ACRC "Hemlibra's reimb. standards need to be reexamined"

Interest is rising on whether reimbursement will be applied regardless of use of ITI therapy

ACRC's statement was sent to MOHW and HIRA

On the 30th, the Anti-Corruption & Civil Rights Commission (ACRC) has expressed the opinion that the reimbursement standards for the hemophilia treatment Hemlibra should be reexamined.

 

In addition, the ACRC forwarded their official statement to the Ministry of Health and Welfare (MOHW) and the Health Insurance Review and Assessment Service (HIRA).

 

Whether the opinion will provide an opportunity for the Hemlibra issue, in which pediatric patients under the age of 12 are currently discontinued from receiving treatment using the drug, may be resolved is gaining attention.

 

ACRC's opinion does not have legal force, however, as the MOHW already expressed its intention to reexamine Hemlibra's reimbursement standards, there is a high possibility the current standards could be improved.

 

The ACRC had previously received civil petitions for grievances from hemophilia patients imploring reexamination of reimbursement standards for Hemlibra.

 

Upon receiving the complaint, ACRC held a roundtable with HIRA and patient groups to exchange opinions regarding the standards involved.

 

Under the current standards, pediatric patients with severe hemophilia A who are less than 12 years of age need to receive immune tolerance induction (ITI·antibody removal) therapies for 2-3 years before receiving prescriptions for Hemlibra with reimbursement.

 

Hemophilia patients had to receive intravenous injections every 2-3 weeks for nearly 3 years to meet the criteria.

 

However, a considerable amount of pediatric patients are unable to even attempt ITI therapy because it was difficult to secure venous blood vessels for the intravenous injection.

 

HCPs of patients in this special condition had prescribed Hemlibra and claimed insurance benefits for such prescriptions from February to March this year.

 

However, HIRA rejected the insurance claims on the grounds that there was insufficient objective data to prove that ITI therapy was impossible.

 

This led to a discontinuation of Hemlibra administrations in hospitals from April.

 

Some of the patients were unable to receive treatment with Hemlibra due to the burden of its uninsured cost, which costs nearly 7.2 million won for 4 weeks.

 

As a result, the ACRC issued their opinion that the reimbursement standards for Hemlibra need to be reexamined so that severe Hemophilia A patients under the age of 12 that 'have difficulty attempting ITI therapy that requires the endurance of great pain in the long-term due to their young age and weak blood vessels' could receive reimbursement for Hemblibra.

 

ACRC referred to how ▲No prerequisite ITI therapy conditions exist for reimbursement of Heblibra in the U.K or Australia ▲ The guidelines by the World Federation of Hemophilia does not restrict Hemlibra's administration to after ITI therapy, and that ▲ it is too harsh to require ITI therapy, a treatment which is accompanied by immense pain, to patients under 12 years of age, as its grounds for making the recommendation.

 

Also, the academic society's opinion that the 'long-term use of Hemlibra can reduce the development of various complications in the long-term' was taken into account.

 

The ACRC's recommendation for correction has no legal force, however, the institution that receives the recommendation needs to inform the ACRC on whether it will or will not accept ACRC's recommendation within a month.

 

Jin Hong Lim, the ACRC adjudication for civil petitions for grievances said, "It is unreasonable to require younger patients to receive a treatment that brings long-term pain to receive reimburse prescription of an effective treatment." Lim continued, "The current insurance benefit standard needs to be reexamined."

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of Hemlibra

Prior to delivering the ACRC's opinion delivery, the Minister of Health and Welfare Kwon Deok-Cheol said in June that he would comprehensively review improving the reimbursement standard of Hemlibra in consideration of the characteristics of pediatric patients with many experts when the National Assembly pointed out that the Hemlibra benefit standard for pediatric patients was too strict.

 

Hemblibra is the first subcutaneous injection formulation for hemophilia treatment introduced by JW Pharmaceutical to Korea from Chugai Pharmaceutical in Japan.

 

The drug was approved in 2019, and granted reimbursement in May last year.

 

Unlike existing treatments, Hemlibra can be easily administered subcutaneously and has its strength in its convenient method of administration.

 

Patients had to find their own veins to directly inject the previous drugs.

 

Moreover, the intravenous injection method was more inconvenient as many of the patients were children.