SOMATULINE DEPOT, Lanreotide Acetate Form

Lanreotide (Somatuline® Depot) is a somatostatin analog.
FDA Approved Indication(s) Somatuline Depot is indicated for: • Long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy • Treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival • Treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short- acting somatostatin analog rescue 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 Somatuline Depot is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Acromegaly (must meet all):

1. Diagnosis of acromegaly as evidenced by one of the following (a or b): a. Pre-treatment insulin-like growth factor-I (IGF-I) level above the upper limit of normal based on age and gender for the reporting laboratory; b. Serum growth hormone (GH) level ≥ 1 µg/mL after a 2-hour oral glucose tolerance test;
2. Prescribed by or in consultation with an endocrinologist;
   3. Age ≥ 18 years;
   4. Inadequate response to surgical resection or pituitary irradiation (see Appendix D), or member is not a candidate for such treatment;
3. Failure of Sandostatin® LAR Depot, unless contraindicated or clinically adverse effects are experienced;
   
   • Prior authorization may be required for Sandostatin LAR Depot

4. Dose does not exceed 120 mg every 4 weeks.
   Approval duration: Medicaid/HIM – 6 months Page 1 of 8

   CLINICAL POLICY Lanreotide Commercial – 6 months or to the member’s renewal date, whichever is longer B. Carcinoid Syndrome (must meet all):

5. Diagnosis of carcinoid syndrome (associated with NETs of the gastrointestinal tract, lung, and thymus, otherwise known as carcinoid tumors);
6. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Failure of Sandostatin LAR Depot, unless contraindicated or clinically adverse effects are experienced;
      
      • Prior authorization may be required for Sandostatin LAR Depot
7. Request meets one of the following (a or b): a. Dose does not exceed 120 mg every 4 weeks; 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 – 6 months or to the member’s renewal date, whichever is longer C. Neuroendocrine Tumors (must meet all):
8. Diagnosis of one of the following (a, b, or c): a. GEP-NET (see Appendix D for tumor types), and: i. If insulinoma, disease is somatostatin receptor (SSTR)-positive; b. Pheochromocytoma or paraganglioma (adrenal NETs); c. One of the following NETs which is SSTR-positive or has hormonal symptoms (i, ii, or iii): i. Thymic NET; ii. Bronchopulmonary NET;
   iii. Grade 3 NET with favorable biology (i.e., relatively low Ki-67 [< 55%] or SSTR-positive);
9. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Failure of Sandostatin LAR Depot, unless contraindicated or clinically adverse effects are experienced;
      
      • Prior authorization may be required for Sandostatin LAR Depot

10. Request meets one of the following (a or b): a. Dose does not exceed 120 mg every 4 weeks; 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 – 6 months or to the member’s renewal date, whichever is longer Page 2 of 8

    CLINICAL POLICY Lanreotide D. Other diagnoses/indications (must meet 1 or 2):

11. 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
12. 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. Acromegaly (must meet all):
13. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
14. Member is responding positively to therapy (see Appendix D);
    
    3. If request is for a dose increase, new dose does not exceed 120 mg every 4 weeks. Approval duration:
       Medicaid/HIM – 12 months Commercial – 6 months or to the member’s renewal date, whichever is longer B. Carcinoid Syndrome and Neuroendocrine Tumors (must meet all):
15. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Somatuline Depot for a covered indication and has received this medication for at least 30 days;

16. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 120 mg every 4 weeks; 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 – 6 months or to the member’s renewal date, whichever is longer Page 3 of 8

    CLINICAL POLICY Lanreotide C. Other diagnoses/indications (must meet 1 or 2):

17. 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

18. 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. 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 GEP: gastroenteropancreatic GH: growth hormone IGF-I: insulin-like growth factor NET: neuroendocrine tumor SSTR: somatostatin 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.
    Dosing Regimen Drug Name Dose Limit/ Maximum Dose See dosing regimen Octreotide acetate (Sandostatin LAR deport) (IM) Acromegaly: 20-40 mg IM every 4 weeks Carcinoid tumors: 20-30 mg IM every 4 weeks
    Neuroendocrine Tumors: 20-30 mg IM every 4 weeks 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. Page 4 of 8

    CLINICAL POLICY Lanreotide Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to lanreotide • Boxed warning(s): none reported Appendix D: General Information • Response to acromegaly therapy (e.g., somatostatin analogs, surgical resection, pituitary irradiation) may include: o Improved GH or IGF-I serum concentrations o Improved tumor mass control • NCCN guidelines - Neuroendocrine and Adrenal Tumors o GEP-NETs  Gastrointestinal tract tumors include the appendix, stomach, colon and rectum, duodenum, gastric, jejunum and ileum.  Pancreatic tumors include insulinoma, gastrinoma, VIPoma (vasoactive intestinal polypeptide), glucagonoma. • For patients with insulinoma, lanreotide should be considered only if the tumor expresses SSTR. o Patients experiencing disease progression on lanreotide should continue treatment with lanreotide if the tumor is functional. Lanreotide may be used in combination with other systemic therapy options. V. Dosage and Administration
    Indication Dosing Regimen Acromegaly Initial: 90 mg SC every 4 weeks for 3 months Maintenance:
    90 to 120 mg SC every 4 weeks
    Dose should be adjusted according to reduction in serum GH or IGF-1 levels and/or changes in symptoms.
    120 mg SC every 4 weeks GEP-NETs, carcinoid syndrome If patients are being treated with Somatuline Depot for both GEP-NET and carcinoid syndrome, do not administer an additional dose Intended for administration by a healthcare provider Maximum Dose Maintenance: 120 mg every 4 weeks 120 mg every 4 weeks VI. Product Availability
    Single-dose prefilled syringes: 60 mg/0.2 mL, 90 mg/0.3 mL, 120 mg/0.5 mL VII.