Tuesday, April 09, 2019

My Trial With Sanofi's Admelog, The Biosimilar Version of Humalog

A while back I blogged about the emergence of biosimilar insulin in the U.S., more than a decade after I studied the topic and discovered some troubling reasons none existed. Since then, in spite of top officials at the U.S. Department of Health and Human Services advocating for a more robust biosimilars market in the U.S., we have seen fewer rather than more, so that's not working out so well for the Trump Administration's promise to bring drug prices way down so far. In late 2018, Merck quietly pulled the plug on its own Lantus biosimilar which was to be branded as Lusduna Nexvue (see more HERE for details). Merck tried to keep its plan to dump its Lantus biosimilar on the down-low, but news emerged from a South Korean securities filing (akin to the U.S. SEC) when co-development partner Samsung Bioepis disclosed the fact that Merck was paying it a termination fee in its filings with Korean regulators.

Anyway, I've been using the Humalog biosimilar branded as Admelog (U-100 insulin lispro rDNA origin) made by Sanofi for the past few weeks. I use vials and syringes since is the least costly way of buying insulin these days. The reason is purely economic: while still paying towards my insurance deductible, I have the option of paying more than $230 for a single vial of Humalog insulin, or I can pay just $99 for the same insulin with a coupon from Sanofi. Insulin pens cost even more than vials do, and you get less insulin in five pens than you do in a single vial of the same insulin (plus syringes are cheap). Several years ago, Maria J. Redondo, MD, PhD, MPH, and assistant professor of pediatrics at Baylor College of Medicine in Houston said "Pens are more expensive than vial and syringe, and different insurance companies cover different pens depending on the formulary."

But I had almost no reservations about switching from Lilly to a Sanofi-made insulin.

Guess what?

Based upon my personal experience, I believe Admelog really IS the same insulin as Humalog, although it does have some hang-time which I attribute to the preservatives used.

When I say that, I mean that I didn't have to make any dosage adjustments (insulin-to-carb ratios or for correction dosages) using Admelog vs. Humalog, so I would call that the same. By comparison, I always had major adjustments that needed to switch (involuntarily) to/from Novo Nordisk's Novolog (U-100 insulin aspart rDNA origin), or when switching to/from Sanofi's own Apidra (U-100 insulin glulisine rDNA origin). Every ratio had to be adjusted for each brand switch. Of course, when insurance makes these changes, they do not give patients any additional test strips needed for the adjustment -- they're on their own, because the formulary manager decided that Humalog, Novolog and Apidra are all "therapeutically equivalent" medicines. Such non-medical switching has become increasingly common over time. For the most part, my experience has been switching between Humalog and Novolog (less so with Apidra, although back in the early 2000's, I did use that, too -- although I think it may have been when insurance actually provided a choice of rapid-acting insulin analogues, each priced at different tiers of the insurance company drug formulary; also now history).

Personally, I don't entirely understand why the Sanofi discount coupon for its insulin varieties is even necessary, except the normal CVS retail price for Sanofi Admelog is an absolutely stunning $481/vial! Indeed, for a biosimilar, the marked down price reportedly being offered to pharmacists is pretty tiny (roughly 15%-20%) when compared to the brand name. Most other generic drugs see discounts magnitudes higher, in the range of 25% to 60% off the brand-name drug's price. In fact, Lilly's own "authorized" generic which will be called Lilly Insulin Lispro (U-100 insulin lispro rDNA origin) will reportedly be LESS expensive than Sanofi's copy of the same insulin, priced at $137.35/vial (see the Lilly press release about its "authorized generic" of Humalog at https://prn.to/2Ug7AHS for more information).

Lilly's move on insulin prices mirrors what was done a few years ago when the entire EpiPen issue exploded due to runaway prices. Mylan effectively calmed its EpiPen PR crisis by introducing a cheaper authorized generic. Now Lilly, following the very same playook, and is hoping for a similar result.

The mere fact that Lilly was able to introduce a "half-price" version with virtually no impact to the company's bottom line says a LOT about the the shenanigans going on behind the scenes. According to CVS, the authorized generic version of Lilly Insulin Lispro is still not available in stores, but a call to Lilly's patient assistance telephone line did reveal that the company expects it to be available at pharmacies nationwide "sometime in the second quarter of 2019", meaning between April and June 2019.

Estimated Manufacturing Cost for one vial of any insulin in 2018: $6 to $8

All of this is utterly insane because a submission to the Journal of the American Medical Association (JAMA) not long ago reportedly estimated the actual cost to manufacture a single vial of any insulin variety to be around $6 to $8 dollars per vial! Compared to many other biotechnology medicines, insulin is pretty simple. Insulin already chemically very well-characterized (most biotech drugs cannot be characterized; insulin can) and it is a non-glycosolated biotech drug (I won't attempt to explain it, just see HERE for more if you're interested); so in many ways, it should be a hell of a lot cheaper than more complex biotech medicines which are not well-characterized and have very complex protein structures. To make most other biotech medicines means maintainence of very tight control over their manufacturing process is somewhat more important than it is with insulin because things can easily go wrong.

The reason insulin is not cheaper is mainly because of secret discounts given to formulary managers at insurance companies, many of which are passed on directly to employers who buy the insurance plans, and the Rx rebate money is used as an offset for high healthcare insurance premiums. If the employer isn't as good of a negotiator, then the insurance company-owned pharmacy benefits manager (PBM) simply keeps the rebate money for itself. And, big employers no longer have such a huge advantage over small employers as was once the case. That's because in recent years, small employers have largely banded together by using so-called Professional Employer Organizations (PEO's) to handle insurance and dental benefits, payroll, unemployment claims, etc. That means that today, the largest U.S. PEO is ADP TotalSource, which as of 2018 reportedly "co-employs more than half a million worksite employees" (see the press release https://mwne.ws/2P7BpbX for details). That makes them bigger than both Kroger and Home Depot, dwarfed only by Walmart and marginally by Amazon (if you're interested, see the Wikipedia listing for "List of largest United States-based employers" at https://bit.ly/2KnQTtr for more detail).

Sanofi Doesn't Appear to Be Working Very Hard to Sell Admelog

The thing is that Sanofi is NOT making it easy for any patient to use their follow-on or biosimilar insulin lispro product, which is a mystery to me. For one thing, the clerk at CVS asked me what my insurance was, and I told her I would not be using insurance to pay for this insulin because I had a choice of paying either $238/vial if its submitted to insurance, or $99/vial if I pay without insurance. One need not be a mathematician to understand that the amount of cash I'll be paying is still nearly 2/3 cheaper ($99/vial vs. $238/vial), even if it doesn't contribute a penny towards my deductible. But it requires Sanofi's coupon to get that price.

Can Medicare Patients Get Admelog at a Discounted Price?

There is also a very strange thing going on with Medicare, with companies trying to charge Medicare patients full price and making their coupons un-available to Medicare patients. On Sanofi's cheekily-named "val-YOU" website where they give insulin coupons to patients (see https://www.admelog.com/savings for the details), the company has a five question "screener" survey to ensure patient "eligibility" for the insulin discount coupon, including asking if "do you currently receive Medicaid?" and "are you currently serving in the U.S. military?" and "do you qualify for Medicare?" ... if someone answers "YES" to any of these three questions (Questions 3, 4 or 5), then Sanofi responds by telling the individual they cannot give you a $99 discount coupon for its insulin. But if the patient answers those three questions "NO", then voila, they get the discount coupon.

Guess what? That's basically bull$#!t.

There is no prohibition that any patient must submit any claim for prescription medications to insurance (or in their case, to Medicaid, Medicare or the VA). Indeed, we have seen examples where many patients discovered the lower-cost generics list offered by different pharmacy retailers are actually much cheaper than what they might otherwise be charged if the script was processed through Medicare Part D.

The Sanofi offer terms say: "This offer is not valid for prescriptions covered by or submitted for reimbursement under Medicaid, Medicare, VA, DOD, TRICARE, or similar federal or state programs, including any state pharmaceutical assistance programs." But if one does not submit the claim through any of those programs, then they are essentially paying for the insulin out-of-pocket and they are theoretically eligible for the discount offer. There is no law requiring anyone to submit a prescription drug claim to insurance or through Medicare or Medicaid.

What Sanofi conveniently omits is that they actually all WANT all Medicare/Medicaid patients to pay through those particular insurance programs because under a sweetheart deal for pharma, Medicare is not able to negotiate any volume-based discounts for prescriptions. But it frequently ends up costing the patients dearly. Its similar to the pharmacist "gag-orders" which Congress only recently banned (see the Kaiser Health News article at https://khn.org/ODc5NTIz for more background on that).

Let me say this: there is no law preventing ANYONE (covered by insurance, Medicare or any other plan) from paying for prescriptions out-of-pocket. That's a personal decision. Usually, its to the patient's benefit to go through insurance or Medicare/Medicaid, but not ALWAYS, and exactly when can be a decision with genuine financial impact.

I'm certainly not advocating fraud, but any patient is always free to pay for any prescription out-of-pocket, which also means that any manufacturer discount coupons offered for cash payers can be given to anyone who pays for a prescription out-of-pocket. I don't see that as remotely un-ethical. What IS unethical is the kind of games that go on with pharmaceutical companies operating in the U.S.

Something else many seniors with Type 1 diabetes discover: if you are a senior on Medicare and use an insulin pump, Medicare will pay for the insulin to effectively "power" your insulin pump as part of Medicare Part B, not Part D. They may make those patients jump through some hoops to get an insulin pump covered (once upon a time, Medicare would only cover patients with Type 1 diabetes, not Type 2 patients who use insulin due to the cost; I don't know if that is still the policy, but I mention it as one of the questions that need to be asked).

I'm not even eligible for Medicare for at least another 15 years, and who knows what that might look like at that time. But the issue of how American patients with diabetes are forced to navigate a thicket of odd rules and secret, back-room discounts paid to various parties in the distribution system for prescription drugs is not about healthcare, its about someone making money. Dr. Elisabeth Rosenthal, M.D. wrote in a coherent opinion piece published in the New York Times (a company she once worked for), "Why Should Americans Be Grateful for $137 Insulin? Germans Get It for $55" (she also adds that Germans get it for $45 if they buy five vials at a time, see the full piece at https://nyti.ms/2Ts28QK for details) suggests that while Americans are relieved at anything that lowers prices, we are still overpaying relative to the rest of the world. As noted, brand-name Lilly Humalog (U-100 insulin lispro rDNA origin) sells for $55/vial in Germany. And in France. And in Sweden. And in Denmark. And across the rest of the world.

When seniors need to fill prescriptions, they are told they are suddenly in-eligible for discount programs offered to everyone else, but again, its not entirely factual. Its the story the pharmaceutical industry WANTS them to believe.

Freedom Caucus Effort to Derail Congressional Efforts on Runaway Insulin Prices

Much more needs to be done to rein-in runaway prescription drug prices in the U.S. and there does seem to be bipartisan desire to address the matter (although it is worth acknowledging that Reps. Jim Jordan, Mark Meadows and several other Republicans who are part of the House Freedom Caucus who happen to be on the House Oversight Committee sent letters to a dozen CEO's of major drug companies warning them that information they might provide to the House investigation into drug pricing could be leaked to the public by Democratic chair Rep. Elijah Cummings in an effort to tank their stock prices. Their letter can be viewed at https://republicans-oversight.house.gov/wp-content/uploads/2019/04/Pharma-Letters.pdf although several media outlets have since addressed that highly unusual and counterproductive move, including BuzzFeed news which broke the story and the snarky Wonkette offered its own spin on what they believe is going on. Suffice to say, this is a highly-unusual move for a minority party in Congress to try and doom any efforts the majority party is pursuing on behalf of the American people, but this is how Republicans now operate.

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