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Industry anxiously awaits reimb of SGLT-2 inhibitors
by Jung, Sae-Im Jul 06, 2023 05:39am
The reimbursement applications that companies of SGLT-2 inhibitors filed to receive reimbursement for their heart failure indication are expected to undergo a difficult journey. The largest barrier to their reimbursement is the concern over the enormous amount of fiscal spending the drugs will bring due to the broad target patient group. According to industry sources on the 4th, the representative SGLT-2 inhibitors ‘Forxiga (dapagliflozin)’ and ‘Jardiance (empagliflozin)’ are working to extend their reimbursement from diabetes to heart failure. Forxiga has applied for the reimbursement of its heart failure reduced ejection fraction treatment indication and plans to apply for reimbursement of its heart failure with preserved ejection fraction indication that it has recently received approval for within the month. Jardiance filed an application for the reimbursement of all types of heart failure regardless of ejection fraction. In addition to diabetes, SLGT-2 inhibitors have already risen as the ‘backbone’ drug in heart failure as well. Not only has the drugs demonstrated excellent effect in heart failure with reduced ejection fraction, but they also reduced the risk of cardiovascular death or exacerbation of heart failure in heart failure with preserved ejection fraction, an area for which no treatment option existed. The rise of the two drugs has also changed the treatment guidelines for chronic heart failure. In the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure that the 3 major heart societies in the U.S. – American College of Cardiology, American Health Association, and the Heart Failure Society of America – that was released last year, the societies gave a Class 2A recommendation for SGLT-2 inhibitors to treat heart failure with mild, reduced, preserved ejections. The Korean Society of Heart Failure also recommended SGLT-2 inhibitors to reduce hospitalization or cardiovascular death due to heart failure in patients with preserved ejection fraction, regardless of diabetes mellitus (recommendation grade 1). This is why experts have been emphasizing the need for the reimbursement of SGLR-2 inhibitors for heart failure. At the Forxiga press conference hosted by AstraZeneca Korea on the 3rd, Professor Jong-Chan Youn of the Catholic University of Korea’s Seoul St. Mary’s Hospital, said, “One out of four patients diagnosed with severe heart failure die within a year of hospitalization. This is why these patients need to use a drug that shows a clear improvement in prognosis from the beginning, which is what SGLT-2 inhibitors do. However, most outpatients do not use SGLT-2 inhibitors for their heart condition due to reluctance in using non-reimbursed treatment options. These patients then experience gradually worsening symptoms and are in dire need of improvement in their prognosis, which is why the SGLT-2 inhibitors need to be reimbursed.” The concern is NHI finances. A sizable amount of NHI finances need to be invested for their reimbursement extension to heart failure. According to the Health Insurance Review and Assessment Service, the number of patients that received treatment for heart failure exceeded 150,000 in 2021. This is a 35,000 increase from 5 years ago. The number of patients with heart failure is expected to increase further due to the rapid population aging in Korea. Seok-min Kang, President of KSHF (Professor of Cardiology at Yonsei Severance Hospital), said, “As the president of KSHF, I have actively expressed my opinion on extending reimbursement to new drugs for heart failure. However, the government’s main concern is that too much finances will be spent due to the indiscriminate use of the drugs after reimbursement. Academically, these are most definitely effective drugs, but the government is reluctant to grant reimbursement due to financial concerns.” The reimbursement of SGLT-2 inhibitors went through the same sluggish progress in diabetes as well. SGLT-2 inhibitors are only allowed reimbursement in combination with some drugs such as metformin, and even these are limited to two-drug combinations. It took 8 years of discussion and persuasion to extend reimbursement for SGLT-2 inhibitors in diabetes. The health authorities had recently discussed reimbursement of heart failure treatment, but Entresto was the only drug that was granted reimbursement extensions. The discussion ended with only a partial extension of the reimbursement standard for Entresto, a drug that is already receiving reimbursement for heart failure with reduced ejection fraction. The authorities were unable to make a decision on the reimbursement extension for Forxiga and Jardiance. Pharmaceutical companies claim that granting reimbursement of SGLT-2 inhibitors will result in the saving of health insurance finances as they will be provided at cheaper prices than existing treatments. They are referring to the price of Entresto, which is priced at KRW 1,774 per tablet. Taken twice a day, Entresto costs KRW 3548 a day. On the other hand, Jardiance (KRW 660) and Forxiga (KRW 734), which are taken once a day, are 1/5 the price of Entresto. However, unlike Entresto, which is only reimbursed for heart failure with reduced ejection fraction, SGLT-2 inhibitors treat all heart failures, therefore, their cheaper price cannot directly translate to financial savings. Also, the recent ‘4 pillars’ strategy that has been presented for heart failure combines the use of 'ARNI/ACEI', 'beta blockers', ''mineralocorticoid receptor antagonists', and 'SGLT-2 inhibitors,’ therefore, the SGLT-2 inhibitors cannot act as a direct substitute for Entresto. Adding on to the injury, Forxiga is embroiled in a drug price reduction lawsuit with the health authorities. Therefore, there also is an opinion that it would be realistically difficult to extend its reimbursement until the lawsuit is completed. Nevertheless, the societies emphasized the need for the government to actively establish comprehensive management measures for chronic diseases, including heart failure. Kang said, “As much as it is important for pharmaceutical companies and the government to reach a consensus, the government also needs to pay more attention and enable the use of good treatments for chronic conditions to be used with reimbursement.”