Turalio - Romvimza - NC Standard

Restricted Product(s)

• Romvimza^TM (vimseltinib) capsules
• Turalio ^® (pexidartinib) capsules

FDA Approved Use

• Romvimza:
  • For the for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
• Turalio :
  • For the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

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 for a cancer diagnosis; OR 
2. The patient is 18 years of age or older; AND 
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., oncologist, orthopedist, orthopedic surgeon) or has consulted with a specialist in the area of the patient’s diagnosis; AND 
4. The patient has a confirmed diagnosis of tenosynovial giant cell tumor (TGCT); AND 
5. The patient has measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; AND 
6. The patient is unable to undergo surgical removal of the tumor, as this would be associated with worsening functional limitation or severe morbidity; AND 
7. If the request is for Turalio:
   1. The prescriber meets all REMS program requirements; AND 
8. 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 
9. 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.

New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, et al. Eur J Cancer. 2009 Jan; 45(2):228-47.

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 Romvimza 14, 20, 30mg capsule to policy. Policy name updated to include new product.

February 2025: Criteria update: Turalio 200mg capsules were removed from policy. P&T statement added.

April 2023: Criteria change: Added patient must be managed by or in consultation with a specialist in the area of the patient’s diagnosis. Added the patient will utilize the generic formulation if using for a cancer diagnosis.

January 2023: Criteria change: Formatting changes. Added new to market Turalio 125 mg capsule to quantity limitations.

April 2020: Original utilization management criteria issued.