PCSK9-Inhibitors-The New Statin

Statins. When they work, they are great. They are inexpensive, they are usually covered by insurance, and they get your bad, or LDL cholesterol, to the levels where doctors want them at. However, not all statins work for everyone. In fact, about 1 in 5 patients on statins have failed to lower their cholesterol to satisfactory levels. This is because of side effects of drugs and because of genetic variations.  Not a problem anymore! The solution is a new injectable form of cholesterol-lowering drugs that the FDA recently approved. Let me introduce you to Praluent and Repatha. These medications are the future and the answer to the problems of any previous cholesterol-lowering drugs. They are a class of drugs called PCSK9 inhibitors.


What is PCSK9?

I am glad you asked. PCSK9 is a gene in the body that helps regulate cholesterol. When a person has an altered form of the gene, PCSK9 inactivates the receptors that are in the liver that are responsible for clearing out bad cholesterol. Because the receptors are inactivated, they do not have the chance to go after the bad cholesterol, which causes the bad LDL cholesterol stay in the blood and levels to increase. With treatment of Praluent and Repatha, PCSK9 is inhibited from binding to the receptors, and, in return, the receptors are free to move about and clear out bad cholesterol like they are supposed to.  This lowers the overall bad cholesterol levels.

There are roughly 37 million adults in the U.S. with untreated high cholesterol. Among those, there are about 11 million who cannot reach their LDL cholesterol goals, though they have been on a first-line treatment like statins. Treatment with a PCSK9 inhibitor can help get these levels where they need to be and prevent additional heart issues.


Administration and Cost

As previously mentioned, these new drugs are injectable. Because of this fact, they are only taken every two weeks, and sometimes once a month, depending on the patient. PCSK9 inhibitors were developed for a reason--- they will specifically help lower cholesterol for those patients who have been unable to get the results that statins are supposed to provide. So, doctors should begin using this treatment if other forms of treatment have not worked for their patient before and if their patient has had a genetic test to determine which drug is appropriate for them.  PCSK9 inhibitors are to be taken along with a statin to see maximum effect as of right now. There is talk of being able to take the PCSK9 alone in the future, but research shows maximum results when the two medications are taken together along with diet and lifestyle changes as well. What is maximum effect? Well, lowering bad cholesterol by up to 70% seems pretty decent to me!


Why now?

You may be thinking where have these drugs been all my life? Actually, they have been in the works for a while. The PCSK9-inhibitors are coming about because not all statins have been working to lower cholesterol for people and researchers, doctors, and drug companies have found a way around it. Yes, these new cholesterol-lowering drugs come with a higher price than any statin prescribed before, with an estimated price tag of $15,000 per year; but, Express Scripts recently agreed to carry both Repatha and Praluent this past week proving that there is hope for patients. Carrying both drugs will be beneficial to patients because one treats one type of gene variation (Praluent), and the other treats both types (Repatha). Express scripts believes that the price is going to be lower than previously expected since the FDA decided to approve both and since they will be providing discount cards as well. In the big scheme of things, the cost of recovering from a heart attack can cost insurance companies and patients anywhere from $700,000 to $1 million in some cases according to insurance providers such as Assurant Employee Benefits; therefore, spending $15,000 to prevent a heart attack seems more logical, right?! 



Moreover, the cost and the fact that the drug is in injectable form are the only limitations to the PCSK9 inhibitors. However, copay assistance programs are in the works, and insurance companies are likely to cover the cost of the drug seeing as this drug is significantly lowering bad cholesterol levels thus reducing risk of heart attacks. The drug is a specialty drug; therefore, coverage will be determined by your specific insurance company. Additionally, because it is a specialty drug, detailed instructions will be available to ensure adequate utilization of the drug is being preformed. Specialty drug programs are known for their access to nurses and help hotlines. This will be available with Express Scripts and other specialty drug companies will be smart to follow suit.  


Final Thoughts

Chromosomes make up a person's DNA and they are expressed in pairs of alleles. A person gets two alleles for each gene, inheriting one allele from each of their parents. The two types of gene variations are homozygous and heterozygous. Heterozygous is when a person has two different alleles of a gene—one dominant and one recessive. Heterozygotes are therefore carriers of a gene trait or abnormality. Heterozygous means different, so the pair might be Pp. Homozygous is when a person has two copies of the same allele—either two dominant or two recessive alleles. Homozygous means the same, so the pair might be PP (homozygous dominant) or pp (homozygous recessive). Praluent is for treatment of heterozygous familial high cholesterol, while Repatha is for both heterozygous and homozygous familial high cholesterol. The only way to find out what type of gene you have or medication you need is to have your doctor order a genetic test for PCSK9. For more information on genetic testing and PCSK9, visit mygenetx.com. MyGenetx is a CLIA certified molecular laboratory, providing laboratory results for use by a healthcare provider for diagnosis and patient management. All test requisitions are reviewed by a clinical physician team, led by Dr. Ford Brewer. The tests offered are not available in New York