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

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01 March 2016: Scottish Minsters Demand Up-Front Medicine Price Negotiation

Scotland’s Health Secretary says no new medicine should be considered by the medicines assessment body, the Scottish Medicines Consortium (SMC), until NHSScotland can be sure it’s getting the best price.

Giving evidence to the Scottish Parliament’s Health and Sport Committee today (Tuesday) Shona Robison MSP revealed she has asked that a review of the SMC she has ordered includes consideration of how medicines submitted to SMC can be offered at the best and fairest price – at the earliest stage in the process.

“The short answer is that we don’t always get the company’s best price first time around or even at all,” Ms Robison told MSPs, adding, “I should be clear that not all the pharmaceutical industry behaves the same way on pricing but, while companies are absolutely entitled to take commercial decisions about how they are pricing their drugs, it is incumbent on all of us to ensure that the NHS has systems in place so that the best value is achieved and the need, for example, for time consuming resubmissions to SMC is avoided.

“We take the view that there should be external commercial negotiations linked with the SMC process. I think the pharmaceutical industry could also do better on fairer pricing without impacting unduly on the return for their shareholders. If we get that into a better place then it means that things like the New Medicines Fund will go further, supporting more people in Scotland. We would expect that, if a pharmaceutical company is able offer a better price elsewhere, there is no reason why they cannot offer that better price to the NHS in Scotland as well.

“There are potential ways in the systems of trying to get an earlier discussion to avoid getting to the position at the end of the process where a better price is then offered on resubmission that could have been offered in the first place, and yet sometimes months have elapsed during that period.”

At the start of her 90-minute evidence session before the Parliament’s Health Committee, the Health Secretary listed the progress that she said has been made since the Committee published their report and recommendations following an inquiry into access to new medicines in 2013.

These advances she said included the benefits being seen from a new collaborative of the Area Drug and Therapeutic Committees of each of Scotland’s 14 territorial NHS Boards. Ms Robison said the collaborative has been working on a national approach to optimised medicines use, supporting strengthened public involvement in the medicines assessment process, and developing and testing a new categorisation and communication policy for formulary decisions.

She also told the Committee of the establishment of a formal programme of work to monitor clinical effectiveness of cancer medicines in real world clinical use, adding that collection of information on the experience of using medicines was also going to be central to the proposed Peer Approved Clinical System (PACS) being trialled for some medicines by NHS Greater Glasgow and Clyde:

“The changes being tested through the PACS are the focus on capturing measurable clinical benefit, monitoring the outcomes and adverse events; the approach of the prescribing clinician leading on seeking peer support on an individual patient basis; and the use of a panel of clinicians to provide oversight of the cases put forward and the consistency this delivers.

“So I suppose the focus of PACS is on the clinician being at the centre of it with oversight of that.”

Shona Robison said that she looked forward to being able to complete the circle and feed information from real world use of medicines back to the SMC. And, although she said there was nothing from the pilot that was causing her any alarm, she admitted that the she didn’t want to move too quickly to introduce a new system in case it might jeopardise the advances in access seen since the introduction of the additional Patient and Clinical Engagement (PACE) stage to SMC’s evaluation of medicines for end of life and very rare conditions, and the increase in approvals of Individual Patient Treatment Requests (IPTRs) for non-SMC-approved medicines:

“I think we are in a better place. We are moving forward with caution around the pilot and moving to that new system over time. We want to make sure we continue with the positive improvements that we have seen but in amongst all that there will sometimes be decisions, whether it is under IPTR or under the new PACS system that will be unpopular and will be difficult.”

Dr Rose Marie Parr, the Scottish Government’s Chief Pharmacist reinforced the Government’s central message:

“We are being cautious – we want to see the main route for access to pharmaceutical companies as actually putting a good case through SMC, putting forward a good quality submission with a fair price and offering at SMC the first time and not by any other route.”

The Committee asked about another of the initiatives introduced since their original report, the creation of a £90 million New Medicines Fund, reinvesting payments made by medicines companies under the UK-wide Pharmaceutical Price Regulation Scheme. The Fund is being used to meet the extra costs for NHS Boards of paying for the medicines that would not have been accepted by SMC – or have had successful IPTRs – under the previous arrangements.

The Chief Pharmacist acknowledged that there had been some overestimates of the receipts and that the number of patients likely to benefit from the Fund will increase:

“I think there will be increasing pressure on the Fund but it is definitely not at risk just now. We would want the independent review to take stock of progress to date.”

Ms Robison addressed the issue of the lack of any information on how the Fund is being used, which so far has not gone beyond publishing an approximate number of patients who are benefiting from it. The Cabinet Secretary revealed that the Government’s desire to share information was, ironically, being thwarted by a Freedom of Information request:

“We think there probably should be more transparency around how the New Medicines Fund is being utilised. We had planned to publish the details of the number of patients treated and the relevant drugs.

“But, the Committee might be aware, that there is a Freedom of Information request ongoing wanting us to provide details of spend on the top ten drugs, which has been an ongoing complicating factor because releasing both patient numbers and spend per drug does pose a risk to commercial in confidence information on pricing.”

Ms Robison said that once this had been resolved she looked forward to publishing information on how the Fund is being spent.