Venclexta - NC Standard

Restricted Product(s)

• Venclexta® (venetoclax)

FDA Approved Use

• For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) 
• In combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

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. 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 chronic lymphocytic leukemia (CLL) OR small lymphocytic lymphoma (SLL); OR 
5. The patient has been newly diagnosed with acute myeloid leukemia (AML); AND 
   1. The patient is 75 years of age or older; OR 
   2. The patient is not able to use induction chemotherapy due to co-morbidities; AND 
   3. The patient has not been treated with chemotherapy for the newly diagnosed AML; AND 
   4. The patient will be taking Venclexta in combination with azacitidine, decitabine or low-dose cytarabine; 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 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

May 2023: Criteria update: Criteria review and formatting changes.

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

January 2020: Criteria change: Allow authorization if currently taking the medication for a cancer diagnosis.

July 2019: Criteria update: Updated coverage criteria for expanded use in naïve patients

February 2019: Updated section 4a – added an OR between age and induction chemotherapy.

January 2019: Added 75 years old to criteria section

December 2018: Updated to reflect FDA expanded indication for AML in adults 75 years or older.

June 2018: Updated to reflect FDA expanded indication for SLL.

April 2016: Original utilization management criteria issued.