mhn Celecoxib Prior Auth Coverage Policy Update

Coverage Criteria

Initial Therapy - Acute Migraine (Elyxyb)

Covered when ALL of the following are met

Elyxyb Acute Migraine Initial: 1) Request is for Elyxyb; 2) Diagnosis of migraine; 3) Age ≥ 18 years; 4) Member meets one of the following (a, b, c, d, or e): a. Age > 65 years; b. Current use of a corticosteroid; c. Current use of an anticoagulant or antiplatelet (e.g., aspirin, warfarin, low molecular weight heparin, direct thrombin inhibitors, factor Xa inhibitors, clopidogrel); d. Prior gastrointestinal bleed or active peptic ulcer disease (not GERD); e. Failure of a ≥ 4 week trial of both of the following (i and ii) up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced: i. Meloxicam; ii. One additional generic NSAID; 5) Dose does not exceed 120 mg (4.8 mL) per day.dose <= 120 mg/day

Approval duration 12 months

Initial Therapy - Celebrex (All Other Indications, Medicaid & CA Commercial)

Covered when ALL of the following are met

Celebrex Other Indications (Medicaid & CA Commercial): 1) Request is for Celebrex; 2) Age ≥ 2 years; 3) For brand Celebrex requests, member must use generic celecoxib unless contraindicated or clinically significant adverse effects are experienced; 4) Member meets one of the following (a, b, c, d, or e): a. Age > 65 years; b. Current use of a corticosteroid; c. Current use of an anticoagulant or antiplatelet (e.g., aspirin, warfarin, low molecular weight heparin, direct thrombin inhibitors, factor Xa inhibitors, clopidogrel); d. Prior gastrointestinal bleed or active peptic ulcer disease (not GERD); e. Failure of a ≥ 4 week trial of both of the following (i and ii) up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced: i. Meloxicam; ii. One additional generic NSAID; 5) Dose does not exceed both of the following: a. 800 mg per day; b. 2 capsules per day.dose <= 800 mg/day AND <= 2 capsules/day

Approval duration 12 months

Initial Therapy - Vyscoxa (All Other Indications)

Covered when ALL of the following are met

Vyscoxa Other Indications: 1) Request for Vyscoxa; 2) Age ≥ 2 years; 3) Member must use generic celecoxib capsule formulation unless contraindicated or clinically significant adverse effects are experienced; 4) Member meets one of the following (a, b, c, d, or e): a. Age > 65 years; b. Current use of corticosteroid; c. Current use of an anticoagulant or antiplatelet (e.g., aspirin, warfarin, low molecular weight heparin, direct thrombin inhibitors, factor Xa inhibitors, clopidogrel); d. Prior gastrointestinal bleed or active peptic ulcer disease (not GERD); e. Failure of a ≥ 4 week trial of both of the following (i and ii) up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced: i. Meloxicam; ii. One additional generic NSAID; 5) Dose does not exceed both of the following: a. 200 mg (20 mL) per dose; b. 400 mg (40 mL) per day.dose <= 400 mg/day and <= 200 mg per dose

Approval duration 12 months

Continued Therapy - Acute Migraine

Continued therapy covered when ALL of the following are met

Continued - Acute Migraine (Elyxyb): 1) Member meets one of the following: a. Currently receiving medication via Centene benefit or member has 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; 2) Member is responding positively to therapy; 3) If request is for a dose increase, new dose does not exceed 120 mg (4.8 mL) per day.

Continued Therapy - Celebrex and Vyscoxa

Continued therapy covered when ALL of the following are met

Continued - Celebrex Other Indications: 1) Member meets one of the following: a. Currently receiving medication via Centene benefit or member has 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; 2) Member is responding positively to therapy; 3) If request is for a dose increase, new dose does not exceed both of the following: a. 800 mg per day; b. 2 capsules per day.

Continued - Vyscoxa Other Indications: 1) Member meets one of the following: a. Currently receiving medication via Centene benefit or member has 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; 2) Member is responding positively to therapy; 3) If request is for a dose increase, new dose does not exceed both of the following: a. 200 mg (20 mL) per dose; b. 400 mg (40 mL) per day.

Coverage is NOT authorized for non‑FDA approved indications that are not specifically addressed in this policy unless the request includes sufficient clinical documentation demonstrating efficacy and safety per the applicable off‑label use processes. For commercial members follow CP.CPA.09; for Medicaid members follow CP.PMN.53, or provide an applicable evidence of coverage document to support authorization.

When there is a conflict between this clinical policy and state Medicaid coverage provisions for a Medicaid member, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific rules or coverage determinations that supersede this policy.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Celebrex, Elyxyb, and Vyscoxa. Requests must document the indication, age, dosing within policy limits, and fulfillment of prior trials or contraindications per the applicable criteria set (e.g., acute migraine criteria for Elyxyb or step/exception criteria for celecoxib products). Approval durations and dose limits are specified in the policy criteria sections.

Prior authorization required for Elyxyb, Celebrex (brand), Vyscoxa
Include indication, member age, prior therapy trials or contraindications, and dosing information

Documentation Required

Documentation Must Be Submitted

Providers must submit documentation (such as office chart notes, lab results, prior medication trials, and other clinical information) supporting that the member has met all approval criteria. Failure to provide sufficient documentation may result in denial or delay of the request.

Initial Therapy Criteria

Initial therapy — Initial therapy criteria vary by product and indication; all require documentation and specified age, prior therapy or risk factors

Initial therapy criteria vary by product and indication; all require documentation and specified age, prior therapy or risk factors

Initial therapy - Elyxyb: See Initial Therapy - Acute Migraine (Elyxyb) for full criteria (age requirement, risk factor/step criteria, and dose limit of 120 mg/day).

Initial therapy - Celebrex: See Initial Therapy - Celebrex (All Other Indications, Medicaid & CA Commercial) for full criteria (age requirement, generic-first requirement for brand requests, risk factor/step criteria, and dose limits up to 800 mg/day and 2 capsules/day).

Initial therapy - Vyscoxa: See Initial Therapy - Vyscoxa (All Other Indications) for full criteria (age requirement, generic-first requirement, risk factor/step criteria, and dose limits up to 400 mg/day and 200 mg per dose).

Continuation Therapy Criteria

Continuation therapy — Continuation therapy criteria mirror initial approval with requirement that member is responding and dose limits are not exceeded

Continuation therapy criteria mirror initial approval with requirement that member is responding and dose limits are not exceeded

Continuation - general: Member currently receiving medication via Centene benefit or previously met initial approval criteria or continuity of care applies; member responding positively to therapy; dose increases must not exceed policy-specified maximums (see product-specific continuation criteria).

Step Therapy / Generic-First Policies

Step	Requirement	Notes / Cross-reference
1	For brand Celebrex requests, member must use generic celecoxib capsule formulation unless contraindicated or clinically significant adverse effects are experienced.	Refer to Step Therapy policy CP.CPA.83 for Oregon Commercial; policy history documents redirection to generic celecoxib per formulary status.

Historical action	Description	Referenced policies / history
Formulary redirection to generic celecoxib	Policy history (2Q 2022 review) added redirection to generic celecoxib for brand Celebrex requests per formulary status; limitation of Elyxyb to its FDA-labeled indication was also added.	References: HIM.PA.109 (historical), CP.CPA.83 (Oregon Commercial) noted; redirection recorded in policy change notes (see 2Q 2022 and 2Q 2023 entries).

Quantity and Dose Limits

inv-24: Celecoxib (Celebrex, Elyxyb, Vyscoxa) — per policy dose limits

Policy summaryPer policy, celecoxib products have formulation-specific maximum daily limits: Elyxyb 120 mg/day; Celebrex up to 800 mg/day (formulation- and indication-dependent); Vyscoxa dosing varies by formulation with per-dose and daily limits.

Elyxyb formulationOral solution: 120 mg/4.8 mL (25 mg/mL); maximum daily dose 120 mg/day.

Celebrex formulationCapsules available in 50, 100, 200, 400 mg; maximum dose up to 800 mg/day depending on indication.

Vyscoxa formulationOral suspension (10 mg/mL) with indication-dependent dosing limits; see product-specific per-dose and daily maximums.

inv-25: Celecoxib (Celebrex) — up to 800 mg/day (formulation and indication dependent)

Maximum daily dose

Definitions, Boxed Warnings and Contraindications

inv-17: Boxed warnings / Contraindications

Cardiovascular boxed warningIncreased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke; boxed warning present for celecoxib products.

Gastrointestinal boxed warningIncreased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines.

Contraindications (selected)Hypersensitivity to celecoxib or components, history of asthma or allergic-type reactions to aspirin/NSAIDs, use in setting of CABG surgery, allergy to sulfonamides.

inv-18: COX-2 inhibitor summary

Mechanism classSelective cyclooxygenase-2 (COX-2) inhibitor — a COX-2 selective NSAID with analgesic and anti-inflammatory effects.

Safety consideration

Background

Celecoxib is a selective COX‑2 inhibitor NSAID available in multiple formulations and marketed under the tradenames Celebrex, Elyxyb, and Vyscoxa (and as generic celecoxib). Indications included in this policy cover osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, juvenile rheumatoid/juvenile idiopathic arthritis (age ≥2 years for most products), acute pain and primary dysmenorrhea (Celebrex), and acute migraine in adults (Elyxyb).

Product availability varies by formulation: capsules are available for Celebrex (50 mg, 100 mg, 200 mg, 400 mg), Elyxyb is available as an oral solution, and Vyscoxa is provided in an oral suspension formulation. Dosing and maximum daily limits are formulation‑ and indication‑dependent (for example, Elyxyb acute migraine dosing is up to 120 mg/day, Celebrex dosing for many indications may be up to 800 mg/day, and Vyscoxa regimens may total 200–400 mg/day depending on the indication).

Use of celecoxib requires individual risk–benefit assessment because of class safety considerations, including boxed warnings for increased risk of serious cardiovascular thrombotic events and serious gastrointestinal bleeding and ulceration; contraindications include hypersensitivity to celecoxib or related NSAIDs and use in the setting of coronary artery bypass graft (CABG) surgery.

OpenPayer

Clinical Policy: Celecoxib (Celebrex, Elyxyb, Vyscoxa)

Coverage Criteria

Provider Actions and Requirements

Initial Therapy Criteria

Continuation Therapy Criteria

Step Therapy / Generic-First Policies

Quantity and Dose Limits

Definitions, Boxed Warnings and Contraindications

Background