April 24, 2013 | By Márcio Barra
NICE, the UK price regulatory agency, gave today a final positive evaluation for two drugs, InterMune’s Esbriet for people who have chronic lung condition idiopathic pulmonary fibrosis, and Novartis’ asthma drug Xolair, in two guidances published today.
Esbriet (pirfenidone) is an oral antifibrotic drug that slows down the irreversible scarring damage that idiophatic pulmonary fibrosis causes in lung tissues. Pirfenidone is recommended for people with idiophatic pulmonary fibrosis who have a forced vital capacity – FVC, the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible – between 50% and 80%.
NICE’s positive recommendation follows the additional evidence provided by InterMune that showcases the drug’s benefits, and a revision of its still under wraps patient access scheme (PAS). NICE’s recommendation however, came with a forewarning that Esbriet had “a modest but measurable effect on slowing the decline in lung function”, but that it was uncertain whether the benefit lasts over time, due to the shortness of the clinical trials. The drug will be available by July to the approximately 6,800 people in England and Wales with idiopathic pulmonary fibrosis, at a cost effective price for the UK NHS.
Novartis’ Xolair (omalizumab) also won approval as a cost effect treatment option for severe, persistent confirmed allergic immunoglobulin E (IgE)-mediated asthma in people aged six years and older. Xolair is a recombinant DNA-derived humanized IgG1k monoclonal antibody that selectively binds to free human immunoglobulin E, an antibody that plays a role in asthma. It is to be used as an add-on to patients who need continuous or frequent treatment with oral corticosteroids ( four or more courses in the previous year).
Like many drugs who were first refused by NICE and later approved, Xolair’s approval comes after a revised Patient Access Scheme from Novartis, which provides this expensive drug – from £1,665 per patient per year for a 75mg dose administered every month to £26,640 per patient per year for the maximum 600mg dose given every fortnight – to patients at an still undisclosed discount.