IMS Health UK Market Access Summit 2015
And with that Angela McFarlane brings things to a close with a brief summary and some recommendations – increased transparency of process and mandates of roles for the NHS, for the industry read the Carter Review and when it comes to Greater Manchester devolution, let’s please make sure we learn from the past.
That’s it for the live coverage form the IMS Health UK Market Access Summit – thanks to IMS Health and all the speakers for a great session.
Some interesting areas for McLellan in terms of the industry helping the NHS achieve efficiency gain: biosimilars and outcomes-based pricing.
McLellan: many CCGs now also projecting a deficit, in large part due to specialised commissioning, so cannot raid these pots of money to support the acute sector. There is no additional funding within the system this year after the £1.8bn injection so the focus is very much on efficiency in 2015. He recommends reading the Carter Review, which is laying down how this is going to happen, and he recommends reading it NOW. It will directly or indirectly influence how the NHS will spend its money, plus also goes into some detail on the Sunshine Act and how it could be deployed in the UK. The task for the pharma industry is to show it can help the NHS in tackling this efficiency challenge.
McLellan: by the start of the next financial year CCGs are going to be rated and if they are not performing their powers will be shifted away. Some CCGs are willing this change to divest areas, but others will have it forced upon them due to underperformance. It is important to remember that CCGs are small organisations – around 30 people – doing things on shoestring budgets, which impacts what they can do and how to engage with them. In secondary care, many of the major centres are in deficit, particularly the teaching hospitals that are now seeing a real squeeze.
McLellan says that, despite the apparent complexity in the system, it could have been a LOT more complex with a different election result, due to a majority government that is backing an existing plan.
Finally, Alastair McLellan, from the HSJ, takes to the stand to wrap things up.
Palmer clarifies, in response to some confusion, that a clinically urgent treatment decision falls within the in-year service plan, so that a physician can get a decision within a few weeks rather than waiting for later in the year.
Ranking decisions unlikely to happen until December, Palmer explains, as 3 month consultation on methodology unlikely to start until August.
Palmer: sees more opportunities for collaboration with the industry on specialised commissioning in the same way that pharma is already ‘doing some of the work’ for NICE, especially for interventions that are genuinely novel and can move disease management forward significantly.
Audience question: who determines what falls under specialised commissioning? Palmer: definition of specialised commissioning is that anything not defined as being in it is, by default, out of it. That can be changed / adjusted but by the Department of Health, so conversations need to start early about the prescriber list if companies have a rare disease drug coming through that does not fall under specialised commissioning.
Comment from Palmer in response to questions: the reality of health economics is that the threshold for getting onto the market will drop over time as volume need rises quicker than budgets. A pretty blunt truth for the pharma industry to hear.
Palmer concludes: as more and more decisions go through specialised commissioning the industry will understand what the criteria are for success and this will have to shape what it brings to the UK market.
Palmer outlines how a common reason for exclusion is where a drug has already been through NICE – they won’t say yes if NICE has said no!
Palmer: The response to the consultation has just been published and further work will now be conducted over the Summer to develop the process for 2016-2017 and beyond. The new process follows five key stages:
- Phase I environmental scanning (new)
- Phase II planning
- Phase III clinical build
- Phase IV impact & consultation
- Phase V governance
He elaborates that at some point soon, the only way to inform of new medical interventions will be through PharmaScan.
The commissioners job is a tricky one, explains Palmer, having to prioritise and rank different interventions in different areas and determin where to spend money, but within the budget. However, he accepts criticism around perhaps insufficient focus on areas like rare diseases, which led to a review on transparency of the ranking scorecard and a new set of principles to be adopted for 2015-2016. A key issue as part of that has been addressing ‘timeliness’ for pharmaceutical manufacturers – knowing when to engage, when to submit, when to expect a decision on access.
A call for collaboration from Palmer: we will be inviting interested manufacturers to contribute to the expansion of the ‘Commissioning through Evaluation’ programme – from the people in this room.
Palmer says six core areas have been priority historically for intervention to manage spiralling costs:
- Publishing data on variations
- Reducing provider incentives (where inappropriate)
- Control the deployment of new interventions (only used where deliver value)
- Increase the broader focus on healthcare value
- Reshape supply
- Reduce avoidable spend in specialised care
Moving forwards, he sees a need to increase the ability for local commissioners to shape their own investments, accelerate design and implementation of new models of care, deliver specialised care in consolidated centres of excellence (shown to improve quality).
Palmer: Budget overspend triggered a review of actual growth rates, which revealed a £5bn gap in funding for specialised services due to 7.2% annual growth rate, far higher than investment growth. This is partially triggered by things which could be dealt with outside specialised services, e.g. chemotherapy, but 50% of overall growth is pinned down to six key areas:
- Mental health
- Renal dialysis
- Neonatal intensive care
It highlights how just publishing data to understand what is driving spend, and understanding variations in delivery of these areas, is key to tackling overspend / budget gap.
Palmer tells us that the only way to get from managing today (firefighting) to managing the future is to selectively forget some of the things we have done in the past. This is particularly true for commissioners as they have to be on top of so many different processes, including service specifications, commissioning policy and clinical reference groups.
Back from a short comfort break here in Euston Square and James Palmer, Clinical Director of Specialised Commissioning, NHS England, takes to the podium. Angela McFarlane introduces him and reminds us that he is still a practicing neurosurgeon two days a week!
In responding to questions, Wootton clarifies that currently 95% of patient services for Greater Manchester are delivered within the region, which probably makes it well-suited for devolution, even in specialised conditions.
Wootton sees enormous potential from the power of data – mobile technologies to remotely monitor patient health and feedback to health systems, identifying problems before patients or doctors are even aware of them – and reducing / managing costs for patients. His closing point – it’s ‘Greater Manchester Devolution’ not ‘DEVO-MANC’….please!
Wootton sees numeours benefits to Greater Manchester devolution, including more flexibility to local needs, with priorities including:
- Seven day access to primary care
- Public health programmes
- Linking Academic health Science Systems (AHSS)
- The Healthier Together decision
- A demential pilot
- Mental health and work initiatives
- Workforce policy alignment
When it comes to medicines, Greater Manchester is already somewhat unique, in that is has operated the Greater Manchester Medicines Management Group for many years, but there is now a request to make this a Policy Unit (possibly Clinical Standards Unit) and build closer relations with NICE. This will still be in line with national policies and standards.
Simon Wootton, from North Manchester CCG, illustrates some of the things on his mind at the IMS Health UK Market Access Summit.
Wootton says the context for Greater Manchester devolution is to unlock efficiencies from the local NHS bodies working more closely together. The plans are built on a long history of collaboration across the Greater Manchester region, stemming back over 30 years, with the ultimate aim being to take control of an estimated budget of £6bn each year from 2016. But…..this is not additional / new funding, it is redeploying and grouping together existing funds in place.
Wootton sees a number of important issues in Greater Manchester (and beyond), including technology / data, lifestyle, funding, whistle-blowing and enormous variations in care across different centres. These challenges are particularly acute in Greater Manchester, where health outcomes are poor and lag behind the rest of the country and a projected £1.2bn funding gap exists between what is required and what is available. This is a problem that cannot be tackled by taking on small, isolated areas.
Now over to Simon Wootton, Chief Operating Officer at the North Manchester CCG. Expect to hear more about the devolution in Manchester, sometimes called DEVO-MANC but a term that Wootton clarifies is wrong, because it is Greater Manchester!
Another question on capacity: are we resourcing sufficiently to support more than three HSTs a year in view of 24% CAGR in specialty products? Godfrey believes the resource is there to support this, but the real question is whether HST is the right process for each product, then resource can be allocated as appropriate.
A challenge from the floor on the time it takes to conduct assessment and deliver market access, e.g. is 27 weeks the best we can do? Godfrey responds by saying that there are ways to do this quicker and a key one is to start the dialogue earlier – for companies to start at least informal dialogue at a much earlier stage, which would help.
Godfrey is also involved in looking at the DoH Accelerated Access Review, MHRA’s Early Access to Medicines and the EMA’s initiatives in Adaptive Licensing, so keeping appraised of novel developments and potential impact on HST.
The ‘infamous’ para 41 is raised – the new techology must still deliver value. Now, an example, looking at eculizumab (Soliris) for atypical Haemolytic Uraemic Syndrome (aHUS), where specific conditions had to be met for funding, such as expert centre coordination and ongoing monitoring, plus a collaborative view on helping to reduce the cost in future. Godfrey’s key takeaways from this are that the earlier discussions can be had with NICE the better (and informal discussions can start very early), understanding what evidence is required (distinct to that for the regulators). Ultimately, developing and delivering HST has been a challenge for those working within it, so dialogue is useful on all sides, she concludes. In line with this there is engagement between NICE and many other bodies, e.g. Rare Disease Advisory Group, Cancer Drugs Fund and Commissioning Through Evaluation.
Josie Godfrey: Helping rare disease patients keeps me awake at night.
Godfrey outlines prioritisation criteria for the NICE Highly Specialised Technology programme, which include definition and geographic spread of the target patient group, level of unmet need, the extent to which a new technology will be used in a highly specialised service and duration of use (lifelong?). The process is then very similar to the HTA process, but there is a lot more proactive work to encourage submissions from not just the industry but also other organisations and patients, as information is so scarce. In assessing, the impact of the technology beyond direct health benefits, but it must still prove to be ‘value for money’.
Josie Godfrey now takes to the stand, to share her views from working within NICE and starts by answering the question over what keeps her awake at night – helping rare disease patients.
McFarlane outlines the key issues she sees as impacting future market access in the UK:
- NHS Five Year Forward View implementation as an overarching theme
- Integrated Health and Social Care Accelerated across England
- Access through NHS England
- Cancer Drugs Fund – where now, commissioning through evaluation?
- Accelerated Access Review
- Provider Deficit (which is “only going to get worse”)
She states that “market access is everyone’s business” – the industry must collaborate internally and externally, plus start early.
McFarlane outlines a case study on sofosbuvir (better known as Sovaldi, for Hepatitis C) as ‘a meeting of minds’, despite parties coming from different views. Patient organisations expressed frustration at delayed entry, but the NHS defended its stance on having to stagger investment to afford it and it is seen as a good example now of where a high-priced drug can still secure access….provided it delivers genuinely ground-breaking shift in patient outcomes.
A history of the market access environment in the UK shows just how much change has taken place in the last 15-20 years. Increased cost constraints / use of generics in primary care has pushed innovation towards specialty markets where there is higher perceived unmet need, but in real terms spending is now dropping so there are real challenges in access to new medicines. The real challenge is trying to balance the needs of different stakeholders – the patients, the NHS and the pharmaceutical industry.
As a preview of what’s to come we’ll also be hearing today from:
- Josie Godfrey, Associate Director, Highly Specialised Technologies, NICE
- Simon Wootton, Chief Operating Officer, North Manchester Clinical Commissioning Group
- James Palmer, Clinical Director Specialised Commissioning, NHS England
- Alastair McLellan, Editor, The Health Service Journal
McFarlane: The UK is a pioneer in the systematic application of real-world evidence due to early adoption of the HTA process, but are payors aware of the scale of the shift to specialty medicines – 94% share of absolute growth over 2013-2018 to come from the specialty sector. Is NICE ready? That said, NCE share of total Rx is moving in the right direction – possibly driven by the Cancer Drugs Fund but perhaps we are getting better at delivering access in this space.
Angela McFarlane opening the IMS Health Market Access Summit.
McFarlane clarifies that while the word ‘Summit’ may seem grandiose, this is about drawing upon the passion and expertise of those in the room to develop specific commitments and recommendations. She invites honest and challenging questions from the audience in line with this. The key issues for her are:
- Protracted access to medicines in the UK
- Constantly changing ‘rules of the game’
- NHS financial challenges
Looks like we have our work cut out sorting those out today!
Angela McFarlane, Senior Principal for IMS Health Local Market Access takes to the stand to kick things off at the inaugural Market Access Summit. “We want to make this the first of many annual summits”, McFarlane explains and invites the attendees for ideas.
Good afternoon. This is Paul Tunnah from pharmaphorum, all set and ready to go at the Royal College of Physicians for the IMS Health UK Market Access Summit. I’ll be providing live coverage for the next few hours of the key issues raised and you can also follow along on Twitter using the hashtag #IMSMASummit
IMS Health Hosts the June 29 UK Market Access Summit 2015
29 Jun 2015
16.00 – 19.30
Event Location: Royal College of General Practitioners, London
IMS Health hosts an industry summit during this year’s UK Market Access event June 29 at the Royal College of General Practitioners in London.
For more information and to register, visit the website.