Medical Policy: 02.01.32
Original Effective Date: August 2007
Reviewed: January 2018
Revised: January 2018
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
The use of platelet-rich plasma (PRP), an autologous growth factor has been proposed as a treatment for various musculoskeletal conditions and as an adjunctive procedure in orthopedic surgeries. The potential benefit of PRP has received considerable interest due to the appeal of a simple, safe, low cost, and minimally invasive method of applying growth factors.
Autologous platelet-derived growth factors (APDGF) also referred to as platelet-rich plasma (PRP), have been proposed for the treatment of multiple orthopedic indications including but not limited to the following: degenerative cartilage lesions; tendonitis; joint capsular injuries; plantar fasciitis; soft tissue trauma (e.g. tendon and ligament ruptures); fractures; osteoarthritis of the knee, hip and shoulder; and muscle injuries and disorders to enhance healing.
Autologous platelets are a rich source of platelet-derived growth factor that function as a transforming growth factor as a mitogen (agent) for fibroblasts, smooth muscle cells, osteoblasts, and vascular endothelial growth factors. Autologous platelet concentrate suspended in plasma, platelet-rich plasma (PRP), can be prepared from samples of centrifuged autologous blood. Exposure to a solution of thrombin and calcium chloride degranulates platelets, releasing the various growth factors. Each growth factor released has a specific role in the cellular process that promotes healing and tissue growth.
Platelet-rich plasma (PRP), is extracted from a small quantity of blood collected from the patient using a standard peripheral vein puncture procedure followed by simple centrifuge to remove most of the larger cells (white and red blood cells) and the majority of the fluid, and concentrate the platelets in a small volume of plasma (the liquid component of the blood) that is platelet-rich. The concentration of platelets and, thereby, the concentration of growth factors can be 5 to 10 times greater or richer than usual.
Although it is not exactly clear how PRP works, many experts have speculated that chronic, painful, degenerative conditions of the connective tissues, such as tendinopathies and osteoarthritis, are the result of failed or inadequate healing responses to repeated subacute injuries. Because connective tissues often have limited blood circulation, they have only a limited innate ability to repair the damages of daily wear and tear. Thus, if such damage regularly exceeds the daily repair capacity, the damage will slowly accumulate until the tissue function becomes impaired. Because the tissues do not suffer an acute insult, the acute healing pathways are not triggered to assist in healing the accumulated damage. Therefore, practitioners speculate that if the acute healing pathways can be activated, the body can be induced to repair the damage. Injection of PRP into the injury site is thought to stimulate an acute injury and may induce an acute healing process.
Platelet-rich plasma (PRP) may also be used during certain types of surgery for some injuries including Achilles tendon rupture, rotator cuff repair, anterior cruciate ligament (ACL) reconstruction, articular cartilage repair, long bone healing and nonunion repair. Non orthopedic indications include wound care, plastic surgery, trauma surgery and general surgery. This is done by preparing the PRP in a special way, the polymerization of fibrin from fibrinogen creates a platelet gel (platelet rich fibrin matrix), which can then be used as an adjunct to surgery with the intent of promoting hemostasis and accelerating healing. Based on review of the literature several systematic reviews reported that the available evidence was poor or limited in the number of studies. Better quality randomized controlled trials are needed to determine the actual benefit of PRP for these surgical applications in which it has been used. Based on study results thus far little or no benefit has been seen when PRP is used in these types of surgical procedures.
Based on review of the peer reviewed medical literature regarding platelet-rich plasma, an autologous platelet-derived growth factor (APDGF), there have been a number of studies looking at whether platelet-rich plasma is effective for conditions affecting bones, muscles, ligaments and other tissues. The potential benefit of PRP has received considerable interest due to the appeal of a simple, safe, low-cost and minimally invasive method of applying growth factors. However, current results of PRP trials are mixed and studies are limited in both size and quality. A systemic review found that a greater portion of the studies reported no benefit from PRP than studies that reported a benefit. It is unknown if the mixed results are due to variability in the conditions studied and outcomes measured, to differences in platelet separation technique, concentration or activation, or to differences in the timing and frequency of administration. Additional studies are needed to resolve these issues. The evidence is insufficient to determine the effects of the technology on net health outcomes.
Osteoarthritis is a common degenerative disease characterized by chronic pain, joint stiffness, reduced function, cartilage degradation, loss of subchondral bone and synovial inflammation. Although symptoms may be alleviated with conservative therapies such as analgesic drugs, lifestyle modifications, and physical therapy, no disease modifying treatment is currently available. New approaches may allow for earlier intervention than joint replacement, autologous protein solution (APS) is a new therapy under investigation for the treatment of osteoarthritis of the knee.
One mechanism of osteoarthritis progression is a degenerative feed-forward cycle caused by pathological increases in inflammatory cytokines and catabolic factors within and adjacent to the synovial space. Inflammatory and catabolic proteins such as interleukin-1 beta, tumor necrosis factor, and matrix metalloproteinase, have been implicated in cartilage degradation and continued osteoarthritis progression. It has been proposed that approaches to block these deleterious proteins could improve patients’ symptoms and perhaps the progression of the disease may be halted or even reversed.
Autologous protein solution (APS) is an autologous blood derived therapy composed of concentrated white blood cells (WBCs), platelets and plasma to contain high concentrations of anti-inflammatory cytokines and anabolic growth factors. White blood cells are the main source of interleukin-1 receptor antagonist in the body which competitively inhibits inflammatory interleukin-1B signaling. Platelets alpha granules contain anabolic growth factors which are important in cartilage repair pathways and synergistically act with anti-inflammatory cytokines on the nuclear factor kappa-light chain enhancer of activated B-cells pathway. Plasma contains anti-inflammatory cytokines including soluble interleukin-1 receptor antagonist-type II and soluble tumor necrosis factor receptor type 1 and type II. The ability of APS to block both interleukin-1B and tumor necrosis factor signaling pathways suggest it may have utility in the treatment of osteoarthritis by blocking the effects of inflammation in chondrocytes, macrophages and cartilage explants.
A small amount of blood is drawn from the patient, autologous protein solution (APS) kits have been developed to process the autologous blood to produce the high concentrations of anti-inflammatory cytokines (proteins) and anabolic growth factors. The APS kit aids separation and concentration of the patient’s blood components through the use of centrifuge. The kit permits autologous protein solution to be prepared at the point of care. The kit includes blood processing devices, a cell separator, cell concentrator and a vial of anticoagulant citrate dextrose solution. The use of prepared APS should be used within 4 hours after drawing blood from the patient. The safety and effectiveness of frozen stored APS has not been established. Prior to injecting APS intra-articularly, the physician may remove any synovial fluid or effusion before the injection. APS should be injected into a single anatomical location not partition into multiple injections or injecting at multiple locations. This is given to inhibit inflammation and reduce cartilage degradation.
Based on review of the peer reviewed medical literature, the literature is limited regarding autologous protein solution (APS) for the treatment of osteoarthritis. Current studies may show promise that symptoms were improved, however, based on study results authors have concluded that well controlled, randomized multicenter clinical studies to establish safety and clinical effectiveness is warranted. The evidence is insufficient to determine the effects on net health outcomes.
In 2014, NICE issued guidance on the use of platelet rich plasma injections for osteoarthritis of the knee. NICE concluded that the current evidence on platelet-rich plasma injections for osteoarthritis of the knee raises no major safety concerns; however, the evidence on efficacy is inadequate in quality. NICE recommends this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
Further research into platelet-rich plasma injections for treating osteoarthritis of the knee should clearly describe patient selection and should take the form of well-designed, controlled studies that compare the procedure against other methods of management. Outcomes should include measures of knee function, patient reported outcome measures and the timing of subsequent interventions. Studies aimed at assessing possible cartilage repair after platelet-rich plasma injections should include detailed radiographic or MRI imaging before and after the procedure.
In 2013, the American Academy of Orthopaedic Surgeons (AAOS) issued guidance on the treatment of osteoarthritis of the knee, evidence based guideline 2nd edition, which states “were unable to recommend for or against growth factor injections and/or platelet rich plasma for patients with symptomatic osteoarthritis of the knee.” Recommendation: Inconclusive (there is a lack of compelling evidence that has resulted in an unclear balance between benefits and potential harm).
Blood products such as platelet rich plasma (PRP) are regulated by the Center for Biologics Evaluation and Research (CBER). CBER is responsible for regulating human cells, tissues, and cellular and tissue based products. The regulation process for these products is described in the U.S. Food and Drug Administration (FDA) 21 CFR 1271 of the Code of Federal Regulations. Under these regulations, certain products including blood products such as PRP are exempt and therefore do not follow the traditional FDA regulatory pathway. To date, FDA has not attempted to regulate activated PRP.
Not applicable
The use of platelet - rich plasma (PRP) is considered investigational for all orthopedic indications including but not limited to the following:
Based on review of the peer reviewed medical literature regarding platelet-rich plasma, an autologous platelet-derived growth factors (APDGF), there have been a number of studies looking at whether platelet-rich plasma is effective for conditions affecting bones, muscles, ligaments and other tissues. The treatment consists of numerous small controlled trials for a wide variety of conditions. Overall, limitations of the studies include small patient populations, and lack of a control group and/or comparison to standard therapy. Current results of PRP trials are mixed, with some trials reporting improvement with PRP and other trials reporting no improvement. It is unknown if the mixed results are due to variability in the conditions studied and outcomes measured, to differences in platelet separation technique, concentration or activation, or to differences in the timing and frequency of administration. Additional studies are needed to resolve these issues. There is inadequate evidence in the peer reviewed medical literature to support clinical effectiveness and therefore is considered investigational.
The use of autologous protein solution (APS) is considered investigational for all orthopedic indications, including but not limited to the treatment of osteoarthritis.
Based on review of the peer reviewed medical literature, the literature is limited regarding autologous protein solution (APS) for the treatment of osteoarthritis. Current studies may show promise that symptoms were improved, however, based on study results authors have concluded that well controlled, randomized multicenter clinical studies to establish safety and clinical effectiveness is warranted. The evidence is insufficient to determine the effects on net health outcomes.
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