Fragmin Patient Assistance - Rx Outreach

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Medicare Part D

The Part D drug benefit provides beneficiaries with coverage for outpatient prescription drugs. FRAGMIN® (dalteparin sodium injection) is potentially covered under Part D when self-administered by a patient or caretaker.  The Part D benefit is administered by private health plans: either stand-alone prescription drug plans (PDPs) or Medicare Advantage prescription drug (MA-PD) plans. Medicare established a standard benefit design for Part D, with an annual deductible and three tiers of co-insurance. Part D plan sponsors may construct their own benefits, so long as their plan provides equal or better coverage than the standard. There is a gap between the initial coverage period and the catastrophic coverage period. While in this gap, known as the “doughnut hole”, the beneficiary is responsible for 100% of drug costs (but may receive a 50% discount on covered brand name drugs).  Some plans provide drug coverage to beneficiaries during the coverage gap, although plans may only cover generic drugs during this period. 

2012 Medicare Part D Standard Benefit Design1

  Deductible Initial Coverage
$2,930 in total
drug costs
Coverage Gap
$3,727.50 in total
drug costs
Catastrophic
Coverage
Medicare pays
75% coinsurance
Medicare pays
95% of drug costs
  Patient pays
first $320 as
deductible
Patient pays
25% coinsurance
Patient pays
100% of drug
costs

50% discount on covered brand-name drugs
Patient pays
5% of drug costs
Cost to Patient $320 $652.50 $3,727.50 5%
  True Out Of Pocket (TrOOP) cost $4,700  

1. Source: CMS Medicare & You 2012 Official Government Handbook. Section3, Table Page 89. Information available at: http://www.medicare.gov/publications/pubs/pdf/10050.pdf. Accessed February 29, 2012.

Indications

FRAGMIN® is a low molecular weight heparin (LMWH) indicated for:

  • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction
  • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness
  • Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in patients with cancer. In these patients, the FRAGMIN® therapy begins with the initial VTE treatment and continues for six months.

Limitations of Use

  • FRAGMIN® is not indicated for the acute treatment of VTE.

Important Safety Information

WARNING: SPINAL/EPIDURAL HEMATOMA

Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

  • Use of indwelling epidural catheters
  • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
  • A history of traumatic or repeated epidural or spinal punctures
  • A history of spinal deformity or spinal surgery
    Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions and Drug Interactions].

  • FRAGMIN® is contraindicated in patients with active major bleeding, history of heparin induced thrombocytopenia, hypersensitivity to dalteparin sodium, heparin, or pork products.
  • FRAGMIN® is contraindicated in patients undergoing epidural/neuraxial anesthesia as a treatment for unstable angina and non-Q-wave MI and for prolonged VTE prophylaxis due to an increased risk of bleeding associated with the dosage of FRAGMIN® recommended for these indications.
  • FRAGMIN®, like other anticoagulants, should be used with extreme caution in patients who have an increased risk of hemorrhage; bleeding can occur at any site during therapy. An unexpected drop in hematocrit or blood pressure should lead to a search for a bleeding site.
  • FRAGMIN® should be used with caution in patients with bleeding diathesis, thrombocytopenia or platelet defects, severe liver or kidney insufficiency, hypertensive or diabetic retinopathy, and recent gastrointestinal bleeding.
  • FRAGMIN® should be used with extreme caution in patients with history of heparin-induced thrombocytopenia.
    • In FRAGMIN® clinical trials supporting non-cancer indications, platelet count of <50,000/mm3 occurred in <1% of patients.
    • In FRAGMIN® clinical trials supporting the extended treatment of symptomatic VTE in patients with cancer, platelet counts of <100,000/mm3 occurred in 13.6% of patients, including 6.5% who also had platelet counts less than 50,000/mm3. In the same clinical trial, thrombocytopenia was reported as an adverse event in 10.9% of patients in the FRAGMIN® arm and 8.1% of patients in the oral anticoagulant arm. FRAGMIN® dose was decreased or interrupted in patients whose platelet counts fell below 100,000/mm3.
  • Thrombocytopenia of any degree should be monitored closely. Heparin-induced thrombocytopenia can occur with administration of FRAGMIN®. The incidence of this complication is unknown at present. In clinical practice, rare cases of thrombocytopenia with thrombosis have also been observed.
  • Each multiple-dose vial of FRAGMIN® contains benzyl alcohol as a preservative. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. Because benzyl alcohol may cross the placenta, use caution when administering FRAGMIN® preserved with benzyl alcohol to pregnant women. If anticoagulation with FRAGMIN® is needed during pregnancy, use preservative-free formulations, where possible.
  • Periodic routine complete blood counts, including platelet count, blood chemistry, and stool occult blood tests are recommended during the course of treatment with FRAGMIN®.
  • The most commonly reported side effect is hematoma at the injection site.
  • Allergic reactions (i.e., pruritus, rash, fever, injection site reaction, bulleous eruption) have occurred. A few cases of anaphylactoid reactions have been reported.
  • Use FRAGMIN® with care in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents because of increased risk of bleeding.
  • FRAGMIN® cannot be used interchangeably (unit for unit) with unfractionated heparin or other low molecular weight heparins.
  • FRAGMIN® Injection is not intended for intramuscular administration.

For more information about FRAGMIN, please see Full Product Information.



Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payor, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payors following the receipt of claims. For additional information, customers should consult with their payors for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record.

This information is intended for use by our healthcare professionals in the United States only. Eisai Inc. recognizes the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here is not appropriate for use outside the United States. This site contains information about products that may have different product labeling in different countries.

FRAGMIN® is a registered trademark of Pfizer Heal AB and is licensed to Eisai Inc.

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This site was last modified on : January 9, 2014 at 12:15pm ET.