Never Give Up - Back to Praluent

I am contemplating launching a new label for some of the blogs, and I should call that new category “never give up”. As I mentioned many times before, always, and I mean always, be prepared to advocate for yourself. I can never stress this enough. 

If there is just one message I can get across to those who are just now learning to navigate FH and its convoluted journey through medicine, therapies and the right specialists, is this: it will take time and patience, and more than anything, it will take effort, to learn and become knowledgeable. And when you get there, put that to good use to advocate for yourself. Never rely on anyone else, no matter how promising their commitment seems to be. 

I know it may seem self-serving, egotistical and self-centered to do so, but at the end of the day, this is about you, your life, your health, your family, your support system. You don’t want to give up because of doctors who may or may not know enough about your condition, because of bureaucracy, or because of neglect from so many people involved in the process. This is your battle. It can get lonely, but you’ll learn in the process that all you have to do is know your condition, know the facts, and speak up. And I assure you that there will be people who will, eventually, listen and help. 

I also need to preface this blog by reminding everyone that I do not endorse any medications over any others. The names of the medications I am referring to in my blogs are what works for me. I know many people who have the same condition (HoFH) and are using a different therapy combination. Just like there are no two bodies alike, there are no two conditions identical, nor two treatments identical.

So, please read this with this in mind. The names are given here just to exemplify my own journey. They do not endorse any of the medicines I am referring to, nor their manufacturers. 

To remind you, close to a year ago (https://livingwithfh.blogspot.com/2025/07/the-end-of-era-good-bye-praluent-hello.html), in the middle of the year, with no changes to my insurance whatsoever, my insurance company decided to stop paying for my PCSK9 inhibitor injection drug (Praluent) and replaced it with Repatha, which they said, they will fully cover. I had been on Praluent since 2016 (9 years) without any issues. My cholesterol dropped by about 40% which was the biggest drop by one medication alone. I was impressed. 

It was like saying “goodbye” to a friend when I had to stop the Praluent and order the new drug. I wanted to cry. Plus, as many of us who are on drugs for the long haul with a life-long condition know, you always wonder what will be the side effects with the new drug? Will I be able to tolerate it? There is always some undesired effect from a drug that you have to either make a decision you can live with or you simply cannot take it. So, I was nervous. I also am extremely incredulous of people to promise you that “two medications are identical, so you can switch to the other one easily.” I personally have not found this to be true at all. There is always a compromise you’re making.

I have tolerated Repatha well but there were some differences that I could notice, especially at the injection site. But tolerable. After three and even six months on Repatha, however, my LDL numbers were higher than my levels while on Praluent. With Praluent, my LDL dipped for the first time in my life under 70 mg/dl which was the target for LDL levels for people with increased risk. Since then, the target has moved to 55 mg/dl for people like me, with very high risk of cardiovascular disease. My levels have never been as low as all that, even with Praluent (and all the other therapies combined). But it was in the 70s range, or lower than 70, 7 times while on Praluent, while it was in the 70s only twice , and never below 70 mg/dl with Repatha. 

So, after 5 months of Repatha I spoke to my cardiologist to see whether we can convince the insurance to let me switch to the Praluent again since the numbers were visibly better. He agreed. He only can request such a change. No amount of advocating to the insurance coming from me would ever convince them. They needed to hear my specialist doctor (not a PCP) reach out and explain the medical need for this. So, he contacted them in November last year with what he thought was a compelling message about switching back to Praluent. 

And his request was denied. I received a letter from my insurance in the mail in November, never explaining why, but just communicating the decision. I called the doctor again in December (because like you already know about me, I don’t quit that easily) and I asked again: can we please appeal this decision. He said, sure, we’ll appeal. (Again, this request came from me, he would have stopped at the denial). And his office did appeal. 

In December, I again, received a letter from the insurance saying “your appeal was denied”. I crossed my arms and pouted for a while. The letter did say I have the right to a second appeal for 6 months since the denial of this one, but I told myself I’ll try again after The Holidays. 

I had a call with my nurse advocate from my insurance earlier this year and I gave her my LDL-C levels and asked her: “do you think I have a case to keep pushing for a switch? My numbers are better on Praluent, my doctor said the goal for all these drugs is to keep the LDL-C levels as low as possible, why can they not see this and just approve the switch? Repatha is obviously not that good for me. And there is an alternative that they have paid for years.” She agreed that looking at the numbers, I do have a case to push for another appeal, but that she encourages me not the appeal alone. To get the cardiologist to call (not write to) the insurance and speak with their medical advisor and explain the medical necessity for such a switch. 

Since January I have been trying to email my cardiologist (several times) to make him understand that he would need to call and speak with someone or else we’ll keep getting denied. I got silence. Weeks went by, my appeal clock was ticking (I was only allowed to appeal until early June), and nothing, no answer from the doctor. 

Well, as my luck would have it, his office messed up some other drugs (somewhat unrelated to the PCSK9 inhibitors) which prompted me to escalate those problems to his clinical pharmacist (since they were drug related) who is the person who actually gets the prior-authorization approvals for all my specialty drugs in the first place (and I thought he would take my requests for appeals to her, but ... maybe not?). She was not aware that I was trying to get my PCSK9 inhibitor switched. The pharmacist and I talked for a while, we looked over my levels (again) in late March and she promised she would appeal a second time and she also agreed that there is a clear case here for better therapy, so we should continue trying. 

And on May 8, I got an email from her and from my insurance nurse advocate to tell me that the insurance did approve the second appeal and they are allowing me to take Praluent for another year. The prescription expires in May 2027, but at that time, we would have to go through the same process again to get it pre-authorized and approved. Next time, I will skip the cardiologist altogether and I will go directly to the pharmacist. 

So, now I am back to my old trusty drug and hoping it’ll perform as well as in the past. 

First Praluent injection in almost a year. High hopes.

Of course, with all this disruption and rollercoaster drug-switchin’ my levels are still higher than they should be, but it takes up to three months for Praluent to work at its full efficiency and I have only taken one injection so far. 

It took, all in all, 7 months to get this switched. Several years ago, when I was advocating to take additional therapy with a newly-approved ANGPTL3 inhibitor infusion, it took me 3 years and a change of medical systems and cardiologists to finally benefit from that therapy. But we did it! (the new doctor and me). 

As they often say “time is plaque” when it comes to “bad” cholesterol and these delays and waits are one of the most burdensome roadblocks in our healthcare and well-being. But I cannot afford to give up. Not ever. Not while I know there is a solution. Time is of the utmost essence here. 

I hope this entry helps, not to scare you, but to give you an example of how this battle is real but how success is also possible. Just stay informed, alert, and state your case. Always. 

The best of luck in your journeys and much, much health! 

Latest numbers (click the picture for a larger view)

The End of an Era: "Good Bye, Praluent. Hello, Repatha."

I have had a long, sinuous, adventuresome path with PCSK9 inhibitor drugs. 

A complete unknown when my FH was diagnosed 42 years ago, a dream or a vague promise for most of my adult life, they have become the drugs that probably extended my life, right along with my very invasive open-heart surgery 9 years ago. 

I remember around 2009 or so, the pharmacist that worked with my cardiologist at the time in Greensboro, NC, shared with me that there was this clinical trial on the horizon (not available yet) where they would test this new class of drugs, called PCSK9 inhibitors, and he thought that I would be a perfect candidate for signing up for it. But as a rule, I don’t want to participate in clinical trials. As a rule, I accept taking a treatment only when it’s been officially approved and only if there is no major impact on the quality of my life. 

Well, PCSK9 inhibitors were not approved, so I said no, however promising their clinical trials were at the time. Then, around 2011 or so, the same pharmacist went through some hoops to find my new information as I had moved to Utah and contacted me to share that they have a clinical trial in Salt Lake City that would allow me to participate. A couple of years or so later, he said they were seeing really good results with these new drugs for FH patients, and to please consider participating. He said he could contact the clinic in Utah on my behalf to give me a referral, but I politely declined again. 

At the time, my LDL levels were still dangerously high, going up and down between 250 and 300 mg/dl, although I was taking cholesterol-lowering drugs that were on the market at the time; but they were not enough. I still said no, I would not consider this but I was absolutely stunned that he remembered me and he went out of his way to find me and share this news with me. 

Fast-forward a couple of more years, and at the end of 2015 (the year when Praluent was finally approved), I was told that I needed pretty much emergency surgery to replace my severely stenotic aortic valve and to ultimately have several bypasses of blocked arteries. 

My surgery was performed in February 2016 and both the surgeon and the cardiologist sat me down very sternly and explained in great detail what intensive damage my very high cholesterol had done for the first 40 years of my life. They both encouraged me that if there is one thing I can do for myself, for a healthier life, and to ease the impact of cholesterol on my arteries, was to keep the cholesterol levels, particularly, the LDL, as low as possible through any therapy I can tolerate. 

My cardiologist at the time had been involved in the PCSK9 clinical trials in Utah, so he was very familiar with the drugs and with FH. He asked me to please consider these drugs as now they were approved and my LDL cholesterol was nowhere near normal. 

After seeing the results of my surgery and living through the really hard and lengthy recovery from it, as well as developing even more heart disease, I decided to start taking a PCSK9 inhibitor drug at least for 6 months or so to see if it truly would impact my levels so dramatically that it would be worth it in the long run. 

My cardiologist prescribed Praluent which I started taking in April 2016, about 2 months after my surgery. 

After the first month, my LDL dropped from 260 to 184. After 3 months, in July 2016, my LDL was 104. I was shocked! There were virtually no side effects. On the day of the injection and a couple of days after I had a runny nose like I was about to get a cold or like my allergies would act up. And then there was nothing else. I asked the cardiologist what made him choose Praluent over Repatha as both were available at the time. He quite simply said: “It was a coin toss! Either one would work. I just went with Praluent.” 

I have been happy with Praluent. Outside of the inconvenience of taking a painful injection every two weeks, worrying about keeping track of the schedule (easy to do with any calendar app), and ensuring I’d pack my injection pen when it would be due while I was traveling, it did wonders for my cholesterol levels - so all the challenges were small prices to pay to ensure my arteries would stay clean. 

My LDL target is 70 mg/dl. Praluent did not manage to lower my levels to lower than the low 100’s but it was better than walking about with 250-300 levels. So, I knew this would be a life-long drug for me. My artery disease, especially in my carotids, has stabilized. My carotid ultrasound used to be worse from year to year up until 2016. For the past 9 years, they have been mostly stable with no visible sign of worsening. 

In 2017, I was called upon to write an amicus brief to defend Regeneron’s lawsuit in court against the Repatha maker, Amgen, who was looking to push Praluent out of the market. I gave the perspective of the patient on Praluent and spoke about how important it was for people to still have access to Praluent, in addition to Repatha for various reasons. 

For me, I don’t like the fact that there is a chance of Repatha increasing your blood sugar levels. I don’t have diabetes, not even closely, but I do have a rich history of diabetes in my own family - virtually everyone with FH has eventually developed diabetes in my family. 

I have now been on Praluent for 9 years and I have managed it pretty well. In a way, I got very comfortable with it and it’s one of those instances of “you’re not afraid of what you know.” Even if there was not much thought, not more than “a coin toss”, in my doctor choosing it for me, it’s become my drug. What I am used to. What I know how it will affect me, for good or bad. That is a level of comfort that I struggle with letting go of. 

But in comes the year 2025 when my insurance company sent me a letter to notify me that starting with this year they will no longer pay for Praluent and I absolutely must switch to Repatha. I was very, very disappointed. I spoke to my cardiologist (I moved back to North Carolina so now I have a new cardiologist) and asked him if he could speak with the insurance company to persuade them to still continue covering my Praluent because I was afraid that my diabetes family history might catch up with me and I don’t want to risk adding another condition to my laundry list of issues. 

The doctor preemptively agreed to talk with them. He actually asked his nurse to call and see what she could find out. The nurse was not very empathetic about it. She called me and in no ambiguous terms said that “a family history of diabetes is not reason enough to not take Repatha and that only proving that elevated blood sugar while taking Repatha would be considered a reason to revise the insurance’s demand for switching to this drug.” It was not clear if this was her opinion, or something she was passing on from the insurance company. She encouraged me to try it and watch my sugar closely and we’ll react based on that, if necessary. 

I also spoke with my insurance company to ask them if I could please stay on Praluent, given my long-time record of it working fine for me, with virtually no side effects, and considering I have a history of diabetes in my family. They said those denying to pay for Praluent are actually not them, but my employer. They also said from what they had seen this year, my employer refused to pay for several other medications and from what they have seen from patients pushing back, they have not been too successful to make the employer eventually pay for a “non-approved” drug ... They said I was free to put in a complaint with the employer but they told me to be prepared to be told “no”. 

So, I conceded and accepted my fate ... Starting in August of this year, I will start taking Repatha and this last week was my last injection of Praluent. It’s like saying goodbye to an old and trusted friend. I have no idea what this new (to me) drug will do to me, but I know enough about how sensitive I am to changing drugs and how every drug is different, although it’s in “the same class” to be a little nervous about this switch. 

Of course, the recent lawsuit that found Amgen guilty of essentially bribing pharmacies to only prefer their product over Regeneron’s Praluent (https://www.fiercepharma.com/pharma/amgen-hook-pay-more-400m-after-regeneron-triumphs-cholesterol-drug-antitrust-suit) gives me additional pause. 

But what can one do? This is one of those cases, I feel, that what is good for the patient, or what the doctor recommends that might be good for the patient, does not always jive with what the money-making industries of pharmaceuticals and insurance companies are willing to make available for the patient. It’s one of the most frustrating parts about dealing with a disease that cannot be managed without medications. It’s adding the burden of unaffordability or muddling through preventable side effects to the burden of the disease itself. It never feels fair or compassionate, in any way. The “do no harm” is definitely overlooked in situations such as this. 

The (small) silver lining I have seen, from what I have read so far about Repatha, is that the drop in LDL levels seems to be higher than the drop with Praluent. But will it mean the same outcome to me? Only time (and trial) will tell. I will report back. 

What Happens to a Prior Authorization When You Switch Doctors?

The drug in this story is Evkeeza, a drug used for HoFH patients in addition to other cholesterol-lowering therapies and which requires prior authorization from the insurance company before your doctor’s lab can administer it to you. This is an infusion drug, which involves you going to the infusion center and getting an infusion the strength of which is calculated based on your weight for an hour every month. 

So, what happens to the prior authorization approved by the insurance company for the doctor that originally prescribed the drug when you switch doctors?! 

To make a really long story short, the answer to this question is: the prior authorization given to your previous doctor is null and void. Your new doctor has to apply for a new one with the same insurance (if the doctor agrees to prescribe it to you), since the doctor’s office is responsible for providing the treatment (not just prescribing the drug). 

To make a really long story even longer: after waiting for two and a half years with the first doctor to even understand what this drug is, get it prescribed and approved, and waiting for the first doctor’s pharmacy to understand what the drug is and how to order it, you now have to wait even longer for the new doctor to apply for the same prior authorization (hope they don’t make a mistake on the request form), and hope that you get approved the second time. 

So, now your two and a half years are more like three ... 

Evkeeza has been approved since February 2021. I asked my first doctor in the summer-fall of that year if he thinks he can get me approved for it. He said he had never heard of it and will research it. It took him till the fall of 2023 (that is two whole years if you’re not counting) to actually prescribe it to me. After his office figured out what the drug is for and how to fill out the paperwork for the prior authorization, I got approved for treatment (for 6 months) in February 2024. Since then, I have been waiting on the first doctor’s pharmacy to figure out where to purchase this from. And this puts us in May 2024. Again, if you’re not counting, two months (soon to be three) have passed from my 6 month-approval, so even if I got the infusion tomorrow, I would only be eligible to get 4 infusions, not 6 which is what I was approved for.  

I called the maker of the drug (Regeneron) and asked if they could help get the drug to the first doctor’s pharmacy. They responded with “Why, yes, yes we can, but we need to know your doctor’s information.” I sent that to them in March 2024. Since then, I have had no communication from the manufacturer, the doctor, or the pharmacy that I can start my treatment. 

Finally, this month (May 2024) I am moving to a new doctor who has heard of the drug, has gotten it into their infusion center and is even treating two patients with it. Score, on my end. Except ... the previous prior authorization does not work for the new doctor. 

His office applied for it last week and now we wait for the insurance to re-approve it (although the patient, my coverage and my medical condition and cholesterol levels have not changed) yet again (hopefully). 

Since this is a new doctor and they don’t have my whole history of diagnoses, treatments tried before and current therapies, I sent the new doctor the following:

• My cholesterol levels with and without any therapy

• My current cholesterol levels (my current LDL is 250 mg/dl - far from my target of 70 mg/dl)

• My surgical report from the open-heart surgeries from 8 years ago (that documents the massive coronary artery disease already present in my arteries)

• My genetic test results (testifying that I have HoFH)

• The prior authorization approval from my insurance for the previous doctor

I spoke with the new doctor’s team and they said they feel confident that the approval will be granted but that it might take about a month (from what they saw before) to receive it. 

I also spoke with a nurse with whom I am connected from the insurance company and she said although she is not in charge of the decision, because she knows my history, she also feels like this is just a formality and that it will be approved. She also can check on the status of the application, so this is a good resource to have in your corner, if your insurance offers it. 

And thus, bureaucracy wins. Healthcare takes a step back. 

In the meantime, I wait - not too patiently, I’ll have to say. And also, more than anything: I hope that once all this is said and done and I do get the treatment, finally, the treatment actually works ... 

Here’s hoping indeed! 

Beware of Unknown Tests and Bogus Charges

The “real” story is long and convoluted, as all medical stories are. But I will distill it to a simple recount: they did one test (MRI); they charged me for three.

I have several MRI/ ultrasound/ CT-scan/ doppler appointments a year to check for various things in various areas of my body: I get a heart echocardiogram (or ultrasound) once a year; a carotid ultrasound, a leg doppler and a stress test (sometimes a nuclear stress test) every two years, and now, more recently, an abdominal MRI (sometimes, ultrasound) every year. They are keeping an eye on various areas in my body that show arterial stenosis due to the built-up of plaque.

This new (and soon to be former – see: http://livingwithfh.blogspot.com/2021/04/educating-doctors-visit-to-my-vascular.html) vascular specialist doctor ordered an abdominal MRI with and without contrast. The day of the test, I checked with the technician that was supposed to do my actual test what exactly the test was – like I said this was a convoluted story and there was some iffiness from the doctor’s office about what test was actually ordered from the radiology department, but I knew that the one thing I was there for, the one thing the doctor and I agreed upon to watch, was my abdominal aorta. So, I was expecting an abdominal aorta MRI.

The radiology technician confirmed he was about to do an abdominal MRI with and without contrast. I was good.

And then, the results came a couple of days later in MyChart: the radiology department had apparently done the following tests that same day:

·       CARDIAC MRI HEART MORPHOLOGY AND FUNCTION W/ WO CONTRAST

·       CARDIAC MRA CHEST WITH AND WITHOUT CONTRAST

·       CARDIAC MRI ABDOMEN ANGIOGRAM WITH AND WITHOUT CONTRAST

I opened each of these tests in MyChart to look for the results of each one. They had copied and pasted the exact same results from clearly an abdominal MRI test: there was no mention of the heart, no mention of the chest arteries, no mention of the heart morphology – there were just mentions of the abdominal aorta, the renal aorta, the mesenteric, and iliac aortas. Also, I noticed that one of the tests said “cardiac MRI angiogram” and what I had was not an angiogram … And each of the three tests had identical – letter for letter – results. Obviously, they were not the same test (why the different names?), but they had the same findings. I was just a little bit upset, you can say.

I panicked, because I know that when the doctor says they did a test and it shows up in your MyChart Test Results section, the next place you’ll see them will be in your bill. I have done these tests enough to know they are never lower than a couple of thousands of dollars (usually more) each.

I approached the mix-up with the doctor who ordered the tests, and he insisted that all three of them had been done. I asked him to show me the results of all of them. He could not – he had the same results three times over, as did I, on my end, in MyChart. He insisted that the tests were done (although I told him time and again that I verified with the radiology tech about what test I was receiving and he did not say I was getting three tests), and that the radiology doctor sent the wrong results. The doctor contacted the radiology doctor after I left his office.

I was almost in tears, because by then I had received the bill which showed I owed roughly $12,000 – about $4000 for each of the three tests. I am lucky to have insurance, but I had not met my deductible and even after that, I was still responsible for a chunk of the cost. It also felt unfair that even the insurance should have to pay for tests I did not get nor that were needed at that time.

A couple of hours after I left the doctor’s office the doctor himself called me to apologize: he talked to the radiology doctor and they had made a mistake: they in fact confirmed what I said all along, that they had performed one test and that was the abdominal MRI without the angiogram part of it and that the other two should be taken out of my account.

A couple of days later, the head of the billing department called me with an apology to assure me that I will only be responsible for one test, an abdominal MRI, and that the other two will be taken out of my bill. I told them the bill was already sent to the insurance who paid their share and they assured me they will refund the money to the insurance and that the insurance overpaid (how many times does this happen: hospitals reimbursing insurance companies?!).

In the end, the final bill was for around $4000 for just one of the three tests, but I wonder how many times this slips and people are overcharged for what they did not get done. Especially for chronic patients, like us, who have a number of tests done every year. I know people who are not savvy enough to read their results online and see what they describe; they just trust what the doctor says and move on. They would have received the bill, shaken their heads that the darn medical system is way over-bloated (which still is) and would have paid.

Some lessons this has taught (or reminded) me (of):

• Always pay attention to the tests they recommend and try to understand what they are for and whether they are needed.
• Question multiple tests – are they for the same thing? Can one test cover the scope of all the multiple tests?
• Ask the doctor to explain whether you need an MRI or would an ultrasound (typically cheaper, but not as accurate as an MRI) be good enough? For areas that are larger (think a whole organ versus one small artery), ultrasounds are usually enough.
• Always read your results and try to make sense of them even if it is just to ask your doctor additional questions about your treatment plan.
• Look at your bill twice: does each charge verify and match your real experience. If not, call the doctor’s office first; remember that the insurance only bills for what they receive from the medical institution. Start with the doctors/ clinic/ hospital to understand why they told you one thing and sent the insurance something else.

In short, as always: stay alert and be your own advocate. Always.

Denied, and Then Approved. Again

If you have followed this blog regularly, you know that I have had trouble in the past being approved for my PCSK9 drug, Praluent. There is a whole process you have to follow to be approved for this drug by your insurance company, way long after a specialist doctor decides that it is your last resort.

I have outlined this struggle and the positive outcome from my last encounter with denial to be approved for the drug in this entry, earlier this year: https://livingwithfh.blogspot.com/2017/04/a-helpful-health-insurance-alas-there.html.

If you read that entry, you'll see that this insurance liaison helped me get my appeal approved, after having been rejected a few times. That man asked me to reach out to him directly should I ever encounter any problems with my approval again. I knew that offer was not going to be left hanging and that I will need his help again, and so I did just recently. But I am jumping ahead of myself!

So, after being approved for Praluent, finally, in the beginning of this year, I had to again obtain a pre-authorization from my insurance for my specialty pharmacy to be able to process my prescription renewal this August (after 6 months). It works like this: the insurance faxes a form to my doctor, and as the insurance representative and the pharmacy manager assured me last time, all they need to see is that my cholesterol level stays low on this drug, to ensure that the drug is still working. So, all they are asking the doctor on the form is what my LDL is, and what it was before starting therapy. Now, I would think that if the cholesterol level is not low, the doctor would not even prescribe the medication, right?! Why would they put me through a treatment that is costly (for anyone), risky (as we are yet to know the full spectrum of long-term side effects of this drug), if the drug is not working for me?! But I know: I ask silly questions!

So, this August, I get a letter from my specialty pharmacy telling me that my pre-authorization has been denied to renew my Praluent prescription, because my doctor has failed to send documentation that shows that there is a reduction in the LDL level while taking this drug – I paraphrased, but that was the gist of it. I was confused, because my LDL level before Praluent was 260, and my last level was 160. So I know my doctor has these levels and his office would have provided them, if needed.

I reached out to the same liaison from my insurance that helped me before, and the whole misunderstanding (again) was cleared up in less than half of a day. It turned out that all that the insurance company received from my doctor with their original request was the “fax form” (I imagine it to be like the fax cover letter with my general information on it), and not my medical records. When he intervened and they requested the information again, they received 26 pages of medical records. After reading those, they approved the pre-authorization for Praluent on the spot. When they received just the “fax form”, they turned around and denied me, without so much as to pause and ask themselves “hmm … maybe there was a fax line interruption and the rest of the pages are missing and we might need to call the doctor and make sure there is nothing else coming”, or something. Anything. I spoke about the broken processes in the medical world in another entry (http://livingwithfh.blogspot.com/2017/08/medical-non-care.html), but they abound, in my opinion, at every level.

This time, the insurance also approved me for a whole new year, instead of the original 6 months. Again, if you have read in the past: so far, I have been on Praluent for 18 months (give or take a couple of months when the drug was denied and I didn't take it), and I needed a pre-authorization from my insurance every 6 months in order for the specialty pharmacy to fill the prescription. After 18 months, the renewal is now required just every year.

I will have to say, it was helpful to have this relationship and be saved an appeal, or several.

I still believe that there are still a lot of rusty links in our processes. Maybe these medications are still very new, maybe the drug processing folks are still too little trained, what have you: if you are on any of these drugs, or any drugs where documentation from the doctor to verify your condition is still needed with every refill, be vigilant and act fast to stand up for your cause. I have made this connection with the insurance person through The FH Foundation who has introduced me to him as they knew about my difficulty to obtain an approval. Your employer (if you have your insurance through them) should have an advocate for your insurance that you can connect with for such cases. I will continue to do my share to push for more changes, more efficiencies to ensure they finally get the message and that filling such drugs gets to be routine for them, but sometimes, it might take a whole village.

The good moral of this story, however, is this: that the insurance companies and the specialty pharmacies, albeit marred in bureaucracies and lack of patient understanding at times, are willing to listen and learn. Or at least some of them are.

A Helpful Health Insurance?! Alas, There Is Such a Thing Indeed!

Why the insurance company finally approved my Praluent prescription and who is paying for it

I feel like I should have written these entries as part of a series: I should have named them all the same thing and then given them an episode number. But I didn't. Who knew it was going to become such a saga?!

If you are just now finding out about my struggles to stay on Praluent, due to my insurance denying my refill last year, then you must read the previous entries. They are, in order:

• The Struggles to Stay on Praluent. And They Are Not What You Might Think: http://livingwithfh.blogspot.com/2016/12/the-struggles-to-stay-on-praluent-and.html
• Between a Rock and a Hard Place with the Praluent Refill Authorization: http://livingwithfh.blogspot.com/2017/01/between-rock-and-hard-place-with.html
• Refill for Praluent APPROVED: http://livingwithfh.blogspot.com/2017/02/refill-for-praluent-approved.html

I suggest that you would read them in successive order, just to understand the whole story, as it progresses. First, I was denied when I needed to refill my prescription (please keep in mind the word “refill”: I had been approved by my insurance to take Praluent; but when the authorization needed to be renewed, after 6 months, I was denied); then, my nurse appealed the decision, to no avail – I got denied again; and lastly, I appealed their decision one last time and they eventually approved the refill, 6 weeks from my original request for a refill. All the details of what happened are in those three entries. If you are riding this roller coaster, as well, please read them and maybe some things will be helpful for you. But also, read on …

Just to be clear: patients of FH for whom statin therapy is not enough, or Homozygous FH patients, or FH patients who are allergic to statins depend on drugs like Repatha or Praluent (PCSK9 inhibitor drugs) to keep their cholesterol levels low. To some of us, this can be the difference between having a heart attack and avoiding one. So, if these drugs work for you, you want your insurance to keep them on their formulary and you want them to keep giving them to you. They are insanely expensive, so the insurance's help with paying for these drugs is paramount to being able to continue the therapy.

After my insurance approved my refill, I thought that was the end of my interaction with the insurance company and with the Specialty Pharmacy which is the entity that actually manages the filling of the prescription. But I was wrong.

As I mentioned before, the FH Foundation (https://thefhfoundation.org/) has reached out to me and wanted to investigate further into what happened with this refill. They work with various insurance companies to smooth out the process for patients that need these drugs

I can tell you I was not alone: several people that read the FH Facebook post mentioned that they had the same experience as mine, where they get approved the first time, and then the refills are problematic. My own cardiologist said that about 80% of his patients get denied for a refill and he cannot figure out why.

Well, after talking with the FH Foundation folks, they put me in touch with a person from my own health insurance who was investigating how they can improve this process for us, FH patients. He emailed me, and asked me a few basic questions about my account (name, date of birth, etc) and then he dug up my file and my history of requesting a refill. After several weeks of digging, he and a manager from the Specialty Pharmacy (you are always dealing with the reps from the Specialty Pharmacy when you fill this prescription) had a conference call with me to talk about what happened.

I went over the story, but it was fast apparent to me that they knew what the story was: I called in for a refill, was told that one would not be allowed without a pre-authorization; my nurse was required to fill out a form to require pre-authorization, and that was denied. Twice. Then, I filed one last appeal, and the insurance magically pre-authorized me for my refill.

To my surprise, the insurance company person as well as the pharmacy manager admitted that what happened was a series of mistakes on their end. The whole time I was calling and placing the order for a refill, they were treating me as a new case, not as a pre-approved case who just wanted a refill. When they did that, they also faxed the wrong form to my nurse: they faxed a form where they ask for all complete records that prove that I have FH. My nurse was half-completing that information, because she was assuming (like me, too), that she had already filled all that information out the first time she asked for the first approval and that the insurance company already has the information they need. But they needed that whole information thoroughly completed again, because in their mind, I was a new patient. This was a mistake made by the people working with my doctor to file the request for the pre-authorization.

According to both the insurance company and my Specialty Pharmacy, when you file for a refill, they require one form with just two questions on it: what was the LDL before therapy and what is the LDL now?! If they see that it dropped (and in my case, significantly), then they approve the refill, because they think the drug must be working. If not, they won't approve it. They don't need any of the previous information, about your family history, or your own history of CVD, or your previous and current medication, etc. They just need the doctor's office to tell them those 2 LDL levels and based on the trend of the numbers, they stop your therapy or continue it.

The people I spoke with apologized profusely and thanked me for being willing to help them “discover gaps in their process and training” so that they can fix this and so that no other patient should encounter this problem again. They also told me, quite surprisingly, again, that their full intent is to keep people like me on therapy, and not make them stop or skip the therapy. If you think about it, as expensive as these drugs are, they are still cheaper than paying for a heart attack or a stroke. So, it is in their interest, too, to keep us on the drugs.

I asked them what made them approve my last appeal and what made them investigate this case in particular. They said the appeal was approved because with the papers that I sent and the clear letter explaining my plea, they could tell right away that the Specialty Pharmacy reps were not listening to me. I asked if my doctor intervened more, and they said: “No. The only thing that approved your pre-authorization was your paperwork, that you submitted with your appeal.” In that, I added tons of documentation to prove my condition, medical history, my history with them, and I clearly stated that this was for a refill and not for a first time approval. When the appeal department got that, they approved it right away. You can read in this blog entry (http://livingwithfh.blogspot.com/2017/02/refill-for-praluent-approved.html) what all the papers were that I sent in with the appeal.

This conference call was the first time in my life, possibly, when I was not frustrated and exasperated, after talking with an insurance company. I was really grateful that they took the time to investigate and they discovered the mistakes in the process, and owned up to them. Hopefully, lots of people like me will have better experiences in the future.

My next pre-authorization is required again in August (after 6 more months since last time), but after that, it will only be required once a year, instead of every 6 months. I will definitely report back with how that next step will go. So far, all the monthly refills have come in pretty painlessly.

Another thing that I found was that the Praluent manufacturer is actually paying my copay, as I have yet not gotten a bill for this year's refills. They explained that sometimes, before they bill me, they look to see if the manufacturer offers a copay card. If they do, they apply it to my balance, and it just so happens that what they offer covers my balance. The manufacturer has never reached out to me, nor has it sent me any notification that they would be doing this. This has been completely behind the scenes, between the manufacturer and the health insurance. They mentioned that my insurance does not accept a copay card from all manufacturers, but they do from the maker of Praluent, as this is a preferred drug for my health insurance.

They also told me that when there is no copay card, and they must cover a significantly expensive drug like Praluent they go next to various foundations. Some foundations might cover the copay partially or fully, after a screening process. This was not my case, because the manufacturer's copay card was accepted. 

Both the insurance liaison as well as the pharmacy manager shared their contact information with me, so that I can contact them directly should this happen again. As I mentioned before: this has been an out of the ordinary experience with a health insurance company. So far, I have been pleasantly surprised by this follow-through and attention to details. Let's hope this holds and not just for me, but for everyone else struggling to get through to these institutions.

Please comment if you want additional information on what I have submitted, or if you have more questions about my interaction with the insurance company, the FH Foundation, or anything else. I'd be happy to help.

Easy journeys to all of you, and to all: much health!

Refill for Praluent APPROVED

This is a continuing story that I am following up from this previous blog post: http://livingwithfh.blogspot.com/2017/01/between-rock-and-hard-place-with.html. Please read that story first, to understand the full context, if you have not followed this from the beginning.

Briefly, I was approved for Praluent last May, in addition to the high dose Lipitor and Zetia I have been taking. In November (6 months since the original approval), my specialty pharmacy required that a pre-authoriaztion was needed in order for them to continue giving me the drug. My doctor's office filed the necessary papers twice with the pharmacy/ insurance company and they were denied the refill both times. Convinced that there was something missing on their paperwork, I decided to appeal a third time myself. I am giving all the reasoning behind why I thought this in the post I linked above. 

And now the update: after my third appeal, the pharmacy approved my refill of Praluent for another 6 months. 

And now the whole story. 

On January 27th, I filed my appeal which was the last one "internal appeal" remaining. I found out that they allow you to appeal three times, "internally", meaning you appeal to the same company that denies you. After that, you can file an "external appeal" which is sent to a third party that evaluates it. So you are no longer dealing with the insurance at that point, but with this other entity. 

When I filed my appeal, I included the following papers:

- the most recent denial letter from them;
- the most recent form faxed by my cardiologist's office to them, and I included the corrections on the form (if you read my previous post you'll see the list of the things they missed when they filed); this included the family history of FH which was not evident in my doctor's papers;
- a letter explaining my case: my long lasting diagnoses with FH, ASCVD, heart problems, atherosclerosis, etc, as well as the fact that I have been approved for this drug before; 
- my heart surgeon's and my cardiologist's phone number and address, in case they needed to confirm anything I was sending in;
- a list of all my diagnoses, which I have downloaded from my cardiologist's web portal;
- a list of all my medications, which I have downloaded from the same place;
- the  discharge papers from last year after my open heart surgery: in there, they list everything they found wrong with my heart (blocked arteries, defective aortic valve and aorta, atherosclerosis), as well as what they did to fix it (quadruple by-pass, replacement of the aorta and aortic valve, aortic arch repair);
- the cholesterol values before I was on Praluent (high 200's for the total cholesterol and mid-200's for the LDL);

Two days ago, I have found a letter from my insurance in the mail with my approval for another 6 months. They mention that they will require a pre-authorization for it again at that time. This time, I think I will cut to the chase and either send the information myself, or go personally to the doctor's office and make my nurse fax exactly what I sent this time. 

I am happy about this outcome, of course, because my numbers are unbelievable on this drug, so I would love to be able to continue the therapy. I am really excited that the drug is still on the market, after the lawsuit that has been developing over the patent (also linked to the previous post). 

Right now, I am just a phone call away from scheduling my next shipment. First, I want to explore some payment options as the $1400 / month bill is a bit high for me. If there are other options for payment or discounts to help with the payment, I would love to know about, and I am exploring those before I call in, but I should be ready to call in a week or less. 

I will update this site if there is any pertinent information about payment options. 

I want to thank the FH Foundation for reaching out to me personally and coaching me through this process. Their wisdom and care for us is amazing and I am forever grateful! 

Stay in touch and stay healthy, everyone!

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!