WHA

TASIGNA (nilotinib)

Self-Administration – oral

Diagnosis considered for coverage:
  • Newly diagnosed Ph+ chronic myeloid leukemia- chronic phase (CML-CP): Indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase
  • Resistant or intolerant Ph+ CML-CP and CML-AP: Indicated for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib
  • Pediatric patients with resistant or intolerant Ph+ CML-CP and CML-AP: Indicated for the treatment of pediatric patients greater than or equal to 1 year of age with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine kinase inhibitor (TKI) therapy
  • Other uses with Supportive Evidence:
    • Newly diagnosed Ph+ Acute Lymphoblastic Leukemia
    • Relapsed or refractory Ph+ Acute Lymphoblastic Leukemia
    • Unresectable Gastrointestinal Stromal Tumors (GIST)
Coverage Criteria:

For diagnosis of newly diagnosed Ph+ Chronic Myeloid Leukemia:

  • Dose does not exceed 300 mg orally twice daily; AND
  • Member is at least 1 year old; AND
  • Diagnosis of Philadelphia chromosome-positive/BCR ABL positive (Ph+/BCR ABL) chronic myelogenous/myeloid leukemia (CML); AND
  • Prescribed by or in consultation with an oncologist and/or hematologist

For diagnosis of resistant or intolerant Ph+ CML in chronic phase (CP) and accelerated phase (AP):

  • Dose does not exceed 400 mg orally twice daily; AND
  • Member is at least 18 years or older; AND
  • Diagnosis of Philadelphia chromosome-positive/BCR ABL positive (Ph+/BCR ABL) chronic myelogenous/myeloid leukemia (CML); AND
  • Trial and failure, contraindication, or intolerance to generic imatinib; AND
  • Prescribed by or in consultation with an oncologist and/or hematologist

For diagnosis of resistant or intolerant Ph+ CML-Chronic Phase (CML-CP), pediatric:

  • Dose does not exceed 230 mg/m2 orally twice daily, rounded to the nearest 50 mg dose (max single dose of 400 mg); AND
  • Member is at least 1 year old; AND
  • Diagnosis of Philadelphia chromosome-positive/BCR ABL positive (Ph+/BCR ABL) chronic myelogenous/myeloid leukemia (CML); AND
  • Trial and failure, contraindication, or intolerance to generic imatinib; AND
  • Prescribed by or in consultation with an oncologist and/or hematologist

For the treatment of newly diagnosed Ph+ Acute Lymphoblastic Leukemia: 

  • Dose does not exceed 400 mg twice daily; AND
  • Diagnosis of Philadelphia chromosome-positive/BCR ABL positive (Ph+/BCR ABL) acute lymphoblastic leukemia (ALL); AND
  • Prescribed by or in consultation with an oncologist and/or hematologist

For the treatment of relapsed or refractory Ph+ Acute Lymphoblastic Leukemia: 

  • Dose does not exceed 400 mg twice daily; AND
  • Diagnosis of Philadelphia chromosome-positive/BCR ABL positive (Ph+/BCR ABL) acute lymphoblastic leukemia (ALL); AND
  • Trial and failure, contraindication, or intolerance to previous TKI therapy; AND
  • Prescribed by or in consultation with an oncologist and/or hematologist

For the treatment of unresectable Gastrointestinal Stromal Tumors (GIST):

  • Dose does not exceed 400 mg twice daily; AND
  • Diagnosis of unresectable Gastrointestinal Stromal Tumors (GIST); AND
  • Trial and failure, contraindication, or intolerance to four previous therapies (e.g. imatinib, avapritinib, sunitinib, regorafenib, ripretinib); AND
  • Prescribed by or in consultation with an oncologist and/or hematologist
Reauthorization Criteria:

For diagnosis of newly diagnosed Ph+ Chronic Myeloid Leukemia:

  • Dose does not exceed 300 mg orally twice daily; AND
  • Patient does not show evidence of progressive disease while on therapy

For diagnosis of resistant or intolerant Ph+ CML in chronic phase (CP) and accelerated phase (AP):

  • Dose does not exceed 400 mg orally twice daily; AND
  • Patient does not show evidence of progressive disease while on therapy

For diagnosis of resistant or intolerant Ph+ CML-Chronic Phase (CML-CP), pediatric:

  • Dose does not exceed 230 mg/m2 orally twice daily, rounded to the nearest 50 mg dose (max single dose of 400 mg); AND
  • Patient does not show evidence of progressive disease while on therapy

For the treatment of newly diagnosed Ph+ Acute Lymphoblastic Leukemia: 

  • Dose does not exceed 400 mg twice daily; AND
  • Patient does not show evidence of progressive disease while on therapy

For the treatment of relapsed or refractory Ph+ Acute Lymphoblastic Leukemia: 

  • Dose does not exceed 400 mg twice daily; AND
  • Patient does not show evidence of progressive disease while on therapy

For the treatment of unresectable Gastrointestinal Stromal Tumors (GIST):

  • Dose does not exceed 400 mg twice daily; AND
  • Patient does not show evidence of progressive disease while on therapy
Coverage Duration: 
  • Initial: 1 year
  • Reauthorization: 1 year
Dosing:
  • Adults with newly diagnosed Ph+ CML-CP:
    • 300 mg twice daily
  • Adults with resistant or intolerant Ph+ CML-CP and CML-AP:
    • 400 mg twice daily
  • Pediatric patients with newly diagnosed Ph+ CML-CP or resistant or intolerant Ph+ CML-CP and CML-AP:
    • 230mg/m2 twice daily, round dose to the nearest 50 mg increment 
    • Max dose: 400 mg/dose
  • Newly diagnosed Ph+ Acute Lymphoblastic Leukemia: 
    • 400 mg twice daily starting on day 8 of induction chemotherapy 
  • Relapsed or refractory Ph+ Acute Lymphoblastic Leukemia: 
    • 400 mg twice daily 
  • Unresectable Gastrointestinal Stromal Tumors (GIST):
    • 400 mg twice daily until disease progression or unacceptable toxicity 
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 
  • Dosing and Administration
    • Dosage forms – capsules: 50 mg, 150 mg and 200 mg
    • Capsules can be opened and contents can be dispersed in 1 teaspoon of applesauce
    • Should be taken on an empty stomach; no food should be consumed for at least 2 hours before and at least 1 hour after doses are taken
  • Contraindicated in patients with hypokalemia, hypomagnesemia and QT syndrome
  • Warnings and Precautions: myelosuppression, QT prolongation, sudden deaths, cardiac and arterial vascular occlusive events, pancreatitis and elevated serum lipase, hepatotoxicity, electrolyte abnormalities, tumor lysis syndrome, hemorrhage, total gastrectomy, lactose, monitoring laboratory tests, fluid retention, effects on growth and development in pediatric patients, embryo-fetal toxicity, and monitoring of BCR-ABL transcript levels
  • Avoid concomitant use with strong CYP 3A4 inhibitors, or reduce Tasigna dose if coadministration cannot be avoided
  • Avoid concomitant use with strong CYP 3A4 inducers, or reduce Tasigna dose if coadministration cannot be avoided
  • Avoid concomitant use of PPIs with Tasigna. Use short-acting antacids or H2 blockers as an alternative to PPIs
  • Women should avoid breastfeeding while taking Tasigna
Policy Updates:
  • 2/15/2022 – New policy approved by P&T.
References:
  • Tasigna Prescribing Information. Novartis Pharmaceutical Company. East Hannover, NJ. August 2021.
  • National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Chronic Myelogenous Leukemia v.1.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf. Accessed November 1, 2021.
  • National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Acute Lymphoblastic Leukemia v.2.2022. Available at: https://www. https://www.nccn.org/professionals/physician_gls/pdf/all.pdf. Accessed November 2, 2021.
  • National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Gastrointestinal Stromal Tumors (GIST) v.1.2021. Available at: https://www. https://www.nccn.org/professionals/physician_gls/pdf/gist.pdf. Accessed November 2, 2021.

Last review date: February 15, 2022