Drugs Requiring Medical Necessity Review for Employer Plans
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Defines Cigna's medical necessity review requirements for drugs under employer plans and lists product-specific criteria and documentation requirements for prior authorization and coverage determinations.
Updated 'Documentation' language to require that documentation noted in the criteria be marked as [documentation required] and include patient-specific identifying information.
Multiple preferred product step requirements were added or updated for numerous drugs (examples include Lybalvi, Arimidex, Flovent products, Pulmicort Flexhaler, and many topical and systemic agents).
Removed preferred product step requirement for select products (examples include Regranex and gabapentin extended-release generic for Gralise).
Symjepi, Alocril, and Alomide were added to the list of products effective 6/1/2026.
Preferred product requirement criteria were added for multiple diabetes and cardiovascular agents including Brenzavvy, bexagliflozin tablets, Farxiga, Invokana, Invokamet, Invokamet XR, Segluromet, Steglatro, and Xigduo XR effective 6/1/2026.
Preferred product requirement criteria were removed for gabapentin extended-release tablets (generic for Gralise) effective 7/1/2026.
Preferred product requirement criteria were added for a broad set of products with various effective dates including additions on 7/1/2026, 7/15/2026, 8/1/2026, and 8/15/2026 (examples: Aczone gels, Fycompa formulations, Vimpat formulations, Briviact, Verquvo).
Preferred product requirement criteria were removed for certain ophthalmic and topical products (examples: tobramycin 0.3%/loteprednol etabonate ophthalmic suspension (generic for Zylet)) effective 6/15/2026.
Coverage Criteria
General medical necessity criteria
Covered when ALL of the following are met:
Approval duration is 12 months unless otherwise noted
Failure to include required documentation may lead to incomplete review or denial
Criteria will be updated as new published data are available
Cigna considers services or drug requests that do not meet the product‑specific criteria set forth in this policy to be not medically necessary. Any other exception not explicitly addressed by the criteria is considered not medically necessary and will not be covered. Documentation requirements noted in the criteria must be provided to support medical necessity determinations.
Effective 7/1/2026, the policy removes the preferred‑product requirement criteria for gabapentin extended‑release tablets (generic for Gralise). This change means the prior preferred‑product step language no longer applies to that generic formulation as of the effective date.
The revision removed preferred‑product requirement criteria for multiple specific products, including ophthalmic and topical agents (for example, tobramycin 0.3%/loteprednol etabonate 0.5% ophthalmic suspension (generic for Zylet) effective 6/15/2026) and other listed products with staggered effective dates. Removal of preferred‑product criteria may change the coverage stance or prior authorization step requirements for these products on and after the stated effective dates.
Claims submitted for services billed with diagnoses or codes that are not covered under this Coverage Policy will be denied as not covered. Additionally, requests or claims that do not meet the policy criteria or lack required documentation are considered not medically necessary and may be denied. Providers should ensure claims include covered codes and any documentation specified in the criteria to avoid denials.
Coding and Reimbursement
| No codes listed |
Provider Actions & Requirements
Prior authorization required for listed drugs
Certain drugs listed in this policy require medical necessity review and prior authorization based on product‑specific criteria; providers should confirm authorization requirements for individual medications via CignaForHCP.com when submitting prior authorization requests.
- Approval duration is 12 months unless otherwise noted.
Updated preferred‑product step and PA criteria
The revision adds and updates many preferred‑product (step) requirements and preferred‑product requirement criteria; providers must follow the updated step/preferred‑product criteria when preparing prior authorization submissions.
- Examples of additions and updates are listed in the Revision Details (multiple effective dates).
Check PA applicability per product/effective date
'May require prior authorization' language has been removed or changed for selected products (for example, Fycompa oral suspension no longer includes 'may require prior authorization'), so prior authorization applicability now varies by product and effective date — verify the current criteria for each drug.
- Example: Fycompa oral suspension — 'may require prior authorization' removed effective 7/1/2026.
Adhere to preferred‑product step therapy edits
Preferred product step (step therapy) requirements have been added, updated, or removed for numerous individual products as documented in the revision history; providers must adhere to these step edits when submitting claims or PA requests.
- Revision Details list specific products and staged effective dates for step requirement changes.
Observe staged effective dates for step requirements
Numerous drugs were assigned or had updates to preferred‑product step requirements with staged effective dates (multiple entries list effective dates such as 6/1/2026, 7/1/2026, 7/15/2026, 8/1/2026); providers should confirm the effective date that applies to the member's plan when requesting authorization.
- Examples in the Revision Details include Lybalvi, Arimidex, Flovent products, Pulmicort Flexhaler, and many others with specified effective dates.
Preferred‑product requirement criteria determine coverage
The revision adds or updates preferred‑product requirement criteria that operate as step/preferred‑product requirements for coverage decisions; coverage will be contingent on meeting these preferred‑product criteria per the effective dates shown.
- Examples of added preferred‑product criteria effective 6/1/2026 include Brenzavvy and multiple SGLT2 agents; removals include gabapentin ER (generic for Gralise) effective 7/1/2026.
Include required supporting documentation with PA
Documentation is required where noted in the criteria (marked as [documentation required]) and may include chart notes, laboratory tests, medical test results, claims records, prescription receipts, and other patient‑specific information; all submitted documentation must include patient‑specific identifying information.
- Updated policy language: documentation noted in criteria must be labeled [documentation required].
- Include patient identifiers on all supporting materials to avoid incomplete review.
Label and include patient identifiers on required documents
When criteria indicate [documentation required], providers must supply the specified supporting records (e.g., chart notes, labs, test results, claims) and ensure materials include patient‑specific identifying information to support medical necessity review.
- Failure to include patient identifiers or required documentation may lead to incomplete review or denial.
Comply with medical necessity review procedures
Follow the policy's medical necessity review processes for listed drugs; specific documentation requirements for each product are described in the product‑specific criteria or revision entries.
- Providers can review product‑specific criteria and documentation expectations on the coverage spreadsheet referenced in the policy.
Denial risk if covered codes are missing
Claims for services not accompanied by covered code(s) under this Coverage Policy will be denied as not covered; ensure submitted services use the covered codes applicable to this policy.
- Coverage Policies relate to plan administration and do not substitute for treatment guidelines.
Risk of denial for missing/insufficient documentation
Failure to include documentation that is labeled [documentation required] or submitting materials without patient‑specific identifying information may result in incomplete review or denial of the request.
- Ensure all supporting documents include patient name and other identifiers.
Denial risk when preferred‑product criteria not met
Requests for drugs that do not meet newly added preferred‑product requirement criteria, or for products that had preferred‑product criteria removed, may be subject to medical necessity review and potential denial — verify whether the product's preferred‑product status changed and supply documentation that meets the updated criteria.
- Examples: added preferred‑product criteria effective 6/1/2026 (Symjepi, Alocril, Alomide); removed preferred‑product criteria for gabapentin ER generic for Gralise effective 7/1/2026.
Background
To be eligible for coverage under this policy, a drug generally must be FDA‑approved, prescribed by a health care professional, purchased from a licensed pharmacy, and determined to be medically necessary. Medical necessity determinations use product‑specific criteria developed from FDA labeling, recognized compendia, and peer‑reviewed evidence; when those criteria and any required supporting documentation are met, Cigna may authorize coverage consistent with the policy.
Definitions
Step Therapy / Preferred Product Requirements
| Change summary | Examples / affected products | Provider action |
|---|---|---|
| Preferred product step requirements have been added, updated, or removed. | ||
| Multiple listed products across revision entries (examples include Aplenzin, Auvelity, Absorica LD, Qbrelis, Firvanq, Flovent Diskus/HFA, Pulmicort Flexhaler, Regranex, Zoryve, insulin products, and many topical, ophthalmic, and systemic agents). | ||
| When submitting prior authorization requests or claims, follow the product-specific step edits and updated step/ preferred-product requirements effective on the dates shown in the revision history. Refer to the policy's revision entries for exact effective dates per product. |
| Change summary | Staged effective dates / examples | Provider action |
|---|---|---|
| Preferred product step requirements were added or updated for many products with staged effective dates. | ||
| Revision entries list staged effective dates (examples): 5/1/2025 and 7/1/2025 for Flovent and related inhaled products; 6/18/2025 and 7/15/2025 for Arimidex/Aromasin/Iluvien; 6/26/2025 and 8/1/2025 for select products; and other staged dates noted in the revision history for numerous items. | ||
| Providers must adhere to the step edits as of each product's effective date when filing PA requests or claims; check the revision history entries for the exact effective date applicable to the product in question and include required supporting documentation where noted. |
| Change summary | Examples / effective dates | Coverage impact / Provider action |
|---|---|---|
| Preferred-product requirement criteria were added or updated for many products; coverage is contingent on meeting those preferred-product requirements per the listed effective dates. | ||
| Examples and effective dates from the revision history: EFFECTIVE 6/1/2026 – Symjepi, Alocril, Alomide; EFFECTIVE 6/1/2026 – Brenzavvy, bexagliflozin tablets, Farxiga, Invokana, Invokamet/XR, Segluromet, Steglatro, Xigduo XR; EFFECTIVE 7/1/2026 – Aczone gels, Aptiom, Fycompa tablets, Vimpat oral solution, penciclovir 1% cream, Zortress, Fexmid, Dymista, and others; EFFECTIVE 7/15/2026 – Allzital/Bupap/Fioricet groups; EFFECTIVE 8/1/2026 – Briviact (tablets and oral solution) and multiple antiepileptics; EFFECTIVE 8/15/2026 – Verquvo; EFFECTIVE 9/1/2026 – additional listings. Removals include gabapentin ER (generic for Gralise) effective 7/1/2026 and other removals noted in the revision entries. | ||
| Coverage determinations will apply the newly added/updated preferred-product criteria on the effective dates indicated. Providers should: 1) Verify the product-specific effective date in the revision history; 2) Include any documentation required by the specific criteria (labelled in the policy as [documentation required] where applicable); and 3) Expect that requests not meeting the preferred-product requirements may be subject to medical necessity review or denial. |
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