Subject: Otezla 2002-A SGM P2023
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 (PsO) who are
candidates for phototherapy or systemic therapy
B. Adults with active psoriatic arthritis
C. Adult patients 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 (PsO)
1. Initial requests: 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.
2. Continuation requests: Chart notes or medical record
documentation of improvement in signs and symptoms.
B. Psoriatic arthritis (PsA)
1. Initial requests: 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.
2. 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. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with
one of the following:
A. Plaque psoriasis: dermatologist
B. Psoriatic arthritis: rheumatologist or dermatologist
C. Bechet’s disease: rheumatologist
IV. CRITERIA FOR INITIAL APPROVAL
A. Plaque psoriasis (PsO)
1. Authorization of 12 months may be granted for adult
members for treatment of plaque psoriasis when one of
the following criteria is met:
i. Member has previously received a biologic or
targeted synthetic drug (e.g., Sotyktu) indicated for
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 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. Psoriatic arthritis (PsA)
1. Authorization of 12 months may be granted for adult
members who have previously received a biologic or
targeted synthetic drug (e.g., Rinvoq, Xeljanz) indicated
for active psoriatic arthritis.
2. Authorization of 12 months may be granted for adult
members for treatment of active psoriatic arthritis when
one of the following criteria is met:
i. Member has had an inadequate response to
methotrexate, leflunomide, or another conventional
synthetic drug (e.g., sulfasalazine) administered at
an adequate dose and duration.
ii. Member has an intolerance or contraindication to
methotrexate or leflunomide (see Appendix B), or
another conventional synthetic drug (e.g.,
sulfasalazine).
iii. Member has enthesitis.
C. Behcet’s disease
1. Authorization of 12 months may be granted for adult
members who have previously received a biologic
indicated for treatment of Behcet’s disease.
2. Authorization of 12 months may be granted for adult
members for 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).
V. CONTINUATION OF THERAPY
A. Plaque psoriasis (PsO)
Authorization of 12 months may be granted for all adult
members (including new members) who are using the
requested medication for plaque psoriasis and who achieve
or maintain a positive clinical response as evidenced by low
disease activity or improvement in signs and symptoms of
the condition when either 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. Psoriatic arthritis (PsA)
Authorization of 12 months may be granted for all adult
members (including new members) who are using the
requested medication for psoriatic arthritis and who achieve
or maintain a 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. Axial disease
6. Skin and/or nail involvement
C. Behcet’s disease
Authorization of 12 months may be granted for all adult
members (including new members) who achieve or maintain
a positive clinical response as evidenced by low disease
activity or improvement in signs and symptoms of the
condition.
VI. OTHER
For all indications: Member cannot use the requested medication
concomitantly with any other biologic drug or targeted synthetic
drug.
VII. DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with
FDA-approved labeling, accepted compendia, and/or evidence-
based practice guidelines.
VIII. APPENDICES
Appendix A: Table. 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, greater
than or equal to 2%)
|
Cream, Ointment, Solution
|
2.5%
|
|
Lotion
|
2%
|
|
Hydrocortisone (base, less
than 2%)
|
Cream, Ointment, Gel,
Lotion, Spray, Solution
|
1%
|
|
Cream, Ointment
|
0.5%
|
|
Hydrocortisone acetate
|
Cream
|
2.5%
|
|
Lotion
|
2%
|
|
Cream
|
1%
|
Appendix B: Examples of Clinical Reasons to Avoid
Pharmacologic Treatment with Methotrexate,
Cyclosporine, Acitretin, or Leflunomide
1. Clinical diagnosis of alcohol use disorder, alcoholic liver disease or
other chronic liver disease
2. Drug interaction
3. Risk of treatment-related toxicity
4. Pregnancy or currently planning pregnancy
5. Breastfeeding
6. Significant comorbidity prohibits use of systemic agents (e.g., liver
or kidney disease, blood dyscrasias, uncontrolled hypertension)
7. Hypersensitivity
8. History of intolerance or adverse event
Place of Service:
Outpatient
The above policy is based on the following references:
- Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.; December 2021.
- 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.
- 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.
- 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.
- 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.
- 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.
- Stein Gold L, Papp K, Pariser D, et al. Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2022;86(1):77-85. doi:10.1016/j.jaad.2021.07.040.
- 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.
- Topical Corticosteroids. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; December 1, 2021. Accessed January 11, 2023.
- Coates LC, Soriano ER, Corp N, et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021. Nat Rev Rheumatol. 2022;18(8):465-479.
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 11, 2023
