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Managing Dyslipidemia: Meeting Patients Where They Are

A new drug on the market, called inclisiran, has shown potential in reducing low-density lipoprotein (LDL), commonly known as bad cholesterol, in patients with cardiovascular disease and that may have heterozygous familial hypercholesterolemia. We explore how inclisiran works, its benefits, and some challenges associated with its use.

How Does Inclisiran Work?
Inclisiran is a small, double-stranded, inhibiting piece of RNA material. It enters into the liver cell, and then is recognized by a protein complex called a RISC complex as a way of determining which messenger RNA (mRNA) should be destroyed. So it tricks hepatocytes into recognizing the mRNA for proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9) as a target for destruction by an RNase, which inhibits the body’s ability to make the PCSK9 protein. Since PCSK9 regulates low-density lipoprotein (LDL) levels in the liver, inhibiting its production results in lower levels of LDL at about 52 percent.

Benefits Over Other Mainstay Therapies
Inclisiran has several benefits over other therapies that target PCSK9. First, this treatment stays in the liver cell until the liver cell dies and the next liver cell is born. So, you get the ability to give a therapy every six months and have a sustained reduction in LDL. In addition to its efficacy, the dosing regimen is less frequent only requiring an initial sub-q injection, another injection at three months, then an injection every six months thereafter. This makes it a more convenient therapy for patients that are non-adherent to other treatments and ones that prefer someone else to administer the shot. Lastly, inclisiran has fewer side effects than other PCSK9 inhibitors suggesting that inclisiran may be better tolerated.

Challenges of Adopting Inclisiran
One of the major challenges is the billing process. Inclisiran is a buy-and-bill therapy, which means that an HCP or healthcare system must purchase the drug, provide it to the patient, and then bill the insurance company. The uncertainty of reimbursement for an expensive drug like inclisiran makes it cost-prohibitive even with aid from manufacturer programs requiring skilled follow-up. Some physicians are concerned for their patients that may receive an initial treatment, come back for a follow-up visit, and then are unable to continue it because the insurance isn’t going to cover it.

Helpful Tips to Overcome Challenges of Using Inclisiran
Patients may want to consider partnering with a Clinical Pharmacist and/or a local infusion clinic to obtain prior authorization early in the process. This way patients may be able to receive inclisiran and mitigate payment issues. Partnering with a local infusion clinic has the added advantage of increasing access where travel may be an access barrier.

Despite these challenges, inclisiran has the potential to be a game-changer in the treatment of patients with cardiovascular disease and/or heterozygous familial hypercholesterolemia. If the outcome data continues to show promise in reducing LDL and increasing adherence and tolerance, it may be a great benefit from a population health standpoint.