oHCM drug Camzyos's last hurdle to reimb remains high

NHIS decides to extend drug price negotiations for the oHCM drug

Government and pharmaceutical company disagree over patient numbers, etc.

The reimbursement journey for ‘Camzyos’, which is seeking insurance reimbursement in Korea, is going to be a rocky road until the end.

 

According to industry sources, the drug pricing negotiations between BMS Pharmaceuticals Korea and the National Health Insurance Service (NHIS) for the obstructive hypertrophic cardiomyopathy (oHCM) drug Camzyos (mavacamten) have been extended after failing to finalize the deal within the deadline.

 

The deadline extension was primarily due to a disagreement over the number of patients eligible for Camzyos.

 

Camzyos’ reimbursement journey faced difficulties, receiving a redeliberation decision from the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee.

 

The drug passed the committee and entered pricing negotiations in August, but the negotiations were not concluded within the 60-day deadline.

 

Camzyos is the first and only cardiac myosin inhibitor that specifically targets excess cross-bridge formation of myosin and actin proteins, the main cause of oHCM.

 

It improves left ventricular hypertrophy and left ventricular outflow tract obstruction by separating myosin from actin, relaxing the overcontracted heart muscle.

 

Due to the lack of a cure, oHC has long been managed with off-label drug use.

 

In fact, the European Society of Cardiology (ESC) revised its HCM guidelines for the first time in 9 years with the introduction of Camzyos.

 

Before then, HCM guidelines have been based on small observational data reported from individual institutions, retrospective analyses, or expert consensus opinions.

 

Therefore, Camzyos was a game-changer in the field.

 

After demonstrating its significant effect in two large-scale Phase III randomized controlled trials (RCTs), Camzyos was recommended at the highest evidence level, A, for the first time among treatment options in the ESC guidelines.

 

The American College of Cardiology (ACC) and American Heart Association (AHA) are also currently preparing to update their guidelines.

 

Based on the Phase III trial data, Camzyos received a breakthrough therapy designation (BTD) and was approved by the US FDA.

 

In the Phase III EXPLORER-HCM trial, which served as the basis for Camzyos’s approval, Camzyos achieved and improved the primary composite endpoint of the proportion of patients with decreased symptom burden (by NYHA class) and functional capacity (peak oxygen consumption, pVO2) by more than 2 times compared with placebo.

 

In particular, 20% of the patients who received treatment with Camzyos achieved both primary endpoints, pVO2 improvement, and the NYHA class requirement.

 

Also, the dynamic left ventricular outflow tract obstruction was reduced by over 4 times with the use of Camzyos.

 

7 out of 10 patients treated with Camzyos improved to the extent that they would not consider surgery, and showed consistent benefits over 30 weeks.

 

“Many patients with oHCM have been anxiously awaiting a new drug due to the lack of a suitable treatment,” said Hyung-Kwan Kim, Professor of Cardiology at Seoul National University Hospital.

 

“In particular, expectations for the drug's reimbursement have increased since it was approved by DREC in July, and we hope that the remaining procedures will be completed as soon as possible so that patients and their caregivers in Korea can benefit from the use of the new drug.”