Infusion treatments such as IVIG and Ketamine or Lidocaine (inpatient/outpatient) are not covered by insurance companies. They typically say that it is experimental or not FDA approved for the type of application that a doctor/patient wants to use for treatment of chronic pain conditions. For instance, "On the other hand, there is a lack of scientific evidence on the effectiveness of intrapleural analgesia for treatment of complex regional pain syndrome with chronic pain involving the thoracic dermatomes." is found in the Aetna Insurance information on RSD/CRPS treatments. In their Clinical Policy Bulletin: CRPS/RSD: Treatments, Number 0447-III, it is stated, “Aetna considers intravenous administration of Ketamine or Lidocaine (including "Ketamine coma") or midazolam experimental and investigational for the treatment of CRPS and other types of chronic pain because its effectiveness for these indications has not been established.” The last time they reviewed this policy was 2/12/2010. In that same policy statement under Background you will also find:

"In a case report, Shirani et al (2008) described the effect of Ketamine infusion in the treatment of severe refractory CRPS I. The patient was initially diagnosed with CRPS I in her right upper extremity. Over the next 6 years, CRPS was consecutively diagnosed in her thoracic region, left upper extremity, and both lower extremities. The severity of her pain, combined with the extensive areas afflicted by CRPS, caused traumatic emotional problems for this patient. Conventional treatments failed to provide long-term relief from pain. The patient was then given several infusions ofIV Ketamine. After the 3rd infusion, the edema, discoloration, and temperature of the affected areas normalized. The patient became completely pain-free. At 1-year follow-up, the patient reported that she has not experienced any pain since the last Ketamine infusion. The authors concluded thattreatment withIV Ketamine appeared to be effective in completely resolving intractable pain caused by severe refractory CRPS I. Moreover, they stated thatmore research on this treatment is needed to better define its effectiveness in CRPS."

In a pilot study, Kiefer and colleagues (2008) investigated the effectiveness of subanesthetic isomeric S(+)-Ketamine in refractory CRPS patients. Four refractory CRPS patients received continuous S(+)-Ketamine-infusions, gradually titrated (50 mg/day - 500 mg/day) over a 10-day period. Pain intensities (average, peak, and least pain) and side effects were rated on visual analog scales, during a 4-day baseline, over 10 treatment days, and 2 days following treatment. Quantitative sensory testing (QST: thermo-, mechanical detection, and pain thresholds) was analyzed at baseline and following treatment. Subanesthetic S(+)-Ketamine showed no reduction of pain and effected no change in thermo- and mechanical detection or pain thresholds. This procedure caused no relevant side effects. The lack of therapeutic response in the first 4 patients led to termination of this pilot study. The authors concluded that S(+)-Ketamine can be gradually titrated to large doses (500 mg/day) without clinically relevant side effects. There was no pain relief or change in QST measurements in this series of long-standing severe CRPS patients.

In an open label phase II study, Kiefer et al (2008) examined the effectiveness of Ketamine in anesthetic dosage in refractory CRPS patients who had failed available standard therapies. A total of 20 American Society of Anesthesiologists (ASA) I-III patients suffering from refractory CRPS received Ketamine in anesthetic dosage over 5 days. Outcome criteria were pain relief, effect on the movement disorder, quality of life, and ability to work at baseline and up to 6 months following treatment. Significant pain relief was observed at 1, 3, and 6 months following treatment (93.5 +/- 11.1 %, 89.4 +/- 17.0 %, 79.3 +/- 25.3 %; p < 0.001). Complete remission from CRPS was observed at 1 month in all patients, at 3 months in 17, and at 6 months in 16 patients. If relapse occurred, significant pain relief was still attained at 3 and 6 months (59.0 +/- 14.7 %, p < 0.004; 50.2 +/- 10.6 %, p < 0.002). Quality of life, the associated movement disorder, and the ability to work significantly improved in the majority of patients at 3 and 6 months. The authors concluded that these findings suggest benefit in pain reduction, associated CRPS symptoms, improved quality of life and ability to work following anesthetic Ketamine in previously refractory CRPS patients. However, they stated that a randomized controlled trial will be needed to prove its effectiveness.

There are many other reference made on this same section of why Aetna makes the choice not to cover Ketamine infusions at this time. They are not alone, many insurance companies are following similar guidelines. Medicare which typically denies many claims and treatments for RSD tends to cover Ketamine Infusions for most patients and the use of Ketamine in the treatment of RSD is FDA approved. Pain patients seeking IVIG infusions tend to hear the same excuses used as to why the insurance companies are not covering the treatment.

<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />

If a modality is FDA approved it means your insurance cannot deny this treatment, but the FDA also gives a list of what conditions it is approved for. If you fall into a category such as peripheral neuropathy you don’t have such luck with IVIG therapy and will be in constant battle with your insurance company to get treatments of this type. IVIG approved for use by FDA for only the following 6 conditions; Primary immunodeficiencies, Immune-mediated thrombocytopenia, Kawasaki disease, Hematopoietic stem cell transplantation in patients older than 20 years (Gamimune-N only), Chronic B-cell lymphocytic leukemia and Pediatric HIV type 1 infection according to the FDA website.

First, this petition raises awareness of benefits the infusion therapies can bring to increasing the quality of life, health and physical abilities of chronic pain patients with Neuropathy conditions. If a patient and doctor are in agreement and studies show that there is a significant improvement in symptoms, insurance companies should be faster at approving these therapies for such Neuropathy conditions, especially when the modality is already approved for other conditions that are being covered by that insurance company. Secondly, we are also using this petition to raise awareness for patients that do not know that other options exist and if interested in infusion treatments they should speak with their healthcare providers about the risks and benefit of such therapy and if they would be a good candidate for the treatment.

Sponsor

Links