HIRA clears all Strensiq pre-approvals from July

Pre-approval on Spinraza and Soliris also completed

Handok’s rare disease treatment Strensiq injection (asfotase alfa) passed the preliminary approval review and processed the first reimbursed administration.

 

Listed for healthcare reimbursement as of June 1, Strensiq is a third drug to be required to receive pre-administration approval for a reimbursed use of the drug.

 

Soliris injection (eculizumab) and Spinraza (nusinersen) are the other drugs required to pass the pre-approval.

 

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Health Insurance Review and Assessment Service (HIRA) Healthcare Review and Assessment Committee has approved of granting reimbursement on two cases that applied in July

 

.Strensiq’s maximum pricings for all doses are set at 806,964 won (12 mg), 1,210,446 won (18 mg), 1,882,916 won (28 mg), 2,689,880 won (40 mg), and 5,379,760 won (80 mg)

 

.Handok has signed the Korean market sales right deal over Strensiq with the U.S.-based company, Alexion on Nov

 

.17, 2016 to strengthen their strategic partnership first made through Soliris

 

.Strensiq is indicated as an enzyme replacement therapy treating bone related symptoms in patients with infantile-onset hypophosphatasia (HPP)

 

.A patient with infantile-onset HPP would receive coverage when qualifying all following conditions—level of alkaline phosphatase (ALP) measures lower than normal range of the certain age and sex group but exceeds normal range of Pyridoxal-5’-phosphate (PLP); bone condition unique to HPP confirmed through radiograph prior to treatment; initial treatment received before the age of 19

 

.A clinical evaluation (height, weight, reparatory function, motor development stage, ambulatory function and pain) has to be conducted prior to the initial treatment, three and six months into the therapy, and every six months from then on

 

.The pre-approvals were respectively deliberated on male children aged four and six

 

.The four-year-old was diagnosed with HPP eight days after the birth, and started using Strensiq from the first month (June 2016)

 

.The six-year-old was diagnosed with the same disease at 11-month-old and started administering the injection from 21st month (January 2016)

 

.These patients were provided with the coverage on the continuous treatment as their clinical evaluation, blood test and radiological report after the administration improved, and they did not reach the administration suspension standards

 

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Meanwhile, two out of three reimbursed administration applications on spinal muscular atrophy (SMA) treatment Spinraza were approved from last month

 

.The health authority requested additional supplementary data

 

.The 28 administration monitoring reports were all cleared

 

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For this time, Soliris did not have anyone requesting for new administration in a patient with paroxysmal nocturnal hemoglobinuria (PNH), but only three out of six new applications on treating atypical hemolytic uremic syndrome (aHUS) have been cleared

 

.The other three have been denied

 

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