Prior authorization: document indication and trials/contraindication

Prior authorization requires documentation that the requested drug is being used for an FDA‑approved indication or an indication supported in accepted compendia, plus evidence the patient tried and had an inadequate treatment response or intolerance to the specified formulary alternative(s) at optimal therapeutic dosages, or a documented clinical reason (expected adverse reaction or contraindication) that prevents trials of those formulary alternative(s). Approvals are for 12 months where stated.

• Requested drug used for FDA‑approved or compendia‑supported indication.
• Document trial and inadequate response or intolerance to required formulary alternative(s) at optimal dosages, OR documented clinical reason preventing those trials.
• Approval duration: 12 months where explicitly stated in the policy.

Prior authorization — general requirement; no specific PA codes listed

The policy text includes prior‑authorization style criteria for listed drugs, but the procedures and billing codes section contains no product‑specific prior authorization codes; providers should use usual CPT/HCPCS/diagnostic codes for reporting services.

• Policy includes clinical prior authorization criteria for drugs (see Sections I–XVII).
• PROCEDURES AND BILLING CODES: use appropriate CPT, HCPCS, Revenue, and/or ICD diagnostic codes as applicable; no specific PA billing codes are listed.

Step therapy: trial and failure of formulary alternatives required

Step‑therapy is required: members must have tried and had an inadequate response or intolerance to the enumerated formulary alternatives (the number and identity of required alternatives vary by drug/group) unless a documented clinical reason prevents those trials.

• Examples: Sections I and VI require trials of BOTH listed alternatives; Section II requires trials of ALL THREE listed alternatives.
• If trials cannot be completed, a documented clinical reason (expected adverse reaction or contraindication) must be provided.

No additional step‑therapy rules in reference section

The referenced chunks that list prescribing references do not specify additional step‑therapy rules beyond those already stated in the drug sections; these reference chunks contain citations only.

• Reference lists (prescribing information) are citations and do not add step‑therapy or authorization rules.
• Follow the step‑therapy requirements detailed in the relevant drug section(s) of the policy.

Required documentation to support prior authorization

Documentation submitted for prior authorization must demonstrate the requested drug is being used for an FDA‑approved indication or an indication supported in accepted compendia and must include evidence of trial and inadequate response or intolerance to the specified formulary alternatives, or a documented clinical reason preventing those trials.

• State the FDA‑approved or compendia‑supported indication.
• Provide records showing trials of required formulary alternative(s) at optimal therapeutic dosages and the inadequate response or intolerance, OR documentation of contraindication or expected adverse reaction preventing the trial.

Reference documents: consult prescribing information for product details

Prescribing information documents for the listed drugs are cited as references and should be consulted for product‑specific prescribing, dosing, and safety details when preparing authorization requests.

• Policy reference list includes product prescribing information (e.g., Tyrvaya, Lantus, Rezvoglar, etc.).
• Consult the cited prescribing information for drug‑specific details supporting the clinical rationale.

Denial risk if criteria not met for Section XVII products

Drugs enumerated in Section XVII are considered not medically necessary when the criteria in this policy are not met; failure to provide required documentation or meet trial requirements may result in denial of coverage for those products.

• Section XVII lists specific products that will be denied if the policy criteria are not satisfied.
• Ensure all required trial documentation or documented clinical reasons are included to avoid denial.

Reference section lists citations only; no authorization/denial rules present

The referenced chunk (references list) contains citations only and does not include authorization or denial criteria; it should be used to locate prescribing information but not as a source of additional coverage rules.

• Reference section lists prescribing information sources and does not change or add to the policy's authorization/denial criteria.
• Use these references to support clinical documentation but rely on the policy sections for coverage rules.