NICE to reconsider GSK’s Tyverb
pharmafile | July 9, 2009 | News story | Research and Development, Sales and Marketing | GSK, NICE, Tyverb
NICE is to reconsider Tyverb under its new lenient approach for end-of-life drugs, after GSK appealed its previous rejection of the treatment on cost-effectiveness grounds.
It is good news for GSK, as the breast cancer drug is currently its biggest hope in oncology – a growing market in which most major companies want a stake.
Simon Jose, general manager of GSK UK, commented: "We welcome the decision of the appeal panel and the opportunity to make a full submission to NICE under the end-of-life criteria. We appreciate that NICE has some very tough decisions to make, especially in this end-of-life setting, but given the considerable survival benefits that Tyverb offers these women, we believe it deserves full and thorough consideration."
Tyverb (lapatinib) is indicated in combination with Roche's Xeloda (capecitabine) for advanced or metastatic breast cancer, where tumours over-express HER2. To receive it, patients must have progressive disease following a prior therapy that has included treatment with Roche's Herceptin.
Tyverb was initially rejected by NICE last summer on grounds it was not cost effective when compared with the standard treatment of Xeloda alone.
In the hope of reversing the decision, GSK offered a patient access scheme to lower the cost to the NHS, under which the drug would be free to patients in the first 12 weeks of treatment. The effort failed and NICE issued final negative guidance in March 2009.
However, following GSK's subsequent appeal, NICE will now reconsider the submission for Tyverb under its new 'end-of-life' criteria, used to assess drugs which treat people with terminal conditions such as cancer.
The approach was introduced in January 2009 in a bid to see more drugs approved on the NHS. It applies to candidates targeting small patient populations with a short life expectancy, and companies can offer new supplementary evidence in light of this.
The appeal panel agreed that GSK and other consultees should be given the opportunity to make a full submission under the new end-of life criteria.
On announcing the news, GSK offered a statement from oncologist Dr Alison Jones, from the University College London Hospital and the Royal Free Hospital.
She said: "It is great that NICE will reconsider the evidence supporting the use of lapatinib as there is a significant unmet medical need for women with this aggressive form of advanced breast cancer. These women have very few treatment options left available to them and lapatinib, when combined with capecitabine, offers a chance of additional time without their disease progressing."
GSK added that the decision provided fresh hope for up to 2,000 women in the UK who could benefit from receiving Tyverb on the NHS, and that it will continue to offer its patient access programme to both NICE and individual NHS Trusts.
Pfizer's Sutent is another oncology treatment to be recently reviewed by NICE, using the new end-of-life criteria, for patients with advanced or metastatic renal cell carcinoma (RCC). The drug was initially rejected on cost effectiveness grounds in August 2008 before new NICE guidance in March reversed that decision.
Related stories:
NICE rejects Erbitux in head and neck cancer
June 24, 2009
NICE recommends Pfizer's Sutent
March 26, 2009
GSK hopeful of NICE approval for Tyverb
January 25, 2009
NICE makes end-of-life drugs more available
January 06, 2009
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