"Camzyos, reimbursement would benefit gov and patients"

Hyung-Kwan Kim, Professor of the Department of Internal Medicine at SNU Hospital

"Patients who received non-reimbursed treatments have shown improvements up to 100%"

"Prescribing treatments that are not effective would only exacerbate the symptoms of patients."

Hyung-Kwan Kim, Professor of the Department of Internal Medicine at Seoul National University Hospital

The reason for delayed drug development in a particular disease typically falls into one of two.

 

It’s either low awareness of the disease or challenges to drug development.

 

Despite falling into these two categories, 'Camzyos (mavacamten)' was developed.

 

It is a first-in-class targeted treatment option for obstructive hypertrophic cardiomyopathy (oHCM).

 

oHCM is a rare heart disease characterized by thickened heart muscles that cause narrowing or obstruction of the left ventricular outflow tract (LVOT).

 

Not only does it cause abnormality in heart structure, but it decreases heart function.

 

The symptoms include shortness of breath, chest pain, dizziness, and fainting.

 

It is a fatal disease that could cause cardiovascular complications and sudden cardiac death.

 

Furthermore, there has been a lack of disease-modifying treatment besides short-term management of symptoms.

 

Thus, the development of Camzyos, which works by significantly reducing cardiac myosin actin cross-bridge formation, was exciting news to doctors.

 

However, the concern is whether it could be covered by insurance reimbursement.

 

Although Camzyos was approved in South Korea in May of last year, it has not yet been covered by reimbursement.

 

BMS is pursuing an application for the drug’s listing and is awaiting the review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA).

 

Daily Pharm interviewed Hyung-Kwan Kim, Professor of the Department of Internal Medicine at Seoul National University Hospital, about Camzyos’ value and the necessity of reimbursement.

 

-HCM diagnosis has increased following the expansion of reimbursement criteria for cardiac ultrasonography.

 

Has the diagnosis rate increased in the real-world?

 

What is the patient size of HCM in Korea? We don’t have accurate data for Korea yet, but the National Health Insurance Service (NHIS) data shows that the number of patients who are diagnosed with HCM has increased since 2010.

 

Between 2010 and 2016, the number of HCM patients doubled.

 

The increase in diagnosis rate may have been due to the routine health examination in Korea: cardiac ultrasonography can be added to the examination option.

 

This supports the trend since the number of diagnoses has increased, particularly among patients over 50.

 

-It seems that there is a low level of awareness among medical personnel regarding oHCM. In fact, due to the lack of effective treatments for HCM, awareness of the condition has been low, and research has not been very active.

 

Even if someone showed signs of suspected HCM or received a diagnosis, the lack of available therapies meant that coordinated care across tertiary healthcare facilities was almost non-existent.

 

Patients were typically advised to manage their symptoms and avoid strenuous exercise, as no competitive treatment options were available.

 

-The development of Camzyos must be particularly meaningful. Previously, beta-blockers and calcium channel blockers were commonly used to treat oHCM.

 

However, these medications do not target the pathophysiological mechanisms of oHCM, leading to limited effectiveness, and many patients do not experience significant improvement.

 

Disopyramide was previously used but is no longer recommended due to its side effects.

 

Furthermore, since it is not prescribed in South Korea, there are few options for treating oHCM.

 

Medical professionals couldn't help but have high expectations when Camzyos became available.

 

Initially skeptical, I found the clinical data remarkably convincing regarding effectiveness.

 

Even data from patients treated with Camzyos abroad showed significant changes in cardiac ultrasonography findings.

 

Among the seven patients under my care who received Camzyos, almost all showed improvement to the extent that it could be 100%, with effects evident within a month.

 

-The clinical results of Camzyos demonstrated improved exercise capacity in oHCM patients.

 

How significant is this result? Exercise capacity can be categorized into objective measures that can be quantitatively assessed and subjective measures that patients evaluate based on their experience.

 

In clinical studies, Camzyos significantly improved both of these indicators.

 

The subjective indicators of patients currently undergoing Camzyos treatment have also improved across the board.

 

NYHA classification has improved by at least one level, with some cases improving from grade 3 to grade 1.

 

In addition to exercise capacity, cardiac function can be evaluated by checking NT-proBNP levels through blood tests.

 

Among the patients under care, those with elevated NT-proBNP levels at the start of Camgios treatment all experienced decreased NT-proBNP levels.

 

Some patients saw remarkable effects, with NT-proBNP levels dropping from 2,000 to 3,000, within the normal range after just one month of Camzyos treatment.

 

-Last year, the European Society of Cardiology (ESC) updated its guidelines for the management of cardiomyopathy for the first time in about 9 years since 2014, adding recommendations for the treatment of Camzyos.

 

What do you think about this? It's promising.

 

I had hoped it would be recommended as a first-line treatment, but ESC seemed to take a conservative approach.

 

Considering the nature of ESC guidelines, where first-line recommendations are not often made right away, there is ample possibility for Camzyos to be recommended as a first-line therapy in the future.

 

-It sounds like Camzyos could possibly be a first-line treatment. Yes.

 

Considering the pathophysiological mechanism of oHCM, I believe it is important for Camzyos to become the first-line treatment option in the long term.

 

This way, we can reduce the unnecessary time and medical expenses of patients who use ineffective medication for 2-3 months.

 

-The concern is that Camzyos is still a non-reimbursed drug.

 

There must be disappointments in the real-world.

 

oHCM is associated with a higher risk of stroke because atrial fibrillation and aneurysms of the left ventricle are not uncommon even in younger age groups.

 

In the case of a oHCM patient in his late 40s, who had no symptoms at all, an aneurysm was found in a screening test conducted every 2-3 years.

 

Currently, in Korea, NOACs (new oral anticoagulants) cannot be used to prevent stroke with aneurysms alone, and warfarin must be used, which requires continuous monitoring when administering warfarin, which is very difficult.

 

So, I explained to the patient that I thought oHCM caused the aneurysm and suggested surgery or treatment with Camzyos.

 

In the end, the patient opted for Camzyos treatment, and within one month, what appeared to be a pericardial aneurysm improved, and the condition of the heart that had been obstructed improved.

 

If he hadn't been treated for Camzyos, his aneurysm would have become stuck, increasing his risk of stroke, and he would have been forced to stay in the hospital and suffer from shortness of breath while being treated with ineffective medications.

 

If Camzyos is covered by reimbursement, patients with similar difficulties will be able to receive many benefits and help.

 

However, it seems that there are many difficulties in discussing reimbursement adequacy with previous treatment options as a comparison.

 

In the real-world practice of medicine, many patients are unable to take their medications due to high non-reimbursement costs and are just waiting for reimbursement.

 

-Camzyos is awaiting the DREC review.

 

As mentioned before, medical personnel voice that there are no comparable treatments to Camzyos.

 

What should government consider when determining the reimbursement? From a short-sighted point of view, reimbursement listing of a drug may seem like a disadvantage in health insurance finances, but if we expand our view on a macro level, we can see that this is not the case.

 

If left untreated, patients with oHCM are at increased risk of developing heart failure, which inevitably increases the direct and indirect health care costs.

 

In addition, an aneurysm increases the risk of stroke, which adds the cost of hospitalization to the cost of stroke medication.

 

These costs can be considered in the long run as more patients are treated with Camzyos before complications occur.

 

If their condition improves, the additional costs associated with emergency room admissions and treatment for other complications can be reduced.

 

Ultimately, patients, doctors, and health authorities can benefit from each other.