Mass General Brigham Health Plan Compounded Drugs Prior Auth

Coverage Criteria for Compounded Drugs

General compound coverage criteria

Authorization may be granted when ALL of the following are met:

Compound-wide criteria: 1. Each active ingredient in the compounded drug is FDA-approved or supported by national compendia for the condition being treated; 2. Therapeutic amounts are supported by national compendia or two peer-reviewed literature sources for the condition and requested route of delivery; 3. If any prescription ingredients require prior authorization and/or step therapy, all drug-specific criteria for those ingredients must also be met; 4. The compounded drug must not include any ingredient withdrawn or removed from the market for safety reasons (refer to Appendix); 5. The patient has tried and failed therapy or had an intolerance to two FDA‑approved commercially available prescription therapeutic alternatives, one of which is the same route of administration as the requested compound, unless one of the exception criteria is met (contraindication to commercially available products; one or no other therapeutic alternatives commercially available; prepared in a strength not commercially available or currently in short supply; prepared in a different dosage form when the member is unable to take the commercially available formulation — mixing/reconstituting per manufacturer instructions does NOT meet this exception; allergy or sensitivity to inactive ingredients); 6. The compounded drug must not be used for cosmetic purposes (e.g., scar treatment, anti-aging, skin lightening); 7. If the compound is subject to the drug-specific/targeted compound program, the member meets all applicable drug-specific criteria for all targeted ingredient(s).

Exception criteria to the two-failure requirement are listed within the compound-wide criteria.

Diclofenac

Diclofenac compounds - Covered when ALL of the following are met:

Diclofenac-specific: 1. Member is 18 years of age or older; 2. Member has a diagnosis of one of the following: osteoarthritis; rheumatoid arthritis; mild to moderate pain; pain due to minor strains, sprains, or contusions; migraine; primary dysmenorrhea; actinic keratosis; ankylosing spondylitis; inflammatory disorder of the eye; photophobia; pain in the eye; 3. The final dosage form will be for oral, topical, or ophthalmic use; 4. The final dosage form and strength of the diclofenac ingredient is not commercially available; 5. The patient has tried and failed therapy or had an intolerance to three FDA‑approved commercially available prescription therapeutic alternatives, one of which is the same route of administration as the requested compound, unless there is a reason for not using an alternative (e.g., contraindication, two or fewer similar products commercially available).

Flurbiprofen

Flurbiprofen compounds - Covered when ALL of the following are met:

Flurbiprofen-specific: 1. Member is 18 years of age or older; 2. Member has a diagnosis of one of the following: osteoarthritis; rheumatoid arthritis; intraoperative miosis inhibition; 3. The final dosage form will be for oral or ophthalmic use; 4. The final dose is not commercially available; 5. The patient has tried and failed therapy or had an intolerance to three FDA‑approved commercially available prescription therapeutic alternatives, one of which is the same route of administration as the requested compound, unless there is a reason for not using an alternative (e.g., contraindication, two or fewer similar products commercially available).

Fluticasone

Fluticasone compounds - Covered when ALL of the following are met:

Fluticasone-specific: 1. Member is 3 months of age or older; 2. Member has a diagnosis of inflammatory and pruritic manifestations of corticosteroid‑responsive dermatoses (e.g., atopic dermatitis, contact dermatitis, eczema, psoriasis); 3. The final dose is not commercially available; 4. The patient has tried and failed therapy or had an intolerance to three FDA‑approved commercially available prescription therapeutic alternatives, one of which is the same route of administration as the requested compound, unless there is a reason for not using an alternative (e.g., contraindication, two or fewer similar products commercially available); 5. The compounded product is not being used for cosmetic purposes (e.g., scar treatment, anti‑aging, skin lightening).

Gabapentin

Gabapentin compounds - Covered when ALL of the following are met:

Gabapentin-specific: 1. Member is 3 years of age or older; 2. Member must have one of the following diagnoses: partial seizures; postherpetic neuralgia; restless leg syndrome (RLS); 3. The final dosage form will be for oral use; 4. The requested dose is not commercially available; 5. The patient has tried and failed therapy or had an intolerance to three FDA‑approved commercially available prescription therapeutic alternatives, one of which is the same route of administration as the requested compound, unless there is a reason for not using an alternative (e.g., contraindication, two or fewer similar products commercially available).

Ketamine

Ketamine compounds - Covered when ALL of the following are met:

Ketamine-specific: 1. Member is 16 years of age or older; 2. ONE of the following: (a) requiring ketamine for conscious sedation prior to a diagnostic or surgical procedure that does not require skeletal muscle relaxation; (b) requiring ketamine for induction of anesthesia prior to administration of other general anesthetic agents; (c) requiring ketamine as a supplement to low‑potency anesthetic agents (e.g., nitrous oxide); 3. The final dosage form will be for injection; 4. The requested dose is not commercially available; 5. The patient has tried and failed therapy or had an intolerance to three FDA‑approved commercially available prescription therapeutic alternatives, one of which is the same route of administration as the requested compound, unless there is a reason for not using an alternative (e.g., contraindication, two or fewer similar products commercially available); 6. The requested dose does not exceed the concentration limit of 100 mg/mL (per prescribing information, 100 mg/mL product must be diluted prior to administration).<= 100 mg/mL

Requested 100 mg/mL concentration must be diluted prior to administration per prescribing information.

Ketoprofen

Ketoprofen compounds - Covered when ALL of the following are met:

Ketoprofen-specific: 1. Member is 18 years of age or older; 2. Member has a diagnosis of ONE of the following: osteoarthritis; rheumatoid arthritis; acute pain; primary dysmenorrhea; 3. The final dosage form will be for oral use; 4. The final dose is not commercially available; 5. The patient has tried and failed therapy or had an intolerance to three FDA‑approved commercially available prescription therapeutic alternatives, one of which is the same route of administration as the requested compound, unless there is a reason for not using an alternative (e.g., contraindication, two or fewer similar products commercially available).

Levocetirizine

Levocetirizine compounds - Covered when ALL of the following are met:

Levocetirizine-specific: 1. Member is 6 months of age or older; 2. Member has a diagnosis of ONE of the following: seasonal or perennial allergic rhinitis; uncomplicated skin manifestations of chronic idiopathic urticaria; 3. The final dosage form will be for oral use; 4. The final dose is not commercially available; 5. The patient has tried and failed therapy or had an intolerance to three FDA‑approved commercially available prescription therapeutic alternatives, one of which is the same route of administration as the requested compound, unless there is a reason for not using an alternative (e.g., contraindication, two or fewer similar products commercially available).

Mometasone

Mometasone compounds - Covered when ALL of the following are met:

Mometasone-specific: 1. Member is 2 years of age or older; 2. Member has a diagnosis of inflammatory and pruritic manifestations of corticosteroid‑responsive dermatoses (e.g., atopic dermatitis, contact dermatitis, eczema, psoriasis); 3. The final dose is not commercially available; 4. The patient has tried and failed therapy or had an intolerance to three FDA‑approved commercially available prescription therapeutic alternatives, one of which is the same route of administration as the requested compound, unless there is a reason for not using an alternative (e.g., contraindication, two or fewer similar products commercially available); 5. The compounded product is not being used for cosmetic purposes (e.g., scar treatment, anti‑aging, skin lightening).

Acyclovir 5% ointment

Acyclovir 5% ointment compounds - Covered when ALL of the following are met:

Acyclovir-specific: 1. Member is 18 years of age or older; 2. Member has a diagnosis of ONE of the following: management of initial genital herpes; limited non‑life‑threatening mucocutaneous herpes simplex virus infection in immunocompromised patients; 3. The final dose is not commercially available; 4. The patient has tried and failed therapy or had an intolerance to three FDA‑approved commercially available prescription therapeutic alternatives, one of which is the same route of administration as the requested compound, unless there is a reason for not using an alternative (e.g., contraindication, two or fewer similar products commercially available).

Doxepin 5% cream

Doxepin cream 5% compounds - Covered when ALL of the following are met:

Doxepin-specific: 1. Member is 18 years of age or older; 2. Requested medication will be used for treatment of moderate pruritis with atopic dermatitis or lichen simplex chronicus; 3. The final dose is not commercially available; 4. The patient has tried and failed therapy or had an intolerance to three FDA‑approved commercially available prescription therapeutic alternatives, one of which is the same route of administration as the requested compound, unless there is a reason for not using an alternative (e.g., contraindication, two or fewer similar products commercially available).

Compounded products intended solely for aesthetic or cosmetic use are not covered. The policy excludes compounds used for purposes such as scar treatment, anti-aging, and skin lightening, and will not meet medical necessity criteria when the requested preparation is for a cosmetic indication.

Any compounded preparation that contains an ingredient that has been withdrawn or removed from the market due to safety or effectiveness is not acceptable for coverage. Refer to the Appendix for the list of withdrawn agents; compounds including those ingredients will not meet criteria and are at risk for denial.

Coding and Concentration Limits

Ketamine limits and requirements

Ketamine concentration limitRequested concentration must not exceed 100 mg/mL (100 mg/mL product must be diluted prior to administration per prescribing information).

Applicable ageMember must be 16 years of age or older for ketamine compounds.

Route/formFinal dosage form must be for injection.

Commercial availabilityRequested dose must not be commercially available to meet coverage criteria.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for compounded drugs billed under the pharmacy benefit. Authorization may be granted for members new to the plan who are currently receiving treatment with the requested compounded medication (authorization does not apply to samples or medications obtained via manufacturer patient assistance programs).

Applies to compounded drugs under the pharmacy benefit
New members currently receiving treatment may be authorized

Step Therapy

Step Therapy / Prior Authorization Interplay

If any prescription ingredient in the compounded product is subject to prior authorization and/or step therapy, all drug‑specific criteria for those ingredient(s) must be satisfied prior to approval of the compound.

All drug‑specific PA or step therapy requirements must be met for each targeted ingredient

Definitions and Alternatives

Commercially available alternative — definition and failure requirements

DefinitionA commercially available alternative is an FDA‑approved, commercially available prescription therapeutic alternative.

Failure requirement (general rule)Patient must have tried and failed therapy or had intolerance to two FDA‑approved commercially available prescription therapeutic alternatives, one of which is the same route as the requested compound, unless an exception applies.

Failure requirement (targeted compounds)For many targeted/ drug‑specific compounds, failure or intolerance to three FDA‑approved commercially available alternatives is required unless a listed exception applies.

Exceptions to failure requirementExceptions include: contraindication to alternatives; one or no other therapeutic alternatives commercially available; strength not commercially available or in short supply; need for different dosage form (not met by simple mixing/reconstituting per labeling); or allergy/sensitivity to inactive ingredients.

Continuation Therapy for Existing Treatment

Continuation therapy for existing treatment

Continuation for members new to plan

Continuation: Authorization may be granted for members new to the plan who are currently receiving treatment with the requested medication (excluding samples or manufacturer patient assistance program supplies).

Step Therapy Requirements

Required prior trials	Notes / exceptions
Failure or intolerance to two FDA-approved commercially available prescription therapeutic alternatives (general rule).
One of the two prior alternatives must have the same route of administration as the requested compounded product; exceptions apply (see Exceptions column).
Exceptions that waive the two‑failure requirement: contraindication to commercially available products; one or no other therapeutic alternatives commercially available; requested strength not commercially available or currently in short supply; required different dosage form because patient cannot use commercially available formulation (mixing/reconstituting per manufacturer instructions does NOT satisfy); allergy or sensitivity to inactive ingredients present in commercially available products.

Site of Care and Administration

Note

Ensure correct final dosage form and site of care by compound

Site‑of‑care and final dosage form requirements depend on the compound: injectable compounds (for example, ketamine) must be for injection and follow the ketamine‑specific guidance (including concentration limits); other compounds require the final dosage form specified in their drug‑specific criteria (oral, topical, ophthalmic).

Ketamine compounds: final dosage form must be injection and requested concentration must not exceed 100 mg/mL.
Other targeted compounds: follow the drug‑specific final dosage form (oral, topical, ophthalmic) listed in the policy.

Background

Compounded medications are custom‑prepared formulations used when commercially available products do not meet a patient’s needs (for example, when an appropriate strength or dosage form is unavailable, or a patient has sensitivity to inactive ingredients). Per policy, each active ingredient in a compounded drug must be FDA‑approved or supported by national compendia, therapeutic amounts must be supported by compendia or peer‑reviewed literature, and requested compounds must satisfy the policy’s trial‑of‑therapy requirements and other compound‑wide criteria before authorization may be granted.

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Compounded Drugs Prior Authorization