Drugs Requiring Medical Necessity Review (product-specific prior authorization list)
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Defines medical necessity review requirements and preferred product step requirements for various drugs under Cigna-administered health benefit plans; affects providers submitting prior authorization requests and Cigna medical directors making coverage determinations.
Added preferred product step requirement for Orlynvah, Brynovin, and Lasix Onyu.
Added preferred product step requirement for opium tincture 10 mg/mL, Ertaczo, Exelderm cream and solution, Jublia, Luzu, oxiconazole nitrate 1% cream, Oxistat cream and lotion, sulconazole nitrate 1% cream and solution, Xolegel, Bevespi Aerosphere, Duaklir Pressair, Ryaltris, Omnaris, Qnasl, Qnasl Children's, Xhance, Zetonna, tavaborole 5% topical solution, miconazole-zinc oxide-petrolatum ointment, and Vusion.
Updated preferred product step requirement for Zoryve 0.3% cream, Zoryve foam, Firvanq, and vancomycin 25 mg/mL oral solution (authorized generic of Firvanq).
Documentation wording changed to require that documentation is 'required where noted in the criteria' and that all documentation must include patient-specific identifying information.
Updated preferred product step requirement for Furoscix, dihydroergotamine mesylate nasal spray (generic Migranal), Trudhesa, Lotemax, Vtama, ArmonAir DigiHaler, Arnuity Ellipta, Flovent Diskus, Flovent HFA, and certain authorized generics.
Coverage Policy — Scope & Limitations
Coverage of services under this policy is determined by medical necessity as defined in the criteria. Any request that does not meet the specified criteria is considered not medically necessary. Criteria will be updated as new published data are available.
Reimbursement is not allowed for services when billed for conditions or diagnoses that are not covered under this Coverage Policy. Claims submitted without covered diagnosis or procedure code(s) applicable to this policy will be denied as not covered.
Provider Responsibilities, Prior Authorization, and Documentation
Denial risk for unsupported codes
Claims submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered.
- When billing, providers must use the most appropriate codes as of the effective date of the submission.
Prior Authorization Required
Cigna covers products as medically necessary when Product Specific Criteria are met. Certain products require medical necessity review / prior authorization. Providers and prescribers should verify whether a medication requires prior authorization via CignaForHCP.com (providers) or the myCigna app/myCigna.com (customers). Approval duration is generally 12 months unless otherwise noted.
- Refer to: Drugs Requiring Medical Necessity Review for Employer Plans
- Approval duration: 12 months unless otherwise noted
Preferred product step requirement
Prescribers must document completion of required step-therapy (preferred product) steps or provide clinical justification when requesting coverage for non-preferred products listed in this policy. Documentation is required where noted in the criteria and must include patient-specific identifying information.
- When step requirements apply, prescribers should either document prior trial of the preferred product(s) or provide rationale for bypassing the step.
- Failure to provide required step documentation or justification may result in denial.
Documentation required
Documentation is required where noted in the criteria as [documentation required]. Acceptable documentation may include, but is not limited to: chart notes, laboratory tests, medical test results, claims records, prescription receipts, and/or other information. All documentation must include patient-specific identifying information.
- Provide documentation at time of prior authorization request or upon request during claims review.
- Incomplete or absent documentation may trigger denial or delay.
Documentation-related denial risk
Failure to provide required documentation, including patient-specific identifying information, or to follow noted documentation requirements may result in claim denials or delays.
- Documentation examples: chart notes, labs, tests, claims records, prescription receipts.
- Prescribers should retain records to support step-therapy completion or medical necessity determinations.
Policy Background and Coverage Eligibility
To be eligible for coverage, a drug must generally be FDA-approved, prescribed by a health care professional, purchased from a licensed pharmacy, and deemed medically necessary. Cigna incorporates FDA labeling, standard compendia, and peer‑reviewed literature when developing medical necessity criteria. Where documentation is required by the criteria, providers must supply supporting materials (for example, chart notes, laboratory tests, medical test results, claims records, or prescription receipts) and all documentation must include patient-specific identifying information.
Preferred Product Step Requirements (Step Therapy)
| Revision entry (example date or label) | Action (added/updated/removed) | Products affected (representative list or examples) |
|---|---|---|
| {"text":"Annual Revision (10/15/2024)","status":""}|{"text":"Added preferred product step requirement","status":""}|{"text":"Aplenzin; bupropion hydrochloride 450 mg ER; Forfivo XL; Iopidine 1%; baclofen 15 mg; doxycycline monohydrate IR 40 mg; ondansetron ODT; sitagliptin/metformin; Furoscix; Lidocan IV/V; Tridacaine; Sovuna","status":""} | ||
| {"text":"Selected Revision, 1 / Selected Revision, 2 (various 11/1/2024 – 2/1/2025)","status":""}|{"text":"Added / Updated preferred product step requirements","status":""}|{"text":"Cabtreo; Qbrelis; Firvanq; vancomycin 25 mg/mL oral solution; Primidone 125 mg; Zoryve 0.3% cream & foam; Neffy; Auvelity; Migranal (dihydroergotamine nasal spray); Trudhesa","status":""} | ||
| {"text":"Selected Revision (early/mid 2025)","status":""}|{"text":"Added preferred product step requirement","status":""}|{"text":"Admelog; Apidra; Fiasp; NovoLog (and authorized generics); Vtama; Azelex; Epiduo; Differin formulations; numerous topical and systemic agents (see revision details)","status":""} | ||
| {"text":"Selected Revisions (mid–late 2025)","status":""}|{"text":"Added and Updated preferred product step requirements; some removals noted","status":""}|{"text":"Fanapt; Basaglar KwikPen; Zyflo; Furoscix; ArmonAir DigiHaler; Arnuity Ellipta; Flovent Diskus; Flovent HFA; Pulmicort Flexhaler; many others (see revision lists)","status":""} | ||
| {"text":"Selected Revision / Annual Revision (10/1/2025 – 12/1/2025)","status":""}|{"text":"Added preferred product step requirements; Updated step requirements for selected products","status":""}|{"text":"Adapalene and tretinoin topical products; insulin glargine and related pens/vials; Seysara; Imvexxy; Zoryve referenced in updates","status":""} | ||
| {"text":"Selected Revision (1/15/2026 and 2/1/2026)","status":""}|{"text":"Updated preferred product step requirement; Revised documentation language","status":""}|{"text":"Zoryve 0.3% cream and foam; Firvanq; vancomycin 25 mg/mL oral solution (authorized generic); Documentation wording changed to require patient-specific identifying information","status":""} | ||
| {"text":"Selected Revision (3/1/2026 and 3/15/2026)","status":""}|{"text":"Added and Updated preferred product step requirements","status":""}|{"text":"Added: Orlynvah; Brynovin; Lasix Onyu; opium tincture 10 mg/mL; Ertaczo; Exelderm (cream & solution); Jublia; Luzu; Oxistat; Xolegel; Bevespi Aerosphere; Duaklir Pressair; Ryaltris; Omnaris; Qnasl (including Children's); Xhance; Zetonna; tavaborole 5% solution; miconazole‑zinc oxide‑petrolatum ointment; Vusion; Blujepa; econazole nitrate topical foam; Brekiya; Exxua; escitalopram 15 mg capsules; ciprofloxacin/hydrocortisone otic; and others. Updated: Furoscix; Migranal (generic); Trudhesa; Lotemax; Vtama; multiple inhaled corticosteroid products","status":""} |
| Requirement | What the provider must submit | Denial risk / notes |
|---|---|---|
| {"text":"Document and demonstrate completion of required preferred product steps (when noted in product criteria)","status":""}|{"text":"Chart notes or medical records showing trial/use of preferred product(s), prescription receipts, claims records, or other supporting clinical documentation that include patient-specific identifying information","status":""}|{"text":"Failure to provide required documentation (including patient-specific identifying information) where noted may trigger denial of the request","status":""} | ||
| {"text":"When unable to complete prior preferred product step, provide clinical justification for medical necessity","status":""}|{"text":"Detailed clinical rationale in chart notes or cover letter, relevant laboratory/test results if applicable, and patient‑specific identifiers","status":""}|{"text":"Insufficient or missing justification/documentation increases risk of denial; requests without required supporting information may be denied as not covered","status":""} | ||
| {"text":"Follow updated step edits on prior authorization requests per the revision effective dates","status":""}|{"text":"Include the specific product names, dates of prior trials, and documentation types (e.g., prescription receipts, claims history) when submitting prior authorization; reference applicable revision dates if relevant","status":""}|{"text":"Claims or prior authorization requests that do not adhere to the updated step requirements may be denied; see policy revision details for products and effective revision dates","status":""} |
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