Prior Authorization : Brand Medically Necessary Drugs and Brand Before Generic Drugs

Brand Medically Necessary Drugs: A Prescriber's Responsibilities

As required in Wis. Admin. Code § DHS 107.10(3)(c) when a prescription is for a BMN drug, the prescriber is required to handwrite "brand medically necessary" directly on the prescription. ForwardHealth also allows the required statement to be handwritten on a separate order attached to the original prescription. Typed certification, signature stamps, or certification handwritten by someone other than the prescriber does not satisfy this requirement. Blanket authorization for an individual member, drug, or prescriber is not acceptable documentation.

Prescribers are also required to complete a PA/BMNA form for BMN drugs that require PA. The PA/BMNA form must include accurate and complete answers and clinical information about the member's medical history and must include the prescriber's handwritten signature and date.

The PA/BMNA form may be faxed or mailed to the pharmacy, or the member may carry the form with the prescription to the pharmacy. The pharmacy provider will use the completed PA/BMNA form to submit a PA request to ForwardHealth. Prescribers should not submit the PA/BMNA form to ForwardHealth.

Prescribers are required to retain a completed, signed, and dated copy of the PA form and any supporting documentation.

For drugs that are subject to BMN policy but do not require PA, prescribers are still required to handwrite "brand medically necessary" on the prescription either directly on the prescription or on a separate order attached to the original prescription, and pharmacy providers are required to submit a DAW/Product Selection Code 1 (Substitution not allowed by prescriber). The completion of the PA/BMNA form is not required.

The Brand Medically Necessary Drugs and Brand Before Generic Drugs data table provides the most current list of the BMN drugs that require PA.

Clinical Criteria for Brand Medically Necessary Drugs That Require Prior Authorization

Clinical criteria for approval of a BMN drug that requires PA are all of the following:

• The drug has been defined by ForwardHealth as a brand drug that requires BMN PA.
• The member satisfies established coverage and PA policy for the generic equivalent drug.
• The prescriber submits detailed documentation of the member's relevant medication treatment history.
• The member has taken the requested BMN drug for at least 30 consecutive days and had a measurable therapeutic response. (Note: Documentation of approximate dates taken may come from the pharmacy or the prescriber.)
• The prescriber has indicated how the BMN drug will prevent recurrence of an unsatisfactory therapeutic response or clinically significant adverse drug reaction.
• The member has experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction to the generic equivalent drug from at least two different manufacturers.

For each generic trial, the following must be documented:

• Generic drug manufacturer or NDC (Note: Documentation may come from the pharmacy or the prescriber.)
• Approximate dates taken (Note: Documentation may come from the pharmacy or the prescriber.)
• A description of the unsatisfactory therapeutic response or clinically significant adverse drug reaction that can be directly attributed to the generic equivalent drug

Note: Member or prescriber preference for the use of a BMN drug will not be considered as criteria to support the need for a BMN drug.

Brand Medically Necessary Drugs With Generic Equivalents on the Preferred Drug List

In addition to meeting the clinical criteria for BMN drugs that require PA, existing PDL policies will apply to BMN drugs with generic equivalents on the PDL. This includes, but is not limited to, policy pertaining to drug classes that require step therapy, drugs that require clinical PA, and drugs that have non-preferred generic equivalents.

In addition to completing the PA/BMNA form for BMN drugs requiring PA, the prescriber is required to complete any other required drug- or drug-class-specific PA form and provide any medical records and/or documentation required for the generic equivalent drug or applicable drug class. Examples include, but are not limited to, the following:

• A BMN drug, where its non-preferred generic equivalent requires a specific PA form
• A drug or drug class that requires specific medical records and/or documentation to be submitted with the PA request

For example, if a prescriber requests BMN PA for a brand drug and the non-preferred generic equivalent drug's PDL PA criteria requires the use of at least two PDL preferred drugs in the same drug class with an unsatisfactory therapeutic response or clinically significant adverse drug reaction, this requirement must also be met before a PA request can be approved for the brand name drug.

The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs.