What To Know: PCSK9 Inhibitors

PCSK9 inhibitors are a new class of drugs that hold promise for patients who have not responded to traditionally used cholesterol lowering drugs. Unfortunately, access to PCSK9 inhibitors has been challenging, with some reports stating that only one third of patients actually get the drug after they have received a prescription for its use.

In this video, hear from 50-State Network advocates Cameron and Craig, along with other patients, who have overcome remarkable denials to PCSK9 Inhibitors.

How do PCSK9 Inhibitors work?

  • An antibody, or protein, that stops proprotein convertase subtilisin-kexin type 9 is called PCSK9. This results in an increased longevity of the receptors in cells that pull LDL-C out of the blood stream. Because these receptors are now able to last longer, they are able to pull more LDL-C out of the blood stream and lower your cholesterol. Learn more
  • PCSK9 Inhibitors have been proven to lower LDL-C levels even in patients who do not respond to existing cholesterol lowering statins. Learn more
  • PCSK9 Inhibitors are taken once every 2 weeks or once monthly.

Why is lowering LDL-C necessary?

  • LDL-C cholesterol is bad because it contributes to plaque, a built up, thick deposit that clogs blood vessels and makes them less flexible. These plaque deposits can lead to atherosclerosis, peripheral artery disease, heart attacks, or strokes. Learn more
  • By increasing absorption of LDL-C into your cells, it reduces the amount in your blood and the chance of plaque being built up.
  • This leads to a decreased risk of developing potentially life threatening medical conditions. If you already have one of the above conditions, it slows the disease progression.

When would I be prescribed a PCSK9 inhibitor instead of another medication, like a statin?

Statins are the most commonly used medications to treat hyperlipidemia, or high cholesterol.

  • In some cases (about 1 in 5 patients), statins don’t work, and that is when a PCSK9 inhibitors are one alternative.

When should I take a PCSK9 inhibitor?

  • If your doctor has told you that you have high cholesterol, high levels of LDL-C, or hyperlipidemia.
  • If you have tried a statin and had little to no success.
  • If you have familial hypercholesterolemia that is difficult to control.
  • If your high cholesterol cannot be managed by dietary or lifestyle changes.
  • If you have HeFH and/or CVD with LDL-C ~ 70-100 mg/dl.
  • If you and your doctor have discussed all treatment options thoroughly and agree that this will be best for you.

Why aren’t I on a PCSK9 Inhibitor yet?

  • Although our experience and repository of knowledge with this class are growing, some doctors are waiting until more long term research has been done to prove the impact of PCSK9 Inhibitors.
  • Your insurance company may refuse to cover your medication because it is costly.
  • Your insurance company may wish you try other medications prior to taking a PCSK9 Inhibitor, again to reduce cost to them.

What experts are saying

dr-seth-j-baum-photoDr. Seth J. Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC

“From my own clinical experience, I firmly believe that patients have a right to know the truth. Insurance companies are demanding that we alter our treatments to suit their arbitrary and monetarily motivated  formularies. No one can appreciate a patient’s medical condition better than his/her physician. Insurance providers deny doctors’ prescriptions. And this is the cause of the purported “under-prescribing” of the PCSK9 inhibitors. This is why the wonder drugs Repatha and Praluent are being under-prescribed. Not for medical reasons, but rather because doctors lack a formidable fighting force. A 90% denial rate for PCSK9 inhibitor prescriptions has been documented. The patients with life-threatening coronary artery disease or familial hypercholesterolemia are the ones in jeopardy.”

Tips from Dr. Baum

  1. Be your own advocate. If you and your doctor decide that a PCSK9 inhibitor is indicated and your insurance company denies the prescription; do not capitulate. Instead, review your policy’s drug formulary. If a PCSK9 inhibitor is listed, and it has been deemed medically indicated by your doctor, you are guaranteed access to the drug. This cannot be denied you.
  2. Next, contact the insurance company and demand treatment. If you are again denied therapy, move to step 3.
  3. Contact your state’s insurance commissioner.
  4. Most critical of all, do not concede. Patients who fight for their rights tend to win. You have the loudest, most meaningful and persuasive voices. Do not be afraid to use them.

American Journal of Managed Care (AJMC)

  • AJMC wanted to study the social value of reducing low-density lipoprotein cholesterol by 50% for patients in these groups, as well as the potential value of PCSK9 Inhibitors.
  • By using National Health and Nutrition Examination Surveys and US Census data, as well as information from insurance claims the AJMC were able to reach the conclusion that treatment would have significant value.
  • Among those treated with LLT In SBG 1 and 2 the value of reducing LDL-C levels by 50% would be $2.9 trillion from 2015-2035. The value of PCSK9 Inhibitor usage would range from $3.4 trillion to $5.1 trillion.
  • Using LLT would result in 1.6 million lives being saved. PCSK9 Inhibitors have the opportunity to save 1.9-2.8 million lives.
  • Lowering LDL-C in high-risk patients has enormous potential social value. PCSK9 Inhibitors may also have a considerable net value depending on the prices payers select.

What To Say: PCSK9 Inhibitors

  • Patients have a right to know the truth. PCSK9 Inhibitors are not being prescribed as much because insurance companies do not see their price as “worth it.”
  • No one understands a patient’s health better than his or her physician. Insurance companies try to claim otherwise by not including PCSK9 Inhibitors in their formularies.
  • Patient access to treatment should be determined exclusively by clinical decisions, not economic decisions.
  • PCSK9 Inhibitors are proven to be effective in the most difficult cases. Even when the standard therapy has failed, PCSK9 Inhibitors can work.
  • Though initially expensive, in the long term PCSK9 Inhibitor therapy saves medical costs from avoiding heart attacks or procedures like bypasses.

Sources

http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-015-0358-8

http://www.nejm.org/doi/full/10.1056/NEJMoa1500858#t=article

http://www.ncbi.nlm.nih.gov/pubmed/27240673

http://www.nejm.org/doi/full/10.1056/NEJMp1508120#t=article

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4684634/

http://www.heart.org/HEARTORG/Conditions/Cholesterol/AboutCholesterol/Good-vs-Bad-Cholesterol_UCM_305561_Article.jsp#.V5Ja8iOAOkp

http://proxy.library.upenn.edu:4807/articles/10.1186/s12916-016-0550-5

http://www.health.harvard.edu/blog/pcsk9-inhibitors-a-major-advance-in-cholesterol-lowering-drug-therapy-201503157801

http://www.ncbi.nlm.nih.gov/pubmed/26968977

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm460082.htm