Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Hyperlipidemia
Treatment: Repatha
The insurer denied Repatha.
The health plan's determination is upheld.

The patient is a female with a history of hypertension, hyperlipidemia, coronary artery disease and percutaneous coronary intervention. She has a history of myalgias with rosuvastatin. There is no documentation of trials of other statins. No low-density lipoprotein (LDL) cholesterol levels were provided.
At issue is the medical necessity of Repatha.

The health plan's determination of medical necessity is upheld in whole.

The requested health service/treatment of Repatha is not medically necessary for this patient.
Repatha (evolocumab) is a member of a class of lipid lowering drugs called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. Current guidelines endorse its use in patients with atherosclerotic cardiovascular disease whose LDL cholesterol levels remain above goal despite maximally tolerated statin therapy. In this instance, it is not possible to determine that this patient's level is above goal as no LDL cholesterol level was documented. Moreover, it is not possible to determine that the patient has complete statin intolerance and that her maximally tolerated statin dose is no statin. 
Per the 2017 Focused Update of the 2016 American College of Cardiology (ACC) Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk, ''A systematic approach to evaluation of possible statin-related adverse effects is critically important to encourage adherence to evidence-based statin treatment.... The approach to statin intolerance should include discontinuation of statin therapy until resolution of symptoms and subsequent rechallenge to verify recurrence of muscle-related symptoms. Whereas there is not a universally accepted definition of statin intolerance, most experts recommend that patients are documented to have unacceptable muscle-related symptoms that resolve with discontinuation of therapy and occur with rechallenge on at least 2 to 3 statins, preferably ones that use different metabolic pathways and have different lipophilicity, and 1 of which is prescribed at the lowest approved dose....Non-statin therapies are not considered to be an alternative to evidence-based statin therapy unless statin intolerance has been systematically and rigorously evaluated and documented.''
The documentation is insufficient to determine that this patient meets these criteria. Thus, the medical literature does not support the use of Repatha in this instance, as there are no recent LDL cholesterol levels and details of the patient's prior statin trials, including the agents tried and their dosages. Per the appeal form, the patient's LDL levels from ranged from 38-59 mg/dl.  The most recent level was 54 mg/dl.  It is unclear what, if any, medication the patient was taking at that time.  There is no documentation of an LDL cholesterol level of 70 md/dl or greater.  The appeal form indicated that the patient has been intolerant to both atorvastatin and rosuvastatin; no dosages were mentioned. 
Therefore, the requested health service/treatment of Repatha is not medically necessary.