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.
