The National Institute for Health and Clinical Excellence yesterday issued new guidances for the National Health Service in England and Wales covering ankylosing spondylitis, anaemia induced by cancer treatment and the management of type 2 diabetes.

NICE has recommended two anti-tumour necrosis factor (anti-TNF) therapies - Abbott Laboratories’ Humira (adalimumab) and Amgen/Wyeth’s Enbrel (etanercept) - as a treatment options for adults with severe AS, but declined to recommend Schering-Plough’s Remicade (infliximab) for this use.

Treatment with Humira and Enbrel is recommended, provided that: - patients have active spinal disease as assessed on two separate occasions 12 weeks apart; and – conventional treatment, with at least two non-steroidal anti-inflammatory drugs (NSAIDs), taken sequentially at maximum tolerated or recommended dosage to control symptoms, has failed.

This is the first time that NICE has reviewed anti-TNF therapies for AS, says Abbott, which also points out that the guidance is the Institute’s third positive opinion for Humira for rheumatological conditions, having recommended it for active and progressive psoriatic arthritis and moderate-to-severe active rheumatoid arthritis last year.

Until recently, treatment for AS has been limited to NSAIDs and physiotherapy, said Bruce Kirkham, consultant rheumatologist at Guy’s Hospital, London. “Use of the anti-TNF class of treatments significantly improves the quality of life of those receiving them,” said Dr Kirkham.

NICE’s chief executive Andrew Dillon, who was executive lead for the appraisal, added that the recommendation offers patients “access to treatments that have previously been subject to postcode prescribing.”

EPO drugs also given thumbs up
Also yesterday, NICE announced that the use of erythropoietin agents is recommended, with iron injections, for anaemia caused by cancer treatment in: - women receiving platinum-based chemotherapy for cancer of the ovaries who have a blood haemoglobin level of 8 g/100 ml or lower; and - people who have very severe anaemia and cannot receive blood transfusions.

The products recommended include Amgen’s Aranesp (darbepoetin), the epoetin alfa products Amgen’s Epogen and Johnson & Johnson’s Procrit (epoetin alfa) and Roche’s NeoRecormon (epoetin beta). Roche welcomed the decision which, it said, followed “one of the longest NICE appraisals in history.”

Chemotherapy-induced anaemia is one of the most commonly-reported symptoms associated with cancer treatment but remains under-recognised and under-treated in the UK, said the firm, which pointed out that while EPOs have been shown to significantly improve the condition, patients in France are eight times more likely, and those in Germany six times more likely, to receive them than those in the UK.

Paul Cornes, consultant clinical oncologist at The Bristol Haematology and Oncology Centre, added that while blood transfusions are the current standard of care for these patients, the decreasing number of blood donors and the Better Blood Transfusion imitative recommends exploring other alternatives. The new NICE guidance offers these patients another option which could improve their quality of life, help conserve scarce blood resources and reduce the risk of transfusion-associated infections, said Dr Cornes.

Management of type 2 diabetes
Meantime, NICE has also updated its guideline on the management of type 2 diabetes, which states that necessary lifestyle changes and side effects of therapy mean that education is key to care of this condition, which it describes as “typically complex and time-consuming.”

NICE says that people with type 2 diabetes should receive structured and ongoing education from when they are first diagnosed, to help them understand and manage their condition. It also recommends that healthcare professionals should provide patients with information about a range of key issues including how best to keep glucose levels under control, how people can make sure they are safe to carry out normal activities such as driving, and individualised dietary advice so that they can make decisions that will keep them healthy.

“People with type 2 diabetes are at a higher risk of a cardiovascular event - many have the same risk of a cardiovascular event as someone without diabetes who has already had their first heart attack. However, with the right care these risks can be minimized,” said Jiten Vora, consultant physician endocrinologist and a member of the guideline development group. “The NICE guideline formalises care and sets out the level of information that needs to be provided by healthcare professionals to give people with diabetes the best chance of having a full and healthy life, for example by providing advice about losing weight. By bringing together everything we know on the care of people with diabetes, healthcare professionals will be best placed to offer individuals the very highest standard of care that they deserve,” added Prof Vora.

The incidence of type 2 diabetes, and the disease’s complications, are on the increase in England and Wales, noted Roger Gadsby, a general practitioner who also served on the guideline development group. “Under this guidance, an individual’s doctor or nurse will assess their risk of cardiovascular disease at least once a year and provide tailored advice and support so that they can make necessary changes in their lifestyle and minimise their risk,” said Dr Gadsby.

Meantime, the day before the guidance was published, Roche reported new research showing that patients with type 2 diabetes lack the education they need to self-manage their condition, even though the law requires the NHS to provide this.

The research found that while 45% out of 872 people with type 2 diabetes wished that more information was available to them about managing and treating their diabetes, only one in three had been offered information about formal education courses by their healthcare professional and just 6% had ever attended formal education; this figure includes insulin users who have a heightened need to manage and understand their diabetes. 67% of the patients questioned said they were confident about their knowledge of how to self-manage, but 65% were experiencing frequent episodes of hypoglycaemia or hyperglycaemia, at least once a year or more, putting them at risk of long-term health complications, the firm added.