pharmaphorum

JUNE 8, 2021

That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s since 2003, which it says has “no evidentiary basis.” — Dr. Patrizia Cavazzoni (@FDACDERDirector) June 7, 2021.

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pharmaphorum

AUGUST 21, 2022

There’s no word yet on its pricing, but for comparison Spravato was launched with an annual price tag of around $32,400, which the Institute for Clinical and Economic Review (ICER) concluded was around 25% to 52% too high to be cost effective.

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Drugs FDA Approval Production Marketing 94

pharmaphorum

AUGUST 18, 2022

million price tag attached to the therapy when it was first made available in Europe, and is also well above the proposed $2.1 million level that cost-effectiveness organisation ICER said would be acceptable in a July report. That payback option was also factored into the ICER review, though notably over a five-year period.

Gene Therapy 52

Gene Therapy FDA Approval Gene Clinical Trials 52

pharmaphorum

JUNE 12, 2022

Beti-cel has already been approved for marketing in Europe as Zynteglo, with a price tag of around $1.8 In April, influential US cost-effectiveness watchdog ICER endorsed beti-cel’s proposed $2.1 million price tag, saying its ability to help patients reach sustained transfusion independence justified its high price.

Gene Therapy 59

Gene Therapy Gene Marketing Trials 59

pharmaphorum

NOVEMBER 24, 2022

One issue has been the cost of the drug, with health technology assessment agency NICE in the UK and the ICER organisation in the US both concluding its price tag means it is not a cost-effective option for health systems.

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Trials Sales Drugs Marketing 52

pharmaphorum

JUNE 2, 2022

And of course, in many cases, these drugs have higher than average price tags compared to the wider market which is due to the limited – or in most cases – non-existent competition within a treatment area.”. Raising questions. According to the organisation, 39% of orphan drugs cost more than $100,000 annually.

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XTalks

DECEMBER 13, 2023

Related: Roctavian Becomes First Gene Therapy for Severe Hemophilia A to Get FDA Nod Casgevy and Lyfgenia Pricing and Warnings The price tags of both gene therapies are steep, given the complexity of developing gene therapies and as therapies meant to be one-time treatments. Vertex-CRISPR’s Casgevy has a US list price of $2.2

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Gene Therapy FDA Approval Gene In-Vivo 98

Pharmaceutical Technology

JUNE 21, 2023

The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective. Despite this, the Institute for Clinical and Economic Review (ICER) claimed that a fairer price would be in the region of $2.9m.

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Gene Therapy Gene Sales Protein 246

pharmaphorum

NOVEMBER 16, 2022

However, with a price tag of €1.58 ICER (the Institute for Clinical and Economic Review) is based in the US and is a non-profit organisation that provides an independent source of evidence review to address questions over the value of a treatment and pricing. How to navigate the new climate. At more than $2.1

Gene Therapy 129

Gene Therapy Gene Marketing Development 129