NICE Draft Approval for MabThera and Rejection for Gilenya

New draft recommendation 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NICE’s new draft guidance on MabThera states that the drug should be an option when used in combination with an extensive range of chemotherapy products for people with advanced follicular lymphoma.

Evidence demonstrates 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 live longer, and increases their quality of life, compared with chemotherapy alone, and is good value for money for the NHS, says NICE.

The appraisal committee also considered the use of MabThera with chlorambucil for advanced follicular lymphoma, concluding that this is also an appropriate use of NHS resources.

Follicular lymphoma is a cancer of the lymphatic tissue, which causes enlargement of the lymph nodes and generalised symptoms.  The lymphatic system produces, stores, and delivers lymphocytes, which are cells that fight infection.  Roughly 1,869 people in England and Wales have follicular lymphoma, and the majority of people are within the advanced stage of the disease.  Advanced follicular lymphoma is not curable and so the intention of disease management is to both increase life expectancy and health-related quality of life.

“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, the 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  For that reason, the committee decided to also recommend rituximab in combination with chlorambucil in the latest draft guidance, to give clinicians wider treatment options for their patients,” he added.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 recommendation now goes to consultation until December 15th, and if no appeals are received, NICE expects to release their final guidance in January.

In other new draft guidance, NICE announced today that they are still unable to recommend Novartis’ Gilenya (fingolimod), which is taken daily to reduce relapses in patients with highly active relapsing-remitting multiple sclerosis (RRMS), as it would not be cost-effective for the NHS in comparison to existing treatments that are currently available, such as beta interferons.

Novartis had offered the drug at a discount under a patient access scheme (PAS), but the appraisal committee was not convinced that, even with this discount, Gilenya would be a cost-effective option for the NHS.

Sir Andrew Dillon commented that “it is important for people with multiple sclerosis to have access to different treatment options wherever possible; however these new treatments must represent value for money so that everyone can get the most out of the NHS.  While Novartis submitted evidence that shows fingolimod can reduce relapses, our independent committee has not been convinced that it is a cost effective treatment option for the NHS, even with the proposed Patient Access Scheme.”

The revised draft guidance has been published as part of a public consultation which is open until January 5. Dillion added that NICE “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 Multiple Sclerosis Society has 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 said that they expect to publish their final recommendation in April 2012.


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