Roche’s Phesgo is applied RSA for reimb in Korea

Despite being a precalculated drug that requires no pricing negotiations

Government considers applying risk-sharing agreement system to drugs that have targeted products...focusing on financial savings

Novartis’ Ilaris receives reimb with RSA and follow-up management as a condition

Korea’s insurance authorities are introducing various measures to reduce drug costs.

 

The government is applying risk-sharing agreements to precalculation drugs and requiring submission of follow-up data for drugs that are exempt from sumitting pharmacoeconomic evaluation data.

 

The drugs subject to the authorities’ measures are Phesgo SC Inj (pertuzumab/trastuzumab) and Ilaris Solution (canakinumab).

 

Phesgo is a biobetter that was developed as a fixed-dose subcutaneous injection formulation of the intravenous injected Herceptin and Perjeta to improve dosing convenience and reduce treatment time for breast cancer patients.

 

Since it is approved as an improved biologic, its insurance price was automatically set at 110% of the upper limit of its targeted products.

 

As a result, Phesgo SC Inj 600/600mg will be listed at KRW 3,490,410, and Phesgo SC Inj 1200/600mg at KRW 5,914,418.

 

According to IQVIA, sales of Herceptin and Perjeta in Korea amounted to KRW 56.5 billion and KRW 111.3 billion, respectively, last year.

 

As an improved version of the two drugs, Phesgo is also expected to record high sales.

 

However, its impact on insurance finances is also expected to be significant.

 

This is why the insurance authorities decided to apply RSA to Phesgo and save insurance finances.

 

The decision was influenced by the fact that Phesgo’s development target, Perjeta, is currently reimbursed through RSA.

 

Like Perjeta, Phesgo is applied the refund-type RSA, under which the company refunds a certain percentage of the claims.

 

"Considering that Phesgo’s target product is an RSA drug, we decided to apply RSA to Phesgo through negotiations with the National Health Insurance Service," explained the insurance authorities.

 

“The product has improved the administration route of the target product, which is convenient for patients to administer, and we expect it to bring financial savings when it replaces the target product." Phesgo passed the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee in August last year, but it took more than a year for it to be listed for reimbursement, the delay which can be explained by the cost-saving measure.

 

Ilaris, which is being reimbursed after 9 years of approval in Korea, also has a number of safeguards in place to reduce costs.

 

It is applied to the refund-type and expenditure cap-type RSA, and conditional follow-up is also required as a PE exemption drug.

 

Its list price is KRW 11,029,469 Ilaris is a rare disease drug for which there are no alternatives and is being publicly reimbursed in over 3 of the A8 countries, allowing the drug to omit submission of pharmacoeconomic evaluation data.

 

However, HIRA’s panel determined that the drug needs to be followed up in the future, including reevaluation of clinical effectiveness and cost-effectiveness, given the uncertainty of its improvement in clinical utility and high cost.

 

Therefore, HIRA imposed a condition on the pharmaceutical company to conduct a prospective clinical study (observation period of 2 years for each patient and submission of observation data and results in 1-year increments) and submit clinical utility and cost-effectiveness data at the end of the RSA term.

 

For example, the pharmaceutical company is required to conduct relevant prospective clinical studies, in an objective, cross-sectional survey format, with at least 2 years of observation per patient, and submit observations and results on a yearly basis.

 

For the NOMID (neonatal onset multisystemic inflammatory disease)/CINCA (chronic infantile neurocutaneous joint syndrome) indication, the company needs to submit efficacy comparison data with existing treatments and cost-effectiveness data at the end of the RSA term.

 

In addition, details such as plans to conduct prospective clinical studies for follow-up management and measures to be taken in case of failure to conduct such studies are required in the RSA.

 

"In the future, drugs that are exempted from economic evaluation, but whose clinical usefulness is unclear, will be thoroughly reevaluated through follow-up management measures," explained a HIRA official.