Cost-effectiveness gatekeeper changes its mind on Amgen's virus-based melanoma med Imlygic

Amgen ($AMGN) parlayed a discount and some new data into NICE backing for its virus-based melanoma drug Imlygic, putting patients in England in line for the pricey, first-of-its-kind treatment.

The National Institute for Health and Care Excellence had previously refused to back Imlygic, which is approved for advanced melanoma that’s not eligible for surgery.

It’s the latest turnabout at the influential cost-effectiveness agency. In recent months, discounts have nudged NICE toward approving Celgene’s ($CELG) Otezla for psoriasis, Pfizer's ($PFE) Bosulif treatment for leukemia and GlaxoSmithKline’s ($GSK) long-denied Benlysta for lupus.

The discounts aren’t public. Imlygic’s list price in the U.K. is £1,670 per 1 ml vial, NICE says. In the U.S., Amgen has said the drug will average $65,000 per patient, but differences in dosing for each patient make that a ballpark estimate only.

Imlygic uses a genetically modified strain of the herpes virus, the so-called cold sore virus, to invade tumors and replicate itself, killing cancer and spurring an immune response to multiply its effect. Injecting Imlygic into melanoma lesions shrank tumors at a statistically significant rate in its Phase III trial.

Amgen is hoping to broaden Imlygic’s field by testing the drug alongside other cancer immunotherapies. The Thousand Oaks, CA-based biotech is already working to combine Imlygic with Merck's ($MRK) PD-1-blocking Keytruda in melanoma and head and neck cancer. It also has a collaboration with Roche ($RHHBY) to see how Imlygic works in breast and colon cancers when paired with Roche’s newly FDA-approved PD-L1 med, Tecentriq.

Other cancer drugs haven’t been so fortunate at NICE as of late. In June, the cost-effectiveness watchdog, whose decisions are closely followed in other countries, stiff-armed Roche’s new skin cancer med Cotellic, intended for use alongside the Swiss drugmaker’s targeted med Zelboraf. Meanwhile, drugmakers are up in arms about NICE’s process for reviewing drugs previously covered--or rejected--by England’s over-budget Cancer Drugs Fund. Eisai is kicking back at delays for its thyroid cancer treatment Lenvima, and Roche is doing the same on a related delay for its breast cancer therapy Perjeta. AstraZeneca ($AZN), whose lung cancer drug Tagrisso was rejected in NICE draft guidance, is calling for agency reform.

Eisai EMEA chief Gary Hendler wants the CDF switch to NICE oversight changed now. “We are calling for urgent transitional arrangements to bridge the gap in a new NICE and CDF process where Lenvima (lenvatinib) has been left off the CDF and ignored for review due to its low budget impact,” he told FiercePharma earlier this month.

On the other hand, Bristol-Myers Squibb’s ($BMY) newly approved melanoma cocktail--which combines its two immunotherapies Opdivo and Yervoy--won a green light at NICE in June, in “one of the fasted drug appraisals NICE has carried out,” said Carole Longson, who heads up NICE’s health technology and evaluation center.

- see the NICE documents

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