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NICE gives partial backing to Ferring's prostate cancer drug

Firmagon on course for use on NHS in England and Wales
National Institute for Health and Care Excellence NICE logo

Patients in England and Wales with prostate cancer that has spread to the spine look likely to get access to treatment with Ferring's Firmagon under the NHS.

The National Institute for Health and Care Excellence (NICE) stopped short of recommending it for more widespread use in prostate cancer patients, however, and Ferring said in a statement it would be considering a response to the decision.

Final draft guidance published by NICE recommends that Firmagon (degarelix depot) should be offered to patients with advanced hormone-dependent prostate cancer that has metastasised to the spine and could compress the spinal cord.

Degarelix is a gonadotropin-releasing hormone (GnRH) antagonist that blocks production of testosterone and has a slightly different mechanism of action to other drugs used in prostate cancer, such as the luteinising hormone releasing hormone (LHRH) agonists leuprolide acetate and goserelin.

It has been shown in trials to reduce testosterone levels - starving tumours of a major growth driver - without the initial 'flare' in the hormone that occurs with LHRH agonists and requires concomitant treatment with anti-androgen drugs to prevent exacerbations in spinal cord compression.

Degarelix also has a significant impact on prostate-specific antigen (PSA) levels, a biomarker for prostate cancer, and according to some data is associated with a reduced risk of cardiovascular disease compared to LHRH agonists.

Commenting on the NICE decision, Dr Patrick Davey, consultant cardiologist at Northampton General Hospital, said it was unfortunate that Firmagon's use was not recommended in a wider patient group.

"Given the high UK prevalence of prostate cancer and also cardiovascular disease (CVD), it means that approximately 1 in 3 men with prostate cancer would have experienced a cardiovascular event," he said.

"Patients with pre-existing CVD are most at risk and the evidence shows that Firmagon has a higher chance of reducing that."

Ferring estimates that Firmagon costs around £12,300 ($20,650) per course - including administration - which NICE considers is acceptable only in the patient subpopulation with spinal involvement.

Among this group, "the likely position of degarelix in the treatment pathway is as first-line hormonal therapy for treating advanced hormone-dependent prostate cancer, that is, at the same point in the pathway as the LHRH agonists," says the agency's appraisal document.

The draft guidance now goes out for a final consultation and - in the absence of an appeal - should come into effect in May.

Despite the limitations on Firmagon's use, Prostate Cancer UK said NICE's decision would nevertheless have a major impact on the quality of life of patients with spinal cord metastases.

"Men whose prostate cancer has spread to the spine are often at risk of even further damage through spinal cord compression and if left untreated this could be crippling," said Mikis Euripides, director of policy at the medical charity.

Prostate Cancer UK is in the midst of a battle with NICE to try to convince the agency to reverse its decision to impose tight restrictions on prescribing of Astellas' Xtandi (enzalutamide).

Article by
Phil Taylor

16th April 2014

From: Sales, Healthcare



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