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