Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Elbow Pain.
Treatment: Injection Of Platelet Rich Plasma (PRP).

The insurer denied the Injection Of Platelet Rich Plasma (PRP). The denial is upheld.

The patient is a female. Radiographs of the patient's right elbow obtained demonstrated no effusion.  There was no osseous or articular abnormality.  Alignment was preserved.  There was no significant soft tissue abnormality.

A telemedicine note stated that the patient was presenting for re-evaluation of right elbow pain.  The patient was previously diagnosed with a right tennis elbow and had been treated conservatively with orthosis, activity modifications, anti-inflammatories, and a cortisone injection.  Cortisone injection administered provided only transient improvement.  The patient was diagnosed with lateral epicondylitis with failure of conservative therapy. The plan was for a platelet-rich plasma injection versus arthroscopic debridement.

No, the health plan should not cover the treatment with Platelet-Rich Plasma.

No, the treatment with Platelet-Rich Plasma is not likely to be more beneficial than any standard treatment or treatments for the insured's condition or disease.

Platelet rich plasma does not have strong research-based evidence to permit conclusions and/or clearly define long-term effects and impact on health outcomes.

The popularity of PRP (platelet-rich plasma) has increased in the medical community, and it has received increased media attention in recent years, particularly because professional athletes have undergone this procedure. There is a need for further basic-science investigation, as well as randomized, controlled trials to identify the benefits, side effects, and adverse effects that may be associated with the use of PRP for muscular and tendinous injuries.

Platelet-rich plasma is defined as autologous blood with a concentration of platelets above baseline values. Platelet-rich plasma has been used in maxillofacial and plastic surgery since the 1990s. Its use is growing given its potential to enhance muscle and tendon healing. In vitro studies suggest that growth factors released by platelets recruit reparative cells and may augment soft-tissue repair. However, minimal clinical evidence is currently available. Many controlled clinical trials are under way, but clinical use should be approached cautiously until high-level clinical evidence supporting platelet-rich plasma efficacy is available. 

A meta-analysis in JBJS (The Journal of Bone & Joint Surgery) concluded: "The current literature is complicated by a lack of standardization of study protocols, platelet-separation techniques, and outcome measures. As a result, there is uncertainty about the evidence to support the increasing clinical use of platelet-rich plasma and autologous blood concentrates as a treatment modality for orthopaedic bone and soft-tissue injuries."

The evidence for PRP injections in individuals who have tendinopathy includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. In pooled analyses of RCTs on PRP for tendinopathy, findings were mixed and generally found that PRP did not have a statistically and/or clinically significant impact on symptoms (i.e. [id est], pain) or functional outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes.

Ahmad et al. conducted a systematic review to evaluate the evidence for PRP for the treatment of lateral epicondylitis. Five randomized controlled trials, one-nonrandomized comparison study and three case series met inclusion criteria. Comparators included blood, bupivacaine, normal saline injections or corticosteroids. Follow-ups ranged from six weeks to three months. Outcomes were conflicting with some studies reporting improvement and other studies reporting no significant differences with PRP. Limitations of the studies included: heterogeneity of outcomes measured; small, heterogeneous patient populations; variations in PRP preparation and post-injection protocol; lack of a non-treatment group; and short-term follow-ups. There is insufficient evidence to support PRP for the treatment of epicondylitis.

As an autologous preparation, PRP has been introduced into clinical practice without being subject to the stringent development required of new drugs. Commercially available PRP preparation devices have FDA (Food and Drug Administration) approval, but this is based on device performance and safety, not evidence of clinical efficacy. Routine use of PRP in clinical practice cannot be recommended given the lack of high-quality clinical evidence supporting its efficacy. Patients should only be offered PRP for musculoskeletal soft tissue injuries within the context of well-designed clinical trials. Clinicians offering PRP should ask manufacturers for the evidence of the platelet and growth factor concentrations, the constitution, and the viability of their PRP product (platelet activation levels). (Keene)

A systematic review/metaanalysis of 12 RCTs comparing efficacy of PRP to corticosteroid injection, bupivacaine, and other treatments for lateral epicondylitis (follow-up three weeks to 24 months) found conflicting results demonstrating superiority of PRP over other agents. The available evidence for all the comparisons was rated as very low quality due to inconsistency, imprecision, and risk of bias in most of the selected studies. The authors concluded that the results of this meta-analysis does not support the use of PRP as conservative treatment in orthopaedics. (Franchini)

Therefore, given the above, the health plan should not cover the treatment with platelet-rich plasma.