When will non-NICE reviewed medicines get taken seriously?

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Bitter pill

The National Institute for Health and Care Excellence, or NICE, is an admirable institution, almost unique among other quangos to have survived numerous government changes and NHS restructures.

Since its creation in 1997, NICE has pioneered the use of cost-effectiveness and, along with Quality Adjusted Life Year (QALY), is the go-to tool by which to measure the value of new products. NICE’s success has been game-changing. It transformed health economics into a professional discipline and, in doing so, the UK became the centre of a new academic field, with a new industry built around the use of economic methods to demonstrate the value of new health technologies.

Despite its excellent work, however, NICE reviews under 50% of newly launched medicines, and far fewer other technologies. This leaves a sizeable proportion of medicines unassessed by NICE. These fall subject to a highly complex system, based largely at a local level, and governed by medicines management – or medicines optimisation – committees and a cadre of pharmacists and pharmacy advisors.

This architecture is diverse in terms of the processes used; operational timelines, inter-relationships between different decision-makers and willingness to engage with industry. It is a multi-layered system that changes by geographical area. As the NHS has been reformed over the years by successive governments, this system has had committee added to existing committee, so that now there are estimated to be 600 different medicines assessment processes across the UK.

These include CCGs, trusts, area prescribing committees, joint formularies, and support services, such as PrescQIPP and MTRAC. It’s a mind-boggling institutional melting pot.

Extreme complexity is all hidden behind the frontline NHS that patients typically experience. Clinicians and other healthcare providers are regularly left bemused by its processes and, meanwhile, industry faces a truly difficult task in trying to engage with them. At a time when the NHS is meant to be focussing on generating efficiencies, it stands opposed to the direction of travel.

 

Ridge and RMOC

Enter Dr Keith Ridge, Chief Pharmaceutical Officer and long-time trailblazer for medicines optimisation and the utilisation of pharmacy services. Ridge recognised two things – the system whereby innumerable local committees reviewed the same clinical data and value propositions to reach separate decisions on new medicines was unnecessarily duplicative and wasteful. Secondly, the same skilled professionals occupied by these processes could be redeployed to concentrate on other useful activities, such as optimising medicines use and, if possible, become involved in clinical care.

To reduce this inefficiency and release the resource tied up in medicines management, Ridge adopted an industry-led proposal. Establish a structure of medicines evaluators, at a regional level, comprised of experts in the field that the rest of the NHS could trust, and adopt their decisions, allowing local teams to be re-deployed and commissioners to focus attention on more pressing areas.

Four Regional Medicines Optimisation Committees, or RMOCs, were born. The idea was that these committees, staffed by relevant experts, would review all new medicines, not looked at by NICE or NHS England, determine their value, advise on positioning and recommend on reimbursement. It would then be for CCGs and trusts to implement this; deploying the majority of medicines managers and pharmacists from evaluating formulary decisions, and allowing them to overcome pinch-points elsewhere in the system.

The future looked promising for medicines not assessed by NICE. Rather than having to navigate a fragmented, widely variable set of formulary decision-makers, an RMOC assessment would suffice. Better still, the plan was that RMOCs not directly involved in the assessment of one particular medicine would ‘mutually recognise’, or adopt, the decision of the RMOC that had done the evaluation, meaning a single, national assessment was possible. This process would be transparent, include all relevant participants, apply standardised, rigorous processes and possibly use the expertise of NICE. A sensible plan.

The Operating Model for RMOCs was finally published in April 2017. Substantially delayed, the document from NHS England reveals that the vision offered by Ridge’s proposals has been substantially curtailed, and RMOCs have had their proposed powers cut. Their position has shifted to become primarily an implementing mechanism for medicines ‘decommissioning’ and cost-saving programmes driven by the centre.

It is now clear that RMOCs no longer offer a solution to a dysfunctional system of multiple evaluations for medicines that are not looked at by NICE. Furthermore, their medicines evaluation role has been put on ice until the end of Spring 2018, and there is no commitment that it will be taken forward at this time. Instead, their priorities have been set clearly in the direction of medicines decommissioning.

RMOCs are no longer Ridge’s baby alone. The programme is now being jointly led by the NHS Clinical Commissioners, the organisation that was recently commissioned by NHS England to recommend a list of 10 products for removal from NHS baseline spending. They will become the bodies that help the NHS take unpopular decisions about where to withdraw funding from certain medicines. In the future expect percentage savings targets to be issued and the appearance of decommissioning lists, akin to PrescQIPP’s well-known ‘DROP List’ publications.

The question then is, how should industry respond to these bodies? It is likely that the move from evaluation to optimisation and decommissioning was a result of fears that an evaluation function would likely lead to more medicine spend on medicines not assessed by NICE. It is said that CCGs reacted negatively to the creation of RMOCs as a set of bodies that would dictate where they were to invest in new medicines.

The status of RMOC recommendations and all other outputs are now only ‘advisory’, as opposed to being mandated. While RMOC involvement in local or regional procurement processes at the moment is unclear, it is likely to evolve over time as part of the NHS’ move towards STPs and accountable care systems.

RMOCs could offer industry a useful opportunity to develop relationships at a more strategic level and discuss ‘value’ in a broader way, over and above cost-containment. Unfortunately, however, it appears that this will simply become an additional layer of bureaucracy with which to engage/wrestle.  

 

Alex Ledger is Deputy Managing Director at Decideum – the views expressed here are entirely his own. Go to decideum.com