Sunday, January 29, 2017

Between a Rock and a Hard Place with the Praluent Refill Authorization

and why I am fighting for this still.

I have been sitting on this post for a while, not wanting to write it. There is so much negativity in the world today that my heart constantly aches. And I felt like this blog post will be negative, and I really don't want to add to that at this point in time, in our world, today.

But I felt, on the other hand, that I needed to continue with the saga of my trying to control my numbers and my advancing heart disease, and since a new chapter has been developing, I knew I needed to relate it. As usual, I hope this helps folks trying to stay healthy, out there.

A brief recap is needed: in December I was posting about how I was trying to refill my Praluent prescription and how the refill was denied twice, by the same insurance company that approved it 6 months before (see post from December here: http://livingwithfh.blogspot.com/2016/12/the-struggles-to-stay-on-praluent-and.html).

The doctor's (cardiologist) office faxed them all the information they requested, and they denied the refill twice. I received the denial letters on both occasions. What struck me as complete 'bogus' reasoning (for lack of a better word) was that in the first letter, they mention that I was denied the refill because I was not meeting 2 conditions, based on the information sent in by the cardiologist. After the nurse faxed them even more information, they sent the second letter of denial and this time, there were 5 (FIVE) conditions that they were looking for and I did not meet. So, it seems like for no reason, every time you give them what they want, they keep moving the finish line, raising the bar even higher. It definitely does not feel fair, but I am sure insurance companies are not in the business of fairness. But I digress.

I examined the list of the 5 conditions to see if I meet them. I am not going to reproduce them here, but if you want them, leave me a comment and I can share them with you.
They are written very much in 'lawyer talk' with 'either / or' and 'both or...' caveats, so they are a bit challenging to decipher, but I meet all five of them. This made me wonder if the nurse filled out some paperwork with mistakes in it, where she might have missed some of the conditions that I am sure I qualify for, unequivocally.

On my last week's appointment with the cardiologist, I asked the nurse if she can share with me what she sent to the insurance. She was not happy to share, but then again, this is not a happy nurse, usually. But she gave me a copy of what she sent, begrudgingly. She added that 'none of her patients ever gets approved for refills and from what she knows, about three quarters of all patients get denied for refills. They are approved for the first 6 months, and then get denied for the refills.” I asked the cardiologist, after she said all that, and gave me the papers, and he confirmed he statement. My cardiologist is also the head of the research program for Praluent and Repatha, for our state, so he works closely with patients just like me, as part of his daily practice.

When looking at the papers that the nurse filed, I could see she missed to check several boxes of conditions that I definitely have recorded in their files. The following things were missed and unchecked on the form she faxed to the insurance company:
  • The diagnosis of Atherosclerothic Cardiovascular Disease (ASCVD);
  • The ASCVD symptom of stable or acute angina;
  • The ASCVD symptom of coronary or other revascularization;
  • They checked that this medication (meaning Praluent) is being used in combination with another PCSK9 drug, which is incorrect;
  • They checked that there is no presence of tendinous xanthomas in me, or any relative, which is incorrect.

However, they have checked many other boxes which still meet the 5 conditions as stated by the second letter I received:

  • They sent my confirmed diagnosis as HeFH (heterozygous familial hypercholesterolemia);
  • For the symptoms of ASCVD, they checked acute coronary symptoms and history of myocardial infraction;
  • They mentioned that I have been on high dose of statins coupled with zetia for more than 12 months (since 2011);
  • They showed that my LDL is higher than 100 mg/dl on statins (the value they used is 184 mg/dl and that was on statins, zetia and one month of 75 mg of Praluent) in addition to the ASCVD;

All I am thinking is that all the things that were missed could have proven to be even more convincing to the insurance company that I am really in need of this drug. However, I know this sounds wimpish and weak, but I cannot get my nurse to re-fax the complete information to the insurance. I have never found her to be extremely helpful, but on top of that, she is also so sick of dealing with the insurance companies and so sick of them continuously denying the applications.

I talked with the cardiologist and he agreed that several things were not checked, and he would ask her to fax it again. With me present, he asked her and she refused. She said “everything is on the paper and everyone gets denied. She (meaning me) is not the only one.” End of story. She also said she included the ICD codes which testify ALL of my diagnoses, but I looked up the codes on the fax sent to the insurance and two of them are for “mixed hyperlipidemia” and one of them I cannot find (I29.10). None of them say coronary heart disease, revascularization, myocardial infraction, AVR, or HeFH.

So, right now, I am pretty much stuck in between an incomplete application filed by my cardiologist's office and an insurance who refuses to renew the drug, even though they qualified me as a patient who needs the drug 6 months before.

What I know for sure is that I cannot have the cardiologist's office appeal this yet again. At least I don't know how to make them do it. But, I still have 90 days left from the last denial letter when I can appeal on my own, and I am getting the papers ready to be sent in today. Fingers crossed.

I am not sure if I could get an approval on my own, but the insurance papers say that I can appeal myself, and add more proof. I will use the papers already signed by the doctor, and add information that is missing in the paper which I can obtain online, from their web portal. Hopefully, this will add to the case.

And now the reason why I am fighting for this so much. During my lifetime, I have seen my total cholesterol levels in the 700's and 500's. For most of my adult life, my numbers have been (on lots of maximum dose of many drugs) in the 300's or, at best and rarely, upper 200's. After six months of Praluent, my numbers are finally in the normal range. 

My numbers, since April 2016, which was the last test before I started Praluent.
(click to enlarge picture)

When I saw those results, I was worried that something else might happen to me. I was worried that these new drugs are so powerful that they are going to render me dead if I quit them – they really did reverse my FH, judging by the numbers, and with virtually no side effects. I was elated at seeing the new values, but also scared, as if something powerful took hold of me. I felt like Bradley Cooper in Limitless. The drug is definitely working, but what happens when I stop taking it?!

There is also a belief that with improving the numbers, the cardiovascular disease will be reversed, too. Praluent (and Repatha) are too new to know by how much it would be reversed, but the studies are being done now, so we'll hopefully know soon.

All I am thinking, every day, is how my heart surgeon described the damage he had found in my heart arteries, and in my aorta and aortic valve, all because of cholesterol build-up. My major goal in life has always been to keep those numbers down, but I could never bring them so low that they would not affect my heart. And after an aortic valve replacement, an aortic graft, an aortic arch repair and a quadruple bypass, I know what all that build-up does to your heart. I was so incredibly lucky to have survived this!

Now, that I know there is something out there to bring those numbers in the normal range and possibly prevent further damage to my heart, carotids, brain, I don't want to leave anything un-turned to ensure I get access to it.

I feel like there are still things I need to explore, and it all starts with the first step. That step, for me, is to appeal once again and add more evidence to my case so that the insurance takes yet another look at my file.

And because when it rains it usually pours, this news came out just a few weeks ago: https://www.bloomberg.com/news/articles/2017-01-05/amgen-wins-ban-on-sanofi-s-sales-of-praluent-cholesterol-drug . Right now, Sanofi is appealing this decision, so there is a delay in this ban being implemented yet. For right now, there is still Praluent on the market and my cardiologist is supplying me with samples. But even if they are continuing to sell, being dependent on one doctor's sample supply is not a viable solution for treatment. I will continue to rebut their decision to not revew this and I will continue to update everyone on how it's going.

I know this fight is not mine alone, and that also gives me strength.

Much health, to all!

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