Tasigna Danziten - NC Standard

• Tasigna® (nilotinib)
• Danziten™ (nilotinib)  

FDA Approved Use:

Tasigna:

• For the treatment of adult and pediatric patients greater than or equal to one year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
• For the treatment of adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. 
• For the treatment of pediatric patients greater than or equal to one year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. 

Danziten:

• For the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
• For the treatment of adult patients with chronic phase (CP) and accelerated phase (AP) Ph+CML resistant to or intolerant to prior therapy that included imatinib.  patients.

Criteria for Approval of Restricted Product(s):

1. The patient is currently taking the requested medication for a cancer diagnosis; AND
   1. The patient will utilize the generic formulation of this product (if available); OR
2. One of the following:
   1. The patient is between 1 year and 17 years of age; AND
      1. The request is for Tasigna; OR
   2. The patient is 18 years of age or older; AND
3. The patient is being managed by or in consultation with an oncologist; AND
4. The patient has been diagnosed with one of the following diagnoses (medical record documentation required):
   1. Newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase; OR
   2. Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP) or accelerated phase (AP); AND 
5. The patient has tried and had an inadequate response, intolerance, or hypersensitivity to ONE of the following: generic imatinib, dasatinib (medical record documentation required); OR
   1. The patient has an FDA labeled contraindication to ALL the following: generic imatinib, dasatinib (medical record documentation required); AND
6. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. Medical records and references / evidence must be provided; AND
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies. 

Duration of Approval:  365 days (1 year)

Quantity Limitations:

quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90-day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually. 

December 2024: Criteria change: Added new to market product Danziten to policy. Clarified trial and failure or contraindication to dasatinib products within the policy given generic Sprycel now available.

July 2023: Criteria change: Criteria review and formatting changes. Clarified patient is 1 year of age or older.

April 2021: Criteria change: Require trial and failure of generic imatinib or Sprycel or contraindication to both.

September 2020: Criteria update: Allow for approval if currently taking for a cancer diagnosis and utilizing the generic (if available).

March 2020: Criteria change: Reformatted criteria. Allow for approval if currently taking for a cancer diagnosis.

May 2018: Updated criteria to include pediatric indication of 1 year and older

April 2017: Original utilization management criteria issued.