[Reporter’s View] Ahead Kymriah’s NHIS negotiations

Only the National Health Insurance Service left to go, the ultra-high-priced novel CAR-T therapy ‘Kymriah (tisagenlecleucel)’ passed all the steps necessary for insurance benefit.

 

In other words, the fate of Kymriah’s reimbursement now lies The fate of Kymriah’s reimbursement, a drug that costs around ₩500 million for a single shot, now lay at the hand of the NHIS negotiations.

 

However, the prevailing view is that the road to reimbursement would not run so smoothly.

 

The drug is indicated for: ▲ adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy, and ▲ patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse The reimbursement standards set for Kymriah that is taking the PE exemption pathway differ by indication.

 

Only the expenditure cap was applied to the B-ALL indication, but for DLBLC, the performance-based type of restriction was added to the expenditure cap.

 

This means that the company would have to share a certain proportion of the cost used by DLBLC patients according to treatment performance.

 

The problem is that unlike the mass-produced general drugs, a single batch of Kymriah is produced with the cells extracted for each patient, which brings the manufacturing cost to be astronomically high.

 

In such cases, when the number of patients exceeds the expenditure cap set by the government, the exceeding cost directly becomes the burden for the company.

 

Of course, Novartis Korea’s ‘efforts’ are essential to bring the ‘drug pricing negotiations’ through and reach an agreement, whether the efforts will definitively bring positive results remains unknown.

 

Other drugs that are mass-produced and generally have a low manufacturing cost are not greatly affected in their profit structure when exceeding the expenditure cap set for the drugs.

 

However, as Kymriah has a high manufacturing cost, just a few patients exceeding the expenditure cap can bring a significant burden.

 

Also, reimbursement in the DLBLC indication has the added limitation of being performance-based.

 

From the NHIS’s perspective, the authorities will be determined to protect the sustainability of its NHI finances by setting the right first step with Kymriah in preparation of the high-priced cell and gene therapies that are expected to pour in in the near future.

 

With negotiations soon to engage, the wish is that those sitting at the negotiation table overcome the compulsion of deriving a certain result and consider the specificity of the manufacturing process as well as the limited number of patients subject to its care, and that the pharmaceutical company’s sincere ‘patient-focused’ mind shine through.