BlueCross BlueShield of Tennessee Medical Policy Manual

Plasma Exchange

DESCRIPTION

Plasma exchange (PE) is a procedure in which the blood of the patient is extracted and processed through a medical device which separates the plasma from other components of blood. The plasma is discarded and replaced with fluid such as albumin, allogenic plasma or a plasma substitute. PE is a nonspecific therapy, because the entire plasma is discarded. PE has been used in a wide variety of acute and chronic conditions, as well as in the setting of solid organ transplantation.

The terms therapeutic apheresis, plasmapheresis, and plasma exchange are often used interchangeably, but when properly used denote different procedures. The American Society for Apheresis (ASFA) definitions for these other procedures are as follows:

The proposed therapeutic use of PE is to rapidly remove toxins or autoantibodies which can accumulate in the plasma as a result of a disease process. PE is a non-specific therapy and essentially a symptomatic treatment since it does not remove the source of the pathogenic factors. Although PE can rapidly reduce levels of serum autoantibodies; a feedback mechanism may lead to a rebound overproduction of the same antibodies.

Note: Applications of PE can be broadly subdivided into 2 general categories: (1) acute self-limited diseases, in which PE is used to lower the circulating pathogenic substance; and (2) chronic diseases, in which there is ongoing production of pathogenic autoantibodies. Treatment goals and duration of treatment with PE need to be clearly established before its initiation; without such treatment goals, the use of an acute short-term course of PE may insidiously evolve to a chronic use of PE with uncertain benefit. For example a meaningful clinical response for chronic inflammatory demyelinating polyneuropathy (CIDP) would be an improvement in neurological disability scores (e.g. Hughes GBS Disability Scale, Overall Disability Sum Score). However, studies show progress made will most likely last only for the short term. Another example would be plasma exchange when used to treat myasthenia gravis or Guillain-Barre’ would show measurable improvement in bedside spirometry readings. Additionally neuromyelitis optica and neuromyelitis optica spectrum disorder (NMO/NMOSD), a rare but clinically aggressive demyelinating disease of the central nervous system, that does not respond to initial treatment of steroids may respond to a short course of plasma exchange treatments, especially if previous treatments resulted in improvements in visual acuity or disability scores.  

POLICY

MEDICAL APPROPRIATENESS

Autoimmune

Hematologic

Transplant

Renal

Neurologic

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

Based on data from published studies and/or clinical support, plasma exchange is considered medically necessary for selected conditions. For all other conditions, there is a lack of data regarding efficacy and clinical support.

SOURCES

American Academy of Neurology. (2016). Continuum. Multiple sclerosis and other demyelinating diseases. Retrieved June 30, 2016 from www.ContinuumJournal.com.

American Society for Apheresis (2016) Guidelines on the use of therapeutic apheresis in clinical practice - evidence-based approach from the writing committee of the American society for apheresis: the seventh special issue. Journal of Clinical Apheresis, 31, 149-162.

Bambauer, R., Latza, R., Bambauer, C., Burgard, D., and Schiel, R. (2013, November) Therapeutic apheresis in autoimmune diseases. Rheumatology: Research and Reviews, 5, 93–103. (Level 2 evidence)

Bonnan, M., & Cabre, P. (2012). Plasma exchange in severe attacks of neuromyelitis optica. Multiple Sclerosis International, 2012, Article ID 787630. (Level 1 evidence)

Centers for Medicare & Medicaid Services. CMS.gov. NCD for apheresis (110.14). Retrieved January 8, 2016 from https://www.cms.gov. 

Codron, P., Cousin, M., Subra, J., Pautot, V., Letournel, F., Verny, C., et. al., (2017, March) Therapeutic plasma exchange in chronic dysimmune peripheral neuropathies: A 10-year retrospective study. Journal of Clinical Apheresis, [e-published ahead of print] Abstract retrieved July 18, 2017 from PubMed database.

Deschamps, R., Gueguen, A., Parquet, N., Saheb, S., Driss, F., Mesnil, M., et. al. (2016, May) Plasma exchange response in 34 patients with severe optic neuritis. Journal of Neurology, 263 (5) 883-887. Abstract retrieved July 18, 2017 from PubMed database.

Gorson, L. (2012)  An update on the management of chronic inflammatory demyelinating polyneuropathy. Therapeutic Advances in Neurological Disorders, 5 (6), 359-373. (Level 5 evidence)

Kobayashim, M., Nanri, K., Taguchi, T., Ishiko, T., Yoshida, M., Yoshikawa, N. et. al., (2015, February) Immunoadsorption therapy for neuromyelitis optica spectrum disorders long after the acute phase. Journal of Apheresis, 30 (1), 43-5. Abstract retrieved July 18, 2017 from PubMed database.

Mehndiratta, M,, Hughes, R., and Pritchard. J. (2015) Plasma exchange for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database of Systematic Reviews, Issue 8. Art. No.: CD003906. (Level 2 evidence)

National Comprehensive Cancer Network. (2017, January). NCCN clinical practice guidelines in oncology®. Waldenstrom’s macroglobulinemia/lymphoplasmacytic lymphoma - V.2.2017. Retrieved April 27, 2017 from http://www.nccn.org.

National Comprehensive Cancer Network. (2018, February). NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Multiple myeloma - V.4.2018. Retrieved July 20, 2018 from http://www.nccn.org.

Nickerson, M and Marrie, R. (2013) The multiple sclerosis relapse experience: patient-reported outcomes from the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry. BMC Neurology, 13 (119). (Level 4 evidence)

Oaklander,  A., Lunn, M., Hughes, R., van Schaik, I., Frost, C., Chalk, C., et. al (2017, January) Treatments for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP): an overview of systematic reviews. Cochrane Database Systems Review. January, 13; 1:CD010369. Abstract retrieved April 27, 2017 from PubMed database.

Sherman, E. and Han, M. (2015) Acute and chronic management of neuromyelitis optica spectrum disorder. Current Treatment Options in Neurology, 17 (48). (Level 2 evidence)

U. S. Food and Drug Administration. (2004, July). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K040041 (Apheresis System). Retrieved November 15, 2010 from http://www.fda.gov.

Walsh, M., Catapano, F., Szpirt, W., Thorlund, K., Bruchfeld, A., Guillevin, L. (2011). Plasma exchange for renal vasculitis and idiopathic rapidly progressive glomerulonephritis: a meta-analysis. American Journal of Kidney Disease, 57 (4), 566-574. (Level 1 evidence - Independent)

ORIGINAL EFFECTIVE DATE:  5/1981

MOST RECENT REVIEW DATE:  12/30/2018

ID_BT

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