Infigratinib (Truseltiq) Form

Infigratinib (Truseltiq™) is a small molecule kinase inhibitor that inhibits fibroblast growth factor receptor (FGFR). FDA Approved Indication(s) Truseltiq is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Truseltiq is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Cholangiocarcinoma (must meet all):

1. Diagnosis of unresectable locally advanced or metastatic cholangiocarcinoma;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Documentation of FGFR2 fusion or rearrangement;
   5. Member has not previously received a selective FGFR inhibitor (e.g., Stivarga®, Pemazyre™);

2. Failure of at least one previous systemic cancer therapy (see Appendix B);

   7. Prescribed as a single agent;
   8. Request meets one of the following (a or b): a. Dose does not exceed 125 mg (2 capsules) per day for 21 days per 28-day cycle; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN
      Approval duration: 6 months Page 1 of 5

   CLINICAL POLICY Infigratinib B. Other diagnoses/indications (must meet 1 or 2):

3. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
4. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Cholangiocarcinoma (must meet all):
5. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Truseltiq for a covered indication and has received this medication for at least 30 days;
6. Member is responding positively to therapy;
   3. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 125 mg (2 capsules) per day for 21 days per 28-day cycle; b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
7. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

8. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND Page 2 of 5

   CLINICAL POLICY Infigratinib criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration FGFR: fibroblast growth factor receptor Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen Dose Limit/ Maximum Dose Varies gemcitabine (Gemzar®) + cisplatin Gemcitabine 1000 mg/m2 IV in combination with cisplatin 25 mg/m2 IV, both on days 1 and 8 every 21 days for 8 cycles Varies Varies Varies Varies Varies Varies Varies 5-fluorouracil + oxaliplatin Varies Varies 5-fluorouracil + cisplatin capecitabine (Xeloda®) + Varies cisplatin capecitabine (Xeloda®) + oxaliplatin gemcitabine + Abraxane® gemcitabine (Gemzar®) + capecitabine (Xeloda®) gemcitabine (Gemzar®) + oxaliplatin 5-fluorouracil capecitabine (Xeloda®) gemcitabine (Gemzar®) FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Appendix C: Contraindications/Boxed Warnings None reported
   Page 3 of 5

   CLINICAL POLICY Infigratinib V. Dosage and Administration
   Indication Dosing Regimen Cholangiocarcinoma 125 mg PO QD for 21 days followed by 7 Maximum Dose 125 mg/day days off therapy, in 28-day cycles VI. Product Availability
   Capsules: 25 mg, 100 mg VII.