Delstrigo listed at ₩19,491 … Zejula’s price cut 6%

from next month

Passed the Health Insurance Policy Deliberation Committee review…Pifeltro priced at ₩7,975… Lynparza’s RSA contract renewed

MSD Korea’s fixed-dose combination product Delstrigo (doravirine·lamivudine·tenofovir disoproxil fumarate) will be listed with insurance benefit next month, at ₩19,491.

 

Also, reimbursement for Takeda Korea’s Zejula cap.

 

100mg (niraparib) has been extended to cover monotherapy for ovarian cancer, upon which the price was cut by 6% and will be reimbursed at the price.

 

The Ministry of Food and Drug Safety held a Health Insurance Policy Deliberation Committee (HIPDC) meeting today and passed the ‘proposed amendment to the drug benefit list and price ceiling table.’ The amended list and table will be effective from October 1st.

 

◆Pifeltro·Delstrigo tab.= MSD Korea’s Pifeltro tab(doravirine) and Delstrigo tab(doravirine·lamivudine·tenofovir) are oral HIV medications that are taken as one tablet, once daily.

 

One year after receiving approval from the MFDS on November 22nd, 2019, the company applied for insurance listing of the two products in December last year and received deliberation for the insurance benefit by HIRA’s Pharmaceutical Benefit Assessment Committee in early June.

 

Delstrigo tab(doravirine·lamivudine·tenofovir disoproxil fumarate르).

At the time, the PBAC determined the drugs to be cost-effective, as they are recommended for the treatment of HIV infections in textbooks and clinical practice guidelines and accepted the price of less than 90% of the weighted average price of its alternatives.

 

The alternatives to Pifeltro are the non-nucleoside reverse transcriptase inhibitors Stocrin and Edurant tablets.

 

And alternatives to Delstrigo are 2 NRTI + NNRTI combo therapies such as Triumeq and ‘Troubadour+stocrin, ‘Descovy+Edurant’.

 

Pifeltro is listed in all A7 countries abroad, and its weighted average price is ₩24,099 per tablet.

 

Delstrigo is listed in the U.S, France, Germany, Italy, U.K, Switzerland among the A7 countries, and is its weighted average price is ₩36,483 per tablet.

 

In the same month, the company had made negotiations with the National Health Insurance Service on the amount of expected claims of each drug.

 

The NHIS expected no additional funds The final listed insurance price of each drug was set at ₩7,975/ tablet for Pifeltro and ₩19,491/tablet for Delstrigo.

 

◆Lynparza 100mg and 150mg = AstraZeneca Korea’s Lynparza tab(olaparib) is a treatment for ovarian cancer including fallopian tube cancer or primary peritoneal cancer.

 

The drug was listed through the risk-sharing agreement scheme (RSA) in October 2017, using the pharmacoevaluation exemption system.

 

However, its reimbursement was first only allowed for up to 15 months as maintenance therapy after chemotherapy, and then the restriction was lifted in May 2019 after discussions between the government and the company to extend reimbursement.

 

After then, the company received MFDS approval on October 29th 2019 and applied for insurance benefits in January 2020.

 

In June of the same year, the agenda was deliberated by HIRA’s Cancer Drug Review Committee, but the company had to reapply for reimbursement in October of the same year.

 

The drug was finally put on the agenda for deliberation by HIRA’s PBAC in April this year.

 

In April, the PBAC confirmed that the drug prolonged PFS compared to placebo from a clinical trial.

 

Also, the committee decided that the ICER is at an acceptable level for use as first-line maintenance therapy and that the drug was cost-effective as second-line maintenance therapy as it cost less than its alternatives, Lynparza cap, and Zejula cap.

 

The adjusted price of Lynparza tab that is listed in all A7 countries is ₩62,062 for the 100mg tab and ₩67,911 for the 150mg tab.

 

Based on the calculated price, the company had been negotiating with the NHIS on the drug’s price and expected claims amount.

 

During the pricing negotiations, both parties agreed on incorporating two types of reimbursement where the company pays back to NHIS a specific portion of the claims amount and a specific portion of the amount of claims that exceed the expected cap.

 

The final price was set at ₩38,842 for 100mg and ₩48,553 for the 150mg dose.

 

Zejula cap.

 

100mg (niraparib).

◆Zejula cap.

 

100mg = Like Lynparza, Takeda Korea’s Zejula cap 100mg(niraparib) is also a treatment for ovarian cancer including fallopian tube cancer or primary peritoneal cancer that is already receiving reimbursement for the indication.

 

200mg of the targeted therapy is taken orally twice a day and has been reimbursed as second-line maintenance therapy for ovarian cancer since December 2019, and the reimbursement has been extended to treat patients with recurrent ovarian cancer who have received 3rd-line or higher chemotherapy since February this year.

 

This time, discussions had been held to extend reimbursement to maintenance monotherapy in ovarian cancer for patients who have responded to first-line platinum-based chemotherapy.

 

The company succeeded in adding the indication by MFDS on August 3rd last year and has requested an extension of reimbursement in the same month.

 

In January, the drug has passed CDRC deliberations and was deliberated by the PBAC in June.

 

At the time, HIRA had determined for reimbursement is appropriate as the drug is recommended as maintenance therapy in ovarian cancer patients who have responded to first-line platinum-based chemotherapy and is cost-effective as it is cheaper than alternative drugs.

 

Also, it is listed in the U.S, France, Japan, Italy, U.K, Switzerland among A7 countries and its weighted average price is set at ₩129,886 per tablet Since then to earlier this month, the company had negotiated with the NHIS on the drug’s price and expected claims amount.

 

Both parties had agreed that the company should pay back a specific portion of the amount of claims that exceed the expected cap, and the price to be set at 6% lower than the current cap of ₩74,184 and at ₩69,733.