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09-J2000-80

Original Effective Date: 06/15/17

Reviewed: 05/10/17

Revised: 00/00/00

Subject: Dupilumab (Dupixent) Injection

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Dupilumab (Dupixent) is a human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by binding to the IL-4R alpha subunit shared by IL-4 and IL-13 receptors. This reduces IL-4 and IL-13 cytokine-induced inflammatory response such as the release of proinflammatory cytokines, chemokines, and IgE, which play roles in the development of atopic dermatitis. Dupilumab was approved in March 2017 by the US Food and Drug Administration (FDA) for “the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable”.

Atopic dermatitis (AD) (a.k.a., atopic eczema) is a chronic, relapsing, pruritic inflammatory skin disease mediated by type 2 helper T (Th2) cells. The disease occurs most frequently in children, but also affects adults. About 70% of AD patients have a family history of atopic diseases (e.g., eczema, asthma, allergic rhinitis). In the US, 10 to15% of children may be affected by AD, with an onset of disease usually occurring before 5 years of age. Some children will continue to have persistent AD into adulthood, and it is estimated that 3 and 7% of adults in the US are affected by AD. Dry skin and severe pruritus are the hallmark signs of AD; however, clinical presentation is highly variable depending upon age and disease activity. In adults, AD is more localized and lichenified, and the areas most often involved are the skin flexures. Treatment goals are to reduce symptoms (pruritus, dermatitis), prevent exacerbations, and improve patient quality of life (QoL). Most patients with AD have mild-to-moderate disease that can often be successfully managed with topical treatments. In patients with moderate-to-severe AD, skin lesions can encompass a large body-surface area (BSA) and are frequently accompanied by intense, persistent pruritus, leading to sleep deprivation, symptoms of anxiety or depression, and poor QoL. Severe AD is often refractory to topical treatments. Several disease severity scales [e.g., Investigator’s Global Assessment (IGA) score, the SCORing Atopic Dermatitis (SCORAD) index, the Eczema Area and Severity Index (EASI), and the patient-oriented eczema measure (POEM)]] and patient QoL measurement scales have been tested and validated for use in clinical trials, but they are not commonly used in clinical practice.

The American Academy of Dermatology (AAD) 2014 Guidelines of Care for the Management of Atopic Dermatitis make various recommendations. The application of moisturizers should be an integral part of the treatment as there is strong evidence that their use can reduce disease severity and the need for pharmacologic intervention. Topical corticosteroids are recommended for AD-affected individuals who have failed to respond to good skin care and regular use of emollients alone. Twice-daily application of corticosteroids is generally recommended for the treatment of AD; however, evidence suggests that once-daily application of some corticosteroids may be sufficient. Proactive, intermittent use of topical corticosteroids as maintenance therapy (1 to 2 times/week) on areas that commonly flare is recommended to help prevent relapses and is more effective than use of emollients alone. Topical calcineurin inhibitors (TCI) are recommended and effective for acute and chronic treatment, along with maintenance, in both adults and children with AD, and are particularly useful in selected clinical situations [i.e., recalcitrance to steroids, use on sensitive areas (e.g., face, anogenital, skin folds), steroid-induced atrophy, and long-term uninterrupted topical steroid use]. Proactive, intermittent use of TCI as maintenance therapy (2 to 3 times/week) on areas that commonly flare is recommended to help prevent relapses while reducing the need for topical corticosteroids, and is more effective than the use of emollients alone. Phototherapy is a second-line treatment, after failure of first-line treatment (emollients, topical steroids, and topical calcineurin inhibitors). Phototherapy can be used as maintenance therapy in patients with chronic disease. Systemic immunomodulatory agents are indicated for the subset of adult and pediatric patients in whom optimized topical regimens and/or phototherapy do not adequately control the signs and symptoms of disease. Systemic immunomodulatory agents are indicated when the patient’s skin disease has significant negative physical, emotional, or social impact. All immunomodulatory agents should be adjusted to the minimal effective dose once response is attained and sustained. Cyclosporine is effective and recommended as a treatment option for patients with AD refractory to conventional topical treatment. Azathioprine is recommended as a systemic agent for the treatment of refractory AD. Methotrexate is recommended as a systemic agent for the treatment of refractory AD. Folate supplementation is recommended during treatment with methotrexate. Mycophenolate mofetil may be considered as an alternative, variably effective therapy for refractory AD. Dupilumab is not addressed in the guidelines due to its recent approval.

The safety and efficacy of dupilumab was established in 2,119 subjects 18 years of age and older with moderate-to-severe AD not adequately controlled by topical medication during three randomized, double-blind, placebo-controlled studies (SOLO-1, SOLO-2, and LIBERTY AD CHRONOS). Disease severity was defined by an IGA score ≥3 in the overall assessment of AD lesions on a severity scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and a minimum BSA involvement of ≥10%. At baseline, 59% of subjects were male, 67% were white, 52% of subjects had a baseline IGA score of 3 (moderate AD), and 48% of subjects had a baseline IGA of 4 (severe AD). The baseline mean EASI score was 33 and the baseline weekly averaged peak pruritus Numeric Rating Scale (NRS) was 7 on a scale of 0 to 10. In all three trials, subjects in the dupilumab group received subcutaneous injections of 600 mg at Week 0, followed by 300 mg every other week. In the monotherapy trials (SOLO-1 and -2) subjects received dupilumab or placebo for 16 weeks. In the concomitant therapy trial (LIBERTY AD CHRONOS) subjects received dupilumab or placebo with concomitant topical corticosteroids and as needed topical calcineurin inhibitors for problem areas only, such as the face, neck, intertriginous and genital areas for 52 weeks. All three trials assessed the primary endpoint of the change from baseline to Week 16 in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and at least a 2-point improvement. Other endpoints include the proportion of subjects with EASI-75 (improvement of at least 75% in EASI score from baseline), and reduction in itch as defined by at least a 4-point improvement in the peak pruritus NRS from baseline to Week 16. The proportion of patients with an IGA score of 0 or 1 and at least a 2-point improvement at week 16 ranged from 36% to 39% for dupilumab-treated patients compared with 9% to 12% for placebo-treated patients. The detailed results are provided in the table below. The most common adverse reactions reported in clinical trials with dupilumab were injection site reactions, conjunctivitis, keratitis, and oral herpes.

Table 1: Efficacy Results at Week 16

Outcome

SOLO-1

SOLO-2

LIBERTY AD CHRONOS

Dupilumab 300 mg Q2W (n=224)

Placebo (n=224)

Dupilumab 300 mg Q2W (n=233)

Placebo (n=236)

Dupilumab 300 mg Q2W + TCS (n=106)

Placebo + TCS (n=315)

IGA 0 or 1

38%

10%

36%

9%

39%

12%

EASI-75

51%

15%

44%

12%

69%

23%

EASI-90

36%

8%

30%

7%

40%

11%

Peak Pruritus NRS (≥4-point improvement)

41%

12%

36%

10%

59%

20%

POSITION STATEMENT:

Comparative Effectiveness

The FDA has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

Initiation of dupilumab (Dupixent) meets the definition of medical necessity when ALL of the following criteria are met:

1. The member is 18 years of age or older

2. Dupilumab is prescribed by a dermatologist OR allergist/immunologist

3. The member has a documented diagnosis of chronic, moderate-to-severe atopic dermatitis (AD) as supported by BOTH of the following (“a” and “b”) [supportive medical record documentation must be submitted]:

a. The member’s AD symptoms have been present for 3 years or more

b. EITHER of the following (“i” or “ii”):

i. 10% or more of the member’s body surface area (BSA) has AD involvement

ii. AD involvement is less than 10% of the member’s BSA but affects certain critical body areas (i.e., face, palms of hands, soles of feet, or genitalia) that severely impairs the member’s activities of daily living

4. Alternative causes of pruritic inflammatory skin disease (e.g., contact dermatitis, psoriasis, scabies, cutaneous drug reactions, ichthyoses, seborrheic dermatitis, etc.) have been ruled out or are being actively managed

5. The member is adherent with conservative, non-pharmacologic measures [i.e., daily use of a skin moisturizer/emollient and limitation of exacerbating factors such as harsh soaps/detergents/cleansers, low humidity, and stress]

6. The member has had an inadequate response to a sufficient trial, OR treatment or continued treatment is not advisable due to an FDA-labeled contraindication or intolerable adverse effect(s), to BOTH of the following topical treatments (“a” and “b”) [the specific duration of treatment, or specific adverse effect(s) or contraindication(s) must be provided]:

a. A topical corticosteroid – EITHER of the following (“i” or “ii”) within the past 6 months:

i. One or more AD disease flares that did not adequately respond to at least 3 weeks of daily treatment with a high-potency topical corticosteroid (group II or greater potency – see Table 2 in “Other” section), unless the member’s AD involvement is limited to the face and intertriginous areas in which a lower-potency corticosteroid may be used

ii. Inadequate response to maintenance therapy that includes intermittent use (at least 2 days per week) for at least 16 weeks of a moderate-to-high-potency topical corticosteroid (group IV or greater potency – see Table 2 in “Other” section), unless the member’s AD involvement is limited to the face and intertriginous areas in which a lower-potency corticosteroid may be used

b. A topical calcineurin inhibitor [i.e., pimecrolimus (Elidel) or tacrolimus (Protopic)] - EITHER of the following (“i” or “ii”) within the past 6 months

i. One or more AD disease flares that did not adequately respond to at least 6 weeks of daily treatment

ii. Inadequate response to maintenance therapy that includes intermittent use (at least 2 days per week) for at least 16 weeks

7. The member has had an inadequate response to a 3-month or longer trial of EITHER of following treatments in the past 12 months, OR treatment or continued treatment is not advisable due to an FDA-labeled contraindication or intolerable adverse effect(s) to BOTH of following treatments (“a” and “b”) [the specific duration of treatment, or specific adverse effect(s) or contraindication(s) must be provided]:

a. Phototherapy (e.g., PUVA, UVB)

b. Systemic immunosuppressant therapy (e.g., cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)

8. Dupilumab will NOT be used in combination with another biologic agent for the treatment of atopic dermatitis [e.g., omalizumab (Xolair), mepolizumab (Nucala), reslizumab (Cinqair), rituximab (Rituxan), etanercept (Enbrel), infliximab products]

9. The dosage of dupilumab does not exceed the following:

a. Loading dose: 600 mg as a single dose

b. Subsequent doses: 300 mg every two weeks

Approval duration: 6 months

Continuation of dupilumab (Dupixent) meets the definition of medical necessity when ALL of the following criteria are met:

1. An authorization or reauthorization for dupilumab has been previously approved by Florida Blue or another health plan in the past 2 years [the use of samples does NOT qualify] for the treatment of moderate to severe atopic dermatitis, OR the member has previously met all indication-specific initiation criteria

2. EITHER of the following based on the duration of dupilumab treatment (“a” or “b”):

a. Less than 18 months of treatment - member has had a clinically meaningful beneficial response to dupilumab therapy as compared to their baseline status (before dupilumab treatment) as evidenced by TWO or more of the following [supportive medical record documentation must be submitted]:

i. Reduction in disease severity (e.g., erythema, dryness, edema/papulation, excoriations, lichenification, oozing/crusting)

ii. Reduction in the frequency or intensity of pruritus

iii. Reduction in the frequency of disease exacerbations/flairs

iv. Reduction in the BSA with AD involvement

v. Improvement in overall patient quality of life (e.g., improved sleep, less depression or anxiety, etc.)

b. 18 or more months of treatment – member continues to maintain a clinically meaningful benefit as compared to before treatment with dupilumab

3. Dupilumab is prescribed by, or in consultation with, a dermatologist OR allergist/immunologist

4. The member continues to be adherent with conservative, non-pharmacologic measures [i.e., daily use of a skin moisturizer/emollient and limitation of exacerbating factors such as harsh soaps/detergents/cleansers, low humidity, and stress]

5. The member is 18 years of age or older

6. Dupilumab will NOT be used in combination with another biologic agent for the treatment of atopic dermatitis [e.g., omalizumab (Xolair), mepolizumab (Nucala), reslizumab (Cinqair), rituximab (Rituxan), etanercept (Enbrel), infliximab products]

7. The dosage of dupilumab does not exceed 300 mg every two weeks

Approval duration: 12 months

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

• For the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupilumab is administered by subcutaneous injection. A member may self-inject after training in subcutaneous injection technique using the pre-filled syringe. Before injection, the pre-filled syringe should be removed from the refrigerator and allowed to reach room temperature (45 minutes)

• The recommended dose is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week. Dupilumab can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.

Dose Adjustments

• No formal trial of the effect of hepatic or renal impairment on the pharmacokinetics of dupilumab was conducted

Drug Availability

• Cartons containing two single-dose, pre-filled syringes (300 mg/2 mL) with needle shield

PRECAUTIONS:

Boxed Warning

• None

Contraindications

• Known hypersensitivity to dupilumab or any of its excipients

Precautions/Warnings

Hypersensitivity - Hypersensitivity reactions, including generalized urticaria and serum sickness or serum sickness-like reactions. were reported in less than 1% of subjects who received dupilumab in clinical trials. If a systemic hypersensitivity reaction occurs, discontinue dupilumab immediately and initiate appropriate therapy.

• Conjunctivitis and Keratitis - Conjunctivitis and keratitis occurred more frequently in subjects who received dupilumab. Members should report new onset or worsening eye symptoms to their healthcare provider.

Comorbid Asthma - The safety and efficacy of dupilumab have not been established in the treatment of asthma. Advise members with comorbid asthma not to adjust or stop their asthma treatment without consultation with their physicians.

Parasitic (Helminth) Infections – Patients with known helminth infections were excluded from participation in clinical studies. It is unknown if dupilumab will influence the immune response against helminth infections.

Live Vaccines - Avoid use of live vaccines in patients treated with dupilumab.

Interactions with CYP450 Substrates - The formation of CYP450 enzymes can be altered by increased levels of certain cytokines; therefore, dupilumab could modulate the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in members receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.

Immunogenicity - Approximately 7% of subjects receiving dupilumab 300 mg Q2W for 16 weeks developed anti-drug antibodies. Of the subjects who developed antibodies to dupilumab, approximately 30% (2% of all subjects) had antibodies that were classified as neutralizing.

Pregnancy - There are no available data on dupilumab use in pregnant women to inform any drug associated risk. Refer to the product label for more information.

Lactation – There are no data on the presence of dupilumab in human milk, the effects on the breastfed infant, or the effects on milk production. Refer to the product label for more information.

Pediatric Use - Safety and efficacy in pediatric patients (<18 years of age) have not been established.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

L20.0

Besnier's prurigo

L20.81

Atopic neurodermatitis

L20.82

Flexural eczema

L20.84

Intrinsic (allergic) eczema

L20.89

Other atopic dermatitis

L20.9

Atopic dermatitis, unspecified

ICD-10 Diagnoses Codes That Support Medical Necessity

C9399

Unclassified drugs or biologicals (Hospital outpatient use ONLY)

J3590

Unclassified biologics

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline review date.

DEFINITIONS:

Eczema Area Severity Index score (EASI) - assesses severity (severity score) and body surface area affected by erythema, induration/papulation/edema, excoriations, and lichenification (area score), which are graded systematically for each of 4 anatomical regions (head and neck, trunk, upper limbs, lower limbs) and assembled in a composite score, with a score range of 0 to 72.

EASI 50 - a percentage improvement of EASI score from baseline that is ≥50%

EASI 75 - a percentage improvement of EASI score from baseline that is ≥75%

EASI 90 - a percentage improvement of EASI score from baseline that is ≥90%

Helper T cells (a.k.a., CD4+ T cells) – a type of lymphocyte or white blood cell (WBC) that matures in the thymus and play an important role in cell-mediated immunity. T helper cells assist other WBCs in immunologic processes by releasing T cell cytokines. Different types of T helper cells secrete different cytokines (e.g. type 2 release IL-4, IL-5, IL-9, IL-10 and IL-13)

Intertriginous area – an area where two skin areas may touch or rub together (e.g., axilla of the arm, the anogenital region, skin folds of the breasts, between digits)

Lichenified - skin that has become thickened and leathery. This often results from continuously rubbing or scratching the skin.

Patient-Oriented Eczema Measure (POEM) – a validated questionnaire, examining seven items (scored 0 to 4 based on frequency of event), used in clinical settings to assess time spent with symptoms and the impact of symptoms on sleep, with a score range of 0 to 28.

Pruritus – itching

Scoring Atopic Dermatitis (SCORAD) - the extent and severity of AD over the body area and the severity of 6 specific symptoms (erythema, edema/papulation, excoriations, lichenification, oozing/crusts, and dryness) are assessed and scored by the investigator. Subjective assessment of itch and sleeplessness is scored by the patient. The SCORAD score is a combined score of body area affected, and investigator and patient symptom scoring, with a score range of 0 to103.

RELATED GUIDELINES:

Psoralens with Ultraviolet A (PUVA), 02-10000-16

OTHER:

Table 2: Relative Potencies of Topical Corticosteroids

Class

Drug

Dosage form(s)

Strength
(%)

I. Very high potency

Augmented betamethasone dipropionate

Ointment

0.05

Clobetasol propionate

Cream, foam, ointment

0.05

Diflorasone diacetate

Ointment

0.05

Halobetasol propionate

Cream, ointment

0.05

II. High potency

Amcinonide

Cream, lotion, ointment

0.1

Augmented betamethasone dipropionate

Cream

0.05

Betamethasone dipropionate

Cream, foam, ointment, solution

0.05

Desoximetasone

Cream, ointment

0.25

Desoximetasone

Gel

0.05

Diflorasone diacetate

Cream

0.05

Fluocinonide

Cream, gel, ointment, solution

0.05

Halcinonide

Cream, ointment

0.1

Mometasone furoate

Ointment

0.1

Triamcinolone acetonide

Cream, ointment

0.5

III to IV. Medium potency

Betamethasone valerate

Cream, foam, lotion, ointment

0.1

Clocortolone pivalate

Cream

0.1

Desoximetasone

Cream

0.05

Fluocinolone acetonide

Cream, ointment

0.025

Flurandrenolide

Cream, ointment

0.05

Fluticasone propionate

Cream

0.05

Fluticasone propionate

Ointment

0.005

Mometasone furoate

Cream

0.1

Triamcinolone acetonide

Cream, ointment

0.1

V. Lower-medium potency

Hydrocortisone butyrate

Cream, ointment, solution

0.1

Hydrocortisone probutate

Cream

0.1

Hydrocortisone valerate

Cream, ointment

0.2

Prednicarbate

Cream

0.1

VI. Low potency

Alclometasone dipropionate

Cream, ointment

0.05

Desonide

Cream, gel, foam, ointment

0.05

Fluocinolone acetonide

Cream, solution

0.01

VII. Lowest potency

Dexamethasone

Cream

0.1

Hydrocortisone

Cream, lotion, ointment, solution

0.25, 0.5, 1

Hydrocortisone acetate

Cream, ointment

0.5 to 1

REFERENCES:

  1. Ashcroft DM, Dimmock P, Garside R, et al. Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomised controlled trials. BMJ. 2005;330(7490):516.
  2. Bieber T. Atopic dermatitis. Engl J Med. 2008 Apr 3;358(14):1483-94.
  3. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 4/17/17]. Available from: http://www.clinicalpharmacology.com/.
  4. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine [cited 4/17/17]. Available from: http://clinicaltrials.gov/.
  5. Cury Martins J, Martins C, Aoki V, et al. Topical tacrolimus for atopic dermatitis. Cochrane Database Syst Rev. 2015 Jul 1;(7):CD009864.
  6. Drake LA, Dinehart SM, Farmer ER, et al: Guidelines of care for the use of topical glucocorticosteroids. J Am Acad Dermatol 1996; 35:615-619.
  7. DRUGDEX System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 4/17/17]. Available from: http://www.thomsonhc.com/.
  8. Dupixent (dupilumab injection) [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; March 2017.
  9. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis. Section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32.
  10. Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis. Section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014 Feb;70(2):338-51.
  11. Institute for Clinical and Economic Review (ICER).Dupilumab and Crisaborole for Atopic Dermatitis: Effectiveness and Value. Draft Evidence Report. March 24, 2017 [cited 4/24/17]. Available from: https://icer-review.org/wp-content/uploads/2016/10/MWCEPAC_Atopic_Dermatitis_Draft_Evidence_Report_032417.pdf
  12. Mortz CG, Andersen KE, Dellgren C, et al. Atopic dermatitis from adolescence to adulthood in the TOACS cohort: prevalence, persistence and comorbidities. Allergy. 2015 Jul;70(7):836-45..
  13. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2017 [4/17/17]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  14. Roekevisch E, Spuls PI, Kuester D, et al. Efficacy and safety of systemic treatments for moderate-to-severe atopic dermatitis: a systematic review. The Journal of allergy and clinical immunology. 2014;133(2):429-438.
  15. Ring J, Alomar A, Bieber T, et al; European Dermatology Forum (EDF), European Academy of Dermatology and Venereology (EADV), European Federation of Allergy (EFA), European Task Force on Atopic Dermatitis (ETFAD), European Society of Pediatric Dermatology (ESPD), Global Allergy and Asthma European Network (GA2LEN). Guidelines for treatment of atopic eczema (atopic dermatitis) part I. J Eur Acad Dermatol Venereol. 2012 Aug;26(8):1045-60.
  16. Schmitt J, von Kobyletzki L, Svensson A, et al. Efficacy and tolerability of proactive treatment with topical corticosteroids and calcineurin inhibitors for atopic eczema: systematic review and meta-analysis of randomized controlled trials. Br J Dermatol. 2011;164(2):415.
  17. Schneider L, Tilles S, Lio P, et al. Atopic dermatitis: a practice parameter update 2012. J Allergy Clin Immunol. 2013 Feb;131(2):295-9.e1-27.
  18. Shaw TE, Currie GP, Koudelka CW, et al. Eczema prevalence in the United States: data from the 2003 National Survey of Children's Health. J Invest Dermatol. 2011;131(1):67.
  19. Sidbury R, Davis DM, Cohen DE, et al. Guidelines of care for the management of atopic dermatitis. Section 3. Management and treatment with phototherapy and systemic agents. J Am Acad Dermatol. 2014 Aug;71(2):327-49.
  20. Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014 Dec;71(6):1218-33.
  21. Simpson EL, Bieber T, Guttman-Yassky E, et al. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. NEJM. 2016;375 (24):2335-2348.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 05/10/17.

GUIDELINE UPDATE INFORMATION:

06/15/17

New Medical Coverage Guideline.

Date Printed: August 20, 2017: 01:52 AM