NICE Draft Guidance Rejects Bayer’s Xofigo

The National Institute for Health and Care Excellence (NICE) today published draft regulatory guidance rejecting Bayer’s Xofigo for patients with prostate cancer. Xofigo has been submitted to the regulatory body to treat patients with hormone relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases. Clinical trials have demonstrated that Xofigo can significantly improve

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NICE Requests Further Information on Genzyme’s Lemtrada

The regulatory body for the NHS in England and Wales has requested additional information from Genzyme prior to making a decision on the submission of Lemtrada. The National Institute for Health and Care Excellence (NICE) are currently unlikely to recommend the use of Genzyme’s Lemtrada (alemtuzumab) for relapsing, remitting multiple sclerosis, as a result of

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NICE Draft Guidance Advises Against Roche’s Perjeta

Draft guidance issued today by the regulatory body, NICE (National Institute for Health and Care Excellence), has confirmed that the NHS in England and Wales has been advised not to routinely provide Roche’s Perjeta (pertuzumab). Perjeta was submitted as a treatment for a type of advanced breast cancer, but has been found not to represent value

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NICE Draft Guidance Backs Hepatitis C Drug

Cost regulator, NICE has recommended the approval of peginterferon alfa on the National Health Service (NHS) in England and Wales to treat children and young people with hepatitis C. The National Institute for Health and Care Excellence (NICE) this morning published draft guidance backing a combination of peginterferon alfa and ribavirin as an option for

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NICE Provides Final Draft Guidance for Lucentis

UK drugs watchdog, NICE, have endorsed the use of Lucentis on the NHS to treat visual impairment caused by diabetic macular oedema after Novartis submitted a revised patient access scheme (PAS) and new drug data. The National Institute for Health and Clinical Excellence published the final draft guidance after a rapid review of the original

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Xolair Endorsement Retracted by NICE

The National Institute for Health and Clinical Excellence (NICE) have released draft guidance withdrawing their recommendation of Novartis’ Xolair for severe persistent allergic asthma. In 2007, NICE circulated guidelines supporting the use of Xolair (omalizumab) on the National Health Service (NHS) for adults whose asthma is poorly controlled.  Then in 2011 they reject the treatment’s

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NICE Requests Further Information on Zelboraf

The National Institute for Health and Clinical Excellence (NICE) has issued a second draft guidance to Roche asking them to provide additional information on the use of their skin cancer drug, Zelboraf (vemurafenib). The request concerns Zelboraf’s use in the treatment of unresectable locally-advanced or metatastic BRAF V600 mutation-positive melanoma, for which NICE announced, in

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NICE Issues Final Draft Approval For Incivo

The UK’s National Institute for Health and Clinical Excellence (NICE) has issued final draft guidance recommending Janssen Cilag’s Incivo (telaprevir), in combination with Roche’s peginterferon alfa and ribavirin, as an option for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease. The final draft guidance recommends the drug as an

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Final NICE Approval for Eli Lilly’s Bydureon

The UK’s National Institute for Health and Clinical Excellence (NICE) announced yesterday that they had confirmed in final guidance a endorsement of the use of Eli Lilly’s Bydureon (prolonged-release exenatide) in triple-therapy regimens as a treatment option for people with type 2 diabetes. The director of NICE’s centre for health technology evaluation, Professor Carole Longson,

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