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

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Thursday, December 08, 2016: An afternoon with SMC

The following article is published in the new edition of Scottish Pharmacist magazine, available on line at http://bit.ly/2h8R6AM

The Scottish Medicines Consortium (SMC) has been meeting in public for over two years, but commercial confidentiality limits how much any observer can be told. In the light of the latest review of access to new medicines in Scotland, John Macgill joined the public gallery at a full meeting of the SMC in Glasgow.

The Scottish Medicines Consortium has been acting on behalf of the NHS in Scotland since 2001 to decide which new medicines should be routinely available to prescribers.

What made it revolutionary was that it included representatives of the pharmaceutical industry from the start and, later, patient representatives. And it was fast, often publishing advice months and years before other health technology appraisal bodies.

For more than eleven years, the SMC met in private. Then, following the recommendations of a review published by the Scottish Government in late 2013, the meetings were opened to the public.

“The main benefit,” according to an SMC spokesman, “is that patient groups and members of the public are now able to observe the SMC Committee meetings to get a better idea of the work we do, and hear at first hand the range of complex issues that members discuss when arriving at these difficult decisions on new medicines.

“SMC is now recognised as one of the most transparent health technology assessment agencies in the world as almost all of our committee’s discussions are held with the public present. Feedback from those observing our meetings between May 2014 and February 2016 showed 82 per cent of people felt they had a better understanding of how SMC works.”

The reality is that you may be able to attend, but you will not get the full picture when you go to watch SMC in action.

On being handed a sheaf of documents for medicines under discussion – which you must sign for and then give back at the end of the meeting – you quickly discover that large sections of each have been redacted. Indeed, the paperwork is only a draft advice document for each medicine submitted by the SMC’s New Drugs Committee, which has already scrutinised the medicine and made a recommendation (that you cannot see) to the full committee.

In many ways, observers should be pleased that they, unlike the 30 SMC members, do not get the full submissions from the companies. These can run to over 100 pages each – a lot of reading when you also have a day job.

Medicines are considered one at a time following a strict sequence.

After any member of the SMC who declares a conflict of interest for the medicine has left the room, and up to two representatives of the submitting company have come to the table, the scrutiny begins.

First a member of the New Drugs Committee reads a short summary. Then a report from any PACE meeting that has been held is read out.

The review that led to meetings being public also saw the introduction of an additional step for some high cost medicines for end of life and very rare conditions: Patient and Clinician Engagement (PACE) meetings. At these, patients, patient organisations and clinicians discuss aspects of a new medicine’s value beyond the health economics, such as the severity of the condition, unmet need, the potential value to patients and carers, and how the medicine might fit into the patient pathway.

The SMC then hears summaries of any patient group submissions before discussion is opened to the whole group. Like the paperwork, this conversation is guarded, members often referring to sections in papers that the public do not have when talking about costs.

Only on rare occasions – the SMC says 11 times across 148 medicines so far – does the SMC go in to closed session:

“We are occasionally unable to be fully open about the information contained in submissions for new medicines because companies state that some of the information in their submission is commercial or academic in confidence,” says the SMC’s spokesman. “This often relates to medicine prices or discounts and consequently this may mean that the cost-effectiveness data that informs some SMC decisions cannot be disclosed to the public.

“As we would like our meetings to be as transparent as possible we are engaging with pharmaceutical industry colleagues involved in SMC to explore how confidential information can be kept to a minimum.”

When the discussions are over the chairman summarises whether the medicine concerned can have some of the SMC’s ‘modifiers’ applied to allow more leeway, for instance if it is for an end of life or very rare condition. Then members vote.

One impact of the move to holding meetings in public is that the vote is now done by secret ballot where, previously, there was discussion until agreement was reached.

The medicines trade body, ABPI Scotland, has questioned whether this is helpful, telling the recent Montgomery Review of access to new medicines:

“We have concerns that voting in public has made decisions less predictable than before, based on the discussion, and that anonymous voting is less transparent with regards the reason for a decision being reached, particularly from a manufacturer perspective. There may be advantages in moving back to consensus decision making which is not anonymous but having this part of the discussion in private.”

The ABPI said the secret vote sometimes did not seem to reflect the discussion that went before it, and has made it more difficult for the companies whose medicines were rejected to find out why.

When I was witnessing proceedings, it took over three hours to consider and decide on seven medicines. The meeting then went in to closed session to discuss four medicines where there had been no submission to SMC from the companies.

A little over a month after the meeting, SMC published advice on twelve medicines. The four that had not been submitted for consideration automatically received a ‘not recommended’. Of the remainder, two were accepted, four accepted with restrictions on how they might be used within their license, and two were not recommended.

What was interesting was, despite the restriction on information, the general discussion the chairman’s summary had allowed me to predict SMC’s decision correctly for six out of the seven medicines.

The central question for me is whether holding the SMC meeting in public helps Scotland’s medicines decision makers make the best decisions.

Group decision making benefits, I feel, from discussion to allow people to listen to the arguments of others and perhaps to be swayed by them. A secret ballot is simply a poll of thirty individuals, albeit better informed by attending the meeting than they were from the paperwork alone.

The public, meanwhile, is invited to watch a process rather than to understand fully the complex argument for and against a new medicine. When the very presence of the public may be constraining the discussion, it is difficult to be sure that making decisions in public has improved the process.

At the same time, it is essential that patient groups and clinicians can make their views known directly to the SMC. Even armed with health economics and research data, the SMC is still a group of people making decisions about people.