ph-99991019
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Otezla (apremilast) Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-99991019

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, and Health Insurance Marketplace formularies.

Otezla (apremilast) Prior Authorization with Quantity Limit

TARGET AGENT(S)

Otezla® (apremilast)

Brand (generic)

GPI

Multisource Code

Quantity Limit (per day or as listed)

Otezla (apremilast)

10 mg, 20 mg & 30 mg tablet starter pack (4 week)

6670001500B720

M, N, O, or Y

1 starter kit (55 tablets)/180 days

30mg tablets

66700015000330

M, N, O, or Y

60 tablets/30 days

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Initial Evaluation

Target Agent(s) will be approved when the ALL of the following are met:

  1. ONE of the following:
    1. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days

OR

    1. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed

                       OR

    1. ALL of the following:
      1. The patient has an FDA labeled indication or an indication supported in DrugDex with 1 or 2a level of evidence or AHFS for the requested agent

AND

      1. ONE of the following:
            1. The patient’s age is within FDA labeling for the requested indication for the requested agent

OR

            1. The prescriber has provided information in support of using the requested agent for the patient’s age

AND

      1. ONE of the following:
  1. The patient has a diagnosis of active psoriatic arthritis (PsA) AND ONE of the following:
        1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months

OR

        1. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PsA

OR

        1. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PsA

OR

        1. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence or AHFS for the treatment of PsA

OR

  1. The patient has a diagnosis of moderate to severe plaque psoriasis (PS) AND ONE of the following:
      1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) used in the treatment of PS for at least 3-months

OR

      1. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of PS

OR

      1. The patient has an FDA labeled contraindication to ALL conventional agents used in the treatment of PS

OR

      1. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence or AHFS for the treatment of PS

OR

  1. The patient has a diagnosis of Behcet’s disease (BD) AND ALL of the following:
    1. The patient has active oral ulcers associated with BD

AND

    1. The patient has had at least 3 occurrences of oral ulcers in the last 12-months

AND

    1. ONE of the following:
        1. The patient 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 BD

OR

        1. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of BD

OR

        1. The patient has an FDA labeled contraindication to ALL conventional agents used in the treatment of BD

OR

        1. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence or AHFS for the treatment of BD

OR

  1. The patient another FDA labeled indication or an indication supported in DrugDex with 1 or 2a level of evidence or AHFS for the requested agent not mentioned previously 

AND

  1. The patient will NOT be using the requested agent in combination with a biologic immunomodulator agent

      AND

  1. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, rheumatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit 

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

    1. ALL of the following:
  1. The requested quantity (dose) is greater than the program quantity limit

AND

  1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication

AND

  1. The prescriber has provided information in support of therapy with a higher dose for the requested indication (e.g., clinical trials, phase III studies, guidelines required)

Length of approval:  12 months

Renewal Evaluation

 Target Agent(s) will be approved when ALL of the following are met:

  1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process

AND

  1. The patient has had clinical benefit with the requested agent

AND

  1. The patient will NOT be using the requested agent in combination with a biologic immunomodulator agent

AND

  1. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, rheumatologist) or has consulted with a specialist in the area of the patient’s diagnosis

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication

AND

      1. The prescriber has provided information in support of therapy with a higher dose for the requested indication (e.g., clinical trials, phase III studies, guidelines required)

Length of approval:  12 months

Contraindicated as Concomitant Therapy

Actemra (tocilizumab)

Avsola (infliximab-axxq)

Cimzia (certolizumab)

Cosentyx (secukinumab)

Enbrel (etanercept)

Entyvio (vedolizumab)

Humira (adalimumab)

Ilumya (tildrakizumab-asmn)

Inflectra (infliximab-dyyb)

Kevzara (sarilumab)

Kineret (anakinra)

Olumiant (baricitinib)

Orencia (abatacept)

Remicade (infliximab)

Renflexis (infliximab-abda)

Riabni (rituximab-arrx)

Rinvoq (upadacitinib)

Rituxan (rituximab)

Rituxan Hycela (rituximab/hyaluronidase human)

Ruxience (rituximab-pvvr)

Siliq (brodalumab)

Simponi (golimumab)

Simponi ARIA (golimumab)

Skyrizi (risankizumab-rzaa)

Stelara (ustekinumab)

Taltz (ixekizumab)

Tremfya (guselkumab)

Truxima (rituximab-abbs)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Tysabri (natalizumab)

Arcalyst (rilonacept)

Ilaris (canakinumab)

FDA APPROVED INDICATIONS AND DOSAGE1

Agent(s)

Indication(s)

Dosage

Otezla®

(apremilast)

Tablet

Treatment of adult patients with active psoriatic arthritis

Initial dose titration:

Day 1: 10 mg morning (am)

Day 2: 10 mg am and 10 mg evening (pm)

Day 3: 10 mg am and 20 mg pm

Day 4: 20 mg am and 20 mg pm

Day 5: 20 mg am and 30 mg pm

Day 6 and thereafter: 30 mg twice daily

Maintenance dose: 30 mg twice daily

Treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy

Treatment of adult patients with oral ulcers associated with Behcet’s disease

CLINICAL RATIONALE

Psoriasis (PS)

Psoriasis (PS) is a chronic inflammatory skin condition that is often associated with systemic manifestations, especially arthritis. Diagnosis is usually clinical, based on the presence of typical erythematous scaly patches, papules, and plaques that are often pruritic and sometimes painful. 

Treatment goals for psoriasis include improvement of skin, nail, and joint lesions plus enhanced quality of life.2

The American Academy of Family Physicians (AAFP) categorizes psoriasis severity into mild to moderate (less than 5% of body surface area [BSA]) and moderate to severe (5% or more of BSA). The AAFP psoriasis treatment guidelines recommend basing treatment on disease severity:2

  • Mild to moderate (less than 5% of BSA and sparing the genitals, hands, feet, and face):
    • Candidate for intermittent therapy: topical corticosteroids, vitamin D analogs (calcipotriene and calcitriol), or tazarotene (Tazorac)
    • Candidate for continuous therapy: calcineurin inhibitors (tacrolimus and pimecrolimus)
  • Severe (5% or more of BSA or involving the genitals, hands, feet, and face):
    • Less than 20% of BSA affected: vitamin D analogs (calcipotriene and calcitriol) with or without phototherapy. These agents have a slower onset of action but a longer disease-free interval than topical corticosteroids
    • 20% or more of BSA affected: systemic therapy with MTX, cyclosporine, acitretin, or biologics. Biologics are recommended for those with concomitant PsA
  • Less commonly used topical therapies include non-medicated moisturizers, salicylic acid, coal tar, and anthralin

The American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) categorize psoriasis severity as limited or mild (less than 3% of BSA), moderate (3% to 10% of BSA), or severe (great than 10% of BSA). The AAD/NPF guidelines also note that psoriasis can be considered severe irrespective of BSA when is occurs in select locations (e.g., hands, feet, scalp, face, or genital area) or when it causes intractable pruritus.5 The AAD psoriasis treatment guidelines recommend the following:3,4

  • Limited disease (less than 5% of BSA):
    • Topical corticosteroids are first line as either monotherapy or in conjunction with non-steroidal topical agents
    • Vitamin D analogs, calcipotriene, calcipotriol, and calcitriol, are other first line agents and are often used in combination with topical corticosteroids
    • Tazarotene is a corticosteroid sparing agent and can be used in combination with topical corticosteroids to produce a synergistic effect and longer durations of treatment benefit and remission
    • Phototherapy is another first line option for limited disease, and allows for selective targeting of localized lesions and resistant areas such as the scalp and skin folds, leaving surrounding, non-lesional skin unaffected
    • Calcineurin inhibitors (tacrolimus and pimecrolimus) may also be considered first line for intertriginous, inverse, face, and genital psoriasis
    • Systemic agents are considered second line and only for short term use
  • Moderate to severe disease without PsA (more than 5% of BSA or psoriasis in vulnerable areas [e.g., face, genitals, hands, and feet] that adversely affects quality of life):
    • UV-therapy is considered first line as monotherapy or in combination with acitretin or MTX
    • If UV-therapy is unavailable first line therapies include MTX, cyclosporine, acitretin, and biologics
    • Second line systemic agents include leflunomide, sulfasalazine, and tacrolimus
  • Biologics are routinely used when one or more traditional systemic agents fail to produce adequate response, but are considered first line in patients with moderate to severe psoriasis with concomitant severe PsA

The National Psoriasis Foundation (NPF) medical board recommend a treat-to-target approach to therapy for psoriasis that include the following:6

  • The preferred assessment instrument for determining disease severity is BSA
  • Target response after treatment initiation should be BSA ≤1% after 3 months
  • Acceptable response is either a BSA ≤3% or a BSA improvement ≥75% from baseline at 3 months after treatment initiation

Psoriatic Arthritis (PsA)

Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disease associated with psoriasis, most commonly presenting with peripheral arthritis, dactylitis, enthesitis, and spondylitis. Treatment involves the use of a variety of interventions, including many agents used for the treatment of other inflammatory arthritis, particularly spondyloarthritis and RA, and other management strategies of the cutaneous manifestations of psoriasis.7

The American Academy of Dermatology (AAD) recommends initiating MTX in most patients with moderate to severe PsA. After 12 to 16 weeks of MTX therapy with appropriate dose escalation, the AAD recommends adding or switching to a TNF inhibitor if there is minimal improvement on MTX monotherapy.3

The American College of Rheumatology (ACR) and the National Psoriasis Foundation (NPF) guidelines for PsA recommend a treat-to-target approach in therapy, regardless of disease activity, and the following:7

  • Active PsA is defined as symptoms at an unacceptably bothersome level as reported by the patient and health care provider to be due to PsA based on the presence of one of the following:
    • Actively inflamed joints
    • Dactylitis
    • Enthesitis
    • Axial disease
    • Active skin and/or nail involvement
    • Extraarticular manifestations such as uveitis or inflammatory bowel disease
  • Disease severity includes level of disease activity at a given time point and the presence/absence of poor prognostic factors and long-term damage
  • Severe PsA disease includes the presence of 1 or more of the following:
    • Erosive disease
    • Elevated markers of inflammation (ESR, CRP) attributable to PsA
    • Long-term damage that interferes with function (i.e., joint deformities)
    • Highly active disease that causes a major impairment in quality of life
    • Active PsA at many sites including dactylitis, enthesitis
    • Function limiting PsA at a few sites
    • Rapidly progressive disease
  • Symptomatic treatments include nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, local glucocorticoid injections
  • Treatment recommendations for active disease:
    • Treatment naïve patients first line options include oral small molecules (OSM), TNF biologics, IL-17 inhibitor, and IL-12/23 inhibitor
      • OSM (i.e., methotrexate [MTX], sulfasalazine, cyclosporine, leflunomide, apremilast) should be considered if the patient does not have severe PsA, does not have severe psoriasis, prefers oral therapy, has concern over starting a biologic, or has contraindications to TNF inhibitor
      • Biologics (i.e., TNF biologic, IL-17 inhibitor, IL-12/23 inhibitor) are recommended as a first line option in patients with severe PsA and/or severe psoriasis
    • Previous treatment with OSM and continued active disease:
      • Switch to a different OSM (except apremilast) in patients without severe PsA or severe PS, contraindications to TNF biologics, prefers oral therapy OR add on apremilast to current OSM therapy
      • May add another OSM (except apremilast) to current OSM therapy for patients that have exhibited partial response to current OSM in patients without severe PsA or severe PS, contraindications to TNF biologics, or prefers oral therapy 
      • Biologic (i.e., TNF biologic, IL-17 inhibitor, IL-12/23 inhibitor) monotherapy
    • Previous treatment with a biologic (i.e., TNF biologic, IL-17 inhibitor, IL-12/23 inhibitor) and continued active disease:
      • Switch to another biologic (i.e., TNF biologic, IL-17 inhibitor, IL-12/23 inhibitor, abatacept, or tofacitinib) monotherapy or add MTX to the current TNF biologic

Behcet’s Disease (BD)8

Behcet’s disease (BD) is a type of vasculitis that involves numerous organ systems, such as the skin, mucosa, joints, eyes, veins, arteries, nervous system, and gastrointestinal system. BD runs a relapsing and remitting course and a multidisciplinary approach is necessary for optimal care. The goal of treatment is to suppress inflammatory exacerbations and recurrences to prevent irreversible organ damage.

Chronic oral ulceration can cause scarring requiring vigorous treatment to prevent oropharyngeal narrowing. The European League Against Rheumatism recommends topical measures, such as steroids, for the treatment of oral and genital ulcers. Colchicine is recommended for the prevention of recurrent mucocutaneous lesions. Patients with lesions that continue to recur despite colchicine may use immunomodulatory or immunosuppressive agents, such as azathioprine, tumor necrosis factor (TNF) inhibitors, or apremilast.

Efficacy1

The efficacy of Otezla for the treatment of oral ulcers associated with BD was established in a multicenter, randomized, placebo-controlled trial. Patients were required to have active oral ulcers at the time of enrollment, have had at least 3 occurrences of oral ulcers within the previous 12 months, and have received treatment with at least one non-biologic therapy. All subjects had a history of recurrent oral ulcers that were currently active. Otezla had a greater reduction in the number of oral ulcers and patient reported ulcer pain when compared to placebo.    

Safety1

Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.

REFERENCES

  1. Otezla Prescribing Information. Celgene Corporation. April 2020.
  2. Weigle, Nancy, MD, et al. Psoriasis. American Academy of Family Physicians. May 2013. 87 (9): 626-633.
  3. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. J Am Acad Dermatol. 2011;65(1):137–174.
  4. Menter A, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. Journal of the American Academy of Dermatology. 2008; 58:826–850. doi: 10.1016/j.jaad.2008.02.039.
  5. Menter, Alan et al. (2019). Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. Journal of the American Academy of Dermatology. doi: https://doi.org/10.1016/j.jaad.2018.11.057.
  6. Armstrong AW, Siegel MP, Bagel J, et al. From the medical board of the National Psoriasis Foundation: treatment targets for plaque psoriasis. Journal of the American Academy of Dermatology. 2017;76(2):290-298. doi: 10.1016/j.jaad.2016.10.017.
  7. Singh, J. A., et al. (2019). 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Care Res, 71: 2-29. doi:10.1002/acr.23789.
  8. Hatemi G, Christensen R, Bang D, et al. 2018 update of the EULAR recommendations for the management of Behçet's syndrome. Ann Rheum Dis 2018; 77:808.

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 
The purpose of pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
 
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment

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