[Desk View] Disclosing drug reimb info must be done properly

Due to concerns about the non-transparency of the selection process for medicinal product reimbursement, the Health Insurance Review & Assessment Service (HIRA) and the National Health Insurance Service (NHIS) are disclosing partial processes and candidates.

 

HIRA discloses, through press releases, the review results from the Cancer Drug Reimbursement Committee, which discusses reimbursement criteria for anticancer agents, as well as review results from the Drug Reimbursement Evaluation Committee (DREC) regarding new drugs and the expanded usage scope of drugs under a risk-sharing agreement (RSA).

 

NHIS updates the initiation of the negotiation process for drugs that have passed the HIRA review and the agreement status on its website.

 

However, the problem is user-friendliness.

 

Information disclosure is intended for public knowledge in the best interest of patients, yet it does not take the user's perspective into account.

 

For instance, in February, HIRA released press reports of the results from the DREC review on the conditional appropriateness of expanded reimbursement criteria for 'Cabometyx.' According to the detailed report, "The efficacy·effectiveness of Cabometyx 20, 40, 60mg (cabozantinib, Ipsen Korea) are for clear cell renal cell carcinoma (ccRCC).

 

Cabometyx is deemed appropriate for expanded reimbursement scope if Cabometyx's company were to accept a price below the evaluated amount." Cabometyx was initially listed for reimbursement in February 2019 as a 'monotherapy for patients with advanced renal cell carcinoma who had previously received VEGF-targeted therapy.' DREC's press release indicates that this drug, reimbursable for treating advanced renal cell carcinoma, can also be appropriate for reimbursement for treating ccRCC.

 

However, ccRCC is the most common type of advanced renal cell carcinoma.

 

Patients with ccRCC are already eligible for reimbursement, so expanding the reimbursement scope does not make sense.

 

The expanded usage scope for this drug was recently reported following the NHIS's update of its website in May, which included news of ongoing negotiations.

 

The negotiation outcome was 'failed.' However, even here, it's impossible to discern for which indication the negotiations were conducted and subsequently fell through.

 

The NHIS only discloses the success or failure of drug negotiations in an Excel file.

 

According to the HIRA press release, the negotiation for expanded reimbursement coverage could have been for 'ccRCC.' However, as previously mentioned, the scope for 'ccRCC' is broad, and it is already reimbursed.

 

Ultimately, the information disclosed by both agencies makes it impossible to know for what specific indication the reimbursement scope of this drug is being expanded.

 

The pharmaceutical company later confirmed that the drug was undergoing reimbursement expansion for 'treatment not only after VEGF-TKI-based first-line therapy but also after immunotherapy-based first-line therapy (ipilimumab+nivolumab or IO+TKI) in ccRCC.' Before the final indication was confirmed, some public even suspected that the HIRA might have mistakenly used 'clear cell renal cell carcinoma (ccRCC)' instead of 'non-clear cell renal cell carcinoma (nccRCC)' in their press release.

 

This suspicion arose because there's a strong demand within the medical community to extend reimbursement coverage for Cabometyx to patients with nccRCC.

 

The two agencies' unhelpful disclosure of information regarding drug reimbursement isn't limited to this instance.

 

Recently, the NHIS announced the initiation of negotiations for Darzalex solution via a website update.

 

However, simply looking at the website doesn't reveal the nature of these negotiations.

 

Confusion arises because the NHIS lists all drugs, whether they are new drugs, drugs with waived price negotiations, or drugs with expanded usage scope, regardless as subjects for drug price negotiation.

 

One can infer that Darzalex solution is undergoing negotiations for an expanded usage scope, given that this drug was mentioned in the HIRA deliberation results from a press release distributed in May, under the section for review results regarding the appropriateness of expanding the usage scope for RSA drugs.

 

But even this doesn't clarify which indication the usage scope is being expanded for.

 

The press release merely states its efficacy and effect as 'multiple myeloma.' Darzalex solution is a well-known drug used for multiple myeloma.

 

Since several reimbursement criteria for multiple myeloma are already established, it remains unclear for which indication reimbursement is being expanded this time unless one directly asks a HIRA or NHIS official.

 

The consumers of drug reimbursement information are generally patients with relevant diseases who are often in desperate situations.

 

This type of information does not gain widespread public interest.

 

Maybe because of this reason, HIRA's and NHIS's information disclosure is unilateral, unhelpful, and, at times, even irresponsible.

 

It's as if they're implying, "You can figure it out with just this much information?" If information disclosure is initiated due to patient demands, then an extra degree of helpfulness should be added.

 

If HIRA and the NHIS intend to continue providing drug reimbursement information in the future, they must do it properly.

 

HIRA and the NHIS should accurately specify the scope of reimbursement coverage for the target diseases of the respective drugs.

 

We are not asking them to disclose the background of their review outcomes or agreement results.

 

We want them to at least, inform us why a particular drug is undergoing review, evaluation, or negotiation.

 

In the future, we hope that those responsible for disclosing drug reimbursement information will adopt a more responsible approach.