In 2013 the Scottish Government announced its intention to broaden the way NHSScotland's medicines gatekeeper, the Scottish Medicines Consortium (SMC), assesses new medicines.

In his response to the Scottish Parliament's Health and Sport Committee report on increasing access to new medicines, the then Health Secretary proposed a wider ‘Scottish Model of Value' [the capital letters are mine].

Already, by this stage, a rapid review was underway into how wider aspects of value might be considered for medicines for end of life and very rare conditions. This led to SMC now including a report from a Patient and Clinician Engagement (PACE) meeting into its consideration of some of these medicines, allowing the views prescribers and recipients to be taken into the mix.

Back in 2013, the Scottish Government told the Committee the rapid review was: "...the first step in a wider process to determine Scotland's requirement to a Value-Based Approach to Assessment. The question of how innovation should, or could, be considered in the new medicines assessment system in Scotland will be taken forward in the Scottish Model of Value."ⁱ

Now, in response to a request from the Committee for updates on progress, the feedback 27 months on is that there has been no movement on designing such a model. Indeed, 14 of the 34 respondents chose not to address the question.

Some who did respond say they regard creating a Scottish Model of Value as a distraction. Others point out that things have moved on: at the time when the Scottish Government put the idea forward, Value Based Pricing was high on the UK Government's agenda, while now it is not. In the interim, however, work has been underway to develop a UK-wide Accelerated Access process to speed up access to transformative health technology.ⁱⁱ

The majority of responses to the Scottish Parliament from patient organisations and industry continue to suggest developing a new model is worthy of investment of time, effort, innovation and a bit of courage.

It is unclear exactly what other considerations might be added to the current assessment of clinical utility and cost effectiveness. Suggested measures of wider value include the benefit of a medicine for carers and care systems; consideration of the burden of the illness in Scotland; and whether a medicine represents an innovation step change from existing therapies.

Some NHS Boards tell the Committee that the very existence of PACE, creating the opportunity for SMC to integrate consideration of specific Scottish information from patients and clinicians, renders any further value-based modifications of SMC's process unnecessary.

The majority opinion is that, while PACE is a step in the right direction towards a Scottish Model of Value, it does not represent the final form for value-based assessment of new medicines.

The medicines industry trade organisation, ABPI Scotland is one of the voices encouraging SMC and government to continue on the path it set out in 2013, particularly in the light of developments such as the English Cancer Drugs Fund and the UK Accelerated Access Review:

"It is vital to patients that policy in Scotland does not fall behind as a result of these developments elsewhere. It is our view that moving towards a Scottish model of value will be central to ensuring that this doesn't happen."

In its evidence, ABPI Scotland reveals that the search for a Scottish model remains on the agenda for industry and the SMC – the subject being one of the areas that the SMC User Group Forum, SMC's liaison body with medicines companies, will be looking at this year.

SMC's parent organisation, Healthcare Improvement Scotland (HIS) has a new strategic delivery plan for medicines committed to increasing its focus on patient choice, self-management and new relationships between patients and professionals in therapeutic decision making. While noting the demise of Value Based Pricing, HIS tells the Committee:

"The SMC is in a position to help determine and enable the research required to underpin an evidence-based approach to the development of a Scottish Model of Value."

It is worth noting that a Scottish Model of Value for medicines would not take government into uncharted territory. The Scottish Government already has a national value-based approach to decision-making, the Scottish Model of Procurement. To quote the relevant Scottish Government website page:

"Like all good ideas, it's a simple concept - business friendly and socially responsible. Looking at outcomes not outputs, it uses the power of public spend to deliver genuine public value beyond simply cost and /or quality in purchasing."ⁱⁱⁱ

On the whole, patient groups continue to support the development of a broader approach to assessment. In its evidence to the Committee, Cancer Research UK says: "There is appetite from patients and their representatives for an assessment approach that better incorporates the value of treatments to patients and wider society – for example, patients and supporters we speak to frequently note that impact on carers is not taken into account in appraisals, and this would be desirable."

The medicines company, Roche, is one of several respondents that suggest what a new Scottish Model of Value might look like:

"Assessing the benefit of a medicine should not only be based on a simple cost per QALY basis [cost per quality adjusted life year: the current core cost-utility measure for an intervention] but also by considering wider benefits, such as societal value, unmet clinical need and the potential impact on the standard of care in Scotland compared to the other nations of the UK and the rest of Europe."

The company says a strength would be in its Scottishness:

"A Scottish Model of Value needs to reflect what is important to the Scottish population. There needs to be an open debate with the Scottish people about what they value most from healthcare and medicines, which could be part of the National Conversation on health currently underway."

Another medicines company, AbbVie, suggests a new model is particularly important at a time of integration of Scotland's health and social care services:

"The integration of care provides an opportunity to consider in greater detail the value of medicines and associated added value services, going beyond the cost of acquisition. For example, improved quality of life, greater personal independence and reduced reliance on carers, the ability for a person to return to work and to ease the demand for institutional care, can help to relieve pressure on already over-extended health and social care services."

Scotland's largest NHS Board, NHS Greater Glasgow and Clyde (NHS GGC), asks why stop at medicines?

"There is no comparative rigor in assessing cost effectiveness of other interventions that may or may not be cost effective for NHS Scotland. In view of current and future financial constraints facing NHS Boards in Scotland, NHS GGC would welcome further work being done to address value of not just medicines but of wider healthcare interventions to inform debate and aid the difficult decisions facing the NHS."

The Health and Social Care Alliance Scotland expresses concern, shared by other respondents, that the information and data gathering systems are not yet in place to allow a true assessment of value to be made:

"At present an insufficient level of research has been carried out in Scotland on ‘Burden of Illness', a key component of plans for Value Based Pricing. As such, we do not have enough information about wider public understanding of the impact of funding certain medicines and the priority setting process. Carrying out further research would give the SMC a greater mandate in its decision-making role based upon firm public opinion."

Breast Cancer Care echoes this concern:

"It is difficult to comment on this without further details about what these new value-based assessments would look like. In any system, however, patients must be given a significant voice in deliberations of value-based assessment and in decision-making. Patients must have a say equal to that of drug manufacturers, health economists and clinical experts."

NHS Forth Valley warns broadening the scope of assessment may not make decisions any easier:

"If value based assessment is pursued it would have to be determined which patient groups and which disease states are more important and therefore more deserving than others."

NHS Lothian adds:

"...in order to truly represent the views of Scottish people it was hoped that the Scottish model of value would provide a framework covering all patients and all diseases so that there is fairness and equity across the system."

The charity Parkinson's UK calls for a broad public debate on any new model, fearing unintended consequences:

"For example, there is a high risk that burden of illness and wider social impact calculations could attribute less value to conditions that primarily affect older people, who are not economically active. They may also be biased in favour of terminal illnesses, and fail to reflect the devastating impact of living with a condition like Parkinson's that is long term, fluctuating, incurable and degenerative."

Ultimately, however it is designed, the Scottish Model of Value for new medicines will still be about best allocation of finite resources. As such, there will continue to be losers as well as winners.

ⁱScottish Government Response

ⁱⁱAccelerated Access Review

ⁱⁱⁱScottish Model of Procurement