Fexclu reimb at ₩939, Kadcyla reimb extended from July

MOHW puts agenda up for 14th HIPDC meeting… passes deliberations

Four items including Daewoong Pharmaceutical’s Fexclu Tab (fexuprazan hydrochloride) will be listed at ₩939 per tablet starting next month as latecomers of the homegrown novel drug K-CAB indicated to treat erosive gastroesophageal reflux disease (GERD).

 

Also, reimbursement of Kadcyla (trastuzumab emtansine), Roche Korea’s second-line treatment for breast cancer, will be extended to cover its treatment as ‘adjuvant treatment of patients with early breast cancer after surgery’, and will accordingly receive a new drug price.

 

The Ministry of Health and Welfare held the 14th Health Insurance Policy Deliberation Committee meeting (Chair: 2nd Vice Minister of Health and Welfare, Ki-Il Lee) today (28th) and announced that the listing and reimbursement extension proposals for 2 new drugs and 1 previously listed drug have been passed after deliberation at the HIPDC meeting.

 

The listing of 4 latecomer fexuprazan hydrochloride drugs including Fexclu Tab 40mg, and reimbursement extensions of two items - Kadcyla inj.

 

100mg and 160mg – passed deliberations and will be applied reimbursement starting July 1st.

 

◆4 items including Fexclu Tab.

 

40mg = Four fexuprazan hydrochloride latecomers used to treat erosive gastroesophageal reflux disease (GERD) will be concurrently listed for reimbursement.

 

The 4 items are Daewoong Pharmaceutical’s Fexclu Tab, Hanall Biopharma’s Abcito Tab, Daewoong Bio’s We Cab Tab, and iN Therapeutics’ Veloxcab Tab.

 

The companies had received marketing authorization from the Ministry of Food and Drug Safety for their respective drugs from December 30th last year to January 11th of this year and applied for reimbursement listing from December 27th last year to January 13th of this year.

 

Upon receiving the reimbursement request, HIRA’s Drug Reimbursement Evaluation Committee reviewed the 4 drugs on the 12th of last month and passed the agenda on to the NHIS.

 

During deliberations, DREC decided that the four drugs’ clinical benefit is non-inferior to K-CAB, and is adequate for reimbursement at ₩939, which is 90% of the weighted average of its alternatives.

 

The NHIS then carried out negotiations on the expected claims amount of each item with the companies from May 25th to June 17th.

 

The drug price has been set at ₩939 per each 40mg strength tablet.

 

◆ Kadcyla Inj 100mg and 160mg = Kadcyla Inj, Roche Korea’s treatment for locally advanced or metastatic breast cancer, had been listed for reimbursement since August 2017.

 

This time, a reimbursement standard for Kadcyla to be administered ‘for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment’ will be added.

 

The company had received additional approval for the above indication on August 8th, 2019 from the MFDS, and requested a reimbursement extension on the same day to HIRA.

 

HIRA had deliberated on the agenda at the DREC meeting held on October 16th of the same year, on August 26th in 2020, and on February 10th.

 

DREC had set the reimbursement standards for Kadcyla in consideration of the reimbursement evaluations made abroad and the additional fiscal sharing plan proposed by the company, after which the DREC members discussed whether the drug should submit pharmacoeconomic evaluation data and be evaluated for its cost-effectiveness.

 

In the case of pharmacoeconomic evaluations, Kadcyla had significantly improved invasive disease-free survival compared to its alternative Herceptin (trastuzumab) and was required to demonstrate its cost-effectiveness.

 

After PE evaluations, DREC decided that the drug’s ICER level was within an acceptable range and is therefore cost-effective.

 

As a result, members at the DREC meeting passed Kadcyla in consideration of how its PE evaluation value was at an acceptable level compared with Herceptin and is listed for reimbursement in all A7 countries.

 

The company thereafter agreed with the NHIS on applying the Utilization cap / Fixed cost per patient type of RSA for Kadcyla's reimbursement, under which the company is required to refund the excess amount used to the NHIS.

 

The agreed price was set at ₩1,956,328 per vial for Kadcyla Inj 100mg, and at ₩2,930,920 for Kadcyla Inj 160mg.