What are the implications of the silo fund on market access?

It was very interesting to see last week that NHS England enacted an £18.7 million funding stream to expedite market access for a single medicine – Gilead’s new Hep C drug Sovaldi (sofosbuvir) in combination with the antiviral ledipasvir. The silo fund was originally approved in April and is now ‘open for business’. The recommendation of the body’s Clinical Priorities Advisory Group (CPAG) means that whilst the drug goes through the NICE process, Sovaldi will be funded for those hep C patients at significant risk of mortality – or who require liver transplantation.’

Consequently many patients with acute liver failure or awaiting transplants can gain early access to Sovaldi whereas previously they would have had to have waited for NICE approval. This is the second time the NHS has intervened to fund a particular disease – following the Cancer Drugs Fund (CDF) but it’s the first time a single drug has been given its own unique cash stream.

Ben Adams has written an excellent article covering this that’s worth a read in the PharmaFocus Market Access supplement

In parallel to this, last week Sir Andrew Dillon, Chief Executive of NICE, is reported in PharmaTimes to have said ‘NICE vs. CDF makes no sense’. He told the Health select Committee that there was a misalignment in the approach NICE takes regarding willingness to pay vs. the CDF. An example of this is Roche’s Kadcyla (trastuzumab emtansine). NICE rejected the drug to treat women with aggressive breast cancer last month based on an assessment of QALY – but the drug can be accessed through the CDF.

We've been mulling over some questions in the office this week about this...

How will NICE, the CDF and Silo funds work together in the future? Which other new, exciting drugs outside of oncology might go down the route of these new silo funds? And what will this mean for NICE – how will the NHS ratify their decisions between the different channels?

This could be a new opportunity for patients to gain access to life-changing medicines that previously may not have been available to them, but there’s also the potential for it to become a whole new political hot potato!

It takes all sorts to make market access work

Why multi-faceted ‘payer intelligence’ is pivotal to market access success

In today’s resource-challenged healthcare environment, a market access strategy is more important than ever in influencing the success of your brand – as payers and policy makers are exerting more and more influence on the fortunes of brands.

Indeed, no brand can really hope to survive and prosper without a well thought-out and clearly defined strategy for securing funding and formulary agreement which involves understanding the multiple payer types who influence the managed uptake of new medicines. 

Market research is therefore vital to help a brand team determine the optimum market access strategy. Developing an effective strategy for negotiating with payers and getting your brand on formulary should ideally begin with MR to “dig deep” to thoroughly understand every aspect of the world of payers.   

All sorts of different issues and business questions to explore and address

It does of course depend on the specific market access challenges facing your brand. Maybe, for example, the need to identify the implications of gain-sharing for the strategy of a brand which is funded via the specialised commissioning route. Likewise, the need to understand the role and influence of MOLs or the relationship between CRGs and the Area Teams.

Just a very few examples of the topics which might require in-depth investigation. Others which readily spring to mind include exploring the implications of the advent of biosimilars for a market access strategy, or understanding how your brand might best tap into the health and social care agenda. An especially common theme is uncovering the relative influence in reality of primary vs. secondary care in the new NHS within the context of a specific situation.

Multiple areas to potentially explore e.g.

• Who are the most relevant stakeholders for your brand and why
• How do the decision-making processes/procedures work?
• Who are key influencers at national, regional and local level?
• What are payers’ conscious and sub-conscious motivations?
• How do these vary by type of payer customer?
• What constitutes ‘value’ in the eyes of different payer types and why?
•  How are national level policies being translated at local level?
• How can pharma best tap into local agendas and commissioning intentions?
• Above all, what are the realities of what is happening on the ground?

Blend of skills in one partner

Careful consideration also needs to be given to the optimum partner with which to work. Successful fulfilment of the above requires all sorts of skills in one partner, including the marriage of NHS consultancy and environmental experience with market research expertise and readily available access to payers. Plus a partner who understands your brand and its many challenges.  Multi-faceted work needs a multi-faceted partner. One who can handle all sorts! 

CCGs – the story behind the headlines and implications for market research

Why the recruitment, screening and sampling process needs to work harder in market research to understand the needs, behaviours, priorities and attitudes in CCGs.

The NHS reforms introduced in 2013 were the most radical shake-up of the health service since it was established in 1948. A central part of the reforms was to give budgetary control to primary care general practitioners, grouped together in Clinical Commissioning Groups (CCGs) – these groups now hold 80 per cent of the NHS budget for patient care. The theory was that primary care doctors are closer to patients and are therefore (a) much better placed to direct resources where they are most required and (b) more able to redesign services to better meet patients' needs.

Over a year has elapsed since the new NHS structure became operational on 1 April 2013 and CCGs came into being as statutory bodies.

So, more than 12 months down the line, where are we? How have CCGs taken to being in the driving seat of commissioning services and determining how and where NHS money is spent?

For example, to what degree do most GPs now feel actively involved in commissioning and how much influence do most GPs have on service design/redesign decision-making? Have the reforms succeeded in effectively engaging most GPs or are most family doctors merely standing on the sidelines looking in?

What industry sources say

Judging from what you read in the press, you could be forgiven for believing that most grassroots GPs are not actively engaged in the work of their CCGs. For example, in a special report in March 2014, Pulse magazine talked of 56 per cent of GPs feeling they had no say in the commissioning decisions made by their respective CCGs.

And more recently, the Nuffield Trust/Kings Fund survey of six CCGs stated that only 12 per cent of GPs who responded to their survey in 2014 felt highly engaged in the work of their CCG compared with 19 per cent in 2013.

"A survey of six CCGs found only 12 per cent of GPs who responded to the survey in 2014 felt highly engaged in the work of their CCG - compared with 19 per cent in 2013"

Adelphi's CCG recruitment experiences

This perspective is certainly backed up by Adelphi's extensive direct experience gleaned from our recruitment activities for market research (MR) projects, plus the profiling information which we maintain on our database of NHS contacts.

We regularly conduct MR to explore CCG priorities, challenges, needs, behaviours, policies, influences on decision-making etc. For these projects, we typically sample between 30 and 150 respondents dependent on whether it is a qualitative or quantitative study and in accordance with the precise nature of the MR objectives involved.

These studies mean speaking to CCG respondents who are well-informed enough to provide reliable comment. Our experience is that some two thirds of GPs are unlikely to be able to provide sufficient depth of insight, whilst there will also be a 'partially-informed' tier of respondents as well as a 'well-informed inner nucleus'.

Factoring these realities into research studies with CCGs is therefore vital. Without paying careful consideration to the various tiers of knowledge, we risk generating ill-informed or misleading results from CCGs.

An Intelligent CCG Screening Process

A very thoughtfully designed screening process is needed and will play a key role in helping to guide and maximise the recruitment process. This needs to capture essential nuggets of knowledge about each respondent's history, together with the profile of the respondent's respective CCG – in the event that this information is not already known or maintained on a database such as Adelphi's multi-relational database of NHS contacts.

Furthermore, the situation is nowhere near as straightforward as the 'two thirds grassroots CCG non-involvement' rule-of-thumb first suggests.

In reality the situation varies markedly from CCG to CCG. That is why investing in a regularly maintained database of CCG profiles and histories is invaluable in assisting the recruitment process.

For example, there are some CCGs which actively involve all their GPs in the CCG's decisions, so that almost all GPs interviewed will be sufficiently informed. On the other hand, there are other CCGs where few individuals know what is really going on. Putting it bluntly, these CCGs simply pay lip service to GP involvement, and thus very few individuals can provide rich insights on how, for example, the CCG makes a key decision.

This is just one example of why an in-depth understanding of the inner workings of different CCGs is critical to maximising recruitment.

"This weight of GP representation on a CCG board has the potential to impact the attitudes, policies and behaviours of that CCG"

Compiling the sample

It also helps to have an in-depth understanding of the composition of each CCG's governing body and the extent to which GPs are represented when compiling the sample. We know that if we take CCGs as a whole, the proportion of GPs sitting on CCG Governing Bodies is actually considerably less than half – somewhere between 40 and 45 per cent. However, this 'overall average' disguises the fact that some CCGs have a much greater GP representation on their governing bodies than others.

This weight of GP representation on a CCG's board has the potential to impact the attitudes, policies and behaviours of that CCG, and may also be another key consideration when designing a representative sample for projects.

Conclusion

These are just two brief examples of why the recruitment, screening and sampling process needs to work harder in market research to explore issues relating to CCGs' needs, behaviours, priorities, attitudes or policies. It isn't just a case of approaching a GP in the hope that he or she will have an informed view. That approach risks getting it wrong and, as with any MR study, if we interview poorly informed respondents it could have far-reaching implications.

So stratifying the samples very carefully for CCG studies is fundamental. Targeting the recruitment is key and designing an intelligent screener is vital.

After all, how else can we find out if 'the most radical shake-up of the NHS since its inception' has really made a difference? This technique will also allow us to understand which factors are truly influencing key decision-making at the heart of CCGs.