Drugs for NSCLC harboring MET alterations pass CDRC review

Merk successfully sets reimbursement standard for Tepmetko on its third attempt

Product photo of Tepmetko

A treatment for non-small cell lung cancer (NSCLC) harboring MET alterations has passed the first stage for reimbursement coverage by national health insurance.

 

Merk's Tepmetko is the drug that passed.

 

On October 2nd, the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) commenced the 7th meeting and set reimbursement standards for anticancer agents, including 'Tepmetko (tepotinib),' a treatment for patients with NSCLC harboring MET alterations.

 

After receiving approval in November 2021, Tepmetko passed the CDRC review on the third attempt.

 

It is the first treatment for NSCLC harboring MET alterations to pass the review in South Korea.

 

The rate of patients with MET alterations in metastatic NSCLC is low, approximately 3-4%.

 

However, due to poor prognosis, anticancer agents targeting such alterations are of paramount importance.

 

In a clinical study, data showed that Tepmetko-treated stage IV patients with MET alterations had a median overall survival of 19.6 months, which was higher than the 13.4 months of immune checkpoint inhibitors.

 

It became the new hope for patients.

 

However, it repeatedly failed to set the reimbursement standards due to insufficiency in data utility.

 

Other anticancer agents targeting MET alterations, such as Tabrecta, had similar results.

 

Tepmetko successfully set the reimbursement standards in its fourth attempt, passing the first stages for receiving reimbursement.

 

When it passes the Drug Reimbursement Evaluation Committee (DREC) of the HIRA, drug pricing negotiations with the National Health Insurance Service (NHIS), Tepmetko would be on the national health insurance reimbursement list.

 

Review results for new drugs (applied for reimbursement decisions) and expanded reimbursement standards.

 

Tepmetko (tepotinib, Merk) and Tibsovo Tab (ivosidenib, Servier Korea) successfully set reimbursement standards.

 

Drugs that successfully expanded reimbursement standards include Jemperli (dostarlimab, GSK) and Neulasta Pre-filled Syringe (pegfilgrastim, Kyowa Kirin Korea).

Along with Tepmetko, Tibsovo Tab (ivosidenib, Servier) successfully set reimbursement standards.

 

The reimbursement standards for Tibsovo are set for use in combination with azacytidine in adult patients over 75 years with newly diagnosed locally advanced or metastatic acute myeloid leukemia (AML) who test positive for isocitrate dehydrogenase-1 (IDH1) mutation or those with accompanying disease who cannot receive chemotherapy.

 

Additionally, Jemperli (dostarlimab, GSK) and Neulasta Pre-filled Syringe (pegfilgrastim), which have applied for expanded reimbursement, were successful in expanding the standards.

 

Jemperli now has established reimbursement standards for use in combination with platinum-based chemotherapy in adult patients with newly diagnosed advanced or relapsed mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer.

 

Neulasta successfully set reimbursement standard for patients receiving cytotoxic chemotherapy for malignant tumors to reduce the occurrence and duration of neutropenia.

 

In contrast, Verzenio failed to establish expanded reimbursement for adjuvant therapy in combination with endocrine therapy for adult patients with early-stage breast cancer who are hormone receptor (HR)-positive or human epidermal growth factor receptor 2 (HER2)-negative or who are likely to have relapses of lymph nodes.

 

The CDRC has established a policy for reviewing the reimbursement coverage of an existing drug when newly added high-price drugs are to be used in combination with a drug that is already covered by reimbursement.

 

Medical organizations, including doctors' associations and hospital associations, requested such improvement last year.