Hemlibra reimbursement disapproval raises anxiety

among pediatric patients

Infringes doctors’ prescription rights… discord between reimbursement standards and request for data

Pharmaceutical costs ₩ 30 million per patient… concerns rise on the possibility of the patients' fully bearing the 2-months’ cost

The head-on clash between the ‘standard to first consider immune tolerance induction (ITI·antibody removal) therapies’ and the ‘due prescription rights of doctors·convenience in administration·saving NHI finances’ have received industry attention.

 

On the 3rd, the Health Insurance Review and Assessment Service (HIRA) held a Pediatric Department Special Review Committee to review medical benefit reimbursement of Hemlibra and disapproved its reimbursement.

 

Therefore the clash between the industry·patient groups and the authorities in normalizing its reimbursement is deemed inevitable.

 

The reimbursement standard for Hemlibra that was implemented in February this year allows reimbursement for pediatric hemophilia patients ▲who failed ITI therapy; ▲who meet the ITI eligibility requirements but have a doctor’s note proving they cannot receive ITI therapy; and ▲whose antibodies reappeared after a successful ITI therapy.

 

On the other hand, for hemophilia patients with antibodies, the reimbursement guidelines recommend to HCPs to first consider using ITI therapy.

 

HIRA’s regulations prioritize the use of ITI therapy in high-antibody patients in years 1-5, patients with frequent bleeding, and patients with intracranial bleeding.

 

The issue arose regarding the reimbursement standard ‘Those who meet the ITI eligibility requirements but have a doctor’s note proving they cannot receive ITI therapy.' The committee requested objective data proving that it was difficult to secure venous blood vessels and that it was impossible to attempt ITI therapy when administering Hemlibra.

 

However, the medical community and patient groups protest saying that “Most patients are under 5 years of age, therefore, providing data on the state of their blood vessels following intravenous injections and objective measurement of their pain is virtually impossible.

 

The specificity of the circumstances and environment isn't being considered.” In other words, their argument is that requesting data based on scientific grounds when there is no objective data to present is in itself nonsense.

 

Two large hospitals, A and B Hospital in Seoul and Daegu, had administered Hemlibra to 4 hemophilia patients under the age of 12 during the last two months according to doctors’ justifiable opinion.

 

The pharmaceutical cost of Hemlibra amounted to 30 million won per patient for the 2 months, and if the hospitals decided to exercise their right of claim rather than suffer the loss, the cost will solely be imposed on the patients.

 

On this, an official from the Korean Society on Thrombosis and Hemostasis said, “Insisting or forcing pediatric hemophilia patients under the age of 12 to receive intravenous ITI therapy is not a desirable means of treating the disease.

 

Also, the HIRA's disapproval of reimbursement for Hemlibra this time is inconsistent with the reimbursement standard that explicitly states that Hemlibra may be administered with a justifiable doctor’s note." Patient groups also strongly expressed their objection, pointing out that “Current standards do not require ITI therapies before existing bypassing therapies.

 

Making the decision to administer Hemlibra does not mean that the doctors did not consider ITI therapies.

 

The committee’s decision to restrict only Hemlibra with such a condition is unacceptable.” Meanwhile, the deliberation results of the Pediatric Department Special Review Committee will be finalized after resolution by the Central Review & Assessment Coordination Committee, and the claims for re-examination and objections to adjust drug costs may be filed within 60 days.

 

Attention is now on whether the voices of the pediatric patients and their parents will be reflected in addition to the efforts made through Cheong Wa Dae’s public petition and Anti-Corruption and the Civil Rights Commission’s adjustment efforts.