NICE approves Roche’s Gazyvaro and Novartis’ Xolair
pharmafile | March 11, 2015 | News story | Research and Development, Sales and Marketing | Gazyvaro, NICE, Novartis, Roche, Xolair, obinutuzumab, omalizumab
NICE today gave the green light to three new biological drugs, after recommending Roche’s Gazyvaro, GSK’s Arzerra and Novartis’ Xolair for use in the NHS.
The healthcare guidance body issued final appraisal determinations in favour of Roche’s Gazyvaro (obinutuzumab) and GSK’s Arzerra (ofatumumab) for chronic lymphocytic leukaemia (CLL), and Novartis’ Xolair (omalizumab) for severe chronic spontaneous urticaria (CSU).
NICE is proposing to recommend Gazyvaro and Arzerra for use in combination with chlorambucil chemotherapy for previously-untreated adult patients with CLL and co-existing medical conditions, who cannot have treatment with fludarabine and bendamustine.
CLL is the most common form of leukaemia in England, with around 2,700 people being diagnosed with the condition each year.
Gazyvaro had initially been rejected by NICE due to uncertainties around the company’s pricing, but later performed a U-turn after Roche agreed to a patient access scheme and submitted cost-effectiveness data.
GSK also agreed a similar price reduction for Arzerra – but sold the drug to Novartis in the companies’ asset-swapping deal of oncology products.
Speaking about the Gazyvaro decision, Jayson Dallas, general manager of Roche UK says: “We are very pleased to have worked with NICE to reach a solution whereby patients will soon be able to routinely access Gazyvaro on the NHS in England and Wales. The priority is to ensure that commissioners are prepared for the publication of final guidance to follow – at which point they will be responsible for making funding available so that clinicians and their patients can access the drug.”
Professor John Gribben, professor of medical oncology at Barts Cancer Institute in London says: “The long-awaited decision from NICE to approve Gazyvaro, the first new treatment to show a survival advantage compared to chlorambucil chemotherapy alone, addresses the need for a tolerable and effective treatment option for these patients and is important for both clinicians and their patients in the fight against this common form of blood cancer.”
Severe skin condition therapy
NICE is also proposing to recommended Novartis’ Xolair as an option for add-on therapy for adults and children aged over 12 who have severe CSU – a skin condition known as hives that causes severe and prolonged bouts of hives or wheals on the skin – if they have not improved after treatment with antihistamines and leukotriene receptor antagonists. An estimated half a million people in the UK may be affected by CSU, who Novartis say can expect to have access to the drug from the summer.
Dr Sinisa Savic, consultant immunologist at St James’s University Hospital Leeds says: “For many years treatment options for patients with the severe form of CSU have been quite limited and there has been a real medical need for an effective, licensed medicine to be available to patients and clinicians. The positive final appraisal determination issued today by NICE is a very welcome and important step forward for healthcare professionals and people living with CSU.”
Professor Carole Longson, director of the NICE centre for health technology evaluation says: “We are pleased that new evidence became available which allowed us to propose recommending omalizumab as a treatment option for people with hives whose condition has not improved with other treatments.
“Chronic spontaneous urticaria is characterised by persistent itching. It can interfere with daily living and sleep and, in severe cases, can be unbearable, disabling and can considerably affect quality of life. This treatment offers those whose condition has not improved with other treatments, a further option to control their symptoms.”
Lilian Anekwe
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