NICE gives appraisal on three drugs, good news for Intermune and GSK, and bad news for Novartis

March 22, 2013 | By Márcio Barra

The UK’s National Institute of Health and Clinical Excellence (NICE) issued three appraisals this week, two of them positive for Intermune’s Esbriet (pirfenidone) and GlaxoSmithKline Revolade (Eltrombopag), and one negative for Novartis Afinitor (Evorolimus).

NICE website

Intermune’s Esbriet (pirfenidone), an innovative treatment for idiopathic pulmonary fibrosis (IPF), received a positive appraisal from NICE, recommending its reimbursement by the UK’s National Health Service (NHS). This drug, a TGF-beta synthesis inhibitor, first had a negative opinion back in 2012, where its reimbursement was recommended against due to its high cost. Now, prompted by Intermune’s decision to provide the drug with a discount and a Patient Access Scheme, NICE’s opinion changed, and the prescription of Esbriet is now recommended. Patient Access Schemes are special procedures, which pharmaceutical companies can propose to NICE to enable patients to gain access to high cost drugs, who may not have a significant benefit over existing treatments.

GlaxoSmithKline Revolade (Eltrombopag) also received some good news from NICE. Like Esbriet, this drug was also ruled out from use after NICE deemed it too expensive to be funded by the NHS. And like Esbriet, after a proposed discount to the NHS and a handy Patient Access Scheme, NICE gave the ok for sale. Revolade is used for the treatment of chronic immune (idiopathic) thrombocytopenic purpora, for use in patients who have had a splenectomy, and whose condition is refractory to other treatments.


Novartis however, received a bit of bad news. Afinitor (Evorolimus), for HER2 negative, hormone-receptor-positive advanced breast cancer, received a negative appraisal, as NICE deemed that it doesn’t offer enough value for its price. The main draw that Afinitor (a kinase inhibitor approved in several other indications such as kidney cancer), is that it offered a novel way to treat breast cancer patients who developed resistance to the gold standard of care in these cases, aromatase inhibitors. But alas, NICE chief Andrew Dillon stated that “using the most appropriate estimates, the committee concluded that everolimus is not a cost-effective treatment option for the NHS.”  Afinitor data from a Phase III, 724-patient trial, which showed more than a doubled median progression-free survival to 7.8 months in combination with exemestane, compared with 3.2 months with exemestane alone, was not enough for NICE in their price benefit-evaluation.


Access to Afinitor may still be possible through the Cancer Drugs Fund.

Follow this link for a interesting short article on NICE’s drug rationing controversies.


Online Pharma Times

Regulatory Focus

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