Ixempra® (ixabepilone) Patient Assistance Program

Bristol-Myers Squibb is pleased to announce the availability of Destination Access Ixempra Patient Assistance Program, a program developed to aid patients and healthcare providers with their reimbursement and patient assistance needs for Ixempra.

  1. How does the program work? Click For Answer
    • The Destination Access Ixempra Patient Assistance Program provides Ixempra at no charge to eligible patients.
      • The Destination Access Ixempra Patient Assistance Program provides free Ixempra to eligible patients who are prescribed Ixempra for an in-label or compendia-accepted tumor diagnosis (please refer to the Ixempra Package Insert, “Indications and Uses,” for labeled indications)
      • Eligible patients will have an annual household adjusted gross income of $75,000 or less
      • Annual enrollment is required. For a patient to remain enrolled in the Program, treatment must be ongoing and provided on an outpatient basis
      • Patients treated with Ixempra who have received a second-level appeal denial or who have reached the maximum level of denied appeals from their health insurer may elect to apply for patient assistance or to continue with the appeals process
      • If the patient is approved for the Destination Access Ixempra Patient Assistance Program, upon enrollment, the physician will be shipped Ixempra on the next business day, excluding weekend delivery unless specifically requested, for the patient's next scheduled treatment date
      • Refill forms may be obtained by clicking on the link below. In addition, the information can be typed directly into the form, saved to the desktop, printed, signed by the prescriber, and faxed to Destination Access for processing. Please note that the Destination Access Program does not provide product replacement or refunding to practices when refill requests are not submitted prior to an enrolled patient's treatment date
      Ixempra Refill Form
    • For uninsured patients, physicians' practices may be eligible for a refund for the cost of Ixempra administered 60 days prior to the patient's Program enrollment date.
    • For insured patients who are denied coverage by their insurer for Ixempra, physician practices may be eligible to receive a refund for the cost of unreimbursed Ixempra administered once the patient has reached a denial of a second-level appeal or the maximum level of denied appeals permitted by their insurer.
    • There is an annual enrollment requirement; treatment must be continuing and provided on an outpatient basis to remain enrolled.
    • If the patient is approved for the Destination Access Ixempra Patient Assistance Program, the physician will be shipped Ixempra on the next business day (excluding weekend delivery unless specifically requested) for the patient's next scheduled treatment date. Product refills for future treatments may be obtained by faxing the completed refill form to Destination Access on a monthly basis, prior to the next scheduled treatment date. Refill forms may be obtained by clicking on the link below. In addition, you have the option to type the information directly into the form, save the completed form to your desktop, print it, obtain the prescriber's signature, and fax it to Destination Access for processing.
  2. How does a patient apply for the Destination Access Ixempra Patient Assistance Program? Click For Answer
      • The patient and healthcare provider will need to complete the enrollment form provided in the link below and obtain any other documentation that is required. The information can be typed directly into the downloaded enrollment form, saved to the desktop, printed, and signed by the prescriber and the patient. Fully completed applications should be faxed to Destination Access for processing. Alternatively, the patient's healthcare provider may call Destination Access to provide certain information requested on the enrollment form over the phone; the specialist will enter the information into the enrollment form prior to faxing it to the practice Download Ixempra Patient Assistance Enrollment Form
      • In addition, to help expedite the completion of the enrollment form, a Patient Enrollment Form Checklist is now available to assist patients in gathering the information that they will need to complete the patient portion of enrollment form, The Patient Enrollment Form Checklist may be obtained by clicking on the link below or by calling Destination Access to have one faxed or emailed to you Download Patient Enrollment Checklist
      • A Destination Access program specialist will contact the patient's healthcare provider on or before the next business day to discuss the options available to the patient, including if the patient qualifies to receive free Ixempra through the Destination Access Ixempra Patient Assistance Program.
      • If the patient would like to be considered for participation in the Destination Access Ixempra Patient Assistance Program, please include a photocopy of the patient's proof of annual household income with the enrollment form. Examples of proof of income include the applicant's most recent federal tax return, and Social Security or retirement income statements. Other documentation for proof of income may be considered. Please call Destination Access for more detailed information about what other forms of proof of income documentation are acceptable
      • Please fax the completed and signed application, along with proof of income documentation, and required signatures to Destination Access at: 1-888-776-2370
      • If the patient meets the eligibility criteria for the Ixempra Patient Assistance Program, a Destination Access program specialist to initiate a product shipment will contact the patient's healthcare provider no later than the next business day
  3. What are the eligibility criteria for the Destination Access Ixempra Patient Assistance Program? Click For Answer
      • Patient must live in the US, Puerto Rico, or the US Virgin Islands.
      • Household annual adjusted gross income must not exceed $75,000. We do review all applications on a case-by-case basis and may consider additional factors when evaluating a patient's level of financial hardship, such as out-of-pocket expenses related to the patient's current disease state. Please contact Destination Access for more information
      • Ixempra must be prescribed to the patient for an in label or compendia-accepted diagnosis (refer to the Ixempra Package Insert, "Indications and Usage," for labeled indications)
      • The program will consider insured patients who have received a second-level appeal denial or who have reached the maximum level of appeal denials permitted by their insurer
      • Patients who have exceeded either an annual or lifetime maximum benefit on their insurance coverage for Ixempra may be considered eligible for patient assistance
      • Treatment must be ongoing in order to receive free product through the Patient Assistance Program. Please note that Destination Access does not provide product replacement as part of its Patient Assistance Program
      • The patient must be treated with Ixempra on an outpatient basis in order to qualify for the Program
      • Incarcerated patients are not eligible to receive Ixempra through the Patient Assistance Program
  4. How does refunding work? Click For Answer
    • Uninsured patients:
      • Healthcare providers may be eligible for a refund of the cost of Ixempra administered 60 days prior to the patient's date of initial enrollment into the Ixempra Patient Assistance Program
      • In order to be considered eligible for refunding, the patient's treatment must be ongoing at the time the patient's completed enrollment form and income documentation is submitted for patient assistance
      • Upon the patient's initial date of enrollment into the Ixempra Patient Assistance Program, a Destination Access specialist will contact the patient's healthcare provider if the practice may be eligible for a refund. The healthcare provider will be faxed a refund application form, including a detailed explanation of the Program's eligibility criteria to receive a refund
      • Once the patient's healthcare provider submits the required information to Destination Access and the practice is eligible to receive a refund, the information will be forwarded to Bristol-Myers Squibb to be processed. On average, the provider should anticipate receiving a refund check within 90 days from the date that the refund is approved by Destination Access. The practice will receive a status notification for any refunding requests by the Destination Access Program
      • Please note that these same eligibility criteria apply to patients who are not covered by their insurer for Ixempra because they have exceeded an annual or lifetime maximum benefit on their insurance coverage
    • Insured patients:
      • Healthcare providers may be eligible to receive a refund for the cost of unreimbursed Ixempra used in treatments administered to eligible patients who have received a second-level appeal denial or who have reached the maximum level of appeal denials permitted by their health plan
      • When the above criterion is met, the patient's healthcare provider should contact Destination Access to let them know if the patient would like to apply for the Program. The healthcare provider will be faxed the enrollment materials which will include a detailed explanation of the information needed to qualify for a refund. The patient and healthcare provider will need to complete the forms and fax them to Destination Access, along with the required proof of income documentation
      • Once the patient's healthcare provider supplies the required information to Destination Access and the practice is eligible to receive a refund, the information will be forwarded to Bristol-Myers Squibb to be processed. On average, the provider should anticipate receiving a refund check within 90 days from the date that the refund is approved by Destination Access. The practice will receive a status notification from a Destination Access Program specialist for any outstanding refunding requests
      • For patients who are still receiving Ixempra therapy at the time of application to the Program, a supply of Ixempra will be shipped directly to the patient's healthcare provider to support the future treatment dates specified on the patient's enrollment form
      • If a patient is no longer receiving treatment with Ixempra, but has received a second-level appeal denial or has reached the maximum level of appeal denials permitted by their health plan, the healthcare provider may still qualify to receive refunding for the cost of any unreimbursed Ixempra treatments that were administering from the start of the patient's initial date of Ixempra treatment, as long as the patient's treatment dates are continuous
  5. Is it possible for patients who have exhausted their health plan's lifetime or annual maximum benefit amount to be considered eligible to receive free product through the Ixempra Patient Assistance Program? Click For Answer
    • Yes, patients who have exceeded their health plan's annual or lifetime maximum benefit amount are considered to be uninsured under the Program guidelines; therefore, if they meet all of the other program eligibility criteria, they may qualify to receive free Ixempra through the Ixempra Patient Assistance Program.

Indications
Ixempra is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting. Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting.

Ixempra is indicated as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.

Important Safety Information including Boxed Warning

Toxicity in hepatic impairment

  • Ixempra (ixabepilone) in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN due to increased risk of toxicity and neutropenia-related death
  • In combination with capecitabine, the overall frequency of grade 3/4 adverse reactions, febrile neutropenia, serious adverse reactions, and toxicity-related deaths was greater in patients with hepatic impairment
  • Caution should be used when using Ixempra as monotherapy in patients with AST or ALT >5 x ULN. Use of Ixempra in patients with AST or ALT >10 x ULN or bilirubin >3 x ULN is not recommended
  • With monotherapy, grade 4 neutropenia, febrile neutropenia, and serious adverse reactions were more frequent in patients with hepatic impairment

Contraindications

  • Ixempra is contraindicated in patients:
    • with a known history of a severe (CTC grade 3/4) hypersensitivity reaction to agents containing Cremophor® EL or its derivatives such as polyoxyethylated castor oil
    • who have a baseline neutrophil count <1500 cells/mm3 or a platelet count <100 000 cells/mm3

Peripheral neuropathy

  • Peripheral neuropathy was common. Patients treated with Ixempra should be monitored for symptoms of neuropathy, such as burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, or neuropathic pain
  • Neuropathy occurred early during treatment; ∼75% of new onset or worsening neuropathy occurred during the first 3 cycles. Patients experiencing new or worsening peripheral neuropathy may require changes in the dose or discontinuation of Ixempra
  • Neuropathy was the most frequent cause of treatment discontinuation due to drug toxicity. Caution should be used when treating patients with diabetes mellitus or preexisting peripheral neuropathy

Myelosuppression

  • Myelosuppression is dose-dependent and primarily manifested as neutropenia
  • Patients should be monitored for myelosuppression; frequent peripheral blood cell counts are recommended for all patients receiving Ixempra
  • Patients who experience severe neutropenia or thrombocytopenia should have their dose reduced. Neutropenia-related deaths occurred in 1.9% of 414 patients with normal hepatic function or mild hepatic impairment treated with Ixempra in combination with capecitabine. Neutropenia-related death occurred in 0.4% of 240 patients with Ixempra as monotherapy

Hypersensitivity reaction

  • Premedicate with an H1 and an H2 antagonist approximately 1 hour before Ixempra infusion and observe for hypersensitivity reactions (eg, flushing, rash, dyspnea, and bronchospasm)
  • In case of severe hypersensitivity reactions, infusion of Ixempra should be stopped and aggressive supportive treatment (eg, epinephrine, corticosteroids) started
  • Patients who experience a hypersensitivity reaction in one cycle of Ixempra must be premedicated in subsequent cycles with a corticosteroid in addition to the H1 and H2 antagonists, and extension of the infusion time should be considered

Pregnancy

  • Women should be advised not to become pregnant when taking Ixempra. If this drug is used during pregnancy or the patient becomes pregnant, the patient should be apprised of the potential hazard to the fetus

Cardiac adverse reactions

  • Caution should be exercised in patients with a history of cardiac disease. Discontinuation of Ixempra should be considered in patients who develop cardiac ischemia or impaired cardiac function due to reports of cardiovascular adverse reactions (eg, myocardial ischemia, supraventricular arrhythmia, and ventricular dysfunction). The frequency of cardiac adverse reactions (myocardial ischemia and ventricular dysfunction) was higher in the Ixempra in combination with capecitabine (1.9%) than in the capecitabine alone (0.3%) treatment group

Potential for cognitive impairment from excipients

  • Ixempra contains dehydrated alcohol USP. Consideration should be given to the possibility of central nervous system and other effects of alcohol

Adverse reactions

Monotherapy

  • The most common adverse reactions (≥20%) reported by patients receiving Ixempra monotherapy were peripheral sensory neuropathy, 62% (grade 3/4: 14%); fatigue/asthenia, 56% (grade 3/4: 13%); myalgia/arthralgia, 49% (grade 3/4: 8%); alopecia, 48% (grade 3/4: 0%); nausea, 42% (grade 3/4: 2%); stomatitis/mucositis, 29% (grade 3/4: 6%); vomiting, 29% (grade 3/4: 1%); diarrhea, 22% (grade 3/4: 1%); and musculoskeletal pain, 20% (grade 3/4: 3%). Drug-associated hematologic abnormalities (>40%) included neutropenia, leukopenia, anemia, and thrombocytopenia. Grade 3/4 hematologic adverse reactions included neutropenia, 54%; leukopenia, 49%; anemia, 8%; and thrombocytopenia, 7%

Combination with capecitabine

  • The most common adverse reactions (≥20%) reported by patients receiving Ixempra in combination with capecitabine compared to capecitabine alone, respectively, were peripheral sensory neuropathy, 65% vs 16% (grade 3/4: 21% vs 0%); palmar-plantar erythrodysesthesia (hand-foot) syndrome, 64% vs 63% (grade 3/4: 18% vs 17%); fatigue/asthenia, 60% vs 29% (grade 3/4: 16% vs 4%); nausea, 53% vs 40% (grade 3/4: 3% vs 2%); diarrhea, 44% vs 39% (grade 3/4: 6% vs 9%); vomiting, 39% vs 24% (grade 3/4: 4% vs 2%); myalgia/arthralgia, 39% vs 5% (grade 3/4: 8% vs <1%); anorexia, 34% vs 15% (grade 3/4: 3% vs 1%); stomatitis/mucositis, 31% vs 20% (grade 3/4: 4% vs 3%); alopecia, 31% vs 3% (grade 3/4: 0% vs 0%); abdominal pain, 24% vs 14% (grade 3/4: 2% vs 1%); nail disorder, 24% vs 10% (grade 3/4: 2% vs <1%); musculoskeletal pain, 23% vs 5% (grade 3/4: 2% vs 0%); and constipation, 22% vs 6% (grade 3/4: 0% vs <1%). Drug-associated hematologic abnormalities (>40%) with Ixempra in combination with capecitabine and capecitabine alone, respectively, included neutropenia, leukopenia, anemia, and thrombocytopenia. Grade 3/4 hematologic adverse reactions included neutropenia, 68% vs 11%; leukopenia, 57% vs 6%; anemia, 10% vs 5%; and thrombocytopenia, 8% vs 4%
Cremophor is a registered trademark of BASF AG.
AST = aspartate aminotransferase; ALT = alanine aminotransferase; ULN = upper limit of normal; CTC = common terminology criteria.

Please see Ixempra US Full Prescribing Information including boxed WARNING regarding hepatic impairment.

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