The Scottish Parliament has heard that reforms to the Scottish Medicines Consortium have reduced the transparency of its decision-making

In evidence to the Health and Sport Committee in Edinburgh today, industry and patient representatives reported that, while the Scottish Medicines Consortium (SMC) now meets in public, the introduction of a secret ballot of its members on whether a new medicine should be accepted means it’s sometimes unclear what was behind the SMC’s final recommendation.

MSPs held a roundtable of six of the organisations that responded to a call for evidence on progress implementing changes that the Committee had asked for in the autumn of 2013, and that the Scottish Government and NHS had agreed to implement.

Sandra Auld, Director of the medicines industry trade organisation, ABPI Scotland, told the Committee that the move to a ballot, introduced when the SMC stopped meeting in private, does not allow the same transparency as the previous approach where a discussion took place leading to a consensus. She added that there were now instances when the vote did not seem to echo what people had said in the run up to it.

Dr Catriona McMahon, Lead Pharmaceutical Industry Representative on SMC, added that this meant that SMC staff were not able to tell a company exactly why their medicine had not been recommended, creating the possibility that the issue that had caused the problem might not be resolved when the company resubmitted.

There was praise for the SMC in the way it has introduced a Patient and Clinical Engagement (PACE) meeting into its consideration of some high cost medicines for end of life and very rare conditions. Patient groups and clinicians welcomed the change and the support SMC gives to those invited to take part.

The Chair of the patient organisation PNH Scotland, Lesley Loeliger, described PACE as an “amazing opportunity”. She asked that the involvement of patients and clinicians should not end at the PACE meeting.

Natalie Frankish of Rare Disease UK in Scotland agreed, saying patients and clinicians should be “offered the same courtesy” as the manufacturer whose medicine was being considered by being able to answer questions at the full SMC meeting.

Leigh Smith, Chair of Melanoma Action and Support Scotland, said she had attended PACE meetings where strong pleas had been made on behalf of a medicines only to be surprised when a very positive PACE report had still not been enough for SMC to say yes.

Supporting the call for patients and clinicians to be present at the SMC decision-making meeting, Ms Smith said that there had been an instance where, had the expert clinician been present, SMC members’ questions and doubts would have been addressed and a medicine would have been accepted where, instead, it was turned down. She added that if a very busy clinician had to choose, she’d suggest attending the SMC was a better use of their time than going to the PACE meeting.

The Committee discussed pricing and value of medicines, asking whether SMC decisions were too heavily influenced by price. While there was broad support from those around the table for consideration of the wider benefits and impacts of a medicine’s use, the NHS representatives repeated their call for manufacturers to submit their best price from the start rather than introducing discounts and access schemes later on in the process.

Leigh Smith pointed to the opportunities that Scotland has with a small patient population to be involved in working with patients and clinicians to gather real world information about medicines. She suggested this would be of great value to the company behind any medicine, which might be willing to pay the NHS for the data.

The industry representatives agreed that there was a significant untapped opportunity for Scotland’s clinical and academic communities to collaborate with medicines companies in gathering information about the wider value of medicines. However, witnesses from the NHS were concerned that the NHS systems are not currently in place to make information available on anything more than a small scale.

Professor Rob Jones, a Consultant Medical Oncologist from the Beatson West of Scotland Cancer Centre, said that while all cancer drug prescribing is captured on the same database, this does not allow anyone to quantify the benefit to any individual patient concerned.

Professor Jones followed up the written evidence he had submitted on behalf of his colleagues about the challenges of getting access to medicines that have not yet been through SMC, or have not been recommended following an SMC appraisal. He pointed to different processes and outcomes for clinicians making the required Individual Patient Treatment Requests (IPTRs) in different parts of Scotland, admitting he had no idea how applications by his counterparts in Lothian were handled.

Lesley Loeliger from PNH Scotland told the hearing that, despite the guidance from the Scottish Government that it should not be a consideration, proving the exceptionality of a patient’s condition or likelihood of benefit from a medicine remained at the heart of IPTR processes. She wondered how in, for instance, a total Scottish patient population of 15, exceptionality of any individual could be demonstrated.

Professor Jones called for consistency across Scotland but said he would wish to keep hold of the option to recognise the specific needs of an individual patient. And he wondered what might replace the IPTR process.

The Scottish Government has promised that IPTRs will be replaced by a clinician-led Peer Approved Clinical System (PACS).

Natalie Frankish from Rare Disease UK in Scotland pointed to the fact that the PACS idea was the result of a broad multidisciplinary consultation so it was frustrating that it isn’t yet in place. She added that it was difficult for patient organisations to comment until there is some information on how it will work in practice.

NHS Greater Glasgow and Clyde, in its written evidence to the Committee, reported that it is running a PACs pilot programme for ultra-orphan medicines. Although both the Board’s Lead Pharmacist for Governance and Director of Finance were witnesses at the Committee, neither was asked for an update on how the pilot is going.