If you have Familial Hypercholesterolemia (FH) or if you have atherosclerotic cardiovascular disease (ASCVD), or both, please take some time to fill out this questionnaire about living with High Cholesterol for the Institute for Clinical and Economic Review (ICER).

Sharing your experience can make a difference.

ICER’s report will inform decisions by health insurance companies, pharmacy benefit managers, and the Centers for Medicare and Medicaid Services about what medications to cover and for whom and may influence the price and out of pocket costs for these treatments.

The deadline is December 11, 2020.

Why are we asking for your input?

ICER has released a draft report on the effectiveness and value of two new treatments for Low Density Lipoprotein cholesterol (LDL-C) lowering for people with ASCVD, FH, or both, who need additional LDL-C lowering in spite of maximally tolerated statin therapy. ICER is specifically considering three groups of people among those with cardiovascular disease – those with FH, with statin related side effects, and with a recent acute coronary syndrome (like a heart attack or unstable angina in the past year).

Family Heart Foundation research from the national CASCADE FH Registry shows that, for many with FH, first-line statin treatment is not enough to lower LDL-C to the level their doctor recommends. Many need combination treatment to reach their goal. Thankfully, there are additional cholesterol treatment options, including ezetimibe, PCSK9 inhibitors (evolocumab, alirocumab), and Lipoprotein Apheresis.

Now, there is one new treatment approved by the FDA in February 2019 – bempedoic acid – and another potential treatment expected to be reviewed by the FDA in late 2020 or early 2021 – inclisiran. The ICER report is evaluating the effectiveness and value of these treatments.

How can you make a difference?

You can help people who make decisions about the accessibility and affordability of new cholesterol lowering treatments – such as your healthcare team or insurance company-  really understand the impact living with cardiovascular disease and/or FH has on real people.

Respond by December 11, 2020 to impact the final report and inform the effectiveness and value of new cholesterol lowering treatments, bempedoic acid and inclisiran.

Here are some specific points you might want to address when you fill out the questionnaire:

• Diagnosis. The questionnaire will ask for your diagnosis. It would be helpful to indicate how old you were when you were diagnosed – whether that is with FH (if you have FH) or with cardiovascular disease. Choose Atherosclerosis if you have cardiovascular disease but do not have FH and choose Familial Hypercholesterolemia if you have FH (with or without cardiovascular disease).
• Your healthcare provider. What kind of healthcare professional manages your cholesterol and/or your cardiovascular disease? Was it hard to find this person and did that delay your care? How many times a year do you see them and how long does it take you to get there?
• Was it easy to lower your cholesterol? Give specifics regarding your LDL levels before treatment, after statin treatment, and the need (if any) for additional treatment to reach the LDL level your healthcare provider recommends. What other medicines do you take to lower your cholesterol now? Have you reached your LDL goal?
• What are your medication preferences? How do you feel about taking a pill (or more than one pill) every day, giving yourself an injection at home, or getting an injection at the doctor’s office?
• Managing side effects. If you have statin-related side effects, talk about what that means in real life. Were the side effects manageable or did you have to stop statin treatment? How many times did you try a statin? Did you develop side effects right away, or did you develop them after taking statins for some time. Were you able to find a statin that worked for you and did it get your LDL low enough? If you could not, how did you feel about not being able to lower your cholesterol with a statin?
• Impact of cardiovascular disease on quality of life. If you have cardiovascular disease (heart attack, stent, bypass, angina, aortic stenosis), share how old you were when you had your first event and what impact that had on your life and on your family, on someone you might consider a caregiver (or if you are a caregiver to someone with cardiovascular disease). Did this impact your ability to work? How did it change your quality of life?
• Impact of additional events on quality of life. If you have had a second cardiovascular event, or more than that, talk about the additional impact, if any, of having another event on you and your family, including a caregiver, and on your quality of life. Did this impact your ability to work? Would you say there is a lasting difference after having more than one cardiovascular event, or is life the same as after your first event? It’s helpful if you share examples to explain what you mean.
• What else do you want decision makers to know? What more do you want to say about living with your condition and getting your cholesterol under control? Is there anything that is not “measurable” that you want to share? Do you worry about your condition and does that interfere with your life? Does having treatment options and getting your LDL to the level your doctor recommends make a difference to your quality of life in a way that is hard to measure? Are there other benefits to treatment, or considerations you think are important when understanding the “value” of a treatment, making it more or less valuable?

Where can I find the full report?

While you may be interested to read the ICER draft report, we recognize that it is long and there are some sections that can be hard to understand. It is not necessary to read the report to answer the questionnaire – living with FH or cardiovascular disease or both is all you need to answer the questions. If you are interested you can learn more about the report and ICER’s process here: https://icer-review.org/topic/high_cholesterol/ 

the Family Heart Foundation’s work with ICER

the Family Heart Foundation has been working hard since 2011 to make sure that FH is well understood so that decisions about diagnosis and care are based on good medical evidence and with an appreciation of the impact that FH and cardiovascular disease has on people’s lives. We do this through research and advocacy – and part of that is asking you to share your perspective.

We have worked with ICER over the past 5 years and have shared published research, including from the Family Heart Foundation’s CASCADE FH Registry. We have also connected ICER with FH medical experts and FH patients. We have highlighted the prevalence, underdiagnosis and undertreatment of this very high-risk population, for whom the FDA has approved (or may approve) additional LDL-lowering treatments, including evolocumab (Repatha), alirocumab (Praluent), bempedoic acid (Nexletol/Nexlizet), and inclisiran.

Who is ICER?

ICER is an independent and non-partisan research organization that objectively evaluates the clinical and economic value of prescription drugs, medical tests, and other health care and health care delivery innovations.

Questions?

Please contact the Family Heart Foundation at info@thefhfoundation.org.

Thank you!