Drug and Biologic Coverage Policy

Effective Date ...... 1/1/2021 Next Review Date… ...... 1/1/2022 Coverage Policy Number ...... P0100

Tetracycline Antibiotics

Table of Contents Related Coverage Resources

Medical Necessity Criteria ...... 1 Sarecycline - (P0092) FDA Approved Indications ...... 4 Background ...... 4 References ...... 4

INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

Medical Necessity Criteria

Please refer to Pharmacy Benefit Coverage Criteria (PBCC) policy P0092, Sarecycline, for acne vulgaris criteria for sarecycline therapy.

Employer Group Plans: Non-covered Tetracycline Antibiotics are considered medically necessary when the following criteria are met:

Employer Group Plans: Employer Group Plans: Value, Advantage, or Cigna Drug Standard, Performance Drug, or Total Savings Prescription Drug Legacy Prescription Drug List List Acticlate® Documented failure/inadequate response, intolerance or not a candidate for (doxycycline hyclate 75 mg ALL of the following: and 150 mg tablets) • doxycycline monohydrate or hyclate 50 mg or 100 mg capsule or tablet • doxycycline hyclate ER 50 mg, 75 mg, 100 mg, 150 mg, or 200 mg tablets • minocycline 50 mg, 75 mg or 100 mg capsule or tablet • minocycline ER 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, or 135 mg tablets • tetracycline 500 mg capsule

Page 1 of 4 Pharmacy Benefit Clinical Criteria: P0100 Adoxa® ALL of the following: (doxycycline monohydrate 50 • Documented intolerance to (1) generic formulation of Adoxa mg and 100 mg tablets, 150 • Documented failure/inadequate response, intolerance, or not a mg capsules, and Pak) candidate for ALL of the following: o doxycycline hyclate ER 50 mg, 75 mg, 100 mg, 150 mg, or 200 mg tablets o minocycline 50 mg, 75 mg or 100 mg capsule or tablet o minocycline ER 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, or 135 mg tablets o tetracycline 500 mg capsule Doryx® ALL of the following: (doxycycline hyclate 50 mg, • Documented intolerance to (1) generic formulation of Doryx 120 mg, 150 mg, and 200 mg • Documented failure/inadequate response, intolerance, or not a delayed release tablets) candidate for ALL of the following: o doxycycline monohydrate or hyclate 50 mg or 100 mg capsule or tablet o minocycline 50 mg, 75 mg or 100 mg capsule or tablet o minocycline ER 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, or 135 mg tablets o tetracycline 500 mg capsule Doxycycline IR ALL of the following: (for rosacea only) • Documented diagnosis of rosacea (doxycycline monohydrate 40 • Documented failure/inadequate response, intolerance, or not a mg biphasic release capsules) candidate for ALL of the following: o doxycycline monohydrate 50 mg tablets o doxycycline hyclate 50 mg delayed release tablets o minocycline 45 mg extended release tablets Minocin® ALL of the following: (minocycline 50 mg, 75 mg, • Documented intolerance to (1) generic formulation of Minocin and 100 mg capsules) • Documented failure/inadequate response, intolerance, or not a candidate for ALL of the following: o doxycycline monohydrate or hyclate 50 mg or 100 mg capsule or tablet o doxycycline hyclate ER 50 mg, 75 mg, 100 mg, 150 mg, or 200 mg tablets o minocycline ER 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, or 135 mg tablets o tetracycline 500 mg capsule Minolira™ ER Documented failure/inadequate response, intolerance, or not a candidate for (minocycline 105 mg and 135 ALL of the following: mg extended-release tablets) o doxycycline monohydrate or hyclate 50 mg or 100 mg capsule or tablet o doxycycline hyclate ER 50 mg, 75 mg, 100 mg, 150 mg, or 200 mg tablets o minocycline 50 mg, 75 mg or 100 mg capsule or tablet o minocycline ER 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, or 135 mg tablets o tetracycline 500 mg capsule Monodox® ALL of the following: (doxycycline monohydrate 50 • Documented intolerance to (1) generic formulation of Monodox mg, 75 mg, and 100 mg • Documented failure/inadequate response, intolerance, or not a capsules) candidate for ALL of the following: o doxycycline hyclate ER 50 mg, 75 mg, 100 mg, 150 mg, or 200 mg tablets o minocycline 50 mg, 75 mg or 100 mg capsule or tablet

Page 2 of 4 Pharmacy Benefit Clinical Criteria: P0100 o minocycline ER 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, or 135 mg tablets o tetracycline 500 mg capsule Oracea® ALL of the following: (for rosacea only) • Documented diagnosis of rosacea (doxycycline monohydrate 40 • Documented intolerance to (1) generic formulation of Oracea* mg biphasic release capsules) • Documented failure/inadequate response, intolerance, or not a candidate for ALL of the following: o doxycycline monohydrate 50 mg tablets o doxycycline hyclate 50 mg delayed release tablets o minocycline 45 mg extended release tablets

* Coverage of the generic formulation of Oracea may require the use of covered alternatives. Solodyn® ALL of the following: (minocycline 55 mg, 65 mg, 80 • Documented intolerance to (1) generic formulation of Solodyn mg, 105 mg, and 115 mg • Documented failure/inadequate response, intolerance, or not a extended release tablets) candidate for ALL of the following: o doxycycline monohydrate or hyclate 50 mg or 100 mg capsule or tablet o doxycycline hyclate ER 50 mg, 75 mg, 100 mg, 150 mg, or 200 mg tablets o minocycline 50 mg, 75 mg, or 100 mg capsule or tablet o tetracycline 500 mg capsule TargaDOX® (doxycycline Documented failure/inadequate response, intolerance or not a candidate for hyclate 50 mg tablets) ALL of the following: • doxycycline monohydrate or hyclate 50 mg or 100 mg capsule or tablet • doxycycline hyclate ER 50 mg, 75 mg, 100 mg, 150 mg, or 200 mg tablets • minocycline 50 mg, 75 mg or 100 mg capsule or tablet • minocycline ER 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, or 135 mg tablets • tetracycline 500 mg capsule Vibramycin® ALL of the following: (doxycycline hyclate 100 mg • Documented intolerance to (1) generic formulation of Vibramycin capsules) • Documented failure/inadequate response, intolerance, or not a candidate for ALL of the following: o doxycycline monohydrate or hyclate 50 mg or 100 mg capsule or tablet o minocycline 50 mg, 75 mg or 100 mg capsule or tablet o minocycline ER 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, or 135 mg tablets o tetracycline 500 mg capsule Ximino™ ER (minocycline 45 Documented failure/inadequate response, intolerance, or not a candidate for mg, 90 mg, 135 mg extended ALL of the following: release capsules) o doxycycline monohydrate or hyclate 50 mg or 100 mg capsule or tablet o doxycycline hyclate ER 50 mg, 75 mg, 100 mg, 150 mg, or 200 mg tablets o minocycline 50 mg, 75 mg or 100 mg capsule or tablet o minocycline ER 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, or 135 mg tablets o tetracycline 500 mg capsule

Initial and reauthorization is up to 12 months unless otherwise stated.

Page 3 of 4 Pharmacy Benefit Clinical Criteria: P0100

When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to therapy.

Note: Receipt of sample product does not satisfy any criteria requirements for coverage.

*If you’re a Cigna provider, please log in to the Cigna for Health Care Professionals website and search for specific patients to view their covered medications.

FDA Approved Indications

FDA Approved Indication Drugs Drugs@FDA. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Background

An individual must document the failure of or intolerance to any Covered Alternative Drug(s) before coverage will be approved for the identified drug. A “Covered Alternative Drug” is a drug in the same therapeutic class that can be expected to have equivalent clinical efficacy and safety when administered to patients under the conditions specified in the FDA-approved product information (Label). The number of Covered Alternative Drugs may vary by employer group plan and Prescription Drug Lists (e.g. “closed” versus “open” formulary plan designs).

Generics The FDA’s generic drug approval process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. Generic drugs must establish the following for approval: • contain the same active ingredients as the innovator drug(inactive ingredients may vary) • be identical in strength, dosage form, and route of administration • have the same use indications • be bioequivalent • meet the same batch requirements for identity, strength, purity, and quality • be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products

A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used. FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs. Not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the FDA must approve it.

References

1. U.S. Food and Drug Administration. Drugs@FDA. U.S. Department of Health & Human Services: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.

“Cigna Companies” refers to operating subsidiaries of Cigna Corporation. All products and services are provided exclusively by or through such operating subsidiaries, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Cigna Behavioral Health, Inc., Cigna Health Management, Inc., QualCare, Inc., and HMO or service company subsidiaries of Cigna Health Corporation. The Cigna name, logo, and other Cigna marks are owned by Cigna Intellectual Property, Inc. © 2020 Cigna.

Page 4 of 4 Pharmacy Benefit Clinical Criteria: P0100