The National Institute for Health and Clinical Excellence has this week published a set of final guidances including Janssen-Cilag’s Stelara for psoriasis, Eli Lilly’s Alimta for non-small cell lung cancer, and Pfizer’s Sutent for stomach tumours.

Stelara (ustekinumab) is the first in a new class of biologics approved to treat the autoimmune disease psoriasis, and has been cleared by the cost regulator on the National Health Service to treat patients considered to have moderate-severe forms of the condition.

According to Jannssen-Cilag, the drug provides “visible and significant improvements in psoriasis severity” and also has the “added advantage of a convenient dosing regimen”, which is comprised of a ‘mere’ five injections a year compared to a possible 104 with its popular rival etanercept.

“Two-thirds of patients taking Stelara in placebo-controlled trials saw a significant, visible improvement in their psoriasis in as little as 12 weeks,” commented Professor Christopher Griffiths, Professor of Dermatology at the University of Manchester, and added: “This is reflective of what I have seen in clinical practice, with patients experiencing considerable improvements in skin clearance with the added benefit of a convenient dosing regimen”.

The Institute has agreed that the drug is indeed a cost-effective use of NHS resources, but only as part of a patient access scheme proposed by the company under which it provides the 90mg dose necessary for patients weighing more than 100kg at the same total cost as for a single 45mg vial, to help keep treatment costs at around £9,335 a year and cap the financial burden.

Elsewhere, the Institute has permitted the use of Eli Lilly’s Alimta on the NHS as a first-line treatment in combination with the chemotherapy cisplatin for patients with non-small cell lung cancer, but only if the disease has spread or the tumour is classed as an
adenocarcinoma or large-cell carcinoma.

Commenting on the guidance, Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said that the independent Appraisal Committee “carefully considered” testimonies from clinical specialists and patients as well as available evidence on the clinical effectiveness of Alimta, and concluded that the drug “could potentially be an important treatment for this group of patients and represented a cost effective use of NHS resources”.

Around 38,000 people are diagnosed with NSCLC in the UK every year - making it one of the most common cancers in the country - of which around 45% are adenocarcinoma (45%) and 10% large cell carcinoma. The prognosis for patients with NSCLC is poor with an expected survival of around six months from diagnosis, and just 20% are still alive a year after diagnosis, and so the availability of an additional weapon against the disease will be welcomed by doctors and patients.

Sutent for GIST
The Institute has also published final guidance recommending the use of Pfizer’s Sutent (sunitinib) in patients who have unresectable (non-operable) or metastatic gastro-intestinal stromal tumours (GIST) and are intolerant/unresponsive to therapy with Novartis’ Glivec/Gleevec (imatinib).

The decision was based on data from a Phase III clinical trial showing that the drug extended the time to tumour progression by almost five months compared to placebo, and after an analysis deemed that using Sutent in patients who have become resistant to or cannot tolerate the gold standard of care is a cost-effective use of NHS resources if, as agreed, Pfizer picks up the tab for the first cycle of treatment.

According to Professor Peter Littlejohns, NICE’s Clinical and Public Health Director, there are around 240 new cases of unresectable/metastatic each year in England and Wales alone, and this guidance “provides these patients with a further treatment option and represents a positive move by the manufacturer, who, by reducing the cost the NHS will have to pay for this treatment, will enable as many eligible patients as possible to access it”.