Keytruda is reimbursed as first-line at ₩2,107,642

HIPBC deliberates and approves reimbursement of 3 new drugs and 1 reimbursement expansion

Xospata ₩214,100… Lutathera ₩22,104,660

The insurance price of MDS Korea’s immuno-oncology drug Keytruda(pembrolizumab) inj.

 

that is used for non-small-cell lung cancer and Hodgkin lymphoma will drop 25.6% with its reimbursement extended from the second-line to the first-line starting next month, Astellas Korea’s Xospata 40mg (gilteritinib), as well as Novartis Korea’s Lutathera Inj.

 

that was supplied in Korea as an urgently requested drug will also be individually listed for reimbursement as an expenditure-cap type RSA after reaching an agreement with the National Health Insurance Service.

 

The Ministry of Health and Welfare announced on the afternoon of the 25th that it had deliberated and passed the ‘amendment to the drug benefit list and the maximum ceiling price table (draft)’ that contains the changes above as an agenda at the 5th Health Insurance Policy Deliberation Committee.

 

◆Keytruda(pembrolizumab) = The immuno-oncology drug Keytruda, which is indicated for the treatment of non-small-cell lung cancer and Hodgkin lymphoma, was listed as second-line treatment in August 2017, and then received an indication extension in February 2018.

 

The company had applied for the reimbursement expansion to the Health Insurance Review and Assessment Service in October 2019 and received deliberation from the Cancer Disease Deliberation Committee on April, August, November 2020, and on May 7th last year.

 

In January of this year, HIRA’s Pharmaceutical Reimbursement Evaluation Committee deliberated and passed Keytruda’s reimbursement expansion agenda.

 

At the time, the PBAC judged that the ICER threshold (economic evaluation result) of Keytruda in NSCLC as monotherapy and as combination therapy in squamous and non-squamous NSCLC was appropriate, and that it was cost-effective as it costs less than its alternative brentuximab vedotin in Hodgkin's lymphoma.

 

Also, the committee considered that the drug was listed for reimbursement in all A7 countries.

 

The company afterward reached a final agreement with the NHIS under the Ministry of Health and Welfare’s negotiation order on the RSA drug price and expected claims amount by mid-February.

 

In the drug pricing negotiations, the company made a refund-type RSA agreement in which the company refunds a specific proportion of the claims amount and a proportion of the amount that exceeds the expected claims cap to the government.

 

Both parties have made an agreement to set the price at ₩2,107,642, a 25.6% discount from the current cap of ₩2,833,278 in consideration of the expanded scope of use, the standard for price cap adjustment, and its fiscal impact on insurance finances.

 

With the refund-type RSA applied, the NHIS expects the actual fiscal spending on the drug to be less than the expected claims amount..

 

◆Xospata Tab40mg (gilteritinib fumarate) = Xospata, which was approved for the treatment of acute myeloid leukemia, applied for reimbursement listing in November 2020 after receiving marketing authorization in March 2020.

 

After deliberation by CDDC in February and PBAC in September, HIRA judged that reimbursement was appropriate for the drug.

 

At the time, HIRA considered the fact that the drug is recommended in adult patients with FLT3-positive AML in clinical guidelines and that its cost-effectiveness also meets the pharmacoeconomic evaluation data exemption drug (PE exemption drug) conditions, and is listed in 5 of the 7 A7 countries – the US, UK, Germany, Italy, and Japan.

 

Relevant societies have also judged that the drug improved convenience in intake as an oral formulation and may become a new treatment alternative for the disease.

 

After passing HIRA review, the company completed drug pricing negotiations with the NHIS as a refund-type RSA.

 

In consideration of its price abroad and fiscal impact, the two parties agreed to set the price at ₩214,100 per vial.

 

◆Lutathera inj.(lutetium Lu 177 dotatate) = Novartis Korea’s Lutathera Inj is a radiolabeled somatostatin analog indicated for the treatment of gastroenteropancreatic neuroendocrine tumors.

 

The drug, which was approved in July 2020, was designated an urgently requested drug when it was first supplied in November 2019 without reimbursement and reimbursed from March 2020 ever since.

 

In November 2020, the company applied for its formal reimbursement listing to HIRA, and the authorities deliberated the case with the CDDC in April 2021 and with DREC in November of the same year.

 

At the time, HIRA considered the fact that the drug was recommended for the treatment of patients whose condition progressed after the current standard-of-care sandostatin lar (octreotide) in clinical guidelines (clinical efficacy aspect) and that the drug met the PE exemption criteria by applying at a price lower than the lowest A7 price(cost-effectiveness aspect), and that the drug is listed in 4 of the 7 A7 countries – the US, France, Japan, and Italy.

 

After passing HIRA review, the company completed drug pricing negotiations with the NHIS as a refund-type RSA at ₩22,104,660 per vial.