Cigna celecoxib step therapy Coverage Update

Coverage Criteria

Step 2 (generic celecoxib) criteria

Approve the Step 2 Product (generic celecoxib) for 1 year if one of the following is met; approve for 30 days for perioperative use.

Step 2 approval conditions: A) Individual has tried two Step 1 Products (oral NSAIDs), either as prescription products or as over-the-counter (OTC) products, at prescription-strength doses for the current condition; OR B) Individual is currently taking chronic systemic corticosteroid therapy (e.g., prednisone), warfarin, clopidogrel, prasugrel, Brilinta (ticagrelor tablets), Xarelto (rivaroxaban tablets and oral suspension), Pradaxa (dabigatran capsules), Eliquis (apixaban tablets), Savaysa (edoxaban tablets), chronic aspirin therapy, fondaparinux injection, or a low molecular weight heparin product (e.g., enoxaparin injection, Fragmin [dalteparin injection]); OR C) Individual has reduced platelet counts or other coagulation disorders; OR D) Individual is > 75 years of age and is using celecoxib for a chronic condition; OR E) Individual has had a documented upper gastrointestinal bleed from a duodenal or gastric ulcer.n/a

Perioperative use approved for 30 days (see separate perioperative node).

Step 2 perioperative use

30-day approval

Perioperative Step 2: Individual is using the product during the preoperative/perioperative/postoperative period.30 days

Approves Step 2 for 30 days.

Step 3 (brand Celebrex) criteria — 1 year

Approve the Step 3 Product (brand Celebrex) for 1 year if BOTH A and B are met.

Step 3 (1-year) requirements: A) Individual meets one of the following: i) Individual has tried two Step 1 products (oral NSAIDs), either as prescription products or as over-the-counter (OTC) products, at prescription-strength doses for the current condition; OR ii) Individual is currently taking chronic systemic corticosteroid therapy (e.g., prednisone), warfarin, clopidogrel, prasugrel, Brilinta (ticagrelor tablets), Xarelto (rivaroxaban tablets and oral suspension), Pradaxa (dabigatran capsules), Eliquis (apixaban tablets), Savaysa (edoxaban tablets), chronic aspirin therapy, fondaparinux injection, or a low molecular weight heparin product (e.g., enoxaparin injection, Fragmin [dalteparin injection]); OR iii) Individual has reduced platelet counts or other coagulation disorders; OR iv) Individual is > 75 years of age and is using celecoxib for a chronic condition; OR v) Individual has had a documented upper gastrointestinal bleed from a duodenal or gastric ulcer; AND B) Individual has tried the Step 2 Product (generic celecoxib).n/a

Both A and B must be met for 1-year approval of brand Celebrex.

Step 3 perioperative use

Approve Step 3 for 30 days if both conditions met

Step 3 perioperative requirements: A) Individual is using the product during the preoperative/perioperative/postoperative period; AND B) Individual has tried the Step 2 Product (generic celecoxib).30 days

Approves brand Celebrex for 30 days for perioperative use after trial of generic celecoxib.

Any request asserting an exception not specifically listed in this policy is regarded as not medically necessary. Providers should rely on the explicit exception criteria within the step therapy rules when seeking coverage; requests based on other, unlisted reasons will not meet coverage requirements and may be denied.

Requests that do not satisfy the policy's step therapy criteria or do not document a qualifying exception are considered not medically necessary. Prior authorization requests must meet the specified Step 1/Step 2/Step 3 requirements or an approved exception to be approved.

Initial Therapy / Step 1

Initial therapy / step 1

Step 1 = multiple oral NSAIDs (listed); Step 2 = generic celecoxib; Step 3 = brand Celebrex.

Initial Step 1 requirement: Patient should try Step 1 oral NSAIDs (two products) at prescription-strength doses for the current condition prior to Step 2/3 unless an exception applies.two Step 1 products

Step 1 includes listed oral NSAIDs (e.g., Cataflam; diclofenac potassium; diclofenac sodium [IR and ER]; diclofenac sodium and misoprostol) and other NSAIDs noted in the policy; some generic naproxen and tolmetin products are not Step 1 products.

Continuation and Duration

Continuation/Duration

Duration of approvals and conditions for ongoing therapy

Continuation for Step 2/3: When approval criteria are met, Step 2 and Step 3 agents are approved for the durations specified: 1 year for chronic indications when initial criteria are met; 30 days for perioperative use.1 year or 30 days

Continued approval requires documentation that initial criteria remain met as described in the policy.

Step Therapy Structure

Requirement	Details
Step 1 trial requirement	Patient must have tried two Step 1 oral NSAID products (prescription or OTC at prescription-strength doses) for the current condition prior to approval of Step 2 (generic celecoxib) or Step 3 (brand Celebrex), unless a listed exception applies.
Step 2 before Step 3	Approval of the Step 3 Product (brand Celebrex) for 1 year requires that the individual has tried the Step 2 Product (generic celecoxib) in addition to meeting one of the Step 1-related exception criteria; for 30-day perioperative approval, the individual must have tried the Step 2 Product and meet perioperative criteria.
Perioperative allowance	Step 2 or Step 3 may be approved for 30 days when used during the preoperative/perioperative/postoperative period; Step 3 30-day approval requires both perioperative use and prior trial of the Step 2 Product.
Exceptions to Step 1 trials	Exceptions allowing Step 2 (or Step 3 when A is met) without prior Step 1 trials include: current chronic systemic corticosteroid therapy; use of anticoagulant/antiplatelet agents (includes specified agents and Xarelto oral suspension); reduced platelet counts or other coagulation disorders; age >75 years using celecoxib for a chronic condition; or documented upper GI bleed from duodenal or gastric ulcer.
Consequence of noncompliance	If the Step Therapy rule is not met at point of service, coverage will be determined by the Step Therapy criteria and requests not meeting the specified criteria or documented exceptions are considered not medically necessary.

Product Identifiers & Required Trials

Product Identifiersmixed

109120	Product Identifier (effective 1/1/23 to 2/27/23)
14735	Product Identifier (effective 2/28/23)

inv-08: Required prior trials — Two Step 1 oral NSAID products tried at prescription-strength doses.

Required prior trialsTwo Step 1 oral NSAID products tried at prescription‑strength doses for the current condition (may be prescription or OTC products).

Acceptable documentationProvider must document trials of two different Step 1 oral NSAIDs at prescription‑strength doses or document a qualifying exception per policy.

Perioperative exceptionIf used during the preoperative/perioperative/postoperative period, approve Step 2 for 30 days without additional Step 1 trial documentation beyond perioperative indication.

Role for Step 2 to Step 3For 1‑year approval of Step 3 (brand Celebrex), trials of two Step 1 products are one of the acceptable A‑criteria and the member must also have tried the Step 2 Product (generic celecoxib).

Provider Actions & Documentation

Step Therapy

Prior Authorization Required: Step Therapy Structure

Prior authorization: Step therapy prior authorization requires that patients try two Step 1 oral NSAIDs before progressing to the Step 2 product (generic celecoxib), and must try Step 2 before approval of the Step 3 product (brand Celebrex) except when a listed exception applies. All approvals are provided for the durations specified below.

Step 1 = oral NSAIDs (examples include diclofenac potassium, diclofenac sodium IR/ER, diclofenac sodium + misoprostol, Cataflam). Some generic naproxen and tolmetin products are NOT Step 1.
Step 2 = generic celecoxib capsules.
Step 3 = brand Celebrex capsules.

Documentation Required

Documentation Required for Approval

Required documentation for approval: Provider must document prior use of two Step 1 products (oral NSAIDs) at prescription-strength doses for the current condition — documentation may include prescription history or chart notes indicating OTC use at prescription-strength dosing. For requests to Step 2 or Step 3 based on clinical exceptions, the provider must document the qualifying exception (see criteria) such as concurrent anticoagulant/antiplatelet therapy, chronic systemic corticosteroid use, coagulation disorder, age > 75 for chronic use, or a documented upper gastrointestinal bleed from a duodenal or gastric ulcer.

Background & Definitions

Celecoxib is a selective COX-2 inhibitor nonsteroidal anti-inflammatory drug indicated for conditions such as osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis (≥2 years), ankylosing spondylitis, acute pain, and primary dysmenorrhea. Its COX-2 selectivity may reduce gastrointestinal risk compared with nonselective NSAIDs while providing analgesic and anti-inflammatory effects similar to other NSAIDs at equipotent doses. This clinical profile underlies the policy's step-therapy approach that reserves generic celecoxib and brand Celebrex for use after trials of conventional oral NSAIDs or when specified clinical exceptions apply.

inv-14: Celecoxib (COX-2 inhibitor) — short definition/key facts.

Drug classCelecoxib is a COX‑2 selective nonsteroidal anti‑inflammatory drug (NSAID).

Mechanism of actionWorks primarily by inhibiting prostaglandin synthesis via cyclooxygenase‑2 (COX‑2) and at therapeutic concentrations does not inhibit COX‑1.

Indications listed in policyOsteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis (≥2 years), ankylosing spondylitis, acute pain, and primary dysmenorrhea.

Revision History

2022-09-07annual_revisionLatest

Step 1 products updated to add Cataflam and fenoprofen; criterion updated to include Xarelto oral suspension (rivaroxaban) in the medication-list criterion.

OpenPayer

Step therapy policy for celecoxib (Celebrex)