Low reimb approval rate hinders Soliris’s use for aHUS

Will the preliminary review process be improved?

HIRA decides to allow initial administration of the drug to aHUS patients, then consider using a preliminary review process for further administrations

The industry’s eyes are on whether the preliminary reimbursement review process for Soliris, a treatment for the rare disease aHUS (atypical hemolytic uremic syndrome), will be eased in Korea.

 

Until now, patients wishing to use Soliris for aHUS with reimbursement had to pass a preliminary review process.

 

However, the problem is its low approval rate.

 

With an approval rate in the 30-40% range every year, it has been a regular topic of discussion in the medical field and at the NA audit.

 

This year, the issue was again raised during the NA audit, and attention has been drawn to the fact that HIRA expressed its intention to conduct a prospective review of the process.

 

According to industry reports on the 27th, Rep Yoon Kim, a member of the Democratic Party of Korea, said to HIRA, “Soliri Inj, a treatment for atypical hemolytic uremic syndrome, has a very low approval rate at the preliminary reimbursement review committee process.

 

If it cannot be used because of too strict standards, the standards need to be improved.” “As it is an acute disease, its use should not be bound by the preliminary review system, but should be started first, and the decision on whether to continue the treatment should be made afterwards.” aHUS is a severe, rare, hereditary disease where 79% of patients die within 3 years of onset, require dialysis, and suffer permanent renal failure.

 

Without Soliris, it can be fatal.

 

However, there are many cases of pre-approval rejections, rendering it difficult to treat patients in the field.

 

However, HIRA has been citing the lack of required application data from long-term care institutions as the reason for the low approval rate, and that there was no problem with the reimbursement standards and review process.

 

However, whether Rep.

 

Yoon Kim’s criticism will improve the system is gaining attention.

 

In its response to the NA’s written inquiry, HIRA said, ‘We will collect opinions from relevant societies on whether first allow the initial treatment with “Soliris Inj,” a drug for atypical hemolytic uremic syndrome, and then conduct preliminary review for further administration of the drug.” However, it seems that the authorities will keep the preliminary review system will be maintained.

 

NA Rep.

 

Jong-Heon Baek pointed out, “It seems inappropriate to operate the pre-review system for aHUS, as it is an acute rare disease.

 

In other countries, considering the characteristics of acute rare diseases, they do not place them in the pre-review system or process the review very quickly.

 

Korea is the only country that does not consider such  characteristics of the disease.” To this, HIRA only responded, ‘Considering the nature of the disease, the drug can be administered immediately after submission of the pre-review application if it is an emergency case, and if approval follows, It is retroactively applied.” This suggests that the authorities are not considering plans to convert the preliminary review process to regular review. The implication is that they will consider exempting the initial dose only.

 

In November, the government decided to switch the preliminary review process for the reimbursement of Soliris and Ultomiris for PNH (Paroxysmal nocturnal hemoglobinuria) to regular review. This is because the existing approval rate has remained stable at over 90%.

 

Upon the change in their reimbursement process, there have been growing calls in the medical community for the removal of prior authorization aHUS in addition to PNH.