Compounded Drugs
Indications for Prior Authorization
Criteria
Compounded drugs**
Compounded drugs are considered experimental/investigational for reasons not listed in this coverage policy section. *Approved national compendia are referenced in the "Coverage of Off-Label or Non-FDA Approved Indications" Guideline **Administrative guideline may not apply to all compound reviews, depending on the ingredients being used and client elections.
Administrative
Length of Approval: 6 months, unless the provider requests for a shorter length of therapy
- Each active ingredient in the compounded drug is FDA-approved or national compendia* supported for the condition being treated AND
- The therapeutic amounts are supported by national compendia* or two peer-reviewed literature for the condition being treated in the requested route of delivery AND
- If a drug included in the compound requires prior authorization and/or step therapy or is non-formulary, all drug-specific criteria must be met AND
- The compounded drug must not include any ingredient that has been withdrawn or removed from the market due to safety reasons (refer to Table 1) AND
- 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 following criteria are met:
- Patient has a contraindication to commercially available products OR
- One or no other therapeutic alternatives are commercially available OR
- Prepared in a strength not commercially available or currently in short supply OR
- Prepared in a different dosage form for a patient who is unable to take the commercially available formulation (mixing or reconstituting commercially available products based on the manufacturer's instructions or the product's approved labeling does NOT meet this criteria). OR
- Patient has an allergy or sensitivity to inactive ingredients (e.g. dyes, preservatives, sugars, etc.) that are found in commercially available products.
- The compounded drug must not be used for a cosmetic purpose. AND
- If the compound is subject to the drug-specific/targeted compound program, the member meets all the applicable drug-specific criteria below for all the targeted ingredient(s) used in the requested compound product.
Diclofenac compounds**
Compounded drugs are considered experimental/investigational for reasons not listed in this coverage policy section. **Administrative guideline and other drug-specific guidelines may apply. This drug-specific criteria only applies to clients who enrolled in the diclofenac targeted compound program.
Prior Authorization
Length of Approval: 6 months, unless the provider requests for a shorter length of therapy
- Compounded drugs that include diclofenac will be considered for coverage under the pharmacy benefit program when the following criteria are met:
- Patient is 18 years of age or older AND
- 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
- The final dosage form will be for oral, topical, or ophthalmic use AND
- The final dosage form and strength of the diclofenac ingredient is not commercially available AND
- 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 there is a reason for not using an alternative (e.g., contraindication, two or less similar products commercially-available).
Flurbiprofen compounds**
Compounded drugs are considered experimental/investigational for reasons not listed in this coverage policy section. **Administrative guideline and other drug-specific guidelines may apply. This drug-specific criteria only applies to clients who enrolled in the flurbiprofen targeted compound program.
Prior Authorization
Length of Approval: 6 months, unless the provider requests for a shorter length of therapy
- Compounded drugs that include flurbiprofen will be considered for coverage under the pharmacy benefit program when the following criteria are met:
- Patient is 18 years of age or older AND
- Diagnosis of one of the following:
- Osteoarthritis
- Rheumatoid arthritis
- Intraoperative miosis inhibition
- The final dosage form will be for oral or ophthalmic use AND
- The final dose is not commercially available AND
- 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 there is a reason for not using an alternative (e.g., contraindication, two or less similar products commercially-available).
Fluticasone compounds**
Compounded drugs are considered experimental/investigational for reasons not listed in this coverage policy section. **Administrative guideline and other drug-specific guidelines may apply. This drug-specific criteria only applies to clients who enrolled in the fluticasone targeted compound program.
Prior Authorization
Length of Approval: 6 months, unless the provider requests for a shorter length of therapy
- Compounded drugs that include fluticasone will be considered for coverage under the pharmacy benefit program when the following criteria are met:
- Patient is 3 months of age or older AND
- Diagnosis of Inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, including but not limited to atopic dermatitis, contact dermatitis, eczema, psoriasis AND
- The final dose is not commercially available AND
- 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 there is a reason for not using an alternative (e.g., contraindication, two or less similar products commercially-available). AND
- The compounded product is not being used for cosmetic purposes (i.e., scar treatment, anti-aging, skin lightening, etc.)
Gabapentin compounds**
Compounded drugs are considered experimental/investigational for reasons not listed in this coverage policy section. **Administrative guideline and other drug-specific guidelines may apply. This drug-specific criteria only applies to clients who enrolled in the gabapentin targeted compound program.
Prior Authorization
Length of Approval: 6 months, unless the provider requests for a shorter length of therapy
- Compounded drugs that include gabapentin will be considered for coverage under the pharmacy benefit program when the following criteria are met:
- Patient is 3 years of age or older AND
- Patient must have one of the following diagnoses:
- Partial seizures
- Postherpetic neuralgia
- Restless leg syndrome (RLS)
- The final dosage form will be for oral use AND
- The requested dose is not commercially available AND
- 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 there is a reason for not using an alternative (e.g., contraindication, two or less similar products commercially-available)
Ketamine compounds**
Compounded drugs are considered experimental/investigational for reasons not listed in this coverage policy section. *According to the prescribing information, 100mg/ml product must be diluted prior to administration. **Administrative guideline and other drug-specific guidelines may apply. This drug-specific criteria only applies to clients who enrolled in the ketamine targeted compound program.
Prior Authorization
Length of Approval: 6 months, unless the provider requests for a shorter length of therapy
- Compounded drugs that include ketamine will be considered for coverage under the pharmacy benefit program when the following criteria are met:
- Patient is 16 years of age or older AND
- One of the following:
- Patient is requiring ketamine for conscious sedation prior to a diagnostic or surgical procedure that do not require skeletal muscle relaxation OR
- Patient is requiring ketamine for the induction of anesthesia prior to the administration of other general anesthetic agents OR
- Patient is requiring ketamine as a supplement to low-potency anesthetic agents, such as nitrous oxide
- The final dosage form will be for injection AND
- The requested dose is not commercially available AND
- 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 there is a reason for not using an alternative (e.g., contraindication, two or less similar products commercially-available). AND
- The requested dose does not exceed the concentration limit of 100mg/mL*
Ketoprofen compounds**
Compounded drugs are considered experimental/investigational for reasons not listed in this coverage policy section. **Administrative guideline and other drug-specific guidelines may apply. This drug-specific criteria only applies to clients who enrolled in the ketoprofen targeted compound program.
Prior Authorization
Length of Approval: 6 months, unless the provider requests for a shorter length of therapy
- Compounded drugs that include ketoprofen will be considered for coverage under the pharmacy benefit program when the following criteria are met:
- Patient is 18 years of age or older AND
- Diagnosis of one of the following:
- Osteoarthritis
- Rheumatoid arthritis
- Acute pain
- Primary dysmenorrhea
- The final dosage form will be for oral use AND
- The final dose is not commercially available AND
- 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 there is a reason for not using an alternative (e.g., contraindication, two or less similar products commercially-available).
Levocetirizine compounds**
Compounded drugs are considered experimental/investigational for reasons not listed in this coverage policy section. **Administrative guideline and other drug-specific guidelines may apply. This drug-specific criteria only applies to clients who enrolled in the levocetirizine targeted compound program.
Prior Authorization
Length of Approval: 6 months, unless the provider requests for a shorter length of therapy
- Compounded drugs that include levocetirizine will be considered for coverage under the pharmacy benefit program when the following criteria are met:
- Patient is 6 months of age or older AND
- Diagnosis of one of the following:
- Seasonal or perennial allergic rhinitis
- Uncomplicated skin manifestations of chronic idiopathic urticaria
- The final dosage form will be for oral use AND
- The final dose is not commercially available AND
- 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 there is a reason for not using an alternative (e.g., contraindication, two or less similar products commercially-available).
Mometasone compounds**
Compounded drugs are considered experimental/investigational for reasons not listed in this coverage policy section. **Administrative guideline and other drug-specific guidelines may apply. This drug-specific criteria only applies to clients who enrolled in the mometasone targeted compound program.
Prior Authorization
Length of Approval: 6 months, unless the provider requests for a shorter length of therapy
- Compounded drugs that include mometasone will be considered for coverage under the pharmacy benefit program when the following criteria are met:
- Patient is 2 years of age or older AND
- Diagnosis of Inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, including but not limited to atopic dermatitis, contact dermatitis, eczema, psoriasis AND
- The final dose is not commercially available AND
- 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 there is a reason for not using an alternative (e.g., contraindication, two or less similar products commercially-available). AND
- The compounded product is not being used for cosmetic purposes (i.e., scar treatment, anti-aging, skin lightening, etc.)
Acyclovir ointment 5% compounds**
Compounded drugs are considered experimental/investigational for reasons not listed in this coverage policy section. **Administrative guideline and other drug-specific guidelines may apply. This drug-specific criteria only applies to clients who enrolled in the Acyclovir ointment 5% targeted compound program.
Prior Authorization
Length of Approval: 6 months, unless the provider requests for a shorter length of therapy
- Compounded drugs that include Acyclovir ointment 5% will be considered for coverage under the pharmacy benefit program when the following criteria are met:
- Patient is 18 years of age or older AND
- Diagnosis for one of the following:
- Management of initial genital herpes
- Limited non-life-threatening mucutaneous herpes simplex virus infection in immunocompromised patients
- The final dose is not commercially available AND
- 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 there is a reason for not using an alternative (e.g., contraindication, two or less similar products commercially-available)
Doxepin cream 5% compounds**
Compounded drugs are considered experimental/investigational for reasons not listed in this coverage policy section. **Administrative guideline and other drug-specific guidelines may apply. This drug-specific criteria only applies to clients who enrolled in the Doxepin cream 5% targeted compound program.
Prior Authorization
Length of Approval: 6 months, unless the provider requests for a shorter length of therapy
- Compounded drugs that include Doxepin cream 5% will be considered for coverage under the pharmacy benefit program when the following criteria are met:
- Patient is 18 years of age or older AND
- Treatment of moderate pruritus with atopic dermatitis or lichen simplex chronicus AND
- The final dose is not commercially available AND
- 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 there is a reason for not using an alternative (e.g., contraindication, two or less similar products commercially-available)
P & T Revisions
2024-07-01, 2023-07-07, 2022-07-06, 2022-01-11, 2021-07-06, 2021-05-20, 2020-07-17, 2020-03-30, 2019-08-19
References
- Compounding and the FDA: Questions and Answers. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm. Accessed July 1, 2024.
- Application of Federal Low to Practice of Pharmacy Compounding. Available at: https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm155666.htm. Accessed July 1, 2024.
- Drugs withdrawn or removed from the market for reasons of safety and effectiveness. Available at: https://www.ecfr.gov/cgi-bin/text-idx?SID=427cfbadfcc9a0a3cee36b57e99712ad&mc=true&node=se21.4.216_124&rgn=div8.Accessed July 1, 2024.
- DRUGDEX [Internet database]. Greenwood Village, CO: Thomson MICROMEDEX, updated periodically. Accessed July 1, 2024.
- Flurbiprofen Tablet Prescribing Information. Teva Pharmaceuticals. Parsippany, NJ. November 2021.
- Gralise prescribing information. Almatica Pharma LLC. Morristown, NJ. April 2023.
- Horizant prescribing information. Arbor Pharmaceuticals, LLC. Atlanta, GA. April 2020.
- Neurontin prescribing information. Pfizer. New York, NY. December 2020.
- Ketalar prescribing information. Par Pharmaceutical. Chestnut Ridge, NY. June 2022.
- Ketoprofen Prescribing Information. Mylan Pharmaceuticals. Morgantown, WV. March 2021.
- Spravato Prescribing Information. Janssen Pharmaceuticals. Titusville, NJ. October 2023.
- Sinuva Prescribing Information. Intersect ENT, Inc. Menlo Park, CA. January 2023.
Revision History
- 2024-07-01: 2024 UM Annual Review. Minor criteria update. Background updates.
- 2023-07-07: 2023 Annual Review. No changes to criteria.
- 2022-07-06: Annual review: updated references, no criteria changes
- 2022-01-11: Annual review: updated references, no criteria changes
- 2021-07-06: Annual review: updated references, no criteria changes
- 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
- 2020-07-17: 2020 Annual Review:updated guideline to specify that two peer reviewed articles required
- 2020-03-30: Added criteria for Acyclovir 5% ointment and Doxepin 5% cream Compounds
- 2019-08-19: 2019 annual review. Background & reference sections updated.
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