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Post by stevil on Nov 23, 2015 18:27:45 GMT -5
Very interesting article, SO why isn't SNY offering Afrezza at a steep discount as opposed to an absurd 3-4x price tag with a "non-inferior" label to boot. Has it not been on market long enough for them to discount (even though it's not selling)? It's still a bit of a "chicken or egg" scenario [insurance, advertising, doctor education etc.] but SNY doesn't seem to be willing to supply either the chicken or the egg, so the process cannot begin. Bottomline: No Omelettes for anyone [shareholders, diabetics, SNY, MNKD]. Maybe there are exclusivity deals already in place for Novo and Huma that must run their course before they can add Afrezza at any price. Maybe SNY is willing to heavily discount. I know I don't have the answers... just throwing out possibilities. DBC, Where did you get your exclusivity theory from? SNY already has a prandial that is well-covered- Apidra. There have been very few true exclusivity coverages that I saw, and even if they did exist, it would only be with one specific insurance carrier, not across the board. And the only one that I can really think of off the top of my head is ProAir/Ventolin HFA inhalers. And the only reason one would be exclusive is because it's the exact same medication (albuterol), just branded differently. So, of course the insurance company would want to protect exclusivity if they could provide the same medication to their client at a cheaper price. I've never heard of exclusivity being tied to drugs with a different molecular composition. People respond differently to different chemicals. It wouldn't be in the client's best interest to limit their options...
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Post by dreamboatcruise on Nov 23, 2015 18:37:37 GMT -5
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Post by stevil on Nov 23, 2015 18:59:26 GMT -5
You were right regarding your comment pertaining to nasal steroids. It was common for intranasal steroids to be excluded, but that's only because Flonase was generic. Nasonex, Omnaris, Rhinocort, and others, would typically be denied coverage because fluticasone (generic flonase) was available for 25% of the cost of those different brands. On most plans, those other drugs would have needed a PA from the doc, with an explanation that fluticasone didn't work and they needed to try X because _____.
I can't say with 100% certainty, but pretty close- I don't think insurance companies make those kinds of deals with pharmas to only accept their drugs and not their competitors. Drugs are excluded from formularies based solely on cost. I can't imagine the FDA would allow certain pharmas to monopolize an insurance carrier (generics can be manufactured by anyone), nor would it be in the insurer's best interest to do so- they would surely piss off their customers. It's why you see a drug get added to the formulary if enough people complain about it...
Excluded drugs are denied coverage at the choice of the insurance company because they couldn't agree on the value of a drug with the pharmaceutical company. If SNY wanted to lower their price, insurance companies would cover Afrezza. I don't believe Novo or Lilly are strong-arming insurance companies, at least not in broad daylight.
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Post by dreamboatcruise on Nov 23, 2015 19:27:30 GMT -5
stevil... I'm having a hard time finding an article that outright states that exclusions are written into deals, but the wording in this article certainly seems to imply that. "The result is a mix of contracts. Express Scripts has an exclusive deal for Viekira Pak that excludes Gilead products from its national formulary, which includes 25 million of its 85 million covered lives. CVS Caremark has an exclusive arrangement for Gilead’s Harvoni, a combination drug that includes Sovaldi and another antiviral, ledipasvir. In addition, some formularies include products from both manufacturers with price concessions from both." www.managedcaremag.com/archives/2015/4/pbms-just-say-no-some-drugs-not-othersIn your opinion all of these rather common cases of having one drug in a class preferred and others not are simply the other companies not agreeing to the same pricing and that at anytime if they did they could gain preferred access? It seems odd that some plans would have Humalog and others Novolog as exclusive preferred if meeting the same price point gained equal status. I could be wrong, but my understanding is that actual exclusions are written into the deals with various companies deemed to have comparable products... i.e. you give me a big discount and I'll only use your product. The above article seems to imply some PBM use the exclusive deals and others don't.
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Post by stevil on Nov 23, 2015 19:37:22 GMT -5
No, that absolutely DOES happen, just not 100% exclusively. I can't remember which drug it was off the top of my head, but there was one brand that was available in the generic copay tier. All of its competitors were something to the tune of 3 times more expensive at the normal brand copay. I'm not saying that drug companies can't strike deals with insurance companies that would give them sole favorable placement on the formulary. I just don't think they can tell the insurance company not to cover any other drugs entirely. It'd be even more surprising if they could play bully to just one drug in particular.
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Post by peppy on Nov 23, 2015 19:40:07 GMT -5
Looking further. Tell me what is wrong with my thinking. 22 % of lives covered. 46% of lives restricted; if 1/2 restricted type 1 could be granted, 23 % of type one lives restricted plus 22% of lives covered. = 45% of type 1 lives could be covered. screencast.com/t/YxJhjE0gGYb5Number of adults using diabetes medication* (millions)Insulin only 2.9 screencast.com/t/kLZT7G7NA1/3 of those people is a million people. Possibility of 500,000 people covered for afrezza use.... 9 months later.... 2000 users? hmmmm, doesn't make sense. Afrezza is non inferior! (the not covered, $4,374.12 annually afrezza $1,406.28 annually apidra)
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Post by stevil on Nov 23, 2015 19:48:14 GMT -5
stevil ... I'm having a hard time finding an article that outright states that exclusions are written into deals, but the wording in this article certainly seems to imply that. "The result is a mix of contracts. Express Scripts has an exclusive deal for Viekira Pak that excludes Gilead products from its national formulary, which includes 25 million of its 85 million covered lives. CVS Caremark has an exclusive arrangement for Gilead’s Harvoni, a combination drug that includes Sovaldi and another antiviral, ledipasvir. In addition, some formularies include products from both manufacturers with price concessions from both." www.managedcaremag.com/archives/2015/4/pbms-just-say-no-some-drugs-not-othersIn your opinion all of these rather common cases of having one drug in a class preferred and others not are simply the other companies not agreeing to the same pricing and that at anytime if they did they could gain preferred access? It seems odd that some plans would have Humalog and others Novolog as exclusive preferred if meeting the same price point gained equal status. I could be wrong, but my understanding is that actual exclusions are written into the deals with various companies deemed to have comparable products... i.e. you give me a big discount and I'll only use your product. The above article seems to imply some PBM use the exclusive deals and others don't. Hmmm just read through your link after I posted. It looks like the rules started changing last year in 2014, so that would have been after I was done in the pharmacy. It does appear that new contracts are being written up for exclusivity, so thanks for making me aware of this change. It makes sense... Pharmas used to use discount cards that would reduce the copay from, say $50 to $25. It would likely be cheaper for the pharma to spend that $25 reimbursing the consumer than it would be to negotiate a cheaper price with the insurance company. Slick move by insurance companies. I'm greatly saddened by this news. Insurance companies have become far too powerful. They've already told physicians what they can't prescribe, and now they're telling their clients you're only allowed to be treated with this... How providers or organizations allowed insurance companies to slowly garner all this power is beyond me. Money talks, and my guess is these companies are lining our politician's pockets with gold. This is unethical.
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Post by dreamboatcruise on Nov 23, 2015 19:57:07 GMT -5
stevil... I would say that logic would seem to dictate that if Aprida is at 40% as covered or preferred, it seems unlikely that contractual barriers would prevent Afrezza from matching that, and yet Afrezza is at only 23%. All I know is that I'm simply left guessing at what is going on behind the curtain. Not a great position to be in as an investor.
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Post by mssciguy on Nov 23, 2015 20:03:09 GMT -5
stevil ... I would say that logic would seem to dictate that if Aprida is at 40% as covered or preferred, it seems unlikely that contractual barriers would prevent Afrezza from matching that, and yet Afrezza is at only 23%. All I know is that I'm simply left guessing at what is going on behind the curtain. Not a great position to be in as an investor. I just looked at the contractual terms b/w sec, mnkd- there IS a non-compete clause. This is a legal minefield. We may be seeing some action (or not) --- maybe all behind the scenes but SNY sure seems little Jekyll and Hyde in appearance, at least publicly.
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Insurance
Nov 23, 2015 20:15:09 GMT -5
via mobile
Post by stevil on Nov 23, 2015 20:15:09 GMT -5
stevil ... I would say that logic would seem to dictate that if Aprida is at 40% as covered or preferred, it seems unlikely that contractual barriers would prevent Afrezza from matching that, and yet Afrezza is at only 23%. All I know is that I'm simply left guessing at what is going on behind the curtain. Not a great position to be in as an investor. I just looked at the contractual terms b/w sec, mnkd- there IS a non-compete clause. This is a legal minefield. We may be seeing some action (or not) --- maybe all behind the scenes but SNY sure seems little Jekyll and Hyde in appearance, at least publicly. How in the world would MNKD agree to a noncompete clause?! Unless they expected a better label that would have freed them from competing with Apidra?
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Post by peppy on Nov 23, 2015 20:18:25 GMT -5
the application was for non inferior my understanding
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Post by jeremg on Nov 23, 2015 20:31:13 GMT -5
I just looked at the contractual terms b/w sec, mnkd- there IS a non-compete clause. This is a legal minefield. We may be seeing some action (or not) --- maybe all behind the scenes but SNY sure seems little Jekyll and Hyde in appearance, at least publicly. How in the world would MNKD agree to a noncompete clause?! Unless they expected a better label that would have freed them from competing with Apidra? Wait a second, do you have the directionality right on that one...? Did MNKD have SNY sign a "non-compete clause" or did MNKD sign a "non-complete clause", the latter would be the stupidest thing I've heard yet regarding this deal. I hope it's the former and contractually SNY can't use Apidra to compete with Afrezza. Anyone care to clarify?
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Post by mnholdem on Nov 23, 2015 20:56:16 GMT -5
It's Sanofi who cannot develop a competing API for five years, as one of the conditions for being given the right to manufacture Technosphere particles within the terms of the agreement. I'm mobile at the mo', so I don't have the Agreement at my fingertips, but I think it was in Article 5, perhaps?
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Insurance
Nov 23, 2015 21:14:41 GMT -5
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Post by Deleted on Nov 23, 2015 21:14:41 GMT -5
It's Sanofi who cannot develop a competing API for five years, as one of the conditions for being given the right to manufacture Technosphere particles within the terms of the agreement. I'm mobile at the mo', so I don't have the Agreement at my fingertips, but I think it was in Article 5, perhaps? Logical.
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Post by benyiju on Nov 23, 2015 21:30:14 GMT -5
It's Sanofi who cannot develop a competing API for five years, as one of the conditions for being given the right to manufacture Technosphere particles within the terms of the agreement. I'm mobile at the mo', so I don't have the Agreement at my fingertips, but I think it was in Article 5, perhaps? I sure hope so. I can't imagine how it could be the other direction. If it is the other direction, the Company has bigger problems that we thought!
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