Afinitor Denied & Pharmacy Benefit Managers

I wrote this originally in January of 2022 and have updated with current status:

I always start with gratitude because I am so grateful for feeling overall pretty well, the ability to do some traveling and a little science because of time and resources, and as always amazing family & friends (lots of overlap there).

And luck. Luck to have the knowledge, time, energy and resources to fight for what I need. This stems from education, growing up and mostly living in the predominant culture and having some experience with healthcare. Ok, so what are you rambling about Amy? The short answer is how our for profit healthcare system makes sick people expend energy and time they may not have in order to (maybe) get life saving drugs they need. And they still may not get them.

Last week I was denied coverage for one of the drugs I've been on since March 2021, one of the two that has kept me stable after the first line (Ibrance) failed. We switched insurances to my spouse's, as I am currently not working (we've been on my insurance for a little over five years). Learning a new system is always challenging, and new insurance is a new system, but again I have the time, so I tried to do my due diligence, particularly because all specialty drugs have to be pre-certified/pre-authorized by a pharmacy benefit manager (PBM), that our insurance uses. Ok. I'm told by insurance I won't have to put off my first treatment of the year, just send the request and you're good. No dice. First treatment put off for a week, but approved, yay! Well, you know stuff happens, so moving on. 

I asked at the same time that my oral drug (everolimus) be put through by the doctor/hospital for pre-certification. It went through to the PBM directly by January 7th. I called insurance a week later, and they had no record of the submission; it turns out they can't see anything submitted to the PBM until it's either approved or denied. I found that out later. But I gave them another week. I called Wednesday of last week, and insurance stated that it had been denied, but there was no reason attached.  I pointed out I was almost out of the drug that was helping keep the cancer stable, and they said to call the PBM directly.

Thus began multiple calls for multiple days including the PBM and the triage nurse at the hospital, who went above and beyond to help. I have a running note with dates, times and summaries as this is still not resolved. But the summary is as follows. Everolimus was denied because this PBM, also billed as a "evidence based pharmacy risk management" company, uses "peer reviewed scientific literature" as part of their process and there is no evidence that everolimus is more beneficial than the placebo. When I was told that I was shocked, having read the study, which did show a benefit in progression free survival (if not overall survival) and significant (in the scientific sense) clinical benefit. They asked that I email the study. 

Interjection. If I had not had training or confidence in my ability to read and review scientific literature I would have been intimidated by this statement (was that the intent?). 

The triage nurse and my oncologist were stunned because everolimus is approved by the National Comprehensive Cancer Network (NCCN), which puts together guidelines for patients and clinicians in treating different cancers. They are reviewed by a bunch of oncologists. You can find them all here as well as the one specific to MBC here. 

Ok, so we appeal. The oncologist sends a "letter of medical necessity"; PBM sends it back because the signature isn't in handwriting; triage nurse sends it back with signature. During this back and forth, the PBM representative explains that the appeal goes to the medical director, but the medical director is part of the group that sets the standards to approve or deny drugs, so the apeal will likely be denied (wtf). But if that fails it goes to an outside reviewer and will likely be approved (also wtf). Now, it's Friday afternoon, and I have one pill left. The PBM is also explaining to me how important the signature is, and I let my frustration through just a little. I explained I had few pills left, and that I'd been on the drug ten months, and it was working on Wednseday. But for some reason on Friday afternoon they finally offer me an emergency 15 day supply. On Friday afternoon. The triage nurse worked overtime to get it ordered late Friday afternoon (from of course a different specialty pharmacy than I've been using).

So, again Amy, what's your point? My point is our healthcare system is broken. The current system is set up with making money as a top priority. I have no problem with making money, but when it's done on the backs of those who are sick, we need to rethink our values. The longer they put this off, the more I have to bug them, the more likely I am to give up and walk away, saving them money. When the system works better for those who have money, time, and cultural resources, and is set against those lacking any one of those, we need to rethink our values AND make changes to align practice with these values.

I am not the only one who has been denied life saving treatment, and I will not be the last. 

I finally received the rejection letter, which states that the denial was due to the drug "not demonstrat(ing) overall survival or quality of life benefit". They cited one study from 2012 that provided evidence for increased progression free survival (the goal of the study) and stated that they could not determine overall survival due to limited time following patients at time of publication. That study also did not measure quality of life (too few studies do, which is another problem). No mention of the 2018 paper or other studies. 

I was appalled and angry at the lack of evidence and time spent to make a decision that has a direct impact on patients' lives.

So, I wrote a letter to the PBM, because now it's not enough that I get this drug that has led to stability these last 10 months, but it should not be denied to others, and they should not have to fight for it when the science is clear that everolimus leads to increased progression free survival, even though it does not lead to increased overall survival. Here is a link to the letter. *

I was able to get everolimus approved (for me) after weeks of work. The only response to the letter I have received (as of 7/27/22) was that it would be forwarded to the clinician who worked my case and the committee that makes decisions on drug approval. I was told it might be July until it could be discussed because the committee had a "large list to review".  I have followed up twice since then and heard nothing. 

 

*Since writing the letter I've learned more about measures of efficacy for clinical trials, including overall survival (OS), progression free survival (PFS), clinical benefit rate (CBR), quality of life (QOL). There's a lot of discussion and passionate disagreement about these endpoints and their usefulness. I do stand by my statement that PFS can lead to increased quality of life for the reasons I outlined, and of course I'd love, love to see increased OS, but there is a real need for drugs that increase in OS and this needs to be included and followed up on by the FDA. Ok, too much for the end of a blog post.