Jakafi - NC Standard

Restricted Product(s):

• Jakafi® (ruxolitinib)

FDA Approved Use:

• Treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults.
• Treatment of polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea.
• Treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.
• Treatment of chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adults and pediatric patients 12 years and older.

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 has been diagnosed with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis; AND
   1. The patient is 18 years of age or older; OR
3. The patient has been diagnosed with steroid-refractory acute graft-versus-host disease (GVHD); AND
   1. The patient is 12 years of age or older; AND
   2. The patient has grade 2-4 GVHD per Mount Sinai Acute GVDH International Consortium Criteria, MAGIC; OR
4. The patient has been diagnosed with polycythemia vera; AND
   1. The patient has tried and failed, or has a contraindication/intolerant to hydroxyurea; AND
   2. The patient is 18 years of age or older; OR
5. The patient has been diagnosed with chronic graft-versus-host disease; AND
   1. The patient is 12 years of age or older; AND
   2. The patient has failed at least one line of systemic therapy; 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.

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.

April 2024: Criteria update: Removed requirement for management by or in consultation with an oncologist.

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

October 2021: Criteria update: Addition of expanded indication for chronic graft-versus-host disease

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

July 2019: Criteria update: Reformatted criteria & added new indication - steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

October 2018: Annual review; No change.

April 2017: Original utilization management criteria issued.