In this Global Health Brief, RGA Middle East's Dr. Avinash Samudre provides a comprehensive overview of platelet-rich plasma (PRP), also known (albeit less commonly) as autologous conditioned plasma (ACP), platelet-rich growth factors (GFs), platelet-rich fibrin (PRF or PRF matrix), and platelet concentrate. PRP's current efficacy status and whether claims for its use should be accepted and covered are also examined.
Platelet-rich plasma (PRP) first emerged in the 1970s as a treatment to replenish platelets for patients with low counts. Since the 1980s, it has gained a toehold in regenerative medicine, with its proponents claiming, from limited research trials, that it might be useful in aiding wound closure, reducing inflammation, and promoting new cell growth.
This has led to increasing utilization, and interest has been growing in its potential efficacy for pain management, treatment of sports injuries, speeding and improving wound healing, and more.
Current discussions in the scientific community about PRP’s potential utility and efficacy are constrained by limitations in existing clinical studies which, along with anecdotes and testimonies, have cast doubt upon claims made by its proponents and opponents alike.
Some PRP champions inappropriately promote it as an FDA-approved treatment, which is not true. While devices to extract and produce PRP are subject to the FDA’s medical device approval pathways, blood products such as PRP are under the purview of the FDA's Center for Biologics Evaluation and Research (CBER), which regulates the use of human cells, tissues, and cell- and tissue-based products. Under the FDA’s approval process for these products, blood products such as PRP are exempt from the FDA's traditional regulatory pathway for new drugs, which often involves animal studies and clinical trials. The governing regulation refers only to safety and practice standards for preparing and handling PRP rather than treatment indications, leaving the actual use of PRP in clinical practice largely unregulated.
For these reasons, any claims involving treatments with PRP should be approached with substantial caution and care.
PRP is an autologous product derived from a patient’s own blood. To obtain it, blood is taken from a patient and processed using a centrifuge to separate out the platelets (or thrombocytes) and the plasma. These two are then combined into a concentrated dose which is injected at or into the specified treatment site. The specific concentration and dosage for each case is determined by the treating physician.
The idea behind using PRP is that the plasma-platelet mixture is rich in the growth factors and cytokines which, in theory, could provide a biological boost to the body’s own healing processes, as they are known to promote soft tissue healing, stimulate cell growth, division, and differentiation, reduce inflammation, fight infection, and provide immunity against pathogens. Thus, it is argued, PRP may also be effective in speeding tissue regeneration, treating inflammation, and even possibly slowing cancer growth and metastasis.
Also, because PRP is derived from a patient’s own body, as with other autologous therapies, the risk of adverse reactions, rejections, and other side effects associated with immune responses are substantially reduced. Side effects of PRP are usually locally confined, mild, and transient, although serious risks such as infection, sepsis, nerve injury, and possibly cancer progression could occur on rare occasions.1 To add to PRP’s appeal, there are claims it could even replace certain medications associated with high risks, such as the opioid painkillers used for severe orthopedic pain, reducing the need to rely on such medications.
The relative ease of preparation, the purported benefits, the relative lack of side effects, and the increasingly visible touting of PRP in the consumer press, when coupled with the comparatively lax regulatory requirements, has reinforced overuse and even abuse of PRP, consequently leading to challenges in health insurance claims.
Several indications for treatment with PRP have been studied, but unfortunately, no conclusive evidence has emerged to date to support it as an effective treatment for any conditions. For example:
There are also studies assessing PRP’s efficacy in combination with other treatments for wound healing or for management of physical pain. Again, the studies have not conclusively shown PRP to have greater efficacy than conventional treatments.
Examples:
These examples demonstrate some of the limitations in clinical studies, which is complicating the fundamental discussion of whether PRP treatment is based on robust evidence or experimental, and so should only be given in the setting of clinical trials, at least for now.
Claims assessors will need to pay particular attention to PRP claims, ideally with input from their medical team.
Although research activities to date have not yet been conclusive about PRP’s efficacy, insurance claims for PRP treatment are becoming more common, including but not limited to the following uses:
As the cost of a single PRP treatment is relatively low (ranging from US$500 to up to US$2,500, depending on the country), claims might be accepted and paid without proper evaluation of the treatment being claimed, mainly because the narrative surrounding PRP use has been confusing. The impact of paying for unproven and often unnecessary PRP treatments can be significant, given that it may be provided to large numbers of people suffering from the aforementioned ailments. Furthermore, PRP treatment often does not stop at one episode, and thus there may be a few claims seen from a single claimant in a year.
At this writing, given the absence of robust, peer-reviewed, quality clinical studies and research conclusively indicating its superiority to other treatment modalities, PRP does not meet the standard of “Medically Necessary” as defined in most insurance policies.
Some insurers also have an exclusion for experimental treatment, which specifies that treatment not yet proven to be effective, or at least more effective than conventional standard of care, is to be excluded from policy benefits. PRP treatments would fall into this category based on the current state of evidence.
To establish that PRP treatment meets the requirement of being medically necessary and is not an experimental treatment, the following is expected:
The most straightforward way of determining the above is when there are already established international guidelines and recommendations provided by expert bodies, clinical colleges, or societies. For example, in the case of orthopedic indications, the International Society of Orthopedic Surgery and Traumatology (SICOT) reached a consensus following a vigorous literature review process that determined the current level of evidence on PRP efficacy is inconclusive.10
In the absence of such guidelines, when faced with any unfamiliar treatment or potential experimental treatment, claims assessors should take care in reviewing the validity of such treatment, ideally enlisting the assistance of the medical team, if available, to ensure that claims are being paid in accordance to instead of against the policy wordings.
Given the level of interest and activity surrounding PRP, it may eventually emerge as an appropriate treatment option for certain conditions. For now, however, its efficacy is still being investigated and so it is therefore considered, for claims assessment purposes, to be experimental.
In the future, if efficacy does become conclusively established and independently vetted and validated by the appropriate authorities, it could become a treatment that is routinely covered by health insurance policies. Until then, due caution should be exercised when a claim for PRP is received.
