Mylan racketeering.....

[gvmom]

http://www.cnbc.com/2017/04/03/mylan-hit-with-racketeering-suit-over-big-price-hikes-of-epipen.html

Wondering how this will affect Mylan, the recall, the price point, and also Auvi-q given their pricing scheme.

Any thoughts?

[Mr. Barlow]

Read the complaint here.

EpiPen Purchasers Accuse Drug Maker Mylan of Fraud, RICO Enterprise in National Class-Action Lawsuit over EpiPen Pricing

My thoughts now are I want to know what discovery comes out of this.  They'll have to prove intent and enterprise at civil burden, assuming the class action is able to move forward.  One can hope some sort of indication of abuse of office comes to light AND just how many were involved to allow this to happen.   A whistleblower or two would be nice. 

[Mr. Barlow]

Oh, and the chorus of ecstatic Mylan-sponsored bloggers, summits, docs, nonprofits, brand ambassadors who failed to maintain adequate ethics.  Not going to forget you. 

The ones who were brave enough to question the status quo, however, lots of love for you all.  .

[gvmom]

My thoughts now are I want to know what discovery comes out of this

Given the insurance companies named in conjunction, I want to know more about how this will affect possible coverage, and how about supply?  Not to mention, really, given the charges, what is going to happen with Kaleo.  They've gotten bad press not just over auvi-q but also evzio.   

Right now, there is supply for filling prescriptions.  There is also new coverage policies because of pricing. 

As this goes along, making it's way through the court, thinking a few months down the road, will Mylan change it's pricing?  Will insurance companies change their tune?  What will kaleo do?  Will they end up being sued?  And, if CVS is part of anything, what happens with their auto-injector?

All of these companies playing their games to make money, but, if they end up toast, what happens to people who need the auto-injectors? 

modified to correct my wording 

[my3guys]

Yep that's my question too gvmom. Depending on where this case goes how easily will we still be able to get autoinjectors?

[Mr. Barlow]

These aren't charges.  It's a private action.  This is civil RICO, not criminal.  Mylan will probably settle this too with some sort of confidentiality agreement that says they admit to nothing. Few cases actually make it to trial, and this is just a complaint requesting approval to move forward with the class action.  Mylan settled the Medicare fraud very early and that, in my non-attorney opinion, was much more serious because HHS has comparatively deep pockets and experience investigating medical fraud, not to mention political support.

Edited to add: For you really unlucky souls, Bresch's mom Gayle Manchin runs your state department of ed.  Dad Manchin is one of the state's elected officials still, yes?  Make some noise VA. Family matters: EpiPens had high-level help getting into schools

[gvmom]

Sorry.... I meant sued. 

Either way, if one company ends up doing something, having ramifications of some sort, that could potentially apply to another company, as a result of this action, and those two companies are the main suppliers of something people medically depend on, in addition to another party mentioned in the case, and their product.... then there could potentially be a situation where the people who medically depend on the product they can really only get from 3 places, could end up screwed.

How has Mylan done since their Medicare fraud settlement?  What are their stats for the people who are depending on them making money?  Do investors not care that there is the fraud settlement, then the recall, and now this?  Anyone wondering what next? 

[GoingNuts]

Well, well, well.

http://www.reuters.com/article/mylan-nl-epipen-idUSL1N1HW0Q6?type=companyNews

[PurpleCat]

 

[gvmom]

Interesting.  Wonder if Sanofi decided to do this before they get grouped together with Mylan.  It is easier to pile on to the side that points the finger to Mylan being unethical rather than wait to be called out for their own pricing scheme.  Does it matter that their product failed given the time period Sanofi is calling Mylan out on?

Also, wondering, if they are trying to capitalize on what is going on with Mylan how well they are going to manage to do that with supply issues and pricing/insurance issues.

Why call attention to yourself right now when your competitor is getting clobbered?  As far as I'm concerned, they aren't any better given how they are working things.... unless somehow they manage to actually change their prices and not just be another company that abuses the insurance racket.

[PurpleCat]

But Sanofi is no longer producing or marketing Auvi Q. 

The rights went back to Kaleo.

[gvmom]

   .... okay... I'm a dingbat....

.... but..... so.... what is Sanofi's gain then?  At the time they were trying to compete against Mylan they were charging the same and insurance companies would cover the Auvi-q.  And, had a failed product that had to be pulled from the market.  So, inherently they were charging the same for defective products.

What really does Sanofi have to gain from that?  Reminding people that their product failed, got pulled from the market, and now a bunch of us who could get it before can't because Kaleo has gone with the same racket as Mylan with the only difference is that the product now works and there is less insurance coverage for it, along with that absurd mark-up?

Are there people that lost their shirts on that first go that are just trying to recoup investment money? 

[nyguy]

  .... okay... I'm a dingbat....

.... but..... so.... what is Sanofi's gain then?  At the time they were trying to compete against Mylan they were charging the same and insurance companies would cover the Auvi-q.  And, had a failed product that had to be pulled from the market.  So, inherently they were charging the same for defective products.

Firstly, Sanofi alleges they pulled the Auvi-Q out of an abundance of caution over potential dosage issues, then chose to revert the rights. Believe what you want and read between the lines, but the success/marketshare and ability to price a product have a lot to do with your break-even. Less marketshare against fixed development costs? Incentive to cut your losses. Sanofi likely cut their losses.

Also, between what was known at the time Auvi-Q was on market vs. now (with all of the Mylan hate/probing)... plus you can sue for past damages.

Alright, not a lawyer, skimming the brief, who knows what holds up in court or what settlement is reached. I'm just reading what Sanofi is alleging and trying to distill it.

Sanofi is arguing that Auvi-Q was generally a Tier 2/Tier 3 drug on 3/4 tier drug plans in the US. It wasn't generic (Tier 1) but was preferred brand or at least not higher tier non-preferred, and copay programs kept it affordable ($0 generally) for consumers.

Starting Spring 2013, Mylan starts negotiating huge rebates to third party payors of 30% or more if Auvi-Q will be the only covered Epinephrine device in the formulary. (Basically, Adrenaclick, Twinject, Auvi-Q, etc. are not covered drugs) only covering Auvi-Q if it was under an extremely restrictive prior authorization. Rebates are a fact of life but large rebates to exclude competition aren't kosher. Mylan started the price hikes (according to sanofi) before EpiPen ever launched - then, once Auvi-Q provided an actual threat, they made up for the price hikes with massive rebate schemes that weren't there before. Key part is the exclusivity on the rebates - you want the rebate, you agree EpiPen is the only autoinjector you cover. EpiPen already had massive brand awareness/marketshare and Auvi-Q was not A/B rated, so it was hard for third parties to ignore the amount of discounting.

Between marketshare (13% at peak) and trying to make up the cost of innovating in the autoinjector market (e.g. cost of development/royalties) Sanofi says they could not intend nor possibly match the EpiPen rebating. Sanofi says once Mylan started the exclusivity scheme, 50% or more of insured patients lost access to Auvi-Q within 2 months (December 2013/Jan 2014). Due to the tiering mentioned earlier, Sanofi had to pay far more per patient to get them $0 copay at the counter than Mylan did.

Moving quicker: Mylan required schools to not stock other autoinjectors to get free EpiPens, Mylan ripped off Medicaid, Sanofi took a bath on Auvi-Q because of anticompetitive actions by Mylan. Mylans conduct hurt consumers for lack/suppression of a better product and them paying for it, third party payors being blindsided by Mylan, etc.

Regarding Kaleo, unless there's some massive secret rebate scheme I don't get why PBMs would pay for Auvi-Q as is. Rebates to PBMs are kept wholly, in part, or not at all by the PBM instead of the plan payer. In a large group plan, rebates go entirely back to the large group payer. In other plans, PBMs keep most of it. I suspect on smaller plans (individual health/smaller employers) the PBMs are paying a large sticker and getting 50%+ of the Auvi-Q purchase price back, which at $4500 a two pack is $2250. I suspect that Kaleo will ultimately end up in similar trouble for different reasons (not allegations from a competitor but some aggrieved parties (companies, plan payers [employers], etc.) filing suit, if there's not some sort of congressional investigation due to the general outrage of drug pricing and ballooning medical costs in this country.

[Mr. Barlow]

Mylan left behind a target-rich environment.  This might be more about optics.  You notice more now because it affects a segment of healthcare with a direct impact on you.  In order to know if this is irregular or odd you'd have to compare to a valid baseline.  I think it was a couple of years ago I read Mylan suing Sanofi or Intelliject over IP, and suppressing a generic's entry to the market as "unsafe."  I might have posted those cases on FAS. 

[ajasfolks2]

Just let this sink in.

https://arstechnica.com/science/2017/06/with-help-of-coal-tax-credits-mylan-had-a-negative-294-percent-tax-rate-in-2016/