Unlock Premium Data: Up to 50% Off InvestingProCLAIM SALE

Roche wins UK watchdog's nod for lymphoma drug after initial snub

Published 09/02/2018, 14:20
Updated 09/02/2018, 14:30
© Reuters. Logo of Swiss drugmaker Roche is seen at its headquarters in Basel
ROG
-

By John Miller

ZURICH (Reuters) - Britain's healthcare watchdog (NICE) recommended Roche's (S:ROG) medicine Gazyvaro for previously untreated advanced follicular lymphoma patients after initially rejecting the Swiss drugmaker's medicine last year as too expensive.

NICE recommended Gazyvaro, also called Gazyva, for use by the National Health Service (NHS) with chemotherapy in patients with higher risk of relapse. The company must provide the drug at a discount, NICE wrote.

The decision will affect about 1,200 people annually, Roche said on Friday. About 1,900 people are diagnosed with follicular lymphona a year in Britain.

Gayzvaro is a more-expensive follow-on to Rituxan, Roche's best-selling, $7 billion(5.02 billion pounds)-per-year medicine that has lost patent protection in Europe and is seeing sales quickly eroded by rivals' cheaper copies.

Last year, NICE opted not to recommend Gazyvaro's broad use in first-line lymphoma, citing, among other things, "concern about the assumptions used in the company’s cost-effectiveness modelling".

To win NICE's change of heart, Roche revamped its analysis including by focussing on higher-risk lymphoma patients. In a statement, the Basel company called the recommendation "a positive example of how solutions can be reached when all parties show flexibility."

A NICE committee that reviewed the drug did object to Roche's characterisation of Gazyvaro, whose generic name is obinutuzumab, as an "innovative medicine."

"Obinutuzumab is not innovative," the panel wrote.

Roche has been steadily seeking expanded approval for Gazyvaro since it was originally approved in 2013 for other blood cancer indications.

© Reuters. Logo of Swiss drugmaker Roche is seen at its headquarters in Basel

The U.S. Food and Drug Administration last year expanded approvals for Gazyva to include previously untreated follicular lymphoma.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.