Sprycel® (dasatinib) Patient Assistance Program

  1. How does the Program work?
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    • The Destination Access Sprycel Patient Assistance Program provides free Sprycel to qualified patients who are prescribed Sprycel
    • Eligible patients will have an annual household adjusted gross income of $75,000 or less. Destination Access reviews 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
    • Annual enrollment is required. For a patient to be enrolled in the Program, treatment must be ongoing and provided on an outpatient basis
    • Patients who are uninsured, who are insured and have been denied coverage for Sprycel, or who have reached an annual or lifetime insurance benefit maximum may be eligible to receive free Sprycel through the Program
    • At the discretion of the patient's healthcare provider, patients may elect to have their Sprycel shipped directly to their residence, as opposed to their healthcare provider's office
    • Patients who have been receiving their Sprycel through the Program for 6 months or less are eligible to refill their Sprycel every 30 days. The patient's healthcare provider may request a refill by faxing the completed refill form to Destination Access on a monthly basis, in 21 days or less from the time of the patient's last shipment of Sprycel
    • Patients whose initial date of enrollment into the Program exceeds 6 months, may be eligible to receive 60-day-supply refills at the discretion of their physician. Please contact Destination Access to learn more
    • 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. Healthcare providers will also be faxed a refill form 14 days following each shipment of Sprycel
    • Sprycel Refill Form with Ship-to-Patient Option
  2. How does a patient apply for the Destination Access Sprycel Patient Assistance Program?
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      • 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
      • Sprycel Patient Assistance Enrollment Form
      • 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
      • You can obtain the Patient Enrollment Form Checklist by clicking on the link below or by calling Destination Access to have one faxed or emailed to you Patient Enrollment Form Checklist
      • A Destination Access program specialist will contact the patient's healthcare provider on or before the next business day to discuss any of the alternative sources of funding or coverage that may be available to the patient, including whether the patient qualifies to receive free Sprycel through the Destination Access Sprycel Patient Assistance Program
      • If the patient would like to be considered for participation in the Destination Access Sprycel 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 application with the required signatures, along with proof of income documentation, to Destination Access at: 1-888-776-2370

      If the patient meets the eligibility criteria for the Sprycel 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 to initiate a product shipment.

  3. What are the eligibility criteria for the Sprycel Patient Assistance Program?
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    • Patient must live in the US, Puerto Rico, or the US Virgin Islands.
    • The patient must have an annual household adjusted gross income of $75,000 or less. Destination Access reviews 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
    • Patients who have exceeded either an annual or lifetime maximum benefit on their insurance coverage for Sprycel may be considered eligible for patient assistance
    • Uninsured and insured patients who are denied coverage for Sprycel by their insurer may be eligible to receive free Sprycel through the Program
    • 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 Sprycel on an outpatient basis in order to qualify for the Program
    • Incarcerated patients are not eligible to receive Sprycel through the Patient Assistance Program
  4. 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 Sprycel Patient Assistance Program?
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      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 Sprycel through the Sprycel Patient Assistance Program.

  5. Are patients who are enrolled in a Medicare Part D Plan eligible to receive free Sprycel through the Program?
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      Generally, patients receiving benefits under a Medicare Part D plan are not eligible for assistance through the Destination Access Sprycel Patient Assistance Program. However, during 2009, Medicare Part D enrollees may apply for assistance through a case-by-case appeals process based on significant financial and medical need. Additionally, new applicants cannot qualify for the program if they are eligible for and receiving the Medicare Part D Low Income Subsidy (LIS).

Did you know you may be eligible to have your medication shipped directly to your home? Learn more about our Ship-to-Patient Option to see if you qualify.

INDICATIONS

SPRYCEL® (dasatinib) is indicated for the treatment of adults with:

  • Chronic, accelerated, or myeloid or lymphoid blast phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior therapy including imatinib
  • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy

IMPORTANT SAFETY INFORMATION

Myelosuppression:

  • Treatment with SPRYCEL® (dasatinib) can cause severe (NCI CTC Grade 3/4) thrombocytopenia, neutropenia, and anemia, occurring more frequently in advanced phase CML or Ph+ ALL than in chronic phase CML. Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities
    • Perform complete blood counts (CBCs) weekly for the first 2 months and then monthly thereafter, or as clinically indicated
    • Myelosuppression was generally reversible and usually managed by dose interruption, dose reduction, or discontinuation
    • Hematopoietic growth factor has been used in patients with resistant myelosuppression

Bleeding Related Events:

  • Sprycel caused platelet dysfunction in vitro and thrombocytopenia in humans
    • In all clinical trials, severe central nervous system (CNS) hemorrhage, including fatalities, occurred in 1% of patients. Severe gastrointestinal (GI) hemorrhage, including fatalities, occurred in 4% of patients receiving SPRYCEL, which generally required treatment interruptions and transfusions. Other cases of severe hemorrhage occurred in 2% of patients
  • Most bleeding events were associated with severe thrombocytopenia
    • Exercise caution in patients required to take medications that inhibit platelet function or anticoagulants

Fluid Retention:

  • Sprycel is associated with fluid retention
    • In clinical trials, fluid retention was severe in up to 10% of patients. Ascites (<1%), generalized edema (<1%), and severe pulmonary edema (1%) were also reported
  • Patients who develop symptoms suggestive of pleural effusion such as dyspnea or dry cough should be evaluated by chest X-ray
  • Severe pleural effusion may require thoracentesis and oxygen therapy
  • Fluid retention was typically managed by supportive care measures that included diuretics or short courses of steroids

QT Prolongation:

  • In vitro data suggest that Sprycel has the potential to prolong cardiac ventricular repolarization (QT interval)
  • In 865 patients with leukemia treated with SPRYCEL in five phase 2 single-arm studies, the maximum mean changes in QTcF (90% upper bound CI) from baseline ranged from 7.0 ms to 13.4 ms
  • In clinical trials of CML patients treated with SPRYCEL (N=2440), 15 patients (<1%) had QTc prolongation as an adverse reaction. Twenty-two patients (1%) experienced a QTcF >500 ms
  • Administer Sprycel with caution to patients who have or may develop prolongation of QTc, including patients with hypokalemia, hypomagnesemia, or congenital long QT syndrome and patients taking anti-arrhythmic drugs, other medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline therapy
    • Correct hypokalemia or hypomagnesemia prior to Sprycel administration

Congestive Heart Failure, Left Ventricular Dysfunction, and Myocardial Infarction:

Cardiac adverse reactions were reported in 5.8% of 258 patients taking Sprycel, including 1.6% of patients with cardiomyopathy, heart failure congestive, diastolic dysfunction, fatal myocardial infarction, and left ventricular dysfunction. Monitor patients for signs or symptoms consistent with cardiac dysfunction and treat appropriately.

Pregnancy:

Sprycel may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of Sprycel in pregnant women. Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant when taking Sprycel.

Nursing Mothers:

It is unknown whether Sprycel is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Sprycel.

Drug Interactions:

Sprycel is a CYP3A4 substrate and a weak time-dependent inhibitor of CYP3A4.

  • Drugs that may increase Sprycel plasma concentrations are:
    • CYP3A4 inhibitors: Concomitant use of Sprycel and drugs that inhibit CYP3A4 should be avoided. If administration of a potent CYP3A4 inhibitor cannot be avoided, close monitoring for toxicity and a Sprycel dose reduction or temporary discontinuation should be considered
      • Strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole). If Sprycel must be administered with a strong CYP3A4 inhibitor, a dose decrease should be considered
      • Grapefruit juice may also increase plasma concentrations of Sprycel and should be avoided
  • Drugs that may decrease Sprycel plasma concentrations are:
    • CYP3A4 inducers: If Sprycel must be administered with a CYP3A4 inducer, a dose increase in Sprycel should be considered.
      • Strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital), should be avoided. Alternative agents with less enzyme induction potential should be considered. If the dose of Sprycel is increased, the patient should be monitored carefully for toxicity
      • St John’s Wort may decrease Sprycel plasma concentrations unpredictably and should be avoided
    • Antacids. Antacids may decrease Sprycel drug levels. Simultaneous administration of SPRYCEL and antacids should be avoided. If antacid therapy is needed, the antacid dose should be administered at least 2 hours prior to or 2 hours after the dose of Sprycel
    • H2 antagonists/proton pump inhibitors, such as famotidine and omeprazole. Long-term suppression of gastric acid secretion by use of H2 antagonists or proton pump inhibitors is likely to reduce Sprycel exposure. Therefore, concomitant use of H2 antagonists or proton pump inhibitors with Sprycel is not recommended
  • Drugs that may have their plasma concentration altered by Sprycel are:
    • CYP3A4 substrates such as simvastatin. CYP3A4 substrates with a narrow therapeutic index should be administered with caution in patients receiving Sprycel

Adverse Reactions:

The safety data reflect exposure to Sprycel in 2182 patients with imatinib resistant or intolerant CML or Ph+ ALL in clinical studies (minimum of 2 years follow-up).

The majority of Sprycel-treated patients experienced adverse reactions at some time. Patients aged 65 years and older are more likely to experience toxicity. In patients resistant or intolerant to prior imatinib therapy, Sprycel was discontinued for adverse reactions in 15% of patients in chronic phase, 16% in accelerated phase, 15% in myeloid blast phase, 8% in lymphoid blast phase CML, and 8% in Ph+ ALL.

  • In patients resistant or intolerant to prior imatinib therapy:
    • The most frequently reported serious adverse reactions included pleural effusion (11%), gastrointestinal bleeding (4%), febrile neutropenia (4%), dyspnea (3%), pneumonia (3%), pyrexia (3%), diarrhea (3%), infection (2%), congestive heart failure/cardiac dysfunction (2%), pericardial effusion (1%), and CNS hemorrhage (1%)
    • The most frequently reported adverse reactions (reported in ≥20% of patients) included myelosuppression, fluid retention events, diarrhea, headache, dyspnea, skin rash, fatigue, nausea, and hemorrhage
    • Grade 3/4 laboratory abnormalities in chronic phase CML patients resistant or intolerant to prior imatinib therapy who received SPRYCEL 100 mg once daily included neutropenia (36%), thrombocytopenia (23%), anemia (13%), hypophosphatemia (10%), and hypokalemia (2%)
  • Grade 3/4 elevations of transaminase or bilirubin and Grade 3/4 hypocalcemia, hypokalemia and hypophosphatemia were reported in patients with all phases of CML, but were reported with an increased frequency in patients with myeloid or lymphoid blast phase CML
    • Elevations in transaminase or bilirubin were usually managed with dose reduction or interruption
    • Patients developing Grade 3/4 hypocalcemia during the course of Sprycel therapy often had recovery with oral calcium supplementation

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