Yesterday, I posted about REVASCOR (Mesoblast's therapy for CHF) being listed as a new drug under Super Health Plan of Texas.
I was in a hurry due to office commitments and instead of putting the post up as a new thread, I posted it under the aGVHD insurance thread.
My sincere apologies. Thanks to
@eyeswideopen for pointing that out. Plus,
@Scottdish posted another update yesterday from an Oregon provider for aGVHD in that thread. So I really think we should not mix aGVHD insurance coverage with that of CHF.
Since my (yesterday's) post was very brief, I have a feeling that many people could not understand its purpose and implication, especially since it was in the aGVHD thread, I am posting it again today but with the added content of addressing questions from
@Lopez@trststl@Yarnos20@choratio@otherperspective and
@Huge Jaxxon as to why REVASCOR has been listed when it has yet not been FDA approved. Some also asked as to why treatment for Chronic Low Back Pain has not been listed since it too is close to a Phase 3 read out.
So first off, for those who missed it, Super Health Plan of Texas which is a managed healthcare company that provides healthcare to Texas residents, has listed Mesoblast's CHF therapy REVASCOR (as well as the aGHVD therapy RYONCIL) in its list of "New Drugs" requiring Utilization Management. See link here:
https://www.superiorhealthplan.com/newsroom/july-2020-new-drugs-requiring-utilization-management.htmlHere is a screenshot:
Reasons why REVASCOR is listed:
1. First, analyzing all the drugs listed at that site we see a mixed bag of drugs already approved by the FDA and others in different stages:
FDA Approved - so these are easy to figure out why they have been included:Fensolvi
Retevmo
Qinlock
Artesunate
Nyvepria
Recarbrio
Oxymetazoline
Gimoti
Fintelpa
Phesgo
BLA submitted with Breakthrough Therapy Designation:Naxitamab
Orphan Drug and Fast Track Designation:Givinostat
Orphan Drug and RMAT Designation:
Revascor (Mesoblast CHF)
BLA / NDA submitted with announced PDUFA date:
Ryoncil (Mesoblast aGVHD)
Veverimer
Winlevi
ViloxazineAccepted Priority Review of BLA:
Valoctocogene Roxaparvovec (after interim analysis of Phase 3 trial)
KTE-X19
Lisocabtagene Maraleucel
Viaskin Peanut
As you can see, all the above which are yet to be approved by the FDA are either BLA submitted, Orphan Drug and or Fast Track/RMAT designation.For REVASCOR, Mesoblast received RMAT designation in 12/2017 and Orphan Drug designation in 06/2019.
2. Here's the kicker from the FDA supporting "
product marketing authorization" through a BLA with confirmatory clinical data. Quote "
FDA confirmed that data from the recently completed 159-patient placebo-controlled trial showing that Revascor reduced major mucosal bleeding events can support product marketing authorization through a Biologics License Application (BLA), with confirmatory clinical data."
This was on 08/27/2019:
https://www.globenewswire.com/news-release/2019/08/27/1906931/0/en/FDA-Provides-Guidance-on-Clinical-Pathway-to-Marketing-Application-for-Revascor-in-End-Stage-Heart-Failure-Patients-With-an-LVAD.html3. REVASCOR is already the
commercial name for Mesoblast's MPC-150-IM. So a commercial name supporting product marketing authorization.
4. Mesoblast's treatment for Chronic Low Back Pain does not meet any of the above criteria. That is why it is not listed, in my opinion.
Utilization Management:
So Superior Health Plan listed those new drugs as requiring Utilization Management. What is Utilization Management (UM)?
UM is a process adopted by Insurance Coverage providers to better utilize doctors/hospital resources to keep costs down. It's a process to maximize efficiency in the already expensive (and escalating) health care system in the US. For those of you who are interested in more detail, you can read this excellent paper on UM (the first 3 paragraphs have good examples):
https://www.ncbi.nlm.nih.gov/books/NBK234995/So folks - understand this about REVASCOR:
Insurance providers are already getting the ball rolling. By including REVASCOR in their UM process, they are not wasting any time and want to maximize coverage while keeping the costs down as soon as FDA approves it.
There are scores of other drugs that are in Phase 3 clinical trials or even some with completed successful Phase 3 trials but they are not included on the "New Drugs" list by Superior Health Plan. That means only two things:1. REVASCOR is in elite company
2. REVASCOR is primed to hit the ground running on Day 1 after FDA approvalYou might be thinking - well it's only one insurance provider - Superior Health Plan. So what's the big deal?Well, think again.
Superior Health Plan is a wholly owned subsidiary of Centene.
Centene -----
1. Centene Corporation is a multi-national company that provides high-quality healthcare services to members
in all 50 US states and
around the world.
2. Centene is the largest Medicaid managed care organization in the U.S., and a leader in California, Florida, New York and Texas, four of the largest Medicaid states
3. Centene had 2019 revenues of $75 billion in USD
4. It acts as an intermediary for Medicare and serves 400,000 Medicare beneficiaries in the US - Medicare is the US Federal health insurance program for people age 65 or older.
CHF is one of the most common reasons those aged 65 and over are hospitalized.@benelong Sorry that I made your heart rate go up and yearn for REVASCOR with that post from yesterday. By the way - I simply love your vocabulary and sentence construction. Spells class.
@otherperspective Sorry my post made you choke on your cereal.
PS: Lastly, some of you tag me as
@Yankee . Well, that is not me, but someone else. Probably my long lost cousin on HC. Please tag me as
@The Yankee. That other guy
@Yankee must be going nuts not knowing why the heck people are tagging him.
(20min delay)