The NHS has always been a complicated machine but, since April this year, it has become something of a Heath Robinson creation.
Major structural reforms abolished the 151 former Primary Care Trusts (PCTs) that made commissioning decisions, replacing them with 211 Clinical Commissioning Groups (CCGs), led by family doctors.
But alongside CCGs sit 23 clinical support units, a somewhat ironic arrangement, as Quintiles’s UK director of market access and innovation, Gareth Williams noted during a recent PMLiVE webinar, given that they are made up of many ex-PCT workers, who advises GPs on how to commission services as they are still novices?
It’s changing the way patients experience the NHS and carving up and creating new patient pathways
“The changes don’t stop there,” he explained. “Clinical senates are also in place to advise on more specialist areas such as cancer and mental health. In charge of them all is the NHS England, which controls specialist commissioning and nearly a third of the overall NHS budget of £109bn, with CCGs taking two-thirds.”
Specifically, Williams says that the NHS England will take on 30 per cent of the budget and will take control of primary care (so that CCGs aren’t in the position of commissioning themselves), acute dentistry, screening and other areas.
CCGs will have 66 per cent of the budget, and take on the majority of acute/hospital services, mental health, community and ambulance services. Around 4 per cent will go to public health boards, which deal with health promotion and public health.
But this is changing the way that patients experience the NHS, and is carving up and creating new patient pathways.
Williams says: “Traditionally I would be ill, go to my GP and they would refer me to a specialist in a hospital. But as the result of private providers coming into NHS systems, you could have five different providers all working on the same care pathway.
“That does one of two things: it dilutes how patients go through the system – so you could be on a formulary in one geographic area but three-quarters of your patients could be going to a different provider and not get access to treatment.
“It also produces potential gaps within healthcare and there is a real need for an integrator role – but I think the NHS has forgotten the need for this. As a result, we have different providers, with different targets, and it almost introduces a perverse incentive for the system not to work.”
A further layer of complexity is then added to the picture by the UK’s health technology assessor NICE, which uses a complicated Quality Life Adjusted Years formula to assess a drug’s cost effectiveness. Finally, there is the spectre of a new drug pricing policy in the guise of value-based pricing (VBP) that is due to come into effect at the start of 2014.
The system is certainly multifaceted, but Williams was optimistic that pharma can understand it.
New NHS stakeholders for pharma
With regards to CCGs, Williams says that they are not payers so much as stakeholders and are focused on what is best for their localities. In many ways bodies such as NICE, whose decisions the NHS in England and Wales is obliged to follow by making recommended drugs available within three months of a ruling, take a back seat to local concerns.
CCGs will need to be convinced that a new drug brings value and is at a cost that can meet their budgetary needs. This is where pharma must up its game to understand local needs and engage with an array of different decision makers across England, he explained.
These groups are also having more of a say in hospital formularies, which list what drugs should be funded in secondary care, Williams said. Drugs here usually constitute the most expensive medicines paid for by the NHS, and pharma must prove its products’ value here too, again focusing on the local aspects of justifying value and cost.
They are having to make tough decisions on what to drop here in order to spend money there
With VBP, though still an unknown quantity for pharma and, perhaps just as worryingly, the Department of Health itself, Janice Haigh, practice leader of market access in Europe at Quintiles, believes the forthcoming changes will not affect fundamental market access needs.
“When payers in England are making savings, they are not putting that into a bank, but rather having to make tough decisions on what to drop here in order to spend money over there,” Haigh told the PMLiVE webinar’s audience. “I don’t think VBP will influence this basic tenant of access.”
For both of the webinar’s speakers, better market access is dependent on hitting three key targets: having the best evidence – including phase III data and real world data; engaging more with payers and understanding who they are; and also getting to the heart of value at a local level.
In fact, looking at real world data Haigh sees the UK as more open to its use when compared to European neighbours like Germany and France, which focus heavily on phase III trial data instead.
Value is key
“Market access continues throughout the lifecycle of a drug,” Williams concluded. “Before marketing approval and sometimes right up until the end of its patent life.
“And to get more patients having more access to your products, you need to demonstrate value throughout the lifecycle, and work with local payers and stakeholders to show value, and how you can help bring savings.”
But what does this mean for pharma? Williams says that a new focus on showing value at a local level is key for the industry when trying to gain better market access for their new products.
CCGs, as they gain more experience, will become better acquainted with their regions and the extent to which their budgets can be stretched – this will lead them to go beyond NICE, Williams says, and do what’s best for their patients.
He also warns that the Innovation Scorecard – which highlights local availability of NICE-approved drugs – is no guarantee of uptake, and phama should be aware that in reality, the Scorecard cannot ensure use. Here, again, knowing and understanding CCGs at their local level is the best way to manoeuvre around this.
Summing up, Williams says that the key to market access is the delivery of a brand’s value proposition in the context of a local need. This can be done by understanding the three main pathways: the patient pathway; the funding pathway; and the decision-making pathway.
“If you understand how the patient flows through the local pathway with all this added complexity, then you also really need to understand how the money flows through the pathway, and finally nail down who are the decision makers and what are their needs,” Williams says.
“By knowing how these all knit together, you can really build up your engagement plan and your value story.”