Pfizer’s Lung Cancer Drug Rejected; Deemed Too Costly

Pfizer Ltd has expressed concern and disappointment that the final appraisal determination (FAD) from the National Institute of Health and Care Excellence (NICE) does not recommend Xalkori (crizotinib) for previously treated, ALK positive advanced non-small cell lung cancer (NSCLC). Whilst NICE has acknowledged that crizotinib may offer eligible patients better outcomes compared to standard chemotherapy, it has not been recommended for use within the NHS because NICE does not consider it to be cost- effective.

Pfizer is concerned about the impact this decision will have on eligible patients with previously treated NSCLC, whose tumors have been identified as ALK positive. As a personalized medicine, crizotinib allows targeted treatment of a specific group of patients who are most likely to benefit. In reality, the UK’s limited and slow-paced adoption of innovative medicines such as crizotinib poses a real threat to both the government’s goal to have UK cancer outcomes among the highest in Europe and its vision to make the UK a world leader in life sciences.

“As someone who cares for lung cancer patients on a regular basis, I am personally very saddened by this decision,” said Dr. Michael Peake, Clinical Lead, National Cancer Intelligence Network and Consultant Physician, University Hospitals of Leicester. “Advanced lung cancer is an aggressive disease with very poor outcomes for many patients. Clinicians recognize the urgent need for personalized medicines that target the specific drivers of an individual patient’s tumor. However, if patients are unable to routinely access such therapies, it leaves them at risk of potentially poorer outcomes than patients in other countries where they have access to personalised medicine.”

Pfizer believes that the health technology assessment system makes it increasingly difficult for innovative medicines to be accepted for use within the NHS and available for the benefit of patients. During the appraisal process, NICE accepted that crizotinib offered patients a “noteworthy” improvement in progression-free survival and the number of patients responding to treatment was “very high” for a second or later line therapy in this difficult-to-treat cancer. Furthermore, NICE acknowledged that crizotinib was likely to extend patients’ lives, but it was uncertain for how long. This was due, in part, to uncertainty in estimating the magnitude of overall survival benefit attributed to crizotinib.

Like many clinical trials for oncology medicines, the crizotinib trial was designed, for ethical reasons, to give patients allocated chemotherapy the opportunity to receive crizotinib once their cancer had progressed. This factor makes it difficult to compare the differences in overall survival between the two arms of the trial, because the majority of patients will have received crizotinib.

Following NICE’s decision not to recommend crizotinib, the only other route for patients with previously treated, ALK positive advanced NSCLC to access the treatment is through the National Cancer Drugs Fund (CDF). However the CDF is only available to patients in England, treatments are not guaranteed to stay on it, and the future of its existence remains unknown. As such, a NICE recommendation still remains the optimal way to ensure all eligible patients in England and Wales have routine access to a second-line therapy. In addition, approval by NICE may improve the uptake of diagnostic testing, a necessary step in the treatment pathway for many targeted medicines.

Dr. David Montgomery, Medical Director, Pfizer Oncology UK, said, “The government’s strategy for personalised care in cancer includes treating people with medicines targeted at the specific characteristics of their cancer. Yet crizotinib has not been well served by the current assessment models employed by NICE. Today’s decision is another example of NICE declining a medicine, which we strongly believe is a clinically and cost-effective treatment. If this trend of negative decisions continues, we could see the UK fall even further behind other European countries for cancer survival rates.”