A NICE yes for latest immunotherapy Bavencio

NICE has recommended Merck KGaA and Pfizer’s Bavencio in previously treated metastatic Merkel Cell Carcinoma, a rare and aggressive form of skin cancer.

This final recommendation is also accompanied by a green light for interim reimbursement via the Cancer Drugs Fund (CDF) in first-line use, pending further data to confirm its cost-effectiveness.

In September last year, Bavencio became the first and only targeted systemic treatment approved for metastatic Merkel Cell Carcinoma (mMCC).

NICE’s decision allows for a launch of the drug in England, Wales and Northern Ireland, giving patients a new option other than chemotherapy, which has limited efficacy and has unpleasant side-effects.

As usual, NICE has agreed funding of the drug after the manufacturers agreed a confidential discount to the headline price with the Department of Health.

In Wales, patients will access the medicine through the separate New Treatment Fund, which reimburses all treatments newly recommended by NICE – including draft recommendations.

The Scottish Medicines Consortium is also reviewing the drug and is expected to make a decision in the first half of 2018.

There are limited treatment options for merkel cell carcinoma, which has been diagnosed in around 1,500 people between 1999 and 2008.

The prognosis is poor – fewer than half of patients surviving more than one year after diagnosis and fewer than 20% surviving beyond five years.

There are thought to be approximately 70 new cases of mMCC in England every year, although the accuracy of this figure is difficult to determine due to the rarity of Merkel Cell Carcinoma.

Bavencio is an anti PD-L1 immunotherapy which works by enabling the patient’s immune system to attack and destroy cancer cells.

NICE has made its recommendation even though the drug has been hurried to market on the back of phase 2 data.

Merck KGaA's Belinda Byrne

Belinda Byrne, UK and Ireland medical director at Merck KGaA, said: “Merck and Pfizer are really pleased with today’s decision by NICE, which will result in patients in England, Wales and Northern Ireland being able to access the first targeted systemic treatment option licensed in the UK for metastatic Merkel Cell Carcinoma.”

“We have worked closely with NICE and the CDF to ensure all mMCC patients can get access to avelumab as early as possible in their treatment.”