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Post by rrtzmd on Oct 13, 2015 10:30:39 GMT -5
The only thing that can change the insurance situation is high quality data demonstrating that afrezza is superior to lispro for treating diabetes. Currently, to move toujeo up the tier ladder, Sanofi is conducting a 3,000 subject "real life" study. Unless Sanofi comes up with something similar that results in demonstrating that afrezza is worth its added expense, it will remain a reimbursed only when "medically necessary" item. I'm in the industry. Your example is not the only thing that can change the insurance situation (although it definitely would). Regardless of what you read of P&T Committees' activities and responsibilities, tiering decisions are ALWAYS made with financial impacts in mind, and not only related to the reduced cost of outcomes. In other words, the combination of the cost of the product, its associated rebate, the relationship between the manufacturer and the PBM (read, the level of rebates received by the PBM for the manufacturer's other drugs), and the PBM's expectation of the manufacturer's intent to drive market share, are all considered on a par with the therapeutic impact of a drug. Also, when prescribed to a diabetic, Afrezza is always "medically necessary." I agree absolutely that "tiering decisions are ALWAYS made with financial impacts in mind..." And with that in mind, SNY would have to cut its prices on afrezza to match the level of lispro, given afrezza's "non-inferior" label. However, I presume you'd prefer SNY and MNKD make some serious money off afrezza -- correct? To reach THAT goal will require a study analogous to the 3,000 patient "real life" study SNY is doing for toujeo. Unfortunately, insurance companies won't agree with your assessment that "when prescribed to a diabetic, Afrezza is always "medically necessary."
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Post by rrtzmd on Oct 12, 2015 21:23:47 GMT -5
Interesting article from a year ago: Sales rep restrictions point to need for a pharma rethink
"This years survey showed that 32% of physicians said they cannot talk to reps, compared to 27% last year. Apply this limit to doctors in organized health systems, and the restrictions become even greater: 42% of doctors affiliated with integrated health networks say they are not allowed to see reps—a 17% increase since last year." Interesting telephone survey of primary care(42%) and specialist(58%) docs: KRC survey of physicians"They value information from pharmaceutical and biotech company representatives and pharmaceutical company-sponsored educational programs featuring physicians speakers as one source of information among many—but these sources are not in the top-tier." "Nearly 2 in 3 physicians said they have been asked by an insurer or pharmacy to switch to a different drug than the one they prescribed." "A third usually prescribe a generic, while most others say they usually prescribe half and half or decide on a case by case basis. Few say they usually prescribe a brand drug that doesn’t have a generic equivalent."
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Post by rrtzmd on Oct 12, 2015 9:54:52 GMT -5
I started this topic because I did not want to derail an existing topic. It seems like sales reps are not as important as they once were. Part of this is due to the internet and the easy access to information. Part of this is due to the new rules designed to prevent bribes, kickbacks, etc. Part of this is due to new rules limiting access to doctors. I have nothing against sales reps. They work hard and these days probably have to work harder than ever. And if they have bad sales because they have a bad drug to sell or their good drug has poor insurance coverage then the sales reps get hurt financially even though it isn't their fault. Do doctors really rely on sales reps to get information? I would think medical journals, professional association lunches, and patients asking about new medications would be as effective if not more effective in educating doctors. A number of people here are very concerned about the number of sales reps selling Afrezza. I would think that mailing information packets to doctors would be just as effective as having a human stop into the office and drop off the same literature. I think sales reps are kind of like travel agents. Yes, there is still a need for them but for many tasks such as buying plane tickets most people can do it by themselves. I do not mean any disrespect but how much difference does the number of reps selling Afrezza really make? Is it a valid excuse for low script numbers? A pretty good article: Following the Script: How Drug Reps Make Friends and Influence Doctors
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Post by rrtzmd on Oct 12, 2015 9:52:37 GMT -5
Can someone articulate simply what will change the insurance situation? I've seen many times the 6-12 months review period (post launch) mentioned (which we are now in), but then what happens at the healthcare companies? It seems the smoking gun we are missing is the authoritative proof that Afrezza lowers A1Cs better than anything else. But other than blogs, such as Finta's, I cant see that proof anywhere else. If I was an insurance company I'm not sure how else I could justify it. There was some reference to a clamp study as providing this , but I believe this has largely been dismissed now. Is that correct? Is there another study underway that might provide this proof? The only other thing that might lead to more coverage I've seen on this board is a case (or two) where the individual has harassed their healthcare provider and then succeeded in coverage. Insurance coverage is clearly the problem (search on the new drug Teojeo and it already has far far better coverage), but I'm lacking the knowledge of how Afrezza's improves. Is it simply time, a long time? The only thing that can change the insurance situation is high quality data demonstrating that afrezza is superior to lispro for treating diabetes. Currently, to move toujeo up the tier ladder, Sanofi is conducting a 3,000 subject "real life" study. Unless Sanofi comes up with something similar that results in demonstrating that afrezza is worth its added expense, it will remain a reimbursed only when "medically necessary" item.
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Post by rrtzmd on Oct 11, 2015 21:08:04 GMT -5
Thanks for the link, but even there the longest study I saw was only 2 years. Although an extreme example, mesothelioma sometimes won't appear until 10-20 years after exposure to asbestos. Regardless, the point I was trying to get to is that although the adverse effect on FEV1 is small with afrezza, there seems to be no explanation as to why it exists at all, or, for that matter, why it resolves after discontinuing afrezza. The same question arises as to why does afrezza cause more anti-insulin antibodies versus subcutaneous insulin. Is the FEV1 effect related in some fashion to the appearance of anti-insulin antibodies? Not knowing the causes of an adverse effect while knowing that there is an adverse effect is bound to inhibit prescribing practice to some extent. Rule #1: primum non nocere. Rule #2: always remember rule #1. Your welcome. You originally stated "preservatives in Afrezza" - if you have done some research then you should be aware that there are only 2 ingredients in Technoshpere Insulin 1.) FDKP 2.) Human Insulin (NO preservatives) What preservatives are used in insulin? Phenol and m-cresol (meta-cresol) www.sciencedirect.com/science/article/pii/S2214750014001541www3.epa.gov/airtoxics/hlthef/cresols.htmlRegarding "preservatives," I think I corrected my error elsewhere. However, afrezza does have a third ingredient -- polysorbate 80.
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Post by rrtzmd on Oct 11, 2015 20:52:51 GMT -5
This is is a simple case of confusion between "Health Partners" and "Health Partners Plans". "Health Partners Plans is an award-winning, not-for-profit health maintenance organization serving more than 245,400 members in Philadelphia, Chester, Delaware, Bucks and Montgomery counties. We offer Medicaid, Medicare and Children’s Health Insurance Program (CHIP) plans." Health Partners Plans covers Afrezza as tier 1 or 2. www.healthpartnersplans.com/providers/resources/formularyLooks like it requires "step therapy" first: afrezza approval
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Post by rrtzmd on Oct 11, 2015 20:42:05 GMT -5
"Offer is not valid for patients if their prescriptions are paid in part or in full by any state or federally funded programs, including, but not limited to, Medicare or Medicaid, Medigap, VA, DOD or TriCare." That comes from the Afrezza coupon site: afrezza coupon
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Post by rrtzmd on Oct 11, 2015 11:46:11 GMT -5
Thanks for the link, but even there the longest study I saw was only 2 years. Although an extreme example, mesothelioma sometimes won't appear until 10-20 years after exposure to asbestos. Regardless, the point I was trying to get to is that although the adverse effect on FEV1 is small with afrezza, there seems to be no explanation as to why it exists at all, or, for that matter, why it resolves after discontinuing afrezza. The same question arises as to why does afrezza cause more anti-insulin antibodies versus subcutaneous insulin. Is the FEV1 effect related in some fashion to the appearance of anti-insulin antibodies? Not knowing the causes of an adverse effect while knowing that there is an adverse effect is bound to inhibit prescribing practice to some extent. Rule #1: primum non nocere. Rule #2: always remember rule #1.
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Post by rrtzmd on Oct 11, 2015 11:28:08 GMT -5
Sorry, my mistake! No preservatives but they do have polysorbate 80 on the list of ingredients.
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Post by rrtzmd on Oct 11, 2015 11:26:16 GMT -5
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Post by rrtzmd on Oct 10, 2015 11:22:41 GMT -5
I did as you said and didn't see what you referred to, but I did use their search function and got this:
NF = non-formulary
I'm pretty sure "NF" means "non-formulary." Perhaps they haven't updated the website yet. Does your source reveal its "tier"?
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Post by rrtzmd on Oct 10, 2015 11:12:04 GMT -5
Well, to be fair, no one has used afrezza for any truly extended period of time -- 5-10 years. Is that correct? COPD, emphysema, lung cancer can require long periods of time to develop. The fact that afrezza has a measurable effect on lung function while being used is disconcerting, even if it does appear to resolve after discontinuing the drug. If the FDKP and insulin and preservatives are cleared so rapidly from the lung, what causes the measurable, persistent detrimental effect on lung function?
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