Praluent, Repatha Costs Outweigh Health Benefits: Study
The high price tag on two new cholesterol-fighting drugs may be so high that it is not worth the cost to take them, according to a new report.
A draft report (PDF) released last week by the Institute for Clinical and Economic Review (ICER) raises questions on the value of Praluent and Repatha; two new cholesterol-lowering drugs known as PCSK9 inhibitors.
According to the report, the drugs are effective, but they might not be “$14,000 per year” effective, which is the price the manufacturers are expecting patients and insurers to pay.
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Learn MoreICER indicates that there is uncertainty about existing evidence on the clinical effectiveness of the drugs for different types of patients. In addition, the report found that there were “serious questions” as to whether the drugs were a sensible value to patients and the health care system given the price tag put on the drugs by the manufacturers.
Praluent (alirocumab) is marketed by Regeneron and Sanofi, and Repatha (evolocumab) is marketed by Amgen. They have a list price of more than $14,000 per year for standard treatment.
ICER estimates that 3.5 million to 15 million Americans who have high cholesterol could be eligible for the drugs.
“Patients, clinicians, insurers – everyone needs good information in order to make the best decisions about the use and pricing of new drugs. Our goal is to meet that need and in doing so not shy away from analyzing cost-effectiveness and potential budget impact,” Dr. Steven D. Pearson, founder and president of ICER noted in a press release. “Even if these drugs were used in just over 25% of eligible patients, then employers, insurers, and patients would need to spend on average more than $20 billion a year for these drugs, a cost that would continue into the future.”
In clinical trials, it appears the drugs reduce LDL cholesterol levels by 55-60% among patients who were already taking statins, such as Lipitor and Crestor, or who could not take statins. However, while the findings gave ICER moderate certainty that the drugs would lower cholesterol levels, there is uncertainty as to whether those low cholesterol numbers will translate into fewer heart attacks and strokes.
The draft report is to be revised by October 27, when the New England Comparative Effectiveness Public Advisory Council (CEPAC) will meet to deliberate on the evidence of effectiveness versus value for the drugs.
6 Comments
DeborahAugust 9, 2023 at 5:40 pm
I took Raptha shots for at least 2 months and began to have tinnitus, insomnia, anxiousness, pain in my joints, high blood sugar, frequent urination which has not stopped and other issues. HORRIBLE. My doctor took me off of it immediately. The tinnitus is still awful and the insomnia. I am concerned about if the rapatha has shifted me into diabetes, because of the frequent urination, etc. Has [Show More]I took Raptha shots for at least 2 months and began to have tinnitus, insomnia, anxiousness, pain in my joints, high blood sugar, frequent urination which has not stopped and other issues. HORRIBLE. My doctor took me off of it immediately. The tinnitus is still awful and the insomnia. I am concerned about if the rapatha has shifted me into diabetes, because of the frequent urination, etc. Has really affected my quality of life. :(
RitaMarch 8, 2019 at 5:25 pm
I have dealt with Fibromyalgia most of my life due to a severe car accident in my teens. But nothing has dealt me such a blow as I have been experiencing since my cardiologist put me on Repatha. I injected this medication into my thigh muscles for a year. I was experiencing severe pain during this time and so I saw my Orthopedic doctor, my hip doctor, had MRI's, x-rays, etc. but nothing pointed to[Show More]I have dealt with Fibromyalgia most of my life due to a severe car accident in my teens. But nothing has dealt me such a blow as I have been experiencing since my cardiologist put me on Repatha. I injected this medication into my thigh muscles for a year. I was experiencing severe pain during this time and so I saw my Orthopedic doctor, my hip doctor, had MRI's, x-rays, etc. but nothing pointed to anything being the cause of my severe leg pain, especially down the fronts of my legs. I could not walk!! I was shut down completely and the suffering was off the charts. I did not even suspect the Repatha because my cardiologist was definite that Repatha had no such side affects. I was in his office barely able to walk with a cane and other assistance, but nothing was said to me about Repatha being the cause. Finally my primary doctor sent me to the Synergy Therapeutic Group for physical and occupational therapy which I've been doing three times a week since Feb. 12, 2019. I am experiencing some improvement but have a long road ahead of me according to their opinion. It was there that I was asked if I was on any statin medications....I said that I was at first but I couldn't take them because of the severe pain they caused me so my cardiologist put me on Repatha. The therapist then told me that Repatha and statins destroy muscle tissue! It hit me like a ton of bricks...at last I knew why my life had been devastated and I no longer had one. I could not walk from my recliner to the bathroom. The pain in my legs, and all the muscles in my body from the waist down were paralyzed, frozen, they did not want to work and the pain was unbearable! I was taking oxycodone just to be able to sleep some. I am going on my second year dealing with this and I want compensation for my intense suffering as a result of taking this drug!! Is anyone aware of a class action law suit against this drug company? I just hope this condition is not permanent!! It's not looking good, I'm still struggling every minute of my day!
JasonJanuary 30, 2019 at 6:06 pm
I've taken the Praluent version for several years now with excellent results, no side effects, however, BXBS has decided to force me onto Repatha. I would imagine it is due to cost or BXBS having a 'sweeheart deal' with Repatha. I see many many more complaints and concerns on the Evolocumab variety of PCSK9 around the web than I do the Alirocumab, many already discussed for me ages ago so... I [Show More]I've taken the Praluent version for several years now with excellent results, no side effects, however, BXBS has decided to force me onto Repatha. I would imagine it is due to cost or BXBS having a 'sweeheart deal' with Repatha. I see many many more complaints and concerns on the Evolocumab variety of PCSK9 around the web than I do the Alirocumab, many already discussed for me ages ago so... I need an accountable person to name in the civil/criminal lawsuits inside BXBS if things should suddenly become life threatening or permanently damaging to me... they were warned it was not a good choice for me but... insist their decision is better than my current care team's decision.. We have altered my lifestyle very much to the better since my original MI/CABG etc using the Alirocumab and the ad hoc decision by BXBS might reverse that, so I'd like to be ready.
BillJanuary 14, 2019 at 9:36 pm
In 2008 I was told that my cholesterol was a little high and Statin treatment was recommended. I was prescribed four different Statins and was intolerant to all of them with severe side effects within two weeks. Because I could not tolerate the Statins I was told to change my diet and see if it would help. Through the next 10 years I watched my diet and exercised 6 to 7 days a week. I was repeated[Show More]In 2008 I was told that my cholesterol was a little high and Statin treatment was recommended. I was prescribed four different Statins and was intolerant to all of them with severe side effects within two weeks. Because I could not tolerate the Statins I was told to change my diet and see if it would help. Through the next 10 years I watched my diet and exercised 6 to 7 days a week. I was repeatedly told that my cholesterol was borderline high but should not be a problem. In May of 2018 I was diagnosed with severe coronary blockages and required a quadruple bypass operation. The surgery was amazingly successful and within 6 weeks I was back to working out and running daily but my LDL cholesterol was still too high. Due to my intolerance for Statins I was prescribed Repatha. I had my first Repatha injection November 16/18 and within 2 days I started to have side effects, (Muscle cramping, back pain, hoarse throat, sinus drip, etc.). By day thirteen the side effects seemed to have dissipated, so on day 14 (Nov 30/18) I had another injection of Repatha. The side effects started within one day and by day four I was in intense pain and could barely walk! In addition to the pain and muscle cramping all over my body, I also started experiencing blurry vision and dizziness. I contacted my Family Doctor and my Endocrinologist in addition to the hotline for Repatha. My doctors instructed me to discontinue Repatha. Today is January 14/2019 and I am still experiencing debilitating pain, cramping, dizziness and hoarse throat. I have been advised by Repatha and both my doctors that these symptoms may last till the end of February 2019! (Three months since my last injection) I sincerely hope that my pain and other symptoms are only temporary but the two comments proceeding mine are not very hopeful!
PamelaJune 4, 2017 at 7:24 pm
I had been on Repatha almost a year. In late March I developed pain in my joints.I stopped taking. I went to my Doctor he said don't take it any more. It is June now and the pain is so bad I can barely stand it. I an 64 and still working. I can't even fasten my bra or hardly pull my pants up. I have a very high pain tolerance. I don't know how much longer I can stand this. I can't sleep at night t[Show More]I had been on Repatha almost a year. In late March I developed pain in my joints.I stopped taking. I went to my Doctor he said don't take it any more. It is June now and the pain is so bad I can barely stand it. I an 64 and still working. I can't even fasten my bra or hardly pull my pants up. I have a very high pain tolerance. I don't know how much longer I can stand this. I can't sleep at night the pain is so bad. It brought my levels down but now I have this. People need to know what this drug will do. I have always been very active. My spine hurts my elbows hurt, my knees hurt my hips hurt my wrists hurt it's awful.
AlanMay 26, 2017 at 7:12 pm
I have been treated for myasthenia gravis since 2004. At about the same time I started statin therapy to to control my cholesterol I also started treatment of my myasthenia gravis with Mestinon low dosage multiple times a day . up until February 2015 , I have been managing well on doses of Mestinon starting with 60 mg tablets taken four times a day . I also have used the extended relief applicatio[Show More]I have been treated for myasthenia gravis since 2004. At about the same time I started statin therapy to to control my cholesterol I also started treatment of my myasthenia gravis with Mestinon low dosage multiple times a day . up until February 2015 , I have been managing well on doses of Mestinon starting with 60 mg tablets taken four times a day . I also have used the extended relief application in the form of 180 mg caplets . With both of these medication vehicles I got acceptable relief from the disease. As time went on I started having minor trouble with multiple deficienies in my body starting with my head anymore my feet. I was no longer able to control my myasthenia, and I've had difficulty with fine motor control and my muscles speaking eating breathing and moving many other voluntary muscles in my body. In consultation with my cardiologist I decided to suspend Statin treatment. My Cardiologist said we can keeper an eye on it. About three months later , I talked to my cardiologist again and he suggested we try the new medication. PCSK9, which came on the market just about one year previously , and was an injectable and I could treat myself at home periodically with these injectors . I was not particularly in favor of using this new medication as there was no real experience with that in their database. After some heated discussion about the meds I succumbed to my cardiologist suggestion and decided to try the medication which was against my intuition . Looking back I should have paid attention to my intuition and not my cardiologist. Within a month after starting the PCSK9 , I had severe losses of motor control. severe loss of motor control in my eyes to chewing, swallowing, breathing, fine motor control of most every muscle in my body, thinking, walking, balance, and other issues. I consulted with my family doctor and in turn he consulted with my cardiologist, and they came to the same conclusion I did, and that I should stop the medication. After March 1 , I took no further dosage of the PCSK9 injections. My reason for stopping the medication was breathing difficulties which frankly scares me to death . My belief is the pharmaceutical industry is fully aware of all the ramifications in the use of this medication , and they are not giving full disclosure in their list of complications with use of the medication. At this point I am not able to to provide normal activity such as driving the car, chewing my food comfortably , swallowing , or any other physical activity which demands a certain amount of strength and endurance . Also affected by the drug is my thinking Pralis , my balance , and clarity of vision . All these negative effects have been brought on since taking the PCSK9 , and since terminating the use of the drugs , the symptoms still persist . I am in the belief that the use of this medication has damaged me permanently , because prior to their use I was a very active and viral member of the society. I have made it a point to let everyone I make contact with , if they know of anyone suffering from myasthenia gravis or any other muscular dystrophy issues , they should have second thoughts about using the PCSK9 medication because some of the side effects can be very devastating and or deadly.