Centene celecoxib coverage Prior Auth update

Coverage and Approval Criteria

Initial Therapy — Elyxyb (Acute Migraine)

Covered when ALL of the following are met for Elyxyb (acute migraine):

Elyxyb Acute Migraine Initial: 1) Request is for Elyxyb; 2) Diagnosis of migraine; 3) Age >= 18 years; 4) Member meets one of the following risk criteria: (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), OR (e) failure of a 24-week trial of both: i) meloxicam and ii) one additional generic NSAID, each up to maximally indicated doses unless contraindicated or clinically significant adverse effects occurred; 5) Requested dose does not exceed 120 mg (4.8 mL) per day.

Approval duration: 12 months

Initial Therapy — Celebrex (Other Indications, Medicaid and CA Commercial)

Covered when ALL of the following are met for Celebrex (Medicaid and California Commercial only):

Celebrex Other Indications Initial: 1) Request is for Celebrex; 2) Age >= 2 years; 3) For brand Celebrex requests, member must use generic celecoxib capsule formulation unless contraindicated or clinically significant adverse effects are experienced; 4) Member meets one of the following: (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), OR (e) failure of a >= 4-week trial of both: i) meloxicam and ii) one additional generic NSAID, each up to maximally indicated doses unless contraindicated or clinically significant adverse effects occurred; 5) Dose does not exceed 800 mg per day and does not exceed 2 capsules per day.

Approval duration: 12 months

Initial Therapy — Vyscoxa (Other Indications)

Covered when ALL of the following are met for Vyscoxa (Other Indications):

Vyscoxa Other Indications Initial: 1) Request is 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) 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), OR (e) failure of a >= 4-week trial of both: i) meloxicam and ii) one additional generic NSAID, each up to maximally indicated doses unless contraindicated or clinically significant adverse effects occurred; 5) Dose does not exceed 200 mg (20 mL) per dose and 400 mg (40 mL) per day.

Approval duration: 12 months

Continued Therapy

Covered continuation when ALL of the following are met:

Continued Therapy General: 1) Member is currently receiving the medication via the Centene benefit or has previously met initial approval criteria OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy; 3) If the request is for a dose increase, the new dose does not exceed the formulation-specific maximums (examples: Elyxyb 120 mg/day [4.8 mL/day]; Celebrex 800 mg/day and 2 capsules/day; Vyscoxa 200 mg [20 mL] per dose and 400 mg [40 mL] per day).

Approval duration: 12 months

Requests for indications that are not FDA‑approved and are not specifically addressed in this policy will be denied unless the provider supplies sufficient documentation of efficacy and safety per Centene off‑label use requirements. Supporting documentation must align with the referenced off‑label use policies (e.g., CP.CPA.09 for Commercial and CP PMN.53 for Medicaid) or with an approved evidence of coverage document demonstrating the requested non‑labeled use is appropriate.

Celecoxib and other NSAIDs carry a boxed warning for an increased risk of serious cardiovascular (CV) thrombotic events (including myocardial infarction and stroke) and for serious, potentially life‑threatening gastrointestinal (GI) bleeding. Clinical decision‑making should individualize use based on the patient’s prior GI history, comorbid conditions (for example, angina, ischemic heart disease, prior MI, coronary artery disease, stroke), age, concurrent medications (such as warfarin or systemic corticosteroids), and the anticipated dose and duration of therapy.

Initial Therapy Requirements by Formulation

Initial Therapy — criteria sets vary by formulation and indication

Initial approval requirements vary by formulation and indication; see specific criteria sets below.

Initial therapy sets: Refer to the specific initial therapy criteria sets for Elyxyb (acute migraine), Celebrex (other indications for Medicaid and California Commercial), and Vyscoxa (other indications).

Initial dosing by indication — dosing regimens and max daily doses differ

Dosing regimens and maximum daily doses differ by indication and by product formulation.

OA dosing (Celebrex / Vyscoxa): Celecoxib (Celebrex): 200 mg PO once daily or 100 mg PO twice daily; maximum 800 mg/day. Celecoxib (Vyscoxa): 200 mg PO once daily or 100 mg PO twice daily; Vyscoxa maximum single dose 200 mg (20 mL); maximum 400 mg/day.

RA dosing:

Continuation Approval Requirements

Continuation Therapy — continuation approval requirements

Continuation approval requirements:

Continuation — Elyxyb/Celebrex/Vyscoxa: 1) Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria OR continuity of care regulations apply for the member's state/product; 2) Member is responding positively to therapy; 3) Requested dose increases must not exceed the specified maximums for the formulation and indication (e.g., Elyxyb 120 mg/day; Celebrex 800 mg/day and 2 capsules/day; Vyscoxa 200 mg per dose and 400 mg/day).

Approval duration: 12 months

Step Therapy and Trial Requirements

Step	Requirement	Details
1	Trial and failure or intolerance of specified NSAIDs required before approval	For acute migraine (Elyxyb): failure of a 24-week trial of both meloxicam and one additional generic NSAID up to maximally indicated doses unless contraindicated or clinically significant adverse effects occur; for other celecoxib formulations for other indications the policy requires failure of a ≥4-week trial of meloxicam and one additional generic NSAID up to maximally indicated doses unless contraindicated or intolerant.

Policy action	Applicability	Notes
Formulary redirection to generic celecoxib	Brand Celebrex requests	For brand Celebrex requests, member must use generic celecoxib unless contraindicated or clinically significant adverse effects are experienced; policy history notes added redirection to generic celecoxib for brand Celebrex per formulary status.

Quantity Limits and Maximum Daily Doses

inv-23: Elyxyb — per-dose/limit value

Limit (per day)120 mg per day (4.8 mL)

FormulationElyxyb oral solution (120 mg/4.8 mL)

Approval duration12 months

inv-24: Celebrex — per-dose/limit value

Maximum daily dose800 mg per day

Capsule limitNo more than 2 capsules per day (for indicated dosing)

Approval duration12 months (Medicaid and California Commercial only)

Prior Authorization, Documentation, and Formulary Actions

Prior Authorization

Prior Authorization Required

Prior Authorization Required — provider must submit documentation that the member meets specific approval criteria. Supporting clinical documentation should be included (e.g., office chart notes, lab results, prior medication trials, imaging) to demonstrate that all criteria are met.

Provider must provide supporting clinical documentation (office notes, labs, medication history).
Requests lacking adequate documentation may be denied.

Step Therapy

Prior authorization and step references

Prior authorization requirements and step therapy applicability are clarified by line of business. For Oregon Commercial, reference Step Therapy policy CP.CPA.83 where noted. For applicable lines of business, step therapy requirements and formulary redirection may apply; see referenced step therapy policies for details.

Step therapy references are included in criteria where applicable.
Policy clarifies applicability by line of business (e.g., California Commercial-only language where specified).

Key Definitions and Safety Warnings

inv-16: Celecoxib class — COX-II NSAID

Drug classCOX-2 selective nonsteroidal anti-inflammatory drug (COX-II NSAID)

Common drug namesCelecoxib (Celebrex), Elyxyb, Vyscoxa, generic celecoxib

Typical usesOA, RA, AS, JRA (>=2 years), acute pain, dysmenorrhea, migraine (product-specific)

inv-17: Boxed warning — FDA boxed warning for increased CV and GI risks

FDA boxed warningIncreased risk of serious cardiovascular thrombotic events (including MI and stroke) and increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation

Clinical implicationWeigh risks vs. benefits and individualize use based on GI history, CV risk, age, and concurrent medications (e.g., warfarin, corticosteroids)

Background and Drug Information

Celecoxib is a selective COX‑2 inhibitor NSAID available in multiple formulations, including capsules and an oral solution/suspension, with product‑specific indications. Indications include treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, juvenile rheumatoid/idiopathic arthritis (age ≥2 years), and certain products/formulations are indicated for acute pain, primary dysmenorrhea, or acute migraine. Prescribing should follow the formulation‑specific dosing limits and safety information detailed elsewhere in this policy.

OpenPayer

Clinical Policy: Celecoxib (Celebrex, Elyxyb, Vyscoxa)

Coverage and Approval Criteria

Initial Therapy Requirements by Formulation

Continuation Approval Requirements

Step Therapy and Trial Requirements

Quantity Limits and Maximum Daily Doses

Prior Authorization, Documentation, and Formulary Actions

Key Definitions and Safety Warnings

Background and Drug Information