SOMAVERT, Pegvisomant Form

Pegvisomant (Somavert®) is a growth hormone receptor antagonist.
FDA Approved Indication(s) Somavert is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-I (IGF-I) levels. 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 Somavert 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 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 a somatostatin analog at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B); Prior authorization may be required for somatostatin analogs

4. Dose does not exceed the following: a. Loading dose: 40 mg once;
   b. Maintenance dose: 30 mg per day. Approval duration:
   Medicaid/HIM – 6 months Commercial – 6 months or to the member's renewal date, whichever is longer Page 1 of 6

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

5. 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
6. 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):
7. 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);
8. Member is responding positively therapy (see Appendix D);
   3. If request is for a dose increase, new dose does not exceed 30 mg per day. Approval duration:
      Medicaid/HIM – 12 months Commercial – 6 months or to the member's renewal date, whichever is longer B. Other diagnoses/indications (must meet 1 or 2):
9. 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

10. 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 6

    CLINICAL POLICY Pegvisomant 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 policy – 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 GH: growth hormone IGF: insulin-like growth factor SRL: somatostatin receptor ligand 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 1,500 mcg/day (SC, IV) 40 mg every 4 weeks (IM) octreotide (Sandostatin® [SC, IV], Sandostatin® LAR Depot [IM]) Acromegaly Initial: 50 mcg SC or IV TID Maintenance: 100 to 500 mcg SC or IV TID
    For patients stable on SC formulation: patients can switch to 20 mg IM intragluteally every 4 weeks for 3 months, then adjust dose based on clinical response Acromegaly 90 mg SC once every 4 weeks for 3 months, then adjust dose based on clinical response Acromegaly 40 mg to 60 mg IM every 4 weeks Somatuline® Depot (lanreotide) Signifor® LAR 60 mg once every 4 weeks (pasireotide) 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. 120 mg once every 4 weeks Appendix C: Contraindications/Boxed Warnings None reported Appendix D: General Information
    • Recommendations from the 13th Acromegaly Consensus Conference (Guistina 2020) include: o Somatostatin receptor ligands (SRLs) such as octreotide LAR and lanreotide are used as first-line medical therapy due to their favorable risk/benefit profiles. Page 3 of 6

    CLINICAL POLICY Pegvisomant o Pegvisomant is generally used as second-line therapy in patients who do not achieve biochemical control with maximal doses of SRL therapy. • Examples of treatment response to acromegaly therapy (including somatostatin analogs, surgical resection or pituitary irradiation) include improvement from baseline in or normalization of GH and/or age- and sex-adjusted IGF-I serum concentrations, or tumor mass control. V. Dosage and Administration
    Indication Acromegaly Dosing Regimen Loading dose: 40 mg SC under healthcare provider supervision Maximum Dose Maintenance: 30 mg/day Maintenance dose: 10 to 30 mg SC QD VI. Product Availability
    Single-use vials with powder for reconstitution: 10 mg, 15 mg, 20 mg, 25 mg, 30 mg
    VII.