Egrifta Gets Approved for the Treatment of Abdominal Fat Accumulation in HIV- Activists Ask Serono to Price it Affordably

Egrifta Gets Approved for the Treatment of Abdominal Fat Accumulation in HIV- Activists Ask Serono to Price it Affordably

Fat busting, but at what cost?: http://blogs.poz.com/tim/archives/2010/11/fat_busting_but_at_w.html 




Press Release from Serono:

http://multivu.prnewswire.com/mnr/emdserono/47019/

Here’s a link to the full prescribing info via Serono’s website:

http://www.emdserono.com/cmg.emdserono_us/en/images/FULL%20PRESCRIBING%20INFORMATION_tcm115_59676.pdf?Version=

A Closer Look at Egrifta, a Newly Approved Treatment for HIV-Associated Belly Fat Gain (Lipohypertrophy)

http://www.thebody.com/content/art59340.html

For physicians interested in learning more about EGRIFTA™ and
the process for prescribing EGRIFTA™, call the AXIS Center
toll-free at 877-714-AXIS (2947).

Egrifta.com will have more information soon about patient assistance and other important issues

Briefing Information for the May 27, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM213260.pdf

LETTER SENT BY ACTIVISTS TO SERONO:

David L. Stern
Executive Vice President
Endocrinology
EMD Serono Inc.
Rockland, MA
Dear David,
Thank you for taking the time to meet with the Fair Pricing Coalition (FPC) on August 9, 2010 regarding the pricing of Egrifta (tesamorelin). We believe that Egrifta, if approved, will be beneficial to many people with HIV-associated lipohypertrophy by improving their self-image, quality of life and adherence to their HIV treatment regimens. However, Egrifta only has a minimal effect on fat deposition with only modest waist circumference changes described.  Further, there is no accompanying mortality data that might convince patients and providers Egrifta was actually worth an exorbitant price.  Moreover, unlike Serostim, Egrifta must be used continuously to retain any effect.  This means continuous drug costs and continuous profits.  Surely, the ultimate price of the drug should be considered in light of these circumstances.
It is for these reasons that we feel strongly that Egrifta must be priced reasonably and affordably to allow the widest access possible for the greatest number of people. While we understand and appreciate the pricing considerations that EMD Serono put forth at the meeting, we also know that the reaction to the final price by patients and their advocates, as well as payers and providers must be favorable in order for this drug to widely accepted, desired by patients and covered by payers.  Moreover, Egrifta is the first drug of its kind for hypertrophy.  Thus, any drugs that follow Egrifta will undoubtedly be priced higher than Egrifta, resulting in a continued upward spiral of drug costs that are healthcare system cannot absorb.
We hope that EMD Serono will consider the concerns we raised at the meeting before determining the final price of Egrifta. As we stated at the meeting, we hope to be able to support the use of Egrifta and your pricing decision.  We will do so only if we believe Egrifta it is priced within a reasonable range.
We look forward to continued dialogue on this matter and hope it will not be necessary to publicly denounce EMD Serono and the final price of Egrifta .
If you have any questions or concerns, please do not hesitate to contact me by phone or e-mail.
Very truly yours,
Jeff Berry
Fair Pricing Coalition

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