‘Pay more policy attention to advanced heart failures'

Large amount of barriers and limitations still remain in the field

[Meeting with Academic Societies]Soo-Yong Lee, Assistant Administrator of the Insurance Committee at KSF

[Interview with Medical Societies] Soo-Yong Lee, Administrative Secretary of the Insurance Committee at KSF Asks authorities to increase benefits for patients at high risk of health failure who have fewer treatment alternatives According to the ‘2020 Heart Failure Fact Sheet’ that was released by the Korean Society of Heart Failure (KSHF), Korea’s prevalence of heart failure in Korea had increased threefold in 16 years from 0.77% of the total population in 2002 to 2.24% in 2018 to exceed 1 million patients.

 

Although drug options that can intervene in the early stages of heart failure have been increasing, options are still limited for severely ill patients with prior hospitalization experience.

 

Therefore, Soo Yong Lee, Professor of Cardiology at Pusan National University Yangsan Hospital (Administrative Secretary, Insurance Committee, KSF) believes that appropriate policy intervention is needed in terms of patient benefits and insurance finance.

 

Soo-Yong Lee, Assistant Administrator of the Insurance Committee at KSF

#In particular, Professor Lee stressed how heart failure has a lower survival rate than most cancers.

 

“The overall survival period of patients with heart failure is 2.6 years for first hospitalizations, 1.8 years for second hospitalizations, and 1.5 years for third hospitalizations.

 

This means that the number of hospitalizations is proportional to the mortality rate of the patients, and 1-2 out of 4-5 patients are re-hospitalized within a month in practice.” Lee further explained that hospital readmissions also impose further financial burdens on the patients.

 

The total medical expense paid by patients with heart failure who have experienced at least 1 hospitalization is around KRW 8-9 million per year, and the burden increases further if the patient’s condition requires the use of an intensive care unit or equipment for dialysis or ECMO.

 

In fact, according to the 2017-2021 health insurance treatment Rep.

 

Sun-woo Kang, member of the National Assembly's Health and Welfare Committee, received from the National Health Insurance Service, the number of patients treated for heart failure increased by 7.1% (158,916 in 2021) every year, increasing the treatment expense as well (an average of 15.6% in 5 years).

 

The heart failure treatment paradigm has been changing with recent studies being conducted on reducing the mortality rate in patients with chronic, therefore, stable heart failure and the introduction of ARNi drugs.

 

Lee said, “Recent studies have focused on how much the condition improves when drugs are used in acute patients after treatment and when drugs are used immediately after stabilization.

 

With the release of SGLT2is and ARNis, the current trend is leaning towards the early use of such treatments” Re-hospitalization of patients despite the availability of early treatment options remains a concern..."Need to improve the treatment environment" However, despite the development of early treatments, the number of readmitted patients has increased constantly due to various factors including the lack of patients' compliance.

 

One treatment that can be considered for use in this situation is vericiguat (product name Verquvo), and the KSF has been highly recommending it with a Class Ⅱa recommendation for preemptive use when a patient’s heart failure worsens even after ample standard therapy.

 

The VICTORIA trial that became the basis of Verquvo’s approval drew attention because it enrolled patients who have recent hospitalization history and have been hospitalized at least once.

 

Compared to most studies of other heart failure drugs that are conducted on chronic patients with good symptom control and low readmission rates, Verquvo’s patient group fundamentally has a higher mortality rate than other studies.

 

Lee said, “In the VICTORIA study, 66.9% of patients were hospitalized for heart failure within 3 months, and 85.7% were HFrEF patients with a left ventricular ejection fraction of 40% or less.

 

The study itself was a brave attempt as most of them were in a very bad condition, to the extent that no drugs would have been effective for them.” Study results showed that Verquvo reduced the risk of death from cardiovascular disease or first hospitalization due to heart failure by 10%, and achieved a 4.2% reduction in annualized absolute risk.

 

Regarding the results, Lee explained that “Patients in the high-risk group used to have a poor prognosis.

 

They were prescribed dobutamine before and are discharged if they seem better, and had to repeat hospitalization due to cardiac arrest until death or await heart transplantations.

 

The study showed that its NNT was 24, which means that 1 out of 24 patients could be discharged because their symptoms improve after using the treatment, which is a very good figure and the best level achieved among heart failure drugs.” He added, “The drug holds great clinical significance as it gives high-risk patients the opportunity to leave the hospital.

 

"In my practice of treating many patients with end-stage heart failure, Verquvo is definitely a welcome rain in the drought.” Emphasis on its benefit in patients at high risk of heart failure...will reimbursement discussions for Verquvo make progress?

 

According to industry sources, Verquvo’s reimbursement has passed review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee and is awaiting to be deliberated by the Drug Reimbursement Evaluation Committee.

 

To add its support, the KSHF has also conveyed its opinion regarding the expansion of Verquvo’s reimbursement standards as its role in the field is clear.

 

Based on the VICTORIA trial, the KSHF expects that 10,000 to 15,000 patients can be treated with Verquvo every year.

 

In particular, Lee judged that when the drug is administered to the high-risk group, this may reduce the need for a heart transplant or hospitalization in an intensive care unit, which can also provide benefits in terms of cost.

 

He said, “The biggest feature of Verquvo is that it has confirmed its effectiveness in severely ill patients.

 

When considering how patients with the LVAD indication incur KRW 150 million to KRW 250 million as expenses every time they use LVAD, if the drug can reduce the frequency of hospitalization or death, reimbursement would also be reasonable in terms of saving insurance finances.” However, Lee expressed concern over how the application of excessively restrictive reimbursement standards may act as a barrier to its use for patients even if the drug is positively considered for reimbursement in the future.

 

In the VICTORIA clinical trial, about 60% of the patients received the three-drug therapy that included RAAS inhibitors.

 

Patients who experienced worsening conditions despite being administered standard therapy according to the patient’s clinical condition were also allowed to use Verquvo in the trial, and therefore this indication may also be reflected in its reimbursement standards in the future.

 

However, as standard therapy treatments are used in primary medical institutions in the early stages of heart failure, a barrier may arise for patients where they may not be eligible to use Verquvo even after being transferred to a general hospital or a tertiary hospital due to set reimbursement standards.

 

Lee said, “I think Verquvo is a necessary drug for patients in the advanced stage, such as those who have used intravenous diuretics or have been hospitalized for heart failure.

 

As a clear patient population exists for the drug, its reimbursement standards should be set promptly in consideration of the urgent need and allow its use in patients who experience worsening heart failure events after standard treatment.”