UK - Summary of NICE Approvals in September 2009

NICE Provisionally Approves Drugs for Crohn’s Disease

The National Institute for Health and Clinical Excellence (NICE) has recommended the use of Humira (adalimumab) and Remicade (infliximab) on the NHS for the treatment of Crohn’s disease, on a preliminary basis.

Abbott Laboratories’ Humira has preliminary approval as an option for induction and maintenance therapy in adults with severe active non-fistulising Crohn’s disease. Schering Plough/ Johnson & Johnson’s Remicade has also been approved but only if the patient is intolerant of Humira, if the patient is a child or if the Crohn’s disease is fistulising.

Humira has been given preference over Remicade purely for cost reasons. They are considered to be as effective as each other, with Humira costing £9,295 a year while Remicade costs £12,584 a year, and so Humira is judged to be more cost effective.

There is no cure for Crohn’s disease, which affects around 60,000 people in the UK, and so treatment strategies focus on reducing the symptoms of the illness and extending periods of remission.

NICE Approves NHS Use of Hycamtin for Cervical Cancer

NICE has issued a final appraisal recommending the use of GlaxoSmithKline’s Hycamtin (topotecan) on the NHS to treat recurrent cervical cancer.

Initially, NICE expressed “considerable uncertainty” over the effectiveness of the drug compared to other available treatments, when taking into account potential side effects, and so it was thought it would be rejected.

However, following a second appraisal committee and additional data submitted by GSK, NICE now recommends the use of Hycamtin, in combination with the chemotherapy cisplatin, to treat recurrent or stage IVB cervical cancer.

However, it is under the condition that the patient must not have received previous therapy with cisplatin, and so only a small number of patients will be eligible, since around 90-95% of the current licensed population for Hycamtin will have already received some form of therapy with cisplatin. This condition is important, however, as response rates in patients who have not been treated with cisplatin are about 45%, compared to just 10% for those who have been exposed to the drug.

NICE Approves Blood-Thinner Efient Under Certain Conditions

NICE has published a final appraisal approving the blood-thinner Efient (prasugrel) for use on the NHS, but only for a select group of patients.

Specifically, NICE has approved Eli Lilly/Daiichi Sankyo’s Efient in combination with aspirin as an option for preventing atherothrombotic events in patients with acute coronary syndromes having percutaneous coronary intervention. However, the drug should only be used in limited cases, firstly when immediate primary PCI for ST-segment-elevation myocardial infarction is necessary. Efient can also be used when stent thrombosis has occurred during treatment with sanofi-aventis and Bristol-Myers Squibb’s blockbuster Plavix (clopidogrel) or if the patient has diabetes mellitus.

NICE Rejects Nexavar for the Treatment of Liver Cancer on the NHS

NICE has rejected Nexavar (sorafenib) for the treatment of liver cancer on the NHS.

The decision comes despite Bayer’s offer to lower the cost of the drug, which has also been turned down for the treatment of kidney cancer on the NHS. Nexavar treats advanced hepatocellular carcinoma (HCC), which accounts for around 90% of all liver tumours.

Janssen-Cilag’s Stelara Approved for Treatment of Psoriasis on the NHS

Stelara (ustekinumab) has been approved for use on the NHS by NICE as a treatment for moderate to severe plaque psoriasis.

Janssen-Cilag’s Stelara is a new, fully human monoclonal antibody which works by targeting the p40 subunit of the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23). The drug also has a convenient dosing regimen with just five injections per year, compared to a possible 104 injections with alternative treatment etanercept.

The drug was considered a cost-effective use of NHS resources but only under a patient access scheme proposed by Janssen Cilag, whereby it provides the 90mg dose necessary for patients weighing more than 100kg at the same cost as a single 45 mg vial, to keep the cost of treatment at £9,335 a year.

Eli Lilly’s Alimta Approved for NHS Use

NICE has approved Eli Lilly’s Alimta (pemetrexed) for use on the NHS, as a first-line treatment for patients with non-small cell lung cancer (NSCLC) in combination with the chemotherapy cisplatin. However, it has only been recommended if the disease has spread, or if the tumour is classed as an adenocarcinoma or large-cell carcinoma.

Every year around 38,000 people are diagnosed with NSCLC in the UK, of which 45% are adenocarcinoma and 10% large cell carcinoma.

Pfizer’s Sutent Recommended for Use on the NHS for GISTs

NICE has published final guidance recommending the use of Sutent (sunitinib) on the NHS in patients who have unresectable or metastatic gastro-intestinal stromal tumours (GIST) and are intolerant or unresponsive to therapy with Novartis’ Glivec (imatinib).

The guidance is subject to a patient access scheme, whereby the manufacturer Pfizer pays for the first cycle of treatment with the drug.

Further reading - A detailed review of the UK pharmaceutical market, including more information on NICE and its appraisal procedures, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)