Cost of cell&gene therapies for clinical patients set

Cost standards to be established for the administration of cell and gene therapies to clinical trial patients

KIDS rationalizes patients’ out-of-pocket cost of drugs used for therapeutic purposes during clinical trials

The government has set out to create standards for the 'cost of clinical trial drugs' to be used as an indicator when giving patients expensive cell and gene therapy drugs at the clinical trial stage.

 

This is to rationally calculate the cost that patients must pay when they are administered investigational drugs for therapeutic purposes.

 

The government plans to look at the cost calculation methods for investigational drugs that are in operation overseas, such as in the US and Europe, and analyze the current state of the system in Korea to create cost standards for each detailed item of investigational drugs.

 

On the 8th, the Korea Institute of Drug Safety & Risk Management announced that it would begin research on establishing a standard for the cost of investigational drugs.

 

The current Pharmaceutical Affairs Act stipulates that drugs in the clinical trial stage can be used for therapeutic purposes.

 

The problem is that there is no reasonable standard for pricing drugs that must be charged to patients, as the manufacturing costs of cell therapies and gene therapies are often high.

 

This is because there are various detailed items that are included when calculating the cost according to the characteristics of each drug, such as cell therapy and gene therapy.

 

The cost of investigational drugs is the price minus the cost of facility and environmental management and research and development and refers to the cost directly incurred in the manufacture of investigational drugs used for individual patients.

 

The KIDS will investigate the cost calculation methods for investigational drugs that are being used in overseas countries such as the US and Europe to establish the cost calculation standards for patient claims for investigational drugs, and examine the cost calculation details when claiming the cost of investigational drugs for therapeutic use in domestic clinical trials.

 

The cost calculation method will also be analyzed by comparing the cases when importing investigational drugs and domestic contract manufacturing drugs.

 

KIDS will also seek to discover the specific cost calculation items used for cell therapies and radiopharmaceuticals that take into account their characteristics, such as the manufacturing process of pharmaceuticals.

 

       Based on this, KIDS plans to prepare a detailed cost standard for each item used to calculate the price of investigational drugs.

 

KIDS explained, “We will study whether detailed items such as raw material costs, material costs, labor costs, manufacturing expenses, and quality inspection costs should be included in the cost calculation of manufactured drugs.

 

We will consider the purpose of the cost stipulated in the Prime Minister's Decree on the Pharmaceutical Affairs Act & Regulation on Safety of Drugs.”        It added, “We will also look at the details of the raw material costs, such as whether the raw material is autologous or allogeneic, the type of source, such as blood, cord blood, skin, or adipose tissue, and the method of collection, such as surgery or blood collection.

 

The goal is to establish standards that can be used by suppliers of investigational drugs when calculating costs.”