Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain, cervical spondylosis and pain

Treatment: Intracept Procedure

The insurer denied coverage for the Intracept Procedure

The denial is upheld

This patient has had low back pain for months. She has had epidural steroid Injections, medial branch blocks, physical therapy and a home exercise program. She has taken nonsteroidal anti-inflammatory drugs (NSAIDs), Tylenol and opiates. She has Modic changes at lumbar (L)5-sacral (S)1. The request is for the Intracept procedure at L5 and S1.

Fischgrund and colleagues (1) published a double-blind, sham controlled randomized controlled trial (RCT) evaluating the Intracept system and radiofrequency (RF) ablation of the basivertebral nerve for the treatment of chronic low back pain. A total of 225 participants with chronic (>= 6 months) isolated lumbar pain who had not responded to at least 6 months of non-operative management were randomized to either a sham (n=78) or treatment (n=147) intervention. In the active treatment group, the RF probe was activated and the temperature at the tip was maintained at 85 Celsius (C)for 15 minutes. The duration of the session in the sham group was the same but the RF treatment was only simulated. Study participants had a minimum Owestry disability index (ODI) of 30 points (on 100 point scale) and a minimum visual analog scale (VAS) of 4 centimeter (cm) (10 cm scale). The primary efficacy endpoint was the comparative change in ODI from baseline to 3 months. Both intention-to-treat (ITT) and per protocol (PP) analysis were pre-planned. A total of 19 of 147 (13% [percent]) participants in the treatment group were excluded from the PP analysis; 16 for a targeting failure, 1 for procedural failure and 2 for protocol non-compliance. One participant in the sham group was excluded from the PP analysis and this was for protocol non-compliance.

At 3 months, in the ITT analysis, there was no statistically significant difference between groups in the primary outcome, mean ODI. ODI improved a mean of 19.0 points in the treatment group and 15.4 points in the sham group, p=0.107. However, there was a difference between groups in the 3-month PP analysis: the mean ODI in the treatment arm improved 20.5 points and 15.2 points in the sham arm, p=0.019. In the 12-month PP analysis, the difference between the treatment and sham groups in mean ODI was no longer statistically significant (22.6 points versus 25.3 points, p=0.153). PP analyses of pain severity (assessed by VAS) found no significant difference between groups in VAS improvement at 3 months (p=0.083) but significantly greater improvement in the treatment compared with the control group at 6 and 12 months. Eight procedure-related events (2.7%) were reported in 6 participants following the 225 procedures; 2 of these 6 participants were in the sham arm. The events included nerve root injury (n=1), lumbar radiculopathy (n=2), retroperitoneal hemorrhage (n=1), and transient motor or sensory deficits (n=4).

The procedure is unlikely to be more beneficial than any of the standard treatments/procedures for this patient.  Because the of the limited number of patients treated so far, complication rates are unknown at this point.

The requested service is not likely to be more beneficial than any standard treatment/procedure and the adverse risks are increased over other treatments/procedures.

The insurer's denial of the Intracept procedure is upheld.