Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan (2024)

Subject: Tremfya

Policy:

Note: The provision of physician samples does not guarantee coverage under the provisions of the pharmacy benefit. All criteria below must be met in order to obtain coverage of guselkumab (Tremfya).

1. Precertification Criteria

Aetna considersguselkumab (Tremfya) medically necessary for members with any of the following indications who meet the following precertification criteria, where the member has hada documented negative TB test (which can include a tuberculosis skin test [PPD], an interferon-release assay [IGRA], or a chest x-ray)* within 6 months of initiating therapy for persons who are naïve to biologics, and repeated yearly for members with risk factors** for TB that are continuing therapy with biologics:

Plaque psoriasis

Initial criteria

1. The member (18 years of age or older) has a documented diagnosis of active moderate to severe chronic plaque psoriasis and is a candidate for systemic therapy or phototherapy; and
2. One of the following criteria is met (a, b, or c):
   1. The member has at least 10% body surface area (BSA) affected by plaque psoriasis; or
   2. The member has at least 5% BSA affected by plaque psoriasis and there is involvement of sensitive areas (i.e., hands, feet, face, or genitals); or
   3. The member has a Psoriasis Area and Severity Index (PASI) score of 10 or more***; and
3. A 3-month treatment with one of the following (a or b) was ineffective, not tolerated, or both (a and b) are contraindicated:
   1. Phototherapy (PUVA, UVB with coal tar or dithranol, UVB standard or narrow-band, or home UVB); or
   2. Systemic conventional DMARDs (e.g., methotrexate, acetretin, cyclosporine); and
4. Guselkumab (Tremfya) will not be used concomitantly with apremilast, tofacitinib, or other biologic DMARDs (e.g., adalimumab, infliximab).

Continuation criteria

1. The member (18 years of age or older) has a documented diagnosis of active moderate to severe chronic plaque psoriasis and is a candidate for systemic therapy or phototherapy; and
2. There is clinical documentation indicating that there is disease stability or improvement; and
3. Guselkumab (Tremfya) will not be used concomitantly with apremilast, tofacitinib, or other biologic DMARDs (e.g., adalimumab, infliximab).

* If the screening testing for TB is positive, there must be documentation of further testing to confirm there is no active disease. Do not administer guselkumab to patients with active TB infection. If there is latent disease, TB treatment must be started before initiation of guselkumab.

** Risk factors for TB include: Persons with close contact to people with infectious TB disease; persons who have recently emigrated from areas of the world with high rates of TB (e.g., Africa, Asia, Eastern Europe, Latin America, Russia); children less than 5 years of age who have a positive TB test; groups with high rates of TB transmission (e.g., homeless persons, injection drug users, persons with HIV infection); persons who work or reside with people who are at an increased risk for active TB (e.g., hospitals, long-term care facilities, correctional facilities, homeless shelters).

*** In exceptional circ*mstances (e.g., disabling acral disease), individuals with severe disease may fall outside of this definition, but may be considered for treatment.

Place of Service:

Outpatient

The above policy is based on the following references:

1. AHFS Drug Information® with AHFSfirstReleases® (www.statref.com). American Society of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
2. DRUGDEX® System [Internet database]. Greenwood Village, CO: Thomson Micromedex. Updated periodically.
3. Drug Facts and Comparisons online. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
4. PDR® Electronic Library™ [Internet database]. Greenwood Village, CO: Thomson Micromedex. Updated periodically.
5. Singh, JA, Saag, KG, Bridges, SL, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care & Research 2015.
6. Tremfya [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; July 2017.
7. Tuberculosis (TB). TB risk factors. Centers for Disease Control and Prevention. Retrieved on 23 August 2017 from: https://www.cdc.gov/tb/topic/basics/risk.htm.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

January 01, 2018

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