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Daily Brief: Biosimilar Herceptin can't make Perjeta cost effective and more

E-cigarettes can save lives - Teva gains approval for EpiPen generic

Herceptin biosimilars can’t make Perjeta cost effective, says NICE


NICE has once again rejected Roche’s HER2-positive breast cancer drug Perjeta for treating patients after surgery in those who have a high risk of the disease recurring.

The Institute had already rejected it in this setting in June, but looked again to see if the arrival of biosimilars of Herceptin (trastuzumab) – which is administered with Perjeta – would help improve its cost effectiveness.

However NICE’s committee concluded that while biosimilar versions of intravenous trastuzumab will help to cut the cost of the adjuvant pertuzumab regimen, it still wasn’t enough to bring it into cost-effectiveness range.

It’s no secret that Roche’s results from its APHINTY trial were disappointing when unveiled last year – they showed adding Perjeta to Herceptin and chemo added just a 1% in disease free survival after three years.

NICE concluded Perjeta made “only a small difference in the proportion of people who remained free of invasive disease, and this effect was itself uncertain”, and said there was a lack of evidence on how long, if at all, adding pertuzumab might improve overall survival.

NICE already recommends Perjeta with trastuzumab and chemo before surgery and where it has either recurred in the breast following initial treatment or has spread to elsewhere in the body.

A consultation on the latest draft guidance is now open until 7 September, with final guidance expected to be published in December.

Read NICE’s latest draft guidance here

Promoting e-cigarettes could save lives, says parliamentary group

E-cigarettes are far less harmful than conventional cigarettes, and the UK government should relax restrictions on their promotion and cut taxes to promote health.

That’s the conclusion of the cross-party Science and Technology committee of MPs.

Their report says the risk to smokers who continue with their habit far outweighs the as-yet-uncertain harm caused by vaping. The MPs cited evidence from Public Health England which concludes that e-cigarettes are 95% safer than smoking.

“E-cigarettes present an opportunity to significantly accelerate already. declining smoking rates, and thereby tackle one of the largest causes of death in the UK today.

Sir Norman Lamb, the committee’s chair, told the Guardian:

“The blunt fact is that 79,000 people in England still die of smoking every year, which is sort of unconscionable, particularly when we know there is the means by which we can reduce the death toll.”

This conclusion is not without controversy however, as a growing body of evidence suggests that vaping does cause damage to the users’ lungs.

A report published in the journal Thorax this week suggests e-cigarettes disable alveolar macrophages which combat bacteria, dust particles and allergens in the lungs.

Teva lifted by approval for EpiPen generic


The FDA has approved Teva’s version of Mylan’s EpiPen, making it the first generic competitor to the costly emergency allergy treatment.

Teva shares rose nearly 6% on the news, and the imminent launch of the rival version is expected to see prices drop in the US.

"This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages," FDA Commissioner Scott Gottlieb said in a statement.

Mylan introduced its own authorised generic form of the EpiPen in 2016, after a national uproar about the branded version's price. The product’s price rose more than 400% over a decade. The authorised generic cost half the price of the original, $300 for a two-pack of injectors.

Article by
Andrew McConaghie

17th August 2018

From: Healthcare



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