Subject: Otezla 2002-A SGM P2022

Drug

OTEZLA  (apremilast)

Policy:

I.    INDICATIONS 

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. 

FDA-Approved Indications
A.   Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
B.   Adults with active psoriatic arthritis
C.   Adults with oral ulcers associated with Behcet’s disease

All other indications are considered experimental/investigational and not medically necessary.

II.   DOCUMENTATION 

Submission of the following information is necessary to initiate the prior authorization review: 

A.   Plaque psoriasis
      1.   Initial requests:
            i.   Chart notes, medical record documentation, or claims history supporting previous medications tried
                 (if applicable), including response to therapy. If therapy is not advisable, documentation of clinical
                 reason to avoid therapy.
            ii.  Continuation requests: Chart notes or medical record documentation of improvement in signs
                 and symptoms. 

B.   Psoriatic arthritis: For continuation requests: Chart notes or medical record documentation supporting
      positive clinical response.

C.   Behcet’s disease (initial requests only): Chart notes, medical record documentation, or claims history
      supporting previous medications tried, including response to therapy (if applicable).

III. CRITERIA FOR INITIAL APPROVAL 

A.   Plaque psoriasis (PsO)
      1.   Authorization of 12 months may be granted for the treatment of plaque psoriasis in members when one
            of the following criteria is met:
            i.   Member has previously received a biologic indicated for the treatment of plaque psoriasis.
            ii.  Member has had an inadequate response or intolerance to ONE of the following:
                 a.   Phototherapy (e.g., UVB, PUVA)
                 b.   Topical therapies (e.g., medium or higher potency topical corticosteroids [see Appendix A],
                       calcineurin inhibitors, vitamin D analogs)
            iii.  Member has a contraindication or clinical reason to avoid BOTH of the following:
                  a.   Phototherapy (e.g., UVB, PUVA)
                  b.   Topical therapies (e.g., medium or higher potency topical corticosteroids, calcineurin inhibitors,
                        vitamin D analogs)
            iv.   Member has had an inadequate response to or intolerance to pharmacological treatment with ONE
                  of the following medications: methotrexate, cyclosporine, or acitretin.
            v.   Member has a clinical reason to avoid pharmacological treatment with ALL of the following
                  medications: methotrexate, cyclosporine, and acitretin (see Appendix B). 

B.   Active psoriatic arthritis (PsA)
      Authorization of 12 months may be granted for treatment of active psoriatic arthritis.

C.   Behcet’s disease
      1.   Authorization of 12 months may be granted for members who have previously received a biologic
            indicated for the treatment of Behcet’s disease.
      2.   Authorization of 12 months may be granted for the treatment of oral ulcers associated with Behcet’s
            disease when the member has had an inadequate response to at least one nonbiologic medication
            for Behcet’s disease (e.g., colchicine, systemic glucocorticoids, azathioprine). 

IV.  CONTINUATION OF THERAPY 

A.   Plaque psoriasis (PsO)
      Authorization of 12 months may be granted for all members (including new members) who are using
      the requested medication for plaque psoriasis and who achieve or maintain positive clinical response as
      evidenced by low disease activity or improvement in signs and symptoms of the condition when any of the
      following is met:
      1.   Reduction in body surface area (BSA) affected from baseline
      2.   Improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning,
            cracking, pain)

B.   Active psoriatic arthritis (PsA)
      Authorization of 12 months may be granted for all members (including new members) who are using the
      requested medication for active psoriatic arthritis and who achieve or maintain positive clinical response as
      evidenced by low disease activity or improvement in signs and symptoms of the condition when there is
      improvement in any of the following from baseline:
      1.   Number of swollen joints
      2.   Number of tender joints
      3.   Dactylitis
      4.   Enthesitis
      5.   Skin and/or nail involvement 

C.   Behcet’s disease
      Authorization of 12 months may be granted for all members (including new members) who achieve or
      maintain positive clinical response as evidenced by low disease activity or improvement in signs and
      symptoms of the condition. 

V.   OTHER 

For all indications: Member cannot use the requested medication concomitantly with any other biologic DMARD or targeted synthetic DMARD. 

VI. DOSAGE AND ADMINISTRATION 

Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines. 

Special Notes:

VII. APPENDIX 

A.  Relative potency of select topical corticosteroid products

Potency	Drug	Dosage form	Strength
I. Super-high potency    (group 1)	Augmented betamethasone dipropionate	Ointment, Lotion, Gel	0.05%
	Clobetasol propionate	Cream, Gel, Ointment, Solution, Cream (emollient), Lotion, Shampoo, Foam, Spray	0.05%
	Fluocinonide	Cream	0.1%
	Flurandrenolide	Tape	4 mcg/cm2
	Halobetasol propionate	Cream, Lotion, Ointment, Foam	0.05%
II. High potency     (group 2)	Amcinonide	Ointment	0.1%
	Augmented betamethasone dipropionate	Cream	0.05%
	Betamethasone dipropionate	Ointment	0.05%
	Clobetasol propionate	Cream	0.025%
	Desoximetasone	Cream, Ointment, Spray	0.25%
		Gel	0.05%
	Diflorasone diacetate	Ointment, Cream (emollient)	0.05%
	Fluocinonide	Cream, Ointment, Gel, Solution	0.05%
	Halcinonide	Cream, Ointment	0.1%
	Halobetasol propionate	Lotion	0.01%
III. High potency      (group 3)	Amcinonide	Cream, Lotion	0.1%
	Betamethasone dipropionate	Cream, hydrophilic emollient	0.05%
	Betamethasone valerate	Ointment	0.1%
		Foam	0.12%
	Desoximetasone	Cream, Ointment	0.05%
	Diflorasone diacetate	Cream	0.05%
	Fluocinonide	Cream, aqueous emollient	0.05%
	Fluticasone propionate	Ointment	0.005%
	Mometasone furoate	Ointment	0.1%
	Triamcinolone acetonide	Cream, Ointment	0.5%
IV. Medium potency      (group 4)	Betamethasone dipropionate	Spray	0.05%
	Clocortolone pivalate	Cream	0.1%
	Fluocinolone acetonide	Ointment	0.025%
	Flurandrenolide	Ointment	0.05%
	Hydrocortisone valerate	Ointment	0.2%
	Mometasone furoate	Cream, Lotion, Solution	0.1%
	Triamcinolone acetonide	Cream	0.1%
		Ointment	0.05% and 0.1%
		Aerosol Spray	0.2 mg per 2-second spray
V. Lower-mid potency     (group 5)	Betamethasone dipropionate	Lotion	0.05%
	Betamethasone valerate	Cream	0.1%
	Desonide	Ointment, Gel	0.05%
	Fluocinolone acetonide	Cream	0.025%
	Flurandrenolide	Cream, Lotion	0.05%
	Fluticasone propionate	Cream, Lotion	0.05%
	Hydrocortisone butyrate	Cream, Lotion, Ointment, Solution	0.1%
	Hydrocortisone probutate	Cream	0.1%
	Hydrocortisone valerate	Cream	0.2%
	Prednicarbate	Cream (emollient), Ointment	0.1%
	Triamcinolone acetonide	Lotion	0.1%
		Ointment	0.025%
VI. Low potency      (group 6)	Alclometasone dipropionate	Cream, Ointment	0.05%
	Betamethasone valerate	Lotion	0.1%
	Desonide	Cream, Lotion, Foam	0.05%
	Fluocinolone acetonide	Cream, Solution, Shampoo, Oil	0.01%
	Triamcinolone acetonide	Cream, lotion	0.025%
VII. Least potent       (group 7)	Hydrocortisone (base, less than 2%)	Cream, Ointment, Solution	2.5%
		Lotion	2%
		Cream, Ointment, Gel, Lotion, Spray, Solution	1%
		Cream, Ointment	0.5%
	Hydrocortisone acetate	Cream	2.5%
		Lotion	2%
		Cream	1%

Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate, Cyclosporine or Acitretin

Clinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease

Breastfeeding

Drug interaction

Cannot be used due to risk of treatment-related toxicity

Pregnancy or currently planning pregnancy

Significant comorbidity prohibits use of systemic agents (examples include liver or kidney disease, blood dyscrasias, uncontrolled hypertension)

Place of Service:

Outpatient

The above policy is based on the following references:

1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.; December 2021.
2. Coates LC, Kavanaugh A, Mease PJ, et al. Group for research and assessment of psoriasis and psoriatic arthritis 2015 treatment recommendation for psoriatic arthritis. Arthritis Rheumatol. 2016 May;68(5):1060-71.
3. Menter A, Gelfand JM, Connor C, et al. Joint AAD-NPF guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6):1445-1486
4. Gossec L,Baraliakos X, Kerschbaumer A, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020;79(6):700-712.
5. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheum. 2018;71:5-32
6. Hatemi G, Christensen R, Bodaghi, et al. 2018 update of the EULAR recommendations for the management of Behcet’s syndrome. Ann Rheum Dis. 2018.; 77: 808-818.
7. gov. National Library of Medicine (US). Identifier NCT03721172, Apremilast as a direct treatment for mild-to-moderate plaque psoriasis versus placebo: an analysis of clinical safety and efficacy (ADVANCE). Available from: https://www.clinicaltrials.gov/ct2/show/NCT03721172.
8. Elmets CA, Korman NJ, Prater EF, et al. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021;84(2):P432-470.
9. Topical Corticosteroids. Drug Facts and Comparisons.  Facts & Comparisons [database online]. St. Louis, MO:  Wolters Kluwer Health Inc; January 15, 2020.  Accessed January 27, 2022.  

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.

June 26, 2022