Reimbursement criteria for Cosentyx and Taltz inj. expanded

MOHW revises reimbursement criteria… Monitoring cycle for Samsca Tablet to be changed

Secukinumab injections such as Novartis Korea’s Cosentyx injection and Ixekizumab injections such as Lilly Korea’s Taltz prefilled syringe injection will be covered as first-line biologics for active and progressive psoriatic arthritis refractory to DMARDs.

 

Also, the monitoring cycle of liver and electrolyte levels in patients for orally administrated Tolvaptan spray-dried powder, such as by Otsuka Korea Pharmaceutical's Samsca Tablet 15mg, will be changed to match the indication.

 

On the 30th, the Ministry of Health and Welfare revised and issued the details regarding the criteria and methods for applying pharmaceutical benefits that contained the abovementioned changes.

 

The revision is effective from August 1st.

 

◆Cosentyx and Taltz PFS Inj.

 

etc.= ◆ The insurance benefit criteria for secukinumab injections such as Cosentyx injection and Ixekizumab injections such as Lilly Korea's Taltz prefilled syringe injection will be expanded.

 

The Health Insurance Review and Assessment Service has decided to expand the reimbursement of first-line biologics to DMARD refractory active and progressive psoriatic arthritis after reviewing domestic and foreign indications, textbooks, clinical treatment guidelines, clinical research papers, related academic opinions and etc.

 

Also, reflecting the experts' opinions and the precautions in the use of biologics issued for the risk of tuberculosis infection, the phrase to test for latent tuberculosis was added like for the TNF-α inhibitor.

 

In addition, the phrase directing three-time administration of the injections was deleted.

 

Specifically, the reimbursement criteria now stipulate that patients eligible for administration are those who saw insufficient treatment effect with two or more types of DMARDs for over 6 months (3 months or more for each) or patients with active and progressive psoriatic arthritis who discontinued treatment due to side effects of the abovementioned drugs.

 

Also, the conditions in the revised details specifically state that the patient should have 3 or more joints with tenderness and 3 or more joints with edema, and that the results should be from two consecutive examinations taken at a 1-month interval.

 

In the evaluation method, the phrase to administer the drug '3 times’ has been deleted from the '3 times in 6 months' condition.

 

In addition, a new criterion has been newly added, stating that the 'Guidelines for treating latent tuberculosis when using TNF-α inhibitor' should be followed when using such drugs.

 

◆Samsca Tablet = The monitoring cycle of liver and electrolyte levels in patients with autosomal dominant polycystic kidney disease (ADPKD) for orally-administrated tolvaptan such as Otsuka Pharmaceutical Korea's Samsca Tablet 15mg, will be changed to match the drug's indications.

 

Looking at the changes in the detailed approval criteria, values such as AST, which were to be measured before the first administration and 'once a month' after administration, were changed 'to be examined before the first administration and every month for the first 18 months and once every three months thereafter during administration.' In addition, the criteria for blood test results that were limited by 'monthly' results when filing claims for reimbursement, was changed to 'according to monitoring' results to match the indications.