Hemlibra's reimbursement criteria to be rediscussed

expectations rise for the reasonable amendment to meet patients' and HCPs' needs

Reimbursement standards will be deliberated by HIRA’s Pharmaceutical Standard Dept· Pediatric Department Special Review Committee for improvements

Other countries do not require prior ITI therapies… respects prescription rights and patients’ benefit

Interest is rising as the Health Insurance Review and Assessment Service (HIRA) plans to call an expert advisory meeting to discuss the more effective operation of immune tolerance induction (ITI·antibody removal) therapies.

 

At the end of this month, HIRA’s Pharmaceutical Standard Department plans to conduct deliberations to come up with reasonable improvement plans by comparing the review results regarding the revision of the reimbursement criteria for Hemlibra that was requested by academic societies and patient groups with cases overseas.

 

The deliberation that will be held is significant in that it responds to the need for the re-establishment of the reimbursement criteria in accordance with the global trends, taking into account the hemophilia patients under the age of 12 that were unattended by existing standards and the convenience of administration.

 

Of course, the best-case scenario would be to reflect the specific criteria for unfeasibility of ITI therapy to the notification in advance, however, the biggest victim and the ones worst affected by the criteria are the pediatric hemophilia patients who were discontinued prescription of Hemlibra since last April, pressing the need for the urgent revision of the standards.

 

On the revision, the Korean Society on Thrombosis and Hemostasis has suggested improving the current reimbursement standards from three aspects.

 

The first is for pediatric patients ineligible for ITI therapy.

 

Patients who are not in year 1-5 of developing antibodies have a very low possibility of success using ITI therapies, however, under the current standards, these pediatric patients are not allowed to use the novel new drug Hemlibra injection until the age of 12 or older, and therefore has to use bypassing therapies.

 

Other advanced countries abroad do not require compulsory use of ITI therapies through reimbursement criteria, and the domestic environment that restricts the use of new drugs needs to change.

 

Also, the authorities do not not require prior use of ITI therapies for the use of bypassing therapies.

 

Also, requesting objective data on why pediatric patients under the age of 5 cannot receive ITI therapy is considered to be the most difficult by HCPs in practice.

 

In this sense, HIRA has the responsibility and duty to objectively and closely review such conditions to reflect reality.

 

Other countries (U.K, Australia, etc.) are reviewing reimbursement for Hemlibra even in patients who are eligible for bypassing therapies.

 

Cost-effectiveness analysis of pediatric patients showed that Hemlibra, which is used as maintenance therapy, is more cost-effective than bypassing therapies that can be used at every bleeding event.

 

These data support the rational validity of the academic society's request to remove the priority consideration criteria of ITI therapies.

 

Even HIRA’s Pharmaceutical Benefit Evaluation Committee had determined that the annual pharmaceutical expense of Hemlibra was cheaper than bypassing therapies in pediatric patients in October 2020.

 

If the current reimbursement criteria reflect even a fraction of the requests and perspective of the patients and prescription circumstances, the situation would dramatically improve for the pediatric patients who were left to use only bypass treatment or bear the severe pain from bleeding.

 

“We hope that the reimbursement criteria are revised soon in consideration of the pediatric hemophilia patients and their families," said an official from the Korean Society on Thrombosis and Hemostasis, expressing his hope.