NHS England has opened three-month public consultations on the use of Janssen’s Velcade and Alexion Pharma’s Soliris in the treatment of refractory antibody-mediated rejection (AMR) post-kidney transplant, a clinical indication for which neither drug has a license.
The consultations, which concern clinical commissioning policies for specialised services and will run until September 17, are being held as a result of some clinicians having starting to use both drugs for the treatment of difficult episodes of kidney rejection and requesting that NHS England consider them for routine commissioning and funding.
But NHS England’s consultation document points out that, while kidney transplant doctors have reported that Velcade (bortezomib) might work to help prevent some types of rejection post-kidney transplant, a review of the published evidence from research has failed to find good evidence that the possible benefits from using the drug outweigh any problem such as side effects.
The review, which examined Velcade’s clinical and cost-effectiveness and safety, found the quality of evidence supporting the drug’s use to be “very low,” ie, limited to uncontrolled studies, including case studies and case reports.
“The uncertainty around the overall benefit means that it is difficult to evaluate the cost-effectiveness and at this stage without evidence of benefit then its overall value would be broadly judged as poor,” says NHS England, adding: “further good-quality studies are needed to establish its clinical efficacy, safety profile and cost-effectiveness.”
Turning to Soliris (eculizumab), the consultation states that, as with Velcade, a review of the published evidence from research has failed to find good evidence that the drug’s possible benefits would outweigh any problems such as side effects for the patient. In addition, the research papers differ in the suggested dose for Soliris, says NHS England, which also comments on the drug’s high cost.
“Further high-quality studies need to be performed in order to determine the clinical efficacy, safety and cost-effectiveness of this very active but also very expensive drug before it can be recommended in current clinical practice,” says the consultation document.
For each of the drugs, NHS England says: “if we are unsure about how well it works then its value is also uncertain. This policy states that NHS England will not currently fund this drug for these reasons. If better evidence becomes available then this policy can be reviewed.”
• Meantime, Janssen has made a filing to the European Medicines Agency to expand Velcade’s label to include its use, in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for the treatment of adult patients with previously-untreated mantle cell lymphoma, a rare and aggressive blood cancer that usually occurs in older adults. Velcade, in combination with other agents, is currently licensed to treat patients with multiple myeloma.