rise above 500.

Launched in October 2010, the portable McGRATH MAC – a development of the award-winning McGRATH design – is the first low-cost video laryngoscope designed to assist both routine and difficult airway intubation in hospitals.

In the US, the majority of the estimated 17 million intubations carried out each year are performed with Covidien products – opening a major market opportunity for the McGRATH MAC.

About 50 million intubation procedures take place globally each year, and that figure is predicted to rise by 5% per year.

“This agreement with Covidien is a significant step forward in the global rollout of the McGRATH MAC video laryngoscope,” said Matt McGrath, CEO of Aircraft Medical. “We expect to now further strengthen our position in the growing video laryngoscope market.”

James E. Willett, General Manager, Respiratory and Monitoring Solutions at Covidien, commented: “Our partnership with Aircraft Medical demonstrates our commitment to deliver clinical value and improve patient outcomes in fast-growing critical-care markets throughout the world.

“By integrating the McGRATH MAC video laryngoscope into our respiratory product portfolio, Covidien can provide critical-care practitioners with a complete intubation solution to meet the needs of the continuum of patients.”

Aircraft Medical, based in Edinburgh, specialises in video laryngoscopes.

Covidien, based in Dublin, is a leading global provider of healthcare products whose 2010 revenue was $10.4 billion.

A new CPAP (continuous positive airway pressure) device from Philips Respironics could enable people with obstructive sleep apnoea (OSA) to manage their own condition more effectively.

The new REMstar Pro (pictured) with AutoIQ is able to track the patient’s sleep breathing over several nights, establish or readjust to a set airway pressure, and check back periodically to adjust the pressure as needed – without clinician intervention.

The first phase of the AutoIQ mode, Auto-Trial, uses an algorithm for a total of 30 days to establish the patient’s treatment needs. At the end of the phase, the device analyses the data to identify and deliver the best airway pressure for the patient.

Following that, Auto-Check checks back every 30 hours to see how the patient is progressing and to automatically adjust the pressure if needed.

Auto-Trial days can be saved to reassess therapy at a later date if the patient’s physical condition or sleeping environment changes.

Throughout the process, AutoIQ keeps the care team informed of the patient’s sleep breathing performance and CPAP compliance.

“REMstar Pro with AutoIQ demonstrates our ongoing pledge to providers and their patients to be their ally in better sleep and breathing,” said John Frank, General Manager for Sleep and Respiratory Care, Philips Home Healthcare Solutions.

“By providing intelligent solutions and advancements in technology, we are shaping the future of sleep therapy.”

Philips Respironics is a unit of Royal Philips Electronics of the Netherlands, a market leader in cardiac care, acute care and home healthcare.

In recent years the German government has introduced a series of reforms designed to radically cut the costs of drugs. With VBP being considered here in the UK, Dr Arnim Jost explains how these measures have affected pharma companies in Germany.

As the biggest pharmaceutical market in Europe and a price reference point for other European markets, success in Germany has always been essential for pharmaceutical companies. However, recent changes in legislation have combined to make Germany an increasingly tough challenge even for the pharmaceutical originators delivering innovative new drugs.

Germany was one of the last countries in Europe to allow pharmaceutical companies to determine prices. Now, with an estimated goal of cutting €2 billion from pharma spending, that is changing, with even new drugs facing tough value assessments before prices are set. With the UK Government considering the adoption of VBP, with fees negotiated on the scienti­fic assessment of a drug’s clinical value, once the Pharmaceutical Price Regulation Scheme expires in 2013, the impact of this change in Germany will be keenly watched by pharmaceutical companies in this country.

Price pressure

Since 2007 and the introduction of GKV-WSG (Gesetzliche Krankenversicherung-Wettbewerbsstaerkungsgesetz), which allowed public insurers the chance to negotiate discount agreements with pharmaceutical companies for generics and off-patent products, companies have seen prices erode.

These public health insurers represent 90% of the population of 82 million, and hence have signi­ficant influence. Over the past twenty years there has been significant consolidation of these organisations, from 1,100 in 1990, to 226 in 2008, and 155 today.

Within the next three to five years that number is set to fall further to just 50. For pharmaceutical companies this consolidation is a double edged sword: there are fewer organisations to target and understand; but each insurer has a far greater buying power and can drive ever stronger discounts across the market.

Price pressure increased in 2010 with the GKV ÄndG (Gesetzliche Krankenversicherung-Aenderungsgesetz), which demanded mandatory discounts for non-reference price products to increase from 6% to 16%, and introduced a retroactive price freeze for all non-reference price products from 1 September 2009 until 31 December 2013, a move expected to save €1.15 billion, according to Policy.io.

Innovative overspend

At this time, pharmaceutical companies were at least allowed to set prices for innovative new products after a drug’s introduction to the market. However, this changed in January 2011, in response to €32 billion spent on medicines by the public health insurers in 2009, creating a signi­ficant deficit.

With the Health Minister claiming innovative drugs were responsible for the overspend, a new law was passed which limits the amount that pharmaceutical companies are allowed to charge for new prescription drugs.

AMNOG (Arzneimittelmarkt-Neuordnungsgesetz) demands pharmaceutical companies provide a value dossier within three months of the product launch, demonstrating the medicine’s cost and bene­fits. If a new drug is found to have additional medicinal benefits, its price will be negotiated between the manufacturer and the insurers within a year.

However, maximum prices – reference prices, in Germany called “festbetrage” – will be set for drugs which do not have any additional benefits over an existing drug.

Evidence based

The implications for pharmaceutical company market access strategies are significant. Market access has now shifted towards justifying the price, towards conducting cost benefit analysis and evidence based medicine. Of course, for the first three months of any product’s life there is little opportunity to undertake evidence based assessment.

Companies in Germany are, therefore, now involving business units, including sales and marketing, up to 12 months before a product launch to create cost benefits dossiers and prepare the value arguments for the medical and pharma-economical experts within the regulatory bodies G-BA (Gemeinsamer Bundesausschuss) and IQWIG (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen).

Companies now need access to greater depth of information regarding the decision makers within G-BA and IQWIG to determine the on-going strategy for this value-based assessment.

Indeed, this process requires far greater information resources – from therapy data, to information about comparable products and product costs. Pharmaceutical companies must now analyse the entire health chain, from diagnosis through therapy to rehabilitation to assess and demonstrate the true potential value of the new product.

They are not, however, as yet able to work effectively with hospitals to ensure drugs are used appropriately in order to achieve the expected benefits. Unlike the UK, where the NHS is being actively encouraged to co-operate with pharmaceutical companies to promote research, innovation and better practice, in Germany the boundaries between health provider and pharmaceutical company are still strong, with hospitals looking to optimise their own working practices without pharmaceutical co-operation.

Clinical autonomy

At primary care level, meanwhile, clinicians have limited opportunity for any strong decision making. Whilst the UK is now pushing hard to reinvigorate the role of clinicians within the health service, clinicians in Germany continue to lose decision making power. GP prescribing is strongly led by the discount agreements between pharmaceutical companies and the public insurance companies: if a prescription does not reflect the agreement, it will be automatically substituted by the pharmacist when it is fulfilled – unless the GP has specifically requested no substitution.

Similarly within secondary care, there is a lack of clinical empowerment. Many hospitals are part of purchasing groups, which has increased buying power, but limited the decision making options for both individual doctors and hospital pharmacists.

However, there are signs of a new level of interaction between pharmaceutical companies and health care services in Germany on the joint development of innovative services. Whilst in the past pharmaceutical companies were constrained from negotiating contracts direct with hospitals or doctors to deliver such services, over the past two years there has been a evolution towards more integrated healthcare contracts that have evolved beyond basic discounting towards shared risk models based on the joint delivery of services – most notably within diabetes.

Moving forward

Given the emphasis on the reduction of drug prices across Europe, the evolution of cost saving on pharmaceuticals within the German market is notable for any similar sized market place, such as the UK. From initial focus on generics, with reference pricing and discount agreements to the impact of AMNOG on the new chemical entities, every aspect of the pharmaceutical market has been affected.

Indeed, despite the market size, this new price point has resulted in companies deciding not to launch new products in the German market due to the problem this would create across Europe with reference pricing: get it wrong in Germany and a pharmaceutical company could end up with an unsustainable price point in many other countries.

The biggest test for pharmaceutical companies in Germany in the coming months will be to understand the challenges created by AMNOG and to determine how best to create the value dossiers. To date, only one product, Merckle Recordati´s Pitavastatin, has passed the examination of the G-BA, but without the approval of a pre-price, there’s only the allocation of a reference price – so the industry has no real evidence of how this process works, or how successful companies will be.

However, with 15 products currently under review, this model will become far clearer in coming months. Market access strategies must be supported by a new depth of information relating to this value-based decision making, most notably granular visibility of the key influencers within G-BA. Armed with this insight, pharmaceutical market access teams will be able to refine their information analysis and determine how best to disseminate the value message to the market.

Dr Arnim Jost is General Manager, Germany, and VP REGION D-ACH, for Cegedim Relationship Management.