LCD/NCD Portal

L28760

 

ALEFACEPT

 

 

03/22/2012

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Indications:

 

Medicare will consider alefacept medically reasonable and necessary for the following criteria:

• The treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

• Retreatment of patients whose initial course of treatment has resulted in a documented meaningful clinical response provided that CD4+T lymphocyte counts are within the normal range, and a minimum of 12 weeks has elapsed since the completion of the previous treatment.

• Prior to treatment with alefacept, it is expected that patients would be treated with topical and UVB therapies, or have a medical contraindication to such therapies, or a basis for a reasonable medical expectation exists that these therapies would not be effective.

• CD4+T lymphocyte counts must be available to the treating physician prior to the administration of each treatment.

• Other systemic treatments must have been considered by the physician and discussed with the patient, but are not required to have been tried.

Limitations:

• Alefacept is NOT currently indicated for treatment in patients who have forms of psoriasis other than chronic plaque psoriasis.

• Alefacept will be considered NOT reasonable or necessary in patients:

o Who are receiving it in combination with other systemic therapies, as these uses are considered INVESTIGATIONAL.

o In whom the CD4+T lymphocyte counts are below 250cells/µL at the time of administration, nor for subsequent doses in any patient in whom the CD4+T lymphocyte counts are less than 250cells/µL for a month.

o In whom the administration is CONTRAINDICATED because of:

 Clinically significant infection.

 Malignancy.

And

 History of systemic malignancy.

Or

 Concurrent treatment with other immunosuppressive therapies (including phototherapy)

Coding Information

 

 

Bill Type Codes

 

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

13x Hospital Outpatient

21x Skilled Nursing - Inpatient (Including Medicare Part A)

23x Skilled Nursing - Outpatient

75x Clinic - Comprehensive Outpatient Rehabilitation Facility (CORF)

85x Critical Access Hospital

 

 

Revenue Codes

 

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

0250 Pharmacy - General Classification

0636 Pharmacy - Drugs Requiring Detailed Coding

 

 

CPT/HCPCS Codes

 

J0215 INJECTION, ALEFACEPT, 0.5 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

696.1 OTHER PSORIASIS AND SIMILAR DISORDERS

 

 

Documentation Requirements

 

• An ICD-9-CM code describing the patient’s medical condition must be submitted with each claim.

• The medical record must document the need for these services, and include the history of prior and current malignancies and clinically significant infections, prior treatments for psoriasis, response to current treatment, response to prior treatments with alefacept, concurrent therapies and medications, and the weekly CD4+ lymphocyte counts prior to each treatment.

• A copy of the invoice for the alefacept must be maintained in the patient’s medical record.

• Documentation must be available to Medicare upon request.

 

 

Utilization Guidelines

 

• It is anticipated that alefacept would be administered at weekly intervals, for a total of 12 consecutive weeks, depending on the patient’s ability to tolerate the therapy.

o Retreatment with an additional 12 week course may be initiated provided that the initial course of treatment resulted in a documented meaningful clinical response and CD4+T lymphocyte counts are within the normal range and a minimum of a 12-week interval has passed since the previous course of treatment.

• It is expected that CD4+T lymphocyte counts will be done once a week prior to each administration of the alefacept.

• It is expected that these services would be performed as indicated by current medical literature and/or standards of practice.

o When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Treatment Logic

• Psoriasis is a chronic immune-mediated disease of the skin affecting an estimated 2% of the population.

o It has been treated with topical, photo and systemic therapies.

o The topical therapies include tars, salicylic acid, corticosteroids, calcipotriene, tazarotene and anthralin.

o Phototherapies include UVB, psoralens plus UVA (PUVA), and more recently laser therapy for localized lesions.

o Systemic therapies include drugs such as methotrexate, cyclosporine, retinoids and an emerging class of biologic drugs including etanercept (Enbrel®) and now alefacept (manufactured by Biogen under the trade name-Amevive).

o Some of the therapies are used in combination so as to minimize toxicities while maximizing response, or as rotational therapy.

• Alefacept is a human fusion protein directed at T-cells expressing the CD2 antigen, preventing lymphocyte activation.

o These lymphocytes are involved in the inflammatory process in psoriatic lesions.

o Alefacept is administered as an intramuscular injection of 15mg at weekly intervals, for a total of 12 consecutive weeks.

• Because alefacept may reduce circulating CD4+ and CD8+ T-lymphocytes, weekly CD4+ tests are required for monitoring while administering the drug.

• Alefacept has been approved by the FDA for treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

• Psoriasis severity is categorized by body surface area (National Psoriasis Foundation) as:

o Mild: covers less than 2% of the body.

o Moderate: covers 2-10% of the body.

o Severe: covers more than 10% of the body.

o Note: Psoriasis of the palms can be severe, even though the percent of body area involved may be minimal.

• Evaluation of the extent of the psoriasis may be measured using the PASI (psoriasis area and severity index) which combines assessments on the percentage of the body area affected, erythema, induration and desquamation.

o Scores range from 0 to 72.

o The Physician Global Assessment (PGA) may also be used.

o It employs a seven-point scale, with:

 0=clear.

 1=almost clear.

 6= marked plaque elevation, scaling or erythema.

 7 = very marked plaque elevation, scaling or erythema.

 

 

Sources of Information and Basis for Decision

 

Biogen, Inc Prescribing Information Amevive®(alefacept)

 

Drew, G. (2000). Psoriasis. Dermatology, 27(2). Retrieved October 3, 20003, from mdconsult database (11345118).

 

Ellis, C. et al. (2001). Treatment of Chronic Plaque Psoriasis by Selective Targeting of Memory Effector T Lymphocytes. New England Journal of Medicine, 345(4), 248-255.

 

FCSO LCD 29054, Alefacept, 03/22/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Krueger, G., Callis, K. (2003). Development and use of alefacept to treat psoriasis. Journal of the American Academy of Dermatology, 49(2). Retrieved October 3, 2003, from mdconsult database (13939609).

 

Krueger, G., Papp, K., Stough, D., Loven, K., Gulliver, W., Ellis, C. (2002). A randomized, double-blind, placebo-controlled phase III study evaluating efficacy and tolerability of 2 courses of alefacept in patients with chronic plaque psoriasis. Journal of the American Academy of Dermatology, 47(6), 821-833.

 

Lebwohl, M. & Ali, S. (2001). Treatment of psoriasis. Part 1. Topical Therapy and phototherapy. Journal of the American Academy of Dermatology, 45(4), 487-498.

 

Lebwohl, M. & Ali, S. (2001). Treatment of psoriasis. Part 2. Systemic therapies. Journal of the American Academy of Dermatology, 45(5), 649-661.

 

Food and Drug Administration. (2003). Letter of FDA approval of Alefacept for marketing.

 

The Medical Letter. (2003). Alefacept (Amevive) for Treatment of Psoriasis, 45(1154), 31-32.

 

 

AMA CPT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply.

 

 

CMS LCD L28760 ALEFACEPT