Will the first oHCM drug Camzyos be reimbursed in Korea?

Will be deliberated by the Pharmacoeconomic Evaluation Subcommittee…starts reimbursement listing discussions in earnest

Whether its innovativeness as a treatment in a field without treatment options will be recognized remains the key to its reimbursement

The industry’s eyes are focused on the reimbursement review progress of Camzyos, the first treatment for obstructive hypertrophic cardiomyopathy.

 

Dailypharm’s coverage found that the pharmacoeconomic evaluations for Camzyos(mavacamten), BMS Pharmaceutical Korea's new drug for obstructive hypertrophic cardiomyopathy (oHCM), is now complete and that it will be submitted for review by the Health Insurance Review and Assessment Service's Pharmacoeconomic Evaluation Subcommittee next month (March).

 

Being the first treatment option in its field, many challenges are expected in its reimbursement approval process.

 

However, as the government has shown a willingness to improve the valuation process for new drugs, including providing preferential treatment for innovative new drugs, it remains to be seen whether this will positively impact Camzyos’s reimbursement process.

 

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.

 

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.

 

Based on these factors, Camzyos appears to meet the criteria for an innovative new drug announced by the government last year, where: ▲ there is no substitute or therapeutically equivalent product or treatment; ▲ has shown clinically meaningful improvement, such as a significant prolongation of survival period; ▲has received the Ministry of Food and Drug Safety’s GIFT (Global Innovative products on Fast Track) designation, US FDA’s Breakthrough Therapy Designation (BTD), and was approved through the European EMA’s Priority Medicines scheme (PRIME).

 

With reimbursement for the breast cancer drug Enhertu (trastuzumab deruxtecan) recently making progress by passing an unusual ICER threshold, attention is focused on whether Camzyos can follow suit.

 

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.