In Part III of his diary, Omar Ali discusses the significance of process mapping and the wide reaching influence of health technology assessments and regulatory bodies.

1.10pm: GP CONSORTIA/CCG – RESPIRATORY ASTHMA PROCESS MAPPING & FORMULARY

I’m trying to step into the main meeting room but one of the CCG/GPs pulls me aside. It’s a mixture of a low-key signal and a discreet ‘thumbing’ to pull away from the group. He wants a quiet word and it’s clear that there are some key issues, agendas and directions that are on the table for this asthma meeting.

The process mapping event takes some four hours – evaluating everything and anything that ‘leads to an asthma admission’, followed by everything and anything that occurs after the admission and leads to discharge – which is then followed by QIPP ‘bottlenecks’, where re-admissions and inefficiencies occur.

It’s always a challenge having so many viewpoints – nurses, physicians, pharmacists, budget holders, and of course patients and carers who often change the whole paradigm when we hear about their experience, expectations and concerns around ‘choice’.

Thoughts for pharma

Respiratory is big. Whether on prescribing budgets, healthcare priorities, implementation of national guidance or QIPP streamlines. Companies haven’t yet got their act together on process mapping of care pathways, but it’s the only way to invest in prescribing up-front drugs for potential ‘return to the QIPP baseline’ over the next three to five years. Needless to say, whilst the NHS talks QIPP, pharma is getting used to it and patients are still puzzled by it.

Asthma

With so much behind National Guidance/BTS, QoF and commissioning cycles, some companies are indeed getting into the mix with Clinical Commissioning Groups and supporting process mapping. That support is vital, as not only does it bring pharma in as key stakeholders, but more importantly there is a level playing field here in the same room bringing the cause back on track.

So often in the NHS we have silo budgets chasing after silo savings. Process mapping brings us out of our silos into the bigger picture and into the ‘process map’. Seeing it happen is a wonderful thing.

COPD

Given we make such a fuss around the cost of drugs, in truth we know two things: the most expensive drug is the one that is not being taken, and the tariff for an admission for COPD at £3,400 is more expensive than the annual price of the most expensive inhaler!

So where’s the issue? It goes like this. Pharmaceutical companies come to us quoting the costs of admissions in COPD then tell us how amazing it would be to reduce these hospitalisations.

They then tell us how amazing their COPD product is and tell us that we would be crazy to not buy their inhaler, which is a fraction of the cost of COPD burden/admissions. The GPs, nurses and patients love it and want it and state they ‘need it’. Medicines Management then look like the bad guys for not funding the said branded inhaler.

4.15pm: DRIVING BACK TO NHS BASE CAMP – CHECKING VOICEMAILS

One of the big five companies has asked me to come and present to their European heads-of-country on ‘payer issues’ in the UK and the influence of HTAs.

It’s a bit short notice and I gather the VP for Europe, Middle-East and Asia will be there. Times are tough and I see this as an example of how the EU can join forces on some of the key payer issues beginning to filter through.

I have one question back to these pharma companies. What is your data on reducing these expensive hospitalisations in COPD? Because in truth, with the data, I buy the story.

In most cases pharma will then spin another story around how compliance is great, or a patient support programme is excellent. But given all the spin that has come on how much COPD costs me in hospitalisations, it’s a shame many of the companies don’t have the evidence to help me.

They have marketing but not the evidence. Show me the money. And the formulary will be yours.

Thoughts for pharma

There is no doubt that the UK is ‘different’, but I don’t imagine global HQ for any of the pharmaceutical companies readily accepting that – especially when the targets are high and sales may not be so. It sometimes takes global agencies to hear about payer issues ‘from the horse’s mouth’.

This was the quote stated to me regarding this piece of work/event. From my work abroad – at NICE I informally interact with a number of contacts in other countries who belong to their residing equivalents – I can’t stress enough the importance of NICE, the SMC and similar bodies.

The last SMC decision on pain management was quoted verbatim within two weeks by three different countries within the EU. I’m also aware from my US/value-based pricing work that when NICE rules on a drug the impact on the US healthcare system is far reaching.

Insurance companies download the information – they can’t believe NICE do all this work transparently and then leave it freely available for anyone to download – and the US agencies then use this information on deciding what percentage they will ask patients to pay.

So, if NICE say no and SMC say no, somewhere a butterfly flaps its wings and then a patient in the US, who has paid extra funds into a private insurance policy, will be told that this particular brand is not covered and that the patient will have to make an additional payment if they want the drug.

To be continued...

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

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

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.”

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