Two points to note in Kymriah’s reimbursement process

for the drug that passed HIRA review

Approved at an unprecedented pace compared to other innovative new drugs… result of proactive engagement of patients, government, and pharmaceutical companies

Passed DREC review 10 months after approval in Korea… RSA performance-based coverage restriction waived for lymphoma patients

The era where a single shot can cure one’s cancer may be imminent, but with a catch: The single-shot would cost ₩500 million.

 

Novartis’s novel CAR-T therapy ‘Kymriah (tisagenlecleucel)’ cleared all the steps necessary for reimbursement under the Health Insurance Review and Assessment Service by receiving approval on its adequacy of reimbursement at the ‘1st Drug Reimbursement Evaluation Committee meeting’ on the 13th this month.

 

Although another hurdle -the drug price negotiation process with the National Health Insurance Service - still remains, Kymriah’s passing of the DREC review was in itself an encouraging event.

 

The case is also notable in terms of its speed in review and reimbursement criteria.

 

◆10 months after MFDS review…Result of ‘longing’ and need Kymirah’s insurance reimbursement listing process was in itself a hot issue.

 

In its every step from reimbursement application, HIRA’s Cancer Disease Deliberation Committee review, to DREC review, the issue caught the attention of the industry, patients, and the media.

 

The drug started its reimbursement listing process under the approval-reimbursement evaluation linkage system in March last year after receiving MFDS approval.

 

6 months later, the agenda was put up for deliberation by the CDDC but deferred.

 

As soon as the results were released through the media, the Korean Alliance of Patient Organizations among others issued a statement condemning the government and the pharmaceutical company.

 

The patient association had before criticized the delay in CDDC review of Kymriah’s reimbursement.

 

Kymriah finally passed the CDDC review in October of the same year.

 

This was also the first day HIRA disclosed CDDC results.

 

And then, Kymriah passed review at the first DREC meeting held in 2022.

 

Statements from KAPO and other associations had poured out at the news of Kymirah’s agenda being deliberated at the DREC meeting.

 

Another drug that received good news on the same day with Kymriah was MSD’s immunotherapy drug ‘Keytruda (pembrolizumab),’ which awaited 5 years (to extend its reimbursement to first-line in non-small-cell lung cancer).

 

For patients in dire need, even the 10 months spent waiting for Kymirah would have been too long.

 

However, considering the average time spent on listing innovative new drugs in Korea and even taking into account the disease and number of patients that benefit from the two drugs, Kymriah’s reimbursement progressed quickly.

 

This progress is highly likely due to a combination of the patients’ ‘desperate longing’ and execution ability.

 

The government would have felt some burden.

 

In addition, Novartis Korea’s efforts in presenting a fiscal-sharing plan through the persuasion of its headquarters are also expected to have played a part.

 

◆Pediatric B-ALL indication is excluded from being applied the performance-based restriction Also, it is notable that the reimbursement standard set by DREC for B-Acute Lymphoblastic leukemia (B-ALL) is relatively lenient among Kymriah’s 2 indications.

 

Kymriah’s indication is for the treatment of ▲ adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy, and ▲ patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse.

 

Kymriah, which is going through the reimbursement listing process through the pharmacoeconomic evaluation exemption system, is applied the expenditure cap type of Risk Sharing Agreement (RSA) scheme.

 

As it is an ultra-high-priced new drug, the prevailing industry assumption was that additional restrictions would be set for its reimbursement in addition to the expenditure cap.

 

This is in line with the government’s plan to converge performance-based type and the expenditure cap type of RSA as an alternative necessary for expanding coverage of high-priced new drugs.

 

As expected, the performance-based type was additionally applied to the DLBLC.

 

indication.

 

The performance-based type limits reimbursement of drug expenditures according to treatment effectiveness after administration.

 

However, no other options were set to restrict reimbursement of Kymriah other than the expenditure cap for the B-ALL indication.

 

Although limited to B-ALL, this could be seen as the government’s allowance of a freer administration of Kymriah in the disease.

 

In such various aspects, Kymriah’s every step of the reimbursement progress is receiving attention Whether the effective but expensive Kymriah can push through the remaining processes and get its name on the reimbursement list remains to be seen.