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ph-91087

Coverage Exception Program Summary

Policy Number: PH-91087

POLICY REVIEW CYCLE

Effective Date	Date of Origin
01-01-2025	01-01-2015

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

This program applies to Blue Partner, Commercial, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

OBJECTIVE

These criteria apply to any request for medication that is not included on the covered drug list (formulary) and can be used to treat a medical condition/disease state that is not otherwise excluded from coverage under the pharmacy benefit.

If the request is for a medication and disease state/medical condition that is addressed with current clinical review criteria that criteria set will be applied.

CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	EXCEPTION CRITERIA FOR APPROVAL The requested medication will be approved when ALL of the following are met: The requested agent is not a drug/drug class/medical condition that is excluded from coverage on the pharmacy benefit AND ONE of the following: The requested agent is not a drug/drug class/medical condition that is restricted to coverage under the medical benefit OR The requested agent is appropriate for self-administration according to patient factors as determined by the provider AND If the requested agent has additional clinical review criteria (e.g., prior authorization), the patient has met the additional clinical review criteria AND The patient has an FDA labeled indication, or an indication supported in AHFS, DrugDex with 1 or 2a level of evidence, or NCCN with 1 or 2a level of evidence for the requested agent AND ONE of the following: The requested agent has formulary alternatives for the diagnosis being treated by the requested agent AND ONE of the following: The patient has tried and had an inadequate response to at least two formulary alternatives, if available, for the diagnosis being treated with the requested agent OR The prescriber has provided information stating that ALL available formulary alternatives are contraindicated, likely to be less effective, or cause an adverse reaction or other harm for the patient OR The requested agent does not have formulary alternatives for the diagnosis being treated with the requested agent OR The prescriber states that the patient is receiving the requested agent AND is at risk if therapy is changed AND If the requested agent is for an Affordable Care Act Copay Waiver product, that criteria has been met Length of Approval: 12 months Table 1: List of drugs/drug classes/medical conditions that are excluded from coverage on the pharmacy benefit

Module

Clinical Criteria for Approval

EXCEPTION CRITERIA FOR APPROVAL

The requested medication will be approved when ALL of the following are met:

The requested agent is not a drug/drug class/medical condition that is excluded from coverage on the pharmacy benefit AND
ONE of the following:
1. The requested agent is not a drug/drug class/medical condition that is restricted to coverage under the medical benefit OR
2. The requested agent is appropriate for self-administration according to patient factors as determined by the provider AND
If the requested agent has additional clinical review criteria (e.g., prior authorization), the patient has met the additional clinical review criteria AND
The patient has an FDA labeled indication, or an indication supported in AHFS, DrugDex with 1 or 2a level of evidence, or NCCN with 1 or 2a level of evidence for the requested agent AND
ONE of the following:
1. The requested agent has formulary alternatives for the diagnosis being treated by the requested agent AND ONE of the following:
  1. The patient has tried and had an inadequate response to at least two formulary alternatives, if available, for the diagnosis being treated with the requested agent OR
  2. The prescriber has provided information stating that ALL available formulary alternatives are contraindicated, likely to be less effective, or cause an adverse reaction or other harm for the patient OR
2. The requested agent does not have formulary alternatives for the diagnosis being treated with the requested agent OR
3. The prescriber states that the patient is receiving the requested agent AND is at risk if therapy is changed AND
4. If the requested agent is for an Affordable Care Act Copay Waiver product, that criteria has been met

Length of Approval: 12 months

Table 1: List of drugs/drug classes/medical conditions that are excluded from coverage on the pharmacy benefit