[Op-Ed] Patients, no time left for 'new drug comb therapies'

Eunyoung Lee, Board of Director of the Korea Alliance of Patients Organization

Eunyoung Lee, Board of Director of the Korea Alliance of Patients Organization

"My father (in his 60s), who has been diagnosed with urothelial carcinoma, is paying 10 million won every three weeks for combination cancer therapy that is non-reimbursed.

 

The disaster medical expense program provided the cost.

 

However, we feel helpless upon the news that the fund is being delayed." This is part of a public complaint filed at the Korea Alliance of Patients Organization.

 

This case reflects the current situation in which access to new drug treatments depends on individuals' financial ability.

 

In April, the government amended part of the National Health Insurance criteria for combinations of anticancer therapy.

 

It was intended to correct an unjust system in which previously reimbursed pharmaceuticals are no longer covered when used in combination with a new, non-reimbursed drug.

 

The Patients Organization and related academics have long demanded this, and it was a significant change that improved access to treatment.

 

The combination therapy containing urothelial treatments 'Padcev (enfortumab)' and 'Keytruda (pembrolizumab)' is the key example.

 

The Padcev + Keytruda combination therapy received approval from the Ministry of Food and Drug Safety in July 2024 as a first-line treatment indication.

 

The clinical trial results demonstrated that the Padcev + Keytruda combination therapy reduced the mortality risk by 53% compared to the existing chemotherapy and extended overall survival by over 2-fold.

 

The results were presented at ASCO GU 2024.

 

In particular, the Padcev combination therapy is already reimbursed in six of the A8 countries whose drug prices Korea references: the United States, the United Kingdom, France, Germany, Japan, and Canada.

 

The United Kingdom is operating the 'Combination Therapy Framework' to enhance patient accessibility.

 

Furthermore, it reportedly allows swift discussion of reimbursement for new drugs developed by different pharmaceutical companies when there is sufficient clinical evidence.

 

However, in Korea, the combination therapy was considered by the Cancer Disease Review Committee (CDRC), but it failed to set reimbursement criteria.

 

It is reportedly anticipated to be reconsidered for CDRC in October.

 

It means that no discussion has yet begun.

 

During this time, patients paid high-priced, non-reimbursed treatment out of pocket.

 

Several patients have given up on receiving treatment.

 

The Padcev + Keytruda combination therapy for one month costs from approximately million won to 10 million won.

 

Urothelial carcinoma is highly likely to relapse and metastasize, and it has only a few treatment options.

 

Despite the clinical efficacy of a combination therapy, the evaluation and negotiation process is complicated for new combination drugs developed by different pharmaceutical companies.

 

Therefore, the reimbursement discussion is being delayed.

 

Whereas the government took the first step toward 'combination with existing reimbursed pharmaceutical and new drug' with the amendment in April, an institutional basis must now be established so that 'combination of new drug-new drug' is reasonably evaluated and discussed.

 

There must be a procedure for reviewing the clinical value of combination therapies and for guiding collaborative models between companies.

 

As the discussion on new drug-new drug combination therapy is being delayed, there are fewer treatment opportunities for patients, and treatment options become more limited.

 

Patients sincerely wish for opportunities to access the currently available treatment, not the launch of new drugs.

 

We wish that clinically proven combination therapies were swiftly and reasonably evaluated.

 

The current situation in which systemic procedures and structural limitations triumph over patients' willingness to continue treatment, and the treatment effectiveness must be improved.