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Nucala price far too high for US market, says ICER

Concludes GlaxoSmithKline's new severe asthma therapy is not value for money

GlaxoSmithKline's headquarters 

GlaxoSmithKline's new severe asthma therapy Nucala needs to have its price slashed by at least two thirds in order to provide value for money, says a new report.

The cost-effectiveness assessment by the Institute for Clinical and Economic Review (ICER) concludes that Nucala (mepolizumab) is over-priced at its $32,500 annual price tag, and would have to be in the range of $7,800 to $12,000 per year to meet its criteria.

Nucala became the first interleukin-5 (IL-5) inhibitor to be approved in the US last month, with the FDA clearing it for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older who have a history of severe, breakthrough asthma attacks.

ICER's draft report finds that Nucala is effective, saying there is "moderate certainty that adding mepolizumab to the current standard of care … provides a comparable or better net health benefit compared to standard care alone in patients with severe eosinophilic asthma".

The benefit comes from reducing the exacerbations from asthma, which can lead to hospitalisations, as well as steroid use which can have side effects in the long term. ICER says however that the relatively short trials used to back Nucala's approval mean it is uncertain whether the benefits will persist.

GSK said it disagreed with the ICER analysis, arguing that the price being charged reflected the value being provided to patients and the costs of developing the new first-in-class therapy. ICER has no power to block the use of a drug but its reports are often used as leverage in negotiations between pharma companies and payer organisations.

Earlier this year, ICER arrived at similar conclusions for Amgen's Repatha (evolocumab) and Sanofi/Regeneron's Praluent (alirocumab) - two cholesterol-lowering PCSK9 inhibitors - suggesting these could need 85% price cuts to justify their use. 

Novo Nordisk's Tresiba just about right 

The organisation does not always recommend such sweeping price cuts however. It recently concluded that the pricing of Novartis' new heart failure therapy Entresto (sacubitril and valsartan) was at the correct level once typical discounts and rebates are applied.

It has just taken a similar stance with Novo Nordisk's new long-acting insulin Tresiba (insulin degludec), which was approved in September and is due for launch early next year at an annual cost of around $7,800.

ICER's draft analysis finds that the price range for the drug should be between $7,000 and $7,150 so, like Entresto, Tresiba will be in the right ballpark with payer discounting.

Both reports will be discussed at a public meeting of the California Technology Assessment Forum on 12 February and are open for comment until 12 January.

Article by
Phil Taylor

23rd December 2015

From: Sales



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