The following article was written in collaboration with the National Evidence-based healthcare Collaborating Agency. – Ed.

 

Other than the nHTA through scholarly works, the National Evidence-based healthcare Collaborating Agency (NECA) also considers the potential value of the technologies that address unmet medical needs or are emerging.

Notably, NECA grants conditional approval for evidence development and separate assessment for innovative health technology.

Regarding conditional approval for evidence development, the Minister of Health and Welfare can approve a technology not recognized as a new health technology due to lack of study but treats disease or illness without alternative health technology, rare disease, or end-stage severe chronic diseases with no alternative treatments.

The approval allows the procedure to enter the clinical environment hastily at specific medical institutions and collect and analyze the outcome to produce clinical evidence for the technology.

The healthcare institutions over the hospital-level may request approval. If the Ministry of Health and Welfare grants conditional health technology approval, the institution may use the technology without reimbursement for three years.

Institutions can use this period to collect clinical evidence in the actual medical field. Afterward, the technology must undergo the nHTA based on the clinical evidence collected in the clinical environment.

For separate assessments for innovative health technology, the evaluation looks at procedures after considering the possibility of new advanced technology, patient requests regarding the technology, and patient satisfaction improvement.

Under the previous system, new medical technologies only received approval after the procedure received verification for its safety and efficacy through nHTA based on published literature.

However, such an evaluation system is disadvantageous for innovative medical technology that lacks time to build a literature basis.

For example, the rate of failure in the new medical technology evaluation from 2016 to 2018 regarding robot and 3D printing fusion medical technology reached 82 percent.

Accordingly, the revised legislation will review medical technologies that combine cutting-edge technologies and medical technologies that treat severe diseases such as cancer and heart disease or improve patient satisfaction.

The separate innovative health technology allows medical procedures with high potentials, such as those that dramatically improve the patient's life or reduce the patient's cost burden, early entry into the market by conducting evaluation based on literature and the potential of newly developed medical technology.

However, even for innovative medical technology, NECA conducts a strict safety verification through literature for invasive medical practices performed inside human tissues as they have a high patient burden.

After approval, NECA grants conditional permission for three to five years in the actual clinical field if it meets several criteria, such as purpose and target of use, duration, and treatment method.

Once the period of use is over, NECA conducts an nHTA on the clinical evidence collected in the clinical environment during that time to prove the effectiveness of the procedure.

However, NECA may decide to discontinue the use of innovative medical technology if the data is falsely submitted or the medical technology is used outside of an approved medical institution.

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