Access for Patients to New Drug Combinations

by Simon Rodwell | 19 January 2016 16:46

When we last reported on this subject, in December 2016, there were concerns about the restrictions NHS England (NHSE) had placed on the access of patients to NICE-approved drug combinations, specifically:

The restrictions applied to patients with brain metastases and to those who had previously been involved in clinical trials, and would have adversely affected patients currently on trials as well as the ability to conduct trials in the future.

We are pleased to report that these restrictions have now been removed. This follows concerns raised by the Melanoma Specialist Advisory Group, which was set up by NHSE at the end of last year to establish and oversee national melanoma systemic therapy algorithms. Melanoma clinicians led by Dr Pippa Corrie (Chair of the NCRI Skin Clinical Studies Group and a Trustee of Melanoma Focus) served on this Group.

Their concerns centred on the ‘Blueteq Criteria’ that govern patient eligibility for combination therapies; in particular, melanoma specialist oncologists felt them to be too restrictive and not reflecting NICE guidance or the emerging clinical evidence base. NHSE accepted these concerns and worked with the Group to revise the criteria.

The revised criteria, effective from 13 March 2017, are summarised below (changes underlined):

Dabrafenib + Trametinib

Criterion 3

Previous
I confirm the patient has no active brain metastases or leptomeningeal metastases ie. brain secondaries treated with surgery or stereotactic radiotherapy and considered to be stable
New
This criterion has now been removed


Ipilimumab + Nivolumab

Criterion 4

Previous
I confirm that the patient has not received previous treatment with any of anti PD1, anti PDL1, PDL2 or CTLA4 antibody
New
I confirm that the patient has not received previous treatment with any of anti PD1, anti PDL1, PDL2 or CTLA4 antibody for metastatic disease

Criterion 5

Previous
I confirm that the patient has only received allowed prior systemic therapy (adjuvant therapy in a trial but not with the agents listed in 4, or BRAF/MEKi targeted therapies)
New
I confirm that the patient has only received allowed prior systemic therapy (prior adjuvant therapy with immune checkpoint inhibitor monotherapy given only as part of a clinical trial or with BRAF/MEKi targeted therapies is allowed; prior adjuvant therapy with ipilimumab + nivolumab is not allowed)

Criterion 6

Previous
I confirm the patient has no active brain metastases or leptomeningeal metastases ie. brain secondaries treated with surgery or stereotactic radiotherapy and considered to be stable
New
I confirm the patient has no symptomatic brain metastases or leptomeningeal metastases currently requiring steroids for symptom control

Clinical Trials

Professor Paul Lorigan
Chairman, Melanoma Focus

14 March 2017


Source URL: http://melanomafocus.com/news-updates/combos/