Cell Therapeutics has gained conditional authorisation from the European Commission to market its treatment for non-Hodgkin’s B-cell lymphoma.

The US biopharma company will be able to market Pixvuri (pixantrone) through a named patient programme in the EU.

This type of authorisation allows a company to quickly market a drug that addresses a major unmet medical need, while waiting for full approval.

According to Cell Therapeutics, the decision follows a phase III clinical trial that showed Pixvari to offer longer progression-free survival and a higher rate of complete response than chemotherapy.

Cell Therapeutics plans to commercialise Pixvari in Europe in the second half of 2012, and will need to complete a post-marketing study to confirm the drug’s clinical efficacy.

The EC decision is a breakthrough for the product, which was rejected by the FDA in 2011 on the grounds that its benefits were unproven. The company is preparing for a second FDA committee review.

With the Government aiming to increase innovation within the NHS, pharma has been tasked with helping to meet the challenge. Omar Ali, in his Matrix Revolutions series, focuses on the means to help the industry find the next big thing.  

With so many documents to read – white papers, NHS initiatives and DH directives – keeping tabs on the direction of travel of the NHS, as well as the pace of change, makes life difficult; and that’s not including the latest clinical trials, review publications and NICE guidance. In this issue of the Matrix Revolutions, I want to review one of the most important and potentially game changing documents to have
crossed my desk: Innovation, Health and Wealth.

The document comes under ‘improvement and efficiency’ from the DH and has an impressive circulation list. However, if the cascade didn’t get past those at directorship level, the average GP and healthcare professional may not have received what is a very important document. It also goes hand-in-hand with a story from NICE in February – Improving access to NICE-approved drugs – which provided the NHS with a best-practice guide on the implementation of local formularies in accordance with national guidance.

Innovation, Health and Wealth calls for all NHS organisations to come to ‘action’ by starting planning processes for the implementation of innovative new treatments approved by NICE.

“…while the NHS is recognised as a world leader in invention, the spread of those inventions within the NHS has often been too slow, and sometimes even the best of them fail to achieve widespread use”

I think we would all recognise this symptom of the NHS and list numerous examples. The UK is well known in being conservative with its adoption and prescribing of new drugs. But when NICE makes deep probing evaluations of new treatments it may be disturbing to find such variation in the implementation of best practice and subsequent availability of new medicines for patients.

It’s well known that when HTA agencies reject drugs the NHS is very good at implementing rapid ‘decommissioned’ formularies, which make general prescribing and availability very limited. However, when NICE does approve a new treatment, the variable uptake observed within the NHS as a whole has resulted in this new initiative.

“The challenge both for the NHS and for its industry partners is to pursue innovations that genuinely add value but not cost”

This is interesting how it adds up… I’m supposed to work with you to find innovations that don’t add cost… The problem with documents is rhetoric and direction. In reality, implementation will come down to precise and specific details. There are not many new drugs that ‘don’t add cost’ – they all add cost! The modelling comes in finding those that may offset some of the costs (QIPP).

“This report has been developed as part of the Prime Minister’s UK Strategy for Health Innovation and Life Sciences. The aim of this strategy is to ensure that the UK maintains and builds on its world leading position for life sciences, that the potential of life sciences to contribute to UK growth is realised, and that the UK remains and grows as an attractive location for investment now and in the future”

The flavour of the document paints a clear picture of investment from pharma which will potentially deteriorate within the UK due to poor uptake/diffusion by the NHS. The difficulty lays in that ‘uptake’ criteria for the NHS doesn’t have ‘investment’ as part of the decision process. For example, if a company invests millions into UK R&D and produces a poor, non-innovative and non-cost effective drug, should we put it on formulary due to the fact they have invested in the UK economy? If the answer is ‘yes’, we all need to change the paradigm and throw QIPP out of the window. I guess the alternative is how long can pharma keep resourcing UK investment and see no return? Not long in this climate. Surely then the answer is as seen above: the challenge of making new, innovative drugs cost effective.

Having helped bring NHS payers, CCG commissioners and pharma together, it brings some common ground on market access. I have found that with all of the details, some dedicated quality time with stakeholders and some flexibility from pharma, we can always find some manner of value-added to the product and/or a financial/value proposition that changes the paradigm. The truth is we don’t spend enough quality time talking together about the real issues. We tend to spend poorly co-ordinated NHS/pharma interactions looking at insane cost-models and budget impacts that are largely irrelevant. Add to that ABPI/compliance and internal concordance issues, and the NHS and pharma are often dancing around the tables instead of having decent commercial business discussions that pave the way to a healthier, wealthier future for both.

Potential barriers
“Poor access to evidence, data and metrics”

I have been impressed with some of the data informatics I have seen that actually represent data handling with a view to Secondary Uses Service (SUS) information, hospital episodes and prescribing by the CCG sector or a PCT. Here, pharma is beginning to excel themselves and it does have an influence on working together. This approach is far better than those companies who have a black-box approach to health economics.

“Insufficient recognition and celebration of innovation and innovators”

It’s hard for NHS innovators to ‘step out’ and stick their heads above the parapets when those around them are stuck in the same old ways. Far from recognition or reward, one can expect pushing uphill and against the grain. The only way to succeed here is to believe in the cause of innovation and true improvement. My feeling is those ‘beacons of light’ are beginning to shine in healthcare – and love it or hate it – one of the strengths of the Health Bill is bringing those leaders to the forefront through sheer necessity. My observation is that the pharma culture celebrates innovation from the core – it’s what you do and what you believe in. Being an optimist, I believe pharma has a role on the ground in bringing some of that innovation to ‘rub-off’ on your NHS customers.

“Financial levers do not reward innovators and can act as a disincentive to adoption and diffusion”

You may have read my previous Matrix Revolutions ‘case’ on Prolia (denosumab) – it had a NICE TAG but saw variable uptake, even a year after its recommendation. This case clearly outlined how micro-economics and financial levers can stall the introduction of new innovative therapies. But getting the tariffs to match, commissioning to fund and finding the code to unlock prescribing took a long time… why? Partly because our own informatics is poor – an example of the NHS barrier – and partly because dealing with payer issues doesn’t come first-hand to most brand teams.
Other financial levers that will inhibit uptake include:

• Enhanced LES & DES warfarin payments to GPs which will be a threatened source of income with new oral anticoagulants.
• QoF cholesterol targets of 5mmol/l in the face of innovative agents which may achieve lower cholesterol targets and reduced outcomes.
• QIPP Indicators aiming for a percentage of metformin and sulphonylurea when newer agents for type 2 diabetes reduce incidence of hypoglycaemic episodes and save money on blood glucose testing strips.

In the next issue of Matrix Revolutions, Omar Ali continues to review the DH’s modernisation plans and also focuses on what makes the diffusion of innovation happen. 

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 can be reached at omar.ali@sash.nhs.uk.

The ABPI Code of Practice is set to be amended to reflect changes to international guidelines and UK law.

Proposals for 17 amendments result from changes to the IFPMA governing code or are responses to the Human Medicines Regulations 2012.

Several of the amendments include minor adjustments to wording. However, additional proposals, including new clauses relating to pharma’s relations with patient groups, could be significant.

Clause 1 – Scope of the code and definition of certain terms – will see up to five amendments introduced with two modifications also suggested to Clause 2 and Clause 23.

If approved, they would be included in the Code and come into effect on 1 July 2012 before becoming fully operative on 1 November 2012.

As a member of the International Federation of Pharmaceutical Manufacturers and Associations, the ABPI is duty bound to bring its own regulations in line with that of the IFPMA.

The proposals have now been sent to member companies, relevant bodies and the Serious Fraud Office.

The Department of Health has unveiled a new 45-point plan for the NHS to follow to identify and treat people with respiratory problems.

A Companion Document to the Outcomes Strategy for COPD and Asthma includes advice on diagnosis and treating people which may help the NHS prevent an estimated 7,800 deaths annually.

Chronic Obstructive Pulmonary Disease (COPD) kills around 23,000 people per year and is the UK’s biggest killer disease. The UK also has the highest prevalence of asthma around the globe with between 1,000 and 1,200 deaths per year.

Health Minister Simon Burns called COPD one of the UK’s “hidden killers” and said with “proper diagnosis and treatment we can make a big difference”.

A key part of the strategy is reducing the variation in COPD diagnosis and care. Currently the north of England had better diagnosis rates than the south – yet has higher death rates.

The NHS currently spends around £1 billion annually on treating COPD. Around 3.2 million adults have the disease – with an estimated 2.1 million going undiagnosed.

The strategy outlines how the NHS should provide the “right interventions” through better provision of a form of artificially aided breathing in hospitals and by providing spirometry lung tests during diagnosis.

It is hoped that following the top five action points in the strategy could lead to savings of around £500 million over the next ten years.

Dame Helena Shovelton, Chief Executive of the British Lung Foundation, backed the plans. “This new action plan shows that the government is serious about fulfilling the promises made in last year’s COPD and asthma strategy, which we campaigned so long to bring about,” she commented.

“By looking to improve diagnosis and treatment, this new action plan will therefore not just save lives, but could dramatically improve the quality of life for hundreds of thousands of COPD sufferers nationwide.”

The NHS is failing to take care of patients who have multiple long-term conditions, according to a new study published in The Lancet.

The study highlighted the growing number of non-elderly patients living with ‘multimorbidity’ and called for a more patient-centred approach.

Difficulties in primary and secondary care management of such patients combines with a lack of relevant clinical research, the authors said.

The study looked at 1.75 million people across Scotland, and found that 23% had two or more chronic diseases such as heart disease, diabetes, cancer, stroke or depression.

Only 9% of people with heart disease and 23% of those with cancer had no other long-term condition.

The incidence of ‘multimorbidity’ was higher in areas of economic deprivation, where it tended to have an earlier onset.

The study noted that care of such patients was often poorly co-ordinated, with patients being referred to a number of specialists who did not work together.

It also noted a lack of health data on ‘multimorbidity’ due to the limitations of clinical trials, where patients with comorbidities are normally excluded.

Calling for “radical change” in the health system, the authors said: “Existing approaches need to be complemented by support for the work of generalists, providing continuity, co-ordination, and above all a personal approach.”

“The status quo isn’t an option because it leads in the wrong direction,” commented lead study author Graham Watt, Professor of General Practice at Glasgow University. He noted that there is a major unmet need for “someone who can oversee all the problems of a patient”.

In an accompanying article, Dr Chris Salisbury of the School of Social and Community Medicine at the University of Bristol observed: “Expenditure on health care rises almost exponentially with the number of chronic disorders that an individual has. This economic burden heightens the need to manage people with several chronic illnesses in more efficient ways.”

He suggested that the caseloads of GPs in more deprived areas should be reduced, and that hospitals should assign patients with ‘multimorbidity’ to a generalist consultant who would co-ordinate their care.

NICE has failed to recommend the use of Sanofi’s Jevtana (cabazitaxel) in final guidance in combination with prednisone or prednisolone as a second line treatment for prostate cancer.

Concerns were raised by NICE’s Appraisal Committee over the cost of the treatment and its side-effects, including haematological adverse events and diarrhoea.

Sir Andrew Dillon, Chief Executive of NICE, said the Committee queried the “nature of the health-related quality of life information” provided by Sanofi.

Sanofi had appealed the decision not to recommend the treatment however, this was dismissed on all points.

NICE recognised that Jevtana resulted in a mean improvement of greater than three months in mean overall survival. But the Committee considered that its cost per QALY gained would exceed £87,500 – considerably higher than the most expensive treatment it has recommended at £50,000.

Additionally, the numerous side-effects, such as fatigue, nausea, vomiting and constipation, associated with Jevtana raised concerns with the Appraisal Committee.

“We need to be sure that new treatments provide sufficient benefits to patients to justify the significant resources the NHS would need to make available,” said Sir Andrew.

“Although cabazitaxel can extend life for some patients, its price remains well above what the independent Committee appraising this drug considered acceptable, given the benefits it offers.”

Allergan’s Botox has been recommended in final draft guidance as an option for the NHS to prevent headaches in certain adults who experience chronic migraine.

NICE advises the injection can be used in patients whose condition has not responded to three prior preventative medications and whose conditions has been appropriately managed.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said Botox is a “preventative therapy” for those with “extremely debilitating” chronic migraines.

In February, NICE failed to recommend the injection after questioning the evidence supplied by Allergan.

However, after additional information and analysis were supplied by Allergan, NICE’s independent Appraisal Committee deemed the treatment to be a good use of NHS resources.

The draft guidance adds that injections of the popular cosmetic treatment should be stopped if headaches have not improved enough after two cycles, or if the amount of “headache days” falls to fewer than 15 per month, over three consecutive months.

Chronic migraines are believed to affect around 1.6% of adults. They are defined as headaches on at least 15 days per month, of which at least 8 are with migraine.

The draft guidance is now open for consultation with final guidance expected in June.

Maxine Vaccine pays tribute to the genius of Vidal Sassoon and gives five reasons why the legendary hairdresser is a role model for medical sales professionals.

In my late teens I worked in a Midlands hairdressing salon. Difficult customers, bitchy colleagues, hours of random chatter – it was ideal training for a career in pharmaceutical sales. Some of us were girls, some of us just acted like we were. But we all had one hero in common. And that hero passed away this week, aged 84.

Vidal Sassoon took the mundane service industry of hairdressing and made it an art, a business and a dream. His talent, energy and sheer chutzpah make him an inspiration for anyone whose work involves contributing to the well-being of the human body.

So in tribute to Sassoon’s revolutionary five-point haircut, here is a five-point guide to true style in medical sales...

1. Start in reality. At the age of 17, Vidal Sassoon joined the 43 Group, an association of Jewish ex-soldiers dedicated to fighting fascism on the streets of East London. They took on Mosley’s Blackshirts and beat them. That toughness and refusal to be the underdog stayed with Sassoon throughout his life.

2. Keep it simple. Sassoon’s trademark hairdressing style avoided elaborate treatments. He wanted to work with the natural shape and life of human hair. The iconic ‘five-point’, inspired by Bauhaus architecture, was a clipped androgynous look whose simplicity disguised its mathematical precision.

3. Care begins at home. Like a present-day GP, Sassoon thought primarily in terms of the self-care model. No more beehives that took an hour to reconstruct each morning. His cuts were low-maintenance and robust, designed for women who had lives to lead.

4. The right words. Sassoon launched his classic range of hair products with the slogan ‘If you don’t look good, we don’t look good’ – a neat play on words that linked the worlds of fashion and business. Even in his eighties, Sassoon’s language was as sharp and elegant as his haircuts.

5. Fit for purpose. Throughout his career, Sassoon remained lean, fit and immaculately dressed. Where many of his contemporaries drank like fishes, he swam like one. His salon performances were balletic displays of controlled energy, expressing his attitude towards human health.

Maxine’s views are not necessarily those of Pharmaceutical Field.