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Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2015, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2015 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-19

Original Effective Date: 09/15/14

Reviewed: 11/12/14

Revised: 12/15/14

Subject: Apremilast (Otezla®) Tablet

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

Previous Information

DESCRIPTION:

Apremilast (Otezla®) was approved by the US Food and Drug Administration (FDA) for the treatment of adults with active psoriatic arthritis (PsA) or moderate-to-severe plaque psoriasis. Apremilast exerts its therapeutic activity through inhibition of phosphodiesterase-4 (PDE-4). PDE-4 inhibition promotes intracellular accumulation of cyclic adenosine monophosphate; this accumulation results in a downregulation of inflammatory responses and ultimately reduces inflammation.

FDA-approval was based on three similarly designed clinical trials, PALACE-1, -2, and -3 (i.e., PsA-1, PsA-2, and Psa-3). All three trials were multi-center, randomized, double-blind, placebo-controlled trials and enrolled a total of 1,493 subjects. Subjects were enrolled if they were diagnosed with active psoriatic arthritis despite previous or current treatment with a disease modifying anti-rheumatic drug (DMARD). Of note, previous treatment with a biologic, including anti-tumor necrosis factor (TNF) agents was allowed and up to 10% of subjects could be previous anti-TNF failures. The primary efficacy endpoint was the proportion of subjects achieving a 20% reduction in the American College of Rheumatology (ACR) response criteria for rheumatoid arthritis, modified for psoriatic arthritis (i.e., ACR20) at 16 weeks. Apremilast treatment resulted in significantly more subjects achieving an ACR20 response at week 16 (38%, 32% and 41% in PsA-1, -2, and -3 respectively) when compared to placebo (19%, 19%, 18%). Additionally, the number of tender and swollen joints, pain assessment and Health Assessment Questionnaire Disability Index were also improved at week 16.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration 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.

NOTE: etanercept (Enbrel), adalimumab (Humira), golimumab (Simponi), and ustekinumab (Stelara) are preferred self-administered products.

NOTE: If the member has failed previous biologic therapy (e.g., two or more preferred products such as etanercept and golimumab, etc.) for any indication listed below, the member is not required to try and fail additional non-biologic pre-requisite therapy (e.g., for RA, if member has previously tried and failed etanercept and golimumab, but does not have a history of methotrexate failure, they do not have to try and fail methotrexate to meet medical necessity criteria).

Initiation of apremilast (Otezla) meets the definition of medical necessity for members diagnosed with ANY of the following conditions when ALL associated criteria are met:

1. Psoriatic Arthritis

a. Member’s disease is active

b. Member has tried and failed or has a contraindication to methotrexate

c. Member has tried and failed or has a contraindication to TWO or more of the following:

i. Adalimumab (Humira)

ii. Etanercept (Enbrel)

iii. Golimumab (Simponi)

iv. Ustekinumab (Stelara)

d. Member is 18 years of age or older

e. Dose does not exceed 30 mg twice daily

2. Plaque Psoriasis

a. Member has moderate to severe chronic plaque psoriasis evidenced by either of the following:

i. psoriasis covers more than 5% of BSA

ii. psoriasis covers less than or equal to 5% of BSA and affects crucial body areas (e.g., face, hands, feet, genitals)

b. Member has tried and failed or has a contraindication to methotrexate

c. Member has tried and failed or has a contraindication to TWO or more of the following:

i. Adalimumab (Humira)

ii. Etanercept (Enbrel)

iii. Golimumab (Simponi)

iv. Ustekinumab (Stelara)

d. Member is 18 years of age or older

e. Dose does not exceed 30 mg twice daily

Continuation of apremilast (Otezla) meets the definition of medical necessity when used for the treatment of active psoriatic arthritis or moderate to severe chronic plaque psoriasis and ALL of the following criteria are met:

1. The member has been approved by another health plan or has met Florida Blue’s initiation coverage criteria

2. The member has demonstrated a beneficial response to therapy

3. The dose does not exceed 30 mg twice daily.

Approval duration: 1 year

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.

Apremilast is indicated for the treatment of adults with active psoriatic arthritis. To reduce the risk of gastrointestinal symptoms, the following titration schedule is recommended:

• Day 1: 10 mg in the morning

• Day 2: 10 mg in morning and 10 mg in evening

• Day 3: 10 mg in morning and 20 mg in evening

• Day 4: 20 mg in morning and 20 mg in evening

• Day 5: 20 mg in morning and 30 mg in evening

• Day 6: 30 mg twice daily

Dose Adjustments: Reduce the dose to 30 mg once daily for persons with severe renal impairment (i.e., creatinine clearance less than 30 ml/min). For initial dose titration, titrate using only the morning schedule and skip evening doses.

Product Availability: apremilast is supplied as 10-, 20-, and 30 mg tablets.

PRECAUTIONS:

Contraindication:

Known hypersensitivity to apremilast or any excipients in the formulation.

Warnings:

Depression: Advise patients, their caregivers, and families to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes and if such changes occur to contact their healthcare provider. Carefully weigh risks and benefits of treatment with apremilast in persons with a history of depression and/or suicidal thoughts or behavior.

Weight Decrease: Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of apremilast.

Drug Interactions: Use with strong cytochrome P450 enzyme inducers (e.g. rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended because loss of efficacy may occur.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J8499

Prescription drug, oral, non-chemotherapeutic, NOS

ICD-9 Diagnoses Codes That Support Medical Necessity

696.0

Psoriatic arthropathy

ICD-10 Diagnoses Codes That Support Medical Necessity (Effective 10/01/15)

L40.59

Other psoriatic arthropathy

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

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

DEFINITIONS:

DMARDs: An acronym for disease-modifying antirheumatic drugs.

RELATED GUIDELINES:

Adalimumab (Humira®), 09-J0000-46
Certolizumab (Cimzia®), 09-J0000-77

Etanercept (Enbrel®), 09-J0000-38

Golimumab (Simponi™), 09-J1000-11

Infliximab (Remicade®), 09-J0000-39

Ustekinumab (Stelara), 09-J1000-16

OTHER:

None Applicable

REFERENCES:

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2012. URL www.clinicalpharmacilogy-ip.com Accessed 7/21/14.
  2. Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Treatment of psoriatic arthritis in a phase 3 randomized, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Ann Rheum Dis. Mar 4 2014. PMID 24595547
  3. Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Supplemental Data: Treatment of psoriatic arthritis in a phase 3 randomized, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Available at: http://ard.bmj.com/content/suppl/2014/03/04/annrheumdis-2013-205056.DC1/annrheumdis-2013-205056supp.docx. Accessed March 2014.
  4. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 7/21/14.
  5. Otezla (apremilast) [package insert]. Celgene Corp. Summit (NJ): March 2014.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 08/13/14.

GUIDELINE UPDATE INFORMATION:

09/15/14

New Medical Coverage Guideline.

12/15/14

Revision to guideline; consisting of

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is copyright 2013, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2013 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association.The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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Date Printed: April 1, 2015: 12:28 AM