These commentaries by John Macgill represent his opinions only and not those of any Ettrickburn client.

Pharmacy technicians may become prescribers

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Profile: Jonathan Burton MBE

Profile: Clare Morrison MBE

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Mind the Gap - Diagnostic Skills for Pharamacists

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Health and the Local Elections – a strange silence

The Pharmacist Will See You Now – The Growth of GP Pharmacy

Montgomery’s Review – Dr Brian Montgomery answers questions on access to new medicines in Scotland

An afternoon with SMC

Pharmacists at SMC

SMC – are drug firms voting with their feet?

Radical Surgery on the Horizon for Scotland’s NHS

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Health and Care in the First Minister’s Programme for Government

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Scotland’s new NHS – a Summer of Speculation

Scotland’s New Health Committee

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Key appointment raises the bar for health & social care partnerships

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Comparison of Funds: New Medicines v Cancer Drugs

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A tribute to five retiring MSPs

New Medicines Review - Health Committee sends findings to Government

Medicines New & Old in the Scottish Cancer Strategy

Great Ambitions, Slow Progress – New Models of Care in Scotland

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Opportunity and Disappointment: MSPs Investigate New Medicines Access

Scottish NHS Strategy calls for 'Realistic Medicine'

The Scottish Model of Value for Medicines: Taking Everything into Consideration

When SMC Says No: An Access to Medicines Lottery

Reviewing the Review: Access to New Medicines in Scotland

A day of psephology and kidology

Insulting the Lifesavers

Worthy of Mention – Health and Science in the Honours List

News Silence from North of the Border

A Christmas PPRS Present from Pharma

Thursday, March 17, 2016: Medicines New & Old in the Scottish Cancer Strategy

The Scottish Government’s new cancer strategy is broad and far-reaching, with a vision for new medicines and plans to redeploy old ones.

Beating Cancer: Ambition and Action[i] is described as the blueprint for cancer care in Scotland over the next five to ten years. It encompasses prevention, detection, treatment, research and continuing care.

It offers a warts and all assessment of what has yet to be achieved to join up services and improve outcomes – and to address the cancer survival divide between Scotland and our neighbours, and between different communities within Scotland. The ambitions, plans and committed extra investment are impressive.

So, to home in on one relatively small aspect of the strategy – what it promises in terms of the role of medicines – is to look at just a few pieces of the jigsaw.

For medical oncologists and the medicines industry the message from the Strategy is that medicines have an important role in treatment alongside surgery and radiotherapy.

The Government says it is committed to improving access to new medicines – at a fair price – and then to scrutinising their real world performance. Ministers also state their commitment to the NHS in Scotland supporting the entry of new precision medicines both through clinical trials and molecular pathology services. Most controversially, perhaps, the Government says it wants to pursue a policy of examining how off-patent medicines can be ‘repurposed’ for the treatment of cancers for which they were not originally licensed.

In the Strategy, ministers look forward to the recommendations this summer from Dr Brian Montgomery’s review of access to new medicines processes, committing the NHS to continuing to ‘evolve’ the appraisals system.

Reiterating the Health Secretary’s recent evidence to the Parliament’s Health and Sport Committee, the Strategy’s section on access to new medicines states:

 “Fair pricing of cancer drugs remains a challenge and we will consider our systems to ensure that Scotland gets best value. We also need to do more in taking a systematic approach to whether new medicines deliver the value that has been shown in clinical trials. We are supporting a project led by NHS Greater Glasgow and Clyde on the clinical effectiveness of cancer medicines in a real life setting.”

The Strategy goes on to state:

 “While the focus is often on new medicines, the increase in repurposing of older off-patent medicines presents opportunities for improved outcomes. Unlike newly licensed medicines there is currently no comprehensive approach to assessing repurposed off-patent medicines and recommending their use across Scotland. There is a need to ensure that we are well placed to maximise the opportunities of these medicines and therefore work will be undertaken to establish what improvements can be made to our current approach.”

Late last year a Bill tabled at Westminster to give Whitehall responsibility for repurposing off-patent medicines into unlicensed indications fell after failing to get UK government support[ii].

Labour MP Nick Thomas-Symonds had sought to create both a duty and a mechanism for the UK Government to license off-patent medicines for new uses where justified by the evidence. Thereafter, he envisaged, the National Institute for Health and Care Excellence (NICE) would appraise them and ensure widespread uptake by the NHS if appropriate.

In a statement on the Bill[iii], the medicines industry trade body, ABPI, pointed out that ministers could already ask NICE to undertake technology appraisals of unlicensed medicines in certain exceptional circumstances. ABPI went on to state:

 “The Department of Health does not believe that the barriers for patients in such instances are primarily about licensing. In the debate in the House of Commons on 7 November [2014], the Minister for Life Sciences, George Freeman MP, said that: “In this landscape, the restraining factor is the lack of information for clinicians about off-label use. We need to encourage greater off-label use through NICE, and to have a culture within our health system that actively supports it”.”

At the other end of the spectrum, Scotland’s First Minister last month committed £4 million to support the development and commercialisation of precision medicines. This development, the new Scottish cancer strategy says, has the potential to transform healthcare:

 “It is expected to bring benefits for individuals and for the health service alike by reducing the risk of wasteful and ineffective prescriptions, providing better and more effective personalised treatment to individuals, tailored to their genetic makeup and the particular characteristics of their disease.

“By knowing the whole genome sequence, it may be possible to offer a diagnosis where there hasn’t been one before, understand better the cause of disease and work out how best it might be managed.”

The Government promises that the remit of the Scottish Cancer Research Network will increase as part of a national commitment to “increase, support and sustain clinical trial activity in cancer”.

The importance of evidence from real world data, including the feedback from patients on their care and wellness, is a recurring theme:

 “To make certain treatments and care is rooted in evidence, we will work to improve the data we collect, analyse and publish, to better reflect the experiences of people with cancer. We want to embed research in the ethos of our healthcare services – allowing individuals access to and participation in clinical trials appropriate to their circumstances. We will underpin and support this work by establishing a new cancer intelligence system to provide high quality, timely information for clinicians and individuals at all stages of their cancer journey, and by funding vital research.”

The Scottish Government’s assessment is that, while it is addressing access to new medicines in cancer, “challenges remain in providing equitable access to high quality surgery and radiotherapy”.

The new cancer strategy is meant to have a shelf life of between five and ten years. In the world of cancer medicines innovation, this is a very long time. It is possible that the whole treatment model for some cancers will have changed before then.

In the light of recent research, the model (in some cancers) of surgery first and most expensive medicine last may no longer offer patients the best pathway.

Cancer Research UK-funded work by university and NHS teams in Manchester and London[iv] published last week showed a “dramatic” effect of using a combination of two medicines for women with HER2 positive breast cancer during what the study called “the window between diagnosis and surgery”. The use of trastuzumab (Herceptin) and lapatinib (Tyverb) was shown to shrink the tumour rapidly. In some cases, it disappeared.

 

[i] Full Strategy http://www.gov.scot/Publications/2016/03/9784

[ii] Pharma Times Report http://www.pharmatimes.com/Article/15-11-09/End_of_the_road_for_Off-Patent_Drugs_Bill.aspx

[iii] ABPI briefing November 2014  http://www.abpi.org.uk/our-work/policy-parliamentary/Documents/medical_innocation_bill.pdf

[iv] CRUK news release http://www.cancerresearchuk.org/about-us/cancer-news/press-release/2016-03-10-drug-combination-shrinks-her2-positive-breast-cancers-within-11-days