CurrentMass General Brigham Health PlanPolicy N/A

Quantity limit override for medications

Defines clinical and documentation requirements for prior authorization of requests to exceed pharmacy quantity limits for medical and specialty medications for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyQuantity limit override for medications

Policy CodePolicy N/A

Change TypeRevised (adopted Optum criteria)

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing FDA‑approved indication or acceptable off‑label guideline support and evidence supporting the higher quantity.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed/updated for Jan P&T and adopted Optum criteria; effective 01/01/2024.

12 monthsstandard approval duration

01/01/2024quantity limit effective date

PA requiredauthorization process

Commercial; MassHealthplans referenced

Coverage Criteria

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Coverage Criteria

Authorization of a medication for higher than the quantity limit may be approved when ALL of the following are met:

ALL of the following

Request involves an FDA‑approved indication.
Off‑label use
- Request involves an off‑label indication and meets accepted off‑label guideline approval criteria.
Situations warranting higher quantity
- One‑time titration or loading‑dose purposes (approval limited to a single authorization for titration).
- Patient is on a dose‑alternating schedule requiring additional quantity.
- Requested strength/dose is commercially unavailable requiring higher quantity of an alternative strength/dose.
- For topical applications, patient requires a larger quantity to cover a larger surface area.
The maximum doses specified under the quantity restriction have been tried for an adequate period and deemed ineffective for the member's condition, OR clinical justification supports that lower doses will be ineffective (e.g., clinical literature, patient attributes, or drug characteristics).
Support for higher dose/quantity
- Higher dose or quantity is supported in the dosage and administration section of the manufacturer's prescribing information.
- Higher dose or quantity is supported by an accepted compendium (e.g., American Hospital Formulary Service Drug Information, Micromedex DRUGDEX System).
- Higher dose or quantity is supported by clinical research: at least two articles from major peer‑reviewed medical journals presenting data that the proposed higher than maximum doses are generally safe and effective for the provided diagnosis.

Provider Actions and Authorization Requirements

Prior Authorization

Quantity Limit Override Prior Authorization

Prior authorization is required for requests to exceed established pharmacy quantity limits; approvals may be granted when criteria below are met.

Applies to Commercial/Exchange pharmacy benefit
Effective 01/01/2024

Step Therapy

Step Therapy Note

Step therapy is listed as a program type for this policy. Specific step requirements are managed separately and are not detailed in this document; clinicians should consult the member’s benefit plan or step therapy program rules when applicable.

Documentation Required

Required Documentation

Provide documentation demonstrating the medical necessity of the requested quantity above the limit. Acceptable documentation includes FDA‑approved indication or, for off‑label uses, evidence meeting off‑label guideline criteria; manufacturer dosing information; supportive compendia (e.g., AHFS, Micromedex DRUGDEX); clinical literature; or two peer‑reviewed articles showing safety and efficacy for the requested higher dose/quantity. For one‑time titration/loading dose authorizations, document the dosing schedule and clinical justification. For requests due to unavailable strength or larger topical surface area coverage, provide evidence the requested strength/quantity is required.

FDA‑approved indication documentation required for on‑label quantity overrides
Off‑label indications must meet off‑label guideline approval criteria
Acceptable references: American Hospital Formulary Service (AHFS), Micromedex DRUGDEX
Two peer‑reviewed articles required when relying on clinical research to support higher than maximum doses
Document titration/loading‑dose justification, alternating dose schedules, unavailable strength, or increased topical surface area needs

Denial Risk

Grounds for Denial

Requests to exceed quantity limits will be denied if they do not involve an FDA‑approved indication or do not meet off‑label guideline approval criteria, lack adequate supporting documentation (compendia, manufacturer dosing, clinical literature, or peer‑reviewed evidence), or if lower doses/maximum doses specified under the quantity restriction have not been tried or justified as likely ineffective.

Background

This policy governs prior authorization requests to exceed standard pharmacy quantity limits for Mass General Brigham Health Plan members. It applies when a prescriber requests a higher than permitted quantity for reasons including titration/loading (one‑time authorization), use of an alternating dose schedule, requested strength or dose that is commercially unavailable, need for larger topical quantities due to greater surface area, or when maximum doses under the restriction have been tried and proven ineffective.

Approvals for quantity limit overrides reference the FDA labeling, recognized compendia, manufacturer dosing, or clinical literature demonstrating safety and efficacy. When approved for reasons other than titration/loading, authorizations are typically granted for 12 months; titration/loading‑dose approvals are one‑time as documented in the coverage criteria.

Prior authorization is required for all requests to exceed established pharmacy quantity limits. Providers should supply clinical documentation that supports the chosen rationale (for example, manufacturer dosing or compendia entries) to demonstrate why the standard quantity limit is insufficient for the member’s treatment.

Definitions

Titration/Loading Dose — Definition

DefinitionTitration/loading-dose one-time authorization

When applicableFor titration or loading-dose purposes a one-time authorization may be granted

Related examplesIncludes patient on a dose‑alternating schedule or when requested strength/dose is commercially unavailable

Topical considerationFor topical applications, larger quantity may be authorized to cover a larger surface area

Off‑label Indication — Requirements

RequirementRequests for off‑label indications must meet off‑label guideline approval criteria

ContextQuantity limit override requests must involve an FDA‑approved indication OR for off‑label uses meet off‑label guideline criteria

Evidence acceptedClinical literature, patient attributes, or characteristics of the drug may support off‑label use when lower doses have not been tried

DocumentationProvide clinical support demonstrating safety and efficacy per policy requirements

Quantity Limits

Quantity Limit Override (pharmacy benefit)

Policy scopeApplies to pharmacy benefit medications where higher than standard quantity limit is requested

Authorization requirementPrior authorization is required for requests to exceed established pharmacy quantity limits

Approval criteriaHigher than standard quantity limit may be authorized when all coverage criteria are met (e.g., FDA‑approved indication or acceptable off‑label support; acceptable clinical rationales)

Approval durationApprovals will be granted for 12 months except titration/loading‑dose which are one‑time