PAGs request expedited new drug listing system to candidates

Korea Alliance of Patients' Organizations propose 4 policies including enacting a basic law for patients, etc. to presidential candidates

With the presidential election two months ahead, patient groups have asked the presidential candidates to introduce an expedited listing system in the National Health Insurance for new drugs directly related to life.

 

On the 7th, the Korea Alliance of Patients' Organizations had set out to propose and deliver ‘4 key patient policies’ for patients in the healthcare industry to the presidential candidates of each party.

 

The 4 key patient policies that were delivered to the candidates were: ▲ Introduction of an expedited NHI listing system for new drugs that are directly related to life ▲Establishment of an integrated patient support platform ▲ Severe disease and patient-focused innovation to the integrated nursing care system ▲Enactment of a basic law for patients Among these, the introduction of an expedited NHI listing system on new drugs that are directly related to life is an agenda being frequently discussed with the advent of 'one-shot treatments’ that can cure a disease with a single dose, on to what extent society may cover such ultra-expensive new drugs.

 

The new drug paradigm has shifted from the era of chemotherapy that had large side effects but less effect to the era of targeted therapies/immunotherapies/ and CAR-T therapies that are groundbreaking in terms of effectiveness and side effects.

 

In line with such a trend, enhancing coverage of the ‘one-shot treatments’ has emerged as a key agenda.

 

KAPO pointed to “the fact that the new drugs are extremely expensive and that it takes over a year for drugs that are directly related to life to be reimbursed after gaining approval due to the ‘pricing tug-of-war’ between the government and pharmaceutical companies” as a key issue, and reminded that these delays are life-threatening issue to those affected.

 

Economically wealthy patients or patients with private insurance can purchase these new drugs to extend their lives, but low-income patients with less economic affordability or those who do not have private insurance are dying because they are unable to receive the benefits of these new drugs.

 

Therefore, KAPO believes that Korea’s universal health insurance should address this life-related issue.

 

For this, KAPO proposed to the candidates that an expedited NHI listing system should be established for new drugs that are used in life-threatening diseases.

 

The expedited system allows rapid reimbursement of new drugs by allowing the company to concurrently apply for the marketing authorization and reimbursement listing to the MFDS (authorization) and HIRA (reimbursement listing) and concurrently review both applications.

 

KAPO said, “The authorities can set a tentative drug price when a new drug is first sold in the market after MFDS approval so that patients could be saved using NHI finances.

 

The difference between it and the final price should be settled after the reimbursement procedures are completed - going through the CDDC and DREC’s reimbursement procedure, pricing negotiations between the company and NHIS, and deliberation by the HIPDC.

 

This way, the government could guarantee patients’ right to promptly access new drugs as stipulated in the Constitution.” However, on how to define and set the scope for ‘new drugs directly related to life,’ KAPO proposed that a ‘social consultative body’ should be established with participation by the government, experts, pharmaceutical companies, public, consumer, and patient groups.

 

KAPO said, “We need to reinforce the patient-focused health insurance system by ensuring low-income patients’ access to new drugs to allow everyone who is ill to be treated and increase public and patient trust in health insurance to reduce dependence on private insurance.

 

Also, the system enables the government to ensure access to new drugs that are directly related to life for all patients – the tax-paying public - regardless of their economic ability.”