Patients with lung cancer will not be able to access Eli Lilly's Portrazza on the National Health Service in England and Wales, after a final rejection from the National Institute for Health and Care Excellence.
In final guidelines the cost regulator has turned down the drug for treating locally advanced or metastatic epidermal growth factor receptor (EGFR)-expressing squamous non-small-cell lung cancer in adults who have not had chemotherapy.
Portrazza (necitumumab) is available at a list price of £1,450 per 800‑mg vial (excluding VAT), which equates to £2,900 per cycle and an average of £30,740 per course (excluding the cost of gemcitabine and cisplatin).
Lilly has offered a Patient Access Scheme under which it offers the drug at a simple discount, but it was not enough to persuade the Institute that it represents a cost-effective use of NHS resources, particularly as it considered that its survival benefit was small.
The committee concluded that the most plausible incremental cost effectiveness ratio for necitumumab compared with gemcitabine plus cisplatin was between £110,000 and £170,000 per QALY gained, and was likely to be towards the upper end of this range, thus well outside the bounds of what is normally considered value for money.
The committee also concluded that the drug did not meet the criteria to be considered for use in the Cancer Drugs Fund as it was not cost-effective and no clinical uncertainties could be addressed from further data collection.
Portrazza was approved by European regulators back in February as the first biologic option for this subset of lung cancer patients, offering a new approach where there has been little progress in twenty years.
Clearance came after the Phase III SQUIRE trial showed that the addition of Portrazza to gemcitabine and cisplatin chemotherapy improves overall survival in patients, with median survival of 11.5 months versus 9.9 months.
Good new for Xofigo, Imlygic
On the plus side, NICE published two sets of final guidelines recommending new treatments for prostate cancer and melanoma.
Bayer's Xofigo (radium‑233 dichloride) was endorsed for as an option for treating hormone-relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases, but only in patients who have already had docetaxel or can't take the chemotherapy.
The cost of a full the course of treatment is estimated to be £24,240, though Bayer has agreed a patient access scheme with the Department of Health that makes the treatment available with a confidential discount applied to all invoices.
Amgen's Imlygic (talimogene laherparepvec) is recommended as an option for treating unresectable, regionally or distantly metastatic (Stage IIIB, IIIC or IVM1a) melanoma that has not spread to bone, brain, lung or other internal organs, in patients how have received docetaxel or can't take it.
The therapy, which is also known as T-Vec, costs £1,670 per 1ml vial (list price), and clinical experts suggest that it would be suitable for about 10 - 15 percent of those with advanced melanoma that has spread and can't be surgically removed.