NICE rejects GSK’s Tyverb
pharmafile | July 9, 2008 | News story | Sales and Marketing |Â Â Â
GlaxoSmithKline's Tyverb is the latest high-cost cancer treatment to be rejected by the medicines watchdog NICE.
Using the breast cancer drug in combination with Roche's Xeloda (capecitabine) costs over £25,000 per year per patient, and NICE said cost of the drug outweighs its clinical benefits.
But GSK is still positive as the decision is only preliminary, and stakeholders may still have time to influence NICE's final decision.
A spokesperson from the company said: "This draft guidance is now open for consultation and GSK remains committed to working with NICE, within its framework, to try to achieve a positive outcome for those patients and their families for whom Tyverb may offer an opportunity to keep the disease at bay for additional weeks and months."
GSK added that the example of Tyverb, as with appraisals for other oncology drugs, showed just how hard it is to reach the NICE threshold for cost effectiveness in end stage cancers.
But NICE approval is not the only market challenge to Tyverb (lapatinib), which so far has only conditional marketing authorisation in Europe.
It was originally fully approved by the EMEA earlier this year, but the regulator quickly called for more data to be provided after concerns over liver side effects emerged.
Tyverb is currently licensed for patients who have first failed to respond to anthracyclines and taxanes and, in the metastatic setting, Herceptin (trastuzumab). Patients that do receive GSK's drug must also have their liver function closely monitored.
Despite the clinical setbacks for Tyverb and its negative decision from NICE, its assessment provide some encouraging news for oncology patients. Guidance came just months after the drug's launch, which will add clout to government claims that NICE can significantly speed up its processes.
GSK said it had approached NICE about Tyverb over a year ago, as European regulators were assessing the drug. This shows that early stage talks with NICE about new products are possible and could be key to improving patient access to new drugs.
