Disease Indications

Hypercholesterolemia

Manufacturer

Esperion Therapeutics

Usage

Oral

Medicine approved by

• 

  European Medical Agency (EMA)

• 

  Food and Drug Administration (FDA)

Patients helped

• 

  Over 1.2 million patients reached

• 

  More than 11,000 patients helped

• 

  100% successful deliveries to 88 countries

We can help with your import documents

We are experts in import regulations. Scroll below to download the import guide for your country.

Clinical trials

The Food and Drugs Administration (FDA) approval of Nexletol (bempedoic acid) for the treatment of adults with high cholesterol who are receiving guideline-recommended statin therapy was based on the data of studies CLEAR Harmony (NCT02666664) and CLEAR Wisdom (NCT02991118).^[1,2]

CLEAR Harmony was a multi-center, randomized, double-blind trial that studied the safety of bempedoic acid in patients with hypercholesterolemia. The 2230 patients were randomized 2:1 to treatment with 180 mg bempedoic acid (n=1488) or placebo (n=742) once daily for 52 weeks.^[1]

CLEAR Wisdom was a comparable study with a similar study design that evaluated the efficacy of bempedoic acid in 779 patients with hypercholesterolemia. Patients were randomized 2:1 to treatment with 180 mg bempedoic acid (n = 522) or placebo (n = 257) once daily for 52 weeks.^[2]

Results

The main efficacy outcome of CLEAR Harmony was safety, and the principal efficacy endpoint was the percent change from baseline in LDL cholesterol (LDL-C) level after 12 weeks.^[1]

Overall, bempedoic acid was well tolerated in patients.^[3]

At week 12, patients treated with bempedoic acid had a LDL-C concentration that was lowered by 19.2 mg/dl (−16.5% from baseline) [95% CI: –20.0,–16.1).^[3]

The main efficacy outcome of CLEAR Wisdom was the percent change from baseline in LDL-C level after 12 weeks.^[2]

Bempedoic acid was able to significantly lower LDL-C level over 12 weeks. The difference between bempedoic acid and placebo in mean percent change in LDL-C from baseline to Week 12 was -17% [95% CI: -21, -14].^[4]

Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Nexletol (bempedoic acid) for the approved indication.^[5]

References

1. Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
Clinical Trial CLEAR Harmony (NCT02666664), cited on Nov 5, 2020

2. Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk (CLEAR Wisdom)
Clinical Trial CLEAR Wisdom (NCT02991118), cited on Nov 5, 2020

3. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol (CLEAR Harmony)
Ray KK, NEJM, Mar 14, 2019

4. Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease (CLEAR Wisdom)
Goldberg AC, JAMA, Nov 12, 2019

5. Full prescribing information [FDA]: Nexletol (bempedoic acid) [PDF] Esperion, Feb 21, 2020

Price & costs

Nexletol (bempedoic acid) treatment costs

The cost for a monthly or yearly treatment of Nexletol (bempedoic acid) depends on your prescription requirements which includes the dosage in mg and medicine type (Capsules).
The price of the medicines you see on sale is the cost set by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.
Make an enquiry and we will help you calculate the total price to buy Nexletol (bempedoic acid) online and have it delivered where you live. From your side, we’ll simply need a prescription from your treating doctor. In some countries we might also need an import license. Our Patient Support team will guide you throughout the process.

Nexletol (bempedoic acid) price and additional costs

The price of Nexletol (bempedoic acid)

The base cost of each medicine is set by the manufacturer. Generally, our Named Patient support fee, shipping costs and any local tax (if applicable) are not included in the product price that is displayed on our website unless stated otherwise.

Our Named Patient support fee

everyone.org provides access to Nexletol (bempedoic acid) on the Named Patient import basis, which means that we work on behalf of the patient in cooperation with their treating doctor. Our Named Patient support fee covers sourcing, logistics and following up to make sure that the order is received safely and in perfect condition. The Named Patient support fee is tiered relative to the cost of the medicine.

Shipping costs

The shipping prices are dependent on the type of shipping necessary for the particular medicine (regular or cold chain) and upon the destination country. The shipping fees may include the shipping from our supplier to our partner pharmacy as well as the shipping costs to deliver the medicine to the patient’s country of residence. The shipping fee might also include the cost of special packaging, such as coolboxes, cool packs and data loggers, as well as transport insurance to guarantee that you receive your medicine in good order.

You can read a detailed overview of prices and costs here.

Payment methods when you buy Nexletol (bempedoic acid)

When you buy Nexletol (bempedoic acid), you can make the payment by bank transfer or by credit card. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.

Nexletol (bempedoic acid) reimbursement

It might be possible for you to claim the cost of Nexletol (bempedoic acid) via your country’s healthcare system. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country’s own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.

Medical insurance

Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details. You can pay by bank transfer or credit card.

Crowdfunding

Crowdfunding might also be an option for you. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveForward, FundRazr and Watsi.