CPAC 'Reducing PMS cases for Zerbaxa deemed valid'

due to its long-term out-of-stock and reimbursement restriction issues

CPAC votes to reduce the no. of surveillance cases from 3000 to 460, and the surveillance period to 6+4

Experts in Korea have agreed that it is valid for MSD Korea to change its post-marketing surveillance plan for ‘Zerbaxa inj (ceftolozane/tazobactam),’ which is used to treat severe multidrug-resistant Pseudomonas aeruginosa infections, in consideration of its usefulness and usage.

 

The biggest reason was due to the company’s difficulty in collecting cases for surveillance caused by its low use due to long-term out-of-stock status, reimbursement restrictions after receiving marketing authorization, and a voluntary recall measure.

 

According to the minutes of the Central Pharmaceutical Affairs Council that was recently disclosed by the Ministry of Food and Drug Safety, the CDDC decided to reduce the required number of cases from 3,000 to 460, and change the surveillance period from 6 years to '6 years + 4 years'.

 

The minutes showed that one committee member said, “The drug is an essential medicine that is necessary for the treatment of carbapenem-resistant patients, and its reason for the sluggish collection of surveillance cases is reasonable.

 

The company's PMS plan that was submitted includes efforts to collect cases in the future, therefore it is deemed appropriate for the council to allow the company to reduce the number of required surveillance cases.” Another member said, “ceftolozane and tazobactam formulations had been voluntarily recalled for a considerable amount of time.

 

Considering its narrow scope of reimbursement and indication, I agree on changing its PMS plan." MSD Korea had previously recalled its products as a precautionary measure due to the non-conformity of sterility tests before shipping them to overseas manufacturing plants in 2020.

 

Also, the drug was granted reimbursement approval only in October 2022, although it was approved in 2017.

 

One committee member said, “I agree on the usefulness of the drug as a national essential drug used to treat patients with multidrug-resistant bacteria.

 

I also agree that the sluggish case collection rate is attributable to the low prevalence rate of its indication, supply disruptions, and non-reimbursement matters.” In other words, experts saw that it was necessary to adjust the drug’s PMS plan and order the collection of 460 cases and extend the surveillance period by 4 years, and wait for the company’s efforts on the low prevalence and supply disruption part.

 

In response, the CPAC said due to its non-reimbursement until recently and out-of-stock issue, it was difficult to report 3,000 cases of Zerbaxa use in the current 6-year period and agreed that around 100 patients commonly register in trials for efficacy evaluation, etc.

 

for ceftolozane and tazobactam use.