Camzyos - NC Standard
Restricted Product(s):
- Camzyos™ (mavacamten)
FDA Approved Use:
- For the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
Criteria for Approval of Restricted Product(s):
1. The patient is 18 years of age or older; AND
2. The patient has been diagnosed with New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) (medical documentation required); AND
3. The patient has had complete echocardiogram assessment of left ventricular ejection fraction (LVEF) with confirmed LVEF ≥ 55% (medical record documentation required); AND
4. The patient has tried and had an inadequate response, intolerance, hypersensitivity, or FDA labeled contraindication to beta blockers (e.g. metoprolol, propranolol, atenolol) (medical record documentation required); AND
5. The patient has tried and had an inadequate response, intolerance, hypersensitivity, or FDA labeled contraindication to calcium channel blockers (e.g. verapamil, diltiazem) (medical record documentation required); AND
6. The patient has confirmed resting oxygen saturation of ≥ 90%; AND
7. The patient will not be on combination therapy with beta blocker and calcium channel blocker while using the requested medication; AND
8. The patient will not be using the requested medication with disopyramide or ranolazine; AND
9. The patient has not been successfully treated with invasive septal reduction (surgical myectomy or percutaneous ASA) within the past 6 months; AND
10. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND
11. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., cardiologist); AND
12. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
Duration of Approval: 210 days
Continuation Coverage
1. The patient has been previously approved for Camzyos with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND
2. The patient has experienced improvement in obstructive hypertrophic cardiomyopathy (HCM) symptoms or manifestations (e.g., improvement in oxygen saturation and/or oxygen consumption or no worsening in NYHA class) (medical record documentation required); AND
3. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND
4. The patient continues to be managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., cardiologist).
Duration of Approval: 365 days (1 year)
Quantity Limitations:
quantity limitations apply to brand and associated generic products.
Medication | Quantity per day (unless specified) |
---|---|
Camzyos (mavacamten) 2.5 mg tablet | 1 tablet |
Camzyos (mavacamten) 5 mg tablet | 1 tablet |
Camzyos (mavacamten) 10 mg tablet | 1 tablet |
Camzyos (mavacamten) 15 mg tablet | 1 tablet |
Quantity Limit Exception Criteria:
1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
Duration of Approval: 365 days (1 year)
References:
all information referenced is from FDA package insert unless otherwise noted below.
Policy Implementation / Update Information:
May 2022: Original utilization management criteria issued.
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