Koselugo/Gomekli – NC Standard

Restricted Product(s)

• Gomekli™ (mirdametinib)
• Koselugo™ (selumetinib)

FDA Approved Use

• Gomekli
  • For the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.
• Koselugo
  • For the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

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. If the request is for Koselugo:
   1. The patient is between 2 and 17 years of age; AND
3. If the request is for Gomekli:
   1. The patient is 2 years of age or older; AND
4. The patient is being managed by or in consultation with an oncologist; AND
5. The patient has a diagnosis of neurofibromatosis type 1 (NF1) (medical record documentation required); AND
6. The patient has symptomatic plexiform neurofibromas (PN) that is inoperable or not amenable to complete resection (e.g., PN that cannot be completely removed without risk for substantial morbidity due to encasement of, or close proximity to, vital structures, invasiveness, or high vascularity of the PN); AND
7. 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
8. 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.

March 2025: Criteria change: Added new to market medication, Gomekli (mirdametinib) 1 mg capsule, 2mg capsule, and 1mg tab for oral suspension. Updated quantity limit chart and added P&T statement.

February 2023: Criteria update: Criteria review and formatting changes. Decreased initial duration of approval to 1 year. Added duration of approval to the quantity limit exception criteria.

Apr 2020: Original utilization management criteria issued.