[Reporter’s View] Advanced new drugs, reimb, and patients

Considerations should be made in line with the shift in drug treatment paradigm and changing attitude of patients

Some drugs can be prescribed regardless of mutation or receptor status at certain stages of a disease.

 

Other drugs can be prescribed regardless of disease if a certain gene mutation is identified in the patient.

 

As such, the field of pharmaceuticals is evolving at a rapid pace.

 

New drugs that are no longer attached to a specific disease are emerging, introduced as all-comers or disease-agnostic drugs.

 

And the emergence of these drugs is heralding a paradigm shift.

 

However, the new drugs are not easily granted reimbursement in Korea.

 

Due to the broad application of the drugs, the government has to consider how their increased use volume may raise financial concern.

 

For all-comer drugs, further concerns remain.

 

Some raise doubts about their efficacy, on how they can be effective regardless of the gene targeted by their mechanism of action.

 

However, although the efficacy may vary, these drugs have proven their effect as all-comer drugs and obtained approval from the Ministry of Food and Drug Safety.

 

The case is not so different for disease-agnostic drugs that target gene mutations either.

 

And the development of precision medicine is heralding the shift in the prescriptions from ‘disease’ to ‘gene,’ announcing the arrival of the era of personalized medicine.

 

Existing targeted therapies, immunotherapies, as well as tumor-agnostic therapies that were listed this year have also suffered much in the course of expanding their scope of reimbursement.

 

Not only because the drugs are expensive but because each drug needs to reconduct value assessments and estimate their increase in usage volume.

 

This is the main framework that supports Korea's health insurance system.

 

While prudence in financial spending is important, the government also needs to consider the demand of the patients and make some compromises.

 

Times have changed.

 

Patients and their families no longer solely depend on their doctors to make decisions.

 

They search papers for new drugs in clinical trial databases like clinicaltrial.gov.

 

Therefore the question remains, how should Korea embrace these advanced new drugs in the future?