NICE rejects Orexigen weight loss pill

NICE has said Orexigen’s weight loss pill, Mysimba, should not be funded on the NHS because of shortcomings in its data.

These shortcomings were judged to be so severe that NICE concluded it could not reach a verdict on the drug’s cost effectiveness at all.

NICE said issues such as lack of representation of overweight people in trials, and an economic model that failed to capture the full treatment pathway, including costs of retreatment and bariatric surgery.

Its  draft guidance therefore concluded there was insufficient evidence to support funding for Mysimba (naltrexone+bupropion) in its authorised use for managing overweight (Body Mass Index 27 to 30) and obesity (BMI of 30 or above).

Costing £73 per pack of 112 tablets at list price, dose is escalated to two tablets in the morning and evening from week four of treatment, bringing the yearly cost to around £952 per patient at full dose.

NICE’s independent appraisal committee noted that Mysimba is an “innovative option” after lifestyle measures, and where GlaxoSmithKline’s Alli (orlistat) is the only pharmaceutical alternative.

The committee heard expert clinical opinion that currently, Alli is the only drug treatment available, but has “socially unacceptable” gastrointestinal side-effects.

Mysimba does not have the same side-effects and may be better tolerated, and the committee concluded that there is a need for new treatment options.

But the committee pointed to shortcomings with Orexigen’s economic analysis, saying the model had important limitations in its structure, implementation, key assumptions, and clinical data used.

It will consult on the guidelines until 30 May. The manufacturer can submit further data or offer to lower the price during the process, ahead of a second draft due later this year.

Mysimba, known as Contrave in the US, was acquired by Orexigen from Takeda in March 2016. This was after recording poor revenues since its launch in 2014, and it achieved just $22 million in sales last year.

 

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