The Sunday Herald’s request for information about the New (previously Rare Conditions) Medicines Fund, created problems for the Scottish Government. And the answer, now that it has been given, only gives part of the picture of a fund that boosts the medicines budget to a far greater extent than any other scheme in the UK.

Paul Hutcheon, an investigative journalist (who I once worked with), is a veteran user of Freedom of Information requests.

He asked the Scottish Government to list the ten medicines that had taken up most of the New Medicines Fund (NMF) budget and how much each of these treatments had cost.

The NMF meets the cost of medicines for end of life and very rare conditions accepted by the SMC under the Patient and Clinical Engagement process, introduced following the new medicines review in 2013. It also pays for medicines not accepted by SMC that are supplied following a successful Individual Patient Treatment Request (IPTR). It covers all therapy areas, not just cancer, and is funded through payments from the pharmaceutical industry under the Pharmaceutical Price Regulation Scheme (PPRS).

Ministers knocked back Mr Hutcheon’s request, as Health Secretary Shona Robison explained to the Health Committee when she gave evidence in early March[i]:

“There should be more transparency in the use of the new medicines fund. We had planned to publish details of the number of patients being treated and the relevant drugs but, as the committee might be aware, there is an on-going freedom of information request that asks us to provide details of the spend on the top 10 drugs. That has been an on-going complicating factor, as releasing patient numbers and spend on drugs poses a risk to commercially confidential information on pricing.

“Once that process has been concluded, we will publish the information that we were planning to publish, and I hope that that will provide a bit more information about how the money in the fund is being spent.”

The process has now been concluded after the Scottish Information Commissioner ruled in favour of the newspaper. However, despite the build-up, the final response to the FOI request is limited in its scope.

The Sunday Herald says[ii] that £18.6m of the £21.7m fund in 2013-14 went on the cystic fibrosis medicine Ivacaftor (brand name Kalydeco), believed to be for two years’ supply. The second highest spend was £660,000 on Eculizumab for haemolytic uraemic syndrome, followed by £455,000 on the cancer drug Pomalidomide.

The high proportion of the then £21 million fund dedicated to Kalydeco is unsurprising given that the measure was introduced in January 2013[iii] specifically to deal with the Cystic Fibrosis Foundation’s persuasive case for the medicine, immediately following its rejection by the Scottish Medicines Consortium (SMC).[iv]

Since then the fund has been increased to £40 million (in October 2014) and then £80 million (in May 2015 for 2015-16), and then £90 million (in February 2016)[v].

At this level, the NMF is nearly three time more generous than the Cancer Drugs Fund (CDF) for England [The NMF is 2.7 times larger as a proportion of the total population than the CDF [vi]].

However, just as was the case for the CDF (underspent in its first three years), the Health Secretary revealed to the Health and Sport Committee[vii] that the amount of the NMF spent in its second year, £21.6 million, had not risen from the first year:

“As the new medicines fund ensures that boards can deliver the policy intentions of the Scottish Government and the Scottish Parliament, it is the boards that receive the resources. In 2014-15, NHS boards required £1.1 million to support SMC decisions and £20.5 million to support individual and group patient treatment requests from the new medicines fund. Any funding that was not required by NHS boards for that purpose in 2014-15 remains available in 2015-16 on top of the new allocation that was made for 2015-16. We work closely with boards on monitoring the use of the funding to ensure that it is adequate to meet a board area’s needs, and we will continue to do that.”

So, if my maths is right, the fund pot for 2016-17 will now stand at over £108.4 million (£90 million plus the £18.4 million underspend from 2014-15), plus any money underspent from the year just ending (2015-2016). That is, unless the £90 million figure given to Parliament in February already includes this.

The NMF deserves continued scrutiny, first because, even without any carry forward of funds from the previous year, it represents a nearly 6% boost in the money budgeted for medicines in Scotland[viii]; and, second, because it has the potential to help us measure whether access to medicines policy changes are working.

So, now that the complication caused by Mr Hutcheon has been resolved, the way should be open for new government ministers to answer two immediate questions: how big is the fund in the new financial year; and what has the fund been spent on in the two years not covered by Mr Hutcheon’s FOI response?

As the fund pays for medicines accepted by SMC under the PACE process and also meets the costs of successful IPTRs, it represents a useful barometer of the impact of the changes in access to medicines policy first recommended in 2013 and now being reviewed by Dr Brian Montgomery[ix].

I believe three further questions are worth asking.

Has the amount of the NMF spent on funding IPTRs changed and – crucially – why? If the PACE system is leading to more medicines being accepted by SMC, clinicians will no longer need to make IPTR requests for them. On the other hand, the medicines industry trade body, ABPI Scotland, told the Health and Sport Committee that the IPTR route becomes more difficult for a medicine considered and then rejected under the PACE process.

In written evidence to the Committee, oncologists from the Beatson West of Scotland Cancer Centre said they remained concerned about the fairness of the IPTR system as the criteria for a successful IPTR were unclear and outcomes seemed to vary depending on where the patient was in Scotland.

So a further question is: is there a fair and proportional distribution across the NHS Boards of patients whose medicines are being funded by the NMF following successful IPTR requests?

The third question for government is: has the advent of the NMF had any knock-on benefit for other patients whose illnesses are neither ‘end of life’ nor very rare?

There are game-changing new medicines coming forward for several chronic conditions that do not fall within the scope of the NMF.

It seems reasonable to hope that funding for these might become easier now that the NMF is relieving local drug budgets of the cost of an increasing number of medicines for end of life and very rare conditions.

 [i] Official Report, Health and Sport Committee 1 March 2016: http://goo.gl/3NxrGw

[ii] Sunday Herald: http://bit.ly/1S9GSZ2

[iii] Scottish Government News Release: http://www.gov.scot/News/Releases/2013/01/medicines-fund14012013

[iv] BBC Report January 2013 http://www.bbc.co.uk/news/uk-scotland-21016879

[v] Parliamentary Answer Question S4W-29677: Jackson Carlaw, West Scotland, Scottish Conservative and Unionist Party, Date Lodged: 03/02/2016

[vi] My comparison of CDF and NMF http://www.ettrickburn.com/default.asp?page=commentary

[vii] Official Report, Health and Sport Committee 1 March 2016: http://goo.gl/fFb3Lf

[viii] As a percentage of the core drugs budget, the additional funding for medicines under the Scottish New Medicines Fund is 3 times more generous than the Cancer Drugs Fund in England (5.8 per cent additional to budget compared to 1.8 per cent – calculations as for reference vi

[ix] Scottish Government News Release: http://news.scotland.gov.uk/News/Review-of-access-to-new-medicines-2209.aspx