CurrentBlue Cross Blue Shield - MassachusettsPolicy 002

COX-2 (COX‑II) inhibitor prior authorization and quantity limits

Defines prior authorization, step therapy, and quantity limit requirements for COX‑II selective NSAIDs (e.g., celecoxib, elyxyb, seglentis) for BCBS Massachusetts commercial members and describes documentation and individual consideration processes.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyCOX-2 (COX‑II) inhibitor prior authorization and quantity limits

Policy CodePolicy 002

Change TypeReformat and content updates (criteria additions/removals)

Effective Date12/2023

Next Review Date

Key ActionSubmit prior authorization using MA eForm #434 and include documentation of trials or contraindications for two traditional NSAIDs.

SourceLink

POLICY UPDATE CHANGES

Reformatted policy and updated individual consideration language; added summary description for NSAIDs and Traditional NSAIDs and criteria for specific products (Elyxyb, Seglentis).

Updated contact information and processes for submitting clinical documentation and exception requests.

24Approval length (months)

2Required prior NSAID failures

130Look-back (days)

621AQCD reference

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Coverage Criteria for COX‑II Inhibitors

Indication-specific coverage (celecoxib, Elyxyb, Seglentis)

Covered when ALL of the following are met (criteria vary by indication):

General: Request meets indication-specific criteria and required prior use/step therapy documentation is provided

Length of approval: 24 months per policy

Acute Pain: Treatment failure with two (2) traditional non-COX-II prescription NSAIDs or a contraindication to NSAID use2 prior NSAID failures

For a non-formulary/non-covered COX-II drug, previous failure with at least two covered formulary alternatives when available

Primary Dysmenorrhea: Treatment failure with two (2) traditional non-COX-II prescription NSAIDs or a contraindication to NSAID use2 prior NSAID failures

For a non-formulary/non-covered COX-II drug, previous failure with at least two covered formulary alternatives when available

Arthritis: One or more of the following: age ≥60 years; OR age ≥2 years with confirmed juvenile rheumatoid arthritis (JRA); OR one or more listed risk factors (history of GI ulcer or bleeding, thrombocytopenia, inflammatory bowel disease); OR concurrent treatment with oral/injectable corticosteroids, anticoagulants, DMARDs, antiplatelet therapy, or 5-ASA agents

Concurrent DMARDs counted if used in the last 130 days

Polyposis: Documented diagnosis of familial adenomatous polyposis; AND for pediatric patients, submission of the patient's clinical information

Elyxyb - Migraine: Age ≥18 years; AND diagnosis of migraine with moderate to severe pain intensity; AND contraindication to or treatment failure with two or more alternatives (NSAIDs and/or triptans)TWQ alternatives failed

Alternatives include NSAIDs (e.g., diclofenac, ibuprofen, naproxen) or triptans (e.g., naratriptan, rizatriptan, sumatriptan)

Seglentis: Diagnosis of severe acute pain requiring an opioid alternative AND documented trial and failure of at least two formulary alternative treatments, or intolerance/inadequate response to those alternatives2 formulary alternatives

Seglentis may be non-formulary/non-covered and prior authorization may be required

We do NOT cover COX‑II inhibitor drugs for patients who are on low‑dose aspirin therapy unless use of the COX‑II agent is specifically warranted per the policy criteria. In addition, COX‑II agents are not covered for members with any of the following safety contraindications: active peptic ulcer disease or bleeding; allergy to aspirin or NSAIDs; sulfa allergy (applies to celecoxib); severe kidney or liver dysfunction; cardiovascular disease; age <18 years unless FDA‑approved for that indication; or congestive heart failure.

The Policy History documents prior changes to product coverage and formatting. Notably, earlier entries record that CAPXIB and Elyxyb were removed in 4/2023 when manufacturers discontinued marketing of those medications; Elyxyb had previously been added as Nonformulary and Seglentis was added in prior updates. The history also documents a 12/2023 reformatting and updates to individual consideration language and clinical summaries for NSAIDs and traditional NSAIDs.

For patient safety, the policy states COX‑II inhibitors are not covered when any listed contraindications apply and reiterates the low‑dose aspirin restriction: COX‑II agents are not covered for members on low‑dose aspirin therapy unless criteria in the policy justify their use. The policy’s contraindication list includes active peptic ulcer disease/bleeding, aspirin/NSAID allergy, sulfa allergy (celecoxib), severe renal or hepatic dysfunction, cardiovascular disease, age <18 unless FDA‑approved, and congestive heart failure.

Coding and Look-back Window

Prior use look‑back window

Look-back windowPrevious 130 days

PurposeUsed to establish prior use or trial/failure of formulary alternatives via prescription claims records

When additional documentation is neededIf prescription claim history is unavailable or does not demonstrate prior use within the previous 130 days, provider must supply supporting clinical documentation

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for certain COX‑II products (for example, celecoxib/Celebrex, Elyxyb, Seglentis). Prior authorization requests are processed by Blue Cross Blue Shield of Massachusetts Pharmacy Operations. Providers may call Pharmacy Operations at 1-800-366-7778 or fax supporting information to 1-800-583-6289. Individual consideration (exceptions) may be requested when clinical criteria are not met; see the Individual Consideration block for additional documentation guidance.

Blue Cross Blue Shield of Massachusetts Pharmacy Operations Dept., 25 Technology Place, Hingham, MA 02043
Phone: 1-800-366-7778
Fax: 1-800-583-6289

Step Therapy

Step Therapy Requirements

Step therapy requires trial and failure of traditional non‑COX‑II prescription NSAIDs prior to approval of COX‑II inhibitors. For Acute Pain and Primary Dysmenorrhea indications, treatment failure with two (2) traditional non‑COX‑II prescription NSAIDs or a documented contraindication to NSAID use is required. For non‑formulary COX‑II drugs, prior treatment failure with, or contraindication to, at least two covered formulary alternatives is required when available.

Definitions and Individual Consideration

COX‑II inhibitor

DefinitionCOX‑II (cyclooxygenase‑II) inhibitor

Mechanism summarySelective inhibition of COX‑II enzyme to reduce prostaglandin synthesis while minimizing COX‑I related gastrointestinal toxicity

Clinical rationaleDeveloped to reduce duodenal ulcer risk associated with COX‑I inhibition while preserving anti‑inflammatory effects

Individual consideration / exception request

DefinitionIndividual consideration / exception request: provider request for coverage of a non‑formulary or non‑preferred medication based on an individual patient's unique clinical circumstances

When to requestWhen standard coverage criteria are unlikely to be clinically effective for the prescribed purpose (e.g., therapeutic contraindications, adverse effects, expected ineffectiveness)

Background

NSAIDs inhibit cyclooxygenase enzymes (COX), blocking the conversion of arachidonic acid to prostaglandins. Two isoforms exist: COX‑I and COX‑II. COX‑II selective agents were developed to reduce gastrointestinal toxicity associated with COX‑I inhibition while maintaining anti‑inflammatory properties; efficacy between selective COX‑II and nonselective NSAIDs is similar at standard doses, and selection should consider gastrointestinal, platelet, and respiratory risk factors.

Initial Therapy and Step Trials

Initial therapy/step trials

Initial coverage requires prior trials of traditional NSAIDs.

Initial step: Trial and failure of two (2) traditional non-COX-II prescription NSAIDs or documented contraindication to NSAID use2 failures

Applies to several indications including acute pain and primary dysmenorrhea; prescription claims within the prior 130 days may be used to establish prior use

Step Therapy Table and Requirements

Requirement	Evidence accepted to meet requirement	Look‑back window
Document trial and failure of two (2) traditional non‑COX‑II prescription NSAIDs or documented contraindication to NSAID use (step therapy)
Prescription claims records (pharmacy claims) demonstrating fills of the alternative agents, or provider documentation detailing agent name, strength, dates if available, and specifics of treatment failure or clinical contraindication
Previous 130 days

Policy Revision History

12/2023reformatted_and_criteria_updateLatest

Reformatted policy and updated individual consideration language to align with 118E MGL § 51A; added summary descriptions for NSAIDs and Traditional NSAIDs and added criteria for Elyxyb (migraine) and Seglentis.

07/2023reformatted

Policy reformatted.

04/2023removal_from_coverage

Updated to remove CAPXIB and Elyxyb after manufacturers removed marketing of the medications.