Currentmedical mutual - ohioPolicy N/A

New Drug Prior Approval (Global Prior Authorization)

This policy governs prior authorization requirements for new prescription drugs under the pharmacy benefit, specifying criteria for initial and extended approvals and documentation expectations for prescribers and payor reviewers.

Policy Summary

Payermedical mutual - ohio

PolicyNew Drug Prior Approval (Global Prior Authorization)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateAug 21, 2025

Key ActionObtain prior authorization and submit documentation showing the patient meets all recommended authorization criteria, including prior trials and response where required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial approval duration

6 monthsExtended approval duration

7Recommended criteria

08/21/2025Next review

Coverage and Authorization Criteria

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Recommended Authorization Criteria: 1. The requested drug is prescribed for an indication that is noted on the product's most recent FDA-approved labeling (package insert); AND 2. Member does not have any contraindications listed in product's most recent FDA-approved labeling (package insert); AND 3. The requested dose follows the dosing guidelines found in the product's most recent FDA-approved labeling (package insert); AND 4. The requested drug is appropriate for the member's current age per the product's most recent FDA-approved labeling (package insert); AND 5. The requested drug will only be used for recommended duration for the indication per the product's most recent FDA-approved labeling (package insert), if specified; AND 6. If the indication in the product's most recent FDA-approved labeling (package insert) specifies the prior use of another medication, the member has had a prior trial on the agent specified; AND 7. If there are alternative medications available for the same indication, the patient must have tried, had an intolerance or failure to, or has contraindications to the alternative medication(s) for the same indication.

All seven conditions must be satisfied for recommended authorization.

Conditions Not Recommended for Approval are listed after the recommended authorization criteria. Requests for indications or uses that are not listed in this policy will be reviewed on a case-by-case basis for evidence of efficacy and medical necessity. All initial approvals are time-limited to the duration specified in the policy, and reauthorization for continued therapy generally requires documentation of a clinical response unless an exception is noted.

Drugs or services determined to be not medically necessary, investigational, or experimental may be denied reimbursement. The Company may also deny coverage if the service is not within the member's scope of benefits or if there is a pattern of inappropriate or excessive billing. Additional documentation supporting medical necessity (for example, patient records, test results, or provider credentials) must be provided upon request and may be required to complete coverage determinations.

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for specified new drugs. Approvals are contingent upon meeting the policy's coverage criteria and any applicable initial/continuation approval durations. All initial approvals are for the duration noted in the policy; reauthorization (if allowed) requires documented response to therapy unless otherwise specified.

Prior authorization required before dispensing for specified drugs
Approvals contingent on meeting the policy's Criteria and Initial/Extended Approval provisions
Initial approval durations apply; continuation requires response to therapy when reauthorization is allowed

Step Therapy

Prior or Alternative Therapy Requirements

When the FDA-approved labeling for the requested drug specifies prior use of another agent, the member must have had a prior trial of that specified agent. If alternative medications exist for the same indication, the patient must have tried—or documented intolerance, failure, or contraindication to—those alternatives prior to approval.

If FDA labeling requires prior use of a specific agent → documentation of prior trial required
If alternatives exist → documentation of trial, intolerance, failure, or contraindication to alternatives required

Documentation Required

Documentation to Support Request and Potential Denial Reasons

The Company may request additional documentation to support medical necessity. Documentation that may be requested includes patient medical records, relevant test results, and provider credentials. Failure to provide requested information may delay or result in denial of coverage. The Company may also deny reimbursement if the drug or service is determined to be not medically necessary, investigational/experimental, outside the member's benefit scope, or part of an inappropriate/excessive billing pattern.

Additional documentation may include patient records, test results, and provider credentials
Denial reasons include: not medically necessary, investigational/experimental, not within benefit scope, or inappropriate/excessive billing patterns
The Company reserves the right to request further documentation and to modify or interpret this policy at its discretion

Initial Approval Conditions

Initial Approval

Initial approvals are time-limited and contingent on meeting the recommended authorization criteria.

Initial Approval: Initial approval duration is 6 months and is granted when all recommended authorization criteria are met.6 months

Initial approval = 6 months; approval contingent on meeting Recommended Authorization Criteria.

Continuation / Extended Approval

Continuation/Extended Approval

Continuation/extended approval requires documented response to therapy unless otherwise noted.

Extended Approval: Extended approval periods are 6 months. Continuation of therapy requires documentation of clinical response to therapy unless an exception is specified in this policy.6 months

Continuation/extension contingent on documented response to therapy.

Step Therapy and Prior-Fail Requirements

Step	Requirement
1	If the product's FDA‑approved labeling specifies prior use of another medication for the requested indication, the member must have had a prior trial on the agent specified in the labeling.
1	When alternative medications exist for the same indication, the member must have tried the alternative(s), had intolerance to them, experienced treatment failure with them, or have documented contraindications to the alternative medication(s).