Most people with multiple sclerosis (MS) in the UK do not receive medication that could alleviate their symptoms and delay the progression of the disease.

A survey of over 10,000 patients by the MS Society found access to drugs was 68% in Northern Ireland, 40% in England, 36% in Scotland and 30% in Wales.

The charity said that limited patient access to specialists was the main reason for the prevalence of under-treatment.

Only two other EU countries, Poland and Romania, had a lower level of uptake of medication for the disease.

The relatively high level of medication for MS in Northern Ireland reflects the fact that only that country offers patients a twice-yearly review with a specialist.

The MS Society called for the NHS to provide every MS patient with a personalised care plan.

The study found that 41% of patients who said they had enough information about drugs still did not take one.

It concluded: “This could be due to barriers to accessing medicines; because individuals make an informed decision not to take them; or because they don't know what information is out there, such as around new treatments or new evidence of efficacy.”

Nick Rijke, Director for Policy and Research at the MS Society, commented: “These findings worryingly suggest that the likelihood of someone receiving a life-changing treatment is often based on luck – like where they live or how helpful their healthcare professional is.”

The Society noted that NHS rationing was denying many patients access to the more expensive MS drugs, even though these might be more effective.

MS affects about 100,000 people in the UK, three quarters of them female.

The first criminal investigation into a death at Stafford General Hospital has found that a patient with a broken hip died as a result of not being given insulin.

Gillian Astbury, aged 66, died in 2007 in a diabetic coma after a new nursing team failed to read her clinical notes.

The Health and Safety Executive (HSE) is investigating the death as a possible criminal violation of the Health and Safety at Work Act, punishable by a fine.

This is the first criminal investigation arising from the Mid-Staffs tragedy, and the first instance of failure to give medication being considered as a crime.

Ms Astbury was admitted to Stafford General Hospital in 2007 with hip and arm fractures following a fall. Her partner reported finding her left without food or cleaning on several occasions.

The inquest jury concluded: “Nursing facilities were poor, staff levels were too low, training was poor, and record keeping and communications systems were poor and inadequately managed.”

The Francis inquiry said the Mid-Staffordshire NHS Foundation Trust had put “corporate self-interest and cost control ahead of quality and patient safety”.

However, NHS Chief Executive Sir David Nicholson blamed the deaths on the Labour Government’s infection control and waiting time targets, which he said monopolised clinical attention in hospitals.

The HSE commented that it will focus on “establishing whether there is evidence of the employer or individuals failing to comply with their responsibilities under the Health and Safety at Work Act.”

The case could have implications for many situations in which healthcare professionals administer medication.

One in five PCTs will miss the mandatory ‘MOT’ health check target in 2012–13.

GPs are required to give the MOT check, which provides early warning of cardiovascular problems, to all patients aged 40–74.

However, according to data obtained by GP magazine, up to nine million eligible patients will not be given the relevant checks and questions.

A PCT that has not even started giving the MOT checks blamed “other pressures” for the omission.

The health MOT records age, height, weight, blood pressure and blood cholesterol (plus blood glucose in certain cases), as well as responses to enquiries about current medication, smoking and family history.

This can provide early warning of heart and circulatory disease and diabetes.

In the year 2011–12, before the MOT became compulsory, the NHS set a target of 20% of eligible patients receiving the checks. However, only 14% did so.

In that year, four PCTs gave no or very few MOTs, and two-thirds of PCTs did not meet the interim target.

A spokeswoman for NHS Cornwall and Isles of Scilly said the programme could not be delivered “owing to other pressures”.

Dr Richard Vautrey, Deputy Chairman of the BMA’s GP Committee, commented that giving the scheme “greater national standards” and “national rates of payment” would have led to “better cost and clinical effectiveness”.

From April 2013, offering five-yearly MOT checks will be among the public health responsibilities of local government.

NHS services for management of chronic pain are inadequate to the needs of many patients, according to a report following the first UK ‘pain summit’.

The report, produced by a coalition of medical experts, identifies lack of clear guidelines, delayed referrals, long waiting times and suboptimal medication as problems affecting pain management services.

It recommends that the planned NICE quality standard on pain management include nationally agreed commissioning guidelines and a data strategy.

According to Beverly Collett, chair of the coalition, “chronic pain is not being taken seriously” though it impacts powerfully on general health.

Collett also argued that the conventional “analgesia staircase” was developed primarily for cancer patients and is less effective in patients with other types of chronic pain, who would benefit from a wider range of drug and non-drug therapies.

The report was produced by the Royal College of General Practitioners and the Faculty of Pain Medicine of the Royal College of Anaesthetists, together with the British Pain Society (a professional organisation) and the Chronic Pain Policy Coalition (an industry-sponsored group).

Chronic pain (persisting for more than three months) affects one in eight people in the UK, and has many causes.

According to the report, patients who would benefit from early intervention are often not referred to a specialist or face long waits for treatment, with reliance on suboptimal medication being the norm.

The report calls for:

• Clear national standards for the identification, assessment and initial management of chronic pain, forming the basis of the NICE quality standard.

• Nationally agreed commissioning guidelines to reduce service variation.

• A data strategy to collect and share information about the extent, severity and medical impact of chronic pain.

• Better education of medical students, clinicians and the public in pain management.

Pharma industry veteran Nigel Brooksby has been appointed Deputy Chair at Health Information – a UK company that provides and distributes patient information on medications.

Health Information, which recently secured funding from MVM Life Science Partners, works with the NHS to improve patient medication compliance.

Brooksby has almost 40 years’ experience in the pharmaceutical industry. His past roles include chair and MD of Sanofi UK and president of the ABPI.

His current roles include chair of the UK Life Sciences Council, board advisor at Doctors.net.uk, board strategic advisor at Healthcare at Home and director at Novocta Biosystems.

Brooksby commented: “There is a real need for patients to understand their conditions and medicines better, and Health Information has helped millions of patients to do this. I am looking forward to the opportunity to help develop this success further.”

Dr Grace Lomax, co-founder of Health Information, said Brooksby’s industry experience “will enable us to support more patients, and to fortify our leading position in the UK market”.

NICE has recommended a further clinical trial to establish how effective MSD’s Daxas (roflumilast) is for adults with severe chronic obstructive pulmonary disease (COPD) in final draft guidance.

Its independent Appraisal Committee concluded further data was required on its clinical and cost effectiveness as an add-on to bronchodilator treatment for people with a history of frequent exacerbations.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says a new trial “is a good opportunity to gather robust evidence”.

The trial should be designed, NICE advises, to analyse how effective  and cost effective Daxas is as an add-on to triple or dual therapy.

The Committee decided that research should aim to generate data around the benefits of Daxas as an add-on treatment to long-acting muscarinic antagonists (LAMA) plus long-acting beta agonists (LABA) plus inhaled corticosteroids (ICS), known as triple therapy, or LAMA plus LABA for those people who are intolerant to, or decline, ICS.

NICE believes that the medication is most likely to be used in addition to triple therapy. However, there was no direct clinical evidence provided by MSD in this way, and no possible way of NICE knowing whether Daxas is a cost-effective use of NHS resources.

There are currently around a million people with COPD in England and Wales. NICE estimates that nearly 90,000 people would be eligible for the treatment by 2015.

“The Committee noted that, in usual practice, roflumilast was most likely to be used in addition to triple therapy, but there were no directly relevant clinical trial data on this treatment regimen for the Committee to consider,” said Professor Longson.

“There are a lot of people with COPD, and those likely to be treated with roflumilast could receive treatment for a long time. This meant that a high degree of uncertainty about the clinical and cost effectiveness was not acceptable to the Committee.”

If NICE does not receive any appeals to the draft guidance, a final decision will be published in January 2012.

Intensive control of type 1 diabetes to maintain near-normal blood glucose levels halves the long-term risk of kidney disease, according to a US trial funded by the National Institutes of Health (NIH).

The landmark Diabetes Control and Complications Trial (DCCT) followed patients for more than 20 years following a 10-year trial period.

The results provide definitive evidence of the long-term benefits of careful medication adjustment soon after diagnosis to optimise the value of insulin and other diabetes-controlling drugs.

This finding adds significantly to the body of evidence supporting an intensive control strategy, despite the financial and logistical challenges it presents, and endorsing the use of new types of insulin and drug delivery strategies that help to address those challenges.

The DCCT was conducted from 1983 to 1993 in 1,441 people with type 1 diabetes, an average of six years after diagnosis. Half of them used conventional blood glucose control (based on daily testing) in the trial and half used a more intensive approach.

After an average of 22 years follow-up, 24 in the intensive group developed significantly reduced kidney function compared to 46 in the conventional group. Intensive control also reduced eye and nerve damage.

Griffin P. Rodgers, Director of the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases, which oversaw the DCCT, commented that it showed “the value of long-term studies”.

“The full benefit of treatment may not be seen for decades, especially for complications of diabetes, such as kidney disease, which can progress slowly but have devastating consequences,” he said.

Diabetes is a leading cause of kidney failure – in the US, it accounts for 38% of patients on dialysis or living with a kidney transplant.

Keen-eyed pharma blogger Maxine Vaccine makes her Pf debut with a look at a classic instance of creative branding.

One of the classic literary studies of marketing is ‘The Lame and the Halt’, written by American journalist Ellis Parker Butler just over a century ago. His character ‘Perkins the Great’ is a brilliant entrepreneur from whose methods we can still learn much about the commercial side of pharma innovation.

The story begins with Perkins and the narrator, his business partner, discussing the possibilities of spring water from an obscure rural district known to the locals as ‘Skunk Swamp’. Perkins describes the product as “sulphur water with a touch of garlic”. His first idea is to sell it as an oral medication for rheumatism.

With the economy of the born marketer, he explains why rheumatism is the ideal target market: “It is prevalent.” He already has the core idea for his marketing campaign: the product will be sold through advertisements across the USA with the catch-phrase Perkins pays the freight.

The real breakthrough comes with his realisation that the product will meet with too much customer resistance as an oral medication. But if customers are advised to bathe in it, not only will they not have to taste it, but they will need to buy more of it. With this application of customer insight, a winning brand is born.

Perkins and the narrator set up a factory on the edge of Skunk Swamp, and are going into business when Perkins has another idea. To add value to the customer service, they can invite customers to save the labels from the massive bottles of spring water – and for every six labels they send back, they will receive the deeds to an acre of the land the water came from.

They target ‘rheumatism districts’ across the USA with a poster and magazine ad campaign – to great effect.

Things get complicated when the Grand Rapids Rheumatic Club of Chicago turn up outside the factory to inspect their “real estate holdings”. Perkins and his business partner make a strategic exit from the market by catching the first train out of town.

Needless to say, this story is a gentle satire on advertising in the days before the FDA. Nothing like that could happen now. Imaginative branding has to be built on the solid foundation of a product whose efficacy is beyond doubt.

But the way in which Perkins innovates his commercial offering – first by introducing a brand-defining procurement concept, then by modifying the product’s application to improve customer targeting, and finally by rewarding customer loyalty with a unique extra benefit – deserves our admiration.

And so does his nerve.

Pharmaceutical companies Lundbeck and Otsuka have formed a global alliance to deliver up to five new psychiatric and neuroscience drugs.

The Danish and Japanese pharma companies, both of which have a strong record in CNS products, have signed a sales and cost share agreement.

The alliance covers two near-term projects from Otsuka and an earlier-stage portfolio of psychiatric disorder treatments, encompassing psychotic, mood and behavioural disorders at all levels of severity, from Lundbeck.

The two companies have identified psychiatric disorders as a major area of unmet need.

Lundbeck is granted co-development and co-commercialisation rights to two Otsuka drugs: aripiprazole depot formulation (which improves compliance in users of the drug) and OPC-34712 (for schizophrenia and major depressive disorder).

Otsuka will have an option to co-develop and co-commercialise up to three early-stage compounds in Lundbeck’s R&D pipeline.

“With the addition of aripiprazole depot formulation and OPC-34712, Lundbeck has significantly broadened its growing psychiatry portfolio with exciting and unique treatments in an area of high unmet needs,” said Ulf Wiinberg, Lundbeck’s President and CEO.

“This collaboration further strengthens our US platform and allows us to be introduced with the US psychiatry community already in 2013."

Dr. Taro Iwamoto, President and Representative Director, Otsuka, commented: “We are very excited that Otsuka and Lundbeck have entered into a co-development and co-commercialisation agreement for aripiprazole depot formulation and OPC-34712, both potential key drivers of future growth for Otsuka’s CNS business.

“Lundbeck’s expertise in developing depression and anxiety treatments and Otsuka’s expertise in developing anti-psychotics will maximise the medical and commercial value of Otsuka’s portfolio in CNS. In addition, our partnership with Lundbeck will enable us to establish a strong platform to deliver these compounds to patients who need them.”

Through the sales and cost share agreement, Otsuka will receive up to US$1.8 billion from Lundbeck – which will see its psychiatry portfolio and US market penetration increase.

The combination of Otsuka’s strong presence in North America and Asia with Lundbeck’s strong presence in Europe, Canada and Latin America mean that the alliance will reach most of the global psychiatric market.

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.