Colesevelam (WelChol) Form

Colesevelam (Welchol®) is a bile acid sequestrant. FDA Approved Indication(s) Welchol is indicated as an adjunct to diet and exercise for: Primary Hyperlipidemia • To reduce elevated low density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.
• To reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) if unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification. Type 2 Diabetes Mellitus • To improve glycemic control in adults with type 2 diabetes mellitus. Limitation(s) of use:
• Welchol should not be used for the treatment of type 1 diabetes or for treating diabetic ketoacidosis. • Welchol has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. 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 Welchol packet for suspension is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Primary Hyperlipidemia (must meet all):

1. Request is for Welchol packet for suspension;
   2. Prescribed for lipid lowering;
   3. Age ≥ 10 years;
   4. Documentation supports inability to swallow pills or clinically significant adverse effects to Welchol tablets;

2. Failure of colestipol granules and cholestyramine powder for suspension at up to maximally indicated doses, each used for ≥ 3 months, unless contraindicated or clinically significant adverse effects are experienced;
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3. Failure of ≥ 3 consecutive months of adherent use of a statin therapy, unless contraindicated or clinically significant adverse effect are experienced;
   7. At the time of request, current (within the last 3 months) serum triglyceride concentrations do not exceed 500 mg/dL;
4. If request is for brand Welchol packet for suspension, member must use generic colesevelam packet for suspension, unless contraindicated or clinically significant adverse effects are experienced;
5. Dose does not exceed oral suspension packet of 3.75 grams (1 packet) per day. Approval duration: 6 months B. Type 2 Diabetes Mellitus (must meet all):
6. Request is for Welchol packet for suspension;
   2. Diagnosis of type 2 diabetes mellitus;
   3. Age ≥ 18 years;
   4. HbA1c drawn within the past 3 months is ≥ 6.5%;
   5. Failure of adherent use of a triple anti-diabetic regimen which must include metformin in combination with agents from any of the following classes for ≥ 3 months, unless clinically significant adverse effects are experienced or all are contraindicated: a. Glucagon-like peptide-1 (GLP-1) receptor agonist; b. Sodium glucose co-transporter 2 (SGLT-2) inhibitor; c. DPP-4 inhibitor; d. Thiazolidinedione (TZD); e. Basal insulin;
7. At the time of request, current (within the last 3 months) serum triglyceride concentrations do not exceed 500 mg/dL;
8. If request is for brand Welchol packet for suspension, member must use generic colesevelam packet for suspension, unless contraindicated or clinically significant adverse effects are experienced;
9. Dose does not exceed oral suspension packet of 3.75 grams (1 packet) per day. Approval duration: 6 months C. Other diagnoses/indications (must meet 1 or 2):

10. 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: 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: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or

    2. 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 Page 2 of 7

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    of business: HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid.
    II. Continued Therapy A. All Indications in Section I (must meet all):

11. 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);
    2. Member is responding positively to therapy;
    3. If request is for brand Welchol packet for suspension, member must use generic colesevelam packet for suspension, unless contraindicated or clinically significant adverse effects are experienced;
12. If request is for a dose increase, new dose does not exceed oral suspension packet of 3.75 grams (1 packet) per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

13. 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: 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: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or

    2. 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: 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 – 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 DPP-4: dipeptidylpeptidase 4 FDA: Food and Drug Administration GLP-1: glucagon-like peptide-1 HeFH: familial hypercholesterolemia LDL-C: low-density lipoprotein cholesterol SGLT-2: sodium glucose co-transporter-2 Page 3 of 7

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    TZD: thiazolidinedione 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 Tablets: 16 g/day Granules: 30 g/day 24 g/day Immediate-release: 2,550 mg/day Extended-release: 2,000 to 2,500 mg/day depending on the formulation colestipol (Colestid®) cholestyramine (Questran®, Prevalite®) metformin
    (e.g., Fortamet®, Glucophage®) Primary Hyperlipidemia Tablets: 2 g PO QD or BID Granules: 5 g PO BID Primary Hyperlipidemia 4 g PO QD or BID Type 2 Diabetes Mellitus Immediate-release: 500 mg to 850 mg PO QD to BID, then titrate up to 2,000 mg/day Extended-release: 500 mg to 1,000 mg PO QD, then titrate up to 2,000 mg/day Type 2 Diabetes Mellitus Refer to prescribing information Type 2 Diabetes Mellitus Refer to prescribing information Refer to prescribing information Refer to prescribing information GLP-1 receptor agonist (e.g., Victoza®, Trulicity®, Byetta®) SGLT-2 inhibitor (e.g., Jardiance®, Invokana®, Farxiga®)
    DPP-4 inhibitor (e.g., Januvia®, Onglyza®, Nesina®) TZD (e.g., pioglitazone, Avandia®) Basal insulin (e.g., insulin glargine) HMG-CoA reductase inhibitors (aka statins) (e.g., atorvastatin, rosuvastatin, lovastatin, etc,) 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. Type 2 Diabetes Mellitus Refer to prescribing information Type 2 Diabetes Mellitus Refer to prescribing information Type 2 Diabetes Mellitus Varies Primary Hyperlipidemia See Appendix D Refer to prescribing information Refer to prescribing information Varies Refer to prescribing information Appendix C: Contraindications/Boxed Warnings • Contraindication(s): o Serum triglyceride concentrations > 500 mg/dL o History of hypertriglyceridemia-induced pancreatitis
    o History of bowel obstruction • Boxed warning(s): none reported Page 4 of 7

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    Appendix D: High, Moderate, and Low Intensity Statins High atorvastatin 40-80 mg
    rosuvastatin 20-40 mg Moderate atorvastatin 10-20 mg fluvastatin XL 80 mg
    fluvastatin 40 mg twice daily lovastatin 40 mg
    pitavastatin 2-4 mg
    pravastatin 40-80 mg
    rosuvastatin 5-10 mg
    simvastatin 20-40 mg Low fluvastatin 20-40 mg
    lovastatin 20 mg pitavastatin 1 mg pravastatin 10-20 mg simvastatin 10 mg Appendix E: Statin Contraindications • Decompensated liver disease (development of jaundice, ascites, variceal bleeding, encephalopathy) • Laboratory-confirmed acute liver injury or rhabdomyolysis resulting from statin treatment • Pregnancy, actively trying to become pregnant, or nursing o In July 2021, the FDA requested removal of the contraindication in pregnant patients. At the time of this review, statin manufacturers have not yet revised their labels.
    https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal- strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancy Immune-mediated hypersensitivity to the HMG-CoA reductase inhibitor drug class (statins) as evidenced by an allergic reaction occurring with at least TWO different statins
    • V. Dosage and Administration
    Indication Primary hyperlipidemia and type 2 diabetes mellitus Dosing Regimen Oral suspension packets: 3.75 g PO QD Maximum Dose Packet: 3.75 g/day VI. Product Availability
    • Tablet: 625 mg • Oral suspension packet: 3.75 g
    VII.