Entresto denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that an enrollee has requested authorization and coverage for Entresto. Current medical literature supports the use of Entresto for the treatment of resistant hypertension. In this case, the patient has resistant hypertension with inadequate control while on medications including angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs). However, the records document that with the substitution of the ARB with Entresto, the patient’s blood pressure is improved and now adequately controlled. In this clinical setting, while hypertension by itself is an “off-label” use for Entresto, it has demonstrated beneficial effects in this patient and is likely to be more beneficial for the treatment of this patient than standard medication classes.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Entresto. Findings: The records provided for review document that this patient presents with a history of sudden cardiac death and sustained ventricular tachycardia. The patient has been treated with an implantable cardioverter defibrillator (ICD) as well as medical therapy with losartan and metoprolol. The patient’s provider has recommended a change in medications from losartan to Entresto. In the medical literature, a study noted that the PARADIGM-HF study demonstrated benefits of treatment with Entresto to be consistent across a broad range of heart failure subgroups, including patients with clinically stable heart failure, as in this patient’s case. The authors found that Entresto improved patients’ quality of life and longevity as well as reduced hospital admissions.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has been diagnosed with hypertension. An echocardiogram revealed moderately reduced systolic function and an ejection fraction of 35%. The patient underwent cardiac catheterization due to chest pain. The report noted non-obstructive coronary artery disease. The patient was noted to have a history of hypertension, hyperlipidemia, and coronary artery disease. There was no report of chronic congestive heart failure (CHF) symptoms or signs of CHF in the physical examination. The patient was being treated with Coreg, Lipitor, and lisinopril. The patient has requested authorization and coverage for Entresto. The Health Plan denied the request and reported the requested medication is not medically necessary for the treatment of this patient.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Entresto 24-26mg. Findings: The physician reviewer found that The use of sacubitril-valsartan (Entresto) is usually reserved for patients who already take spironolactone and who require additional medication for blood pressure control, and particularly patients with a left ventricular ejection fraction (LVEF) less than 55 percent. Also, in this case, the severity of heart failure symptoms and New York Heart Association (NYHA) class is not clear. It is not clear if his symptoms were improving or worsening with therapy prior to starting Entresto. Additionally, a recent trial by Solomon and colleagues showed no difference in outcomes in patients treated with valsartan alone or sacubitril-valsartan.

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 Entresto, then check the rights and deadlines that apply to your plan.