Zetia denials in California external review

What the reviewers wrote

Where the denial was overturned

The patient is a 43-year-old male who has significant coronary artery disease (CAD) and has had two stents placed. His cardiologist indicates he is in the “high risk” group, and has established a target LDL of less than 70 mg/dL. The patient was prescribed Lipitor 80mg in March 2006 but was functionally taking Lipitor 40mg. At that time Zetia was added to his medication regimen. Follow-up testing in April 2006, while on Lipitor 40mg daily and Zetia 10mg daily, indicated the patient had achieved his target LDL (61 mg/dL). He began a trial of Vytorin 10/80 in May of 2006 and his LDL was off target in June 0f 2006 (113 mg/dL). The patient’s request for authorization of Zetia was denied by the Health Plan citing a lack of medical necessity.This is a patient with known CAD for whom achieving and maintaining the declared LDL target of less than 70 mg/dL is very important.

A 58-year-old male enrollee has requested Zetia 10 mg for the treatment of his coronary disease. Findings: The physician reviewer found that this patient has multivessel stenting and diabetes and is at very high risk of developing future coronary events and aggressive lipid therapy is warranted. This conclusion is consistent with the findings by Smith and colleagues and the American Heart Association/American College of Cardiology guidelines referenced above. Elevated homocysteine levels have been shown to put patients at higher risk of future atherosclerotic disease. Although further studies are needed, it is common clinical practice to attempt to lower homocysteine levels with medications in very high risk patients such as this patient.

Where the denial was upheld

The patient is a 54-year-old female with rheumatoid arthritis, apparently being managed by both her internist and her rheumatologist. She is receiving a regimen of Enbrel, methotrexate, Plaquenil, Celebrex, and folic acid supplements for control of her arthritis. The records imply that the patient is doing well enough that she is able to continue working as a physical therapist. The patient has hypercholesterolemia. The patient’s provider has recommended Zetia over statin drugs because Zetia has a better probability of less liver toxicity than statin drugs. It is stated that the patient is following appropriate dietary measures, but her activity limitations prevent better non-pharmacologic control of her lipids; the degree of activity limitation is unclear from the records provided.

The patient is a 54-year old woman with significant risk factors for coronary artery disease (CAD) including family history, marked elevation of LDL and systemic hypertension. There was a trial of Lipitor with no clear elevation of her CPK or proximal muscle weakness. The patient is requesting authorization and coverage for Zetia, and the Health Plan has denied her request based upon their determination that Zetia is not medically necessary. The current American Heart Association (AHA) and American College of Cardiology (ACC) guidelines strongly favor the lowering of LDL in a patient such as this with three risk factors and an elevated LDL. The data best supports a statin in terms of efficacy and safety. There is specific data that favors an ace-inhibitor and Lipitor as having a direct impact on mortality.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Zetia, then check the rights and deadlines that apply to your plan.