CurrentCentenePolicy CP.PMN.250

Colesevelam (Welchol) Clinical Policy

Defines medical necessity, prior authorization, step therapy, and dosing limits for colesevelam (Welchol) oral suspension packets for members under Centene lines of business (HIM, Medicaid). Applies to requests for Welchol packet for suspension for primary hyperlipidemia and type 2 diabetes mellitus.

Policy Summary

PayerCentene

PolicyColesevelam (Welchol) Clinical Policy

Policy CodePolicy CP.PMN.250

Change TypeNo material change

Effective DateDec 1, 2020

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria, including recent labs and prior therapy trial documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12approval duration (months)

3.75 gmax packet dose/day

≥10min age (hyperlipidemia)

≥18min age (T2DM)

≤500 mg/dLtriglyceride threshold

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Coverage and Medical Necessity Criteria

Initial therapy - Primary Hyperlipidemia

Covered when ALL of the following are met for Primary Hyperlipidemia:

Primary Hyperlipidemia criteria: 1) Request is for Welchol packet for suspension;

Primary Hyperlipidemia criteria: 2) Prescribed for lipid lowering;

Primary Hyperlipidemia criteria: 3) Age ≥ 10 years;

Primary Hyperlipidemia criteria: 4) Documentation supports inability to swallow pills or clinically significant adverse effects to Welchol tablets;

Primary Hyperlipidemia criteria: 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;

Primary Hyperlipidemia criteria: 6) Failure of ≥ 3 consecutive months of adherent statin therapy, unless contraindicated or clinically significant adverse effects are experienced;

Primary Hyperlipidemia criteria: 7) At the time of request, current (within the last 3 months) serum triglyceride concentrations do not exceed 500 mg/dL;<= 500 mg/dL

Primary Hyperlipidemia criteria: 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;

Primary Hyperlipidemia criteria: 9) Dose does not exceed oral suspension packet of 3.75 grams (1 packet) per day.<= 3.75 g/day

Approval duration: 12 months

Initial therapy - Type 2 Diabetes Mellitus

Covered when ALL of the following are met for Type 2 Diabetes Mellitus:

Type 2 Diabetes Mellitus criteria: 1) Request is for Welchol packet for suspension;

Type 2 Diabetes Mellitus criteria: 2) Diagnosis of type 2 diabetes mellitus;

Type 2 Diabetes Mellitus criteria: 3) Age ≥ 18 years;

Type 2 Diabetes Mellitus criteria: 4) HbA1c drawn within the past 3 months is ≥ 6.5%;>= 6.5% within past 3 months

Continuation therapy

Continuation/renewal criteria (All indications):

Continuation criteria: 1) Member meets one of the following: a) Currently receiving medication via Centene benefit or previously met initial approval criteria; or b) Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;

Continuation criteria: 2) Member is responding positively to therapy;

Continuation criteria: 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;

Continuation criteria: 4) If request is for a dose increase, new dose does not exceed oral suspension packet of 3.75 grams (1 packet) per day.<= 3.75 g/day

Requests for uses that are non‑FDA approved and not specifically addressed in this policy will not be authorized unless the provider submits sufficient documentation demonstrating efficacy and safety consistent with applicable off‑label use policies. See the referenced off‑label use policies (HIM.PA.154 for Health Insurance Marketplace and CP.PMN.53 for Medicaid) or the member’s evidence of coverage for acceptable supporting documentation.

Some clinical decisions in lipid management depend on statin eligibility. Appendix E lists statin‑specific contraindications such as decompensated liver disease, laboratory‑confirmed statin‑induced acute liver injury or rhabdomyolysis, pregnancy (including actively trying to conceive or nursing), and immune‑mediated hypersensitivity to statins. These contraindications are provided to inform when statin therapy may be inappropriate and could affect prior‑therapy or step‑therapy requirements.

Colesevelam (Welchol) is not indicated for the treatment of type 1 diabetes or for diabetic ketoacidosis (DKA), and such uses are considered not medically necessary under this policy. Additionally, requests for non‑FDA approved indications without adequate supporting documentation will be denied unless the off‑label use policies are satisfied.

Product Coding and Key Clinical Thresholds

Covered NDC / productNDCCovered

NDC	Welchol packet for suspension (oral suspension packet 3.75 g)

Serum triglycerides — required threshold at time of request

Required triglyceride thresholdSerum triglycerides must be <= 500 mg/dL at the time of request (current within last 3 months)

Contraindication noteRequests may be denied if triglycerides > 500 mg/dL or history of hypertriglyceridemia-induced pancreatitis

Supporting timeframeTriglyceride result must be current within the last 3 months per policy criteria

HbA1c (for T2DM) — A1c threshold/timeframe

HbA1c thresholdHbA1c must be >= 6.5%

Required timeframeHbA1c drawn within the past 3 months

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Welchol (colesevelam) packet for suspension. Approval is contingent on meeting the clinical criteria in this policy and submission of required supporting documentation. Requests that do not meet the criteria or lack appropriate documentation may be denied.

Prior authorization required for Welchol packet for suspension
Approvals based on meeting clinical criteria in this policy

Documentation Required

Documentation Required to Support Medical Necessity

Providers must submit documentation (e.g., office chart notes, lab results, medication history) demonstrating that the member meets all applicable approval criteria. Documentation should align with medical necessity definitions and the Health Plan's coverage determination processes.

Include recent labs (e.g., triglycerides, HbA1c where applicable)

Initial Approval Criteria by Indication

Initial therapy — criteria summary by indication

Top-level initial approval criteria summary and branching by indication:

Indication branch: Initial approval is determined by indication-specific criteria. See indication-specific sections for required elements.

Primary Hyperlipidemia branch: Requires age ≥ 10 years, prescribed for lipid lowering, pill-swallowing limitation or tablet intolerance, prior trials of colestipol and cholestyramine, prior statin trial, triglycerides <= 500 mg/dL, generic redirection when applicable, and dose <= 3.75 g/day.

Type 2 Diabetes Mellitus branch: Requires age ≥ 18 years, diagnosis of type 2 diabetes, HbA1c ≥ 6.5% within past 3 months, failure of a metformin-inclusive triple anti-diabetic regimen for ≥ 3 months, triglycerides <= 500 mg/dL, generic redirection when applicable, and dose <= 3.75 g/day.

Renewal and Ongoing Use Criteria

Continuation Therapy — criteria

Continuation/renewal criteria applicable to all indications:

Continuation — enrollment or prior approval: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria, or is covered under applicable continuity of care provisions;

Continuation — response: 2) Member is responding positively to therapy;

Continuation — generic redirection: 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;

Continuation — dosing limit: 4) Dose increase does not exceed oral suspension packet of 3.75 grams (1 packet) per day.

Step Therapy Rules and Exceptions

Requirement	Details	Duration / Minimum trial	Exemptions
Prior trials of bile acid sequestrant alternatives
Colestipol granules and cholestyramine powder; used at up to maximally indicated doses
>= 3 months each
Unless contraindicated or clinically significant adverse effects

Coverage-label	State / Statute	Effective date	Notes
neutral
Illinois HIM bypass per IL HB 5395
1/1/2026
Step therapy requirements do not apply to Illinois HIM requests as of this date; policy record notes addition of bypass in 4Q2025 review

Dose and Quantity Limits

Welchol oral suspension packet — daily packet dose/value (3.75)

Daily packet dose (value)3.75 g per packet — oral suspension dosing regimen 3.75 g PO once daily

UnitOne packet = 3.75 grams

IndicationsUsed for primary hyperlipidemia and type 2 diabetes mellitus as specified in dosing guidance

oral suspension packet — maximum packet size/value (3.75 g)

Maximum packet size/value3.75 g per packet (maximum packet dose = 3.75 g/day)

Maximum daily doseMaximum dose equals one packet (3.75 g) per day

Formulation note

Drug, Formulations, and Key Terms

Colesevelam (Welchol) — key drug definition and indication summary

Drug class and nameColesevelam (Welchol) — a bile acid sequestrant

Primary indicationAdjunct to diet and exercise to reduce LDL-C in adults with primary hyperlipidemia; also indicated for certain pediatric HeFH patients (boys and postmenarchal girls 10–17) unable to reach LDL-C targets

Diabetes indicationUsed to improve glycemic control in adults with type 2 diabetes mellitus (not indicated for type 1 diabetes or diabetic ketoacidosis)

LimitationsNot studied in Fredrickson Types I, III, IV, and V; not for type 1 diabetes or DKA

Product forms and dosing — tablet strength and oral suspension packet dosing/regimen

Tablet strength625 mg tablet

Clinical Background

Colesevelam (Welchol) is a bile acid sequestrant indicated as an adjunct to diet and exercise to reduce low‑density lipoprotein cholesterol (LDL‑C) in adults and certain pediatric HeFH patients and to improve glycemic control in adults with type 2 diabetes mellitus. It is available as 625 mg tablets and 3.75 g oral suspension packets; the oral suspension packet dosing regimen is 3.75 g PO once daily with a maximum of 3.75 g/day. Welchol is not indicated for type 1 diabetes or diabetic ketoacidosis and has not been studied in Fredrickson Types I, III, IV, or V dyslipidemias.

Policy Summary

PayerCentene

PolicyColesevelam (Welchol) Clinical Policy

Policy CodePolicy CP.PMN.250

Change TypeNo material change

Effective DateDec 1, 2020

Next Review Date

SourceLink

On This Page

Type 2 Diabetes Mellitus criteria:

5) Failure of adherent use of a triple anti-diabetic regimen which must include metformin in combination with agents from GLP-1 RA, SGLT-2 inhibitor, DPP-4 inhibitor, TZD, or basal insulin for ≥ 3 months, unless clinically significant adverse effects are experienced or all are contraindicated;

Type 2 Diabetes Mellitus criteria: 6) At the time of request, current (within the last 3 months) serum triglyceride concentrations do not exceed 500 mg/dL;<= 500 mg/dL

Type 2 Diabetes Mellitus criteria: 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;

Type 2 Diabetes Mellitus criteria: 8) Dose does not exceed oral suspension packet of 3.75 grams (1 packet) per day.<= 3.75 g/day

Approval duration: 12 months

Applies toAdults with type 2 diabetes mellitus (age >= 18 years) requesting Welchol packet for suspension

Provide chart notes showing intolerance/contraindication to required step therapy agents and prior medication trials

If continuation of therapy, include documentation of prior approval or evidence of current therapy and clinical benefit

Step Therapy

Step Therapy Requirements

Step therapy is required per the criteria unless a valid contraindication or clinically significant adverse effect is documented. For Primary Hyperlipidemia, providers must document failure of colestipol granules and cholestyramine powder each for ≥ 3 months at up to maximally indicated doses, and failure of ≥ 3 months of adherent statin therapy unless contraindicated. For Type 2 Diabetes Mellitus, failure of an adherent triple anti‑diabetic regimen (including metformin) for ≥ 3 months is required unless contraindicated.

Primary Hyperlipidemia: colestipol granules and cholestyramine powder each ≥ 3 months (unless contraindicated)
Primary Hyperlipidemia: ≥ 3 months adherent statin therapy unless contraindicated
Type 2 Diabetes Mellitus: ≥ 3 months adherent triple anti‑diabetic regimen including metformin unless contraindicated
Step therapy requirements do not apply for Illinois HIM requests per IL HB 5395 effective 1/1/2026

Prior Authorization

Illinois Step Therapy Bypass (IL HB 5395)

A step therapy bypass applies for Illinois HIM requests per Illinois HB 5395 (effective 1/1/2026). For requests subject to this law, the step therapy requirements described in this policy do not apply; however, providers must still submit documentation supporting medical necessity and any other applicable criteria.

IL HIM step therapy bypass effective 1/1/2026 — do not require step trials for Illinois HIM requests
Documentation of diagnosis and medical necessity still required for coverage determinations

Documentation Required

Statin Contraindications and Provider Action

Statin therapy is required as a step for primary hyperlipidemia unless statins are contraindicated. Documented statin contraindications that may justify bypassing statin trial include pregnancy (or actively trying to become pregnant, or nursing), decompensated liver disease, laboratory‑confirmed acute liver injury or rhabdomyolysis from statins, or immune‑mediated hypersensitivity to the statin class. If a statin is contraindicated, provide supporting clinical documentation in the request.

Common contraindications: pregnancy/trying to conceive/nursing; decompensated liver disease; prior statin‑induced acute liver injury or rhabdomyolysis; immune‑mediated hypersensitivity to statins
Include specific clinical notes and laboratory results to substantiate contraindication

Note

Coverage Determinations and Administrative Guidance

Coverage determinations are guided by this clinical policy but remain subject to the terms of the member's coverage documents and applicable state and federal requirements. Providers should ensure submitted documentation aligns with the Health Plan's medical necessity definitions and be aware that meeting policy criteria does not guarantee payment if other coverage limits or exclusions apply.

Coverage determinations follow this clinical policy and the member's benefit documents
Decisions subject to exclusions, limits, and state/federal regulations

General requirements: Provider must submit documentation (office chart notes, labs, trial/failure documentation) supporting that member has met all approval criteria; approval duration for initial requests is 12 months.

Initial therapy — dosing and approval duration

Dosing and approval duration notes for initial therapy:

Dosing: Oral suspension packet: 3.75 g PO once daily; maximum packet dose 3.75 g/day.

Approval duration: Initial authorization period: 12 months for chronic indications (primary hyperlipidemia and type 2 diabetes mellitus).

Continuation — approval duration: Approval duration for continuations: 12 months.

Continuation therapy — duration considerations

Renewal duration considerations reflected in review history:

Duration adjustment: Initial approval duration was extended from 6 months to 12 months for chronic indications (primary hyperlipidemia and type 2 diabetes mellitus) as documented in the 4Q 2025 review history.

Oral suspension packet supplied as 3.75 g single-dose packets

Oral suspension packet dosing/regimenOral suspension packet: 3.75 g PO once daily

Maximum packet doseMaximum packet dose = 3.75 g/day (one packet)

Statin contraindications (context) — brief definition/context for contraindications referenced elsewhere

Context for statin contraindicationsStatin contraindications listed include decompensated liver disease, laboratory‑confirmed acute liver injury or rhabdomyolysis from statins, pregnancy/actively trying to become pregnant or nursing, and immune‑mediated hypersensitivity to statins (reaction to at least two different statins)

Regulatory noteFDA requested removal of pregnancy contraindication in July 2021; manufacturers had not yet revised labels at time of review

Clinical relevanceThese contraindications may influence lipid‑lowering therapy choices and coverage decisions where statin therapy is relevant