Working Group Rejects NHS Retreatment Rules

The letter below was sent in July to NHS England by Dr Pippa Corrie, who leads the NHSE Melanoma Working Group, in response to new algorithms that would have the effect of limiting patients’ access to melanoma (and renal) therapies following breaks in treatment. The rules, disseminated in March 2017, have caused ‘great concern and unhappiness across the oncology community’, observes Dr Corrie, who goes on to say:

‘Highly trained specialist oncologists are best placed to make decisions around retreatment of patients; rules setting arbitrary treatment breaks with no evidence base are unhelpful to everyone. Oncologists have been making these decisions for years without the need to seek permission…

‘We understand that there may be an underlying concern to avoid unnecessary expenditure on high cost drugs. However, imposing additional administrative burdens… is likely to have a disastrous negative effect, incurring more rather than less costs.’

We will be posting further documents from the exchange of correspondence between this working group and NHSE. In the meantime we encourage any patient, clinician or member of the general public who is concerned about this issue – and wishes to play an active role in helping to protect patients’ interests – to sign up as a Clinical Reference Group stakeholder in order to comment on the new rules.

To register, please go to https://www.england.nhs.uk/commissioning/spec-services/get-involved/crg-stake-reg/.

Dr Corrie’s letter in full

Thank you for sharing the melanoma algorithms with us. The NHSE Melanoma Working Group is unable to approve them since we do not accept the principle outlined on page 2 regarding planned treatment breaks. We understand that this incorporates information recently disseminated in a specialised service circular (SSC 1726) dated 17 March 2017, which has caused great concern and unhappiness across the oncology community. We know that many trusts have been grappling with how to respond to this circular, so we jointly wish to register strong objection on behalf of all our melanoma specialist colleagues, as well as those treating other types of cancers.

Our objections to the principles set out in the SSC are summarised below. Essentially, the new rules are unnecessary and unfounded. There is no evidence that extended breaks in treatment have any detrimental impact on restarting systemic therapies and the duration of breaks that are allowed – or disallowed – set out in the SSC are completely arbitrary. An unintended consequence of these new rules (the SSC is inaccurate to state that these rules have previously been in existence) may well be that patients are denied access to efficacious treatments, with consequent reduction in their survival.

We understand others have raised objections in various different fora and we would be extremely grateful if our objections could be raised with and discussed by the national chemotherapy CRG with a request to rescind them please.

SSC 1726 states:

NHS England receives requests for chemotherapy relating to treatment breaks. Chemotherapy is defined as systemic anti-cancer therapy comprising cytotoxic drugs, targeted small molecule agents (the ‘-inibs’) and monoclonal antibodies (the ‘-mabs’). For the purposes of this circular a treatment break is defined as a break in the standard treatment schedule of greater than four weeks beyond the expected cycle length and without there being any evidence of progression of the cancer.

Currently, such requests are considered through the IFR process requiring completion of an IFR form and consideration by an IFR panel.

Neither this group, nor our colleagues across the country recognize that such an IFR process currently exists in routine practice and is clearly not being adhered to in any consistent manner. Each one of us has experienced stopping various SACT regimens for a variety of reasons, most of us have never had to apply for permission to restart treatment in the absence of disease progression, since this is part and parcel of our daily work as specialist oncologists and we are trusted to make appropriate decisions for our patients.

From April 2017, NHS England is implementing a new process for dealing with such requests which should reduce the time to approval, where appropriate, and reduce the administrative burden for both Trusts and commissioners.

Since these requests are currently not being made routinely, implementing this new process can only generate additional layers of bureaucracy and increase the already overburdened administrative system for both Trusts and commissioners. They will generate unnecessary stress for patients, work for doctors and pharmacists, as well as extra clinic visits.

The process for requesting funding following a break in treatment:

A request for funding ongoing chemotherapy should be made via this process following a break in treatment when all the following apply:

  • There has been a break in treatment of more than 4 weeks beyond the expected cycle length for all systemic anti-cancer therapy (SACT)
  • The exceptions to this are:

with systemic immune checkpoint inhibitor therapies (ie currently ipilimumab, pembrolizumab and nivolumab and potentially in the future atezolizumab, durvalumab and avelumab) where a break in treatment of up to 12 weeks from the previous dose is allowed

or

where a different maximum duration of treatment break is explicitly documented in the NHS England approval criteria for that specific drug or on the relevant NHS England chemotherapy algorithm.

We do not understand why treatment breaks for toxicity must be restricted in this way, nor why permission is required to retreat patients receiving any form of SACT if they have not progressed on prior treatment. In practice, a number of drug-related toxicities continue beyond the allowed treatment breaks and these patients should be entitled to restart their treatment without doctors having to apply for permission to do so.

Highly trained specialist oncologists are best placed to make decisions around retreatment of patients; rules setting arbitrary treatment breaks with no evidence base are unhelpful to everyone. Oncologists have been making these decisions for years without the need to seek permission, contrary to the initial statement set out by the SSC.

We understand that there may be an underlying concern to avoid unnecessary expenditure on high cost drugs. However, imposing additional administrative burdens outlined here is likely to have a disastrous negative effect, incurring more rather than less costs. This is exemplified by the experience we have learned from colleagues on consulting about this SSC. We have discovered examples where CDF access to high cost drugs such as cetuximab and pertuzumab mandates the need to apply for IFRs if a treatment break occurs. Since IFRs are in virtually all cases turned down, to avoid risk of this happening, patients are being continued on treatment beyond the time frame they would wish, in order to avoid the risk of not being able to treat at all. This perverse situation means that patients are exposed to more drug, more risk of toxicity, more hospital visits, generating more NHS costs above and beyond those which specialist clinicians consider to be necessary.

We can envisage a similar situation occurring in melanoma management. Particularly where patients have made a good/complete response to anti-PD1 antibody treatment, clinicians and patients are discussing whether to stop after being on continues treatment for 1 year or more. The justification for stopping is based on long term follow-up of patients treated in clinical trials demonstrating survival plateaus and the rationale for stopping clearly has benefits for both patients and for the NHS. However, the discussion with patients includes the reassurance that they have the option to restart treatment on progression, which could be many months in the future. This is within NICE guidelines and reflects standard practice when administering traditional cytotoxic chemotherapy. For example, a standard course of palliative gemcitabine chemotherapy is usually up to 6 cycles. Patients who are responding or stable at this time have their treatment stopped and are placed on surveillance. If their cancer returns on imaging 3 or 6 months later, then the same gemcitabine chemotherapy is restarted. This has never previously required central permission to restart cytotoxic chemotherapy regimens. Since use of the IFR process is in the vast majority of cases associated with a negative outcome, rather than risk the uncertainty of an application being turned down, clinicians and patients will simply elect to continue on anti-PD1 antibodies long term, for fear of having future access denied them. This seems to go against the very goal the process sets out to achieve, since high cost drug expenditure will be increased rather than decreased.

Where the above criteria are met a decision on the adequacy of the clinical justification for extending the break can be made by the appropriate regional cancer pharmacist. In making that decision they should ensure:

  • That the extended treatment break does not appear to be a treatment strategy planned in advance (unless to allow for holidays etc.) but is an unplanned extended treatment break in reaction to unforeseen events (e.g. longer than expected recovery from surgery or toxicity).
  • That the patient’s disease has not progressed during the treatment break.

The first bullet point above serves to confirm our expectation that IFRs for planned treatment breaks will not be approved. We fail to understand why planned treatment breaks are considered to be unacceptable, given that such breaks only serve to offer benefits both to patients and the healthcare system as a whole. This has been demonstrated previously in UK clinical trials such as the FOCUS2 advanced colorectal cancer trial, which showed that survival with intermittent blocks of chemotherapy versus continuous dosing was similar, but intermittent dosing offered improved patient quality of life as well as health care cost savings. The rules within SSC 1726 call into question whether clinicians have been properly involved in its construction and whether it is fit for purpose. The disquiet it has generated across the country indicates an urgent need for national consultation with the clinical community before further work on the national treatment algorithms can proceed.

P G Corrie PhD FRCP
Consultant and Associate Lecturer in Medical Oncology
On behalf of the NHSE Melanoma Working Group

NHSE Melanoma Working Group Members:
Professor Paul Lorigan, Professor Poulam Patel, Dr Matthew Wheater, Dr David Chao

 
 
 
 

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