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

VACANCY Reporter/Researcher: Health and Care Policy in Scotland

Prescribing in Mental Illness – A Practice Pharmacist’s Perspective

What Matters to You? Communication in Pharmacy

Prescribing in Mental Illness – A Patient’s Perspective

Focusing the Vision: Dr Rose Marie Parr on the new strategy for Scottish pharmacy

All the things that could go wrong - looking ahead to the SNP conference

Ask Once, Get Help Fast? Pharmacy and Mental Health

Automation and Delegation in Pharmacy: Understanding the Moving Parts

Pharmacy First in Forth Valley One Year On

Initiatives Highlight Potential of Community Pharmacy

Trying to concentrate on the day job

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

The Future’s Bright – in General Practice

Community Pharmacy in a Changing Environment

Disclosing payments to doctors – has Sir Malcolm done the pharma industry a favour?

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

CMO: Scotland’s pharmacists “absolutely ideally placed” to practice Realistic Medicine

Profile: Maree Todd – MSP and Pharmacist

Scottish Parliament Health Committee Work Programme

Scotland’s new NHS – a Summer of Speculation

Scotland’s New Health Committee

Two million voices in Scotland – is integration the big opportunity to listen?

Medicines – levelling the playing field

Key appointment raises the bar for health & social care partnerships

What did our new MSPs do before?

SMC says no then NICE says yes – three times

SNP promises single formulary and a review of Scotland’s NHS

More Generous than the CDF – but less transparent

Comparison of Funds: New Medicines v Cancer Drugs

Bonfire of the Boards? SNP signals NHS Review

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

Scottish Minsters Demand Up-Front Medicine Price Negotiation

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

Monday, January 25, 2016: Reviewing the Review: Access to New Medicines in Scotland

The Scottish Parliament's health committee has published the responses to its call for evidence on what's happened since they recommended changes to improve access to new medicines for people in Scotland. The feedback shows a divide between NHS boards concerned about justifying the extra spending, and patient groups wondering why some medicines continue to be blocked.

Back in 2013, having held a lengthy inquiry into why so many new medicines were failing to reach patients in Scotland, the Scottish Parliament's Health and Sport Committee called for a series of modifications to the way the Scottish Medicines Consortium (SMC) went about deciding what medicines it would recommend to Scotland's 14 NHS Boards

The Scottish Government accepted the report and the SMC acted quickly, creating an extra stage where some new medicines for very rare or end of life conditions are considered by a new Patient and Clinician Engagement (PACE) meeting of clinicians and patients. The PACE report, alongside that of the New Medicines Committee, is then considered by the full SMC meeting. The aim was to create the possibility that a medicine's significant benefit to patients might take it across the line where otherwise it would not be deemed cost effective.

SMC also agreed to hold its meetings in public and to allow the company whose medicine was under consideration to be present to answer questions.

Now the verdict on the changes so far is in. The Committee has published the responses of 30 organisations (14 NHS and clinical, nine industry and seven patient groups) and one individual.

The one individual is Dr Andrew Walker, the Glasgow University economist who during his time on the Scottish Medicines Consortium worked hard to try to demystify its processes and remind people that it was ultimately in the business of health technology assessment not emotion. His judgement so far: "SMC has delivered what the Scottish Parliament asked for, including more extensive stakeholder involvement. However, this has come at a cost to the process of including PACE and to the NHS in terms of funding new medicines."

SMC's mothership, Healthcare Improvement Scotland says, since making the changes, "SMC has accepted significantly more new medicines for end of life and very rare conditions with an increase of around 40% in the acceptance rate for these medicines."

In their joint submission NHS Scotland Directors of Pharmacy and the Scottish Association of Medical Directors say "The new SMC processes, including the Patient and Clinician Engagement (PACE) system, has improved access to 28 end of life and rare diseases medicines that previously may not have been accepted on the basis of cost effectiveness", adding they now "would support further consideration of mechanisms to monitor patient outcomes".

Some NHS Boards are simply not convinced that it has been the right thing to do, with several expressing concerns about the impact on the medicines budget combined with additional management costs of new treatments.

NHS Borders is perhaps the most forthright: "The introduction of these processes for end of life treatments seems hard to justify," it states. "Why should treatment at this stage of life be prioritised above other life stages and why should different cost effectiveness thresholds apply?" The Board echoes others when it says: "The NHS has a finite budget and areas for investment must be prioritised. NHS Borders is concerned the changes to the SMC process has led to less cost-effective drugs being approved at the expense of more cost-effective treatments."

Patient organisations express a different concern – that important medicines are still being turned down. Breast cancer charities point to four medicines for people with incurable secondary breast cancer that were considered under the new PACE system and not approved.

In its evidence Breast Cancer Now states: "For so many women with incurable secondary breast cancer, innovative medicines represent a glimmer of hope; a door to the possibility of more time to make memories that will last beyond their lifetime. Too many of these doors are still being slammed shut," adding that, in the case of breast cancer, "it is unclear what tangible influence the new process has had on decision making."

The organisation calls on medicines companies to "acknowledge their responsibility to be flexible in offering a fair price that gives these drugs the best chance of being made available on the NHS" and for the Scottish Government to "make sure that the systems in place in Scotland are fully geared towards securing a fair deal and unlocking innovative treatment options for women with breast cancer."

For its part the industry's submissions welcome the changes as being part of an evolution in the process, suggest next steps and, in common with several patient groups, ask that the patients and specialist clinicians invited to the PACE meetings also be involved in discussions at the decision-making SMC meeting rather than just submitting a report.

The industry body ABPI Scotland says it is concerned about the change, introduced when the SMC began meeting in public, from members reaching a consensus to holding a secret vote. "We believe that decisions are now less predictable and at times do not reflect the nature of the committee discussion, and the reasons given in official advice and during feedback meetings can only reflect individual views and not the committee opinion because this is unknown."

At the end of its process, SMC makes a recommendation to Scotland's local NHS Boards whether a medicine should be used. Cancer Research UK believes this may need to be toughened. In its submission, it says "The Scottish Government should consider the impact of making SMC appraisal decisions binding on Health Boards, so these must be followed where a doctor judges that a patient should have an SMC-approved treatment."

Dr Andrew Walker wonders whether national then local decisions are both needed. In his submission he asks the Health Committee to consider a series of what he calls ‘consensus statements' to focus the debate on what change, if any, is still needed:

  • One set of national guidance is preferred to 14 local guidance.
  • A dedicated agency led by NHS clinicians is the best way to achieve this, so long as this takes account of all stakeholder views.
  • Guidance should be issued for all new medicines at the time they become available.
  • The agency should be accountable to Scottish Parliament via the Cabinet Secretary.
  • Criteria for the agency to make decisions should focus on clinical effectiveness (health benefit) and cost-effectiveness but can consider other issues.
  • Each pharma company has a responsibility to make the case for a new medicine; the agency has a responsibility to respond in line with stated criteria in a way that is rapid, transparent, and consistent.

Source: The Scottish Parliament Health and Sport Committee