| Coverage Policy Manual | |
| Policy #: | 1997216 |
| Category: | Medicine |
| Initiated: | January 1993 |
| Last Review: | January 2024 |
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| Apheresis, Therapeutic (Plasma Exchange Transfusion) | |
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| Description: |
Therapeutic apheresis is the process where blood is withdrawn from the body, shunted into an ultra centrifuge, and separated into its constituents. Fluid constituents may be discarded and replaced with normal saline, fresh frozen plasma, or human albumin. Cellular elements may be extracted for various therapeutic purposes.
The rationale for plasma exchange (PE) is based on the fact that circulating substances, such as toxins or autoantibodies, can accumulate in the plasma. Also, it is hypothesized that removal of these factors can be therapeutic in certain situations. PE is essentially a symptomatic therapy, since it does not remove the source of the pathogenic factors. Therefore the success of PE will depend on whether the pathogenic substances are accessible through the circulation, and whether their rate of production and transfer to the plasma component can be adequately addressed by PE. For example, PE can rapidly reduce levels of serum autoantibodies; however, through a feedback mechanism, this rapid reduction may lead to a rebound overproduction of the same antibodies. This rebound production of antibodies is thought to render the replicating pathogenic clone of lymphocytes more vulnerable to cytotoxic drugs; therefore, PE is sometimes used in conjunction with cyclophosphamide.
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Policy/ Coverage: |
Effective January 2021
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Plasmapheresis/plasma exchange (CPT 36514) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
Autoimmune
Hematologic
Neurologic
Renal
Transplantation
Therapeutic apheresis meets primary coverage criteria when:
In order to be reimbursed on the basis of procedure code 36514, the physician must be physically present with the patient at some time during the course of the apheresis, and the medical record must document this. If the physician sees the patient on the day of the apheresis, but not during the apheresis treatment, the physician should bill an evaluation and management code.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Plasmapheresis/plasma exchange for all other indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, plasmapheresis/plasma exchange for all indications other than those listed above is considered investigational. Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.
Effective prior to January 2021
Plasmapheresis/plasma exchange (CPT 36514) meets primary coverage criteria for effectiveness and is covered for:
Autoimmune
Hematologic
Neurologic
Renal
Transplantation
Therapeutic apheresis is covered when:
In order to be reimbursed on the basis of procedure code 36514, the physician must be physically present with the patient at some time during the course of the apheresis, and the medical record must document this. If the physician sees the patient on the day of the apheresis, but not during the apheresis treatment, the physician should bill an evaluation and management code.
Plasmapheresis/plasma exchange for all other indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, plasmapheresis/plasma exchange is considered investigational. Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.
Effective prior to June 2012
Plasmapheresis/plasma exchange (CPT 36514) meets primary coverage criteria for effectiveness and is covered for:
Therapeutic apheresis is covered when:
Apheresis for treatment of acute renal failure secondary to multiple myeloma is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For contracts without primary coverage criteria, apheresis for treatment of acute renal failure secondary to multiple myeloma is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
In order to be reimbursed on the basis of procedure code 36514, the physician must be physically present with the patient at some time during the course of the apheresis, and the medical record must document this. If the physician
sees the patient on the day of the apheresis, but not during the apheresis treatment, the physician should bill an evaluation and management code.
Effective September 2006 – May 2010
Plasmapheresis/plasma exchange (CPT 36514) meets primary coverage criteria for effectiveness and is covered for:
Therapeutic apheresis is covered when:
Apheresis for treatment of acute renal failure secondary to multiple myeloma is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For contracts without primary coverage criteria, apheresis for treatment of acute renal failure secondary to multiple myeloma is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
In order to be reimbursed on the basis of procedure code 36514, the physician must be physically present with the patient at some time during the course of the apheresis, and the medical record must document this. If the physician sees the patient on the day of the apheresis, but not during the apheresis treatment, the physician should bill an evaluation and management code.
Effective, May 2003 – August 2006
Plasmapheresis/plasma exchange (CPT 36514) is covered for:
Therapeutic apheresis is covered when:
Apheresis does not meet primary coverage criteria for treatment of acute renal failure secondary to multiple myeloma. (Effective, December 2005)
In order to be reimbursed on the basis of procedure code 36514, the physician must be physically present with the patient at some time during the course of the apheresis, and the medical record must document this. If the physician sees the patient on the day of the apheresis, but not during the apheresis treatment, the physician should bill an evaluation and management code.
Effective, September 2001 – April 2003
Plasmapheresis/plasma exchange (CPT 36520) is covered for: (1) Hemophilia with inhibitors; (2) Polyneuropathy, chronic relapsing, with severe or life-threatening symptoms, in patients who have not responded to more conventional therapy; (3) Rheumatoid vasculitis, with severe or life threatening symptoms, not responding to more conventional therapy; (4) Multiple myeloma; (5) Myeloid leukemia; (6) disorders of plasma protein metabolism; (7) primary thrombocytopenias; (8) Refsum's disease; (9) acute infective polyneuritis; (10) myasthenia gravis; (11) myasthenic syndromes; (12) polyarteritis nodosa and allied conditions; (13) acute nephritis; (14) acute glomerulonephritis; (15) diffuse diseases of connective tissue; (16) poisoning by cardiotonic glycosides and drugs of similar action; (17) toxic effect on noxious substances eaten as food - mushrooms; (18) toxic effect of other substances, chiefly nonmedicinal- organophosphate and carbamate.
Therapeutic apheresis is covered when: (1) A physician (or a number of physicians) expected to perform medical services and to respond to medical emergencies at all times during patient care hours; (2) Each patient is under the care of a physician; (3) All non-physician services are furnished under the direct personal supervision of a physician.
In order to be reimbursed on the basis of procedure code 36520, the physician must be physically present with the patient at some time during the course of the apheresis, and the medical record must document this. If the physician sees the patient on the day of the apheresis, but not during the apheresis treatment, the physician should bill an evaluation and management.
Effective, January 1993 – August 2001
Plasmapheresis/plasma exchange (CPT 36520) is covered for the conditions described in the ICD-9-CM code section of this policy and for: (1) Hemophilia with inhibitors; (2) Polyneuropathy, chronic relapsing, with severe or life-threatening symptoms, in patients who have not responded to more conventional therapy; (3) Rheumatoid vasculitis, with severe or life threatening symptoms, not responding to more conventional therapy.
Therapeutic apheresis is covered when: (1) A physician (or a number of physicians) expected to perform medical services and to respond to medical emergencies at all times during patient care hours; (2) Each patient is under the care of a physician; (3) All non-physician services are furnished under the direct personal supervision of a physician.
In order to be reimbursed on the basis of procedure code 36520, the physician must be physically present with the patient at some time during the course of the apheresis, and the medical record must document this. If the physician sees the patient on the day of the apheresis, but not during the apheresis treatment, the physician should bill an evaluation and management code.
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| Rationale: |
Investigational Indications
Chronic Autoimmune Diseases
Over the past 10 years, randomized trials of PE have been conducted and, in general, have shown a lack of effectiveness as treatment of chronic autoimmune diseases. For example, in 1983 Dwosh and colleagues reported on 26 patients with chronic rheumatoid arthritis randomized in a crossover design to either true or sham PE. The authors concluded that PP/PE did not have any clinical benefit despite impressive laboratory changes. Similarly, on the basis of another randomized controlled trial, Lewis and colleagues reported that PE had no benefit in patients with SLE and glomerulonephritis compared to standard therapy regimen of prednisone and cyclophosphamide. Finally, Miller and colleagues conducted a randomized trial of PE in the treatment of 39 patients with polymyositis and dermatomyositis and found that it was no more effective than sham pheresis. Guillaume and colleagues reported on a study of 40 patients with pemphigus randomized to receive either prednisone alone or prednisone plus plasmapheresis. The goal of the study was to determine whether plasmapheresis could reduce the required dose of steroids, thus limiting its toxicity. Unfortunately, disease control in the 2 groups was the same, and the authors concluded that plasmapheresis in conjunction with low-dose steroids is not effective in treating pemphigus.
Another potential type of evidence in support of the clinical effectiveness of PE is the identification of a pathogenic component of plasma that is reliably eliminated by plasmapheresis. Although many laboratory abnormalities are associated with autoimmune connective tissue diseases, it is unclear which, if any, are the cause of the clinical manifestations of the disease. Furthermore, it is not known to what extent plasma levels parallel clinical disease. For example, in the controlled trials cited above, PE reliably reduced circulating autoantibodies and immune complexes, but without demonstrable clinical benefit. It may be that the patient had already suffered irreversible damage, or that the pathogenesis of the disease was a local process unrelated to circulating factors.
Multiple Sclerosis (MS)
There have been several controlled, randomized trials of PE in patients with MS that have reported inconclusive results. Khatri studied 54 patients with chronic progressive MS randomized to receive sham or true PE. The degree of improvement in the PE group was greater than that in the control group. Weiner reported on a study that randomized patients with acute attacks of MS to receive either PE or sham treatments; there was no statistical difference in improvement between groups, although patients receiving PE did have a faster recovery rate from acute attacks. A Canadian trial randomized 168 patients with progressive MS to receive either PE or immunosuppressive therapy. There were no significant differences in the rates of treatment failures between groups.
Rapidly Progressive Glomerulonephritis (RPGN)
PE has long been considered a treatment alternative in immune-mediated RPGN. However, there have been few controlled clinical trials published, and their interpretation is difficult due to small number of patients, choice of intermediate outcomes (i.e., the reduction in antibody levels as opposed to more direct patient outcomes), and heterogeneity in patient groups. Aside from cases of Goodpasture’s disease, the rationale for PE in idiopathic RPGN is not as strong, due to the lack of an identifiable immune component. Studies of PE in this population have not demonstrated a significant improvement in outcome compared to the use of pulse steroid therapy.
Lambert-Eaton Myasthenic Syndrome (LEMS) and Other Paraneoplastic Syndromes
The presumed autoimmune nature of LEMS and other paraneoplastic syndromes led to the use of a variety of immunomodulatory therapies, including plasma exchange. However, there are minimal data in the published literature and no controlled trials. The largest case series focusing on LEMS was reported by Tim and colleagues and included 73 patients with LEMS, 31 of which were found to have lung cancer. Although detailed treatment strategies are not provided, 19 underwent plasmapheresis, with 27% reporting a moderate to marked response. However, the improvement after plasmapheresis, even when marked was only transient. Patients also received other therapies, for example, various chemotherapy regimens for the underlying lung cancer. In addition, 53 of the 73 patients received 3,4 diaminopyridine, with 79% reporting marked or moderate responses. A small randomized controlled trial of 3,4 diaminopyridine has also reported positive results, confirming other anecdotal reports. Anderson and colleagues reported on a case series of 12 patients with paraneoplastic cerebellar degeneration. Although plasmapheresis was associated with an acute drop in the autoantibody titer, only 2 patients showed a minor improvement in neurologic symptoms.
Stiff-Man Syndrome
The mainstay of treatment of stiff-man syndrome is diazepam. The published literature regarding plasmapheresis consists of small case series and anecdotal reports.
Asthma
There has been some research interest in the use of plasmapheresis in patients with severe, steroid dependent asthma. However, preliminary results do not suggest treatment effectiveness.
Medically Necessary Indications
Acute Fulminant CNS Demyelination
The policy statement, which suggests that plasmapheresis may be considered medically necessary in patients with acute fulminant CNS demyelination, is based on the results of a randomized, double-blinded trial, in which 22 patients with multiple sclerosis or other acute idiopathic inflammatory demyelinating disease of the CNS were enrolled a minimum of 14 days after having failed to respond to at least 5 days of high-dose corticosteroids. Patients were randomized to receive either 7 real or sham PE procedures over a 14-day period. The primary outcome was a targeted neurologic deficit (i.e., aphasia, cognitive dysfunction, etc.). Overall, moderate to marked improvement of the targeted outcome was obtained in 42% of the treatment group, compared to only 6% in the placebo group.
Paraproteinemic Polyneuropathies
A randomized, double-blinded trial compared PE to sham treatment in 39 patients with MGUS associated polyneuropathy. After twice weekly Pes for 3 weeks, the treatment group reported improvements in neurologic function in the IgG and IgA groups, but not the IgM MGUS groups. In addition, those from the sham group who were later crossed over to the PE group also reported improvement.
Additional Information
In 1996, the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology published an assessment of plasmapheresis. Indications were categorized as established, investigational, or possibly useful. The quality of the data was graded as Class I (randomized controlled trials), Class II (well-designed clinical studies) or Class III (evidence provided by expert opinion, nonrandomized historical controls, or case reports of 1 or more). In addition, in 2000, the American Society for Apheresis conducted a literature review on a variety of indications for plasmapheresis and offered recommendations based on the class system, as described above.
Two articles on plasmapheresis (PP) combined with IVIG have been published from good institutions (Johns Hopkins and Mayo Clinic). The Mayo Clinic article compared 1) high dose IVIG; 2) PP with low dose IVIG and anti-CD-20 antibody (rituximab); and 3) PP, low dose IVIG, and Thymoglobulin. This was not a randomized controlled trial, but a comparison of 3 different treatments done at different times on uncontrolled patients. They concluded that none of the 3 treatments prevented all rejections, but all of the treatments appeared to prevent some rejections.
2010 Update
A search of the MEDLINE database was performed for the period April 2006 through April 2009. The search identified; 3 systematic reviews, 2 professional society guidelines, and 3 randomized controlled trials.
In 2007, the American Society for Apheresis (ASFA) released The New Approach to Assignment of ASFA Categories- Introductions to the Fourth Special Issue: Clinical Applications of Therapeutic Apheresis (Shaz, 2007). The following is a detailed description of the ASFA categories.
The following indications received ASFA Category I recommendations: cryoglobulinemia, hyperviscosity in monoclonal gammopathies, thrombotic thrombocytopenic purpura (TTP), Acute inflammatory demyeliniating polyneuropathy (Guillain-Barre Syndrome), Myasthenia Gravis, IgGg/IgA, severe PANDAS and severe Syndenham’s chorea and Goodpasture’s syndrome.
Guillain-Barre Syndrome
In 2002, The Cochrane Collaboration published, Plasma exchange for Guillain-Barré syndrome (Raphaël, 2002), a systematic review of the evidence concerning the efficacy of plasma exchange for treating Guillain-Barré syndrome. Six eligible trials were identified, comparing plasma exchange versus supportive treatment alone. Primary outcome measures included time to recover walking with aid and time to onset of motor recovery in mildly affected patients. Secondary outcome measures included improvement in disability grade at 4 weeks. A subgroup analysis showed plasma exchange was beneficial in patients with mild, moderate, and severe (needing ventilation) Guillain-Barré syndrome. The authors concluded that plasma exchange has been proven to be superior to supportive treatment alone in Guillain-Barré syndrome. Consequently, plasma exchange should be regarded as the treatment against which new treatments, such as intravenous immunoglobulin, should be judged. This review noted that the value of plasma exchange in children younger than 12 years old is not known.
A systematic review conducted in the United Kingdom (UK) (Hughes, 2007) evaluated the available randomized trials of immunotherapy to treat Guillain-Barré syndrome. In 4 trials with severely affected adult participants (n=585), those treated with PE improved significantly more on the disability scale 4 weeks after randomization than those who did not. In 5 trials (n=582), the improvement on the disability grade scale with intravenous immunoglobulin (IVIg) was very similar to that with PE. There was also no significant difference between IVIg and PE for any of the other outcome measures. There was 1 trial that included patients (n=91) with the mild form of Guillain-Barré syndrome who were able to walk unaided at enrollment. Patients were randomized to receive either two sessions of PE in 3 days or supportive care. The number of patients with one or more grades of improvement at 1 month was significantly greater, 26/45 in the treated compared to the control group, 13/45. Fewer patients in the PE-treated group had clinical deterioration (4%) as compared to the control group (39%) or required ventilation; PE group (2% ) versus the control group (13%). In 1 trial (n=148), following PE with IVIg did not produce significant extra benefit. Limited evidence from 3 open trials in children suggested that IVIg hastens recovery compared with supportive care alone. None of the treatments significantly reduced mortality. The authors concluded that “since approximately 20% of patients die or have persistent disability despite immunotherapy, more research is needed to identify better treatment regimens and new therapeutic strategies.”
In 2003, a report of the Quality Standards Subcommittee of the American Academy of Neurology (AAN), Practice parameter: Immunotherapy for Guillain-Barré syndrome, was published (Hughes, 2003). The following are the key findings: 1) treatment with PE or IVIg hastens recovery from Guillain-Barré syndrome; 2) combining the two treatments is not beneficial, and 3) steroid treatment given alone is not beneficial. The AAN’s recommendations are: 1) PE is recommended for nonambulatant adult patients with Guillain-Barré syndrome who seek treatment within 4 weeks of the onset of neuropathic symptoms (PE should also be considered for ambulant patients examined within 2 weeks of the onset of neuropathic symptoms); 2) IVIg is recommended for nonambulant adult patients with Guillain-Barré syndrome within 2 or possibly 4 weeks of the onset of neuropathic symptoms (the effects of PE and IVIg are equivalent); 3) corticosteroids are not recommended for the management of Guillain-Barré syndrome; 4) sequential treatment with PE followed by IVIg, or immunoabsorption followed by IVIg is not recommended for patients with Guillain-Barré syndrome; and 5) PE and IVIg are treatment options for children with severe Guillain-Barré syndrome.
There is a lack of adequate randomized controlled trials of treatment in children to define a clear role of PE in all forms of PE in children. However, PE could be considered a treatment option for children younger than 10 years old with severe Guillain-Barré syndrome based on extrapolation of the available evidence in adults.
Cryoglobulinemia
The Tedeschi et al (Tedeschi, 2007) review of cryoglobulinemia states that for most patients with cryoglobulinemia, the treatment is directed at the underlying disease including Type I (associated with malignancies) as well as with mixed cryoglobulinemia (MC) including that associated with hepatitis C. However, for patients who present with severe, multisystem involvement from MC including; nephropathy, skin ulcers, sensory motor neuropathy, and widespread vasculitis, plasma exchange is used to rapidly reduce the levels of circulating immune complexes and toxic substances. However, PE is not used as monotherapy, as rebound can occur after cessation. Immunusuppressive therapy is considered the first-line intervention.
TTP and HUS
In 2009, a Cochrane systematic review, Interventions for haemolytic uraemic syndrome (HUS) and thrombotic thrombocytopenic purpura (TTP) evaluated the benefits and harms of different interventions for HUS and TTP (separately) (Michael, 2009). Interventions compared with placebo or supportive therapy or a comparison of two or more interventions. Interventions examined included heparin, aspirin/dipyridamole, prostanoids, ticlopidine, vincristine, fresh frozen plasma (FFP) infusion, plasmapheresis with FFP, systemic corticosteroids, Shiga toxin binding agents or immunosuppressive agents. For TTP, 6 RCTs (n= 331 participants) were identified evaluating PE with FFP as the control. Interventions tested included antiplatelet therapy (APT) plus PE with FFP, FFP transfusion and PE with cryosupernatant plasma (CSP). Two studies compared plasma infusion (PI) to PE with FFP and showed a significant increase in failure of remission at 2 weeks and all-cause mortality in the PI group. The authors concluded that PE with FFP is the most effective treatment available for TTP. Seven RCTs included children with HUS. None of the assessed interventions was superior to supportive therapy alone for all-cause mortality, neurological/extrarenal events, renal biopsy changes, proteinuria or hypertension at the last follow-up visit. Bleeding was significantly higher in those receiving anticoagulation therapy compared to supportive therapy alone. For patients with HUS, supportive therapy including dialysis was the most effective treatment. All studies in HUS have been conducted in the diarrheal form of the disease. There were no RCTs evaluating the effectiveness of any interventions on patients with atypical HUS who have a more chronic and relapsing course. A recent review article by Noris describes the data supporting use of PE in the atypical form of this disease, with results showing remission in up to 60% of patients (Noris, 2009).
PANDAS and Chorea
Perlmutter et al.conducted a randomized controlled trial to evaluate the effectiveness of plasma exchange and IVIg in reducing the severity of neuropsychiatric symptoms in children diagnosed in the PANDAS subgroup (Perlmutter, 1999). Children (n= 30) with clear evidence of a strep infection as the trigger of their obsessive compulsive disorder and tics were randomized to receive PE (n= 10; five to six procedures over 2 weeks), IVIg (n= 9; 2gm/kg over 2 days) or placebo (n= 10; mimic IVIg). All were severely ill at the time of treatment. At 1 month, both active treatment groups demonstrated symptom improvement, but those in the placebo group were unchanged. The treatment effect was still apparent after 1 year. However, 50% of the children were on the same or higher doses of their baseline medications, thus it is not entirely clear that IVIg or PE had a beneficial effect. This study needs to be replicated with a larger number of patients. Authors noted that children in the placebo group (IVIg control group) subsequently received PE in an open trial and had only minor improvements.
Garvey et al. conducted a randomized controlled trial designed to determine if IVIg or PE would be superior to prednisone in decreasing the severity of chorea (Garvey, 2005). Children with Syndenham’s chorea (n=18) were randomized to treatment with PE (n= 8; five to six procedures over 1 to 2 weeks), IVIg (n= 4; 2gm/kg over 2 days), or prednisone (n= 6; 1mg/kg/day for 10 days followed by taper over next 10 days). The primary outcome was chorea severity at 1 month. The secondary outcome variable was chorea severity at 1 year following treatment. There was no significant difference between the baseline chorea severity scores by the treatment group. Chorea severity was assessed at baseline and at 1, 2, 3, 6, and 12 months following treatment. The chorea rating scale scores range from 0 (no chorea) to 18 (severe or paralytic chorea). A score of 9 or higher was required for study entry. Baseline medications to control choreatic symptoms were discontinued 1 week prior to baseline assessment and each follow-up evaluation. Mean chorea severity for the entire group was lower at the 1-month follow-up evaluation (overall 48% improvement). The between-group differences were not statistically significant. Larger studies are needed to confirm these clinical observations.
Summary
In conclusion, the available evidence is sufficient regarding PE for the treatment of patients with all severity grades of Guillain-Barré syndrome. This therapy has a beneficial impact on net health outcome for all severity grades. The policy statement has been modified to include Guillain-Barré syndrome severity grades 1–2 as medically necessary. The published studies are insufficient regarding PE for treatment of GBS in the pediatric population. However, based on extrapolated evidence in adults and clinical input, PE may be considered as a treatment option for children younger than 10 years old with severe GBS.
The available evidence is sufficient regarding PE for the treatment of patients with severe manifestations of mixed cryoglobulinemia (MC); cryoglobulinemic nephropathy, skin ulcers, sensory motor neuropathy, and widespread vasculitis when used in combination with immunosuppressive treatment. This therapy has a beneficial impact on net health outcomes. The policy statement has been modified to include coverage for severe manifestations of mixed MC when used in combination with immunosuppressive therapy.
The available literature regarding plasma exchange for the treatment of PANDAS and Sydenaham’s chorea (SC) are inadequate to draw clinical conclusions or to evaluate the impact on net health outcome.
The evidence regarding plasma exchange as a therapy for Refsum’s disease, cryoglobulinemia (except for severe MC) and myasthenia gravis with anti-MuSk antibodies is limited to case reports. This therapy is investigational for Refsum’s disease, cryoglobulinemia with the exception of severe MC and myasthenia gravis with anti-MuSk antibodies given the insufficient evidence to evaluate the impact on net health outcome.
2012 Update
A literature was conducted through May 2012. A summary of the relevant articles identified in the search are included.
A 2011 RCT from Iran addresses PE for treating young children with severe GBS (El-Bayoumi, 2011). The study included 41 children with GBS who required mechanical ventilation and had muscle weakness for no more than 14 days. Patients were randomized to receive PE (n=21) or intravenous immunoglobulin (IVIg) (n=20). Mean age of the patients was 96 months in the PE group and 106 months in the IVIg group. Duration of ventilation, the primary outcome, was a mean of 11 days (standard deviation [SD]=1.5) in the PE group and 13 days (SD=2.1) in the IVIg group, p=0.037. Duration of stay in the intensive care unit, a secondary outcome, was 15.0 days (SD=2.6 days) in the PE group and 16.5 days (SD=2.1 days) in the IVIg group; p=0.94.
A 2011 RCT from Germany randomized patients with myasthenic crisis to treatment with PE (n=10) or immunoadsorption (IA) (n=9) (Kohler, 2011). In both groups, 3 apheresis treatments were performed within 7 days; patients could have additional treatments if needed. A total of 16/19 (84%) of patients, 8 in each group, completed the study and were included in the efficacy analysis. The mean number of treatments was 3.5 in the PE group and 3.4 in the IA group (p>0.05). The primary outcome was change in the modified clinical score (maximum of 3 points) on day 14 after the last treatment. The baseline modified clinical score was 2.6 in the PE group and 2.5 in the IA group. At day 14, score improvement was 1.6 points in the PE group and 1.4 points in the IA group; p>0.05. Within the 180 days after treatment, 1 patient in the PE group and 3 patients in the IA group experienced another myasthenic crisis; the number of events was too small for meaningful statistical analysis for this outcome. There were no statistically significant differences in outcomes in this study, but the sample was very small and the study was probably underpowered.
In 2011, Walsh and colleagues published a meta-analysis of studies on plasma exchange in adults with the diagnosis of either idiopathic renal vasculitis or rapidly progressive glomerulonephritis (Walsh, 2011). A total of 9 trials including 387 patients were identified. The clinical populations in the studies were somewhat ill-defined, but most patients appeared to have ANCA-associated vasculitis. In a pooled analysis of study findings, there was a significantly lower risk of end-stage renal disease in patients treated with adjunctive PE compared to standard care alone (RR 0.64, 95% confidence interval [CI]: 0.47 to 0.88). The risk of death did not differ significantly in the 2 groups (RR:1.01, 95% CI: 0.71-1.40).
In 2011, the American Academy of Neurology (Therapeutics and Technology Assessment Subcommittee) issued an evidence-based guideline on plasmapheresis in the treatment of neurological disorders (Cortese, 2011).
The primary conclusions based on their evidence review are as follows:
Established effective
Acute inflammatory demyelinating polyneuropathy/ Guillain-Barre syndrome
Chronic inflammatory demyelinating polyneuropathy, short-term treatment
Probably effective
Relapses in multiple sclerosis
Possibly effective
Fulminant demyelinating CNS disease
Established ineffective
Chronic or secondary progressive multiple sclerosis
Insufficient evidence
Myasthenia gravis
Sydenham’s chorea
Acute obsessive-compulsive disorder and tics in PANDAS
The policy has been changed to include coverage, based on expert opinion, for plasma exchange for dense deposit disease with Factor H deficiency and/or elevated C3 nephritis factor, catastrophic antiphospholipid syndrome, focal segmental glomerulosclerosis after renal transplant, and myeloma with acute renal failure.
2013 Update
A literature search was conducted using the MEDLINE database through May 2013. There was no new information identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
Guillain-Barré Syndrome (GBS)
In 2012, The Cochrane Collaboration published an updated systematic review of the evidence concerning the efficacy of PE for treating GBS (Raphael, 2012). Six eligible trials (n=649) were identified comparing PE versus supportive treatment alone. No additional trials were published since the 2002 review. The primary outcome measures of the review included time to recover walking with aid and time to onset of motor recovery in mildly affected patients. A pooled analysis of data from 3 trials found that PE significantly increased the proportion of patients who recovered the ability to walk with assistance after 4 weeks (RR: 1.60, 95% confidence interval [CI]: 1.19 to 2.15). Data on time to onset of motor recovery were not pooled. Pooled analyses found that PE led to significant improvement in secondary outcomes including reduced time to recover walking without aid, increased likelihood of full muscle strength recovery and reduced likelihood of severe motor sequelae. However, there was a significantly higher risk of relapse in the group that received PE compared to supportive treatment alone (RR: 2.89, 95% CI: 1.05 to 7.93, 6 trials).
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
A 2012 Cochrane review by Mehnidiratta and Hughes identified 2 randomized trials on PE for CIDP (Mehndiratta, 2012). Both trials were considered to be of high quality but both had small sample sizes. One trial with 29 patients used a parallel design and compared PE to sham treatment. The other study included 15 patients and used a cross-over design to compare PE and sham treatment. A pooled analysis of data from the 2 trials found a statistically significantly greater improvement in impairment after 4 weeks with PE versus sham (mean difference 31 points on the Neuropathy Impairment Score, 95% CI: 16 to 45 points). The scale ranges from 0 (normal) to 280 (maximally affected). Data on other outcomes were not suitable for pooled analysis.
In 2010, the American Society for Apheresis (ASFA) released updated guidelines on the use of therapeutic apheresis (Szczepiorkowski, 2010). The guidelines modified and simplified the categories introduced in 2007; for example, the following is a detailed description of the ASFA categories.
Category I includes diseases for which TA is accepted as first-line treatment, either as the sole treatment or in conjunction with other treatments. Note that this designation need not imply that TA is mandatory in all cases.
Category II denotes diseases for which TA is accepted as second-line treatment, either as the sole treatment or in conjunction with other treatments.
Category III diseases are those for which the optimum role of TE is not established and treatment decisions on an individual basis are recommended.
Category IV indicates disorders for which published evidence suggests or demonstrates that TE is ineffective or harmful.
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Myasthenia Gravis
A 2011 trial by Barth and colleagues in Canada randomized patients with myasthenia gravis to treatment with PE (n=43) or IVIg (n=41) (Barth, 2011). Patients had moderate to severe myasthenia gravis, as defined by a score of at least 10.5 on the Quantitative Myasthenia Gravis Score for disease severity (QMGS), and worsening weakness requiring a change in treatment. Patients were not experiencing myasthenic crisis. At day 14, there was not a statistically significant difference between groups in the change on the QMGS score, the primary efficacy outcome. Mean QMGS scores at day 14 were 4.7 in the
PE group and 3.2 in the IVIg group, p=0.13. Moreover, at day 14, 69% were considered improved on PE versus 65% in IVIg; the difference between groups was not statistically significant, p=0.74. Safety outcomes were published in 2013 (Ebadi, 2013). Forty-two patients received a total of 203 PE procedures; 40 completed the full-course of 5 procedures. Complications occurred in 19 of 42 patients (45%). Two of the complications were serious. One patient had hypertension, congestive heart failure and pneumonia; all of these were unrelated to the procedures. The other patient had a myocardial infarction which could have been exacerbated by PE.
The results from the few trials evaluating treatment of myasthenia gravis suggest that PE is reasonably safe in patients with moderate to severe myasthenia crisis. There is some evidence on the comparative efficacy of PE versus IVIg, but the trials are small and report mixed results, and therefore definitive conclusions cannot be made.
Renal
Long-term outcomes of patients from the Jayne and colleagues trial were published in 2013 (Jayne, 2013). Median follow-up was 3.95 years. A total of 70 of 136 patients had died, 35 (51%) in the PE group and 35 (51%) in the IV methylprednisolone group; the difference between groups was not statistically significant, p=0.75. Similarly, there was not a statistically significant difference between groups in the proportion of patients with end-stage renal disease (33% in the PE group versus 49% in the IV methylprednisolone group, p=0.08). According to findings of this trial, PE appears to have a short-term benefit on preserving renal function in this population, but long-term efficacy remains uncertain.
The 2014 National Comprehensive Cancer Network (NCCN) guideline on multiple myeloma stated that plasmapheresis is an adjunctive treatment for patients being treated for multiple myeloma who cannot be treated with stem cell transplant. Primary treatments include chemotherapy, targeted therapy, and steroids given alone or in combination (NCCN, 2014).
Neuromyelitis Optica
Neuromyelitis optica (NMO) is a rare inflammatory disorder of the central nervous system that predominantly affects the optic nerves and spinal cord. No RCTs evaluating PE for treatment of patients with NMO were identified. Several retrospective nonrandomized studies have evaluated PE as add-on therapy to intravenous (IV) corticosteroids.
In 2015, Abboud and colleagues reviewed 83 admissions for acute relapse of NMO at a single center in the United States (Abboud, 2015). Relapses could involve the spinal cord, the optic nerve, and/or the brain. Patients were initially treated with IV corticosteroids alone for 5 days, and if they did not respond, they were then treated with 5-7 sessions of PE in their second week of hospitalization. Eighteen relapses (16 patients) were treated with IV corticosteroid therapy alone, and 65 relapses (43 patients) were treated with IV corticosteroid plus PE. Patients were assessed using the Expanded Disability Status Score (EDSS) which has a possible range of 1 to 10, with higher numbers indicating more disability. The primary end point was a return to baseline EDSS (before admission) on discharge. The EDSS scores at baseline and discharge were calculated retrospectively based on available records and without blinding to treatment group.
In the relapses treated with IV corticosteroids only, the median baseline EDSS was 2.5, which increased to 4.5 at presentation and decreased to a median of 4 at discharge. In comparison, among the relapses that were also treated with PE, the median baseline EDSS was 5.75 which increased to 7.75 at presentation and decreased to a median of 6.5 at discharge. At discharge, 3 relapses (17%) in the IV corticosteroid-only group improved to baseline EDSS or lower at discharge compared with 31 relapses in the IV corticosteroid plus PE group (p=0.016). Follow-up data at approximately 1 year (range, 6-18 months) were available on 50 of 65 relapses (77%). At this longer term follow-up point, 6 relapses in the IVMP only group and 33 in the IVMP group improved to an EDSS equal or below their baseline EDSS
(p=0.039).
The study did not directly compare the efficacy of IV corticosteroid treatment alone with IV corticosteroids plus PE since the treatments were applied sequentially. Moreover, the patient populations differed; patients who received PE add-on treatment were older and more disabled at baseline. The finding that a greater proportion of the more severely ill population had resolution of acute relapses suggests that combination IV corticosteroid and PE therapy may be more beneficial than IV corticosteroids alone. However, to draw definitive conclusions, findings would need to be confirmed in randomized trials. Another study limitation was a lack of patient-level analyses and lack of other outcome measures at 1 year measuring disease progression.
Two other studies were conducted at a facility in Martinique and they compared outcomes in patients treated before and after PE was introduced as a treatment. A 2009 study by Bonnan and colleagues focused on spinal attacks associated with NMO (Bonnan, 2009). The study reported on 43 patients with NMO, 18 of who received PE as add-on therapy for at least 1 spinal attack. The study period was 1982 to 2008 and PE was introduced at the facility in 1999. The patients experienced a total of 96 spinal attacks; PE was used in 29 attacks. The PE-treated and corticosteroid-only groups had similar EDSS scores prior to the spinal attacks, and there was greater reduction in EDSSs following treatment with PE. In the PE group, the mean acute EDSS (SD) was 7.9 (1.3) and the mean EDSS after therapy was 5.1 (2.4), a mean decrease of 2.8 points. In comparison, the mean acute EDSS in the corticosteroid-only group was 8.0 (1.4) and the mean EDSS after treatment was 6.8 (1.9), a mean decrease of 1.2 points. The analysis was done on a per attack basis rather than a per-patient basis.
The 2012 study by Merle and colleagues evaluated the impact of PE as an add-on therapy on optic outcomes in 32 patients treated for acute optic neuritis between 1996 and 2010 (Merle, 2012). In 2006, PE was added to the treatment protocol and 16 of the 32 patients also received 5 daily consecutive PEs in the intensive care unit. Study outcomes were obtained from an eye examination performed at least 6 months after optic neuritis treatment. At the final follow-up visit, visual acuity was significantly better in the PE group than the corticosteroid-only group (20/400 vs 20/50, respectively, p=0.04). Visual acuity gain was 20/200 in the corticosteroid group and 20/30 in the PE group (p=0.01). Outcomes could be impacted by confounding factors. For example, longer disease duration was associated with poorer outcomes in univariate analysis and, at baseline, disease duration was significantly longer in the corticosteroid group than the PE group (mean, 10.8 and 5.8 years, respectively, p<0.001).
Limitations of the Bonnan and Merle and studies include that patients may have overlapped between studies and lack of randomization may have led to baseline between-group differences in factors that affected outcomes. In addition, both studies are subject to bias due to use of historical controls, ie, patients in the latter time period received PE and care could also have improved over time in other ways that led to improved outcomes.
The U.S. National Institute of Neurological Disorders and Stroke (NINDS) has an informational webpage on neuromyelitis optica which states that several treatments are available off-label to reduce symptoms and prevent relapses (NINDS, 2015). These include mycophenolate mofetil, rituximab, and azathioprine. The informational page also states that individuals with frequent relapses have used low-dose steroids for longer periods. Plasma exchange is mentioned as a potential alternative treatment in patients who are unresponsive to corticosteroid treatment, but is not specifically recommended. The NINDS website does not cite any evidence in support of any of the treatments for neuromyelitis optica.
In summary, the available nonrandomized retrospective studies have methodological limitations and findings need to be confirmed in well-designed and conducted randomized trials.
Sepsis
In 2014, Rimmer and colleagues published a systematic review and meta-analysis of literature on PE for treatment of sepsis and septic shock (Rimmer, 2014). The authors identified 4 RCTs comparing PE with usual care; the trials included a total of 194 patients. All of the trials were rated as unclear or high risk of bias. In a pooled analysis of data from the 4 trials, PE was not significantly associated with a reduction in mortality risk (RR=0.83; 95% CI, 0.45 to 1.52). Data were insufficient for pooled analyses of other outcomes. The evidence identified in this systematic review is insufficient for drawing conclusions about the impact of PE for treating sepsis on the net health outcome.
In the 2014 National Comprehensive Cancer Network guideline on multiple myeloma, the use of plasmapheresis to improve renal function is a category 2B recommendation. Plasmapheresis should also be used as adjunctive therapy for hyperviscosity (NCCN, 2015).
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2018. No new literature was identified that would prompt a change in the coverage statement.
2019 Update
A literature search was conducted through December 2018. There was no new information identified that would prompt a change in the coverage statement.
2020 Update
A literature search was conducted through December 2019. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2020. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2021. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2022. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2023. No new literature was identified that would prompt a change in the coverage statement.
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
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