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Post by boca1girl on Sept 23, 2017 6:37:53 GMT -5
IF Afrezza obtains a new classification (ultra rapid, etc.), does anyone on this board know for a FACT, that PBM's have to cover the drug on their formularies?
Must they cover the new drug class or can they choose not to?
IF they must cover Afrezza in a new class, would it be a Tier 1,2, 3, or 4?
We can all speculate, but does anyone here have experience working for/with PBM's?
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Post by ghochr on Sept 23, 2017 7:29:36 GMT -5
They see them, they just haven't been targeting them. Some have many patients on Afrezza. You're not kidding either, I didn't get to look at the script count until 7 pm tonight. Whatcha think the year's end will be? So is Mannkind seeing PCP or not ? I am confused of the contrasting contradictory |
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Post by akemp3000 on Sept 23, 2017 7:42:37 GMT -5
IF Afrezza obtains a new classification (ultra rapid, etc.), does anyone on this board know for a FACT, that PBM's have to cover the drug on their formularies? Must they cover the new drug class or can they choose not to? IF they must cover Afrezza in a new class, would it be a Tier 1,2, 3, or 4? We can all speculate, but does anyone here have experience working for/with PBM's? I was told by a highly respected PharmD specializing in geriatric drug interaction, who has been on the speaker circuit for several major BPs that Medicare Part D requires insurance companies to approve a minimum of two drugs within each classification. If only one drug exists in a classification, it is approved. This would seem to launch a big win for Afrezza...IF...the FDA approves the new classification requested by MNKD. If anyone knows differently or more please share. |
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Post by Deleted on Sept 23, 2017 8:02:14 GMT -5
MannKind will visit any doctor if that doctor is willing to listen. Case in point, my PCP.
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Post by sportsrancho on Sept 23, 2017 8:24:53 GMT -5
MannKind will visit any doctor if that doctor is willing to listen. Case in point, my PCP. And mine, so to speak, Dr. Combs. ( And others I know ). It's just up to this point Endos have been their target. There has been GP's prescribing from the very start. The kids got their first " off label " script from one. |
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Post by ghochr on Sept 23, 2017 9:15:25 GMT -5
MannKind will visit any doctor if that doctor is willing to listen. Case in point, my PCP. Exactly my point too. |
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Post by matt on Sept 23, 2017 13:51:03 GMT -5
IF Afrezza obtains a new classification (ultra rapid, etc.), does anyone on this board know for a FACT, that PBM's have to cover the drug on their formularies? Must they cover the new drug class or can they choose not to? IF they must cover Afrezza in a new class, would it be a Tier 1,2, 3, or 4? We can all speculate, but does anyone here have experience working for/with PBM's? There are plenty of drugs, and drug categories, that are uncovered and that includes drugs in categories that are specifically excluded from Medicare Part D by law. Like any private insurance, if somebody is unhappy with the formulary they can ask for a waiver. To my knowledge, FDA never uses the word "class" in a formal sense, and it appears nowhere in 21 USC Chapter 9 (which is the legal text of the Food, Drug, and Cosmetic Act). If somebody can find statutory authority to the contrary, please provide the reference because I have looked and found none. The drug world is sufficiently complex, and the range of mechanisms of action so varied, that it would be extremely difficult to have a formal class structure. There are lots of medicines that come in regular dosing and with extended release dosing; Glucophage and Glucophage XR have different release characteristics, but both are based on metformin, both are considered biguanides, and each has a separate listing on formularies. Afrezza is labeled as "AFREZZA® (insulin human) Inhalation Powder" which provides plenty of leeway for a provider to decide that it is insulin, albeit with different PK/PD, and thus provide a no coverage or limited coverage decision. |
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Post by mnholdem on Sept 24, 2017 10:56:42 GMT -5
CEO Michael Castagna - Ronman & Renshaw Investors Conference (Sept 11, 2017) Excerpt: We have enhanced our payer coverage, so we’ve now covered on [Indiscernible] like Express Scripts and Anthem with no prior authorization; Medimpact with no PA, we have Medicaid coverage; we’ve got Etna and a few other plans. And the plans now that we haven’t continued to work with really is because we’re waiting for the FDA label change. And so before you go out and contract and lock-up your pricing for three years, if you do get a new category with a label change, which could be ultra-acting, that really sets a different contracting strategy and price point. And so we didn’t want to go out and lock up the rest of the market, and so we have that outcome and know which that looks like, and I’ll talk about the FDA label change in a second.
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Post by mnholdem on Sept 24, 2017 11:10:20 GMT -5
MannKind will visit any doctor if that doctor is willing to listen. Case in point, my PCP. And mine, so to speak, Dr. Combs. ( And others I know ). It's just up to this point Endos have been their target. There has been GP's prescribing from the very start. The kids got their first " off label " script from one. CEO Michael Castagna excerpt from the Sept 11 Rodman & Renshaw Investors Conference: When we recapitalize the Company, the proceeds of that will be looking to do one of two things, scale up consumer and/or scale up our sales force to cover primary care docs even more. We do believe there is a large opportunity sitting there that primary care docs are willing to prescribe the drug. |
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Post by agedhippie on Sept 24, 2017 11:24:50 GMT -5
... And so before you go out and contract and lock-up your pricing for three years, if you do get a new category with a label change, which could be ultra-acting, that really sets a different contracting strategy and price point. And so we didn’t want to go out and lock up the rest of the market, and so we have that outcome and know which that looks like, and I’ll talk about the FDA label change in a second.I wonder if Mike's comment means that if they don't get the ultra-rapid label they are open to reducing the price? |
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Post by mnholdem on Sept 24, 2017 12:17:26 GMT -5
The "Ultra" definition would be a catalyst, of course, but the bottom line with the label upgrade is what will the FDA let MannKind claim about Afrezza that they couldn't say before. The "new" claims could certainly affect payer negotiations, IMO.
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Post by mango on Sept 24, 2017 17:50:16 GMT -5
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Post by boca1girl on Sept 25, 2017 8:51:28 GMT -5
When Mike described the label change objectives during the Q&A, there wasn't a mention of a new "classification" for Afrezza.
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Post by madog365 on Sept 25, 2017 8:56:19 GMT -5
When Mike described the label change objectives during the Q&A, there wasn't a mention of a new "classification" for Afrezza. I noticed that as well, but the new classification has been mentioned before as requested for the label change. Maybe Mike doesn't want to over promise and under deliver as the previous management has done on many occasions. |
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