The Implications of the NHS White Paper

Viewed by many as the greatest shake up to the NHS since its inception, the NHS White Paper is likely to have a major impact on the way the industry interfaces with the NHS. This PM Society Hot Topics meeting, (held at Pfizer in Tadworth, Surrey) brought together a general practitioner and a formulary development pharmacist who are both heavily engaged with the new agenda to discuss the implications of the White Paper. Ivor EisenstadtWhat will be the new commissioning arrangements in the NHS? How might 'payer-related' outcomes affect the industry? How can prescribing be linked to outcomes? And what might be the opportunities and threats to the pharmaceutical industry and to agencies supporting the industry?

Ivor Eisenstadt, Chairman of the Society's Education Sub Committee thanked Sam Taylor, Head of Healthcare Strategy at Pfizer for opening the meeting and also for the generosity of Pfizer in hosting the event, which had begun with a networking reception where delegates were able to meet prior to the meeting.

The White Paper from the GP's perspective

Joe McGilligan is Chairman of ESyDoc, a commissioning consortium in East Surrey that has 170,000 patients and 78 active GP partners, though it covers about 130 GPs in total. ESyDoc will inherit a budget of £236 million from Surrey NHS. Over the four years ESyDoc has been in existence Joe has been elected its leader each year. He also sits on the local strategic partnership with the local councils covering the Surrey area. As chairman of the SASH programme board Joe is keen to ensure that the system works. In Joe's view the problem has always been that as soon as part of the NHS runs in to trouble it has been made into somebody else's problem and the debt has just been passed around.

Joe McGilliganWith the advent of practice-based commissioning in 2004 Joe was tired of other people making changes that affected him and decided he wanted to be involved in making the decisions. He was no longer prepared to put up with on-the-hoof knee-jerk reactions. With 22 more years' experience ahead of him as a GP Joe does not want at the end of his career to wish he had done something different. There now a real opportunity to make a difference, in Joe's view, as it is the first time since 1948 that primary care has been asked what they think the NHS should be providing.

Fundholding with teeth

Healthcare has always been provider driven. The NHS is a huge industry, the second largest employer in the world, and also the envy of the world. Yet is has never been copied because it is hugely bureaucratic and expensive.

GPs have been given the mantle of looking after the patient ‘from cradle to grave' and the one single fixed point in the NHS is that everyone knows who their GP is. Now the GP will hold the budget to look after the patient. This idea has been talked about since 1988 when Edwina Currie and the Conservatives introduced fundholding, but it was then scrapped by the next Government in 1997. Now, with the White Paper, finally it is going to happen, but this time it is fundholding with teeth, in Joe's opinion. This time, rather than just a few entrepreneurial GPs making a quick buck, everyone has to be involved. And it needs people (like Joe) to lead with it.

Under the White Paper the commissioning arrangements will be that below the Secretary of State for Health there will be the NHS Commissioning Board and then GP commissioning through consortia. A total of 70% of the budget will be given to GP consortia, equating to £70 billion. GP consortia will have statutory powers and responsibilities for commissioning while the NHS Commissioning Board will deal with specialist services, primary care contractors, maternity and prisons. Public Health and PPI (Patient and Public Involvement in Health) will move to local authorities. There will be more flexibilities and freedoms to make decisions at consortium level and, most importantly, commissioning will be outcomes based.

When will it happen?

Shadow GP consortia will begin in 2011 (Joe's ESyDoc consortium has been put forward as a pathfinder) and the shadow NHS Commissioning Board will start in April 2011 and be live by April 2012 when SHAs will be abolished. All GP consortia will be in place by 2013 and will hold the contracts at that time, with PCTs abolished by 2013. Another important milestone is the health needs assessment from April 2012. Also, the patient will have the right to choose any GP practice from 2012, meaning practices will not be able to turn patients away on the basis of area. The idea is that good practices should benefit and bad practices will wither on the vine and disappear. In fact, in reality very few people swap GPs and Joe believes that the relationship between GP and patient will never change, whatever goes on organisationally.

Joe went on to explain how tariffs can drive wedges between organisations. Some hospitals ‘suck in' patients to make money. If a patient has been in A & E for three hours 59 minutes they are admitted otherwise the four-hour wait will be breached (incurring a fine). Because the patient is admitted (unnecessarily) for a day this adds extra costs. Unfortunately there are also ‘perverse incentives'. Monitor insists that Foundation Trusts have a 9% surplus each year. This creates a reverse incentive for Trusts to make a profit from commissioners, and yet commissioners can be bankrupted because of this.

The patient comes first

For the GP is that the patient's wishes are paramount. Choice has been talked about for the last 10 years. Patients all want choice - to see who they want, when they want. But the patient has to be directed by professionals. Unfortunately, in the current economic climate, patients' needs will be more important than their wants. If patients are allowed to concentrate only on what they want (e.g. plastic surgery) they neglect what they actually need (e.g. cardiac surgery). Sadly, in Joe's view, the NHS always oils the squeakiest wheel and as soon as a patient makes a fuss they get what they want. However, by giving the responsibility to GPs, the GP can actually discuss with the patient what is best for them.

When prescribing is linked to outcomes, everything must be evidence based rather than emotionally based. In diseases like lung or kidney cancer, are drugs that prolong life by three months and cost a huge amount of money actually in the patient's best interest? In fact, there is evidence now that by giving palliative care early in a diagnosis patients actually live longer than with expensive drugs. This is because of the way the human psyche works: if you feel better you live longer and with a better quality of life. Unfortunately there is no pressure group to say that palliative care works and no drug company money behind it.

Age-related outcomes

Joe believes that the current Quality and Outcomes Framework (QOF) is wrong. GPs have to prescribe statins to everyone when actually there is no evidence that anyone over 80 will benefit (if you get to the age of 80 with a cholesterol of 6 Joe's view is that cholesterol is in fact ‘oiling' the blood vessels rather than clogging them up). One-third of all hospital admissions are due to drug-related effects and it is vital to start looking at the individual patient and not the target. For this reason, in future QOF will be aligned to outcomes rather than targets.

Hardly any patients with haematological cancers die at home. They all die on ITU on expensive drugs when everyone, including the consultant, knows that they will die but no-one will ask the question whether the patient wants to be in ITU - most people don't. GPs will look to make this one of the outcomes, and to discuss end of life and quality of care with patients. In Joe's view QIPP (Quality, Improvement, Productivity and Performance) is actually what the GP should be doing every single day anyway (and it should be taught at medical school).

The end of the quick financial win

GPs are also tired of the idea of quick wins for financial gain and are annoyed by constant directives to change from this drug to that drug to save money. All the evidence shows that atorvastatin is the most cost-effective statin, with much better long-term outcomes, but simvastatin is cheaper. Yet atorvastatin would save money in five years' time. If a patient then sues because he or she did not get the right drug all the budget savings are negated, so it is important to look at the value of the drugs, not their cost.

Because there is so much waste in the NHS, changes to pathways can make savings, which can then be reinvested. The Government is not taking money out of the NHS; simply they want to make £20 billion-worth of efficiencies to reinvest. Market forces mean that London hospitals can be up to 43% more expensive than in Brighton, yet half of Joe's Surrey patients go to St George's Hospital in London because that has historically always been the case. However when the GP is controlling the budget, this is where savings will be made.

Hospital drug deals can also be detrimental to the community. A steroid nasal spray prescribed in hospital can cost £3 but as much as £11 in the community, whereas a similar drug costs £5 in the hospital and also £5 in the community. That is the drug that should be used so as not to bankrupt the health economy. Joe stressed that thinking needs to be joined up across all the organisational boundaries - if hospitals do deals behind GPs' backs it will bankrupt the system.

Opportunities and threats for the industry

With regard to opportunities for the pharmaceutical industry, the first is obviously in the area of training, in Joe's view. Also, the industry understands organisation and efficiencies far better than GPs. Other strong points are analysing data, assessing quality and QALYs - all aspects, which the GP needs to understand. In addition, guidelines must be adhered to in order to commission effectively, and industry can help GPs interpret these.

For example, savings can be made from alternative drug regimens and invest-to-save schemes. This is what GPs want to ensure that patients stay well for longer. Joe cited the example of MURs (Medicines Use Review) undertaken by pharmacies. Unfortunately the pharmacy is paid £25 per review, whether the patient is on one drug or 10, so they tend not to assess complex cases, which take too much time. Also, many patients in nursing homes are prescribed drugs by a locum or the out-of-hours doctor and the medication is never reviewed. All these patients should be targeted - so many patients end up in hospital with needless drug interactions.

Joe believes that many companies do put a lot back into the NHS but more could be done in terms of education and training, and public education. Joe's consortium has had a drug company undertake a review of every COPD patient and as a result the local Trust now has the lowest readmission rate for COPD in the southeast. His consortium is also working with two other companies to review every diabetic, and expert patients are chairing these review bodies.

With regard to threats for the pharmaceutical industry, regulation of prescribing will be much tighter because there will be peer-to-peer review. Another threat is disorganisation. With the PCTs and SHAs abolished, who will make the decisions- Joe believes that GP consortia will still need that expertise and buy it in from the people previously at the PCT or SHA.

Joe was shocked to read recently that the amount of money spent on research and development in the pharmaceutical industry has actually dropped for the first time in the UK. Clearly every drug company is finding the economic climate difficult. Also, deals will be much harder to do, and pharmaceutical companies will have to battle much harder just to get market share.

Getting it right

In closing Joe quoted Barack Obama who said: ‘Change will not come if we wait for some other person or some other time.' Joe stressed that the changes in the NHS will not happen overnight, and will not happen if left to somebody else. That is why Joe stood up to be counted. Everyone must work together and start making changes. As a society we will not be able to afford the healthcare we used to have, i.e. free at the point of sale.

When Joe first started this journey he was ignored as a crank GP. He was laughed at by the PCT and when he asked about fair shares he was publicly ridiculed by the Director of Public Health who said that anyone over the age of six who wanted something to be fair needed to see a psychologist. For Joe it not about winning, but about getting it right. The important thing now is to actually get it right.

Discussion

Asked about the situation where, say, a cancer consultant has traditionally preferred drug X, yet the GP consortium believes drug Y to be more cost-effective, Joe stressed that networks will have to make an evidence-based decision, rather than an emotionally based one. He also believes that ‘old style' consultants will no longer be able behave as they done for years (for example, not turning up for clinics and leaving patients to registrars because they are doing their private work). Pharma need to talk to primary care about secondary care issues. GPs will need to buy in expert help to advise on drugs ? currently PCTs tell GPs what to prescribe, but if the GP is buying the advice, then he or she is going to listen to it.

Asked what will happen to those consortia that are not up to speed like Joe's, Joe explained that the idea that is that groups of practices that are not in consortia will be given to an established consortium to be managed (this will be decided by the NHS Commissioning Board). Practices will gain from being in a consortium, and benefit from not having to re-invent the wheel for themselves. Joe stressed that super specialist medicine will be held at NHS Commissioning Board level, and also that consortia will not work in isolation, but also with the clinical networks to ensure patients get the best treatment.

As to whether he believes the dynamics between the GP and the pharmaceutical industry will change, Joe sees it working as a partnership and a huge amount of cross-fertilisation could happen. Pharma is a massive industry, which the NHS cannot do without, but the NHS needs to use the most cost-effective solution for society and the country as whole rather than what is best for each individual company.

It was noted that Andrew Lansley has stated that consortia need to develop from the bottom up and be locally sensitive, but speaking to individual GPs and those in PCTs there is a feeling that there is pressure to create ‘super consortia'. These would perhaps manage risk and have economies of scale, but perhaps not the local sensitivity. Joe conceded that consortia will have to work together in big federations, but that the real changes at the grass roots will have to be locally sensitive.

With regard to the process of who will represent each practice, Joe hopes consortia will follow his group and have elections ? that is the only way to do it, in Joe's view, because you have to be trusted by your peers. The biggest challenge Joe has faced in operating as a consortium was not being taken seriously by the people who make decisions. It has been a challenge keeping the consortium going while being continually knocked back by the current system. In his 11 years as a GP in his area Joe has worked with six different chief executives at the hospital and four chief executives at the PCT. This means Joe is the only one with the corporate memory of all the mistakes that were made over and over again, and this has been frustrating. 

Joe McGilligan is a GP partner at Greystone Medical Practice in Redhill and an active member of the Local Medical Committee (LMC) for Surrey and Sussex. He has always been an advocate of an integrated approach to healthcare and is a member of the national PBC clinical network, Clinical Advisor to NHS Surrey (including Medicines Management) and Chairman of the SASH Programme Board redesigning acute services. Joe is also Chairman of ESyDoc, a commissioning organisation that covers 20 practices in East Surrey, which puts the patient first and reinvests in local services.


 

 

Key elements of the NHS White Paper from a formulary viewpoint

Omar AliOmar Ali, Formulary Advisor to Surrey and Sussex Healthcare Trust, began by noting that as a result of the White Paper, PCT formulary advisors will be offering to work with consortia like Joe's and it will be interesting to see how Joe chooses who will work with him. Omar added that the idea of value-based pricing challenges the pharmaceutical industry because it means that drug companies will be paid according to the value of a new drug and not necessarily the price at which the company offers the drug. Joe and his consortium will want to pay for activities that have outcomes and Omar suspects that in the future consortia will not pay per patient for COPD care, for example, but will instead commission provider services to reduce COPD hospital admissions (say by 15%). No provider will therefore use a drug that will not achieve this outcome.

Tariffs and making a profit

Omar noted that while the Government has given the cash register to consortia like Joe's; in reality these outcomes have to be achieved in the context of a flatline budget. Omar went on to cite the example of non-elective CABG for which the national tariff price to the GP is £9795. Those providing CABG must ensure they can undertake the procedure within that cost, and many are currently losing out because it actually costs them £11,000, which means a deficit over the year of £50 million. The new White Paper will lower the collar on the tariff charged so CABG can cost anything less than £9795. For outpatient time (often with the SHO and not the consultant and lasting around seven minutes) the GP receives a bill of £266, so it is clear why the commissioning clusters are keen to start controlling what is happening. It is also clear that a lot of this outpatient work can be redesigned and moved into the community ? the patient doesn't need to have to drive around for half an hour to find a parking space for a brief outpatient appointment with the SHO.

Currently everything has a price in the NHS, rather like a hotel tariff. How does a hotel work out the cost of a room? They factor in the maid, the laundry, free tea and coffee etc, and also their profit. Similarly foundation Trusts will be looking for a profit in future with economic analysis tilted towards income generation

Also every disease condition has a trim point. For CABG this is 43 days so the patient has 43 days to get treated & discharged. But what if the patient has a stroke or a pulmonary embolism? What if they need dialysis? The patient could then be in hospital for three months but after 43 days not only does the GP get the bill for £9795 but there is also a clock running at £318 per day for the stay in hospital. The frustration is that the GP has no control over why the patient had the complication of the stroke – it could have been poor infection control or poor surgical technique. Or inappropriate use of prescribed agents peri/post operatively.

Competition from other providers

Surrey currently has 1.1 million people under four main acute Trusts, with the PCT in control. When the PCT dissolves in 18 months' time GP clusters will look for providers. Medicines management and pharmacists will still be working but in different guises, and working under different organisations (like Virgin Healthcare, Price Waterhouse Coopers, or Lloyds, all of whom are setting up medicines management teams), or under the wing of the consortia. These will be the new customers for the pharmaceutical industry. But how does pharma relate to a company like Virgin Healthcare? The new dialogue will be interesting, in Omar's view.

Omar believes that there will be competition from other providers for procedures such as hip and knee replacement. American companies like IHP (International Health Partners) are already in the game and hiring pharmacists and ex-medicines management people. And as well as offering a consortium pharmacists and medicines management expertise, these companies are likely to offer all kinds of additional kick backs.

Will postcode prescribing get worse? Omar's answer is yes, there will be situations where everyone is using different drugs. However Omar views this as positive for the industry because pharma will no longer have to deal with amorphous PCTs who ‘don't see reps', or prevent GPs from seeing reps. The difficulty for pharma will be to navigate agencies that are not its customers but who are independently trying to make money. In two years' time everyone in the NHS will be working for a company, whether a cluster, a foundation trust or a provider service. That means that a drug company will take a product to, say, Virgin Healthcare whose function will be making money, meaning the dialogue changes from a ‘selling' perspective to a ‘transactional' one.

Value-based pricing

The concept of value-based pricing stemmed from the OFT stating the NHS was paying too much for some drugs. Omar values research and development and appreciates the fact that the pharmaceutical industry employ many people, and that it takes 10-15 years and hundreds molecules to develop just one drug. After launch there may be only five years left on a drug's patent and if it has cost £10 billion to bring it to market, then it doesn't leave much time to make even a small profit. Value-based pricing will abolish this road map (PPRS redundant by 2014) that says the pharmaceutical industry should get return on investment, though this could well come back to bite the NHS in Omar's view.

A number of drugs are currently out of kilter in terms of the value they provide relative to their cost. While everyone is saying it is good that NICE will not be around any more and everyone will have access to all the drugs, the other half of the story is that the Government will set the price for a drug with NICE to a cost that is effective. This means working backwards: instead of a company spending 10 years launching a molecule for, say, renal cancer which costs £3000 per month for and gives an extra six weeks of life (and NICE saying no) NICE and the Government will look at the value that drug over and above what the drug is treating and assess the value at, say, £1500. The manufacturer then has a choice: either they take the money offered or they decide to stay with the price of £3000, in which case it will go to high court arbitration and either the company will be told to undertake a head-to-head trial with certain payer-related outcomes, or there will be no agreement and the reimbursement will be set at the value-based outcome price. If anyone wants to use the drug the remainder of the cost is then up to the individual, or the company, or the insurance agency. This introduces the whole language of co-payment and medical insurance (like in the US, or other countries in Europe). This is the way forward and Omar believes it will be rocky.

Outcome frameworks

Currently NICE are also looking at NHS outcome frameworks. As well as effectiveness (reduction in death, etc) this includes the patient experience, something that has hitherto been ignored by the NHS (Omar has no doubt that Virgin Healthcare will pick the CABG patient up in limousine). The new model will drive doctors to look after patients and care for them in the way they want to be cared for so that the patient is safe and in secure hands.

NICE has already produced outcome indicators in two or three conditions, bringing out the different elements of value that will be placed on the prescribing of drugs, and using validated ‘QALYable' results. With hip and knee replacement they found a cost per QALY of £1000 (many of the drugs used currently are £50,000 to £200,000 per quality adjusted life year).

Omar believes that the pharmaceutical industry has a lot to offer in terms of partnership working companies need to change the way they work. The language is now that of a business transaction, rather than simply selling. There will be compacts rather than joint working with a transactional relationship, rather than just giving materials away for free.

Payer-related outcomes

With regard to payer-related outcomes, not many people realise that the tariff for one admission for COPD is £3500. What kind of drugs do we want to use to help bring these costs down by avoiding admissions for COPD? Value-based pricing will turn the screws on the kind of evidence accepted from pharma thus far. If the GP consortium wants to use the most expensive branded drug (Spiriva) for COPD patients they will turn to someone like Omar to evaluate the evidence for them. Omar will look at the RCTs versus placebo and assess whether the outcomes are good from a respiratory point of view (FEV1), and also in terms of hospitalisation, patient quality of life, all cause mortality, and dropout rate. Omar would also ask, based on the evidence, why the drug costs ten times as much as the generic, when it is not ten times better than placebo. Value-based pricing will say use the drug by all means, but not at the price the company is charging. Omar believes this is a serious wake-up call. He agrees with Joe that the Government cannot retreat from what it has started, and as soon as co-payment is opened up, we will never go back to the free service.

Best practice tariffs

Currently even if a CABG goes wrong, the cost to the GP is still the same and there is nothing to account for how well (or badly) it has been done. Best practice tariffs will mean that the bypass costs £10,000 in total but only £7000 of this is for carrying out the procedure. The remainder is only payable if there is no subsequent wound infection, for example, no MRSA within 30 days, and no related readmission for thrombosis or cardiac MI. Best practice tariffs will therefore split activity and outcomes, meaning the GP consortium pays not just for having CABG done, but for having it done well. It also means Trusts will no longer be able to deliver these procedures on the cheap, and if outcomes are shoddy the provider will not earn enough money to continue providing the service.

The challenge for pharmaceutical advisors in today's climate is how to tailor the drug budget to outcomes. For respiratory drugs, for example, locally we have found little correlation between outcome (health utilization, A&E admissions) and which drug is used. How the drug is used is far more important than which drug is used. With regard to the prescribing management pathway, if the expensive branded drugs are not found to be preventing A & E admissions, then what is the point of using them? You might as well use the generics, in Omar's view. Appropriate use of the more expensive drugs can lead to fewer hospitalisations and less morbidity. But some practices are not using the latest drugs and their patients are all in A & E. In the old school of medicines management these practices would be praised for having a cheap drugs budget and making savings. The new model would see that their practice needs updating, by using newer drugs, looking at the relevant NICE guidance. This is where care pathways are crucial, along with nursing and doctor time.

Beyond 2014

Commissioning and outcomes activity will be the way forward beyond 2014. This means that after a while Joe's consortium will get tired of paying people to look after their diabetic patients because they will not have enough budget. He will then commission on outcomes. By paying X amount per patient he will want to see a reduction in amputations by 10%, reduction of hypoglycaemia admissions by 15% and cardiovascular morbidity and mortality reduced by 20% at five years. How this is delivered is up to the provider. It will not be acceptable to have an inflated budget with patients still having amputations. This is where the evidence for drugs comes into play. Without the evidence consortia like Joe's will not take the risk.

As to what to do now (rather than in 2014) managed exit and entry is important. Looking at tafluprost eye drops, the only preservative-free prostaglandin analogue, Omar's PCT spends £1.5 million on 36 different glaucoma eye drops. Of this, £1 million is spent on just 3 of these and the other £0.5 million is spent on the other 34. Managed exit set out that ophthalmologists can use the new preservative-free tafluprost but that they should also switch to generic latanoprost when it comes to the market next year. Doing this now represents a save-to-invest policy. Quality, innovation and prevention (QIPP) cost money – but as we have seen, there is no money. So to achieve the QIPP agenda, the productivity element has to pay for the other three letters of QIPP.

Squaring the circle

Patient choice, patient demand, and what the public purse will pay for is a circle that will never be squared, in Omar's view. Patients expect to get the best drug, whatever the budget. The GP needs to look after the patient, but also needs people like Omar to be able to show how best to spend the budget. Is it better to treat 100 people well with an expensive branded drug but then run out of money, or to treat 1000 people not quite so well so that the money goes further?

Omar has a template for working with GP clusters, which has finally brought outcomes & prescribing patterns together. This is because it contains the commissioning cost-effectiveness data as well as the provider cost-effectiveness data. For example, botox for achalasia is a high-cost drug, which is not reimbursed within the tariff. If the patient has achalasia with oesophageal spasm the surgeon can either undertake a dilation procedure or he can use botox off label, for which there is no PCT funding. But the outcome with botox may be better with less perforation, good symptom control, and of course patients do not have surgical comorbidities. Under the old model botox did not get funded, but in the new model the hospital may pay for the botox themselves because it has a better outcome, and they may then charge a different amount for doing the service. In the new world Omar believes we will look at new ways like this to fund the better outcomes.

To give intravenous iron hospitals currently require the patient attend hospital for three separate infusions, and each time the hospital charges the GP £500. What if a company offers intravenous iron that can be given in just one infusion but it costs more? Sadly the hospital managers would rather give the cheaper drug three times, because it earns more money for the hospital and income generation is important. The loser in this is the patient, but the other potential loser is the novel product. Income generation is the whole tenet of the White Paper. If calling patients in three times for intravenous iron generates £1.5 million why would the hospital choose to use a single infusion that loses them £1 million?

Patient-centred care

In 2008 before the White Paper, the buzzwords were individualised patient budgets, co-payment, and insurance liabilities. Now we will also have packaged care. Instead of complaining how much diabetes care costs, Omar recommends taking a step back and assessing what you want it to cost. So for, say, £375 for the first year of care, you need to factor in QOF and the relevant guidance and see what you can give the patient for that money. This could include 15 minutes with the GP, 15 minutes with the nurse, ongoing follow up, and 25 minutes' healthcare assistance. It will not take account of unscheduled care, but the hope is that less of this will be needed because care is better. The good thing about patient-centred care is that the patient can buy in and out, for example the patient may prefer to spend more time with the nurse and less with the doctor. Also, the care can be added to (via co-payment).

Omar believes that joint working is driving the industry backwards. BUPA, Virgin Healthcare and AXA will be able to offer more. He believes pharma needs to forget the way they are selling and instead enter into a compact. Pharmacists who used to work in the NHS will be working for BUPA and sitting on the formulary committee, advising consortia and providing medicines management services. There will be fragmentation and co-payment, and the language will be completely different. The UK is the last country in the world where you can get off a plane in Gatwick and be treated for free. That will change.

Discussion

Omar stressed that pharmaceutical companies in the UK are still under the influence of global companies and global's key messages. But a six-week study against placebo will no longer suffice. Phase 2 and 3 studies do not currently need to be oriented to outcomes because the FDA do not ask for this, just proof of concept to get the product in the showroom. Omar conceded however that for some companies this is changing.

On the topic of potentially losing income generation, Omar noted that consortia will do two things: first GPs like Joe will go elsewhere if they are not happy with the service they are provided with. That will mean loss of income (800 patients x zero is worse than 800 patients times less money than before); second, very soon consortia like Joe's will be able to call on the services of a specialist neurologist, cardiologist and paediatric specialist to regularly assess the patient, say discharged from Great Ormond Street with cystic fibrosis and on a long list of drugs, and consider what is really needed. So the GP but will have access to specialist advice validate the high-cost treatments and ensure that they are used appropriately.

Omar Ali qualified with a hospital pharmacy background and currently works as a Formulary Advisor to Surrey & Sussex Healthcare NHS Trust. He is an advisor to three Drugs and Therapeutics Committees in the south of England. He is also a senior lecturer at the University of Portsmouth PGDip/MSc Pharmacy programme and an examiner at the University of Surrey. He currently holds a position on NICE on the ERG for Cost Impact Modelling.

 

Held on: 23/11/2010