Up to 400 public health specialists have voiced their concerns about the Health and Social Care Bill and called for the House of Lords to reject the controversial reforms.

In an open letter published in The Telegraph, the specialists warn the proposals will put patient safety at risk, waste money and weaken authorities’ abilities to fight diseases and tackle health emergencies.

Dr David McCoy, who coordinated the letter, says the Bill will “erode the NHS’s ethical and co-operative foundations and that it will not deliver efficiency, quality, fairness or choice”.

The second reading in the House of Lords begins next week with Baroness Williams expected to lead the opposition against the legislation.

The letter is a blow to the Government who had hoped to gain their support following the amendments to the Bill after the recommendations made by the NHS Future Forum.

Shadow Health Secretary John Healy said the Prime Minister was in “denial” about the level of support the reforms have and the “damage his plans are doing to the NHS”.

He said: “There is no mandate for the Bill, either from the election or the coalition agreement. With the Government having railroaded its plans through the Commons, heavy responsibility is now going to be shouldered by the Lords.”

Mr Cameron accepts there are healthcare professionals that are “wary about parts of our proposals” but says that “many GPs, many doctors and many in the health service recognise that change is necessary” to improve standards of care.

'”I think the reforms are right, I think they will improve patient care,” he told ITV’s Daybreak. “Above all, they will be good for patients. They are going to give you more power and control over the care you get, a greater choice too, which I think patients will welcome.”

A Department of Health spokesman said they were disappointed that the specialists “who pride themselves in the use of evidence” have fallen back into “such generalised assertions for which there is not one shred of evidence” when writing the letter.

“The reforms to public health arrangements are a once in a lifetime opportunity to put public health at the heart of local health plans,” he added.

“NHS staff and the general public are looking to senior leaders in public health to lead the implementation of the changes to secure better health results for all, not to rubbish them.”

The Government has claimed people who ignore receiving the seasonal flu vaccine are playing “Russian roulette with their lives”.

A DH survey found that 87% of holidaymakers get the necessary injections to combat tropical diseases, but separate figures reveal that less than half under-65s advised to get the flu jab were vaccinated.

Chief Medical Officer, Professor Dame Sally Davies, says there is “no reason not to get vaccinated” and urged those eligible to get the jab as soon as possible.

Pregnant women, patients with long-term conditions such as diabetes and asthma, and anyone with a neurological condition can get the vaccination free of charge.

Frontline health and social care workers, carers, pensioners and those in nursing homes are also encouraged to get vaccinated. But the survey found that only a third of frontline doctors and nurses opted to have the flu jab last winter.

More than 600 people died with flu in Britain last year, the majority of whom were young or middle aged. But the Chief Medical Officer says this number could be reduced if people took just a matter of minutes to get vaccinated.

“A five-minute appointment to have the flu jab could save your life,” said Professor Davies. “Flu can be a serious illness – particularly for those in at risk groups. It can result in a spell in hospital, and sadly, flu can kill. The best way to protect yourself is to be vaccinated.

“It takes five to ten days for the vaccine to take effect so I’d urge everyone in an at risk group to get vaccinated as soon as they are able.”

The National Director of Immunisation, Professor David Salisbury, added that it was equally as important to be covered against tropical diseases as it is the flu and the sooner they do the better.

“It is very important that people in these groups get vaccinated early in the flu season so they are protected before flu starts to circulate.

“About three-quarters of older people get their flu vaccine each year, but only around half of younger people in at risk groups get vaccinated. Seasonal flu is not the same as getting a cold – it can seriously affect your health.”

Sanofi’s prostate cancer drug Jevtana (cabazitaxel) has not been recommended by NICE in draft guidance in combination with prednisone or prednisolone as a second line treatment.

NICE’s Appraisal Committee raised concerns about the medication’s cost effectiveness, its associated adverse effects and evidence supplied by the manufacturer.

Sir Andrew Dillon, NICE Chief Executive, says that the Committee was “particularly concerned” about the uncertainty on patients’ renal and cardiac systems.

A number of factors are taken into consideration by NICE’s Appraisal Committees when assessing the cost effectiveness of a treatment. These include the medication’s clinical effectiveness, its side effects, the benefits it brings to patients and the financial cost.

This formula then enables them to determine the cost of using the drug to provide a year of the best quality of life available or quality adjusted life year (QALY). NICE says they usually recommend treatments that cost around £30,000 per QALY or less, however the cost of Jevtana was far greater than this figure.

“The manufacturer of cabazitaxel provided one study on the effectiveness of the drug; in this study cabazitaxel was shown to extend life by approximately 10 weeks,” said Sir Andrew. “Although cabazitaxel has been shown to be effective, it is also associated with a number of adverse events.”

He added that the Appraisal Committee was also concerned about the “validity” of the health related information supplied by Sanofi after it provided one study which demonstrated a median overall survival gain of 2.4 months and an mean overall survival gain of 4.2 in its model.

“The Committee also felt that the treatment did not meet the criteria to be considered under NICE’s special arrangements for end of life, as based on the current data the length of the life extension could not be considered robustly proven to be at least three months,” added the Chief Executive.

“Once all these factors had been taken into account it was estimated that the cost per QALY would be more than £89,000. Therefore the committee concluded that cabazitaxel would not be a cost effective use of limited NHS resources.”

If a drug does meet the criteria to be considered under the Institute’s supplementary advice for end of life treatments, a higher cost per QALY may be accepted by NICE. There is currently no set threshold cost per QALY that meets this criterion, but since the supplementary advice was introduced, the only drug recommended under this method has been Sunitinib for renal cell carcinoma at a cost of £50,000.

NICE said that Javtana did not meet this criterion because the Committee did not consider the length of the life extension to be “sufficiently robust”.

GSK’s Benlysta (belimumab) has not been recommended in draft guidance for treating systemic lupus erythematosus (SLE).

Questions were raised by NICE’s independent Appraisal Committee over concerns about the medication’s cost and clinical effectiveness against standard treatment options.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says evidence “did not persuade the Committee that belimumab was good value for money”.

A Patient Access Scheme had been agreed between GSK and the DH for the treatment, although details of the agreement have been kept confidential at the request of Glaxo.

SLE is an incurable autoimmune condition, which mainly affects women. There are believed to be around 15,000 people in England and Wales with SLE, nine-out-of-ten are female.

The whole body is affected by SLE as the immune system attacks healthy parts of tissue and organs which may lead to serious internal damage.

It is a complex, poorly-understood condition and may be difficult to diagnose as symptoms are often similar to more common conditions.

“Systemic lupus erythematosus (SLE) is a debilitating condition which severely affects an individual’s quality of life,” said Professor Longson. “NICE’s independent appraisal committee has looked very carefully at the evidence provided on the use of belimumab for treating SLE, including the views of people with the condition, those who represent them, and clinical specialists.”

Although it is not licensed, certain patients with severe cases of the disease are treated with MabThera (rituximab). The Committee considered it relevant to compare Benlysta with MabThera, however NICE says there is no reliable data to show the relative efficacy between the two.

“Whilst recognising the severity of the disease, the Committee concluded that based on this evidence, belimumab could not be considered a good use of NHS resources,” added Professor Longson.

The decision is now open for consultation.

How well do you understand the various priorities of a key element of your customer-base: the payer? Omar Ali pens Part II of a typical day in the life of a Formulary Pharmacist.

10AM : GP REFUSED PRESCRIBING OF A PAIN DRUG/ACTION ASAP
OK, we have been here before – this product is non-formulary. It has never been applied for. The GP is well within rights to refuse prescribing. The consultant knows it is non-formulary and has ‘requested’ via a letter – actually stating it is non-formulary, so would the GP kindly prescribe it.

The GP is irate, and the patient is now confused and unhappy: “why wont you prescribe what the expert/consultant has asked for?” There is a stalemate. Not a great scenario – this call is backed up with emails going back with two PCT advisers, a commissioner, a GP and a pain nurse. This will mean going to see the consultant and being firm: these are the rules of engagement, this is the financial framework, this is how I can help you manage your patient.

Thoughts for pharma

We call this ‘lockdown’. It’s a process by which redundancy is built into the formulary processes to ensure compliance, limited loopholes and consequential policing. What’s crazy is I know the brand, and I know the rep. Every month she asks: “when is the next D&T?” I tell her – and nothing happens. Next month, she asks again. So what’s happening?

The representative knows she needs a consultant to bring her brand to the D&T but can’t/won’t affect it. The representative then considers ways around the D&T; KOL to find loopholes, write to the GP, prescribe on FP10(HP), do a non-formulary request, try IFR, etc. In fact, exhaust all opportunities except the one that is needed: D&T approval.

Sometimes the pharma company has a brand philosophy which doesn’t press the right buttons: they have representatives calling the wrong people, the quality of the representative is not good enough, the seniority/decision-making-abilities are lacking.

This ‘lockdown’ effect will usually mean that the company goes round in circles. It focuses on new materials and a wonderfully articulated campaign – usually around ‘Edith’, a 50-year-old patient who is suffering from constipation and can’t enjoy her grandchildren. “If only you would prescribe the brand for her. You would if it was your own grandmother”.

The ‘payer avoidance’ strategy will not work. Lockdown is getting tighter. With Clinical Commissioning Groups it will be even more so. The financial framework will be more akin to trying to prescribe a non-formulary drug whilst working for BUPA, who would neither tolerate nor reimburse because the formulary is under a financial restrictions.

Indeed, the pain market has also intensified. This means numerous brands shouting for a louder voice in an intense market. Neuropathy, Opioids, Fentanyl/breakthrough Ca pain – add these up and you have pharma running around competing for a slice of the pie. Given all the warnings we had with COX-IIs, now we have them with NSAIDS, and of course even the weak Opioids have ‘addictive warnings’ all over them.

It is not surprising we are caught in the headlights of where to go in the name of safety and analgesia. Please someone, be it a brand manager or someone with payer access, see the bigger picture. Help us with the whole pathway. See our needs and work in partnership with us.

11AM : MEETING WITH PHARMA BRAND MANAGER
It’s not often I get a visit from a brand manager! We have been struggling for some time attempting to commission a funding pathway for an osteoporosis product – see earlier Matrix Revolutions. However, we may have a solution now with a variety of process mapping models.

I have finally received a number of options and interestingly the applicable HRG codes for activity within this domain. This has been a headache, despite a NICE TAG within the context of this ongoing saga. A resolution is long overdue. After a lot of liaising and a lot of technical HRG work-up, we may end up up with a streamlined prescribing pathway which lines up the PCT, the GPC, the acute trust, and fracture liaison service.

Thoughts for pharma

There is an intriguing change of paradigm when I am sat having an adult conversation with a brand manager compared to a ‘rep-call’. I realise that brand managers can’t go and see all their customers face-to-face.

But the paradigm shift is palpable. Why? Here we have it: The representative is ‘detailing me’ – that is never going to compare with an adult conversation with a brand manager who gets the bigger picture.

But something else, potentially more devastating: the brand manager is able to vocalise the ‘brand story’ in a far more compelling way than the ‘local rep’. That’s interesting, because the local rep is trained in the ‘brand messages’.

Even if you put aside that the brand manager has a ‘big picture understanding’, the fact that the value of the brand was unbelievably clear means that somewhere along the factory chain of sales force effectiveness and tier upon tier of managers, the message is lost in Chinese whispers. Why? I don’t actually know.

The representatives that are sent to see me are not in the same locator of food chain as I am. In effect, pharma is sending people of a certain authority that doesn’t fit with where I am. Even with account management. Remember, I talk clinical, I talk financial, I do commissioning maps, I do total drug budgets – I still have a boss.

However, pharma send people to see me with the following authority: “I need to get my medic to answer that…I need to get my line-manager to answer that…I need to call in my health economics person to see you…I need to call my regional account manager to approve that…”

When will I see all these people? Why do I need to see them all? Is it all ABPI, is it internal compliance, or is it sales force design? I’m not all for it, but I do see where some industry leaders are coming from in proposing authorised account managers answerable to MDs with budgets run at their own liability and expertise.

I recently did a ‘Payer Process Mapping Day’ for a pharma company/team of Executive Healthcare Development Managers. It fascinated me. Pharma has spoon-fed even higher NHS teams to such a level, that if you clear the playing field and ask them to come up with solutions to landscapes, they go blank. at day, the summarising  suggestions was simply: “we need a toolkit from head-office”. It was worrying. My conclusion?

We need to innovate within the NHS. Pharma companies are stakeholders. We should be asking you to help us innovate, but the people you are sending me… while I’m wanting them to look at the traffic jams I have ahead of me, and help navigate local influencing factors, they are waiting for a tool-kit from head-office!

11.30AM : CARDIOLOGY CONSULTANTS FORUM
Cardiology prescribing has so many focal features right now, I’m struggling to keep up with payer issues. This is due to a mixture of NHS demands, D&T processes, a sizable shift in coronary intervention work – and the drugs required within such units) and recent launches of new products that are proving challenging to implement within our health economy.

The format takes place as follows: I basically ‘gatecrash’ the forum and hijack a section of the agenda to use the opportunity for both information flow – in both directions, buy-in – to various prescribing initiatives, D&T processes and budgetary issues, and input to a number of shared-care-prescribing guidelines.

The aim is to open GPC/CCG cluster prescribing. A lot of this is about supportive communications; managing up – to my Chief and Director of Finance, and managing down – to pharmacy team on formulary policing. I need to take the consultants from ‘one place to another place’ within each micro-managed sub therapy. It’s a give-and-take scenario.

Thoughts for pharma

Cardiology has never really left the ‘priorities’ list. Right now, although there are some exciting and challenging implementations, I foresee a rocky road ahead. Antiplatelets. With the onset of generic clopidogrel’s price suddenly dropping like a stone – Plavix was £40 pcm, generic clopidogrel is now £2.50pcm, the Director of Finance is looking at the cost savings that we have built into our financial planning.

But here’s the catch – not only do we have branded prasugrel, we also now have branded ticagrelor, both pushing upward of £50pcm+. So how do we manage this? I have potential new pipleline antiplatelets which have offerings to interventional cardiology versus a savings plan that I will need to explain if I renege on. Tough. After much consternation, we’d put prasugrel onto our formulary, and now we have displaced this with ticagrelor.

We still have the generic clopidogrel as first line – but we always, always need a second line drug. Interestingly, neither company appears to have come forward with a QIPP line yet. One of them have thought about patient access schemes. NICE looks like it will be happy to support either. Cardiac networks play an important role – the cardiologists just want somewhere else to go after generic failure.

This was a learning curve for me. Whilst the clinical ‘story’ for either brand never really did magical wonders for the payers, the cardiac network is influential, and I think the companies are now maybe reconciling a ‘payer value story’.

There was a scary moment for one of the companies – a serious hospital discount nearly had us giving away one of the brands as a 12-month supply on the rucksack of a patient discharged from the angio suite – with a cost-saving share with the PCT. The company in question quickly made that disappear! It’s fascinating and like a game of chess sometimes…

Dronedarone. Even with a NICE TAG behind it, this has not been easy to implement. It really does take some serious ‘heads-together’ and I have never seen such fierce debate between clinicians and payers. Affordability and the increasing prevalence of AF makes for a great D&T discussion.

The next meeting I have with the directorate is to implement the use of this agent in young patients – outside NICE who recommended in 75yr+ – as the clinicians see greatest benefit here. This is where the payer’s approach needs serious consideration. All being well, I’ve managed to create an amber/shared care with PCT funding to keep all happy – let’s see what happens at the formalisation and authorisation meeting.

NICE chest pain implementation. There are significant stakeholders here with a number of large meetings across the PCT – payers, consultants, commissioners, coronary care units, etc. The implementation involves a number of small ‘mini-projects’, putting different drugs into the formulary for specific uses to help implement NICE.

That’s the way proper process mapping occurs. It’s more about the drug assisting the pathway, not about the drug per se. I see a lot of work to be done here. But I also expect to see consistency across the PCT.

Read Omar’s previous article in this series on Account Management in pharma.

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’s choice of using GSK’s Cervarix to vaccinate against cervical cancer is less cost-effective than Merck’s Gardasil, a new study has found.

Authors of the Health Protection Agency (HPA) study stated that, if equally priced, Merck’s Gardasil was more cost-effective, despite the fact that Cervarix may provide better protection against cervical cancer, but said that “considerable uncertainty” remains about the differential benefits of the two vaccines.

In 2008, the UK Government chose Cervarix for its Human papillomavirus (HPV) vaccination programme, believed to be the cheapest option.

But since then, new evidence has emerged to differentiate the two vaccines.

The HPA has now found that Cervarix would need to be between £19 to £35 cheaper to match Gardasil’s price.

Also, Cervarix has proved to give better protection against cervical cancer caused by HPV types other than 16 and 18. Gardasil has also shown protection against vulvar, vaginal and anal cancer.

A spokesman for the HPA said: “The Department of Health will use the results of this study as part of its decision-making process when reviewing its current vaccine choice.”

The selection of the vaccine will be re-evaluated when the current tender for the vaccination programme expires before the end of 2011.

“Deciding which vaccine to use for national immunisation programmes is a complex task. Many factors, including the cost of the vaccine, must be taken in to account,” added the HPA spokesman.

Both vaccines protect against HPV types 16 and 18, which are responsible for over 70% of cervical cancer cases, as well as other types of cancer. Gardasil also vaccinates against types 6 and 11, which cause the majority of genital warts as well as a rare disease called respiratory papillomatosis.

Human papillomavirus is a common sexually transmitted infection seen most often in young women. There are more than 100 types of HPVs; some cause genital warts, but others cause cancers including cervical cancer.

HPV testing is currently being integrated into England's cervical cancer screening programme, and will be fully incorporated within the year.

Cervarix was found to protect against five of the most common cancer-causing viruses in July 2009.

Further delays to the progress of the controversial Health and Social Care Bill are expected due to several challenges to its proposals during its passage through the House of Lords.

Baroness Glenys Thornton intends to seek crossbench alliances in order to question aspects of the reforms, including the role of the health secretary and competition regulation.

Labour’s health spokeswoman said to the HSJ that peers were likely to “demand” that the legislation was analysed in a Lords bill committee, rather than on the floor of the house.

A bill committee is the only way the house can hear evidence from external bodies.

The Baroness says the rare move away from a discussion on the floor would be justified due to the Bill’s length, complexity and as it has been significantly amended following the Government’s NHS Future Forum’s recommendations.

It’s believed that the move to a committee discussion has support from Lib Dem peers, although it is understood the Government has serious concerns about the resistance and further delays.

Baroness Thornton raised a number of issues that had not been discussed in the House of Commons because a lack of time and other amendments had not been scrutinised fully.

She said that due to the Bill’s impact being so “big and fundamental” it would usually be subject to a comprehensive parliamentary debate and a draft bill before the proposed legislation was published.

“There is certainty a case that some parts of this bill need more attention,” she said.

“Clearly the Government might find itself in some difficulty.

“We are taking this bill very seriously… There is a cohort of members who are well informed about this bill.”

She added that it was impossible to predict likely further delays but said that royal assent may be take place beyond when it is currently expected in early 2012.

The only solution to the NHS funding crisis is to reduce the amount of beds and hospital-based jobs, says NHS Confederation head Mike Farrar.

The NHS Confed Chief Executive said in an article with the Guardian that shifting healthcare services into the community and centralising surgery provision is the only way to avoid wholesale loss of NHS service provision.

Mr Farrar says that “radically re-orienting services to reduce hospital stays and offering new forms of care” will help the NHS improve and keep it financially stable.

He noted that the Government’s £20 billion efficiency savings target by 2015 was already increasing NHS waiting times and raising the threat of the health service cutting services to “salami slice its way out of financial trouble”.

Farrar also said that there was a danger of the NHS reducing access to “less effective treatments”, though in fact this is already taking place in most Trusts.

To avoid financial disaster on the one hand or disastrous loss of services on the other, he argued, the only way forward is to shift the focus of services into the community – and immediately utilise the benefits of service redesign by closing down much of the existing in-patient hospital provision.

Surgery can be relocated to major centres and out-patient services to primary and home-based care, he said, with hospitals ceasing to be the main providers of secondary care.

His stark message is that without this reconfiguration of services – which will only be possible if funding is made available for service redesign – healthcare in the UK “faces a bleak future”.

The only solution to the NHS funding crisis is “radically re-orienting services to reduce hospital stays and offering new forms of care,” according to NHS Confederation head Mike Farrar (pictured).

Farrar, a long-term supporter of medtech innovation as a facilitator of NHS service redesign, has said in a Guardian article that shifting healthcare services into the community and centralising surgery provision is the only way to avoid wholesale loss of NHS service provision.

He noted that the imperative of achieving £20 billion of savings by 2015 was already increasing NHS waiting times and raising the threat of the health service cutting services to “salami slice its way out of financial trouble”.

Farrar also said that there was a danger of the NHS reducing access to “less effective treatments”, though in fact this is already taking place in most Trusts.

To avoid financial disaster on the one hand or disastrous loss of services on the other, he argued, the only way forward is to shift the focus of services into the community – and immediately to cash in on the benefits of service redesign by closing down much of the existing in-patient hospital provision.

Surgery can be relocated to major centres and out-patient services to primary and home-based care, he said, with hospitals ceasing to be the main providers of secondary care.

Farrar’s argument echoes the emphasis of Lord Darzi’s NHS Review (2008), but with the crucial further twist of a serious funding crisis.

His stark message is that without this reconfiguration of services – which will only be possible if funding is made available for service redesign – healthcare in the UK “faces a bleak future”.

The medtech industry has argued for years that the use of new technologies to shift more diagnosis, monitoring and treatment into the community is essential to the future of the NHS. Now, a leading NHS figure has said there is no other option.

Eli Lilly has received a positive opinion from the CHMP for Alimta as continuation maintenance therapy of advanced nonsquamous non-small cell lung cancer (NSCLC).

The recommendation is for the pemetrexed injection to be used as part of maintenance therapy, a relatively new concept in lung cancer treatment to commence immediately after patients have completed first-line treatment, in an effort to sustain disease control.

Dr Allen Melemed, Senior Medical Director of Alimta at Lilly Oncology, said: “Lung cancer is one of the most difficult cancers to treat and new therapy options are much needed.”

The CHMP’s recommendation will be reviewed by the European Commission, which will decide whether to approve the treatment for indication in Europe.

Dr Melemed commented: “If approved, Alimta would be the first tailored treatment option based on efficacy that can potentially extend lives beginning in first-line treatment and continuing through maintenance in advanced nonsquamous non-small cell lung cancer.”

No chemotherapy is currently approved as ‘continuation maintenance’ treatment. Currently approved lung cancer maintenance therapies use different medicines in the first-line and maintenance phases of treatment.

The CHMP's opinion was based on clinical research results from Paramount, a randomised, double-blind Phase III study involving patients with advanced nonsquamous NSCLC. Participants received initial therapy with four cycles of Alimta plus cisplatin. Patients whose disease did not progress continued to the maintenance phase, where survival was assessed in patients who received Alimta plus best supportive care (BSC), compared with those who received a placebo plus BSC.

Alimta is already approved in the first-line, maintenance and second-line settings in the EU and US for the indication. The treatment was originally recommended by NICE in September 2009 to treat the cancer on the NHS in the UK, but reversed its decision in December 2009, citing data uncertainties. NICE came to a final recommendation in June 2010.

Lung cancer is the most common form of cancer in the world, causing 1.3 million cancer deaths each year. NSCLC contributes to 85-90% of all lung cancers.