Alefacept (Amevive®) is covered for adults age 18 or older with severe, chronic plaque psoriasis, when administered by a dermatologist or rheumatologist as a monotherapy and, the following patient selection criteria are met:

1. Patient has plaque psoriasis (696.1) that has been present for more than one year with a minimum body surface involvement of 10%; and
2. Patient has failed to adequately respond to standard systemic agents (e.g., methotrexate, cyclosporin); and
3. Patient has failed to adequately respond to standard phototherapy (e.g., PUVA, UVB).

The CD4+T lymphocyte counts of patients receiving alefacept must be monitored before initiating each dose of a 12-week regimen. Alefacept is contraindicated and not covered in patients with CD4+ T lymphocyte counts less than 250 cells/µl. Alefacept should be discontinued if CD4+ T lymphocyte counts remain below 250 cells/µl for one month.

In patients whose initial course of treatment resulted in remission, re-treatment with an additional 12-week course may be initiated provided the CD4+T lymphocyte counts are within normal range, and a minimum of a 12-week interval has passed since the previous course of treatment.  Data on re-treatment beyond two cycles is limited. 

The use of alefacept for therapy beyond two 12-week cycles, in combination with phototherapy or other systemic therapies, or any diagnosis not listed on this policy is considered experimental/investigational, and therefore, not covered.  A participating, preferred, or network provider can bill the member for the denied service. 

The recommended dose is 15 mg given once weekly as an IM injection. Report J0215 for alefacept.

Coverage for alefacept is determined according to individual or group customer benefits.  Alefacept is not reimbursable under the prescription drug benefit.

Description

Psoriasis is a T-cell mediated inflammatory disorder of the skin that can cause considerable discomfort. Psoriasis can affect people of all ages.  It is characterized by accelerated skin growth that leads to skin cells building up on the surface of the skin, forming red, raised scaly plaques.  These plaques commonly occur on the scalp, sacral area, elbows, and knees.  The involved areas can be extensive and can cover a substantial percentage of a patient’s body.  It can be considered severe if it occurs on critical areas such as palms or soles.  There is no cure for psoriasis.

Alefacept (Amevive®) treats plaque psoriasis through a unique immunosuppressive mechanism of action.  Specifically, alefacept is believed to work by simultaneously blocking and reducing the cellular component of the immune system that is thought to play a significant role in the disease process.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient’s condition.

PRN References

10/2003, Highmark pays for Alefacept for adults with severe, plaque psoriasis

Treatment of Chronic Plaque Psoriasis by Selective Targeting of Memory Effector T Lymphocytes, New England Journal of Medicine, Vol. 345, No.4, July, 2001

A Randomized, Double-Blind, Placebo-Controlled Phase III Study Evaluating Efficacy and Tolerability of Two Courses of Alefacept in Patients with Chronic Plaque Psoriasis, Journal American Academy Dermatology, Vol. 47, No. 6, December, 2002

Intramuscular Alefacept Improves Health-Related Quality of Life in Patients With Chronic Plaque Psoriasis, Dermatology, Vol. 206, No. 4, January, 2003

Biogen, Inc. Amevive (alefacept) package insert. Cambridge, MA: Biogen; February, 2003

Alefacept for Chronic Plaque Psoriasis: A Selective Therapy With Long-Lasting Disease Remissions and an Encouraging Safety Profile, Dermatology Nursing, Vol. 15, No.3, June, 2003