Sotorasib (Lumakras) Form

Sotorasib (Lumakras®) is an inhibitor of KRASG12C, a tumor-restricted, mutant-oncogenic form of the RAS GTPase, KRAS. FDA Approved Indication(s) Lumakras is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. 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 Lumakras is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Non-Small Cell Lung Cancer (must meet all):

1. Diagnosis of recurrent, locally advanced or metastatic NSCLC;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Disease is positive for KRAS G12C mutation;
   5. Member has received at least one systemic therapy (see Appendix B);
   6. Member has not received prior treatment with Krazati™;
   7. Request meets one of the following (a or b): a. Dose does not exceed 960 mg per day; 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:
      Medicaid/HIM – 6 months
      Commercial – 12 months or duration of request, whichever is less
      B. Other diagnoses/indications (must meet 1 or 2):

2. 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): Page 1 of 6

   CLINICAL POLICY Sotorasib 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

3. 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. Non-Small Cell Lung Cancer (must meet all):
4. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Lumakras for a covered indication and has received this medication for at least 30 days;
5. 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 960 mg per day; 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:
      Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):
6. 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

7. 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.
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   CLINICAL POLICY Sotorasib 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 NSCLC: non-small cell lung cancer 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.
   Dosing Regimen Drug Name Varies Dose Limit/ Maximum Dose Varies cisplatin- or carboplatin- containing chemotherapy Imfinzi® (durvalumab) Keytruda® (pembrolizumab) Libtayo® (cemiplimab- rwlc) Opdivo® (nivolumab) Tecentriq® (atezolizumab) Yervoy® (ipilimumab) Imjudo® (tremelimumab) 10 mg/kg IV every 2 weeks or 1,500 mg every 4 weeks 200 mg IV every 3 weeks OR 400 mg every 6 weeks up to 24 months 350 mg IV every 3 weeks 1,500 mg every 4 weeks 400 mg every 6 weeks 350 mg every 3 weeks 480 mg every 4 weeks 1,680 mg every 4 weeks 1 mg/kg every 6 weeks See dosing regimen 240 mg IV every 2 weeks or 480 mg IV every 4 weeks 840 mg IV every 2 weeks, 1,200 mg IV every 3 weeks, or 1,680 mg IV every 4 weeks In combination with Opdivo: 1 mg/kg IV every 6 weeks Patients ≥ 30 kg: 75 mg IV on day 1 every 3 weeks for cycles 1 through 4 in combination with durvalumab and platinum-based chemotherapy; cycle 5 no dose; cycle 6 - 75 mg IV on day 1 in combination with durvalumab Patients < 30 kg: 1 mg/kg on day 1 every 3 weeks for cycles 1 through 4 in combination with durvalumab and Page 3 of 6

   CLINICAL POLICY Sotorasib Drug Name Dosing Regimen Dose Limit/ Maximum Dose platinum-based chemotherapy; cycle 5 no dose; cycle 6 - 1 mg/kg IV on day 1 in combination with durvalumab 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. Appendix C: Contraindications/Boxed Warnings None reported
   V. Dosage and Administration
   Indication NSCLC Dosing Regimen 960 mg PO QD Maximum Dose 960 mg/day VI. Product Availability
   Tablet: 120 mg, 320 mg VII.