Reimbursement listing of Handok’s Doptelet near

Negotiations with the National Health Insurance Service are in progress after the company accepted the DREC results

Expectations rise on its role as a new treatment option for thrombocytopenia

Doptelet, Handok’s newly introduced drug, is close to being listed for insurance reimbursement in Korea.

 

According to industry sources, Handok has accepted the conditions presented by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service for Doptelet (avatrombopag), a treatment for immune thrombocytopenia (ITP) and 'thrombocytopenia in patients with chronic liver disease scheduled for surgery,' and is in the negotiation stage with the National Health Insurance Service.'' Handok introduced Doptelet from the global biopharmaceutical company SOBI.

 

The drug is an oral thrombopoietin receptor agonist (TPO-RA) used to help treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP) when other treatments have  It is used in various countries, including the United States, Europe, Australia, and Japan, and was approved by the US Food and Drug Administration (FDA) in June 2019 and the European Medicines Agency (EMA) in January 2021 for the treatment of immune thrombocytopenia.

 

Doptelet offers a new option for both patients new to and those already experienced with TPO-RA treatment for chronic immune thrombocytopenia.

 

The results of the Phase III 302 Study showed that the cumulative number of weeks with a platelet response (platelet count of 50,000/μL or higher) in the Doptelet group was 12.4 weeks (median), which was significantly longer than the 0 weeks (median) in the placebo group, and that 65.6% of patients in the Doptelet group showed a rapid platelet response on day 8 of treatment.

 

These results were consistent regardless of whether or not the patient had previous TPO-RA treatment experience.

 

A retrospective analysis of patients who switched from existing TPO-RA to Doptelet also showed that Doptelet had excellent therapeutic effects.

 

In an analysis of a total of 44 patients in the United States, 93% of patients who switched to Doptelet reached a platelet count of 50,000/μL or higher, and 86% of patients reached a platelet count of 100,000/μL or higher.

 

In particular, in patients who did not see sufficient effects with existing TPO-RA, the platelet count (median) increased from 28,000/uL to 88,000/uL after taking Doptelet.

 

Doptelet has also demonstrated its efficacy in patients with chronic liver disease who are having difficulty undergoing invasive procedures due to thrombocytopenia.

 

The results of the ADAPT-1 and ADAPT-2 trials showed that the percentage of patients with chronic liver disease and thrombocytopenia of less than 40,000/uL who did not require platelet transfusions or rescue therapy after the procedure was 22.9% and 34.9%, respectively, in the ADAPT1 and ADAPT2 placebo groups.

 

In contrast, 65.6% and 68.6% of the patients in the Doptelet group did not require platelet transfusions or rescue therapy in the ADAPT-1 and ADAPT-2 trials, respectively.

 

In patients with 40,000/uL to 50,000/uL, 88.1% and 87.9% of patients in the Doptelet group did not require platelet transfusions or rescue therapy, while 38.2% and 33.3% of patients in the placebo group did not require platelet transfusions or rescue therapy in each clinical trial.

 

Meanwhile, following the strategic partnership last year, Handok established a joint venture with SOBI in April this year.

 

Handok-Sobi develops and sells rare disease drugs in Korea, with Handok and Sobi holding 49% and 51% of the shares, respectively.

 

And Handok's newly introduced drug, ‘Doptelet,' is nearing insurance reimbursement listing in Korea.