‘Will raise ICER threshold for innovative new drugs’

“Need to carefully review applying the pharmacoeconomic evaluation exemption system to pediatric drugs”

MOHW “Revised relevant regulations in August to newly add ‘innovativeness’ as a condition”

The government has reaffirmed its policy to flexibly evaluate the ICER (incremental cost-effectiveness ratio) threshold for drugs that demonstrate innovativeness in order to strengthen patient access to new drugs.

 

The intent is to increase the ICER threshold of new drugs based on previously announced criteria such as substitutability, prolonged survival outcomes, and whether the drug is a fast-track drug.

 

The government maintained its position that it should be cautious about the need to extend the pharmacoeconomic exemption system to pediatric rare disease drugs and anti-cancer drugs.

 

The Ministry of Health and Welfare's Pharmaceutical Benefits Division explained so in response to a written inquiry made during the NA Audit by Representative Myung-ok Seo of the People Power Party.

 

Rep Seo pointed out the limitations and problems with the economic and non-economic indicators used to evaluate life.

 

Rep.

 

Seo asked whether the MOHW plans to raise the ICER threshold to improve access to new drugs based on analyses of recently listed drugs that have undergone pharmacoeconomic evaluations in comparison to those set in major overseas countries.

 

The MOHW judges the cost-effectiveness of a new drug by comparing its clinical utility, such as the length of patient survival, to the additional cost.

 

The MOHW replied that it revised the relevant regulations in August this year by specifying the ‘innovativeness’ condition among the ICER threshold evaluation factors based on the ‘Measure to Improve the Drug Pricing System Reflecting Innovation Value of New Drugs’ announced in December last year.

 

Based on this, new drugs that satisfy the conditions of innovativeness will have their ICER value adjusted upward.

 

The conditions for innovativeness are: ▲ there is no equivalent product or treatment that is substitutable or therapeutically equivalent; ▲ is recognized for a significant clinical improvement in the final outcome indicator, such as prolongation of survival; or ▲ the drug is a new drug approved under Article 35(4)(2) of the Pharmaceutical Affairs Act as a GIFT or equivalent.

 

The MOHW said, “New drugs that meet the conditions of innovativeness will be flexibly evaluated with ICER thresholds that reflect their fair value.

 

The government will strive to improve public health and ease economic burdens by strengthening patient access to new drugs for serious diseases such as cancer and rare diseases." In addition, the MOHW also plans to support the improvement of patient access to rare disease drugs through policy operations.

 

Specifically, the ministry explained that it has reviewed measures to improve insurance listing of rare disease drugs in accordance with the ‘Specific tasks for improving access to rare disease drug reimbursement benefits’ in the Comprehensive Plan for Rare Diseases to support the prompt registration of treatments.

 

It added that it secured flexibility in the ICER value, a criterion for pharmacoeconomic evaluation by adding 'innovation' to the evaluation factor, and has been implementing a parallel negotiation-evaluation system since January last year and a pilot project for the approval-evaluation-negotiation system since the second half of last year.

 

The MOHW also pointed out that overseas cases such as Canada and the United Kingdom are applying measures such as flexible application of ICER values and expansion of the risk-sharing agreement systems to strengthen access to rare disease treatments, and the MOHW is also promoting policies modeled after them.

 

To expedite the reimbursement of rare disease drugs, the MOHW replied that it will operate a pharmacoeconomic evaluation exemption system and a risk-sharing agreement system, and actively identify improvements to the system by collecting opinions on-site.

 

However, the ministry expressed caution about expanding the pharmacoeconomic evaluation exemption criteria to include rare disease drugs and anti-cancer drugs for children.

 

“In January last year, the MOHW revised the relevant regulations to add new drugs that treat non-life-threatening pediatric diseases but have a small number of patients and are clinically proven to improve quality of life,’ the MOHW said, explaining that “Crysvita Inj, a new drug for treating X-linked hypophosphatemia, which was approved in May last year, is a typical example.” “The pharmacoeconomic evaluation exemption system is operated as an exception that substitutes the cost-effectiveness evaluation by referencing a drug’s listed price in other countries,” the MFDS said, adding, “The proposal to expand the pharmacoeconomic evaluation exemptions to adult patients needs to be carefully promoted through public discussion.”