NICE draft “yes” for MabThera, “no” to Gilenya

by | 1st Dec 2011 | News

New draft guidance from the National Institute for Health and Clinical Excellence (NICE) is good news for Roche's MabThera (rituximab) but not for Novartis' Gilenya (fingolimod).

New draft guidance from the National Institute for Health and Clinical Excellence (NICE) is good news for Roche’s MabThera (rituximab) but not for Novartis’ Gilenya (fingolimod).

NICE’s new draft guidance on MabThera says the drug should be an option when used in combination with a wide range of chemotherapy products for people with advanced follicular lymphoma.

Evidence shows that adding MabThera to chemotherapy treatments cyclophosphamide, vincristine and prednisolone (CVP), cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP), mitoxantrone, chlorambucil and prednisolone (MCP) and cyclophosphamide, doxorubicin, etoposide, prednisolone and interferon-a (CHVPi), helps people to live longer and improves their quality of life, compared with chemotherapy alone, and it is also good value for money for the NHS, says NICE.

The Institute’s appraisal committee also considered the use of MabThera plus chlorambucil for advanced follicular lymphoma, and concluded that this is an appropriate use of NHS resources.

“The committee heard from patient experts that rituximab treatment improves their quality of life. We also know a range of choice and availability of treatments has a positive effect on patients and their families,” said Professor Peter Littlejohns, clinical and public health director at NICE.

“At the second committee meeting, members heard from the clinical specialist that some older people are not fit enough to receive the most common types of chemotherapy. For that reason, the committee decided to also recommend rituximab in combination with chlorambucil in the latest draft guidance, to give clinicians wider treatment options for their patients,” he added.

The draft guidance now goes out for consultation until December 15, and if no appeals are received, NICE expects to public its final guidance in January.

However, in other new draft guidance, NICE says that it is still unable to recommend Novartis’ Gilenya (fingolimod), which could reduce relapses in patients with highly active relapsing-remitting multiple sclerosis (RRMS), because it would not be cost-effective for the NHS.

Novartis had offered the drug at a discount under a patient access scheme (PAS), but NICE’s independent appraisal committee has not been convinced that, even with this discount, Gilenya would be a cost-effective option for the NHS, compared with treatments currently offered to people with highly active RRMS such as beta interferons.

This revised draft guidance has been published as part of a public consultation which is open until January 5, and Sir Andrew Dillon, NICE’s chief executive, said: “we encourage healthcare professionals, people with MS and our other stakeholders to comment on our independent committee’s provisional recommendation so that they can contribute to the development of this guidance.”

The MS Society has also urged people with MS to contact NICE with their views during the consultation, describing the latest draft guidance as “incredibly disheartening.”

The appraisal committee will meet again in February to review the comments received, and NICE says it expects to publish its final guidance in April 2012.

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