The demise of the Individual Patient Treatment Request (IPTR) in Scotland was heralded more than two years ago. But it is still in use and as controversial as ever.

While the Scottish Government has just announced an independent review of the medicines appraisal body for NHSScotland, The Scottish Medicines Consortium (SMC), the process a clinician has to follow to prescribe any medicine that the SMC has not recommended remains fundamentally unchanged, and their chances of success remain variable.

Healthcare Improvement Scotland (HIS) states the IPTR process: "is designed to provide an opportunity for clinicians to pursue, on a case by case basis on behalf of individual patients, a medicine that has not been accepted by the Scottish Medicines Consortium (SMC) or HIS following their appraisal on clinical and cost effectiveness."

Taking evidence in 2012 and 2013, it became clear to the Scottish Parliament's Health and Sport Committee that the IPTR system was flawed. Different NHS Boards were approaching it differently. Some felt it was for medicines use in-license and others off-license. Doctors reported having to write lengthy papers reassessing clinical trial evidence; others that they applied more in hope than expectation. And an overarching theme was that, to be successful, a clinician had to prove that their patient's case was 'exceptional' compared with others with the same condition.

The Committee concluded that IPTRs, and specifically exceptionality, "are a barrier to access to medicines for clinicians who want to prescribe medicines that they believe are best for their patients".

In response the Scottish Government announced in October 2013 that IPTRs were being replaced by a new Peer Approved Clinical System (PACS) that would be "clearly linked to clinical opinion".

The then Health Secretary Alex Neil MSP told the Committee:

"The new PACS guidance will be issued shortly and will clarify that there is a single, national system to be applied locally, and this will be clinically led. Variation in approach to such decision-making will be minimised through strict auditing arrangements."

In the meantime, the Government predicted, the new PACE process [see my blog ] giving extra weight during SMC assessment to medicines for end of life and very rare conditions would "significantly reduce the current dependence" on IPTRs.

The following month NHS Boards were told to stop using exceptionality and to exercise flexibility in their IPTR decision making.

More than two years on, the responses to the Health Committee's call for evidence on the progress of implementing the changes shows the new PACS has not been rolled out, though a pilot is underway in NHS Greater Glasgow and Clyde.

In its evidence to the Committee, the charity Beating Bowel Cancer quotes a letter written at the end of last year to Malcolm Chisholm MSP by the Health Secretary Shona Robison MSP, in which she states:

"The hope is for PACS to be fully rolled out when we are confident it is delivering at least as much flexibility for clinicians and patients as the interim Individual Patient Treatment Request (IPTR) process."

One big change since the Committee reported is the creation of the £80 million New Medicines Fund, resourced from repayments made by the medicines industry under the UK-wide Pharmaceutical Price Regulation Scheme (PPRS). The Government says the Fund is there to meet the extra cost of medicines accepted by SMC under the PACE process and successful IPTR applications. Ministers say more than 1000 patients have been supported so far. However, several submissions to the Committee express concern about the Fund's long term future with less than three years left of the current PPRS agreement.

In evidence to the Committee on IPTR, NHS Lanarkshire and NHS Grampian both say the new more flexible approach has led to a higher rate of acceptance of IPTRs, while NHS Fife says that more medicines being approved by SMC has led to a reduction in the number of IPTRs.

NHS Lothian tells the Committee that, despite the changes, IPTR panels still come under considerable criticism for not supporting applications for end of life medicines that are not recommended by SMC. NHS Lothian adds: "The IPTR panel are now less likely to approve a medicine which has been through SMC with the new PACE process, as there will have been every opportunity for any added value of the medicine to a patient, patient's family, and carers to have been considered."

The makers of these medicines do not report progress. The industry trade body ABPI Scotland in its evidence says: "We believe that the flaws in the IPTR system as identified by the Committee in its report in 2013, most notably its inequity, persist." One member company, Novartis, adds: "Anecdotally there appears to be an increasing difficulty in obtaining approvals for IPTRs. There has not been any monitoring published to track IPTR applications and approvals."

Clinicians at the Beatson West of Scotland Cancer Centre report to the Committee that:

"By and large, the sense of our group is that the 'threshold' for SMC acceptance of cancer drugs (most of which are considered for 'rare diseases or end of life medicines') has lowered since July 2013. This is probably the most important barometer of success for cancer patients."

But the Beatson oncologists say of IPTRs:

"Opinions are divided among our group regarding the extent to which the 'threshold for acceptance' has changed since early July 2013. Some clinicians note a clear improvement in access by this route (where previously it was a 'no' unless there was compelling reason to say 'yes', now it is 'yes' unless there is compelling reason to say 'no'), but others report no change. This difference in experience probably reflects differences in access to small numbers of key drugs in specific diseases and the 'superspecialisation' of oncologists within our group.

"Some of our group question the validity of the process by which IPTR decisions are made, although the transparent involvement of disease-specialist oncologists is welcomed.

"Whilst there was a previous clear instruction from the Scottish Government to redefine the criteria by which an IPTR should be assessed, most clinicians at the Beatson feel that the revised criteria remain poorly defined. It is, therefore, difficult to know which individual patient factors are likely to result in a successful IPTR.

"There is also some evidence that the IPTR decision making criteria are now quite different between the regions of Scotland. and that these differences have resulted in some patients being able to access drugs in one part of Scotland where access would have been denied had they lived in another. This has resulted in some low-level 'postcode prescribing' within Scotland, a practice which none of us support."

The charity, Beating Bowel Cancer expresses disappointment with the extent of progress:

"Our primary concern still remains that a small but significant number of patients are still forced to rely on discredited IPTRs to access non SMC-approved medicines."

The charity calls on the Scottish Government to "take action against health boards that are not processing IPTR applications based on the letter and spirit of the reforms".

In 2013, Beating Bowel Cancer proposed a 'triple-lock' approach to IPTRs where, if two independent clinicians agreed with a patient's doctor that a medicine was likely to be of benefit, there would be a presumption that the request would be met.

The charity reminds the Committee of this option in its latest submission. In doing so it echoes the principle behind the Scottish Government's proposed PACS: that clinical opinion should be the deciding factor.

ⁱSource

ⁱMy blog

ⁱSource

ⁱSource