Appeal type: Experimental/Investigational
Decision: Overturned

This is a female patient with a history of cluster headaches.  She was being treated by a neurologist and had reported that her headaches had worsened since her last visit; she had 4 attacks in one week.  Her treatments included verapamil, Imitrex, Emgality and Ajovy.  The patient was uncertain if the Ajovy had helped because she reported increasing her verapamil at the same time of Ajovy treatment.  She has received intravenous ketamine to treat her cluster headaches.

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome.  There is a significant amount of research on ketamine improvement in headaches, although majority of data is on migraines.  Intravenous (IV) ketamine has good data in terms of efficacy for migraine improvement.  Furthermore, the patient has also been on intravenous (IV) ketamine with great results.  She has tried verapamil, Imitrex, Emgality and Ajovy.  Therefore, the scientific evidence in peer-reviewed literature does support a result of improvement in health outcome to support this service as likely to be more beneficial than any other standard treatment.

According to Pomeroy et al. (2017), "This is a retrospective review of 77 patients who underwent administration of intravenous, subanesthetic ketamine for CM or NDPH.  All patients had previously failed aggressive outpatient and inpatient treatments.  Records were reviewed for patients treated between January 2006 and December 2014.  The mean headache pain rating using a 0-10 pain scale was an average of 7.1 at admission and 3.8 on discharge (P<.0001).  The majority (55/77, 71.4%) of patients were classified as acute responders defined as at least 2-point improvement in headache pain at discharge.  Some (15/77, 27.3%) acute responders maintained this benefit at their follow-up office visit but sustained response did not achieve statistical significance.  The mean length of infusion was 4.8 days.  Most patients tolerated ketamine well.  A number of adverse events were observed, but very few were serious."

According to Cohen et al. (2018), "The use of ketamine in headache disorders has surged over the past few years in light of several studies demonstrating benefit.165167 In a single RCT that involved patients with migraine headache, a bolus of subcutaneous ketamine 80 g/kg was associated with an approximately 50% reduction in acute migrainous pain compared with placebo and an approximate 75% reduction in chronic migrainous pain at 7- to 10-day follow-up when administered in thrice-a-day dosing for 3 weeks.168 However, a second RCT that investigated the effects of intranasal ketamine 25 mg compared with intranasal midazolam 2 mg found that ketamine reduced the severity but not the duration of migrainous aura, with no significant group differences in pain scores observed.169 In a retrospective study that involved 49 patients diagnosed with 7 different chronic pain conditions with neuropathic pain features, a 5.9-point (10-cm VAS) reduction in pain scores was observed following a ketamine infusion (median dose, 0.9 mg/kg over 3045 minutes; median number of infusions, 4), with 38% of patients reporting greater than 3 weeks of relief (Table 33)."

The patient has cluster headaches which have few treatments.  IV ketamine has been shown to be beneficial in cluster headaches.     

Intravenous guanethidine, ketamine for cluster headaches is the best available treatment for this patient at this time.     
  
The patient has cluster headaches which have few treatments.  IV ketamine has been shown to be beneficial in cluster headaches.  The requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient.                                                    

The carrier's denial of coverage for intravenous guanethidine, ketamine for cluster headaches given during the date range under review should be reversed.