Ongentys listed at ₩2,515 & Prevymis at ₩145,000

On the evening of the 27th, a partial revision of criteria for pharmaceutical reimbursed list & upper limit amount will be revised

SK Chemicals' parkinson's syndrome treatment, Ongentys 50mg (Opicapone) will be listed at ₩2,515 per capsule starting October 1st.

 

MSD Korea's CMV infection and disease prevention drug Prevymis (Letermovir) 240mg was listed at ₩145,000, and Ferring Korea's infertility treatment, Rekovelle PFS (Follitropin delta) is applied at ₩71,494 per 12 μg/0.36 mL, starting next month (September 1).

 

The MOHW announced that a partial revision of criteria for pharmaceutical reimbursed list & upper limit amount table' with the above contents was presented to the general meeting of the Health Insurance Policy Deliberation Committee on the evening of the 27th, and that the deliberation was passed and resolved at midnight.

 

◆Ongentys= Ongentys Capsule is a standard therapy for Levodopa/Dopa decarboxylase (DDCI), which is a drug approved by the MFDS as an adjuvant treatment for Parkinson's syndrome patients with movement agitation symptoms that do not improve symptoms.

 

All.

 

By taking it once a day, the number of target patients in Korea reaches about 78,000.

 

The company received the application for insurance registration on November 29, as soon as it was approved, and was deliberated by the HIRA on May 7 this year.

 

At that time, the committee recommended this drug as a treatment for the indication in textbooks and clinical practice guidelines, and determined that it had clinical utility, and that clinical trials proved non-inferiority to drugs of the same mechanism.

 

The effect is non-inferior to that of alternative drugs, but the cost required increases based on the applied drug price.

 

Accordingly, it was judged that there was a benefit adequacy when the drug rating was accepted below the evaluation amount (weighted average price of alternative drugs).

 

Excluded countries are listed in the UK, Germany, and Italy among A7, with an adjusted average price of ₩4,957.

 

The company accepted the level of the evaluation amount as recommended by the Drug Review Committee, and agreed to negotiate drug prices with the NHIS to July 27th of the same month.

 

The drug price was agreed at ₩2,515, reflecting the price cuts of some alternative drugs.

 

Considering the number of patients using drugs, the NHIS is expected to charge about ₩6.8 billion in the first year, and there will be no additional financial requirements as alternative drugs exist.

 

The registration date and insurance coverage date were confirmed as of October 1, taking into account the domestic supply schedule of pharmaceutical companies..

 

◆Prevymis= Previmis is a drug that prevents cytomegalovirus (CMV) infection and disease in adult patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT), and has been approved by the MFDS on December 26, 2018.

 

The company applied for insurance registration on April 30, 2019, and discussed two times on January 20 and April 17 at the Economic Evaluation Subcommittee under the HIRA.

 

On May 7th, it was judged that it had the validity of reimbursement, and negotiated drug prices with the NHIS from the 27th of the same month to July 27th .

 

At that time, the committee was judged that it was recommended as a CMV infection prophylaxis for patients with allogeneic hematopoietic stem cell transplantation in textbooks and clinical practice guidelines, clinical trials showed improved clinical usefulness compared to unpreventive therapy, and cost-effectiveness was also evaluated economically compared to non-prophylaxis therapy (cost-effectiveness analysis, ICER).

 

Excluded Countries are listed in the A7 countries, and domestic fiscal impacts are expected to be claimed about ₩4.5 billion per year.

 

In summary, the NHIS and the company agreed on the insurance listing price with a 240mg content of ₩145,000 and a 480mg content of ₩238,700.

 

The registration date and insurance coverage date are September 1st.

 

◆Rekovelle PFS= This drug is a self-injectable pen used to induce superovulation for the purpose of infertility treatment, and was approved by the MFDS on December 27 last year.

 

The company applied for insurance registration on January 8th of this year, and the the commitee decided on a conditional non-reimbursement decision that if it accepted the weighted average price or less of the alternative drug through a deliberation on May 7th.

 

.The committee judged that it was published in related textbooks at that time, and it is recommended for inducing ovulation by stimulating follicle growth and development in clinical practice guidelines

 

.However, in the case of cost-effectiveness, compared to the four components of the same family follicle stimulating hormone injections (follitropin-α, follitropin-β, follitropin, urofollitropin), which are alternative drugs, the clinical usefulness is specific, and the cost is determined to be expensive based on the applied drug price

 

.It was recommended to accept the alternative drug at an amount below the weighted average price

 

.Among the A7 countries, it is listed in France, Germany, Italy, and the United Kingdom

 

.The adjusted average price is ₩133,497 for 12 µg content, ₩399,437 for 36 µg content, and ₩798,149 for 72 µg content

 

.The company accepted this and agreed to list the health insurance through negotiations with the NHIS from June 9 to July 30

 

.Considering the expected market share based on clinical usefulness, the estimated billing amount for the first year was agreed at around ₩1 billion

 

.The NHIS predicts that there will be no additional fiscal requirements because alternative drugs exist

 

.The date of registration and coverage of this drug is September 1st

 

.Vice Minister Kim Kang-rip said, "We expect to expand access to treatment as the burden of patient costs is eased by expanding the health insurance benefits for three medicines, including injections for inducing superovulation for infertility treatment."