CurrentCentenePolicy CP PMN.250

Colesevelam (Welchol) oral suspension packets — coverage criteria and prior authorization

Covers medical necessity and prior authorization criteria for colesevelam (Welchol) packet for suspension for primary hyperlipidemia and type 2 diabetes mellitus for Centene lines of business (HIM, Medicaid). Affects prescribers seeking coverage for the suspension packet formulation.

Policy Summary

PayerCentene

PolicyColesevelam (Welchol) oral suspension packets — coverage criteria and prior authorization

Policy CodePolicy CP PMN.250

Change TypeNo material clinical or coverage changes

Effective DateDec 1, 2020

Next Review Date

Key ActionSubmit prior authorization for Welchol suspension packets with documentation of indication-specific criteria and supporting clinical records.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6initial approval (months)

12continued approval (months)

3.75 gmax dose (per day)

500 mg/dLtriglyceride cutoff

≥10 yrmin age (hyperlipidemia)

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Coverage Criteria for Colesevelam (Welchol) Oral Suspension

Initial Therapy - Primary Hyperlipidemia

Covered when ALL of the following are met:

Primary Hyperlipidemia initial criteria: 1) Request is for Welchol packet for suspension; 2) Prescribed for lipid lowering; 3) Documentation supports inability to swallow pills or clinically significant adverse effects to Welchol tablets; 4) Age >= 10 years; 5) 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; 6) Failure of >= 3 consecutive months of adherent statin therapy, unless contraindicated or clinically significant adverse effects are experienced; 7) 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.dose <= 3.75 g/day; triglycerides <= 500 mg/dL

Approval duration: 6 months

Initial Therapy - Type 2 Diabetes Mellitus

Covered when ALL of the following are met:

Type 2 Diabetes initial criteria: 1) 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 >= 6.5%; 5) Failure of adherent use of a triple anti-diabetic regimen which must include metformin in combination with agents from classes (GLP-1 receptor agonist, DPP-4 inhibitor, SGLT-2 inhibitor, TZD, or basal insulin) for >= 3 months unless contraindicated or clinically significant adverse effects are experienced; 6) Current (within the last 3 months) serum triglyceride concentrations do not exceed 500 mg/dL; 7) 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; 8) Dose does not exceed oral suspension packet of 3.75 grams (1 packet) per day.HbA1c >= 6.5%; dose <= 3.75 g/day; triglycerides <= 500 mg/dL

Approval duration: 6 months

Continued Therapy

Covered when ANY of the following are met (a or b) and all continuation requirements:

Continued therapy criteria: a) Member is currently receiving medication via Centene benefit or has previously met initial approval criteria; OR b) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations. AND member is responding positively to therapy; 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; If request is for a dose increase, new dose must not exceed oral suspension packet of 3.75 grams (1 packet) per day.dose <= 3.75 g/day

Approval duration: 12 months

Contraindications

Not covered / contraindicated when ANY of the following are present:

Contraindications list: Serum triglyceride concentrations >=500 mg/dL; history of hypertriglyceridemia-induced pancreatitis; history of bowel obstruction; laboratory-confirmed acute liver injury or rhabdomyolysis from statin treatment; decompensated liver disease; pregnancy, actively trying to become pregnant, or nursing; immune-mediated hypersensitivity to HMG-CoA reductase inhibitors evidenced by reaction to at least two different statins.

Items compiled from Appendix C and E

Dosing and Formulation

Coverage requests should align with labeled dosing and available products:

Dosing and formulation: Oral suspension packets: 3.75 g PO once daily (3.75 g QD); Tablet available as 625 mg. Requests should specify formulation and dose consistent with labeled regimens.

From Dosage and Product Availability sections

Non‑FDA approved indications not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the plan's off‑label use requirements (see applicable off‑label policies referenced by the plan).

Use of colesevelam is excluded/contraindicated for patients with serum triglyceride concentrations of 500 mg/dL and for those with a history of hypertriglyceridemia‑induced pancreatitis.

Colesevelam is not indicated for the treatment of type 1 diabetes or diabetic ketoacidosis. Use is contraindicated when serum triglyceride concentrations are ≥ 500 mg/dL or when there is a history of hypertriglyceridemia‑induced pancreatitis.

The policy appendix notes statin contraindications including pregnancy, active attempts to conceive, and nursing; it also documents that the FDA requested removal of the pregnancy contraindication in July 2021 but manufacturers had not updated labels at the time of review. This label discrepancy is informational and may affect interpretation of statin use in pregnancy.

Product Availability, Codes, and Key Clinical Thresholds

Product availabilityNDC

Tablet 625 mg	Colesevelam tablet strength (label-stated product availability)
Oral suspension packet 3.75 g	Colesevelam oral suspension packet strength

Serum triglyceride concentration — <= 500 mg/dL

Serum triglyceride concentration (requirement)Current (within the last 3 months) serum triglyceride concentrations do not exceed 500 mg/dL

ContextApplies to initial requests for Welchol packet for suspension for both primary hyperlipidemia and type 2 diabetes mellitus

Verification timeframeTriglyceride result must be within the last 3 months at time of request

Age for primary hyperlipidemia suspension — >= 10 years

Minimum age (primary hyperlipidemia)Age ≥ 10 years

Applicable indicationRequirement for initial therapy with Welchol packet for suspension for primary hyperlipidemia

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization: formulation and dose

Prior authorization is required for Welchol oral suspension packets. Requests must specify the formulation (oral suspension packet) and the requested dose. Documentation should clearly support the formulation and dose (oral suspension packet 3.75 g PO QD is the dosing regimen and maximum single‑day packet).

Specify formulation: oral suspension packet (3.75 g)
Specify dose: do not exceed 3.75 g (1 packet) per day
Include documentation that formulation and dose are medically necessary

Documentation Required

Documentation Required — risk of denial if incomplete

Provider must submit supporting clinical documentation with the prior authorization request (e.g., office chart notes, lab results, medication trials, and notes on pill‑swallowing ability or adverse effects). Requests that lack required documentation may be denied.

Background and Clinical Context

Colesevelam is a bile acid sequestrant indicated to reduce elevated LDL‑C in adults with primary hyperlipidemia and to improve glycemic control in adults with type 2 diabetes mellitus.

Definitions and Abbreviations

HeFH — Heterozygous familial hypercholesterolemia

TermHeFH = Heterozygous familial hypercholesterolemia

Use in policyReferenced in Appendices/General Information as abbreviation key

RelevanceBackground clinical context for LDL-C lowering indications

LDL-C — Low-density lipoprotein cholesterol

TermLDL-C = Low-density lipoprotein cholesterol

Use in policyDefines the lipid parameter targeted by colesevelam for primary hyperlipidemia

Appendix location

Policy Summary

PayerCentene

PolicyColesevelam (Welchol) oral suspension packets — coverage criteria and prior authorization

Policy CodePolicy CP PMN.250

Change TypeNo material clinical or coverage changes

Effective DateDec 1, 2020

Next Review Date

Key ActionSubmit prior authorization for Welchol suspension packets with documentation of indication-specific criteria and supporting clinical records.

SourceLink

On This Page

Source sectionPrimary Hyperlipidemia initial criteria

Age for type 2 diabetes mellitus — > 18 years

Minimum age (type 2 diabetes mellitus)Age > 18 years

Applicable indicationRequirement for initial therapy with Welchol packet for suspension for type 2 diabetes mellitus

Source sectionType 2 Diabetes Mellitus initial criteria

Serum triglyceride concentration (contraindication threshold) — >= 500 mg/dL

Contraindication thresholdSerum triglyceride concentrations ≥500 mg/dL

Clinical consequencePresence of this triglyceride level is listed as a contraindication and would trigger denial

Related contraindicationHistory of hypertriglyceridemia-induced pancreatitis is also listed alongside this threshold

Include chart notes and labs demonstrating diagnosis and current triglyceride level (within last 3 months)
Document inability to swallow tablets or clinically significant adverse effects to tablets when requesting suspension
Document prior trials (and dates/doses) of alternative bile acid sequestrants and statin adherence where applicable

Step Therapy

Step Therapy Required: trials of alternatives and adherent therapies

Step therapy requirements: prior to approval for Welchol oral suspension packets, providers must document trials of alternative bile acid sequestrants (colestipol granules and cholestyramine powder for suspension) at maximally indicated doses for ≥ 3 months each, unless contraindicated or clinically significant adverse effects occurred. For primary hyperlipidemia, also document trial of at least 3 months of adherent statin therapy unless contraindicated or not tolerated. For type 2 diabetes mellitus, document failure of an adherent triple anti‑diabetic regimen (including metformin) as specified.

Colestipol granules and cholestyramine powder for suspension: trials of up to maximally indicated doses for ≥ 3 months each, unless contraindicated
Adherent statin therapy: ≥ 3 consecutive months of adherence unless contraindicated or adverse effects
Type 2 diabetes: adherent triple regimen including metformin for ≥ 3 months unless contraindicated

Note

Formulary redirection: generic preferred

If a brand Welchol packet for suspension is requested, the member must use the generic colesevelam suspension when available unless there is a documented contraindication or clinically significant adverse effect to the generic. This aligns with formulary redirection to generics.

Brand requests will be redirected to generic colesevelam suspension unless contraindicated or adverse effects documented
Check formulary status and prior authorization requirements for the generic product

Denial Risk

Contraindications — do not approve if present

Contraindications and lab thresholds must be documented. Do not approve if serum triglycerides ≥ 500 mg/dL or there is a history of hypertriglyceridemia‑induced pancreatitis. Also note history of bowel obstruction is a contraindication per appendix.

Ensure recent (within 3 months) serum triglyceride level is provided and < 500 mg/dL
Document absence of history of hypertriglyceridemia‑induced pancreatitis
Document absence of bowel obstruction

Listed in Appendix A: Abbreviation/Acronym Key

SGLT-2 — Sodium glucose co-transporter-2

TermSGLT-2 = Sodium glucose co-transporter-2

ContextOne of the antidiabetic drug classes referenced in the required triple regimen for type 2 diabetes criteria

Appendix locationListed in Appendix A: Abbreviation/Acronym Key

Contraindication — Conditions including serum triglyceride concentrations ≥500 mg/dL and history of pancreatitis

Definition (contraindication)Includes serum triglyceride concentrations ≥500 mg/dL and history of hypertriglyceridemia-induced pancreatitis

Additional itemsAlso lists history of bowel obstruction among contraindications

Policy effectPresence of any listed contraindication is a basis for non‑coverage/denial

Statin contraindication (pregnancy) — Note regarding FDA requested label change and manufacturer updates

Statin pregnancy contraindication noteAlthough the FDA requested removal of the contraindication in pregnancy in July 2021, manufacturers had not revised labels at time of review; pregnancy remains listed in the statin appendix

ScopeThis note appears in the statin contraindications appendix and may affect interpretation for statin therapy but is informational for colesevelam

Source appendixAppendix E: Statin Contraindications