GSK’s pricing deal for Tyverb fails to sway NICE

pharmafile | October 15, 2008 | News story | Sales and Marketing |  GSK, NICE, breast cancer 

NICE has spurned GSK's risk-sharing proposal for its breast cancer treatment Tyverb, saying the drug is still too expensive to be used on the NHS.

GSK had offered to cover Tyverb's initial costs to give it a chance to prove its effectiveness, but the Institute's second draft appraisal maintains it does not represent value for money.

Simon Jose, general manager for GSK UK Pharmaceuticals, said the company strongly believed the wrong decision had been made.

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"For patients with ErbB2-positive advanced breast cancer and who have few treatment options left, Tyverb offers real hope of slowing the disease. We therefore remain wholly committed to working with the NHS and NICE to make this innovative medicine available," he added.

NICE was assessing Tyverb (lapatinib), in combination with Roche's Xeloda (capecitabine), for women with previously treated advanced or metastatic breast cancer.

In July NICE's first draft appraisal of Tyverb rejected the drug on cost-effectiveness grounds, prompting GSK's proposed 'patient access programme'.

The company offered to bear the cost of Tyverb for all eligible patients for up to the first 12 weeks of treatment, after which the NHS would only fund it for patients who continued to see clinical benefits.

The company said the risk-sharing proposal was designed to give patients access to the treatment and deliver value at a threshold that should have been acceptable to NICE.

But NICE has again rejected Tyverb, saying it would not be a cost-effective use of NHS resources – even when the proposed patient access scheme was taken into account.

NICE also said there was not enough evidence to show Tyverb was more cost-effective than the 'off-label' use of Roche's Herceptin (trastuzumab), concluding that GSK's analysis for this was 'unsupportable'.

GSK said it would keep working to make Tyverb available, but that it is impossible to propose another access programme at present.

The company will now try to show that continued use of Herceptin – which is often used by women suffering from late stage breast cancer despite not being approved for this indication – is comparable to using Tyverb. It says it can then prove Tyverb could save the NHS money.

GSK said that if NICE's draft recommendation is upheld in its final guidance – due February 2009 – it would place UK patients at a disadvantage compared to those in European countries like Germany, Denmark and Greece, where Tyverb is reimbursed.

Topping-up patient care

Repeated negative decisions from NICE have sparked a review into whether NHS patients should be able to top up NHS care privately – a practice currently banned by the government.

Bernadette Murdoch, director of communications for UK pharma at GSK, commented on the top-up issue in light of NICE's draft decision on Tyverb.

She said: "We don't believe that top ups are the answer in the long-term to the problem, but if the NHS decides not to pay for a medicine, then it should be a patient's democratic right to access it. However, we did have hopes that this patient access programme would provide equitable access for all."

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