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?

Let's pretend it's 2025 and you are the Chief Medical Officer or Pharmaceutical Officer for a national commercial health insurance plan.  Pharma X has just presented their clinical profile and cost projections for Product X, a new GLP-1.

In two days, you will need to give your recommendation to the Pharmacy and Therapeutics Committee before a vote on this product.

 

Here are the currently approved agents on your formulary:  

 

You already have 3 GLP-1's on the market – Products Y, Z, and Q.

Product Y and Z are self-injectables that have similar efficacy at reducing both hemoglobin A1c and weight. 

Product Q is an oral pill that is moderately less effective than Products Y and Z.

Product Y 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, the oral pill, has also just released its post-launch study proving the same cardiovascular prevention results.

 

Through contracting, on the injectable side, you are currently receiving a 20% rebate off the WAC (wholesale acquisition cost) for Product Z, but only a 10% on Product Y;  thus, Product Z is placed on the preferred tier (lower copay/coinsurance) and Product Y is placed on the non-preferred tier (high copay/coinsurance).  In addition to Product Y being placed on the non-referred tier due to higher cost, it also has a preauthorization requirement to “step” through either Product Z or Product Q first.

Product Q, the oral formulation with less efficacy, has reflected this in their pricing and rebates; thus, it is co-preferred with Product Z on the preferred tier.

The average cost of the 3 products after rebates is currently around $1,500 per member/per month.

 

 

Pharma X has presented the following clinical-trial results and projected cost of Product X to you, your key-opinion leaders in endocrinology, and your pharmacy team:

 

CLINICAL TRIAL X OF PRODUCT X:  

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

TRIAL DESIGN:  A double-blind, randomized, placebo-controlled trial of Product X.

TRIAL DURATION:  26 weeks.

TRIAL SIZE:  150 patients, all 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.

PROJECTED WHOLESALE ACQUISITION COST:  $2,000 per month, per member.

 

*Double-blind – Neither provider or patient know whether the treatment given is Product X or placebo.

* Ramdomized - Random draw as to whether the patient gets treatment or not)

* Placebo-control – The comparator treatment that is not being studied, either with or without an active ingredient. 

CONCLUSION/RESULTS:   

1.        Product X showed a 1-point drop in hemoglobin A1c versus placebo.  

2.        Product X showed an average weight loss of 15 pounds versus placebo.   

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

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

5.        The discontinuation rate was 25%.

 

Pharma X tells you that the WAC price before rebates for Product X will be at a 30% premium to the average $1,500 monthly net price of existing products. 

Their justification for doing so is because their product is once monthly instead of once weekly, as well as they are approved for younger patients, and that they are providing a new self-injector with new technology that sends information to both the provider and the specialty pharmacy regarding whether the medication was administered correctly and at the appropriate times, using Bluetooth technology.

 

Your key-opinion-leaders voice concerns.

They point out that Product X was not compared directly to existing GLP-1, and that even using indirect comparison, Product X is less effective then Y, Z, or Q.  They also point out that the clinical trial length was only 26 weeks versus 52 weeks, and only contained 150 test patients.

They also express safety concerns, especially now that children 12 and older are now eligible, citing the 33% side-effect profile and 25% discontinuation rate, and additionally, though the product is administered once a month rather than weekly, that won’t necessarily translate to cheaper, especially now that a new cohort of ages 12 and older was added to the previous age group of 15 and older.

 

However, 10% of your plan's in-network endocrinologists have already called you, telling you that they believe this drug is better and they'd like to try it, especially for their patients that have failed the other GLP-1's.

 

Your PBM (Pharmacy Benefit Manager) informs you that Product Z, your current preferred injectable GLP-1, has just offered you a 40% rebate instead of the previous 20% - if you make their product one of two products on the preferred tier.

The PBM advises making Product X and Product Z your preferred products based on rebates offered and putting Products Y and Q on either a non-preferred tier or excluding them completely as medical-necessity-only products.

 

As the insurance company stakeholder, you don’t care how you get to a lower net cost, high WAC/high rebate or low WAC/low rebate – all you care about is getting the best cost and not having to raise premiums for your members, if all drugs are equal or near equal.

You also realize that PBMs make their profit almost exclusively from rebates. 

What choice will you make and what tools in your toolbox do you have to mitigate costs? 

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