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IQWiG finds some value in Pfizer's Inlyta

Cost effectiveness body decides cancer drug has benefits over Bayer's Nexavar

German HTA body IQWiG

German cost effectiveness watchdog IQWiG has decided that the side effect profile of Pfizer's new kidney cancer drug Inlyta (axitinib) could give it an edge over Bayer's rival Nexavar.

Inlyta was launched in Europe in September as a treatment for people with advanced renal cell carcinoma in whom previous treatment with Pfizer's own Sutent (sunitinib) or a cytokine was unsuccessful. 

IQWiG said in its assessment of the drug that it had a “hint of considerable added benefit” over Nexavar (sorafenib), thanks to its lower risk of certain side effects.

However, IQWiG decided that Inlyta's benefits over another competitor, Novartis' Afinitor (everolimus), could not be proven because of a lack of suitable data from Pfizer.

IQWiG (the German Institute for Quality and Efficiency in Health Care) examined Inlyta under the country's AMNOG legislation, which sees the Federal Joint Committee (G-BA) specify appropriate comparator therapies for each assessment.

The G-BA wanted Inlyta to be compared against Afinitor in cases of ineffective previous treatment using Sutent, and against Nexavar if patients had previously received a cytokine, in line with two comparators' licences.

Despite this, IQWiG received no useable data from Pfizer for its Afinitor comparison, and said its assessment of Inlyta against Nexavar had to be based on just one study, known as AXIS.

Using this study IQWiG said it found no statistically significant differences in terms of overall survival, symptoms and health-related quality of life between the two drugs.

It concluded that with respect to these outcome measures Inlyta “has neither advantages nor disadvantages” over Nexavar.

There was also a mixed picture when it came to the side effect profiles of the two drugs. For example, hair loss (alopecia), skin rash and the hand-foot syndrome occurred less often with Inlyta, while disturbances of the voice (dysphonia) were less common in Nexavar patients.

Nevertheless, although IQWiG said the side effect results were “subject to several uncertainties”, it concluded that “there is a hint of a considerable added benefit of axitinib in comparison with sorafenib”.

Although a less than emphatic recommendation, the assessment is a more positive one for Pfizer than NICE's recent draft ruling on Inlyta, which doesn't back the drug against Nexavar or Afinitor.

IQWiG's assessment dossier is now with the G-BA, which will consult with the pharma companies and other stakeholder before publishing its early benefit analysis within the next three months. 

18th January 2013

From: Sales, Regulatory



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