In light of NICE’S latest policy change, Steven Bradshaw comments on how this decision will effect second line treatment of non-small cell lung cancer.
Dr Steven Bradshaw, Medical Expert
As a regularly-published medical expert with a significant degree of experience in HTA submissions and market access of pharmaceuticals, Dr Steven Bradshaw act as a consultant to some of the top pharmaceuticals companies, healthcare research organizations and government think tanks in the world.
Recently appointed European Director of MTKXS, Steven Bradshaw’s extensive healthcare policy experience is often sought to shed light on the current issues facing the pharmaceuticals industry. That is why Bradshaw felt he must comment on the recent decision taken by the National Institute of Health and Care Excellence (NICE) to update its recommendations for the treatment of non-small cell lung cancer (NSCLC), which has progressed after a patient has undergone chemotherapy.
First-Line, Second Line Treatment with EGFR-TK Inhibitors
According to Pharmatimes, the Institute has made alterations to existing guidance, which will bar access to AstraZeneca’s Iressa (gefitinib), yet will still permit the use of Roche’s Tarceva (erlotinib) on a case by case basis. This policy has been put in place to reflect the most up-to-date evidence.
NICE went on to point out that since the publication of the original guidance for these treatments, clinical practice algorithms have changed. The Institute further noted that current practise is to have patients with NSCLC receive tumour testing for EGFR-TK mutation status at the point of diagnosis, before being afforded first-line therapy. This allows experts to make sure that the most appropriate treatment plan for the patient is chosen.
When it comes to first-line treatments in the case that tumours carry this mutation, NICE has already suggested the employment of both Iressa and Tarceva, which are both proven as effective EGFR-TK inhibitors. However, the independent advisory committee exploring the matter were informed by independent clinical specialists, that, after a patient has received these drugs in the process of first-line treatment, in clinical practise, they are unlikely to receive any benefits from an EGFR-TK inhibitor when it comes to second-line treatment, because of the reduced sensitivity to them.
The committee were also informed that there may be a case of a delayed diagnosis of mutation status for a small group of patients. They were further told that whilst in some instances, it is acceptable to wait two weeks for confirmation and treatment, when a patient holds an aggressive case of the disease, they need to be referred for immediate treatment so that experts can confirm EGFR-TK mutation status.
This is why NICE has provisionally given the green light to Tarceva as a treatment option for the disease in cases where the patient has had non-targeted chemotherapy in its new draft guidance. However, the Institute stipulated that this is only an option when the status of the tumour is delayed.
NICE further stipulated that the patients’ condition reacts to the first two cycles of treatment with Tarceva, and that Roche supplies the drug with a discount agreed through the patient access scheme.
Andrew Dillon NICE’s Chief Executive commented on the issue. Dillon said: “The ongoing review of these two treatments incorporates new evidence on the clinical and cost effectiveness of erlotinib and gefitinib – the revised recommendations aim to ensure that patients are offered the most appropriate treatments.”
Steven Bradshaw Comments
In my opinion, NICE are making their recommendations based on the evidence they have; that’s all they can do in this era of cost containment. What this move suggests is that we continually need to conduct research to better understand biomarkers that can identify those patients who will better respond to new treatments.