Otezla (apremilast)

POLICY NUMBER

L.5.01.508

Otezla (apremilast)

Otezla XR (apremilast extended-release)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism(s) by which apremilast exerts its therapeutic action is not well defined.

Otezla (apremilast) is indicated for the treatment of the following:

• Adult patients and pediatric patients 6 years of age and older weighing at least 20kg with active psoriatic arthritis;

• Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy;

• Pediatric patients 6 years of age and older weighing at least 20kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; AND

• Adult patients with oral ulcers associated with Behçet’s Disease

Otezla XR (apremilast extended-release) is indicated for treatment of the following:

• Adult patients and pediatric patients 6 years of age and older weighing at least 50 kg with active psoriatic arthritis;

• Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy;

• Pediatric patients 6 years of age and older weighing at least 50kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; AND

• Adult patients with oral ulcers associated with Behçet’s Disease

Quantity Limits

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Initial Evaluation

Otezla (apremilast) and Otezla XR (apremilast extended-release) may be considered medically necessary when ALL of the following criteria are met:

1. ONE of the following:

   1. The individual has a documented diagnosis of active psoriatic arthritis and ALL of the following:

      1. ONE of the following:

         1. The individual is 18 years of age or older OR

         2. The individual is 6 to 17 years of age and ONE of the following:

            1. The request is for Otezla, and the individual weighs at least 20kg; OR

            2. The request is for Otezla XR, and the individual weighs at least 50kg; AND

      2. ONE of the following:

         1. The individual has tried and had an inadequate response (see Policy Guidelines) to at least one conventional agent (i.e. leflunomide, methotrexate, sulfasalazine) used in the treatment of psoriatic arthritis for at least 3 months;

         2. The individual has an intolerance, hypersensitivity, or FDA labeled contraindication to ALL conventional agents used in the treatment of psoriatic arthritis; OR

         3. The individual's medication history indicates use of another biologic immunomodulatory agent for the treatment of psoriatic arthritis;

   2. The individual has a documented diagnosis of plaque psoriasis and ALL of the following:

      1. ONE of the following:

         1. The individual is 18 years of age or older with mild to severe plaque psoriasis;OR

         2. The individual is 6 to 17 years of age and ONE of the following:

            1. The request is for Otezla, and the individual weighs at least 20kg; OR

            2. The request is for Otezla XR, and the individual weighs at least 50kg; AND

            3. ONE of the following:

               1. Involvement of >10 % of total body surface area (BSA); OR

               2. <10% BSA with involvement of sensitive areas of the body or areas that would significantly impact daily function (e.g., face, neck, hands, feet, genitals);

      2. ONE of the following:

         1. The individual has tried and had an inadequate response (see Policy Guidelines) to at least ONE conventional agent (i.e., acitretin, calcipotriene, calcitriol, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) used in the treatment of psoriasis for at least a 3-month duration:

2. The individual has an intolerance, hypersensitivity, or FDA labeled contraindication to ALL conventional agents used in the treatment of psoriasis; OR

3. The individual's medication history indicates use of a biologic immunomodulatory agent for the treatment of psoriasis; OR

4. The individual has a documented diagnosis of Behcet’s Disease and ALL of the following:

   1. The individual is 18 years of age or older;

   2. The individual has had at least 3 occurrences of oral ulcers in the last 12-months; AND

   3. ONE of the following:

      1. The individual has tried and had an inadequate response to ONE conventional agent (i.e. topical oral corticosteroids [i.e., triamcinolone dental paste], colchicine, azathioprine) used in the treatment of Behcet’s Disease; OR

      2. The individual has an intolerance, hypersensitivity, or FDA labeled contraindication to ALL conventional agents used in the treatment of Behcet’s Disease;

5. The prescriber is a specialist in the area of the individual’s diagnosis or has consulted with a specialist in the area of the individual’s diagnosis (i.e., dermatologist, rheumatologist);

6. The individual is not currently being treated with another immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, anti-IgE antibody, JAK inhibitor etc.);

7. The individual does not have an FDA labeled contraindication to the requested agent; AND

8. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 12 months

Renewal Evaluation

Otezla (apremilast) may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has been previously approved through the BCBSMS PA process;

2. The individual has documented clinical improvement (i.e., slowing of disease progression or decrease in symptom severity and/or frequency);

3. The individual is not currently being treated with another immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, anti-IgE antibody, JAK inhibitor etc.);

4. The individual does not have an FDA labeled contraindication to the requested agent; AND

5. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 12 months

POLICY EXCEPTIONS

Prior Authorization is not required for Federal Employee Program (FEP) members.

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [ie, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

Medication Failure

Medication failure is defined as disease progression at generally accepted doses (for ≥3 months use) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.

BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

01/01/2017: New policy added. Policy number L.5.01.508.

02/13/2017: Policy statements for psoriatic arthritis and chronic plaque psoriasis updated to add the following criteria that was effective 01/01/2017: Member is not currently being treated with a biologic immunomodulator agent.

04/01/2017: Policy evaluated and updated.

11/14/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

11/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added statement that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Policy statement revised to state that Otezla® (apremilast) may be considered medically necessary for members diagnosed with one of the listed conditions when all of the associated criteria are met. For Psoriatic arthritis, added length of approval of 12 months.

01/28/2019: Policy section updated to list conventional agent prerequisites for psoriasis.

08/04/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Otezla. Updated medically necessary criteria for psoriatic arthritis and chronic plaque psoriasis to reference the Policy Guidelines for the definition of failure and to list examples of immunomodulatory agents. Added approval criteria for Behcet's Disease and renewal criteria for Otezla. Policy Guidelines updated to define medication failure. Sources updated.

11/01/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy section updated to combine criteria for psoriatic arthritis, chronic plaque psoriasis, and Behcet's Disease into one medically necessary statement. Renewal criteria updated to state that the member has documented clinical improvement. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders." Added information regarding BCBSMS request for medical records. Sources updated. Code Reference section updated to add HCPCS code J8499.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

03/31/2025: Effective 06/01/2025 - Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Otezla (apremilast). Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Medically necessary policy criteria updated regarding individuals with a documented diagnosis of psoriatic arthritis, plaque psoriasis, and Behcet's Disease. Added criteria regarding prescribers and FDA labeled contraindications. Renewal evaluation criteria updated regarding current treatment and contraindications. Sources updated. Policy update effective 06/01/2025.

11/15/2025: Policy description updated to add Otezla XR. Updated quantity limits. Policy statement updated to add pediatric indications for Otezla and Otezla XR. Also updated criteria for topicals and body surface area involvement. Sources updated.

SOURCE(S)

Otezla prescribing information. Amgen Inc. August 2025. Last accessed October 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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