First RSA drug ‘Erbitux’ to receive second reevaluations

Reevaluations to start in June… companies brace for impact

RSA renewals become more difficult with the approval of latecomers

The term of risk-sharing agreements of major anticancer drugs are again nearing expiry.

 

Starting with Merck’s ‘Erbitux (cetuximab), the first drug to be reimbursed with the RSA scheme in Korea, a series of other drugs are also awaiting reevaluations until 2023.

 

According to industry sources, the colorectal cancer treatment Erbitux’s RSA term expires in June.

 

Also, RSA terms for Astella’s ‘Xtandi (enzalutamide),’ Amgen’s ‘Kyprolis (carfilzomib),’ Lilly’s ‘Cyramza (ramucirumab),’ Janssen’s ‘Darzalex (daratumumab),’ Biogen’s ‘Spinraza (nusinercen),’ Sanofi’s ‘Dupixent (dupilumab)’ is nearing expiry.

 

With reevaluations imminent, the mixed concerns held by the stakeholders (government, pharmaceutical companies, patients) are resurfacing.

 

For Erbitux, this is the second time the drug is up for RSA renewal.

 

As all these drugs would need to cut prices, therefore whether the company may reach a consensus with the government and succeed in renewing its agreement remains a focus of attention.

 

Of course, no drugs have failed to renew their RSAs yet, but as the price of the drugs would need to inevitably fall as re-evaluation progresses, every news renewal brings tension to its stakeholders.

 

In Korea, RSA drugs are required to undergo evaluations for clinical efficacy and cost-effectiveness every time their term expires, unlike general drugs that demonstrate their cost-effectiveness at the time of approval through pharmacoeconomic evaluations.

 

The cost-effectiveness evaluations are inevitably affected by the price of its alternatives at the time of evaluations, and during the 5-year RSA term, the price of the alternative drugs are cut through various post-management mechanisms (reduction of original drug prices due to generic listings, volume-price linkage system, price cap discounts due to reimbursement expansions, etc).

 

In addition, the revisions made in 2020 now allow latecomers to sign RSA agreements, therefore the price of the latecomers can now directly affect the cost-effectiveness of the first entrants.

 

This has added to the already-long list of issues that had been constantly raised about RSA renewals in the industry.

 

However, the entry of latecomer drugs into the RSA scheme has been a long-awaited wish from the industry’s perspective, and the government made the decision to expand RSA benefits after various discussions.

 

Also, it is not unreasonable for price adjustments to be made for drugs that have alternatives with the same mechanism of action, even if their indications are not identical.

 

An official from a multinational pharmaceutical company said, “All companies ahead of reevaluations have their own concerns.

 

If the government alleviates the standards by resetting the reevaluation period or by simplifying the data required for submissions, it will be easier to reach an agreement,” he said.

 

He added, “If the RSAs are not renewed and the drugs become non-reimbursed, the confusion will only be transferred to the field and the patients.

 

It is now time to prepare the right mechanism to maintain the RSA system, the main scheme that is being used to list high-priced drugs.”