Kisqali & Kisqali Femara Co-Pack - NC Standard

Restricted Product(s)

• Kisqali® (ribociclib) 
• Kisqali® Femara Co-pack (ribociclib/letrozole)

FDA Approved Use

• For the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence in combination with an aromatase inhibitor for the adjuvant treatment.
• For the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy, or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.
  

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 has been diagnosed with ONE of the following: 
   1. The patient has stage II and III early breast cancer at high risk of recurrence; AND 
      1. The patient has hormone receptor (HR) positive breast cancer; AND 
      2. The patient has human epidermal growth factor receptor 2 (HER2) negative breast cancer; AND 
      3. The patient is taking Kisqali in combination with an aromatase inhibitor; OR 
   2. The patient has been diagnosed with advanced or metastatic breast cancer; AND 
      1. The patient has hormone receptor (HR) positive breast cancer; AND 
      2. The patient has human epidermal growth factor receptor 2 (HER2) negative breast cancer; AND 
      3. The patient has one of the following: 
         1. The patient is taking Kisqali in combination with an aromatase inhibitor (i.e., anastrozole, exemestane, or letrozole); OR 
         2. The patient will be taking Kisqali in combination with fulvestrant as initial endocrine-based therapy; OR 
         3. The patient has disease progression on endocrine therapy; AND 
4. The patient is post-menopausal; OR 
   1. The patient is a pre/perimenopausal woman or a man; AND 
      1. The patient is being treated with a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards; AND
5. 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; AND 
6. 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

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.

October 2024: Criteria change: Expanded indication for approval in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor–positive, human epidermal growth factor receptor 2–negative stage II and III early breast cancer at high risk of recurrence. Added approval point for pre/perimenopausal women or men with use of a LHRH agonist. Added limitation of use section.

January 2024: Criteria change: Removed preference of Ibrance and Verzenio before use of Kisqali. Removed requirement for specialist prescriber and medical record documentation.

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

December 2021: Criteria update: Expanded indication to include males

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

November 2019: Criteria change: Preference for the use of Ibrance and Verzenio added.

August 2019: Criteria update: Updated QL section for clarification on each strength of co-pack

September 2018: Updated policy to reflect indication update

May 2017: Added new to market Kisqali Femara Co-Pack to policy.

March 2017: Policy Originated