Diagnosis: Hypercholesterolemia

Treatment: Injection, Inclisiran, 1 mg (milligram)

The insurer denied coverage for injection, Inclisiran, 1 mg (milligram).

The denial is overturned.

This is the case of a patient with a history of hypercholesterolemia, refractory to high intensity statin therapy (rosuvastatin 10 milligram (mg)). Past medical history is relevant for atherosclerotic cardiovascular disease with a stent placed in the mid left anterior descending artery, and hypertension. Family history was significant for familial hypercholesterolemia. The patient was treated with rosuvastatin 10 mg daily and ezetimibe 10 mg daily. Serum blood testing revealed a total cholesterol of 190, low-density lipoprotein (LDL) of 120 mg/dl (deciliter) and high-density lipoprotein (HDL) of 49mg/dl. The patient physician submitted a prescription for Inclisiran therapy along with a letter stating that LDL cholesterol has been elevated despite more than 8 weeks of maximal statin and ezetimibe therapy.

The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. This patient has atherosclerotic coronary artery disease and persistent elevation of LDL cholesterol despite treatment with maximally tolerated statins. Addition of a non-statin agent such Inclisiran in this setting has been associated with significant event rate reduction regardless of serum LDL level (Reference 1, 2). Current American Heart Association and American College of Cardiology guidelines recommend addition of proprotein convertase subtilisin/kexin type 9 (PCSK-9) inhibitor therapy to maximally tolerated statin therapy in patients at high risk for future atherosclerotic cardiovascular disease (ASCVD) events including those with multivessel disease and diabetes (Reference 1,2). Such patients benefit from treatment with non-statin therapy such as Inclisiran when LDL cholesterol levels are not at goal (Reference 3). In conclusion, the proposed treatment is medically necessary and is more effective than the formulary medication as the patient has a contraindication to ezetimibe.

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.

The medical necessity for injection, Inclisiran, 1 mg is substantiated.