NICE has extended its 'horizon scanning' approach to reviewing new drugs, with a number of unlicensed drugs named in its latest work programme.

The Institute's tenth 'wave' shows a growing trend towards identifying innovative - and often costly - new drugs well in advance of their launch, with the ultimate aim of providing the NHS with guidance as soon after regulatory approval as possible.

The strategy is intended to overcome the phenomenon of 'NICE blight' where some NHS bodies await NICE guidance before prescribing the drug, resulting in delayed access to vital treatment for some patients. Pharma companies have at the same time been reluctant to agree to early NICE appraisals, claiming many products cannot prove their clinical and cost-effectiveness at launch, but greater industry involvement in the timing and selection of topics has helped create broader agreement.

Refinements to how NICE operates have also helped this process, including a new agreement on data confidentiality between the industry and the Institute.

A NICE spokesman said publication dates for the tenth wave appraisals had not yet been set, but would follow on from the final appraisal from the preceding programme, due in May 2006.

Atrasentan and Taxotere for hormone refractory prostate cancer (HRPC): Prostate cancer is the most common cancer among UK men, and the second leading cause of annual cancer deaths after lung cancer. There were 10,000 deaths from prostate cancer in 2002 and the disease is expected to overtake lung cancer as the biggest cancer killer in the next few years.

NICE has announced two separate appraisals in the area - one for Abbott's atrasentan (ABT-627), a first-in-class endothelin A receptor antagonist which blocks the production of cancer cells, and Taxotere, Aventis' top-selling metastatic breast cancer and non-small cell lung cancer drug.

Aventis filed for a licence to treat HRPC through a combination of Taxotere and prednisolone in February, and has already gained US approval through an FDA fast track process, indicating the advance in treatment the drug could represent for patients. New data presented in June showed Taxotere is the first and only treatment to significantly improve survival in men with the disease by 20% or more compared to current standard treatment, mitoxantrone plus daily prednisolone.

Erbitux (cetuximab): due to be approved by the European Commission in the next few weeks for colorectal cancer, is to be reviewed by NICE for head and neck cancer.

Lilly's Alimta (pemetrexed disodium) for treatment of mesotheliomia: Lilly has submitted a dual European submission for its new cancer drug Alimta. The first part is for Alimta combined with cisplatin, for the treatment of malignant pleural mesotheliomia and the second is for Alimta as a single-agent in the second line treatment of non-small cell lung cancer. NICE will review the drug for the treatment of mesotheliomia, which is expected to increase to around 3,000 cases a year by 2010 in England and Wales.

Sanofi's Eloxatin (oxaliplatin), Aventis' Campto (irinotecan) and Roche's Xeloda (capecitabine): all currently approved by NICE for advanced and metastatic colorectal cancer. NICE will now look at emerging evidence for their use as adjuvant therapy in early colorectal cancer.

Eyetech and Pfizer's Macugen (pegaptanib) for age-related macular degeneration: Macugen is a novel monoclonal antibody treatment for age-related macular degeneration (AMD), one of the biggest causes of irreversible loss of vision in the over 50s in the developed world.  The companies expect to make an FDA filing in the third quarter of 2004, and say it represents a significant advance over existing treatments. The drug is thought to work by blocking vascular endothelial growth factor (VEGF) which is responsible for abnormal blood vessel growth and blood vessel leakage. Genentech and Roche's colorectal cancer drug Avastin, hailed as a major breakthrough, is another VEGF-inhibitor.

NICE's appraisal of Novartis' treatment for wet AMD, Visudyne, was one of the most controversial of recent years, with the Institute initially only recommending the drug in a subset of patients. The NHS has been allowed nine months to implement the guidance rather than the standard three, provoking outrage from patient groups who say the delay could be critical for patients.

Elan and Biogen Idec's Antegren (natalizumab) for multiple sclerosis: Antegren is a highly promising new treatment for multiple sclerosis which has just been submitted to the EMEA based on one year data from two ongoing phase III trials.The drug is the first alpha-4 antagonist in the new selective adhesion molecule (SAM) inhibitor class. Antegren works by blocking the migration of immune cells into chronically inflamed tissue where they may cause or maintain inflammation. The drug is also in development to treat Crohn's disease and rheumatoid arthritis.

The protracted NICE appraisal of beta interferon treatments and glatiramer for MS was one of the most contentious ever, with a special payment-by-results scheme being set up in 2002 to allow greater access to the drugs after NICE twice rejected the drugs on the grounds of clinical and cost-effectiveness.

Abbott's Humira (adalimumab) for rheumatoid arthritis: Launched across Europe in late 2003, Humira is the latest challenger in the TNF-blocker class of drugs for the treatment of rheumatoid arthritis and other autoimmune diseases. Wyeth's Enbrel and Schering-Plough's Remicade gained NICE approval as second line treatments in March 2002.

Cambridge Antibody Technology's Trabio (lerdelimumab) for prevention of scarring after glaucoma filtration surgery: Trabio is a new drug currently in phase III trials, and could be used instead of antiproliferative drugs such as mitomycin or 5-fluoracil, current standard treatments for the indication. The drug, one of Cambridge Antibody Technology's leading candidates, was awarded European orphan drug status in May 2001.

Servier's Protelos (strontium ranelate) for osteoporosis: Phase III trial data published in early 2004 showed new promise for strontium which was used (in a different formulation) as long ago as the 1950s. The drug stimulates bone formation and reduces bone resorption.

Inhaled insulin: At least three inhaled insulin products are in late-stage development, but Exubera, the collaboration between Aventis, Pfizer and Nektar Therapeutics is the nearest to market ­ the drug filed with the EMEA in March this year.

Corticosteroids for asthma: Between four and five million people in England and Wales have asthma, with inhaled corticosteroids the current mainstay of treatment strategies. In 2001, twelve million prescriptions were dispensed for the drugs, costing £300 million. NICE said: "There is a wide variation in the price of available corticosteroids, but it is not clear that the more expensive drugs are more effective than the cheaper in the majority of patients."

Other technology appraisals in the work programme:

• Carmustine implants (Gliadel Wafers) for newly diagnosed high-grade glioma
• Biventricular pacing (cardiac resynchronisation) for heart failure
• Methadone and bupenorphine as opiate substitutes
• Naltrexone as a treatment for relapse prevention in opiate users

Clinical guidelines:

• Attention Deficit Hyperactivity Disorder (ADHD) in children, young people and adults
• Care and management of osteoarthritis
• Drug treatment
• Management of faecal incontinence

Related links:

For more information visit: www.nice.org.uk

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