Camzyos’s reimbursement decision imminent

Company reached the ‘make or break’ point of drug pricing negotiations

NHIS to complete last-minute negotiations with BMS… oHCM diagnoses on the rise with ultrasound coverage

Will the oHCM treatment paradigm change after the domestic approval of the new drug?

Obstructive hypertrophic cardiomyopathy (oHCM), has been regarded as a difficult-to-treat area due to the lack of a cure.

 

However, with the recent introduction of new drugs and reimbursement granted for its diagnostic test, expectations are rising for a paradigm shift in oHCM treatment – the key to which will be whether or not the newly introduced treatment will be reimbursed.

 

According to the industry sources on the 28th, the National Health Insurance Service and BMS Pharmaceutical Korea have been negotiating the drug price of the oHCM treatment Camzyos (mavacamten) since August.

 

oHCM is a rare and potentially fatal heart disease in which the thickened left ventricular muscle blocks blood flow to the rest of the body, causing symptoms ranging from shortness of breath to heart failure, syncope, and sudden cardiac death.

 

Camzyos was approved by the Korean Ministry of Food and Drug Safety in May 2023 for the treatment of oHCM as a treatment that selectively inhibits the excessive cross-linking of cardiac myosin and actin, which is responsible for the development of oHCM.

 

Specifically, the drug is inidicated to improve exercise function and symptoms in patients with symptomatic (NYHA class II-III, mild and moderate) oHCM.

 

After years of symptomatic management with off-label agents due to the lack of a cure, the introduction of Camzyos has been regarded as a paradigm shift in its treatment landscape.

 

Last year, the European Society of Cardiology (ESC) updated its guidelines for the first time in 9 years, recommending Camzyos the highest evidence level A for the first time among treatment options.

 

‘Until now, the treatment of oHCM has focused on symptom relief and prevention of complications, rather than addressing the underlying cause,’ said Professor Hyung Kwan Kim, Department of Cardiology at Seoul National University Hospital.

 

“As oHCM is a disease where many complications can occur at a young age and leave sequelae, we expect the approval of the new drug to provide a better treatment environment for patients.’ The problem is that despite the availability of the new drug, patient access to such is still low due to so-called financial toxicity and the high burden of drug cost.

 

Furthermore, the recent reduced patient burden for oHCM’s diagnostic test, which is leading to an increase in the number of patients, further highlights the reimbursement hurdle.  As of 2023, the total number of oHCM patients registered in Korea is about 20,000.

 

However, the actual number is expected to be higher given the prevalence of oHCM.

 

It is generally believed that oHCM occurs in 1 in 200 to 500 people in the general population, and if this prevalence rate is applied to the entire Korean population, it is estimated that approximately 100,000 to 250,000 people in Korea have oHCM.

 

Fortunately, the diagnosis rate of oHCM in Korea is on the rise as echocardiography, which is used to diagnose hypertrophic cardiomyopathy, has been covered for people with known or suspected heart disease since 2021.

 

As a result, the diagnosis rate of patients with oHCM, which was Camzyos’s treatment target, has also increased with the reimbursement extension of echocardiography in 2021.

 

In 2021, 466 patients were diagnosed with oHCM, about 1.6 times more than the 291 patients diagnosed in 2020, the year the reimbursement was extended.  In other words, the reimbursement of the diagnostic test has increased the number of diagnosed patients, but the therapeutic reimbursement ‘hurdle’ is limiting treatment on site.

 

From the patient’s perspective, they are left to wait and see if the final stage of the reimbursement discussion - the ‘drug price negotiation’ - will conclude successfully.

 

However, there has been no news regarding the conclusion of the drug price negotiation since it passed the NHIS Drug Reimbursement Evaluation Committee in July after being put on hold once.

 

This means that the NHIS and pharmaceutical companies have yet to reach an agreement on the total expected claims amount and the level of financial sharing.

 

“The drug passed DREC review in July, but its drug price negotiations started in August,” said a pharmaceutical industry official who requested anonymity.

 

“Considering the 60-day drug price negotiation period, it is likely that the negotiation period will end in early October.

 

Since it was not listed in October, the drug is expected to be applied for reimbursement at the end of this year at this timeline.”