Dupixent 200mg, newly listed

Ministry of Health and Welfare, Promote revision of drug reimbursement list dated April 1

Cabometyx / Erbitux, RSA renewal contract negotiations

Zaledeep succeeds by skipping negotiations

Sanofi-Aventis Korea's severe atopic dermatitis treatment Dupixent PFS 300mg has expanded insurance coverage to pediatric and adolescent patients, and products with 200mg content will be newly listed next month with an expanded range.

 

Taking this as an opportunity, the government is planning to expand the scope of benefits for special calculations based on eliminating blind spots in existing treatments for severe atopic dermatitis.

 

Janssen Korea Erleada, which is used for the treatment of metastatic prostate cancer (mHSPC), will be newly listed as a risk-sharing contract (RSA) reimbursement type at around 20,000 won.

 

According to the industry on the 21st, the Ministry of Health and Welfare plans to revise the 'drug reimbursement list and reimbursement upper limit table' and is pushing to apply it on the 1st of next month.

 

There are a total of 4 new drugs being promoted, 1 drug that has been expanded in the scope of use (benefit), and 4 items that are under contract renewal negotiations with the NHIS due to the expiration of the RSA period.

 

◆Newly listed item = Erleada is newly listed next month at 20,045 won so that it can be applied for health insurance.

 

This drug is used in combination with androgen deprivation therapy (ADT) for the treatment of patients with hormone-responsive metastatic prostate cancer.

 

Currently, A7 is registered in a total of seven countries, including the United States, Japan, France, Germany, Italy, Switzerland, and the United Kingdom.

 

The company applied for insurance listing to the Review and Assessment Service on November 30, 2021, a year later.

 

proceeded.

 

At the time, the committee judged that the cost-effectiveness ratio was included in the acceptable range as a result of the economic evaluation, but the reimbursement was appropriate when the drug price was lowered in consideration of the financial impact such as the possibility of an increase in market share.

 

As the company accepted this result, the drug was put on the negotiating table of the NHIS, and immediately entered into negotiations on the drug price and expected billing amount, and was successfully registered in April.

 

The corporation expects that this drug will be cheaper than alternative treatments, and actual additional finance will be insignificant when considering the RSA refund rate in the future.

 

Dupixent, which is used for severe atopic skin disease in adults, is also listed as a 200mg product with reduced content.

 

Similar to the 300mg content product already registered and covered by insurance, RSA refund type, total amount limit type, and initial treatment cost refund type were applied to this content product in combination.

 

In addition, Bukwang Pharmaceutical's Zaledeep 5mg and 10mg content products, which have stepped on the track of skipping drug price negotiations with the NHIS, are also listed at 102 won and 153 won per capsule, respectively.

 

◆ Expansion of scope of use = The scope of reimbursement for Dupixent 200mg, which is already registered, will be expanded from adults currently applied to children and adolescents in the future.

 

Currently, it is estimated that 5,000 Korean adults with atopic dermatitis are receiving benefits.

 

The government plans to broaden the reimbursement standard so that the drug can be widely used for children (6-11 years old) and adolescents (12-17 years old) with atopic dermatitis.

 

The number of these patients is estimated to be 2550.

 

The drug's benefit for children and adolescents is being applied to all A7 countries, and it is also being applied to adults in Korea, so its clinical usefulness has already been proven.

 

Following the increase in benefits this time, the company negotiated with the NHIS again and set the price at 696,852 won per share, a 1.5% cut.

 

At the same time, the government expands the scope of application of special calculations accordingly.

 

It is to adjust the benefit standard while expanding the benefit from the existing adult target to children and adolescents.

 

This is because if the current registration standards for calculation special cases are maintained, pediatric patients fall under the pharmaceutical reimbursement standards, but cannot meet the registration standards for calculation special cases, creating a blind spot where special cases are not applied.

 

◆ RSA Expiration Evaluation Items = Negotiations were made to renew contracts for 4 items of drugs covered by insurance through RSA.

 

The target is Cabometyx, a renal cell cancer drug from Ipsen Korea, and Erbitux Inj.

 

5mg/mL (cetuximab), colorectal cancer, and head and neck cancer treatment from Merck.

 

Before the contract period of the RSA drug expires, the government has the Pharmaceutical Review Committee evaluate the drug's clinical usefulness and cost-effectiveness, and proceed with contract renewal negotiations with the NHIS.

 

The types of negotiations include lower drug prices, expected billing amounts, reimbursement rates, and caps.

 

The target drugs for this time were contracts with Cabometyx or Erbitux, which limit the amount of use per patient, and as the companies expressed their intention to renew the contract, the procedure was followed.

 

As a result of the negotiations, Cabometyx will be cut by 2.5% for each content, and Erbitux will be cut by 8.5%.

 

In the case of Erbitux, the new drug price will be applied as of May 1 due to the renewal of the contract.