Appeal type: Medical necessity
Decision: Upheld

This is a patient with cervical radiculopathy.  Records provided indicate that a request for ketamine HCl powder compound was denied as the current compounded drug product plan criteria does not allow coverage of ketamine HCl powder compound if the compound contains any of the following ingredients: bulk powder.  There is a correspondence note indicating that the request for compounded topical cream was denied as an order for a drug to be considered for coverage under Medicare part D, a drug must meet the definition of part D drug and must contain at least one ingredient that meets the definition of a part D drug.  Compounded medications that do not contain at least one ingredient that meets the definition of a part D drug are excluded from coverage under the Medicare part D drug benefit.  It is noted that this compounded cream contains ketoprofen powder (pow), baclofen pow, ketamine pow, lidocaine pow, piroxicam pow, liquigel liquid (liq), propylene gl liq, ethoxy liq, and kris-eter liq, none of which are part D ingredients.
There is a handwritten letter of appeal that is only partially legible that states that the patient has been on this compound itself for 15 years.  At issue is the medical necessity of Ketamine HCL Powder Compound.
The health plan's determination is upheld.  This compounded topical cream contains bulk powder.  There is no evidence supporting compounded topical ketamine cream for the treatment of cervical radiculopathy.  There is no Food and Drug Administration (FDA-approved topical formulation of this drug.  Per The Official Disability Guidelines (ODG) Online Version, Pain Chapter, Topical analgesics, compounded (Non-FDA Approved Formulations), "Topical compounded analgesics in general are largely experimental in use with few randomized controlled trials to determine efficacy or safety ... There is little to no research to support the use of many these agents  Ketamine: Not recommended.  There is no FDA-approved topical formulation of this drug.
Topical ketamine has only been studied in open label and case studies for use for CRPS I and post-herpetic neuralgia and both have shown encouraging results.  There is no exact recommendation for percentage of drug delivery.  The exact mechanism of action remains undetermined.  It has been suggested that the effects of ketamine for pain treatment are most likely due to actions in the brain rather than in the periphery. (Gammaitoni, 2000) (Lynch 2005) (Finch, 2009) (Ushida, 2002) (Asbill, 2014) There are two studies of combination of topical 2% amitriptyline and 1% ketamine.  The open label study showed a reduction in neuropathic pain.  A follow-up, double-blind, randomized, placebo-controlled study did not replicate the results." 

There is little to no evidence to support the use of topical ketamine for the treatment of neuropathic pain related to complex regional pain syndrome (CRPS) and no evidence to support use of this topical cream for the treatment of cervical radiculopathy.  This compounded topical cream is not FDA approved and has not been proven to be either safe or effective.  This treatment would not be considered standard of care.
The provider states that the medication is being used to assist the patient in avoiding opioid pain medications.  There are a multitude of other oral medications that can be used to manage these symptoms and avoid opioid use.  The request for compounded topical ketamine cream (Ketamine HcL Powder Compound) is not medically necessary.