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Otezla (apremilast) Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-91019

 

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

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

07-01-2024            

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Otezla®

(apremilast)

Tablets

Treatment of adult patients with active psoriatic arthritis

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

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

1

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

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 (greater 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*:(3,4,5,9)

  • Mild to moderate disease (less than 5% of BSA):
    • Topical corticosteroids strength of recommendation A
    • Off-label use of 0.1% tacrolimus for psoriasis involving the face as well as inverse psoriasis strength of evidence B
    • Long-term use (up to 52 weeks) of topical vitamin D analogs including calcipotriene, calcitriol, tacalcitol, and maxacalcitol strength of recommendation A
    • Use of calcipotriene foam and calcipotriene plus betamethasone dipropionate gel for the treatment of mild to moderate scalp psoriasis level of recommendation A
    • Use of taclicitiol ointment or calcipotriene combined with hydrocortisone for facial psoriasis strength of recommendation B
    • Vitamin D analogs in combination with topical corticosteroids strength of recommendation A
    • Topical tazarotene alone or in combination with narrowband ultraviolet B (NB-UVB) strength of recommendation B, or topical corticosteroids strength of recommendation  A
    • Topical salicylic acid alone or in combination with topical corticosteroids strength of recommendation B
    • Coal tar preparations strength of evidence A
  • Moderate to severe disease without PsA (5% or more of BSA or psoriasis in vulnerable areas [e.g., face, genitals, hands, and feet] that adversely affects quality of life):
    • Methotrexate  (adults) strength of evidence A
    • Methotrexate is less effective than TNF-inhibitors strength of evidence B
    • Combination therapy with methotrexate and NB-UVB (adult patients) strength of evidence B
    • Cyclosporine for patients with severe, recalcitrant strength of recommendation A , erythrodermic, generalized pustular, and/or palmoplantar psoriasis strength of recommendation B
    • Acitretin as monotherapy or in combination with psoralen plus ultraviolet light (PUVA) or broad band ultraviolet light (BB-UVA strength of evidence B
    • If UV-therapy is unavailable, first line therapies include MTX, cyclosporine, acitretin, and biologics
    • Apremilast strength of recommendation A
    • TNF-α inhibiters monotherapy strength of evidence A or in combination with topical corticosteroids with or without a vitamin D analogue strength of evidence B or in combination with acitretin strength of evidence C
    • TNF-α inhibitors should be considered as a preferred treatment option for patients concomitant PsA
    • Infliximab strength of evidence A
    • IL-12/IL-23 Inhibitors monotherapy strength of evidence A or in combination with topical corticosteroids with or without a vitamin D analogue strength of evidence C or in combination with acitretin or methotrexate strength of evidence B
    • IL-12/IL-23 inhibitors in combination with apremilast or cyclosporine strength of evidence C 
    • IL-17 inhibitors monotherapy strength of evidence A  
    • IL-23 inhibitors monotherapy for moderate to severe plaque psoriasis or as monotherapy for generalized pustular psoriasis strength of evidence B

* Strength of recommendation and descriptions

Strength of recommendation 

Description

A

Recommendation based on consistent and good-quality patient-oriented evidence

B

Recommendation based on inconsistent or limited-quantity patient-orientated evidence

C

Recommendation based on consensus, opinion, case studies, or disease-orientated evidence

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. Primary failure is defined as initial nonresponse to treatment. Primary failure to a TNF-α inhibitor does not preclude successful response to a different TNF-α inhibitor. Failure of another biologic therapy does not preclude successful response to ustekinumab.(9) 

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 less than or equal to 1% after 3 months
  • Acceptable response is either a BSA less than or equal to 3% or a BSA improvement greater than or equal to 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)

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.(8)

Chronic oral ulceration can cause scaring 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.(8)

Efficacy

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.(1)     

Safety

Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.(1)

REFERENCES                                                                                                                                                                           

Number

Reference

1

Otezla Prescribing Information. Celgene Corporation. December 2021.

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, 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.

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.

9

Elmets CA, 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 Volume 84 Number 2:432-470.

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Otezla

apremilast tab  ; apremilast tab starter therapy pack

10 & 20 & 30 MG ; 30 MG

M ; N ; O ; Y

N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Day Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Otezla

apremilast tab

30 MG

60

Tablets

30

DAYS

Otezla

apremilast tab starter therapy pack

10 & 20 & 30 MG

1

Kit

180

DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Otezla

apremilast tab  ; apremilast tab starter therapy pack

10 & 20 & 30 MG ; 30 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Otezla

apremilast tab

30 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Otezla

apremilast tab starter therapy pack

10 & 20 & 30 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical 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. The requested agent is eligible for continuation of therapy AND ONE of the following:

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy

      1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
      2. 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. BOTH of the following:
      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
          2. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of PsA OR
          3. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PsA OR
          4. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of PsA OR
        2. The patient has a diagnosis of 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
          2. The patient has an intolerance or hypersensitivity  to ONE conventional agent used in the treatment of PS OR
          3. The patient has an FDA labeled contraindication to ALL conventional agents used in the treatment of PS OR
          4. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of PS OR
        3. 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
          2. The patient has had at least 3 occurrences of oral ulcers in the last 12-months AND
          3. 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
            2. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of BD  OR
            3. The patient has an FDA labeled contraindication to ALL conventional agents used in the treatment of BD OR
            4. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of BD OR
        4. The patient has another FDA labeled indication for the requested agent not mentioned previously AND
      2. If the patient has an FDA labeled indication, then ONE of the following:
        1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
        2. There is support for using the requested agent for the patient’s age for the requested indication OR
    2. The patient has another indication that is supported in compendia for the requested agent not mentioned previously AND
  1. ONE of the following (Please refer to “Agents NOT to be used Concomitantly” table): 
    1. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
    2. The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
      1. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND
      2. There is support for the use of combination therapy (copy of support required, e.g., clinical trials, phase III studies, guidelines) AND
  2. 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
  3. The patient does NOT have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence

Length of approval:  12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

 

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 [Note: patients not previously approved for the requested agent will require initial evaluation review] AND
  2. The patient has had clinical benefit with the requested agent AND
  3. ONE of the following (Please refer to “Agents NOT to be used Concomitantly” table): 
    1. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
    2. The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
      1. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND
      2. There is support for the use of combination therapy (copy of support required, e.g., clinical trials, phase III studies, guidelines) AND
  4. 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
  5. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of approval:  12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

QL with PA

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. ALL of the following:
    1. The requested quantity (dose) exceeds the program quantity limit AND
    2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
    3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
  3. ALL of the following:
    1. The requested quantity (dose) exceeds the program quantity limit AND
    2. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
    3. There is support of therapy with a higher dose for the requested indication (e.g., clinical trials, phase III studies, guidelines required)

Length of Approval: up to 12 months

CONTRAINDICATION AGENTS

Contraindicated as Concomitant Therapy

Agents NOT to be used Concomitantly

Abrilada (adalimumab-afzb)

Actemra (tocilizumab)

Adalimumab

Adbry (tralokinumab-ldrm)

Amjevita (adalimumab-atto)

Arcalyst (rilonacept)

Avsola (infliximab-axxq)

Benlysta (belimumab)

Bimzelx (bimekizumab-bkzx)

Cibinqo (abrocitinib)

Cimzia (certolizumab)

Cinqair (reslizumab)

Cosentyx (secukinumab)

Cyltezo (adalimumab-adbm)

Dupixent (dupilumab)

Enbrel (etanercept)

Entyvio (vedolizumab)

Fasenra (benralizumab)

Hadlima (adalimumab-bwwd)

Hulio (adalimumab-fkjp)

Humira (adalimumab)

Hyrimoz (adalimumab-adaz)

Idacio (adalimumab-aacf)

Ilaris (canakinumab)

Ilumya (tildrakizumab-asmn)

Inflectra (infliximab-dyyb)

Infliximab

Kevzara (sarilumab)

Kineret (anakinra)

Litfulo (ritlecitinib)

Nucala (mepolizumab)

Olumiant (baricitinib)

Omvoh (mirikizumab-mrkz)

Opzelura (ruxolitinib)

Orencia (abatacept)

Otezla (apremilast)

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)

Sotyktu (deucravacitinib) 

Stelara (ustekinumab)

Taltz (ixekizumab)

Tezspire (tezepelumab-ekko)

Tremfya (guselkumab)

Truxima (rituximab-abbs)

Tysabri (natalizumab)

Velsipity (etrasimod)

Wezlana (ustekinumab-auub)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Xolair (omalizumab)

Yuflyma (adalimumab-aaty)

Yusimry (adalimumab-aqvh)

Zeposia (ozanimod)

Zymfentra (infliximab-dyyb)

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 Blue Cross and Blue Shield of Alabama’s 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.

 

 

 

Commercial _ PS _ Otezla_PAQL _ProgSum_ 07-01-2024