CurrentBlue Cross Blue Shield - MassachusettsPolicy 005

Outpatient Pharmacy Prior Authorization and New Drug/Indication Review

Defines BCBSMA pharmacy prior authorization processes for outpatient retail medications, management of new brand drugs and new FDA indications, and options for individual consideration; applies to commercial members with pharmacy benefits.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyOutpatient Pharmacy Prior Authorization and New Drug/Indication Review

Policy CodePolicy 005

Change TypeNo material changes

Effective DateJul 1, 2023

Next Review Date

Key ActionObtain prior authorization for outpatient retail pharmacy requests by submitting the BCBSMA Prior Authorization/Formulary Exception form or contacting Pharmacy Operations.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Prior Authorization requireddrugs covered by this policy

Rx benefit appliescoverage pathway

Pharmacy Operations phoneprovider contact

7/1/2023last update

Coverage and Review Criteria

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Coverage and Review Logic

Coverage decisions and processes

Prior Authorization Requirement: Prior authorization must be obtained for outpatient retail pharmacy medications governed by this policy for commercial members with pharmacy benefits.

Requests may be submitted via the BCBSMA Prior Authorization/Formulary Exception form, by phone, fax, or mail to Pharmacy Operations (see contact details).

New Drug/New Indication Review: New brand‑name drugs (new to market) or new FDA indications for existing drugs will be held under review and considered non‑formulary and not covered until Pharmacy & Therapeutics or business review is completed.

During the evaluation period, established prior authorization, formulary Step Therapy, or Quality Care Dosing criteria for the therapeutic class may be applied; physicians may request an exception based on medical necessity.

Individual Consideration: Physicians may submit supporting clinical documentation for individual consideration when requests do not meet standard clinical criteria or when requesting coverage for non‑FDA indications during evaluation periods.

Submit documentation to Blue Cross Blue Shield of Massachusetts Pharmacy Operations (25 Technology Place, Hingham, MA 02043) by phone, fax, or mail for review.

New-to-market brand medications and medications with newly approved FDA indications are treated as non-formulary and non-covered while BCBSMA conducts its evaluation. During the evaluation period the drug or new indication is held pending review by the Pharmacy & Therapeutics Committee or a business review, and clinical and/or administrative requirements may be applied.

Physicians may request an exception for medical necessity while the product or new indication is under review; approvals for requests for new-to-market drugs will be based on the FDA-approved indications for that drug, and if the drug’s therapeutic class is managed through prior authorization, formulary Step Therapy, or Quality Care Dosing, the current established criteria for that class will be applied. For requests for non-FDA indications, individual consideration requires submission of supporting clinical documentation.

Provider Submission Requirements & Operational Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for outpatient retail pharmacy requests for indications listed and not listed in this policy. Physicians must submit a completed Prior Authorization/Formulary Exception form or call BCBSMA Pharmacy Operations to request prior authorization verbally. Submission pathways include phone, fax, mail, or the attached form.

Phone: 1-800-366-7778
Fax: 1-800-583-6289
Mail: Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department, 25 Technology Place, Hingham, MA 02043
Form: Formulary Exception/Prior Authorization form (attached to policy)

Step Therapy

Step Therapy / Quality Care Dosing May Apply

During review, formulary Step Therapy or Quality Care Dosing rules will be applied when the drug under evaluation belongs to a therapeutic class managed by those programs. Step therapy may be applied during evaluation in accordance with existing formulary criteria.

Documentation Required

Submit Prior Authorization and Supporting Clinical Documentation

For requests that do not meet the policy's clinical criteria, physicians must submit the Prior Authorization/Formulary Exception form and any supporting clinical documentation for individual consideration. Individual consideration requests should include relevant clinical information and will be reviewed against current scientific literature.

Send supporting clinical documentation with the Prior Authorization/Formulary Exception form for individual consideration
Individual consideration submissions accepted by phone, fax, or mail

Denial Risk

Non-formulary / Non-covered While Under Review

New drugs and new FDA-approved indications will be considered non-formulary and not covered while under BCBSMA review. During this evaluation period the drug will be non-covered until the Pharmacy & Therapeutics Committee (or business review) completes its review. Providers may request medical necessity exceptions while a product is under review; incomplete requests or missing documentation may result in denial or delay.

New brand-name drugs are often placed on evaluation and treated as non-formulary/non-covered during review
New FDA-approved indications for existing medications will be held under review and considered non-formulary/non-covered until review is complete
Physicians may request a medical necessity exception; approvals for new-to-market drugs will be based on FDA-approved indications
For new-to-market medications requested for non-FDA indications, individual consideration applies and supporting clinical documentation is required

Policy Background

This policy governs the administrative and clinical review processes BCBSMA uses for formulary placement and coverage determinations of outpatient pharmacy drugs, including newly FDA-approved brand-name medications and newly approved FDA indications for existing drugs. It applies to outpatient retail pharmacy requests for commercial members with pharmacy benefits.

During evaluation periods, new-to-market drugs and medications with new FDA indications will be considered non-formulary and non-covered until Pharmacy & Therapeutics or business review is completed. Established prior authorization, Step Therapy, or Quality Care Dosing criteria for the therapeutic class may be applied while the review is ongoing.

Providers seeking coverage for individual patients during review periods must submit the Prior Authorization/Formulary Exception form or supporting clinical documentation to BCBSMA Pharmacy Operations for individual consideration; review decisions will consider the FDA-approved indication and the clinical documentation provided.

Key Definitions

New to market medication

DefinitionA recently FDA-approved brand-name drug undergoing an evaluation period by BCBSMA Pharmacy & Therapeutics before formulary placement.

Coverage status during evaluationConsidered non-formulary and non-covered while under review until the Pharmacy & Therapeutics committee completes its evaluation.

Exception pathwayPhysicians may request a medical-necessity exception during the evaluation; approvals are based on FDA‑approved indications and may be subject to existing therapeutic-class criteria (prior authorization, Step Therapy, or Quality Care Dosing).

Documentation for non‑FDA indicationsFor exception requests for a new to market medication for a non‑FDA approved indication, providers must submit supporting clinical documentation for individual consideration.

New indication

DefinitionAn FDA-approved new use for an existing medication which is held under review by BCBSMA until a Pharmacy & Therapeutics or business review is completed.

Coverage status during reviewThe medication and its new indication are considered non-formulary and not covered while under review.

Review triggersApplies whether the existing medication already has a policy or does not have a policy at the time the new FDA indication is approved.

Outcome of reviewFollowing committee or business review, BCBSMA will update the formulary and coverage decisions accordingly.

Policy Revision History

2023-07-01policy_effectiveLatest

Policy effective date and latest update: policy last updated and effective 7/1/2023.

2017-06-01administrative_update

Updated address for Pharmacy Operations.

2016-11-01content_update

Updated to add New Indication language.

2014-08-01format_and_language_update

Updated language and format of the policy.

2014-02-01administrative_update

Updated Operations contact information.

2011-05-01coverage_criteria_update

Updated criteria for approval of new-to-market medications while under review and removed drug table.

2000-04-01policy_creation

New policy created and made effective 4/1/2000.