Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Elevated triglycerides

Treatment: Omega-3-acid Ethyl Esters 1GM OR CAPS (Lovaza)

The insurer denied coverage for Omega-3-acid Ethyl Esters 1GM OR CAPS (Lovaza). The denial was upheld.

This patient is a female who is more than a decade post stem cell transplant for the treatment of myelodysplastic syndrome. Current problems include severe hearing loss, neuro- cognitive dysfunction, ovarian failure, history of low normal heart function by echocardiogram, with subsequent normal echo and a history of basal cell carcinoma x2. She continues on hormone replacement therapy with regular withdrawal bleeds. A recent fasting lipid panel reveals that her total cholesterol has improved and it is 163, down from 263. Her LDL was 85 today and was 170 on the previous visit. Triglycerides continue to be elevated and are now 187 but the level has improved from the past summer when it was 247. Her physicians recommended that she start omega-3 1 g daily. The patient complains of chest tightness during cold weather. She has a history of reactive airway disease and symptoms appear to be consistent with asthma. The patient has been given a prescription for albuterol to take PRN for the symptoms. The patient does not have any history of chest pain that is precipitated by exercise or exposure to cold or has any other characteristics of angina pectoris. She has not had a stress test nor has she ever been treated with nitroglycerin medications.

There are at least 2 issues that need discussion concerning this case. One, whether or not there is good evidence that treating elevated triglycerides really makes a difference in decreasing mortality from coronary heart disease and second whether there is any evidence for specifically using Lovaza or similar natural omega-3 fatty acids is beneficial. A recent meta-analysis from the Emerging Risk Factors Collaboration evaluated 302,430 people free of known vascular disease at baseline in 68 prospective studies.(1)  With adjustment for age and sex, triglycerides showed a strong, stepwise association with both cardio vascular disease (CVD) and ischemic stroke; however, after adjustment for standard risk factors and for HDL-C and non-HDL-C, the associations for both CVD and stroke were no longer significant. The attenuation was primarily from the adjustment for HDL-C and non-HDL-C, which led to the conclusion that "for population-wide assessment of vascular risk, triglyceride measurement provides no additional information about vascular risk given knowledge of HDL-C and total cholesterol levels, although there may be separate reasons to measure triglyceride concentration (e.g., prevention of pancreatitis)."(1)  

Reports have indicated possible risks treating triglycerides.(4,5) An increase of 0.7% in LDL-C levels was noted for OM-3-A EE compared with a decrease of 2.8% for placebo; this was reported as a net increase of 3.5% (P = 0.05). OM-3-A EE was also associated with reduced levels of apolipoprotein B, remnant-like particle cholesterol, apolipoprotein CIII, and lipoprotein-associated phospholipase A2 levels, as well as changes in the size and composition of lipoproteins.(6)
This patient did not have any history of coronary artery disease (CAD) and did not have significant risk factors for CAD such as hypertension, diabetes mellitus, cigarette smoking and a positive family history. The medications that she received as chemotherapy may produce damage to the heart muscle but do not have an effect of precipitating CAD. According to the references cited this is not definitely an independent cardiac risk. Treatment of elevated triglycerides are approved if the level is greater than 500 mg/DL or if the patient has pancreatitis, neither of which were present in this patient. In addition, it is not definitely known if treatment with naturally occurring or prescription Omega 3 fatty acids are beneficial. Therefore, coverage for Lovaza or omega-3-acid ethyl esters daily is not medically necessary.

Based on the above, the medical necessity for Omega-3-acid Ethyl Esters 1GM OR CAPS (Lovaza) is not substantiated.  The insurer's denial is upheld.