Specialist nurses have backed an appeal against a draft ruling from the National Institute for Health and Care Excellence, which restricted the use of a prostate cancer drug by the NHS.
NICE held an appeal hearing on 25 June into its draft guidance on dagarelix (Firmagon) for the treatment of advanced hormone-dependent prostate cancer.
The drug is administered as a deep subcutaneous injection and, according to its manufacturers, rapidly reduces levels of testosterone by blocking the GnRH receptors in the pituitary gland.
“Many nurses will be familiar with degarelix and we feel that it is unjust to limit its use”
NICE’s original appraisal consultation document, published in January, recommended the use of dagarelix for patients at risk of spinal cord compression.
However, its final appraisal document (FAD), published in April, said the drug should be restricted to patients who presented with signs and symptoms of spinal cord compression, rather than those considered at risk.
Ferring Pharmaceuticals, which makes the drug, claimed this would reduce the number of patients to less than a third of those eligible for treatment under the original draft document.
The company and a number of healthcare organisations, including the British Association of Urological Nurses, said they were concerned about the “restrictive guidance being proposed” and appealed against it.
It said degarelix has shown several advantages over existing hormonal therapies, including a more rapid reduction in prostate specific antigen, better control of serum alkaline phosphatase, and significant reduction in PSA progression.
It also said clinical studies had demonstrated fewer musculoskeletal events and a lower incidence of urinary tract events in men treated with degarelix, than with luteinizing hormone-releasing hormone (LHRH) agonists.
Bruce Turner, a spokesman for the British Association of Urological Nurses, said: “This drug is the only GnRH antagonist on the market and is important to have in our armoury for advanced prostate cancer.
“Many nurses will be familiar with degarelix and we feel that it is unjust to limit its use – the use of the drug ought to lie with the clinician,” he told Nursing Times.
He said: “The mainstay of treatment in the advanced prostate cancer setting is testosterone suppression with androgen deprivation therapy, as prostate cancer initially relies on systemic testosterone for its development.
“Degarelix suppresses testosterone within 24 hours of the initial injection. It has been shown to maintain lower testosterone levels and prostate specific antigen levels for longer than the alternative drugs, LHRH agonists,” he added.
“Limiting degarelix to patients with spinal cord compression denies many patients access to this drug which is beneficial in many other settings – for example, where rapid testosterone suppression is required,” said Mr Turner, who is an advanced nurse practitioner at Homerton University Hospital NHS foundation Trust and Barts Health NHS Trust.
Degarelix was approved for the treatment of advanced hormone-dependent prostate cancer in both the European Union and US in 2009.
The result of the appeal against the NICE guidance will not be known for two to three months.