The issue regarding reimbursement standards set for pulmonary arterial hypertension drugs finally bore fruit three years after experts in Korea including the Korean Society of Cardiology, Korean Pulmonary Hypertension Society, The Korean Society of Hypertension, and The Korean Academy of Tuberculosis and Respiratory Diseases publicized the issue.

The accumulated academic evidence presented by the academic societies on how the active use of combination therapy in the early stages directly translates to improved prognosis has shifted the government to actively embrace the data.

According to societies including KSC on the 21st, the Ministry of Health and Welfare will be amending the standards for reimbursement of pulmonary arterial hypertension drugs and apply the changes from February.

The average 3-year survival rate of patients with pulmonary arterial hypertension in Korea is 54.3%, ranking the lowest among OECD countries. One of the main reasons attributable to this is considered to be the fact that combined use of drugs is only allowed for reimbursement in high-risk patients in Korea, unlike global clinical practice guidelines that recommend combination therapy from the early stages of treatment.

The relevant academic societies’ efforts since 2019, such as holding NA debates, releasing a Korean clinical treatment guideline, proposing improvements to relevant institutions worked as momentum and recently brought rapid change in the reimbursement guidelines.

In the amendment announced by the MOHW, the phrase “Use of two-drug combinations are recognized for patients who have used monotherapy for over 3 months and saw an inadequate clinical response, who may use combination therapy by adding one more drug with a different mechanism of action” remains the same.

However, the criteria used to judge clinical response were eased greatly compared to before, with reference to the guidelines overseas.

The standard of the 6-minute walking distance that was set at ‘less than 300 meters’ was amended to ‘less than 440 meters,’ and the standard that patients should belong to ‘Class IV pulmonary hypertension’ under the WHO Functional Classification was eased to ‘Class III or higher.’

Also, the Peak O2 consumption level was set to ‘below 15mL/min/kg, alleviated from ‘below 12mL/min/kg’; the diagnostic index for acute respiratory distress or heart failure BNP/NT-proBNP set to ‘50/300 or higher’ from the ‘300/1800 or higher’; Hemodynamics index to ‘RAP 8mmHg or higher or below CI 2.5L/min/㎡’ from the ‘RAP over 15mmHg or CI 2.0L/min/㎡or less.’

This corresponds to the intermediate-risk group under the 3-stage evaluation criteria that classify patients as low/intermediate/high-risk groups that was proposed by the Special Committee for the Establishment of Practice Guideline for Pulmonary Hypertension in 2020. In the past, only high-risk group patients were allowed to benefit from using the combination therapy, but the improved standards now allow moderate-risk patients to use combination therapy for their conditions as well.

Patients who also satisfy at least one of the following criteria - ▲clinical evidence of right ventricular failure ▲speed of symptom progression ▲syncope ▲WHO Functional Classification – as well as at least one of the following criteria - ▲BNP/NT-proBNP ▲echocardiography findings ▲Hemodynamics index – at the same time may add one more type of drug with a different mechanism of action that was not used in the two-drug combination therapy.

In the past, only selexipag oral tablets were recognized for reimbursement, but the scope was extended to drugs with other mechanisms of action.

Regarding such change, the academic society’s response is that ‘the most urgent issue has now been addressed’

Jae-Hyeong Park, Professor of Cardiology at Chungnam National University Hospital, said, “the standards set to judge the clinical response in patients have been greatly alleviated. This closely corresponds to the amendment proposed by the society, so I believe many inconveniences in practice will be resolved.”

Park added, “I would like to express gratitude to the health authorities for accepting most of the content in the latest guidelines of overseas academic societies," adding, It would have been better if the use of three-drug combinations were also allowed for initial patients whose condition worsens greatly, but still, this is a big change.”