Camzyos

Mavacamten

• Brand(s): Camzyos
• Dosage Form/Strength: 2.5 mg, 5 mg, 10 mg, 15 mg Capsule
• Effective date: August 26, 2024

Initial Criteria:

For the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) of New York Heart Association (NYHA) class II to III in adult patients who meet ALL the following criteria:

1. 18 years of age or older;
   AND
2. Has a confirmed diagnosis of symptomatic obstructive hypertrophic cardiomyopathy (oHCM);
   AND
3. Documented left ventricular ejection fraction (LVEF) equal to or greater than 55% at rest determined by echocardiography;
   AND
4. Left ventricular (LV) wall thickness equal to or greater than 15 mm [or equal to or greater than 13 mm with a family history of hypertrophic cardiomyopathy (HCM)];
   AND
5. Left ventricular outflow tract (LVOT) peak gradient equal to or greater than 50 mm Hg at rest, after Valsalva maneuver, or postexercise as confirmed by echocardiography;
   AND
6. Patient must be receiving the standard of care (SOC) treatment for oHCM with a beta-blocker (BB) and/or a non-dihydropyridine calcium channel blocker (ND-CCB) (e.g., verapamil, diltiazem) and experience clinical deterioration in symptoms or echocardiography while receiving these treatments (Note 1);
   AND
7. All initial requests must be prescribed by a cardiologist or prescriber with expertise in the diagnosis of HCM working with a specialized clinic with this expertise. (Note 2)

Discontinuation Criteria:

Funding of mavacamten will be discontinued upon meeting one or more of the following conditions:

1. LVEF less than or equal to 30?termined by echocardiography;
   OR
2. LVEF is less than 50% on two consecutive occasions determined by echocardiography while on at least 2.5 mg daily of mavacamten;
   OR
3. Receives septal reduction therapy (SRT).

Duration of Initial Approval: 6 months

Renewal Criteria:

Renewal of funding will be provided for patients who do not meet the discontinuation criteria and who demonstrate benefit from treatment with mavacamten.

Additionally, patients must meet at least one of the following criteria;

1. LVEF 50-55% regardless of Valsalva LVOT gradient;
   OR
2. LVEF greater than 55% and Valsalva LVOT gradient less than 30 mm Hg;
   OR
3. LVEF greater than or equal to 55% and Valsalva LVOT gradient greater than or equal to 30 mm Hg

Duration of Approval of Renewals: 1 year

Notes:

1. Case-by-case consideration will be provided for requests for patients who have contraindications, experienced toxicities/adverse reactions to the usual SOC therapies for the treatment of oHCM. Requests must include clinical details as to why the SOC treatments could not be used or a clinical consult note.
2. Requests for renewal of funding initiated by a cardiologist may be continued by another prescriber upon meeting the renewal criteria.

Recommended dose:

Refer to the product monograph for dose titration guidance.

Maintenance dose: 2.5 mg to 15 mg daily.