ModifiedCignaPolicy N/A

STEP THERAPY POLICY

Defines step therapy requirements for nonsteroidal anti-inflammatory drugs (NSAIDs) across Step 1a/2a, Step 1b/2b (naproxen+PPI Vimovo), and Step 1c/2c (ibuprofen+H2RA Duexis) including product lists, required prior trials, exceptions, and approval durations for Cigna-administered plans.

Policy Summary

PayerCigna

PolicySTEP THERAPY POLICY

Policy CodePolicy N/A

Change TypeSelected additions, removals, and step reassignments (multiple revisions)

Effective Date

Next Review Date

Key ActionDocument and verify required prior trials (two Step 1a prescription NSAIDs for Step 2a; one prescription naproxen + one prescription PPI for Vimovo; one prescription ibuprofen + one prescription H2RA for Duexis) and include formulation, prescription vs OTC status, and relevant condition or risk factors when requesting approval.

POLICY UPDATE CHANGES

Coxanto capsule was added to the Policy to Step 2a.

Indomethacin oral suspension (generic Indocin suspension) was added to Step 2a.

Cataflam (brand) and several obsolete brand names (Fenortho, Mobic, Voltaren Gel, Voltaren XR, Qmiiz ODT, Relafen) were removed from the Policy.

Fenopron (fenoprofen calcium capsules) was added to Step 2a.

Diclofenac potassium 25 mg capsules and naproxen DR 500 mg tablets were moved from Step 1a to Step 2a; diclofenac sodium 1% topical gel was moved from Step 2a to Step 1a.

Orudis was added to Step 2a.

3Step groups (1a/2a, 1b/2b, 1c/2c)

~40Listed NSAID products

1Approval duration (yrs)

Summary of changes and impact

This is a Step Therapy policy for nonsteroidal anti-inflammatory drugs (NSAIDs) that encourages use of lower-step and topical products prior to higher-step combination or branded products to promote cost‑effective prescribing. The program prioritizes trials of Step 1 products before Step 2 products and provides one‑year approvals when criteria are met. The policy aligns with clinical guidance that supports topical NSAIDs for many osteoarthritis and musculoskeletal indications and emphasizes safety considerations related to cardiovascular, gastrointestinal, and renal risks as well as Beers Criteria concerns in older adults.

Step groups3 (1a/2a, 1b/2b, 1c/2c)

Listed NSAID products~40

Approval duration1 year

Last review2026-01-14

Early Annual Revision (01/17/2024)Revision

Coxanto capsule was added to the Policy to Step 2a.

02/14/2024Revision

Indomethacin oral suspension (generic Indocin suspension) was added to Step 2a.

01/22/2025Revision

Cataflam and several obsolete brand names (Fenortho, Mobic, Voltaren Gel, Voltaren XR, Qmiiz ODT, Relafen) were removed from the Policy.

03/05/2025Revision

Fenopron (fenoprofen calcium capsules) was added to Step 2a.

03/05/2025Revision

Diclofenac potassium 25 mg capsules and naproxen DR 500 mg tablets were moved from Step 1a to Step 2a; diclofenac sodium 1% topical gel was moved from Step 2a to Step 1a.

02/11/2026RevisionLatest

Orudis was added to Step 2a.

Step therapy program overview & rules

General program rules

Step therapy program (general rules): approvals require evidence of prior trials of preferred NSAIDs or alternatives as specified below. Two Step 1a trials are required before Step 2a agents are approved unless an exception or specific alternative criterion is met. For Vimovo and Duexis there are product-specific prior-trial requirements described in their groups. Over-the-counter (OTC) NSAID products (e.g., OTC naproxen, OTC ibuprofen, OTC diclofenac topical) count toward prior trial requirements when documentation supports patient use at therapeutic dosing and duration.

Program rule: Member must have tried and failed or had contraindication/intolerance to two different Step 1a NSAID alternatives prior to approval of Step 2a (oral prescription NSAIDs) products, unless a specific "any" exception listed under Step 2a applies.

Vimovo (naproxen/esomeprazole) and Duexis (ibuprofen/famotidine) have separate Step 2b and 2c requirements; prior use of the same combination product (Vimovo or Duexis) or generic fixed combination equivalent does NOT count as meeting the Step 1 trial requirement for approval of that same combination product.

OTC counting note: Documented OTC use may be counted toward required trials if dose and duration are appropriate and clearly recorded in the medical record or pharmacy history.

NSAID product groups by step

Step 1a NSAIDs (products listed)mixed

diclofenac potassium 50 mg tablets	Step 1a product
diclofenac sodium (IR and ER)	Step 1a product
diclofenac sodium and misoprostol	Step 1a product
diclofenac sodium 1% topical gel	Step 1a product (topical)

Step 2a NSAIDs (products listed)mixed

diclofenac sodium topical solution 1.5%	Step 2a topical
etodolac (IR and ER)	Step 2a
flurbiprofen	Step 2a
ibuprofen	Step 2a
indomethacin (IR and ER)	Step 2a
ketoprofen IR 50 mg and 75 mg	Step 2a
ketorolac tablets	Step 2a
meclofenamate	Step 2a
mefenamic acid	Step 2a
meloxicam tablets	Step 2a

1–10 of 32

1/4

Step 1b (prescription naproxen) and Step 1b PPIsmixed

Prescription naproxen sodium	Step 1b
Prescription naproxen	Step 1b
dexlansoprazole	Step 1b PPI
esomeprazole magnesium	Step 1b PPI
esomeprazole strontium	Step 1b PPI
lansoprazole	Step 1b PPI
omeprazole	Step 1b PPI

Step 2bmixed

Vimovo

naproxen/esomeprazole delayed-release tablets (Step 2b)

Step 1c (prescription ibuprofen) and Step 1c H2RAsmixed

Prescription ibuprofen (oral)	Step 1c
cimetidine (oral)	Step 1c H2RA
famotidine (oral)	Step 1c H2RA
ranitidine (oral)	Step 1c H2RA
nizatidine (oral)	Step 1c H2RA

Step 2cmixed

Duexis

ibuprofen/famotidine tablets (Step 2c)

What providers must do

Step Therapy

Step therapy trials required before Step 2 products

Prior trials required: two Step 1a prescription NSAIDs for Step 2a; one prescription naproxen + one prescription PPI for Vimovo (Step 2b); one prescription ibuprofen + one prescription H2RA for Duexis (Step 2c). Separate trials required; prior use of the Step 2 product does not count.

Two Step 1a prescription NSAIDs required before Step 2a.
Vimovo (Step 2b): one prescription naproxen AND one prescription PPI required.
Duexis (Step 2c): one prescription ibuprofen AND one prescription H2RA required.

Documentation Required

Document prior trials and product specifics

Providers must document prior trials (prescription vs OTC, formulation) and indicate condition (e.g., chronic musculoskeletal pain, hand/knee OA) or swallowing difficulty or risk factors for NSAID toxicity when seeking approval under topical/alternative criteria.

Definitions, guidelines referenced, and safety notes

The program’s intent is to encourage use of lower‑step or topical NSAID products before advancing to Step 2 agents. It references guideline recommendations that favor topical NSAIDs for hand and knee osteoarthritis and notes safety concerns including cardiovascular, gastrointestinal, and renal risks and Beers Criteria guidance for older adults.

Guidelines referencedACR/Arthritis Foundation 2019; EULAR 2018; OARSI 2019; Beers Criteria 2023

DefinitionsIR = Immediate-release; ER = Extended-release; DR = Delayed-release

Recent material revisions

Early Annual Revision (01/17/2024)Revision

Coxanto capsule was added to the Policy to Step 2a.

02/14/2024Revision

Indomethacin oral suspension (generic Indocin suspension) was added to Step 2a.

03/05/2025Revision

Fenopron (fenoprofen calcium capsules) was added to Step 2a.

Policy Summary

PayerCigna

PolicySTEP THERAPY POLICY

Policy CodePolicy N/A

Change TypeSelected additions, removals, and step reassignments (multiple revisions)

Effective Date

Next Review Date

On This Page

Step 2a — NSAIDs (oral prescription) approval criteria

Step 2a — Oral prescription NSAIDs: approval when ANY one of the following is met (i.e., at least one listed condition/exception qualifies). Notes on alternatives and examples are included in the leaf notes.

Any of the following:

1) Patient has trialed and had inadequate response, intolerance, or contraindication to two different Step 1a alternatives (these may include topical NSAIDs, acetaminophen when appropriate, non-pharmacologic therapy, or other listed preferred agents). Note: topical NSAIDs are appropriate alternatives for hand or knee OA; topical agents are not expected to be efficacious for hip OA.

2) Patient has a condition or clinical circumstance where topical NSAIDs or other Step 1 alternatives are not appropriate (examples: widespread multi-joint disease where topical dosing would exceed safe limits, swallowing difficulty preventing topical or certain oral formulations, or inability to apply topical formulation to the affected site).

3) Patient has an acute indication requiring an oral prescription NSAID and prior Step 1a alternatives are not feasible or are contraindicated (examples: acute severe musculoskeletal injury requiring oral therapy, certain postsurgical pain scenarios).

4) Patient has documented trial and failure or intolerance to topical NSAIDs plus one additional Step 1a oral alternative (counts as two Step 1a trials if documented).

5) Patient has documentation of specific risk examples or contraindications to Step 1a agents (e.g., severe topical application intolerance, allergy to multiple Step 1 agents, documented drug–drug interaction that precludes Step 1 options).

Step 2b — Vimovo (naproxen/esomeprazole) approval criteria

Step 2b — Vimovo (naproxen/esomeprazole) approval: ALL of the following must be met.

All of the following:

1) Member has documented trial and inadequate response, intolerance, or contraindication to two different Step 1a NSAID alternatives (these trials must be separate agents and documented). Note: prior use of Vimovo or generic naproxen plus esomeprazole fixed-combination product does NOT satisfy the Step 1a trial requirement for approval of Vimovo.

2) Clinical justification that a single fixed-dose naproxen/esomeprazole product is medically necessary (for example, need for gastroprotection with ongoing naproxen therapy where PPI co-prescribing adherence is a concern or previous GI ulcer/bleed on NSAID therapy that responded to PPI co-therapy).

3) The requested use is for an indication consistent with benefit coverage and not excluded by plan language.

Step 2c — Duexis (ibuprofen/famotidine) approval criteria

Step 2c — Duexis (ibuprofen/famotidine) approval: ALL of the following must be met.

All of the following:

1) Member has documented trial and inadequate response, intolerance, or contraindication to two different Step 1a NSAID alternatives (these must be distinct agents and documented). Note: prior use of Duexis or generic ibuprofen plus famotidine fixed-combination product does NOT satisfy the Step 1a trial requirement for approval of Duexis.

2) Clinical justification that a single fixed-dose ibuprofen/famotidine product is medically necessary (for example, need for gastroprotection with ongoing ibuprofen therapy where H2-blocker co-prescribing adherence is a concern or history of NSAID-related GI complications benefitting from H2-blocker protection).

3) The requested use is for an indication consistent with benefit coverage and not excluded by plan language.

Indicate whether prior use was prescription or OTC and the formulation (tablet, suspension, topical, etc.).
Specify the treated condition (e.g., chronic musculoskeletal pain, hand or knee osteoarthritis).
Document swallowing difficulty or inability to swallow tablets/liquids when requesting topical/alternative products.
Document relevant risk factors for NSAID-associated toxicity (e.g., prior GI bleed, peptic ulcer disease, impaired renal function, cardiovascular disease, concomitant anticoagulants, elderly with impaired hepatic function).

Denial Risk

Non-counting trials

Claims for Step 2 products will be denied if only OTC trials, trials of different NSAID classes (e.g., COX-2 instead of naproxen), or prior use of the same Step 2 product are presented where prescription trials are required.

OTC-only trials do not count when a prescription trial is required.
Trials of a different NSAID class (e.g., COX-2/celecoxib instead of naproxen) do not satisfy naproxen requirement.
Prior use of the same Step 2 product (Vimovo or Duexis) does not count as the required separate trials.

Billing Rule

Approval duration

All approvals are provided for 1 year in duration.

03/05/2025Revision

Diclofenac potassium 25 mg capsules and naproxen DR 500 mg tablets were moved from Step 1a to Step 2a; diclofenac sodium 1% topical gel was moved from Step 2a to Step 1a.

02/11/2026RevisionLatest

Orudis was added to Step 2a.