HIRA sets plan for performance assessment of 'Qarziba'

Qarziba has been listed for reimbursement on December 1…the 6th drug to sign a performance-based RSA

Healthcare providers with patients receiving qualifying drugs must submit monitoring reports every 3 or 2 years

Product photo of Qarziba

The Health Insurance Review and Assessment Service (HIRA) has established a performance assessment plant for Qarziba and notified healthcare providers to submit documents.

 

Qarziba is a high-cost treatment for severe diseases.

 

As of December 1, the drug was listed for reimbursement under the condition of patient performance-based Risk Sharing Agreements (RSA) for treatment effects monitoring and follow-up of reimbursement appropriateness.

 

According to sources on December 11, the number of drugs under the patient performance-based RSA increased to six, with the addition of Qarziba.

 

Patient performance-based RSA is a new payment system in which pharmaceutical companies' refund rate varies depending on a patient's performance after receiving a medicine.

 

As a result, healthcare providers that have administered those medicines must submit patient monitoring documents to HIRA to follow up on patient performance.

 

The performance assessment, introduced to Kymriah in 2022, has expanded to six drugs, including Zolgensma, Spinraza, Evrysdi, Luxturna, and Qarziba.

 

These drugs are subjected to 'Monitoring reimbursement for high-cost medicines.' Qarziba was designated the first drug for a "Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations." The drug's ceiling price is KRW 11.48 million, and patients can receive the medicine for KRW 10.50 million yearly with a 5% co-patient rate and the ceiling price for co-patients applied.

 

The HIRA explained that healthcare providers must submit a document for a patient who qualifies for the reimbursement standard of Qarziba and has received a drug.

 

The assessment period for the high-risk group is 3 years, and recurrent/refractory is 2 years.

 

As a result, healthcare providers must submit monitoring reports every 6 months, 12 months, and every year.

 

Required documents include ▲consent form for long-term follow-up investigation for Qarziba administration ▲patient information for Qarziba administration ▲monitoring reports for Qarziba administration.

 

These monitoring reports must be submitted four times: within 7 months, 13 months, 26 months, and 38 months following the first treatment initiation.

 

If a patient passes away, the monitoring report must be submitted immediately.

 

For patients who die at a facility other than the one administering Qarziba, that facility should label the case as "lost to follow-up" and include detailed notes in the special remarks section.

 

For patients who fail to attend follow-up visits, facilities should also mark the case as "lost to follow-up" and note relevant details.

 

Additionally, cases where assessments cannot be conducted due to the patient's condition should be noted as "unable to evaluate" with relevant details.

 

The HIRA will evaluate patient survival and condition at each evaluation point.

 

"Until the monitoring system is developed, healthcare providers should submit monitoring reports via email.

 

Once the system is ready, reports should be submitted through the "high-cost drug management system" available on the healthcare provider portal," a HIRA personnel remarked.