NSCLC treatment Vizimpro coverage effective from December

HIRA to accept public opinion on the revised notice of anticancer reimbursement until today

The healthcare reimbursement on Pfizer’s non-small cell lung cancer (NSCLC) treatment Vizimpro (dacomitinib) would be granted from Dec.

 

1.

 

But the drug has to pass the Ministry of Health and Welfare (MOHW) Health Insurance Policy Deliberation Committee (HIPDC) on Nov.

 

27 to be fully approved.

 

Prior to the HIPDC deliberation, the Health Insurance Review and Assessment Service (HIRA) is to accept the public opinion on the revised ‘Notice on Drugs Prescribed and Administered to Cancer Patients’ that contains the detail of establishing the reimbursement standard for Vizimpro.

 

In last February, Vizimpro was approved for the South Korean market as a first-line treatment for patients with locally advanced or metastatic NSCLCL with epidermal growth factor receptor (EGFR) exon 19 deletion or L858R substitution on exon 21.

 

After reviewing textbooks, guidelines and clinical literatures to set reimbursement standard on the initial administration for NSCLCL, HIRA found a textbook mentioning Vizimpro as a new drug categorized as second generation Tyrosine kinase inhibitor (TKI).

 

And the National Comprehensive Cancer Network (NCCN) guideline recommends the drug as 'category 1’ for treatment patients with sensitizing EGFR-positive advanced, metastatic NSCLC, when the European Society for Medical Oncology (ESMO) recommends it as I and B, and the Pan-Asian ESMO guideline as I and A.

 

Apparently, a randomized, open-label, Phase III clinical trial compared Vizimpro and Iressa (gefitinib) head-to-head with a group of patients with newly diagnosed stage IIIB/IV NSCLC along with exon 19 deletion or L858R substitution on exon 21.

 

The trial found the each drug marked median overall survival (mOS) of 34.1 months vs.

 

26.8 months, median progression-free survival (mPFS) of 14.7 months vs.

 

9.2 months, and objective response rate (ORR) of 75 percent and 72 percent, respectively.

 

HIRA official said, “The guideline currently recommends the applicant drug to the patient group with the EGFR-activating mutation, and other EGFR-TKI clinical trial did not find many of patients without 19 deletion or L858R substitution.

 

The reimbursement standard was set considering the limited size of patients, who have an off-label EGFR-activating mutation.” Vizimpro has completed the pricing negotiation with the National Health Insurance Service (NHIS), after the Drug Reimbursement Evaluation Committee (DREC) green lit the reimbursement on Nov.

 

12.