The National Health Insurance Service has selected ‘Soliris (eculizumab)’ as a ‘subject for PVA monitoring’ and began monitoring its claims amount, believing that its use has increased over a certain level.

However, all of the prior authorization applications for the same drug had been rejected last month. In other words, the drug is double trouble as it is being assessed for price cuts due to its increased claims amount while being rejected for reimbursement in its prior authorization applications.

According to the industry on the 6th, the NHIS had selected and informed companies of the drugs under the Price-Volume Agreement that will be evaluated in the first quarter of 2022, including Soliris.

The PVA system is a means for the NHIS and the pharmaceutical company to share the amount of rising drug cost that is applied to drugs whose usage increases rapidly. After negotiations with the NHIS, the company needs to maintain the use volume that it has agreed upon to avoid price cuts.

Therefore, drugs that are found to have been used over that certain level according to the NHIS’ claims amount may be subject to price cuts, being subject for the adjustment of its upper limit.

Soliris is also known to have been caught under NHIS’ radar for exceeding the claims amount.

If the NHIS deems that Soliris’ use volume has increased after monitoring its case, the authorities will conduct negotiations with its company, Handok, and push for price cuts.

An NHIS official said, “We will be selecting subjects for negotiations after monitoring the evidence. Soliris is also one of the drugs being monitored. The drugs up for monitoring this time are those whose claims have increased by 30% or more or those that have increased over 60% annually during the compared period or by over 10%‧5 billion won.”

However, one thing to note is that Soliris’s applications for prior authorization are being being continuously disapproved for reimbursement by the NHIS.

Soliris is currently indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

However, due to the high price of the drug – which costs 5.13 million won per vial – the MOHW and HIRA had set a hurdle that requires prior authorization for insurance benefit when approving the drug for reimbursement.

And according to HIRA, all 3 of the prior authorization applications (2 new, 1 re-deliberation case) made for Soliris that were deliberated by the Healthcare Review and Assessment Committee in November last year were rejected. All 3 applications were for the use of Soliris in aHUS.

For aHUS treatment, only 3 of the 47 applications filed for prior authorization last year were approved and administered to patients.

As a result, although Soliris is not being administered much due to the series of disapprovals by NHIS during the prior authorization review, the drug is still subject to monitoring for price cuts due to its expanded indication that raised the claims amount.

HIRA explained, “The applications were denied after reviewing the supplementary medical records that were submitted because the subjects were not eligible for administration as specified in the notice and were determined to have secondary thrombotic microangiopathy that was caused by drugs such as immunosuppressants.”