Starting Dec. 1, Camzyos (mavacamten), BMS' treatment for obstructive hypertrophic cardiomyopathy (oHCM), will receive insurance benefits.
The Ministry of Health and Welfare decided to do so at this year’s 23rd Health Insurance Policy Review Committee meeting on Thursday.
In May last year, Camzyos won approval from the Ministry of Food and Drug Safety for “treating adult patients with symptomatic (NYHA class II-III) oHCM to improve exercise function and symptoms.”
Camzyos is evaluated as a drug that inhibits myosin to relieve excessive contraction of the myocardium, relax the myocardium, reduce dynamic left ventricular outflow tract (LVOT) obstruction, improve cardiac structure, cardiac biomarkers, and exercise function in patients with hypertrophic cardiomyopathy, going beyond the limitations of conventional therapies that have focused on symptomatic relief.
Clinical practice guidelines introduce Camzyos as a cardiac myosin inhibitor for hypertrophic cardiomyopathy and recommend its addition to treating symptomatic oHCM despite using beta-blockers and calcium channel blockers. It also recommends Camzyos as a monotherapy in patients contraindicated or intolerant to verapamil, diltiazem, or disopyramide.
The Korean Society of Heart Failure and the Korean Society of Cardiology also appraised Camzyos as “the first treatment to improve the pathophysiology of symptomatic obstructive hypertrophic cardiomyopathy, saying it “has demonstrated excellent clinical effects, such as reducing LVOT pressure difference after exercise, and significantly reduces the need for surgical treatment, and therefore should be reimbursed.”
In line with these opinions, the Pharmaceutical Reimbursement Review Committee concluded that Camzyos “has an acceptable cost-effectiveness ratio based on the economic evaluation using the risk-sharing proposal proposed by the pharmaceutical company and is therefore reimbursable.”
However, due to the large number of patients and the cumulative financial impact of long-term treatment, Camzyos is to be applied by the “total limit” risk-sharing program and the “refundable” risk-sharing program.
The reimbursement criteria for Camzyos are: Adult patients with symptomatic (NYHA class II to III) oHCM who have been treated with beta-blockers or non-dihydropyridine calcium channel blockers for at least four weeks and have not responded, and as the combination therapy with first-line therapy (beta-blocker or non-dihydropyridine calcium channel blocker) if the patient has a left ventricular ejection fraction (LVEF) of 55 percent or greater by echocardiography at rest and a left ventricular outflow tract (LVOT) gradient of 50 mm Hg or greater by Valsalva maneuver or exercise load. However, monotherapy is allowed if the first-line therapy cannot be administered due to contraindications or serious side effects.
The upper price limit is 61,619 won ($44.17) per capsule for all four Camzyos doses of 2.5 mg, 5 mg, 10 mg, and 15 mg formulations.
The number of patients eligible for Camzyos is estimated to be 1,565 per year, with an annual financial requirement of 35.19 billion won. Still, the refundable risk-sharing program is expected to lower the financial requirement.
The annual medication cost per person is 22.49 million won, and the patient's out-of-pocket expenses are expected to be about 2.25 million won when a 10 percent co-payment is applied under the special calculation system.
Hypertrophic cardiomyopathy is a hereditary disease of the myocardium that usually develops in adolescence and young adulthood and is known as a common cause of sudden death in athletes.
It is mainly characterized by thickening of the left ventricular wall and ventricular septum. During systole, the mitral valve leaflets move toward the enlarged ventricular septum, creating a pressure difference within the ventricle, which is called obstructive HCM.
Depending on the thickness of the affected ventricle and the degree of stenosis of the left ventricular outflow tract or right ventricular outflow tract, oHCM can be asymptomatic to symptomatic of severe heart failure.
Patients may tire quickly and experience shortness of breath, palpitations, dizziness, chest pain, and, in cases of severe myocardial thickening, fainting. Sudden death can also occur due to ventricular tachycardia or ventricular fibrillation.