The majority of physicians find visits from sales representatives useful and of value to their practice, new research has found.

Figures from Cegedim Strategic Data (CSD) revealed that 93.8% of physicians worldwide see value in appointments with only 6.2% of the opinion that appointments are “not at all useful or of value”.

Bruno Sarfati, CEO, CSD, says the results highlight the importance sales visits still hold, although there are still “gaps to be filled” to fully convince all physicians.

CSD analysed data from 11 key pharmaceutical countries, including both mature and emerging markets, based on more than 5.6 million product detailing mentions.

It found that at the end of last year, traditional detailing spending represented 61% of audited marketing channels worldwide.

Of the respondents who valued sales calls, a third (33.3%) described them as ‘very useful and of value’, with a further 60.5% saying they are ‘somewhat useful and of value’.

Almost all of US physicians (97.9%) found some value in calls from representatives. Physicians in Russia and Brazil were the most impressed with nearly half (47.7% and 46% respectively) finding visits very useful, although only 17.1% of Japanese physicians believed this to be the case.

The study also revealed there to be no distinct difference between established and emerging markets, despite an increase in the number of sales and marketing positions in developing regions.

As part of the study, CSD also investigated which of the top ranked international companies in total promotion spending provided the highest level of satisfaction. Eli Lilly came out of top, followed by Johnson & Johnson with Novartis in third. Pfizer, which spent the most money, came sixth.

Bruno Sarfati said the overall results were positive but new working methods may have to be introduced in the future. “The results of CSD’s study show that physicians still value visits from sales reps,” he said.

“A recent qualitative study showed that physicians are looking for rep interactions which are tailored to their daily practice. In the current industry environment it is inevitable that changes will be made to the way rep calls are conducted as we know it today.”

In Part III of his diary, Omar Ali discusses the significance of process mapping and the wide reaching influence of health technology assessments and regulatory bodies.

1.10pm: GP CONSORTIA/CCG – RESPIRATORY ASTHMA PROCESS MAPPING & FORMULARY

I’m trying to step into the main meeting room but one of the CCG/GPs pulls me aside. It’s a mixture of a low-key signal and a discreet ‘thumbing’ to pull away from the group. He wants a quiet word and it’s clear that there are some key issues, agendas and directions that are on the table for this asthma meeting.

The process mapping event takes some four hours – evaluating everything and anything that ‘leads to an asthma admission’, followed by everything and anything that occurs after the admission and leads to discharge – which is then followed by QIPP ‘bottlenecks’, where re-admissions and inefficiencies occur.

It’s always a challenge having so many viewpoints – nurses, physicians, pharmacists, budget holders, and of course patients and carers who often change the whole paradigm when we hear about their experience, expectations and concerns around ‘choice’.

Thoughts for pharma

Respiratory is big. Whether on prescribing budgets, healthcare priorities, implementation of national guidance or QIPP streamlines. Companies haven’t yet got their act together on process mapping of care pathways, but it’s the only way to invest in prescribing up-front drugs for potential ‘return to the QIPP baseline’ over the next three to five years. Needless to say, whilst the NHS talks QIPP, pharma is getting used to it and patients are still puzzled by it.

Asthma

With so much behind National Guidance/BTS, QoF and commissioning cycles, some companies are indeed getting into the mix with Clinical Commissioning Groups and supporting process mapping. That support is vital, as not only does it bring pharma in as key stakeholders, but more importantly there is a level playing field here in the same room bringing the cause back on track.

So often in the NHS we have silo budgets chasing after silo savings. Process mapping brings us out of our silos into the bigger picture and into the ‘process map’. Seeing it happen is a wonderful thing.

COPD

Given we make such a fuss around the cost of drugs, in truth we know two things: the most expensive drug is the one that is not being taken, and the tariff for an admission for COPD at £3,400 is more expensive than the annual price of the most expensive inhaler!

So where’s the issue? It goes like this. Pharmaceutical companies come to us quoting the costs of admissions in COPD then tell us how amazing it would be to reduce these hospitalisations.

They then tell us how amazing their COPD product is and tell us that we would be crazy to not buy their inhaler, which is a fraction of the cost of COPD burden/admissions. The GPs, nurses and patients love it and want it and state they ‘need it’. Medicines Management then look like the bad guys for not funding the said branded inhaler.

4.15pm: DRIVING BACK TO NHS BASE CAMP – CHECKING VOICEMAILS

One of the big five companies has asked me to come and present to their European heads-of-country on ‘payer issues’ in the UK and the influence of HTAs.

It’s a bit short notice and I gather the VP for Europe, Middle-East and Asia will be there. Times are tough and I see this as an example of how the EU can join forces on some of the key payer issues beginning to filter through.

I have one question back to these pharma companies. What is your data on reducing these expensive hospitalisations in COPD? Because in truth, with the data, I buy the story.

In most cases pharma will then spin another story around how compliance is great, or a patient support programme is excellent. But given all the spin that has come on how much COPD costs me in hospitalisations, it’s a shame many of the companies don’t have the evidence to help me.

They have marketing but not the evidence. Show me the money. And the formulary will be yours.

Thoughts for pharma

There is no doubt that the UK is ‘different’, but I don’t imagine global HQ for any of the pharmaceutical companies readily accepting that – especially when the targets are high and sales may not be so. It sometimes takes global agencies to hear about payer issues ‘from the horse’s mouth’.

This was the quote stated to me regarding this piece of work/event. From my work abroad – at NICE I informally interact with a number of contacts in other countries who belong to their residing equivalents – I can’t stress enough the importance of NICE, the SMC and similar bodies.

The last SMC decision on pain management was quoted verbatim within two weeks by three different countries within the EU. I’m also aware from my US/value-based pricing work that when NICE rules on a drug the impact on the US healthcare system is far reaching.

Insurance companies download the information – they can’t believe NICE do all this work transparently and then leave it freely available for anyone to download – and the US agencies then use this information on deciding what percentage they will ask patients to pay.

So, if NICE say no and SMC say no, somewhere a butterfly flaps its wings and then a patient in the US, who has paid extra funds into a private insurance policy, will be told that this particular brand is not covered and that the patient will have to make an additional payment if they want the drug.

To be continued...

Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Healthcare NHS Trust and sits on the External Reference Group for Cost Impact Modelling for NICE. He may be reached on omar.ali@sash.nhs.uk.

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.

John Wilkinson (pictured), Chief Executive of Eucomed, has received a special Career award from the International Vascular and Endovascular Course (IVEC) in Milan.

The award recognises the medtech industry’s contribution to the development of vascular and endovascular surgery.

IVEC Chairman Giorgio Biasi presented the award to John Wilkinson to “honour the excellence of a distinguished scientist and eminent colleague who has contributed enormously in promoting, divulging and spreading culture, development and achievements in the field of vascular and endovascular techniques.”

Following the award presentation, Wilkinson gave the Edmondo Malan Lecture on ‘Development and Achievements in Endovascular Procedures as a Result of a Continuous and Ingenious Co-operation between Physicians and Industry’.

He discussed the long history of collaborative working between clinicians and industry over 200 years, with ideas from doctors and surgeons being developed by companies, culminating in such revolutionary devices as the drug-eluting stent.

Wilkinson also emphasised the need for innovation to be built on a platform of ethical interaction and transparency, and for industry to support education and training in the delivery of new therapies.

Finally, he drew attention to the demographic and economic challenges facing Europe’s health systems, and called for a collaborative approach between all stakeholders to support innovative solutions to these urgent problems.

Eucomed is the leading European medical technology industry association. It represents 4,500 designers, manufacturers and suppliers of medical technologies.

Roche is to merge with and fully acquire oral therapeutics developer Anadys Pharmaceuticals in a $230 million cash deal.

The acquisition follows Roche’s plans to expand future treatment options for patients with hepatitis C virus (HCV) infection.

Jean-Jacques Garaud, Global Head of Roche Pharma Research and Early Development, said: “Our aim is to offer physicians and hepatitis patients a powerful combination of therapies that bring us closer to a cure.”

San Diego-based Anadys’ most advanced drug candidate, Setrobuvir (ANA598), is a direct-acting antiviral (DAA) inhibitor, which is currently being evaluated in a Phase II study in combination with Roche’s Pegasys (pegylated interferon) and Copegus (ribavirin).

Roche plans to explore Setrobuvir’s use in combination with other DAAs already within its portfolio, with and without interferon.

Steve Worland, President and CEO of Anadys, said: “With Roche’s considerable capabilities and experience in HCV, this acquisition provides the best chance of success for the new potential treatments our team has been dedicated to developing.”

In addition to its lead programme with ANA598, Anadys is developing ANA773, an oral, small-molecule inducer of innate immunity that may prove useful for treating HCV as well as other chronic infections and cancer.

Headquartered in Basel, Switzerland, Roche provides research-focused healthcare with strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotechnology company with focus in oncology, virology, inflammation, metabolism and CNS medicines.

Seven medical devices, diagnostics and healthcare IT have been named in Cleveland Clinic’s Top 10 Medical Innovations for 2012.

The list of medical devices and therapies was chosen by a panel of physicians and scientists at Cleveland Clinic, named one of “America’s Best Hospitals” by the US News & World Report survey.

The annual list recognises new techniques, therapies and approaches to treat medical conditions.

The selection criteria for qualifying in the Top 10 Medical Innovations required nominations to:

• Have significant potential for short-term clinical impact (either a major improvement in patient benefit or an improved function that enhances healthcare delivery)
• Have a high probability of success
• Be on the market or close to being introduced
• Have sufficient data available to support its nomination.

The Top 10 Medical Innovations for 2012 are:

10. Genetically Modified Mosquitoes to Reduce Disease Threat

9. Novel Diabetes Therapy: SGLT2 Inhibitors

8. Harnessing Big Data to Improve Health Care – Health care data requires advanced technologies to efficiently process it. Analytics can be applied to better hospital operations and tracking outcomes for clinical and surgical procedures.

7. Active Bionic Prosthesis: Wearable Robotic Devices

6. Implantable Device to Treat Complex Brain Aneurysms

5. Increasing Discovery with Next-Generation Gene Sequencing

4. Medical Apps for Mobile Devices

3. Concussion Management System for Athletes – Patient management tools can instantly detect brain injuries at the moment of contact.

2. CT Scans for Early Detection of Lung Cancer

1. Catheter-Based Renal Denervation to Control Resistant Hypertension

Cleveland Clinic is a non-profit academic medical centre that integrates clinical and hospital care with research and education.

The FDA has approved Eli Lilly’s Cialis (tadalafil) to treat men with signs and symptoms of Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED).

The drug works by inhibiting the phosphodiesterase type 5 enzyme (PDE5), helping to produce vascular relaxation and increase blood flow to the penis. These enzymes are also found in the prostate and bladder, where problems can occur with BPH.

Claus Roehrborn, Chairman of the Department of Urology at The University of Texas Southwestern Medical Centre, said: “Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a significant therapeutic option for men and physicians.”

The approval totals three indications: both ED and signs and symptoms of BPH separately, as well as for men who have both conditions.

Dave Ricks, Lilly USA President, said: “These additional indications for Cialis reinforce our commitment to providing medical innovation in the area of men's health.”

“We're encouraged that Cialis provides a new treatment option for men affected by both ED and the signs and symptoms of BPH,” commented Mr Ricks.

The FDA clearance was based on clinical research gathered from three placebo-controlled efficacy and safety studies involved 1,989 men.

BPH is a condition where the prostate enlarges, which can cause urinary problems. Approximately 50% of men between 40-70 years old suffer from erectile dysfunction. Several studies have shown that many men with ED also experience the symptoms of BPH.

Only a fraction of GPs had to participate in an election to be appointed to the boards of the new Clinical Commissioning Groups, new research has found.

The study by Pulse found that an astonishing 95% of doctors were not elected and, although almost all positions were open for election, only 7% were challenged.

Dr Una Duffy, a GP from Luton, Bedfordshire, says there is a “widespread apathy to commissioning” and that the majority of doctors are happy to let “enthusiasts get on with it”.

The investigation was conducted amid claims of a ‘jobs for the boys’ culture where elections were not inclusive of salaried GPs, locums or even female doctors.

Nearly 1,000 board posts across 150 prospective groups were examined during the study. Research found that although the majority were open for election, less than a tenth were challenged by alternative candidates.

The findings have raised concerns that a host of board members are now working without proper authority after 213 positions were filled without a vote being cast.

Not only do the results indicate a lack of engagement with the switch to CCGs than ministers and the Government has declared, but they also raise worries around the level of grassroots general practice interest.

Dr Peter Holden, General Practitioner Committee negotiator, says the results of the study highlight the ‘pathetic’ level of engagement GPs have with the switch to clinical-based commissioning.

“It proves that people driving this are enthusiasts,” he said. “My belief is competition is healthy for democracy. If these people have just walked in there they may not have the confidence of the profession that such a victory might imply.

“My concern is the average GP has not realised the power of the CCGs. If we've elected people into positions of absolute power and authority without any means of calling them to account, we've just signed out own death warrant.”

The BMA has now issued guidance advising that CCG’s repeat elections when they are legally responsible for commissioning. The Association also called for ‘periodic re-mandating’ every three years to ensure grassroots general practices have their say.

The FDA has granted US approval to Zynex for NexWave, a medical device to be used in electrotherapy treatment.

The next generation medtech system combines three modes of medical technology to provide a wide range of pain and muscle rehabilitation therapies: traditional TENS, interferential and neuromuscular electrical stimulation – through one non-invasive device.

Thomas Sandgaard, CEO of Zynex, said: “The combined modalities of our NexWave provide doctors and clinicians a more comprehensive pain therapy solution for their patients. This device was designed with the patient in mind, as it is compact and easy to use.”

US-based Zynex Medical engineers and manufactures its own design of electrotherapy medical devices for pain relief, pain management and stroke and spinal cord injury rehabilitation.

The FDA has approved Calgary Scientific’s medical imaging device, ResolutionMD Mobile, as a mobile diagnostic app for use in the US.

The new technology gives physicians remote access to patient images and reports stored within any healthcare facility, enabling clinical diagnosis of the patient from any location.

Dr James A. Brink, Professor and Chair of the Department of Diagnostic Radiology at Yale University School of Medicine, said: “The ability to view diagnostic quality images on mobile devices promises to speed healthcare delivery, particularly for urgent conditions or after hours.”

The mobile app promises complete security and advanced capabilities through minimal bandwidth, even on 3/4G wireless. The technology also ensures that patient image data cannot be lost or stolen, and no highly sensitive or confidential patient data is ever retained on the device.

Dr Byron Osing, CEO and Chair of Calgary Scientific, said: “Lost or stolen patient data is a critical issue in the medical IT sector, with regular announcements of significant HIPAA compliance fines being levied and legal settlements in the tens of millions of dollars.”

“The FDA clearance of the ResolutionMD solution is a key strategic step forward for the Medical IT sector in enabling a high performance and secure ‘mHealth’ paradigm, as well as ensuring that vast regions of the world that are currently dependent upon wireless connectivity can now leapfrog directly into the realm of advanced medical solutions," added Dr Osing. 

Non-diagnostic versions of the app are already licensed under OEM agreements with global leaders in medical imaging and information technology.

The software has also been approved by Health Canada, has acquired the CE Mark for distribution in the EU, and is available on Apple iPhone and iPad devices. 

Calgary Scientific is a provider of accessible, advanced visualisation solutions in medical imaging and web, mobility and collaboration enablement technologies, used to help industries achieve secure access with their existing technology.