CurrentBlue Cross Blue Shield - North CarolinaPolicy N/A

Brand-name medication DAW waiver when A-rated generic available

Defines criteria under which additional member cost-share or fees for a brand-name drug may be waived when an A‑rated generic equivalent exists; applies to providers and prescribers serving Blue Cross NC members.

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyBrand-name medication DAW waiver when A-rated generic available

Policy CodePolicy N/A

Change TypeRevised criteria and duration

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must indicate DAW, document trial of an A-rated generic, submit FDA MedWatch form, and request prior authorization for a fee waiver.

SourceLink

POLICY UPDATE CHANGES

Updated requirement to trial an A-rated generic equivalent.

Updated duration of approval to 3 years (1095 days).

Reformatted criteria in March 2024 and previously updated duration to 1 year.

5number of discrete waiver criteria listed

1095duration of approval

A-ratedgeneric equivalency required

NCapplicable state

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyBrand-name medication DAW waiver when A-rated generic available

Policy CodePolicy N/A

Change TypeRevised criteria and duration

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must indicate DAW, document trial of an A-rated generic, submit FDA MedWatch form, and request prior authorization for a fee waiver.

SourceLink

On This Page

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Brand-name fee waiver criteria

Additional fees may be waived for a brand name medication when a generic is available if ALL of the following are met:

Waiver approval criteria

Prescriber has indicated 'Dispense As Written (DAW)' on the prescription.
Patient has tried an A-rated generic equivalent to the brand-name medication.
Clinical justification (one required)
- Patient had a documented allergic reaction to an excipient present in the generic formulation but absent in the brand-name equivalent.
- Patient had a documented life‑threatening side effect to the generic medication that required medical intervention and did not occur with the brand.
Prescriber completed and submitted an FDA MedWatch Adverse Event Reporting Form and provided a copy of the completed form (authorization will not be considered unless the form is completed and submitted).

No explicit exclusions are listed in this policy beyond failure to meet the stated documentation and criteria. In practice, requests will be denied if required elements are missing—examples include absence of a Dispense As Written (DAW) instruction on the prescription, no documented trial of an A‑rated generic equivalent, or failure to submit a completed FDA MedWatch form (a copy must be provided).

This policy defines procedural criteria for waiving additional member cost-share or brand‑name fees when an A‑rated generic equivalent exists; it is not framed as a clinical not medically necessary determination. Approval is based on meeting the specific administrative and clinical documentation requirements listed (DAW, trial of an A‑rated generic, documented excipient allergy or life‑threatening reaction as applicable, and submission of a completed FDA MedWatch form).

Provider Requirements and Authorization Process

Prior Authorization

Brand-name DAW waiver prior authorization

Prior authorization for a brand-name fee waiver requires the prescriber to indicate 'Dispense As Written (DAW)' on the prescription, document a trial of an A-rated generic equivalent, show either a documented allergic reaction to a generic excipient (absent in the brand) or a documented life‑threatening side effect to the generic not seen with the brand, and submit a completed FDA MedWatch form.

All listed conditions (1–5) must be met for waiver approval
Duration of approval: 1095 days (3 years)

Step Therapy

Trial of A-rated generic required

The patient must have tried an A‑rated generic equivalent to the brand medication before a fee waiver for the brand will be approved.

Documentation Required

Required documentation from prescriber

The prescriber must indicate 'Dispense As Written (DAW)' on the prescription, provide documentation of a trial of an A‑rated generic equivalent, and document the clinical rationale (e.g., allergic reaction to a generic excipient or a life‑threatening adverse reaction to the generic). A copy of the completed FDA MedWatch form must also be submitted.

DAW must be indicated on the prescription (item 1)
Documentation of trial of an A‑rated generic equivalent (item 2)
Clinical justification: documented excipient allergy or life‑threatening reaction (items 3–4)
Submit copy of completed FDA MedWatch form (item 5)

Denial Risk

FDA MedWatch form required

Authorization will not be considered unless the prescriber completes and submits an FDA MedWatch Adverse Event Reporting Form; the prescriber must provide a copy of the completed MedWatch form with the request.

MedWatch form must be completed and submitted to the FDA
Copy of completed MedWatch form must be provided with the authorization request

Policy Background and Rationale

This policy applies when a patient cannot tolerate an A‑rated generic equivalent due to an excipient (inactive ingredient) allergy or a life‑threatening adverse event attributable to the generic but not observed with the brand product. In such cases, the policy permits waiver of additional fees for the brand product when supported by documentation, including a documented trial of the generic and a completed FDA MedWatch Adverse Event Reporting Form. The duration of approval for an authorized waiver is 1095 days (3 years).

Key Definitions

inv-11: DAW — Dispense As Written definition.

DefinitionDispense As Written (DAW) — prescriber's instruction on the prescription that the brand product must be dispensed without substitution.

Requirement for waiverPrescriber must indicate 'Dispense As Written (DAW)' on the prescription for brand-name fee waiver consideration.

Documentation noteDAW indication is one of the required criteria and must be present along with trial of A-rated generic and MedWatch submission.

inv-12: A-rated generic — definition of FDA therapeutic equivalence rating.

DefinitionA-rated generic — a generic drug rated as therapeutically equivalent by the FDA to the brand-name product.

Step therapy implicationPatient must have tried an A-rated generic equivalent to the brand medication prior to approval of a fee waiver.

Policy changeApril 2026 update explicitly requires trial of an A-rated generic equivalent as part of waiver criteria.

OpenPayer

Brand-name medication DAW waiver when A-rated generic available

Criteria for Waiving Brand-Name Medication Fee When A‑Rated Generic Available

Coding and Approval Duration

Provider Requirements and Authorization Process

Policy Background and Rationale

Key Definitions

Document Changes