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IQWiG unimpressed with Cosentyx in two new indications

Concludes Novartis drug has no added benefit in ankylosing spondylitis or psoriatic arthritis

Germany's cost regulator has decided there is no evidence for an added benefit of Novartis's Cosentyx in ankylosing spondylitis and psoriatic arthritis compared to established drugs.

The Institute for Quality and Efficiency in Health Care (IQWiG) said it had arrived at that conclusion because Novartis had not submitted any comparative studies with TNF inhibitor drugs, the standard biologic therapy for these indications.

IQWiG came to a similar verdict when it reviewed the first-in-class interleukin-17 inhibitor for plaque psoriasis last year, although it did conclude that the drug had value in psoriasis patients who had exhausted all other treatment options.

Cosentyx has been approved in the EU for ankylosing spondylitis and psoriatic arthritis since November 2015, after getting a green light for plaque psoriasis the previous January.

IQWiG's review has now been passed on to the Federal Joint Committee (G-BA), which will deliver a final verdict on the drug's pricing after a comment period. For now, it seems the likelihood is that Cosentyx will struggle to get premium pricing in Germany.

Mixed fortunes for cancer drugs
There was better news for Novartis in an IQWiG review of its melanoma combination - Tafinlar (dabrafenib) and Mekinist (trametinib) - after the agency concluded that the drugs provided "considerable added benefit" for men with this type of skin cancer.

IQWiG had agreed last year that the combination had considerable added benefit in women but could not quantify the effect in men.

Novartis has since submitted additional data from the COMBI-v study, which compared Tafinlar/Mekinist with Roche's Zelboraf (vemurafenib) and showed benefits on overall survival. The company recently acquired the two cancer drugs from GlaxoSmithKline (GSK).

Meanwhile, a clear example of how the IQWiG process is a two-way street has come from its latest review of Bayer's colorectal cancer therapy Stivarga (regorafenib), in which it concludes an added benefit is "no longer proven".

Additional data submitted by Bayer has now revealed "additional negative effects of Stivarga regarding quality of life" - notably diarrhoea - which IQWiG now considers outweigh the drug's benefits in reducing all-cause mortality.

Finally, IQWiG's review of the combination of Roche's melanoma therapy Cotellic (cobimetinib) with Zelboraf compared to Zelboraf given alone has concluded that there is a "minor benefit".

The agency said the positive effects of the Cotellic/Zelboraf combination on overall survival were offset by side effects, notably diarrhoea, nausea, vomiting and serous retinopathy/retinal detachment.

Article by
Phil Taylor

23rd March 2016

From: Regulatory



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