New arrangements affecting patient access to melanoma treatment in England

The National Institute for Health and Care Excellence (NICE) recently issued a positive recommendation for the combination of Ipililumab and Nivolumab for the treatment of advanced metastatic melanoma in adults. Whilst awaiting implementation by NICE, the combination was granted interim funding through the new Cancer Drugs Fund (CDF).
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It came as a great surprise to us when we recently learned that NHS England has restricted the circumstances in which the drugs would be funded and available to patients on the CDF, through the implementation of a new set of criteria.

 These new restrictions are not consistent with either the NICE guidance or the license for the indication.  Given the unprecedented nature of this decision by NHS England, it was initially unclear whether these restrictions would apply once the combination therapy became available through routine (baseline commissioning), at which point NICE guidance would ordinarily apply.  NHSE has now confirmed its intention to apply the “same criteria as was in place for interim funding”.



Impacting patients
The Myfanwy Townsend Melanoma Research Fund is concerned by this decision for a number of reasons. Firstly, these restrictions will impact the number of advanced melanoma patients who would be able to access this innovative treatment, many of whom would have had this option had the NICE guidelines been fully implemented. Secondly, this decision is not consistent with the existing statutory obligations and patients’ rights as set out in the NHS Constitution, with regards to the full implementation of NICE guidelines.

Future funding in question
The decision also sets a dangerous precedent for the future commissioning and funding of treatments on the NHS, which may also now be subject to these changes.  There also appears to be significant risk of misunderstanding and unnecessary distress amongst clinicians and patients, who were not consulted on this new approach. According to NHS England, these criteria are based on their interpretation of the evidence base that has driven the NICE recommendation and an attempt to translate this recommendation into a clinical guide. In reality, they will significantly reduce the numbers of patients able to use NICE-approved medicines.
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Patient rights in question
We feel that this approach undermines existing statutory obligations and patients’ rights, as set out in the NHS Constitution. There is a binding legal obligation on NHS bodies to make available products recommended by NICE as therapy options, where the treating doctor considers that such treatment is appropriate.  No additional criteria or hurdles may be imposed. The imposition of these criteria sets a worrying precedent that future patient access to treatments proven to be cost effective by NICE will be consistently restricted by NHS England.

Impact on clinical trials
The nature of some of the restrictions may have inadvertent consequences for the recruitment and conduct of clinical trials in the UK. For example, some of the criteria imposed by NHS England would preclude patients who havbristol-meyers squibb research lab for melanomae previously received an immunotherapy treatment within a clinical trial setting from subsequently receiving NICE recommended treatments.

The restriction risks seriously effecting recruitment into on-going clinical trials because clinicians will be unwilling to limit their patients’ subsequent treatment options with NICE approved therapies. It would also disenfranchise those patients that have already entered a trial in good faith with the belief that they would have access to a full range of therapies if their disease progressed.

Unity is strength
We will be working with Bristol-Meyers Squibb and the Melanoma Taskforce and other like-minded charities in the hope that members will express a desire to voice their collective views, by writing directly to Peter Clark, the Chair of the NHS Chemotherapy CRG and copy this to Sir Bruce Keogh, the NHS Medical Director.

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If this situation affects you, if you have been denied access to treatment as a result of this new policy or if you would simply like your voice to be heard, please do contact

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