The people are voicing both positive and negative reactions on the pharmacoeconomic evaluation (PE) exemption track opened to antibiotics.

Considering the unique characteristic of the drug, expanding the coverage on antibiotics with the difficulty of conducting PE is an improvement. But there is a dispute brewing on the definition of antibiotics.

In March, Korea’s Ministry of Health and Welfare (MOHW) and Health Insurance Review and Assessment Service (HIRA) preannounced the revised regulation of pharmaceutical healthcare reimbursement subject evaluation criteria and procedure, and started accepting relevant public opinion.

The noticeable changes in the regulation related to PE exemption track is expanding the subject scope, currently limited to rare disease only, to include tuberculosis treatment, antibiotics, and emergency antidotes essential to promote public health.

◆A definition of antibiotics could cause confusion

The controversial issue is in the definition of ‘antibiotics,’ which could get limited to ‘antibacterial.’ Apparently, the government has expressed intention to positively review the issue as raised by Korean Research-based Pharmaceutical Industry Association (KRPIA).

As a medical term, antibiotics means ‘antimicrobial medicine’ functioning as ‘antibacterial (treating bacterial infection),’ ‘antifungal (treating fungal infection),’ and ‘antiviral (treating viral infection).’ And constant rise of antimicrobial resistance (AMR) has been addressed as the most alarming public health issue around the world.

Usually, many people interchangeably use the term antibiotics as antibacterial or antimicrobial. But medically speaking, drugs used to impede growth of microbe, like bacteria, fungus and virus, are categorized as antimicrobial medicines.

President Choi Jung Hyun (Infectious Disease Division of the Catholic University of Korea Eunpyeong St. Mary’s Hospital) of Korean Society for Antimicrobial Therapy (KSAT) said, “As PEs were conducted without full understanding of newly developed antibiotic and antifungal drugs targeting antibiotic-resistant bacteria, which cannot be treated with other existing options, the drugs were impossible to enter the Korean market. The sources of infectious diseases like bacteria, fungus and virus should be handled by taking in account of possible development of AMR during treatment.

◆The background of introducing PE exemption track on antibiotics

The objective of revising the regulation is to revisit some of criteria in PE exemption track to include drugs, challenged to produce PE results but essential to public health improvement.

The clinical trial on antibiotics tests non-inferiority against a reference drug. As antibiotics have to treat infectious disease, it is unethical to confirm superiority or to use a drug with developed AMR and diminished treatment effect as a reference drug to confirm superiority.

Under such circumstances, PE has been pointed out as the cause of delay in listing antibiotics regardless of the high medical needs. The industry highly anticipates the revised PE exemption benefit would contribute in promptly and reliably supplying new antibiotic and antifungal drugs to Korean market.

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) also approve new antibacterial and antifungal drugs based on non-inferiority clinical trial results.

President Choi stressed, “We would like to express our appreciation for the government’s effort to secure infectious disease treatment crucial in responding against severe infection seriously threatening the public health. The regulation revision would provide the foundation to have stable access to antibiotic and antifungal drugs to treat antibiotic-resistant bacteria. It would also be a great help for developing the antimicrobial stewardship and resistant bacteria practice guideline the academic society is leading.”

Introduced in 2015, the PE exemption track, also known as ‘special PE benefit,’ excludes rare disease treatment or anticancer treatment from the PE data submission requirement, a part of pharmaceutical reimbursement review process.

The drugs listed with PE exemption track are applied with expenditure cap type risk sharing agreement (RSA). However, the public has been constantly demanding for the PE exemption subject to expand as drug other than anticancer or rare disease treatment struggling to prove the cost-effectiveness. This marks the first revision made since the system was established in 2015.