Why Vyndamax and Tabrecta’s reimb were unable to pass DREC

despite high demand

Vyndamax did not satisfy RSA terms

Tabrecta lacks evidence to demonstrate clinical efficacy

# i1 The reasons why Vyndamax and Tabrecta, the two drugs that had high reimbursement demand, were unable to pass the Health Insurance Review and Assessment Service’s review were revealed.

 

The two drugs were determined to be ineligible for reimbursement by HIRA’s Drug Reimbursement Evaluation Committee (DREC) at its meeting that was held in April, and the results of the relevant meeting were disclosed recently.

 

According to the industry sources on the 14th, Vyndamax and Tabrecta were reviewed by the DREC on April 6.

 

Vyndamax Capsule (tafamidis, Pfizer), a treatment for transthyretin amyloid cardiomyopathy (ATTR-CM), was reviewed by the DREC in April, 9 months after passing the Drug Reimbursement Standard Subcommittee deliberations in July last year.

 

The drug was deemed to be eligible for the Risk-Sharing Agreement scheme due to its lack of alternative treatment options, disease severity, social impact, and impact on public healthcare.

 

However, the authorities failed to close the gap with the pharmaceutical company on the terms of the RSA.

 

DREC requested the refund plan proposed by the subcommittee, ‘full refund for the initial treatment through a Refund-type RSA, then and simple refund rate Refund-type RSA and Expenditure Cap-type RSA,’ should be applied for Vyndamax’s reimbursement to reflect the uncertainties including its effect during the initial treatment period.

 

However, as the suggested refund plan was not implemented, and the pharmacoeconomic evaluation results were deemed to be cost-ineffective, the committee decided on its non-reimbursement.

 

Regarding its clinical efficacy, the committee pointed out that the drug had reduced all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo in adult patients with hereditary or wild-type ATTR-CM, but the degree of clinical improvement varied depending on the type and stage of the disease, and there are limitations in that there is no study with a sufficient number of patients or observation period to analyze the varying effect.

 

In the case of Tabrecta (capmatinib, Novartis), the lack of evidence to judge its clinical usefulness acted as an obstacle to its reimbursement.

 

DREC determined the drug to be non-reimbursable as the drug is approved drug for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer with MET exon 14 skipping mutations, but there is insufficient evidence to determine its clinical usefulness, and the cost required is higher than its alternative drugs.

 

DREC selected the pembrolizumab+pemetrexed+platinum therapy and pemetrexed+platinum therapy as alternatives to Tabrecta.

 

For patients who have previously used immune checkpoint inhibitors and failed first-line platinum-based therapy, DREC selected docetaxel monotherapy as the alternative option.

 

Based on these selections, the 3-week administration cost required for Tabrecta was higher than its alternative therapies.

 

The survival period of patients with ATTR-CM is only 2 to 3.5 years if not treated properly, and known for its poor treatment results due to a lack of treatment options.

 

Tabrecta is the only treatment for ATTR-CM, which brought out the high demand for its insurance reimbursement.

 

However, due to the large number of expenses required, the industry opinion is that it will be difficult to receive reimbursement if the pharmaceutical company lets go of its terms for risk-sharing in the future.

 

Tabrecta also drew attention as the first NSCLC treatment that confirmed the MET exon 14 deletion mutation.

 

In addition to Tabrecta, Tepmetko (Tepotinib, Merck), which is in the same class, is also undergoing a reimbursement review, with no progress.

 

Therefore, without providing more evidence to support its clinical usefulness, it seems unlikely that Tabrecta will be covered and reimbursed in Korea.