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DESCRIPTIONPsoriasis is characterized by red, thickened plaque with a silvery scale. Lesions may vary in size and degree of inflammation. The extent of skin involvement is categorized as localized or generalized based on the severity of the disease and its overall impact on the patient's quality of life. Medical treatment for localized psoriasis begins with a combination of topical corticosteroids and coal tar or calcipotriene. For lesions that are difficult to control with initial therapy, anthralin or tazarotene may be tried. The primary goal of therapy is to maintain control of lesions. Cure is seldom achieved. If control becomes difficult or if psoriasis is generalized, patients may benefit from phototherapy and/or systemic therapy.
Adalimumab (Humira®) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). Increased levels of TNF are also found in psoriasis plaques. Adalimumab may reduce the epidermal thickness and infiltration of inflammatory cells.
Etanercept (Enbrel®) is a dimeric fusion protein that binds specifically to tumor necrosis factor (TNF) and blocks its interaction with cell surface TNF receptors. Etanercept inhibits binding of both TNFa and TNFß to cell surface TNF receptors, rendering TNF biologically inactive which can result in a significant reduction in inflammation.
Infliximab (Remicade®) is a monoclonal antibody that blocks activity of a key inflammatory mediator called tumor necrosis factor alpha (TNF-alpha).
Ustekinumab (Stelara®) is a human IgG1k monoclonal antibody against the p40 subunit of the IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses.
Apremilast (Otezla®) is an oral inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism by which it exerts it therapeutic action in psoriasis patients is not well defined.
Secukinumab (Cosentyx™) is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. It inhibits the release of proinflammatory cytokines and chemokines.
Ixekizumab (Taltz™) is a humanized IgG4 monoclonal antibody that selectively binds with the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of proinflammatory cytokines and chemokines.
Raptiva® was voluntarily withdrawn from the market by the manufacturer, GenentechTM effective June 8, 2009. This was the result of several cases of reported progressive multifocal leukoencephalopathy in patients who were taking Raptiva®.
Amevive® was voluntarily withdrawn from the market by the manufacturer, Astellas Pharma U.S. Inc. effective November 16, 2011.
FDA APPROVED INDICATIONS
The following medications are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy:
Infliximab (Remicade®) is indicated for the treatment of adult patients with chronic severe (i.e. extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.
POLICYPrior authorization is required.
Etanercept (Enbrel®), Adalimumab (Humira®), Ustekinumab (Stelara®), Secukinumab (Cosentyx™), Infliximab (Remicade®) and Ixekizumab (Taltz™) are considered medically necessary for adults age 18 and older and apremilast (Otezla®) in patients with moderate to severe chronic plaque psoriasis only when systemic therapy or phototherapy is indicated and the following criteria have been met:
1. Patient has a diagnosis of chronic plaque psoriasis, determined by a board certified dermatologist, present for greater than 1 year and involving 10% or more of total body surface area as determined by the Psoriasis Area and Severity Index (PASI).
2. Patient has failed previous treatment with at least 1 of the following systemic or photo therapies:
3. For Humira® only:
4. For Enbrel® only:
5. For Stelara® only:
6. For Remicade® only:
7. For Otezla® only:
8. For Cosentyx™ only:
9. For Taltz™ only:
POLICY EXCEPTIONSState Health Plan (State and School Employees): Prior authorization is not required for State Health Plan members. However, these biologic drugs will be reviewed for medical necessity based on medical 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 Nervous/Mental Conditions, 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.
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 [i.e, 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.
POLICY HISTORY7/20/2004: Approved by Pharmacy & Therapeutics (P&T) Committee
8/24/2004: Alefacept (Amevive®) and Efalizumab (Raptiva®) medical policies merged with Chronic Plaque Psoriasis medical policy and archived
9/30/2004: Code Reference section completed
10/28/2005: Description section updated; deleted the statement "of the p75 TNF receptor" in the Etanercept definition; chart updated to include PUVB and PUVA. FDA approved indications revised; deleted dosing information, added link to Anti-Rheumatic Biologicals medical policy. Policy section updated; Accredo telephone # for Enbrel® changed from 1-866-489-1899 to 1-866-240-3373. Fax # changed from 1-866-489-1901 to 1-866-481-7762. Accredo telephone # for Raptiva® changed from 1-866-898-0136 to 1-866-240-3373. Fax # changed from 1-866-898-0136 to 1-866-481-7762. CuraScript telephone # changed from 1-888-875-8062 to 1-877-462-6211. Fax # changed from 1-888-875-8050 to 1-877-462-6234. Under Alefacept deleted step 2 about patient response to corticosteroids treatment. Added statement about Entanercept use and link to Anti-Rheumatic Biologicals medical policy. Sources updated; Raptiva® added
11/04/2005: Code Reference section updated, the drug's brand name added to the description of codes J0215 (Amevive®), J1438 (Enbrel®) and S0162 (Raptiva®)
11/2005: Approved by Pharmacy & Therapeutics (P & T) Committee
6/27/2006: CuraScript fax number changed to 1-866-239-5502
8/22/2006: Coverage of Enbrel dosing addressed
9/27/2006: Remicade® information added to policy
2/16/2007: Fax number for Enbrel® and Remicade® changed from 1-866-481-7762 to 1-866-489-1901. Added Accredo telephone and fax number for Raptiva®
4/24/2007: Remicade® added to drug table
10/17/2007: Added Accredo is our preferred provider for Amevive®
2/4/2008: Added Humira® prescribing information. J0135 added.
01/01/2009: Accredo and CuraScript preferred provider information removed. BCBSMS information added.
3/9/2008: Notice of withdrawal of Raptiva® from the market added to policy.
10/30/2009: Policy Subtitle updated to add Ustekinumab (Stelara™), and to remove Efalizumab (Raptiva®), Description Section updated with Ustekinumab (Stelara™) description, FDA indication, and identification names, Effectiveness of Treatment Table removed, and Efalizumab (Raptiva®) description removed, Policy Statement Section updated to add Ustekinumab (Stelara™) medically necessary and treatment information, Policy Sources Section updated to add Ustekinumab (Stelara™) prescribing information, Coding Section updated to add CPT4 code J3490 to Covered Codes Table to be used to code Ustekinumab (Stelara™), HCPCS code S0162 removed from Covered Codes Table.
02/28/2011: Added new HCPCS J3357 for Stelara™ to the Code Reference section.
03/31/2011: Policy statement updated to state that effective 04/01/11, new starts are only considered for Enbrel or Stelara after failed treatment with Humira.
01/09/2013: Added the following to the Policy Exceptions section: State Health Plan (State and School Employees): Prior authorization is not required for State Health Plan members. However, these biologic drugs will be reviewed for medical necessity based on medical policy guidelines.
11/15/2013: Policy reviewed; no changes to policy statement. Policy reformatted for clarity purposes.
07/29/2014: Policy statement revised to remove "Tacrolimus" from the list of criteria and add "previous" to the statement: Patient has failed previous treatment with at least 1 of the following systemic or photo therapies.
11/05/2014: Policy updated to add coverage guidelines for apremilast (Otezla®). Medically necessary policy statement updated to add apremilast (Otezla®) for patients with moderate to severe chronic plaque psoriasis. Added policy statement that Otezla® is only considered after failed treatment with Humira®. Sources section updated to add Otezla® prescribing information.
05/29/2015: Policy updated to add coverage guidelines for Secukinumab (Cosentyx™).
08/26/2015: Medical policy revised to add ICD-10 codes.
05/26/2016: Policy number L.5.01.412 added. Policy Guidelines updated to add medically necessary and investigative definitions.
10/20/2016: Policy updated to remove information regarding Alefacept (Amevive®) and to add coverage guidelines for Ixekizumab (Taltz™). For Taltz™, documentation of failed treatment with Humira® is required, and dosing is 160mg (two 80mg injections) at week 0, followed by 80mg at weeks 2, 4, 6, 8, 10, and 12, then 80mg every 4 weeks. Sources updated. Code Reference section updated to remove HCPCS code J0215.
11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
SOURCE(S)Psoriasis and Psoriatic Arthritis Treatment Monograph. National Psoriasis Foundation 2003.
American Academy of Dermatology Association, Guidelines of Care for Psoriasis. Available at: http://www.aadassociation.org/Guidelines/psoriasis.html.
Biogen, Inc. Amevive (alefacept) package insert.
Facts & Comparisons. Amevive monograph.
Genetech, Raptiva product information. Available at: http://www.gene.com/gene/products/information/immunological/raptiva/insert.jsp. Accessed November 2003.
Enbrel (etanercept) package insert.
Clinical Pharmacology Online. Methotrexate monograph. Available at: http://cp.gsm.com. Accessed June 2004.
Clinical Pharmacology Online. Cyclosporine monograph. Available at: http://cp.gsm.com. Accessed June 2004.
Laburte C, et al. Efficacy and safety of oral cyclosporin A for long-term treatment of chronic severe plaque psoriasis. Br J Dermatol. 1 Mar 2004; 130 (3): 366-75.
Raptiva® Prescribing Information (added 10-28-2005)
Remicade® Prescribing Information (added 9-27-2006)
Humira® Prescribing Information (added 2-4-2008)
Stelara™ Prescribing Information (added 10-29-2009)
Otezla® Prescribing Information (added 11-5-2014)
Cosentyx™ Prescribing Information
Taltz™ Prescribing Information
CODE REFERENCEThis 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.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.