NICE needs more Velcade data
pharmafile | November 12, 2013 | News story | Sales and Marketing | NHS, NICE, Velcade, eric low
NICE has slowed the progress of Janssen Cilag’s Velcade towards becoming an NHS treatment for multiple myeloma by asking the manufacturer to provide more information.
The watchdog says it cannot currently recommend Velcade (bortezomib) in combination with dexamethasone and thalidomide – the latter two, with alkylating agent cyclophosphamide, represent the current standard treatment in the UK.
In draft guidance published today, NICE requires further data about the effectiveness of Velcade as a treatment for some patients who have been newly-diagnosed with the condition.
“The independent Appraisal Committee could not assess whether bortezomib in combination with dexamethasone is a cost-effective treatment option because it did not have sufficient information to do so,” said Dr Carole Longson, Health Technology Evaluation Centre director at NICE.
“The next step in the NICE process is for the manufacturer to consider the Committee’s comments and respond to its request for further evidence,” she added.
NICE wants to know more in particular about Velcade with dexamethasone, compared to the current standard treatment in newly-diagnosed patients who are suitable for high dose chemotherapy with haematopoietic stem cell transplantation.
Myeloma UK chief executive Eric Low said he was disappointed with the draft guidance.
“We appreciate that this is a difficult appraisal but we are very clear about the strong clinical argument for the use of Velcade as an induction treatment for some patients in whom high-dose therapy and stem cell transplantation is planned,” he said.
Low added that he was confident that working with NICE “over the coming weeks to mitigate their concerns and issues and also closely with the manufacturer, we will have a positive outcome”.
Velcade is already an NHS option to treat progressive multiple myeloma in people who are at first relapse after one prior therapy and who have had – or are unsuitable for – a bone marrow transplant.
A course of Velcade with dexamethasone is estimated to be £12,260, and the average cost of Velcade plus dexamethasone and thalidomide is more than double that at £24,840.
NICE says there is no question that Velcade and dexamethasone produces statistically significant improvements in overall response rates compared with vincristine, adriamycin and dexamethasone.
Treatment with Velcade, thalidomide and dexamethasone is also better when it comes to progression-free survival compared with thalidomide and dexamethasone.
The sticking point is that there is no direct evidence to compare Velcade, thalidomide and dexamethasone or Velcade and dexamethasone with cyclophosphamide, thalidomide and dexamethasone – the current UK standard of care.
At present NICE estimates the cost per quality-adjusted life year (QALY) for Velcade, thalidomide and dexamethasone compared with cyclophosphamide, thalidomide and dexamethasone was ‘likely to be substantially higher’ than the £39,000 per QALY compared with thalidomide and dexamethasone.
Adam Hill
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