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NICE backs five new drugs after discounts agreed

Includes Novartis’ previously rejected lung cancer and melanoma therapies Zykadia and Mekinist

The UK drug-prescribing watchdog has backed the funding of five new drugs for cancer, high cholesterol and a chronic and debilitating skin disease.

All five of the new recommendations have come about because the manufacturers of the drugs have agreed deals that will reduce the price of therapy to the National Health Service (NHS).

The latest round of positive appraisals was particularly good news for Novartis, with the National Institute for Health and Care Excellence (NICE) giving a green light to two of its cancer drugs - ALK inhibitor Zykadia (ceritinib) for lung cancer and melanoma treatment Mekinist (trametinib), a MEK inhibitor.

It also gave the nod to two cholesterol-lowering PCSK9 inhibitors - Sanofi's Praluent (alirocumab) and Amgen's Repatha (evolocumab) - and agreed to fund the use of AbbVie's widely-used TNF blocker Humira (adalimumab) for hidradenitis suppurativa, a painful and itchy condition affecting the sweat glands.

NICE reversed its earlier stance on Zykadia for the treatment of ALK-positive non-small cell lung cancer (NSCLC) in patients previously treated with Pfizer's Xalkori (crizotinib) after Novartis agreed an undisclosed reduction on its list price.

Earlier guidance questioned the extent of the drug's benefit, but NICE now says it is likely to prolong life in patients whose disease has progressed despite Xalkori and it is cost-effective at the lower price.

The agency also gave its blessing to the use of Mekinist in combination with Novartis' TAF inhibitor Tafinlar (dabrafenib) for BRAF V600 mutation-positive melanoma that has spread and cannot be surgically removed.

Once again, the recommendation came after Novartis agreed a discount on the list price of £10,080 for 28 days' treatment with the two drugs. NICE had previously recommended the use of Tafinlar in melanoma in 2014 - before GlaxoSmithKline (GSK) transferred rights to the drug along with the rest of its cancer portfolio to Novartis.

The verdict is the second piece of good news for melanoma patients from NICE in a week, after the agency backed the use of Bristol-Myers Squibb's immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab) in record time.

Cholesterol antibodies
NICE also issued positive final guidance for Praluent and Repatha for adults with primary hypercholesterolaemia or mixed dyslipidaemia who do not respond to or cannot tolerate other drugs such as statins.

Amgen and Sanofi have both agreed discounts on the £4,000-plus per annum list price for the antibodies - in both cases after the drugs were initially rejected in draft guidance on the grounds that their price made it hard to justify routine use in the absence of hard data on cardiovascular outcomes.

Finally, new guidance backs the use of Humira in people with active moderate to severe hidradentitis, which is also known as acne inversa or Verneuil's disease. The drug can be prescribed - at a discounted price - for patients who do not respond to conventional systemic therapy such as oral antibiotics.

AbbVie has agreed to supply a 40mg prefilled pen or syringe of Humira at the discounted price of £284 for this indication, which compares with the list price of more than £350 per pen or syringe when used for other approved indications such as rheumatoid arthritis.

Article by
Phil Taylor

22nd June 2016

From: Regulatory



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