Diary of a self-confessed NHS budget-holder

by emma 29. September 2011 15:21

diary budget holder

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

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

A good catch

by emma 16. September 2011 15:11

a good catch

Keeping hold of key members of staff has always been an issue for successful organisations. To avoid head-hunters, Anton Franckeiss explains valuable measures to increase employee retention and satisfaction.

Although the pharmaceutical industry is one that consumers tend to depend on to provide instant cures or magical remedies to our all too human frailties, it actually operates to a longer timeframe. Any new treatment for our remedies may take only seconds to swallow, but will have been in development for many years, and possibly even decades. But despite its foundation in long-term projects, the industry also experiences higher than average staff turnover rates – a circumstance that the industry shares with IT and financial services. While the requirement for specialist knowledge and professional skills is a common factor across all three of these sectors that should not be ignored, human resource (HR) professionals within the industry should resist the temptation to believe that there is a single cure that can be prescribed and administered.

Although the analogy may be a simplistic one, especially in the industry context, adopting a holistic view that sees retention rates as one of the vital signs of the ‘patient’ (ie the workforce of each pharmaceutical company) may be helpful. Recent surveys, both by Pharmaceutical Field and by the Chartered Institute of Personnel and Development, have shown a slowing of staff turnover rates in the industry. Yet the reasons may be at least partly a reflection of the broader labour market and economy.

In an era of slow economic growth after a sharp recession, employees are seeing redundancies elsewhere – or even closer to home – and may have drawn the conclusion that the metaphorical frying pan might be a happier place to be for the medium-term than the unknown quantity of the metaphorical fire. There is, however, no room for complacency here. If the factors at play are limiting turnover rather than actively encouraging retention, the ‘condition’ could flare up again at short notice depending on movements in the broader economy: a chronic condition, after all, requires monitoring and management to ensure that any chances of it becoming acute are minimised.

Road to recovery

The analogy of a chronic condition, however, should be challenged. A continuing situation of poor retention does not imply that this either must simply be lived with or will inevitably get worse. There is no reason that the prognosis should be gloomy, although a combination therapy approach will be required and the regime will need to be maintained for some time before improvements in the underlying condition are secured. The key to success lies in the depth of understanding that the doctor – in this case the HR functions of companies in the industries – can acquire about their patient.

Without research, dialogue and communication, companies can too easily assume that they understand the retention factor priorities of their workforce, while the employees actually see the outlook rather differently. A 2006 survey by Talent Drain, for example, showed that employees rank ‘cooperation’ as the second most important factor, while employers listed this in ninth place.

Employers also typically overstate the impact of pay and financial rewards, while underestimating the importance to employees of opportunities for personal growth. What appears as a mission critical role contribution through one end of the telescope looks more like one component of an on-going personal biography from the other. In an industry that embraces great diversity of roles – from sales to scientific specialists – there is likely to be a similar diversity of outlook – the intelligent response is to seek understanding rather than to assume that a single remedy can be applied in all cases. Feedback to HR from line management in different operational areas could be helpful here, so keep lines of dialogue open.

The right prescription

Employee motivation and engagement requires similar treatment; although recent surveys say suggest turnover is reduced, they also suggest what an earlier Pharmaceutical Field article, called The Fear Factor, highlighted. Pro-actively seeking to increase engagement will enhance the chances of turning a cure into a preventative approach. The highly engaged will be less easily tempted away when external economic factors change. Again, an appreciation of potential complexity will be helpful. Scientific staff may be balancing a need to supervise and manage others and commercial encouragement from the organisation to develop their leadership skills with their personal commitment to their professional discipline. Acknowledging such a potential conflict of factors will be a far more productive way of identifying motivational approaches than failing to address it.

There are also industry-specific challenges to address, one of which was highlighted in an interview between the BBC’s Evan Davis and GSK Chief Executive Andrew Witty in the former’s recent book, Made in Britain: “One of the things we say to our scientists is that you have to be comfortable with failure. [There are] great scientists in this company who will never succeed in their entire career … Of 10,000 new molecules that we might synthesise, so that we might create 10,000 possible new drugs, probably one will be a drug.”

Strategies that promote innovation – the use of multi-disciplinary project teams where each can make their own distinct contribution and gain inspiration from other – can help here in other ways. But also allow staff with specialist skills to receive peer, as well as line management, feedback on the value of their contribution. It was a point by Alistair Flaister in a People Management article, Organisational learning: The social network, when he made the important point that: “The real engine of creativity and organisational success is to be found in internal networks of friendship and collaboration.”

Line managers have other contributions to make, not least in listening acutely and in building a supportive and encouraging team culture. It’s a point underlined in the 2010 Work Foundation report, Exceeding Expectations: the principles of outstanding leadership, which identified two elements common to the approaches of outstanding leaders in creating a working environment:

The first is the need to develop an open and supportive atmosphere to create the conditions for trust and respect, and the second is to ensure the workplace enabled success and satisfaction.

Part of the latter element may require support from HR in terms of fresh thinking. Depending on the severity of the case, HR might also ponder the benefits of making a referral to a specialist consultant. Helping specialist staff to make the transition to a leadership role is not simply a progression or promotion through a series of levels of leadership. It requires them to make a fundamental transition from development of a professional discipline to that of a broader organisational and commercial role. It also requires the transfer and application of new behaviours that challenge and enhance their performance and contribution. Two other factors that The Work Foundation found as common to outstanding leaders is a willingness to be flexible in their approach to process, and a willingness to adapt roles to give individuals the maximum opportunity to achieve personal growth and job satisfaction. An organisational willingness to be similarly flexible in role definition and organisational design can support good leaders within the company to deploy this approach successfully.

Never say no

Think of a talented individual that the company should seek to retain, and then imagine how they might feel if they heard the words “I’d love to be more flexible, but I’ve spoken to HR and they said …” It’s also helpful to remain mindful that disengagement is unlikely to be a proactive personal choice – employees are more likely to become disengaged as a reaction.

Ultimately, employee retention is not so much a condition as a symptom. An indicator that employee engagement is low, that opportunities to satisfy personal motivations are too limited, that opportunities for progression are overly limited or unclear, or that employees are not receiving positive feedback on their performance and/or contribution when praise is due. The answer is not to treat the isolated symptom, but to investigate the underlying condition and develop a comprehensive talent management strategy that will systematically improve organisational health. Even in an industry where specialist skills are a key requirement in many roles, an employee value proposition and a recruitment strategy that identifies employees with a strong cultural fit are still important requirements. Any industry dependent on innovation and intellectual property should appreciate that human resources are its critical input. And most employees – who will, after all, have chosen to make an application to join the organisation and done so in good faith – are ultimately looking for something relatively straightforward: regular reminders of several good reasons to stay. That, of course, is easy to say, but there’s something positive to be said for making it easy to do.

Anton Franckeiss is the Managing Director of ASK Europe.

Executive Committee complete at Ipsen

by emma 31. August 2011 13:42

Pf industry news

Ipsen has filled all the positions in the Group’s Executive Committee after making two new appointments.

Nathalie Joannes has been appointed Executive Vice President, General Counsel, and Susheel Surpal has joined as Executive Vice President, Chief Financial Officer.

Mr Surpal had been a member of the Executive Committee and Financial Director of LABCO since 2009 and will commence his new role in the coming weeks. Nathalie Joannes joins from Genzyme where she served as Senior Vice President and Chief European Counsel for the past three years. She will begin her role on 1st October 2011.

The company has also entered into a strategic partnership agreement with Inspiration Biopharmaceuticals to launch Inspiration’s haemophilia product portfolio in Europe.

Inspiration aims to file a Marketing Authorisation Application with the EMA for its intravenous recombinant factor IX, IB1001, for the treatment and prevention of bleeding in individuals with haemophilia B by the end of this year.

Diary of a self-confessed NHS budget-holder

by emma 31. August 2011 11:17

diary budget holder

Pharma’s Account Management model is built on the principle that frontline professionals develop and deliver brand value propositions that align with the key priorities of key customers. But in a changing market where new customers are emerging, how well do you understand those priorities? Omar Ali pens Part I of a typical day in the life of a Formulary Pharmacist.

Despite consumers’ apparent lust for TV medical dramas and gruesome surgical documentaries, it’s unlikely that the viewing public would find a biopic centring on the work of a Formulary Pharmacist particularly enticing. But, for an audience of pharmaceutical sales professionals charged with understanding its customer-base, gaining an insight into the breadth and depth – and far-reaching implications – of a typical week in the life of NHS prescribing advisers, medicines management and formulary pharmacists should provide much food for thought.

Pharma appears desperate to establish the ‘key priorities’ of its many customers. This article, based on typical encounters with medical sales professionals, is a genuine attempt to outline mine.

A MONDAY MORNING, SOMEWHERE IN SURREY
8.10am: GI CONSULTANT / IBD.
(Discussion in the corridor)
Arrived at my NHS base camp. Stopped in the corridor by one of the GI Consultants who wants to set up a GPC/CCG commissioning group on GI Inflammatory Disease with one of the local Consortia - we ran one with Rheumatology framed around an osteoporosis brand. We put a date in the diary to discuss. I will be coordinating an IBD lunch event to facilitate joined-up working. Bringing in the GPCs is easy - I can text most of the GPs on the Commissioning Board of our local clusters, such is the relationship required for joined-up thinking. He’s very committed to his cause – and has very recently impressed significant knowledge and application of commissioning processes involved. Needless to say, many of his choice agents are either off-license or difficult to source from community pharmacies. He also has a whole stack of biologics he’s keen to use – but without some PCT discussions (and now outreaching to GPCs) he won’t get very far.

Thoughts for pharma

GI/IBD has become very noisy and in certain areas very controversial. Biologics are testing the very essence of ‘affordability’ in the NHS. We also know that by using them correctly, we can prevent signi­cant morbidity – surgery/admissions/etc. However, joined-up thinking doesn’t occur by magic – and you have a signifi­cant role in making this happen. When we coordinate this GPC/Hospital IBD lunch event, I am certain I will be discussing with various stakeholders, including pharma. NICE in principle supports a number of products but there are complexities. For example, bringing patients in for an IV infusion will generate income for the Trust – which funds a nurse who provides additional services. Patients treated at home may be a preferred option – there is no VAT. Home healthcare is not without its headaches around delivery, months’ supply ordered and administrative burden.

I am still disappointed at the level of pharma support I have seen here. There is far more that can be done to bring a clinical context into a financial framework. I call this the ‘Mortgage Principle’ – translating falling in love with a house into a financial framework with a defined loan: value and %APR with monthly repayments – see previous Matrix Revolutions. There seems to be a vast gap in understanding NHS processes – not just from pharma, but also from consultants – so improved process mapping from chronic disease to A&E through to post-discharge is essential. It also brings out the ‘true-cost’ of the disease in IBD – not just the ‘drug’s cost’. If our consultant doesn’t move ahead and advance his prescribing base, he will end up referring more patients to tertiary centres (which will only increase PCT costs) – so it’s important to put things into context here. Process Map the patient and the money will follow. If this is not tackled by pharma, I foresee the future of managed care entering here very neatly. Looking after the whole pathway and pushing pharma out to bystanders – look at companies like IHP, United Healthcare & Medco, it’s happening.

8.40am: Pharmacy Base.
(Discussion with the boss)
Arrived to my desk – finally. This time it’s the Chief waiting with an IFR/one-off-request that needs sorting. It’s the usual story: this time it’s a urology product that a GP is refusing to prescribe. We are having to push through the IFR/one-off-request – and also liaise with the GP for a medium-term solution (the patient is travelling significant distances to obtain this). This means some research, PCT discussions, GP emails and a phone call to the patient. I will also try and perch on the urology consultant’s shoulders (he runs a clinic this afternoon) and coordinate future D&T processes. Most of all, we need to ensure that the patient is central to this whole system – which is easier said than done. It’s good timing though – I have been in discussions with urology, working through the top-ten spend on the drug list to see where we have efficiency savings (something which is occurring across the whole trust in conjunction with PCTs & GPCs). This product initially came up as ‘not-on-the-radar’ but clearly needs some attention. I have our medicines information pharmacist conducting background research – I have emailed the specialist commissioning pharmacist at the PCT and CCd the prescribing adviser who has just evaluated a recent APC paper on overactive bladder prescribing (which we are discussing at our next D&T).

Thoughts for pharma

Urology is big on the radar. Many prescribing items are specialist, while there are significant prescribing efficiency savings aimed at ‘overactive bladder’ and linked into a more encompassing discussion with endocrinologists, and the ongoing story behind testosterone. I am sure I am sitting on a business card of a testosterone brand, but which company it was I cannot recall. Thumbing through my cards – the stack waiting for a call back is big – I can’t really see through the thick fog of various companies/pharma/sub-companies/take-overs. Note to self: request all staff to ensure reps write their brands on their business cards when they call at the pharmacy. Key priorities around urology that are high on the radar across primary/secondary care are as follows:

  • Urinary retention/BPH
    Is it just me or has Combodart lost its way? I remember some very exciting joined up thinking on preventing unnecessary referrals and bringing consultants out to primary care. Given urology consultants admit themselves that DREs to exclude prostate Ca is not easy, liability and governance for getting GPs to this was always heading into a cul-de-sac. I think there is a ‘new campaign’, though I’m not sure what it is. We have both finasteride and dutasteride on our joint formulary – but I’m not seeing the right financial framework on the ground. I can see NHS PCOs moving backwards, lifting finasteride back on the pedestal and not even considering the Combodart story. If there is a value proposition around this brand someone better get this moving within commissioning circles fast. To add to this, tamsulosin’s patent expiry further hastens the need for the value story here. If the last D&T rejection we had is anything to go by this is either off the radar or must be a third drop-down detail on someone’s bonus scheme.
  • Urinary incontinence
    We have NICE, LUTS and SMC. HTA is all important. Most of pharma focuses on product differentiation. They need to, NICE is an open forum for prescribing. But I don’t see a commissioning story or a decent value proposition for payers. Please don’t state you want to run me through a cost model – that is not a ‘value proposition’. I have yet to see a company come to me and talk about QIPP. Where are you guys? Please don’t moan at the NHS for using generic oxybuytnin first-line – we get the opposition, what we don’t get is a Payer ‘QIPP Value Proposition’ around your brand. Too much n=1 for my liking. The only brand working the NHS has to some extent are the solifenacin crowd – they certainly have significant clinician/KOL buy-in if the Payers are left somewhat ‘wanting’. I’m unsure where exactly duloxetine & fesoteradine are heading, or what their value story is – despite SMC approval. Maybe it’s just me.
  • Bladder instillation
    This is hotting up big time. Why? Because there are costs to both primary and secondary care – and furthermore, despite numerous products – some without a license – for conditions such as interstitial cystitis there is significant unmet need on cure rates, relapse rates and hospitalisations. Someone, somewhere will win big when they map out to us what already suspect – hospitalisation costs here are huge, and process mapping will show how these are sectored into various health economies. At the moment, everyone is walking and talking product – bag of saline/infuse like this/lovely twisty connector/etc. Just waiting for someone like United or Medco to come and show us the path to the land of milk and honey. It appears no-one else will.
  • Testosterone
    It’s back! The story has become interesting all over again, and all credit to pharma. The link with diabetes is moving this higher and higher up the agenda. It is fraught with issues. Everything from best mode of delivery to patient/compliance and desired effect, through to overlap with specialties – is this endocrine or urology or both, same pathway or different pathway? The pharmaceutical arguments in testosterone are worthy but having no coat hanger to hang your outcomes on makes for difficulty in pulling out the cheque book. There is a ‘gap-effect’ in situ – from academic niceties to clinical practice. I’m not sure the pull is there yet – and again, I return to my translation into a financial argument. Furthermore, there are cost savings and efficiencies to be had and this is where a product-matrix weighted with Payer Related Priorities would assist a brand in its Payer Value Proposition – if it indeed cares to invest in one.

It goes a bit like this:

1. What’s important to payers with a view to testosterone replacement?
2. Rank this list in a weighted manner so that they all add up to 100% (ie they may say evidence w%, compliance x%, safety y%, cost z% – w+x+y+z must all add up to 100%
3. Now you have your weighting, get the payers to allocate the numbers for each of the testosterone brands
4. Now you have not just who is the winner, but also how and why
5. So if, for instance, compliance is 25% weighting of the whole game, then if you spend 80% of your time talking about compliance, this may not be effecting your exposure time with payers to maximum benefit –remember the clinicians will have a different matrix. You may have the best compliance story – well done, that’s 25/25 but you will never score higher than this. There is another 75 points in this exam that you haven’t answered yet. You need to find out ‘what is the % weight that formulary/prescribing advisers give to the ‘testosterone story’ – once you have this value, you know how important it is.

9.30am: Meeting with Obs & Gynae Consultant / re: Formulary Application
This should be quick. We’ve recently put on some pessaries to our formulary. Obs and gynae want to use them in difficult/pre-specified labour/delivery situations. Now the company has whipped over a freezer to their unit. Yes, they are stored in the freezer, and no, before you ask, I don’t know whether we defrost before use or just pop them into our patients freezing cold. Have had a discussion about this with my wife over dinner, she is also a pharmacist – not a good move. Anyway, I’ve been firm but clear. The pharmacy doesn’t have a freezer, we need to discuss with the company about a freezer. There will be no prescribing of this new product within the Trust until we resolve the ‘freezer’ issue. All credit to the company, supportive they are, quick to respond they have been and, as I write, and you read, one of my staff is coordinating logistics around this. This is a classic example of simple supportive strategy. I looked back at the minutes of our D&T Form and smiled to myself… “accepted onto formulary, pending freezer.”

omarali Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Healthcare NHS Trust & sits on the External Reference Group for Cost Impact Modelling for NICE. He may be reached on omar.ali@sash.nhs.uk

Lost in Translation

by emma 28. July 2011 16:59

omar_small

The frustrations that pharma – and clinicians – face when trying to secure a drug on formulary have been well documented. But Omar Ali (pictured) explains that understanding the Payer’s ‘language’ can greatly increase the chances of success.

The NHS changes over the last decade have shifted power away from secondary care to varying degrees in different specialties. These new NHS changes are further exaggerating this. Pharma has a significant role in facilitating consultants in keeping in step with these changes, supporting them through the brave new world, and ensuring that they learn a second language – the language of the Payer.

A very good friend of mine – she is a Consultant Cardiologist – said to me not so long ago: “Omar, I don’t see why I have to justify my prescribing to you. This is the drug I want, just give it to me.” This was a delicate discussion. I needed to handle myself carefully but be firm to the point. There were also two pharma representatives at the table. Basically my reply went something like this: “Dear Dr, regardless of what you feel about justifying your prescribing decisions to me, this is the process, this is the financial framework for the managed entry of new drugs into the health economy – so get with the programme.” I also added that I could help her if she’s interested in how to best go about this. Within the next
three months I was indeed requested to present at a mandatory briefing for all consultants within the Trust on the current financial position and the future of our organisation with the new financial framework for commissioning new products onto formulary – my presentation was sandwiched in between our CEO and the Department of Finance!

So what can pharma do to assist my Consultant Cardiologist colleague to better ‘frame’ her positional argument to me? There are five key factors to consider:

1. Understand the Health Bill and commissioning: secondary care is somewhat hidden from much of these changes. Pharma needs to pull these influential clinicians out of their comfort zones and brief them on the changing NHS.

2. Understanding the Drug and Therapeutic (D&T) processes/ APC Formularies: many clinicians are frustrated with the system, do not understand and speak the ‘Payer language’ and so disengage from the process as a result. Pharma needs to bring them back to the table and empower them in a new way.

3. How to get a drug ‘through the D&T’: – it’s a simple workshop and a skill that can be learned with clinical and geo-political factors brought in. Use your brand as a ‘case example’, but the principles are the same. Many consultants will echo the discussion I had
with my consultant – frustration at the barriers to access, pointing accusingly at cost savings, and not prepared for the Payer’s rigorous Q&A. In a way, these KOLs need to be briefed in a secure environment as to what they may face when in front of the firing line
of the PCT/D&T Committee.

4. What makes a good D&T Application: streams of new drugs fail at the first hurdle. Quality of submissions are often poor and do not resonate with the Payer’s audience. They still resound of “I’m professor of cardiology, if I bang my fist on the table I will get my drug funded”. You have a role, duty and responsibility in assisting one of your most valuable
support mechanisms. Without KOL support the Payer’s influence is actually irrelevant.

5. Understand the difference between ‘being on formulary’ and ‘commissioning a new drug
into a pathway’: most consultants don’t fully understand how their own activity is reimbursed; issues around expensive drugs, tariffs for admissions/outpatients – and related trim-points – and implications of red/amber/green prescribing guidance. The subsequent generation of a shared care guidance is critical for your brand. Without this will mean a lack of prescribing which results in a reduction of sales.

We currently have at least eight new brands which have passed D&T application, have passed PCT APC, and are on formulary; but do NOT have a shared care guidance in place. This means they are in ‘limbo’. They are in ‘hyper-space’. A consultant simply won’t be able to prescribe it. The GP won’t be able to continue. This is about joint working, bringing
stakeholders around the table, bringing examples of best practice from around the country, and bringing your agenda so that it becomes higher on my own.

The KOL ‘demand’ factor

It’s one thing for a Payer having to deal with a well prepared consultant who understands the financial process and has made a convincing positional QIPP framework for your brand. It’s quite another when the KOL has not even turned up and has disengaged from the application and support process. That speaks volumes to the Payer. Please don’t confuse ‘KOL demand’ for a treatment option with a ‘KOL demanding a brand’.

Payers look for and make a judgement on ‘KOL demand’ for a product. It is critical when deciding on an initial interest level. Remember that Payers are often ‘fighting off’ consultants from various disciplines and specialties wanting new products. The silence from KOLs with reference to your brand can be deafening in what it spells out: “this product holds no value to us”. Make sure they are knocking on my door with ‘demand’. Now once we have engaged, what I don’t want is your KOL simply ‘demanding the product’. What I want now is a financial QIPP framework focusing on how we redesign our services around a new intervention, in both clinical and commissioning terms.

What disappoints me is that the majority of D&T support to consultant KOLs I see today from pharma falls under two main themes:

1. Pharma translates ‘the need for evidence’ into dumping ream after ream of largely irrelevant clinical papers onto the desk of the consultant – which further makes them want to disengage.

2. Pharma translates ‘the need for a better quality application’ into taking the D&T form
and having their medical departments complete them on the behalf of the consultant.
Trust me, when these come to D&T you can see them a mile away!

Given pharma is always touting joint working why don’t you work together on this issue? Coordinate your timetable of formulary applications, enrol your KOLs into a D&T workshop where they receive some skills set training and ‘mock D&T’, and empower them in the ways of the new NHS. And have your executive teams keep them abreast of local payer
influencers and mechanisms with underlying framework for prescribing pathways.

Falling in love

Some of you will know I’m currently in the process of moving house. We have just gone in to the market and indeed have fallen in love with a house in Guildford. Now here’s the thing. We fell in love with the house when we first saw it and this continued throughout
our viewing. We have pictured it becoming our home, almost living out the years. The garden is perfect, the rooms all fit with what we want and, although it’s not quite the ‘moon’, it sure as hell is a good way towards it.

Now, to get into the house – our new home – we need to go and see the bank. It wasn’t a great first meeting, I can tell you. All of a sudden we found ourselves wrestling with APRs,
2yr/3yr/5yr fixed plans, repayment versus interest only, deposit amounts, indicative financial re-payments and limitations on loan to value thresholds that have unsettled us somewhat. We came out of that meeting a little dizzy, somewhat dejected and unsure now of what and where we want to go. We still don’t relish the idea of going back. We won’t say it out loud, but we are slowly losing this house.

The discussion at the bank was a far cry from the romantic notion of what was to be our home. The bank was not really interested in the lovely garden, wonderful residential location and how we could see our children growing up in the various rooms within the property. No, it seems the meeting with the bank revolved around a very different language. It was a financial framework. It was a requirement we have to prepare for adequately to get us into our next home. I now know we could have been better prepared
and that poor preparation may have cost us our ‘moon’. I learned that I had to get with the programme, regardless of my views of bankers’ bonuses, financial hurdles and an annoyance at justifying our income/expenses to a third party.

There is no way I will get into my dream home without getting to grips with the financial framework that is required to proceed the dream into reality. Many of your KOL consultants have already done the first part. They see the USP of your product, the
clinical need is palpable, they have patients waiting to reap the benefits of your drug. In essence they’ve fallen in love with the brand. But here’s the thing, are they prepared for meeting with the bank? Are they prepared to entangle with the financial framework
to get them their gold standard product? Or are they in danger of losing their dream home because they have not got with the financial framework?

Think about it.

Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Health 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.

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