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.

The Government needs to do more to support life sciences in the UK and create an environment where the industry can flourish, a new survey has found.

RSA’s The UK Life Sciences Leaders’ Survey 2011 revealed worries over the NHS reforms, medicine pricing and reimbursement, employment issues and the cost of research amongst its leaders.

Nick Stephens, CEO of RSA, says the Government “urgently needs to do more to ensure that education, regulation, access to medicines and the NHS research base align to support the industry’s continued contribution to the UK economy”.

The report is the second annual survey of industry bosses. Last year the general feeling was of optimism with leaders believing the recently elected coalition Government would improve the business environment.

But twelve months later the mood has changed with results finding leaders claim the UK is not competing effectively globally, creating opportunities for early phase/smaller companies or making the most of its unique selling points: the NHS and skills in innovation and discovery.

Leaders also raised concerns about the increasing cost of working in the UK, the implication of R&D as a result of the NHS reforms, the regulatory burden on operations and the process from development to market. They also advised that fiscal and tax incentives should be given to SMEs to help their growth and the UK compete globally.

Worries were also raised about the introduction of value-based pricing. However, in contrast, health technology assessments were broadly welcomed as a means of enhancing value and meeting therapeutic requirements, the report found.

During the tough economic environment, the survey found that leaders would focus on innovation, creating flexible organisations and processes, and refocusing research and development to weather the current storm.

In a perfect world, leaders revealed they would investing in R&D and make the healthcare sector, regulatory and commercial environment work closer together to achieve better outcomes for patients and the pharmaceutical industry.

Stephen Whitehead, CEO, ABPI, says the survey shows more support is needed for biopharmaceutical companies in the ever-changing NHS. “There is much that the Government has done to support the industry, particularly through the Growth Review and the Office for Life Sciences,” he said. “But we need to build on this as part of a continuing relationship with NHS and Government to explore how unnecessary bureaucracy can be eliminated from the healthcare system so that new treatments can reach patients as quickly as possible.”

NICE has appointed a new external assessment centre to support its Medical Technologies Evaluation Programme.

The new assessment centre, developed by Newcastle upon Tyne Hospitals NHS Foundation Trust Medical Physics Department in partnership with York Health Economics Consortium, will provide independent assessment of the clinical and health economic evidence for medical technologies.

It will also develop and facilitate independent research to assist suppliers when NICE guidance recommends that further research should be carried out on a medical device or diagnostic.

The new assessment centres were selected for their knowledge and expertise in the evaluation of medical technologies.

To date, one more external assessment centre, CEDAR – part of Cardiff and Vale University Local Health Board – has been commissioned.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said: “We’re delighted to welcome the new joint external assessment centre based at Newcastle and York. Their input to the production of NICE medical technology guidance will be essential, providing independent assessment of the evidence available for devices going through the NICE evaluation process.

“Where the relevant NICE advisory committee identifies that a technology has considerable potential but insufficient evidence to support widespread adoption across the NHS, it may make recommendations for further research. In such cases, the external assessment centre will play a key role in facilitating the development of further relevant evidence.

“We look forward to working with the centre, and benefitting from their combined technical and economics expertise in supporting the development of robust guidance for the NHS.”

Established by NICE in 2009, the Medical Technologies Evaluation Programme is focused specifically on innovative medical technologies. Seven NICE medical technology guidance documents have been published to date.

Mobisante has launched its MobiUS SP1 in the US, the world’s first smartphone-based ultrasound imaging system.

The device joins other portable point-of-care diagnostics that have recently entered the mobile health sector, including GE’s handheld visualisation tool Vscan and Siemens' Acuson P10.

The £4,700 MobiUS SP1 is designed for use in foetal, cardiac, pelvic, paediatric, musculoskeletal, peripheral vessel and abdominal imaging, providing the potential for enhanced patient care in any location, even remote areas.

The mobile health technology uses both cellular and WiFi networks, and consists of a Windows Mobile 6.5-based Toshiba TG01 smartphone, an ultrasound probe and computer software.

The manufacturer claims that the system could also be more suitable for use in low-income regions than traditional ultrasound equipment due to its lower operating costs and the increased convenience it would provide for patients.

Mobisante actually received FDA clearance for the device in February 2011, but it took eight months to implement necessary FDA-mandated controls.

The company is exploring the option of making a version of the product for healthcare-specific tablet computers as well.

MedX Health’s skin imaging diagnostic systems, MoleMate and SIMSYS, have been granted FDA approval for sale in the US.

These non-invasive medical technologies use light to look beneath suspicious moles, creating accurate images to help physicians evaluate lesions, often eliminating the need for painful and expensive skin biopsies.

Steve Guillen, President and CEO of MedX Health, said: “The US market alone is estimated to be a $1 billion opportunity, and MoleMate and SIMSYS are the only FDA approved and patent protected siascopy products in this important health segment.”

MoleMate features a hand-held scanner designed for office use, providing images of the pigment, blood, and collagen below the mole or lesion.

SIMSYS allows image capture and storage as well as special features that can be used to compare moles. It will support ‘mole mapping’ in 2012, where the entire surface of the patient's skin is photographed to observe changes over time, so that suspicious moles can be monitored more closely.

Dr. R. H. Falcon, a dermatologist in New York, said: “I chose this technology because it gives me extra information about my patients’ suspicious moles and lesions through the additional views of the skin and helps me and the patients to come to a more informed decision about removal.”

Almost 13 million people in the US have a history of non-melanoma skin cancer, usually diagnosed as basal cell carcinoma or squamous cell carcinoma. The survival rate for patients whose melanoma is detected early is about 99%. This statistic falls to 15% for patients with advanced disease.

The MoleMate and SIMSYS medical technologies are already available in Australia, Europe and the UK.

New 3G mobile data routers have enabled a West Midlands breast screening service to achieve more effective communication of clinical information with local hospitals.

Herefordshire data handling specialist Hicks Associates Ltd has supplied and fitted the routers to three trailers (pictured) for the Warwickshire, Solihull & Coventry breast screening service.

The mobile data ‘dongles’ previously used by the trailers to access work lists from the hospitals caused network issues and problems with weak signals inside the trailer.

The new 3G routers offer several advantages over the previous solution:

• The use of two SIM cards, from different network providers, allows automatic switchover between networks if the signal level drops below a certain point.
• The external antenna fitted to the trailer gives much higher signal strength.
• The integrated four-port 100Mbps switch allows up to four devices to share the remote connection and to communicate using normal network protocols.
• The system allows (via a secure VPN client) the equipment supplier to perform remote diagnostics on the modality.

While the new technology would not be suitable for handling images, it promises to save time and improve reliability in communication of work lists and other text information.