Please login to the form below

Not currently logged in
Email:
Password:

Gilead wins over IQWiG with new Eviplera data

German HTA body says it can now recognise the triple HIV pill has 'added benefit

German HTA body IQWiG

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) has reversed its negative recommendation for Gilead's Eviplera after the pharma company provided key study data.

The triple combination HIV pill was ruled in April to provide no additional benefit by the health technology assessment (HTA) advisers, despite rilpivirine – one of the Eviplera's components – being backed.

IQWiG said Gilead had failed to provide “important data” for Eviplera's first assessment under Germany's AMNOG legislation.

As a result IQWiG was unable to say whether it provided “added benefit”, in effect meaning it would hand a negative recommendation to the drug pricing watchdog the German Federal Joint Committee (G-BA), which is responsible for issuing final guidance.

IQWiG's new ruling was made possible after Gilead provided additional data from ongoing studies in the form of new subgroup analyses for Eviplera during the commenting period for the guidance.

“There is now proof that also in the fixed combination with emtricitabine and tenofovir disoproxil, rilpivirine offers a considerable added benefit for men infected with HIV-1. For women, the available studies provide corresponding indications. This matches the result of the dossier assessment of April 2012 on rilpivirine as a single agent,” IQWiG said in a statement.

Data from the manufacturer also suggested Eviplera may have fewer neurological side effects than monotherapy rilpivirine, but “a few uncertainties” in Gilead's analysis meant this was just an “indication of lesser harm”, IQWiG said. 

Eviplera combines Tibotec and Johnson & Johnson's Edurant (rilpivirine) with Gilead's own double therapy Truvada (emtricitabine and tenofovir disproxil). 

It was approved in Europe in November last year as a once-daily treatment for patients starting antiretroviral therapy for the first time.

16th July 2012

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Hanson Zandi

Hanson Zandi’s philosophy is to go that extra mile. Look deeper. Discuss further.Study longer. Work harder.This focussed work ethic combined...

Latest intelligence

Blog_icon_understanding-the-adoption-ladder-in-closed-loop-marketing.png
Flexible content checklist – five questions to ask
To ensure that your content gets used by local markets and has a real impact, consider these questions when commissioning or developing core materials....
Experience design of physical spaces: a human-centred approach
Anna Tamasi from Blue Latitude Health highlights the key considerations and best practices for spatial design from a user experience design perspective....
Stronger together
A patient-focused strategy is high on the agenda, with a top-down approach favoured by industry leaders...

Infographics