JW Pharmaceutical agrees on RSA renewal terms for Hemlibra

Will continue to receive reimbursement through the RSA scheme

Contract expires in April...new 5-year RSA is in place

RSA renewal discussions for leukemia drug 'Venclexta' may pass the deadline

JW Pharmaceutical has reportedly agreed to renew its risk-sharing agreement (RSA) for its hemophilia treatment ‘Hemlibra SC injection’ with the National Health Insurance Service.

 

The company for the leukemia drug ‘Venclexta Tab,’ which was also in the process of negotiating the terms of RSA renewal, is expected to push for a temporary extension of the contract as it failed to reach an agreement by the RSA negotiation deadline.

 

JW Pharmaceutical signed an RSA contract for Hemlibra from May 1, 2020, to April 30 this year.

 

The expenditure cap type of RSA was applied.

 

Hemlibra was unable to reach an agreement in the first round of renewal negotiations but succeeded in reaching an agreement in subsequent negotiations.

 

In May 2020, Hemlibra was first reimbursed for severe hemophilia A antibody patients, and the coverage was extended to patients without antibodies last year.

 

As there are more patients without antibodies than those with antibodies among the 1,700 hemophilia A patients in Korea, the number of insurance claims is expected to increase.

 

Last year, the company's annual sales exceeded KRW 10 billion.

 

With the successful renewal, the RSA contract will continue to be applied for 5 years from May 1 this year to April 30, 2029.

 

On the other hand, discussions on the leukemia drug Venclexta (AbbVie, venetoclax) are having difficulty reaching an agreement within the RSA contract deadline.

 

Venclexta is currently reimbursed as a third-line or greater monotherapy in patients with chronic lymphocytic leukemia (CLL) who have relapsed or are refractory to chemotherapy and B-cell receptor inhibitors, or as a combination therapy in the second-line in patients with chronic lymphocytic leukemia (CLL) who have received at least one prior chemotherapy.

 

The drug’s RSA contract term is from April 1, 2020, through March 31 this year, and was applied the expenditure cap type RSA.

 

In February last year, the drug’s insurance ceiling price was reduced by 12.2% due to the expanded scope of its use.

 

The NHIS and its pharmaceutical company are expected to push for a temporary RSA extension as it would be difficult for the parties to reach an agreement by the end of the RSA term.

 

Sanofi had also signed a temporary term extension agreement for its Dupixent after its contract expired in December last year, and the company successfully renewed its RSA last month.