Imbruvica - NC Standard

• Imbruvica® (ibrutinib) 

• For the treatment of adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
• For the treatment of adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion 
• For the treatment of adult patients with Waldenström’s macroglobulinemia (WM) 
• For the treatment of adult and pediatric patients aged 1 year of age and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy

1. The patient is currently taking the requested medication for a cancer diagnosis; AND
   1. Members requiring the dosages below will achieve them through the 140 mg capsule formulation (opposed to tablet):
      1. 140 mg daily, achieved by one 140 mg capsule (opposed to the 140 mg tablet)
      2. 280 mg daily, achieved by two 140 mg capsules (opposed the 280 mg tablet); OR
   2. The provider provides documentation to support the use of tablets over capsules; AND
   3. The patient will utilize the generic formulation of this product (if available); OR 
2. The patient is being managed by or in consultation with an oncologist; AND
3. The patient has been diagnosed with Waldenström’s macroglobulinemia (WM) (medical record documentation required); AND
   1. The patient is 18 years of age or older; OR
4. The patient has been diagnosed with Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with or without 17p deletion (medical record documentation required); AND 
   1. The patient is 18 years of age or older; OR 
5. The patient has chronic graft versus host disease (cGVHD) (medical record documentation required); AND
   1. The patient is 18 years of age or older; AND
      1. The patient has had a trial and failure or has a clinical contraindication/intolerance to systemic corticosteroids; AND
      2. The patient has received hematopoietic stem cell transplantation (HSCT); OR 
   2. The patient is ≥ 1 year to less than 22 years of age; AND
      1. The patient has had a trial and failure of one or more systemic therapies; AND 
      2. The patient has received hematopoietic stem cell transplantation (HSCT); 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 2025: Criteria update: Removed discontinued 560 mg tablet. Added P&T statement.

July 2023: Criteria change: Updated for preference of capsules over tablets to criteria point one to require for all reviews.

May 2023: Criteria change: Removed indications due to voluntary FDA approved removal of the indications for treatment of adults with mantle cell lymphoma and treatment of adults with marginal zone lymphoma.

January 2023: Criteria update: Formatting update to include age for all adult indications

September 2022v2: Criteria change: Added new to market oral suspension to quantity limitations.

September 2022: Criteria change: Formatting updates. Updated age to include pediatric and adult patients for chronic graft versus host disease.

August 2022: Criteria change: Formatting updates. Added medical record documentation required for diagnosis.

June 2020: Criteria change: Changed quantity limit of 140 mg capsules from 4 capsules/day to 3 capsules/day. Allow for approval if currently taking for a cancer diagnosis and utilizing the generic (if available).

Sep: 2019: Criteria update: Preference of capsules over tablets created.

Mar 2018: Added new to market tablets and new to market 70 mg capsule to quantity limitations.

Aug 2017: Updated format; Added criteria for new FDA indication cGVHD

Jan 2017: Original utilization management criteria issued