As the reevaluation nears for drugs approved under risk-sharing agreements (RSA), experts are actively discussing how to improve the RSA system.
RSA refers to an agreement between a pharmaceutical company and the National Health Insurance Service (NHIS) to share the responsibility for uncertainties regarding the drug’s efficacy.
On Tuesday at the National Assembly, Rep. Kim Seung-hee of the opposition Korea Liberty Party, Korean Association for Clinical Oncology (KACO), and Korean Cancer Study Group (KCSG) held a debate forum to improve the RSA system for expensive novel drugs.
Experts said RSAs helped patients get more access to expensive new drugs at the forum, chaired by KCSG President Kang Jin-hyoung, a professor of medical oncology at the Catholic University of Korea.
However, the government should improve the RSA system because drugs in RSAs should go through an economic feasibility test to obtain the regulator’s reevaluation.
Adopted in December 2013, the RSA system allows a four-year contract (evaluation period of one year after three years) between a drugmaker and the national insurer for substitutable drugs or those with an equivalent in therapeutic positions, or anticancer drugs without any other treatment and rare disease treatments.
Twenty-six drugs under RSAs, including the first one Evoltra Injection (ingredient: clofarabine), a treatment for childhood leukemia, are subject to reevaluation.
|Rep. Kim Seung-hee of the opposition Korea Liberty Party, Korean Association for Clinical Oncology (KACO), and Korean Cancer Study Group (KCSG) hold a debate forum to improve the risk-sharing agreement system for expensive novel drugs at the National Assembly, Tuesday.|
Seo Dong-cheol, a professor at Chung-Ang University’s College of Pharmacy, said drugmakers might face changes in a new contract over the possibility of the substitute drug and the criteria for reimbursement. Thus, the government should consider replacing the economic feasibility test with a performance report including the effectiveness of the drug, Seo said.
“Rather than making the drugmaker submit materials for an economic feasibility assessment, the regulator has to decide for the renewal of the contract based on the clinical effectiveness,” Seo said. “Doing a complete economic feasibility evaluation twice means that the second assessment comes after three years from the first assessment. Then, many problems can occur due to the time difference and changed situations.”
Experts also pointed out that the RSA system makes the government spend excessive insurance budget for minority patients with cancer and rare diseases, which is unfair to patients suffering from other diseases. RSAs can make it difficult to expand a drug’s indications, they said.
Also, the timing of reimbursement registration has not been advanced, even after the nation started the system. If a drug in RSA fails to get a contract renewal, the criteria for drug pricing can become vague, they also noted.
To make the RSA system better, experts suggested the government-led “clinical trials for the public interest” as a complementary measure.
“At a recent debate forum, clinical trials for public interest were mentioned (by Professor Kim Beom-seok of Seoul National University Hospital). They can be a complementary solution,” said Kim Bong-seok, a member of KACO and a professor at Seoul Bohun Hospital’s hemato-oncology division.
Kim explained what “clinical trials for the public interest” meant by taking an example.
“Let’s say a drug comes in a 100ml vial and we prescribe 134 ml of the drug after calculating the patient’s weight. Then, we have to discard the leftover of a 200ml drug. The clinical trials for public interest mean we study what effects we could see if we use the 100ml drug on the patient,” he said.
Using 100ml drug is not allowed under the current system, he noted. “The government can carry out this kind of trials,” Kim said.
Some other experts claimed that the RSA system should also be applied to drugs under the same lineage of the RSA-approved medicines because the RSA system could hurt market competition amid a faster development of late-coming medications.
“Drugs under RSAs are approved with the criteria of whether they have substitute drugs, but the market releases of latecomers are getting faster,” said Kim Seong-ho, senior director of the Korean Research-based Pharma Industry Association. “If the substitute drug is an approval condition for drugs under RSAs, drugmakers cannot help but hesitate to choose an RSA while a latecomer drug might come on the market during the re-evaluation period.”
A patient group urged a measure to reduce the registration time for reimbursement of new drugs.
“The RSA system has limitations not in access to drugs but in shortening the registration time for reimbursement,” said Lee Eun-young, director of the Korea Alliance of Patients Organization.
The Ministry of Health and Welfare said the government was aware of the RSA system’s problems such as the uncertain criteria of the economic feasibility assessment for a reevaluation of drugs. The ministry said government officials are discussing ways to improve the system.
“Regarding the reevaluation of drugs under RSAs, the Health Insurance Review & Assessment Service, drugmakers, and the ministry had all different opinions on what kind of conditions to apply,” said Kwak Myoung-seob, head of the ministry’s pharmaceutical benefits division. “As re-evaluations will continue, we surely have to make decisions in a certain way.”
However, Kwak was cautious in commenting on an opinion about registering a drug for reimbursement first and then seeking re-evaluation. As for clinical trials for public interest and use of “real world data,” he said he was not sure because the government should consider if drugmakers would accept such suggestions or not.
The ministry official did not agree with other experts’ comments that the RSA system has made it longer for drugs under RSAs to be registered for reimbursement than other drugs in general.
“From the perspective of the health and welfare ministry, the time for drug reimbursement registration should be counted from the application date. We need to recheck the exact registration period,” Kwak said.
He went on to say that the drug reimbursement registration includes the drug pricing negotiations with the NHIS and the Pharmaceutical Reimbursement Evaluation Committee where no acceptance of a price can lead to a none-reimbursement decision.
“It is drugmakers that make the final decision whether to have an RSA or accept a drug price. While they make a key decision, I doubt that the government has to take the full responsibility for a long period of drug reimbursement registration,” he said.
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