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ph-1051

Interleukin (IL)-1 Inhibitors Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1051

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
7/1/2023

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Arcalyst^® (rilonacept) Subcutaneous injection	Treatment of Cryopyrin Associated Periodic Syndrome (CAPS), including Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older Maintenance of remission of deficiency of interleukin-1 receptor antagonist (DIRA) in adults and pediatric patients weighing at least 10 kg Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older		1

Agent(s)

FDA Indication(s)

Notes

Ref#

Arcalyst^®

(rilonacept)

Subcutaneous injection

Treatment of Cryopyrin Associated Periodic Syndrome (CAPS), including Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older

Maintenance of remission of deficiency of interleukin-1 receptor antagonist (DIRA) in adults and pediatric patients weighing at least 10 kg

Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older

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

CLINICAL RATIONALE

Cryopyrin-Associated Periodic Syndromes (CAPS)	Cryopyrin-associated periodic syndrome (CAPS) is a rare autosomal dominant hereditary autoimmune disorder associated with a defect in the cryopyrin protein.(2) CAPS syndrome is caused by a gain of function mutation in the NLRP3 gene leading to over secretion of fever causing cytokine IL-1B.(6) There are three distinct phenotypes related to a defect in the same gene but differ in the organs involved and disease severity.(2) Familial cold autoinflammatory syndrome (FCAS) is the mildest form and more common in the United States. Muckle-Wells syndrome (MWS) is the intermediate phenotype and more common in Europe. Neonatal-onset multisystem inflammatory disease (NOMID) is the least common disease and is the most severe form.(3) An international task force recommends both of the following diagnostic criteria need to be present for a diagnosis of CAPS and its subtypes:(6) Raised inflammatory markers (CRP/SAA) The presence of at least two of the following signs/symptoms: Urticaria-like rash Cold/stress triggered episodes Sensorineural hearing loss Musculoskeletal symptoms of arthralgia/arthritis/myalgia Chronic aseptic meningitis Skeletal abnormalities of epiphyseal overgrowth/frontal bossing FCAS is characterized by a hive-like rash that is associated with exposure to cold and other environmental triggers and with symptoms lasting up to 24 hours.(2) Patients experience urticaria, arthralgia, fever with chills, severe thirst, red-eyes, and headache after a general cold exposure, including air conditioning. In MWS, inflammation can occur spontaneously as well as from triggers, such as stress, cold, or exercise, with episodes lasting from one to three days. MWS shares the same characteristics as FCAS, but is also characterized by renal amyloidosis, sensorineural hearing loss, and conjunctivitis. Hearing loss, partial or complete, often develop by teenage years.(3) NOMID is characterized by neonatal onset of cutaneous symptoms along with fever with inflammation in multiple organ systems. NOMID shares most of the same characteristics with FCAS and MWS, but also has more severe arthropathy, chronic urticaria, and CNS involvement. CNS manifestations range from hearing loss to aseptic meningitis and mental disabilities. Arthropathy typically affects the large joints, resulting in joint enlargement and functional disability.(3) Interleukin (IL)-1- beta inhibitors (anakinra, rilonacept, and canakinumab) have shown effectiveness in preventing and alleviating symptoms of CAPS and reducing levels of inflammatory indices, including serum amyloid A.(2) Treatment with non-steroidal anti-inflammatory drugs, disease modifying antirheumatic drugs, and glucocorticoids were offered only some patients partial symptom control.(3)
Deficiency of the IL-1 Receptor Antagonist (DIRA)	Deficiency of the IL-1 Receptor Antagonist (DIRA) syndrome is a relatively new autoinflammatory disease linked to activation of the IL-1 pathway. The DIRA syndrome is distinct from the cryopyrinopathies by its neonatal onset of sterile multifocal osteomyelitis, periostitis, and neutrophilic pustulosis.(7) DIRA is caused by a loss of function of the endogenous IL-1 receptor antagonist, which results in unopposed proinflammatory signaling via cytokines IL-1alpha and IL-1beta on IL-1 receptor type 1. There has been a common homozygous mutation in the IL1RN gene detected in a number of patients. DIRA has similar cutaneous and systemic features as infantile pustular psoriasis and SAPHO (synovitis, acne, pustulosis, hyperostosis, and osteitis) syndrome. The diagnosis of DIRA can be confirmed via genetic testing.(7) DIRA is extremely responsive to IL-1 blockade and anakinra has been used empirically. The FDA approved anakinra as treatment for DIRA and rilonacept as maintenance therapy once a patient has achieved remission of DIRA.(8)
Recurrent Pericarditis	Pericarditis is inflammation of the pericardial layers around the heart and is the most common form of pericardial disease. Pericarditis may be caused infections, post-cardiac injury syndrome, or pericarditis may be idiopathic. Pericarditis is categorized into four types, acute, incessant, recurrent, and chronic. These categories are based on the length of time of the attack and the presentation. Acute pericarditis is an event lasting 4 weeks or less, incessant is an event lasting more than 4 weeks without a remission, recurrent pericarditis is new signs and symptoms of pericarditis after a symptom-free interval of 4 to 6 weeks, and chronic is an event lasting more than 3 months. Roughly 20% to 30% of patients that develop acute pericarditis will have recurrences, and 50% of patients that have a recurrence will experience more recurrences.(9) The European Society of Cardiology (ESC) guidelines indicate that acute pericarditis is diagnosed based on the presence of at least 2 of the 4 following criteria:(10) Chest pain Pericardial rub Electrocardiogram (ECG) changes New or worsening pericardial effusion Elevated inflammatory markers (i.e., C-reactive protein [CRP], erythrocyte sedimentation rate [ESR], and white blood cell [WBC] count elevation) and evidence of pericardial inflammation by imaging may help diagnose the disease and monitor disease activity.(10) The ESC guidelines recommend the following for the treatment of recurrent pericarditis:(10) First line therapy: Aspirin or NSAID with colchicine and exercise restrictions for at least a 6 month trial Second line therapy: low dose corticosteroids Third line: Anakinra, azathioprine, IVIG Fourth line: pericardiectomy The American College of Cardiology note that mycophenolate mofetil and methotrexate have also been shown to be effective in the treatment of recurrent pericarditis that are not responsive to corticosteroids, corticosteroid dependent, or intolerant to corticosteroids.(9)
Safety(1)	Arcalyst does not have any FDA labeled contraindications.

REFERENCES

Number	Reference
1	Arcalyst prescribing information. Regeneron Pharmaceuticals, Inc. May 2021.
2	American College of Rheumatology. Cryopyrin-Associated Autoinflammatory Syndromes. Updated December 2021. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Cryopyrin-Associated-Autoinflammatory-Syndrome-CAPS-Juvenile.
3	Yu, J. R., & Leslie, K. S. (2010). Cryopyrin-associated periodic syndrome: an update on diagnosis and treatment response. Current allergy and asthma reports, 11(1), 12-20.
4	~~American College of Rheumatology. Familial Mediterranean Fever. Updated December 2021. Available at:~~ ~~https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Familial-Mediterranean-Fever-Juvenile.~~ Reference no longer used.
5	~~Ozen S, Demirkaya E, Erer B, et al. EULAR recommendations for the management of familial Mediterranean fever. Ann Rheum Dis 2016; 75:644.~~ Reference no longer used.
6	Kuemmerle-Deschner JB, Ozen S, Tyrrell PN, et al. Diagnostic criteria for cryopyrin-associated periodic syndrome (CAPS). Ann Rheum Dis 2017; 76:942.
7	Cowen EW, Goldbach-Mansky R. DIRA, DITRA, and new insights into pathways of skin inflammation: what's in a name? Arch Dermatol 2012; 148:381.
8	Aksentijevich I, Masters SL, Ferguson PJ, et al. An autoinflammatory disease with deficiency of the interleukin-1-receptor antagonist. N Engl J Med 2009; 360:2426.
9	Chiabrando JG, Bonaventura A, Vecchié A, et al. Management of Acute and Recurrent Pericarditis: JACC State-of-the-Art Review. J Am Coll Cardiol 2020; 75:76.
10	Adler Y, Charron P, Imazio M, et al. 2015 ESC guidelines for the diagnosis and management of pericardial diseases: The Task Force for the Diagnosis and Management of Pericardial Diseases of the European Society of Cardiology (ESC). Eur Heart J 2015;36:2921–64.

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)	Target Generic Agent(s)	Strength	Targeted MSC	Available MSC	Preferred Status	Effective Date

Arcalyst	Rilonacept For Inj 220 MG	220 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	Effective Date

Arcalyst	Rilonacept For Inj 220 MG	220 MG	8	VIALS	28	DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Arcalyst	Rilonacept For Inj 220 MG	220 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
Arcalyst	Rilonacept For Inj 220 MG	220 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 ALL of the following are met: ONE of the following: BOTH of the following: The patient has ONE of the following indications: Cryopyrin Associated Periodic Syndrome (CAPS) OR Familial Cold Auto-Inflammatory Syndrome (FCAS) OR Muckle-Wells Syndrome (MWS) AND BOTH of the following: The patient has elevated pretreatment serum inflammatory markers (C-reactive protein/serum amyloid A) AND The patient has at least TWO of the following symptoms typical for CAPS: Urticaria-like rash Cold/stress triggered episodes Sensorineural hearing loss Musculoskeletal symptoms of arthralgia/arthritis/myalgia Chronic aseptic meningitis Skeletal abnormalities of epiphyseal overgrowth/frontal bossing OR BOTH of the following: The patient has a diagnosis of deficiency of interleukin-1 receptor antagonist AND The requested agent is being used for maintenance of remission OR The patient has a diagnosis of recurrent pericarditis AND ONE of the following BOTH of the following: The patient has tried and had an inadequate response to at least a 6-month trial of colchicine in combination with an NSAID used in the treatment of recurrent pericarditis AND The patient has tried and had an inadequate response to systemic corticosteroids used in the treatment of recurrent pericarditis OR The patient has an intolerance or hypersensitivity to colchicine in combination with NSAIDs AND systemic corticosteroids used in the treatment of recurrent pericarditis OR The patient has tried and had an inadequate response to an oral immunosuppressant (i.e., azathioprine, methotrexate, mycophenolate) used in the treatment of recurrent pericarditis OR The patient has an intolerance or hypersensitivity to oral immunosuppressants used in the treatment of recurrent pericarditis OR The patient has an FDA labeled contraindication to colchicine in combination with an NSAID, systemic corticosteroids, AND oral immunosuppressants used in the treatment of recurrent pericarditis OR The patient has another FDA approved indication for the requested agent OR The patient has another indication that is supported in compendia for the requested agent AND If the patient has an FDA approved indication, then ONE of the following: The patient’s age is within FDA labeling for the requested indication for the requested agent OR The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, pediatrician, cardiologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND ONE of the following (Please refer to “Agents NOT to be used Concomitantly” table): 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 The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following: The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required) AND 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: The patient has been previously approved for the requested agent through plan’s Prior Authorization process AND The patient has had clinical benefit with the requested agent AND The prescriber is a specialist in area of the patient’s diagnosis (e.g., allergist, immunologist, pediatrician, cardiologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND ONE of the following (Please refer to “Agents NOT to be used Concomitantly” table): 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 The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following: The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required) AND 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.

Module

Clinical Criteria for Approval

Initial Evaluation

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

ONE of the following:
1. BOTH of the following:
  1. The patient has ONE of the following indications:
    1. Cryopyrin Associated Periodic Syndrome (CAPS) OR
    2. Familial Cold Auto-Inflammatory Syndrome (FCAS) OR
    3. Muckle-Wells Syndrome (MWS) AND
  2. BOTH of the following:
    1. The patient has elevated pretreatment serum inflammatory markers (C-reactive protein/serum amyloid A) AND
    2. The patient has at least TWO of the following symptoms typical for CAPS:
      1. Urticaria-like rash
      2. Cold/stress triggered episodes
      3. Sensorineural hearing loss
      4. Musculoskeletal symptoms of arthralgia/arthritis/myalgia
      5. Chronic aseptic meningitis
      6. Skeletal abnormalities of epiphyseal overgrowth/frontal bossing OR
2. BOTH of the following:
  1. The patient has a diagnosis of deficiency of interleukin-1 receptor antagonist AND
  2. The requested agent is being used for maintenance of remission OR
3. The patient has a diagnosis of recurrent pericarditis AND ONE of the following
  1. BOTH of the following:
    1. The patient has tried and had an inadequate response to at least a 6-month trial of colchicine in combination with an NSAID used in the treatment of recurrent pericarditis AND
    2. The patient has tried and had an inadequate response to systemic corticosteroids used in the treatment of recurrent pericarditis OR
  2. The patient has an intolerance or hypersensitivity to colchicine in combination with NSAIDs AND systemic corticosteroids used in the treatment of recurrent pericarditis OR
  3. The patient has tried and had an inadequate response to an oral immunosuppressant (i.e., azathioprine, methotrexate, mycophenolate) used in the treatment of recurrent pericarditis OR
  4. The patient has an intolerance or hypersensitivity to oral immunosuppressants used in the treatment of recurrent pericarditis OR
  5. The patient has an FDA labeled contraindication to colchicine in combination with an NSAID, systemic corticosteroids, AND oral immunosuppressants used in the treatment of recurrent pericarditis OR
4. The patient has another FDA approved indication for the requested agent OR
5. The patient has another indication that is supported in compendia for the requested agent AND
If the patient has an FDA approved 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. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, pediatrician, cardiologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
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. The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required) AND
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:

The patient has been previously approved for the requested agent through plan’s Prior Authorization process AND
The patient has had clinical benefit with the requested agent AND
The prescriber is a specialist in area of the patient’s diagnosis (e.g., allergist, immunologist, pediatrician, cardiologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
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. The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required) AND
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
	Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met: The requested quantity (dose) does NOT exceed the program quantity limit OR ALL of the following: The requested quantity (dose) is greater than the program quantity limit AND The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR ALL of the following: The requested quantity (dose) is greater than the program quantity limit AND The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND The prescriber has provided information in support of therapy with a higher dose for the requested indication Length of Approval: 12 months

Module

Clinical Criteria for Approval

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

The requested quantity (dose) does NOT exceed the program quantity limit OR
ALL of the following:
1. The requested quantity (dose) is greater than 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
ALL of the following:
1. The requested quantity (dose) is greater than the program quantity limit AND
2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months

CONTRAINDICATION AGENTS

Contraindicated as Concomitant Therapy
Agents NOT to be used Concomitantly Adbry (tralokinumab-ldrm) Actemra (tocilizumab) Amjevita (adalimumab-atto) Arcalyst (rilonacept) Avsola (infliximab-axxq) Benlysta (belimumab) Cibinqo (abrocitinib) Cimzia (certolizumab) Cinqair (reslizumab) Cosentyx (secukinumab) Dupixent (dupilumab) Enbrel (etanercept) Entyvio (vedolizumab) Fasenra (benralizumab) Humira (adalimumab) Ilaris (canakinumab) Ilumya (tildrakizumab-asmn) Inflectra (infliximab-dyyb) Infliximab Kevzara (sarilumab) Kineret (anakinra) Nucala (mepolizumab) Olumiant (baricitinib) 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) Xeljanz (tofacitinib) Xeljanz XR (tofacitinib extended release) Xolair (omalizumab) Zeposia (ozanimod)

Contraindicated as Concomitant Therapy

Agents NOT to be used Concomitantly

Adbry (tralokinumab-ldrm)

Actemra (tocilizumab)

Amjevita (adalimumab-atto)

Arcalyst (rilonacept)

Avsola (infliximab-axxq)

Benlysta (belimumab)

Cibinqo (abrocitinib)

Cimzia (certolizumab)

Cinqair (reslizumab)

Cosentyx (secukinumab)

Dupixent (dupilumab)

Enbrel (etanercept)

Entyvio (vedolizumab)

Fasenra (benralizumab)

Humira (adalimumab)

Ilaris (canakinumab)

Ilumya (tildrakizumab-asmn)

Inflectra (infliximab-dyyb)

Infliximab

Kevzara (sarilumab)

Kineret (anakinra)

Nucala (mepolizumab)

Olumiant (baricitinib)

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)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Xolair (omalizumab)

Zeposia (ozanimod)

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 _ Interleukin (IL)-1 Inhibitors Prior Authorization with Quantity Limit _ProgSum_ 7/1/2023

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