Part 1 of a 2-Part, Critical-Thinking Exercise ...

 

Okay, so I'm going to start this post off by talking about politics, but the actual exercise itself has nothing to do with politics (see below).  The point is to apply these same critical thinking techniques to politics, if you/we can tuck our beliefs under long enough to do so :) 

Because IMO, the problem with politics today is that regardless of how intelligent people actually are, they often go with their beliefs first, ignoring any facts to the contrary that don't support their narrative (dismissing them as "fake news), as well as often using other people's opinions to support that belief instead of fact - in short, lack of critical thinking or even questioning what they are told.

As for me, I'm sure I've even been duped, especially when younger (I was quite naive/too trusting of people), but quite honestly, I'm also fairly naturally fair-minded and can see many sides to the same issue (which frustrates people to no end lol).

Helping that along, I was also trained in critical thinking through my education - not only as a social worker to avoid biases, but even starting as early as high school.  I had an American History/Civics teacher, Mr. Gauzmann, who forced us to argue for the other side of several arguments.  I really hated having to do this when he put me on the plus side of slavery during history lessons of the civil war.  

I begged him to be put on the Union side, the moral side of this argument, but he said, "In order to understand the "wrong" side, you have to understand how the wrong side thinks, why they think the way they do - and not what propaganda tells you they think, but why they're laying their own lives on the line for this issue.  Put yourself in their mindset, even if you don't agree with them, to try to understand them better."

Needless to say, I still didn't agree with them or hold the same values, but I did understand the mindset better.  

The only "for" arguments I could come up with were continued support of a certain standard of living through no-cost labor,  "trickle-down economics" (which has never once worked at a federal or even state level, only locally, but nevertheless, often used as an argument), lack of federal government control over state control, biblical misinterpretations of scripture, and atrocities which happened to women and children as a result of the "starving out" of the South during the civil war - none of which were justifications, in my mind, and even with the last one, they did have a choice in war.

But let's take the ability to critically think completely off politics for this exercise (but perhaps apply it to politics in your own lives)?

Honing these critical-thinking skills, as mentioned previously, I have  been transcribing pre-launch interviews for an independent marketing company between Big Pharma and insurance companies, public and private, international as well as national, as well as key-opinion clinical leaders in particular disease states, both doctors and pharmacists. 

Let me just say, these people are masters at critical-thinking, considering all they have to keep in mind, and it hones my skills by even listening to them.

So as a "fun" exercise (lol), I'm going to give you a "mock" example of a fictional new drug to come to market. 

Let's see how well you can critically think, shall we?

Okay, so let's pretend it's 2025 and you are the VP of Pharmacy for a national commercial health insurance plan.  In two days, you have to give your recommendation to the Pharmacy and Therapeutics committee for a vote, whether or not to add this product to your formulary. 

Part 1/Question 1 is your evaluation of the new drug itself based on its clinical trial, how it compares with other drugs already in the class, and is its price justified?  

Part 2/Question 2 is what tools you have in your toolbox to mitigate and manage the drug cost?

 

Now - remember the the IRA (Inflation Reduction Act) will be in full effect by 2025, which will lower copay costs to us, the consumers, to no more than $50  - especially in diabetes - which Big Pharma will likely respond to by simply raising their prices, putting the burden on insurance companies, who will, in turn, raise their premiums ;)

So Fictional Product X is a new GLP-1 that has just entered the market for type 2 diabetes.

You already have 3 GLP-1's on the market.

Product Y and Z are both self-injected, either daily or once weekly, both proving to have similar efficacy at significantly reducing both hemoglobin A1c and weight and are fairly safe.

Product Y has just published a post-launch 2-year study also proving long-term prevention of cardiovascular events, with Product Z's results expected to be published soon with similar results. 

Product Q is an oral pill, slightly less effective than Y and Z, but also proven in a post-launch study to offer some cardiovascular protection.

Through contracting, you received a bigger rebate for Product Z than Product Y; thus, Product Z is on the preferred tier (lower copay/coinsurance).

Product Q, the oral formulation (to give providers and patients a choice, especially those who have trouble self-injecting) is co-preferred on the preferred tier. 

Thus, because of its higher cost, Product Y is non-preferred (higher copay/coinsurance, likely a step through either Product Z or Product Q before you can get to it).

Also, another recent anti-diabetes class is available, the class of SGLT2 inhibitors, which have been found to be just as effective.

Your company's PBM - Pharmacy Benefit Manager (the company that contracts and manages all your pharmaceutical products) tells you Product Y - the currently non-preferred drug -  is now offering an even steeper rebate of an additional 20%, if they are made 1 of 2 preferred options on the formulary, after this new drug launches.  

You don't care how you get to a better bottom-line net cost -  whether high wholesale cost/higher rebate or low wholesale cost/low rebates,  just so long as at the end of the day - if all products are equal or near equal in efficacy and safety - you get the best deal so you don't have to raise your premiums for members.

(The PBM, however, does care - because they make most of their large profits off high wholesale cost/high rebates ;)

Your key-opinion expert endocrinologist says the efficacy of this new longer-acting GLP-1 is actually somewhat less than the others, and she has some some safety concerns. 

However, 10% of your plan's in-network endocrinologists have called you, telling you they believe this drug is actually better and they'd like to try it, especially for their patients that have failed the other GLP-1's, they don't care what it costs, especially now that their patients only have to pay no more than $50 with the Inflation Reduction Act.

*Now remember, this is a pharmaceutical company, trying to sell you a product - so think carefully and critically  - think to yourself, "What's wrong with this picture?"*or "What is missing from this trial?"

 

FICTIONAL CLINICAL TRIAL OF FICTIONAL PRODUCT X:  

INDICATION:  An FDA-approved treatment of diabetes type 2 in patients 12 years and older.  

TRIAL DESIGN:  A double-blind (both patient and doctor are blind to who is receiving what), randomized (random draw as to whether the patient gets treatment or not), placebo-controlled (a placebo is the comparator, either a pill with no active ingredients or has active ingredients) controlled clinical trial.  

TRIAL DURATION:  12 weeks.  

TRIAL SIZE:  150 patients, all formally diagnosed with type 2 diabetes.   

DOSAGE:  A once-monthly injection -  8 mg, 12 mg, or 16 mg based on weight.  

PLACEBO:  Active comparator; metformin (biguanide drug class).   

INCLUSIONS:  Formal diagnosis of type 2 diabetes, 12 years of age or older, both treatment-naive and treatment-experienced patients.  

EXCLUSIONS:  Patients 0-11 years of age, patients with history of a vascular or cardiovascular event in the last two years.  History of endocrine or thyroid tumors or cancer.   

PRIMARY ENDPOINT:  The reduction of hemoglobin A1c from baseline by 1% versus the active-comparator  placebo (metformin) by Week 12.  

SECOND ENDPOINT:   Weight loss of 1.5 pounds by 0 pounds by active-comparator placebo (metformin) by Week 12.

CONCLUSION/RESULTS:   

- Product X showed a 1% percent greater drop in hemoglobin A1c versus placebo.  

- Product X showed an average loss of 1 pound more than placebo.   

- Side effects were nausea, vomiting, and constipation in 33% of the patients. 

- Severe adverse events were retinopathy reported in 10% of the patients by Week 12, and 2% thyroid and pancreatic tumor formation by Week 12.  

- Discontinuation rate was 25%.

______________________

Now, the pharmaceutical company notes that there was no head-to-head comparison against other GLP-1's, nor SGLT2's (though both were on the market when the study began and have become the standard of care by many endocrinologists.)

However, in their presentation, they have a slide of side-by-side comparison with  another GLP-1.

All previous trials for GLP-1's have gone on 26 weeks rather than 12 weeks, so let's pretend their results at 12 weeks were up to at least 10% better than Product X.

The WAC or wholesale acquisition price, or list-price range before rebates for GLP-1's already on the market is now $1,000 to $1,500 per month/$12,000 to $18,000 annually.

However, the manufacturer of Product X tells you that the WAC price before rebates for Product X will be at a 30% per-dose premium to the others, making it $1,300 to $1,950 a month ($15,600 to $23,000 annually).

They are justifying this 30% premium cost because they are once monthly instead of once weekly, which they say not only saves cost, but they believe will to promote better patient adherence, plus they are approved for younger patients, plus they provide a new self-injector with new technology that sends information about whether the medication was administered correctly, at the appropriate times, using Bluetooth technology, to both the pharmacy and the provider, also ensuring better patient adherence.

So Part 1/Question 1 is what do you think of the efficacy and safety of this drug and its outcomes in the clinical trials, especially versus others in the market basket?

Any data gaps, things that stand out to you, positively or negatively?

Feel free to comment any questions or comments below, but okay if you don't and just want to do this exercise quietly to yourself - it's a GREAT critical-thinking exercise :)

Check in tomorrow for things you may or may not have overlooked, plus Part 2 - how will you manage your pharmaceutical costs? ;)