CurrentCignaPolicy 1602

Drugs Requiring Medical Necessity Review (Preferred Product Step Requirements)

Defines medical necessity and prior authorization / preferred product step requirements for drugs under Cigna-administered health benefit plans; applies to providers and pharmacy benefit administrators making coverage requests for Cigna members.

Policy Summary

PayerCigna

PolicyDrugs Requiring Medical Necessity Review (Preferred Product Step Requirements)

Policy CodePolicy 1602

Change TypeAdded/Updated preferred product step requirementssome removals and clarifications

Effective DateOct 7, 2025

Next Review Date

Key ActionObtain prior authorization and document medical necessity per product-specific criteria (see CignaForHCP.com for requirements).

SourceLink

POLICY UPDATE CHANGES

Added preferred product step requirement for multiple individual products (many lists across revisions).

Removed preferred product step requirements for specified products (examples include Syndros, Iluvien).

Updated preferred product step requirements for many products (numerous updates listed across revisions).

Documentation is required where noted in the criteria and may include chart notes, labs, test results, claims records, prescription receipts, and/or other information.

12 monthsdefault approval duration

2025-10-07policy effective date

2024–2025

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Coverage and Medical Necessity Criteria

General Medical Necessity

Covered when Product Specific Criteria are met.

General coverage conditions: Drug is FDA-approved, prescribed by a health care professional, purchased from a licensed pharmacy, and medically necessary; Product Specific Criteria must be met; approval duration is 12 months unless otherwise noted.

Refer to product-specific criteria lists and documentation requirements on CignaForHCP.com.

Any other exception is considered not medically necessary. Criteria will be updated as new published data are available.

Services billed for conditions or diagnoses that are not covered under this Coverage Policy will be denied as not medically necessary.

Covered / Affected Codes & Approval Duration

Covered / Affected Codesmixed

No codes listed

inv-05: Approval duration

Approval duration12 months (default)

ExceptionsApproval duration may differ if noted in product-specific criteria or revision details

Policy identifierCoverage Policy Number: 1602

Effective guidanceApproval durations stated in the policy apply to Cigna-administered health benefit plans unless an individual product entry specifies otherwise

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Drugs listed in this Coverage Policy require medical necessity review (prior authorization). Providers should check CignaForHCP.com for the current list of medications and for guidance on how to submit prior authorization requests.

Approval duration is 12 months unless otherwise noted.
Prior authorization is required for drugs not on the covered drug list when medical necessity criteria must be met through the coverage review process.

Step Therapy

Preferred Product Step Therapy

Preferred product step requirements have been added or updated for many listed drugs. Members may be required to try a preferred product(s) before a non-preferred product will be approved. See the policy revision history for specific drugs and effective dates.

Examples of recent step requirement additions/updates include Aplenzin, MoviPrep, Admelog, Vtama, and numerous topical and oral products (see Revision Details).

Policy Background

To be eligible for coverage, a drug must generally be FDA-approved, prescribed by a health care professional, purchased from a licensed pharmacy and be medically necessary. Documentation is required where noted in the criteria and may include chart notes, laboratory tests, medical test results, claims records, prescription receipts, and/or other information.

Definitions and Key Terms

inv-11: Medical necessity — Medical necessity criteria

General medical necessityCovered when Product Specific Criteria are met; drug must be FDA-approved, prescribed by a health care professional, purchased from a licensed pharmacy, and be medically necessary

Coverage scopeApplies to products listed in the policy (alphabetized by therapy class and brand name) requiring medical necessity review

Prior authorizationDrugs listed require medical necessity review (prior authorization); providers can check CignaForHCP.com for which medications require prior authorization

DocumentationDocumentation may be required as noted in product-specific criteria (e.g., chart notes, labs, test results, claims records) to support medical necessity

Denial riskServices or claims for conditions/diagnoses not covered under this policy will be denied as not medically necessary

Preferred Product Step — Initial Therapy

Preferred Product Step (Initial Therapy)

Preferred product step requirements apply as noted below.

Preferred product step: For listed products, a preferred product step requirement has been added or updated; members may need to try designated preferred products before non-preferred options are approved.

Specific step requirements and affected products are listed in the policy's product revision details with effective dates.

Step Therapy Product Lists and Tables

Step	Summary of change / affected products	Effective date
1	Added preferred product step requirement for: Aplenzin; bupropion hydrochloride 450 mg extended release tablets; Forfivo XL; Iopidine 1%; baclofen 15 mg tablets; doxycycline monohydrate IR 40 mg; ondansetron ODT; sitagliptin/metformin tablets; Furoscix; Lidocan IV; Lidocan V; Tridacaine; Sovuna. Also updated preferred product step requirements for multiple other products as noted in the revision.	10/15/2024
1	Added preferred product step requirement for: Admelog; Apidra; Fiasp; Fiasp PumpCart; insulin aspart 100 units/mL injection (authorized generic for NovoLog); NovoLog; Vtama. Also (separately) added requirements effective 6/1/2025 for Azelex; Epiduo; Epiduo Forte; adapalene 0.1% swab; Differin (cream, gel, lotion); clonidine ER (authorized generic for Nexiclon XR); Nexiclon XR; Adlarity; Arakoda; Coartem; Krintafel; Opipza; topiramate 50 mg sprinkle capsules; Aspruzyo Sprinkle; clobetasol propionate 0.025% cream; Halog 0.1% cream; auranofin 3 mg capsules; Omeclamox-Pak; Pylera; Talicia; Voquezna DualPak; Voquezna TriplePak; Finacea (foam, gel); Emrosi; Regranex. Updated requirements for Fanapt; Basaglar KwikPen; Ridaura; Zyflo.	4/1/2025 (and additional entries effective 6/1/2025 and 5/1/2025)
1	Added preferred product step requirement for numerous topical and other products including: adapalene 0.1% cream; adapalene 0.3% gel (and pump); adapalene 0.1% lotion/solution; Altreno; Atralin; multiple Retin-A formulations; tretinoin creams/gels/microsphere gels; Tezruly; Combogesic; Arbli; bisoprolol fumarate 2.5 mg tablets; Lopressor oral solution; EdurantPED; Symbravo; Crinone 4% Gel; Noritate; Zilxi. Updated preferred product step requirements for Differin 0.1% cream; Qtern; Steglujan; Fosrenol oral powder; Ermeza; levothyroxine capsules (Tirosint generic); Thyquidity; Tirosint; Tirosint-SOL; Zoryve 0.3% cream and foam. (Additional update notes include amendments effective 10/1/2025 and 10/7/2025.)	10/7/2025 and 10/1/2025 (revision entries; some items effective 10/15/2025)