Vascepa (icosapent ethyl)

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Vascepa (icosapent ethyl) is a prescription medicine used as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia and as an adjunct to statin therapy to reduce the risk of of cardiovascular events.

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What is Vascepa (icosapent ethyl) for?

Vascepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct therapy for adult patients with:

  • elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or, diabetes mellitus and two or more additional risk factors for cardiovascular disease as an adjunct to maximally tolerated statin therapy.
  • severe (≥ 500 mg/dL) hypertriglyceridemia as an adjunct to diet.

Where has Vascepa (icosapent ethyl) been approved?

Vascepa (icosapent ethyl) has been approved by:

  • Food and Drug Administration (FDA), USA:
    • On July 27, 2012 to reduce triglyceride levels in adults with severe hypertriglyceridemia
    • On December 13, 2019 to reduce cardiovascular risk
  • Health Canada on January 2, 2020 to reduce cardiovascular risk
  • European Medicines Agency (EMA) on January 29, 2021 under the brand name Vazkepa to reduce cardiovascular risk

    Vascepa (icosapent ethyl) was first approved in 2012 for severe hypertriglyceridemia (≥500 mg/dL) as an adjunct therapy to diet to reduce triglyceride (TG) levels. In 2019, the approval has been expanded by the Food and Drug Administration (FDA) to use Vascepa (icosapent ethyl) as an add-on therapy to maximally-tolerated statin therapy for the reduction of cardiovascular risk among adults with elevated triglyceride (≥150 mg/dL) levels. Patients must also have either established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease. Vascepa (icosapent ethyl) is the first FDA-approved drug to reduce cardiovascular risk among adults with elevated triglyceride (≥150 mg/dL) levels as an add-on to maximally-tolerated statin therapy.[1,2] (Note that in Canada it is approved for the indication of severe hypertriglyceridemia only.)

    Vascepa’s (icosapent ethyl) approval for the two indications was based on two studies: MARINE, and REDUCE-IT.[2]

    The results of the MARINE study were used for the first approval. MARINE, with 151 patients enrolled, was a randomized, placebo controlled, double-blind, parallel-group study of adult patients with severe hypertriglyceridemia to assess the effects of Vascepa (icosapent ethyl) 4 grams per day. Patients whose baseline TG levels were between 500 and 2,000 mg/dL were enrolled in this study for 12 weeks. The effects were measured in changes in the major lipoprotein lipid parameters. Vascepa (icosapent ethyl) 4 grams per day reduced median TG, VLDL-C, and Apo B levels from baseline relative to placebo. The reduction in TG observed with Vascepa (icosapent ethyl) was not associated with elevations in LDL-C levels relative to placebo.[2]

    Results of the REDUCE-IT trial were used for the second indication, with 8,179 patients enrolled. The study was randomized to two arms, either 4 grams of icosapent ethyl or a placebo, with primary endpoint being the five-point MACE [major adverse cardiovascular events]: cardiovascular death, myocardial infarctions, stroke, hospitalization for unstable angina, or revascularization.[3]

    Primary endpoint: 25% relative risk reduction (RRR)[4]

    Secondary endpoints:[4]

    • Cardiovascular death or nonfatal heart attack: 25% RRR
    • Fatal or nonfatal heart attack: 31% RRR
    • Urgent or emergent revascularization: 35% RRR
    • Cardiovascular death: 20% RRR
    • Hospitalization for unstable angina: 32% RRR
    • Fatal or nonfatal stroke: 28% RRR
    • Total mortality, nonfatal heart attack or nonfatal stroke: 23% RRR

    Vascepa (icosapent ethyl) was associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization, where the incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. Vascepa (icosapent ethyl) was also associated with an increased risk of bleeding events, where the incidence of bleeding was higher among patients who were also taking other medications that increase the risk of bleeding, such as aspirin, clopidogrel or warfarin at the same time. Musculoskeletal pain, peripheral edema (swelling of legs and hands), and arthralgia (joint pain) were the most common side effects reported in the clinical trials.[1,2]

    Vascepa’s (icosapent ethyl) active ingredient is the omega-3 fatty acid, derived from fish oil, and patients with allergic reaction to fish or shellfish are advised not to take it.[1,2]

    Please refer to the full prescribing information below for comprehensive information about the safety, effectiveness and adverse effects of Vascepa (icosapent ethyl) for the approved indications.[1]

    Reference

    1. U.S. Food and Drug Administration. FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups. 13/12/2019 (last update: 13/12/2019), cited on 14/02/2020.
    2. Full prescribing information [FDA]: Vascepa (icosapent ethyl)[PDF], Amarin Pharma Inc., Dec. 2019.
    3. MD Magazine. The REDUCE-IT trial and CV outcomes. 15/08/2019 (last update: 15/08/2019), cited on 14/02/2020.
    4. Amarin Corporation. Investor relations / Vascepa® (icosapent ethyl) 26% reduction in key secondary composite endpoint of cardiovascular death, heart attacks and stroke demonstrated in REDUCE-IT™ supports 25% overall reduction in five-point major adverse cardiovascular event primary composite endpoint. 10/11/2018 (last update: 10/11/2018), cited on 14/02/2020.
    5. Vascepa (icosapent ethyl) price in other currencies*

      Package Euro Australian dollars Canadian dollar New Zealand dollar Nigerian naira Singapore dollar Pound sterling United States dollar
      120 gelatine capsules of 1 g 648 EUR 1072 AUD 948 CAD 1168 NZD 742643 NGN 940 SGD 557 GBP 690 USD
      240 gelatine capsules of 0.5 g 672 EUR 1112 AUD 983 CAD 1212 NZD 770355 NGN 975 SGD 578 GBP 716 USD

      *The prices listed above are based on the cheapest package size and strength everyone.org has access to. Please make an enquiry for more specific pricing. The prices listed above are a guide only, we operate in Euros.

      Vascepa (icosapent ethyl) treatment costs

      The cost for a monthly or yearly treatment of Vascepa (icosapent ethyl) depends on your prescription requirements which includes the dosage in g/mg/ml/etc 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 Vascepa (icosapent ethyl) 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.

      Vascepa (icosapent ethyl) price and additional costs

      The price of Vascepa (icosapent ethyl)

      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 Vascepa (icosapent ethyl) 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 Vascepa (icosapent ethyl)

      When you buy Vascepa (icosapent ethyl), 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.

      Vascepa (icosapent ethyl) reimbursement

      It might be possible for you to claim the cost of Vascepa (icosapent ethyl) 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.

VASCEPA (ICOSAPENT-ETHYL) Package Capsules

120 gelatine capsules of 1 g, 240 gelatine capsules of 0.5 g

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