Sunday, July 7, 2024

Things to Consider Before Using Ozempic

Though I'm prediabetic, I only weigh 128 pounds (making my BMI 22) and have been thin most of my life, so Ozempic wouldn't be an option for me, even if I went into type 2 diabetes, unless my BMI was greater - so this post is for anyone who does qualify and is considering Ozempic (or even if you don't and just want to use it for weight loss and pay out of pocket, as many do). 

And though I'd like to lose 10 pounds still, I'm not about to use Ozempic for it, because temporary use isn't what it's designed for and there is a proven boomerang effect in doing so - you will gain all of your weight back (and then some, if you don't also diet and exercise), with a couple of months. 

But before I get to the specifics of Ozempic, a little background ...

So most people know what I do for a living, and that Contract #1 is transcribing the price-test marketing interviews before new drugs launch, between Big Pharma and insurance companies, both public and private, as well as key-opinion-leading clinicians. 

Unfortunately, the interviews have dwindled since the Inflation Reduction Act, which goes into full effect in 2025, and isn't targeting inflation as a whole, nor is it regulating prices (I wish).

The IRA only targets Medicare copays - meaning that as of 2025, Medicare members will never pay more than a $50 copay for any pharmaceutical drug, regardless of the price.  

Also, Medicare will drop a list of 10 medications every September which Medicare will offer to renegotiate lower prices on, and if pharma won't negotiate, they will no longer be covered - and private insurance will reflect those prices (though will pay slightly more). 

Thus, though passed two years ago, it doesn't officially go into effect until 2025, and they've also dropped the first list of target drugs last September as a warning shot - which has left insurance companies and pharma scrambling to figure out how to accomplish this (without actually dropping the price, of course, though some did for insulin before the last list was dropped last year because they knew they'd be on it). 😂

The government doesn't care HOW pharma and insurance companies accomplish this, just that they get it done, so that no Medicare patient ever pays more than $50 for a prescription. 

What this means for me and Contract 1 is, I guess there's no sense in doing price-testing if you know you're going to overcharge and may end up on Medicare's shit list, with the Medicare consumer now paying no more out of pocket for any drug than a $50 copay anyway, right? 😂

Thus, the work has dwindled over the past year with Contract 1 and so I picked up Contract 2, going back to regular medical transcription.  It takes me 1-1/2 days at Contract 2 to make what I could make in a 3 hours with Contract 1, but c'est la vie; this is the going rate for medical transcription, now, after competing with electronic medical records and outsourcing to India still, when we used to make $50K with benefits. 

(At least this newer, smaller company is fair with QA, not cutthroat over few resources, and verbally abusive and bullying because you're not face-to-face, like other companies, and that's worth a million to me!)

ANYWAY -  to the point of this post, finally ...

The work that I have received is regarding "me-too" Ozempic-like drugs coming out soon, and I just learned that the the Novo Nordisk type 2 diabetes/weight loss injected drug, semaglutide - the active ingredient their drugs Ozempic, Wegovy and Rybelsus (oral formulation) - has boosted the national GDP of Denmark by 1.7% in 2023, and is expected to rise to 2% in 2024.

So essentially, because the U.S. pays the most for pharmaceuticals out of any country in the world, we have paid for the boost in Denmark's economy - so Denmark is a wealthier country because of semaglutide, mostly because of us!

You're welcome, Denmark!  😂

I say that because America, paying the outrageous prices that we do for drugs compared to the rest of the world, is largely responsible for that boost. 

So what is semaglutide and how does it work?

Semaglutide is an injectable incretin mimetic of GLP-1.  In layman's terms, this means it's a "mimic" or synthetic version of the GLP-1 hormone,  which is the body's natural incretin hormone that is responsible for not only stimulating the pancreas to produce more insulin (which regulates blood sugar), but triggers the satiation mechanism in the brain into thinking you're full (though this mechanism is still not well understood). 

Additionally, it thus can create nausea/vomiting/and even diarrhea or constipation if you eat past the brain's satiation-point hormone release.

Thus, all of this combined will result in weight loss - on average, at least 20 pounds, but up to 75 pounds has been recorded IF you also diet and exercise, too (and the effects are sustained longer, and more weight is lost,  if you also diet and exercise).

Additionally, we already knew that semaglutide showed a reduction in cardiovascular events in people with type 2 diabetes due to the original 2016 SUSTAIN clinical trial, but in November 2023, the SELECT clinical trial just proved that even people without type 2 diabetes showed a reduction in cardiovascular events. (New England Journal of Medicine.)

Then just this past May, a European study showed that semaglutide also reduced the risk of kidney failure in people with type 2 diabetes (not yet published in the NEJM or can't find yet).

Though this study hasn't been done in non-type 2 diabetics yet, we can extrapolate, to a certain degree, that the same would happen in non-diabetics, just like the cardiovascular reduction.

Sounds like a wonder drug, right?

Somewhat, but not so fast - there are some things to consider -  especially if American.


The official FDA label states that semaglutide (as the injectible product Ozempic) is only indicated for blood sugar control for type 2 diabetics with a BMI over 27% - NOT weight loss. 

If you're not diabetic and you want to use injectable semaglutide for weight loss only, you have to buy the exact same semaglutide from the exact same company, only called Wegovy. 

(FYI, Novo Nordisk also makes Rybelsus, which is an oral formulation of semaglutide for needle-phobics, but it's less effective and only costs $50 less than the more-effective injection, so most people opt for the injectable.)

Why does the same product, by the same company, have two different product names and lines?

Because Novo Nordisk knew that insurance companies do not cover weight loss drugs.  So if they put both blood sugar control AND weight loss indications on the same label for the same product, insurance companies would never cover it, and thus, the product would never be used, for either blood sugar control OR weight loss.

Thus, the solution was to then put the same drug out as 2 separate products, with 2 separate indications. 

Smart move, right? 

And it worked - your insurance WILL cover Ozempic *IF* you're a type 2 diabetic using it for blood sugar control (after you've tried 1 or 2, even 3 other products first, because of the price).

However, if you're NOT a type 2 diabetic and using it instead for weight loss only, then you MUST use Wegovy and your insurance will NOT cover it - UNLESS - your employer has specifically "carved out" a weight-loss rider on your employer's health plan, but this is rare. 

And the cost? 

Even though though it's the same drug, Ozempic is $1,000 a month without insurance, and Wegovy is $1,300 a month without insurance. . 

If you DO have insurance -  and you have type 2 diabetes and your BMI is greater is 27% or greater -  you will pay around $780 a month until you hit your deductible (and considering most health care plans now have high deductibles, that would likely take you anywhere from 3 to 6 months).  

After meeting your deductible, and if on typical 80/20 copay plans, you will pay $200 a month.

For Wegovy, since insurance coverage is rare, you're going to continue pay $1,300 per month. 

Subsidized/partially subsidized or socialized health care?

Yes, please - at least and especially with pharmaceuticals.

Now - lots of little clinics and docs are popping up and prescribing Ozempic, either suddenly finding a lot more people with type 2 diabetes, these days, or finding ways around it, but either way, you're likely going to pay more out of pocket for it. 

In fact, LA has gotten the reputation for finding ways not only to get it, but to overpay to get it - to the degree that legitimate type 2 diabetics couldn't get it, for a while, as they bought them out! 

Regardless, even if you truly meet the criteria and have insurance, you're going to pay a minimum of $2,400 a year , but since most don't, are you ready to pay $12,000 to $16,000 a year for it?

That's like buying a car every year for the rest of your life!

Also consider this ...

If you go on it before you develop type 2 diabetes, you likely won't develop it - so yeah, you're going to pay $16K a year for Wegovy, for the rest of your life - even higher with inflation.

With regards to the IRA and Medicare's new "shit list" of overpriced drugs to renegotiate, many are speculating Ozempic will be on it, this September, but we shall see.  

Last year, they targeted expensive drugs of equal efficacy that have never reduced their price in 20 years, despite the market being flooded with competitors, including generic -   i.e, insulin and the novel anticoagulants of Eliquis, Xarelto, Brilinta and Pradaxa. 

(For why the pharma market doesn't play by the same market rules as every other product, keep reading below.)

However, semaglutide has no direct competitors of equal efficacy yet and no generics, so the government might just wait for pipeline competitors to launch to see if the prices drop then or not (likely not - again, see why below).


Speaking of that cost, we'll start with the financial "side effects" before the clinical ones. 

Though many people use semaglutide for a temporary event like a wedding, etc., it doesn't actually work that way - if you stop semaglutide, you will gain the weight back, the majority of people do, especially if you don't also diet and exercise.

Which means, you - and your insurance company - will be paying the above amounts for the rest of your life (unless you move to Europe).

The good news is, lately I have done a couple of test-marketing interviews for some "me-too" drugs in the pipeline with the same mechanism of action from other countries.

The bad news is, in America, flooding the market with more of a product, even if generic, doesn't bring the price of pharmaceuticals down much, if at all.

This is partly due to still increased demand, but mostly due to the way that PBMs operate. 

PBMs or Pharmacy Benefit Managers are the often third-party companies that manage the pharmacy benefits for your health insurance plan, although a few insurance companies have bought their own PBM, over the last couple of years, due to the below issues I'm about to tell you about.

PBMs rely almost solely on "rebates" on certain drugs for their profit.  The bigger the rebate off the price, the more profit they make, 

Worse, unlike insurance companies, PBMs are not yet legally required to disclose the total rebate percentage received back and where that money goes, to either their insurance-company clients nor its members. 

They have to guarantee insurance companies a rebate percent back , sure - but they don't have to disclose to them the entire rebate percentage they're getting back from the pharmaceutical company, nor where it goes - back into other programs within the company or in their pockets..

So for example - and I'm just making up these percentages, but they are reflective of the types of deals made -  let's say PBM  #1 negotiates a deal for Ozempic where it they get an upfront discount of 10% off the WAC (wholesale acquisition price) PLUS a rebate of 30% on every vial sold.

However, here's the catch  - the PBM, and their client, have to both promise that:

1.  A certain amount of volume of Ozempic will be bought over a year's time.   
2.  Ozempic is their preferred drug over Trulicity (another GLP-1 with somewhat less efficacy)or even excludes Trulicity altogether off  their formulary. 
3.  There will be no prior-authorization requirements other than what's on the label - the doctor attests they have type 2 diabetes without lab-test documentation, 27% or higher BMI - period. 
4.  There will be no more than one step through another drug first, such as metformin, before you can to get to their drug.

PBM #1 takes the deal, excludes Trulicity so that Ozempic is either the only option for patients, or is offered at a lesser copay.

The PBM gets to keep half of the 10% upfront discount plus 20%  of the 30% rebate at purchase of the agreed volume. 

Thus, in the end, the PBM gets a total of a 35% discount, but their client, the insurance company, only gets a 15% discount to put towards lower premiums - and the insurance company doesn't even know, because PBMs do not have to disclose the total rebate percentage!

Now, PBM #2 doesn't take  the same deal.

Maybe because they also own their own PBM rather than use a third-party and thus don't depend on rebates as their income. Maybe they fear that the rebates will not offset the total increased cost for the sheer volume of Ozempic.  Or maybe even some think the the physicians should be primarily responsible for making the choices as to what's best for the patient rather than an entirely financial decision. 

Thus, the insurance company sends PBM 2 a a counter contract in front of Novo Nordisk, and also reminds them that if Ozempic prices get too high, then they can always prefer Trulicity over Ozempic. 

So let's say  PBM 2's counteroffer contract says they will: 

1.   Put Ozempic on the formulary - BUT -  at parity price to Trulicity, with no volume-utilization guarantee, and they'll just let the prescribers and the market decide what's best to use for the patient.
2.  Need at least a 2-year price-freeze.  
3. Require patients to get a prior authorization before approval, such as producing lab tests to prove type 2 diabetes rather than just physician attestation, that your BMI must be 35% rather than 27%, and that an endocrinologist has to prescribe it rather than your PCP.  
4.  Require that patients must have tried metformin and an SGLT first.  
5.  Require that patients also have to subscribe to a third-party digital health and wellness program for diet and exercise, to ensure optimum outcomes, with proof of usage and results before they'll reauthorize it, next year.   

Novo Nordisk then says: "Um, okay -  but if you do, we'll only offer you the basic 1% pay-to-play discount with no rebates at all ..." 

"However ...  if you can convince your insurance client to loosen up  some of those restrictions, we'll give you a 5% rebate or even higher, depending on how many you convince them loosen.  But still, because we're at parity to Trulicity, the rebates will never go higher than 10%, of which you'll get 8%, they'll get 2%."

So the PBM will go back try to convince the insurance company to loosen some restrictions, because they'll get rebates and a profit, that way, and the lion's share of the rebates. 

See how that works, now?

Thus, because the rebate amounts and contracting differ so dramatically, rather than letting the market decide, the profit and losses for the pharma company vary' thus, the price never goes down substantially. 

Because of this, the pharmaceutical industry in America is one of the few market players that does not follow normal market rules and trends.

So just because you have other players now, even generics or biosimilars, doesn't mean the price will go down as with other consumer products. 

Now, the second concern regarding chronicity is clinical rather than financial.

Because although we're also seeing positive outcomes with cardiovascular and kidney results, we really don't know yet what the long-term effects of semaglutide are.  

It has been out 8 years, and we haven't seen any yet, but there is no drug out there without them, and we need more time.

Because remember, you're messing with your pancreas and insulin production.

And keep in mind, pancreatic cancer is the deadliest - I'm not saying semaglutide CAUSES pancreatic cancer, there's no evidence whatsoever to support that (at least not yet) - I'm just saying we don't know and you're messing with your pancreas. 

Though we have made huge leaps in cancer treatment over the past decade with immunotherapy, they seem to have no effect whatsoever on pancreatic cancer, we cannot seem to make a dent.  If caught early enough, it can go into remission, but since the early stages are symptomless, most people aren't. 

Also, if caught in later stages and you are lucky enough to put it in remission, the recurrence rate is astronomical, so if it doesn't get you the first time, it will likely in the second or third time.

And even if it's not pancreatic, all of our systems are more connected than we ever knew, after so much immunologic research, even on things like psoriasis, where we now know that other organ systems are damaged than the skin, like GI and arthritic problems related 

The body can be like a set of dominos in a "cascade" effect - you mess with/fix one chink in the immunologic chain, but trigger a chain of events further down in the immunologic cascade.

Just something to think about - we don't know. 

Lastly, "Ozempic face" has become treated as if it's  "side effect."

It's actually not a side effect of Ozempic, it's a side effects of rapid weight loss - if you lose weight faster than your skin can keep up, it will sag.

In fact, the same happens with bariatric surgery - which, by the way, only costs $20,000 and it's a one time deal versus $12K to $16 K a year for the rest of your life

Now, as I said, for me personally, although I'm prediabetic and would like to lose a few pounds, I only weigh 128 pounds, so even if I do transition to type 2 diabetes, I would never be able to take semaglutide as long as my BMI isn't 27% or greater anyway, so it isn't a concern for me, and I wouldn't want to use it even temporarily because the swing in blood sugar might in and of itself trigger diabetes, because your pancreas is confused!

Now, I know that some people will read this and still go "Sign me up!" but just some things to think about before jumping on that bandwagon, right? 

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