Handok orphan drug ‘Strensiq’ cleared for reimbursement

The orphan drug Strensiq(asfotase alfa), imported and sold by Handok, has crossed the threshold of the Drug Reimbursement Evaluation Committee. The potential for health insurance coverage is increased.

According to the Health Insurance Review and Assessment Service(HIRA) on July 7, the Drug Reimbursement Evaluation Committee(DREC) held a second meeting in 2020, and deliberated on the adequacy of health insurance benefits for Strensiq which is filed by Handok.

The president of HIRA evaluates the adequacy of drug reimbursement through the deliberation of DREC in accordance with Article 11-2 of the Rules on the Criteria of Medical Care Benefit of the National Health Insurance.

The committee acknowledged both the clinical effectiveness and economics of the Strensiq, and concluded that health insurance benefits would be appropriate for the drug.

Strensiq, which is approved by the Ministry of Food and Drug Safety in February 2016, is effective when used as a long-term enzyme replacement therapy to treat bone symptoms in patients with childhood-onset hypophosphatasia.

In this case, childhood includes peripartum, infancy(0~6 months after birth), and adolescence(6 months to 18 years of age at the time of onset).

The two dosages(40mg/mL, 100mg/mL) of Strensiq were approved, of which 40mg/mL was imported $1.07 million worth in 2018.

As Strensiq is passed by DREC, the National Health Insurance Service and Handok will start negotiations on drug price.

Once the drug price negotiations are concluded between the National Health Insurance Service and the company, Strensiq will be reviewed by the Health Insurance Policy Deliberative Committee and may be reimbursed after the minister of the Ministry of Health and Welfare notice.