Calquence - NC Standard

• Calquence® (acalabrutinib)

• For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
• For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
• For the treatment of adult patients with previously untreated mantle cell lymphoma in combination with bendamustine and rituximab who are ineligible for autologous hematopoietic stem cell transplantation.

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 mantle cell lymphoma (MCL) (medical record documentation required); AND
   1. The patient has received at least one prior therapy; OR
   2. The patient has not received any prior treatment for MCL; AND
      1. The requested medication will be used combination with bendamustine and rituximab; AND
      2. The patient is not eligible for autologous hematopoietic stem cell transplantation; OR
5. The patient has been diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (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 apply to brand and associated generic products.

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)  

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

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.

February 2025v2: Criteria change: Added new FDA indication for the treatment of adult patients with previously untreated mantle cell lymphoma in combination with bendamustine and rituximab who are ineligible for autologous hematopoietic stem cell transplantation.

February 2025: Criteria update: Removed obsolete product, Calquence 100 mg capsule. Added P&T statement.

August 2022: Criteria update: Added new to market tablets to quantity limitations and corrected previous formulation of capsules. Formatting updates.  Added medical record documentation required for diagnosis.

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

Dec 2019: Criteria update: Added new FDA indication of chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL)

Nov 2017: Original utilization management criteria issued.