Mabthera coverage extended and Strensiq newly listed

MOHW to update pharmaceutical reimbursement standard and method as of June 1

Healthcare reimbursement would be granted on AbbVie Korea’s adult psoriasis treatment Skyrizi prefilled syringe (risankizumab) and Handok’s rare disease treatment Strensiq Injection (asfotase alfa) with new reimbursement standards.

 

Korea’s Ministry of Health and Welfare (MOHW) announced the finalized changes in the revised Healthcare Reimbursement Standard and Method would be effective from June 1.

 

◆Skyrizi prefilled syringe: A new detailed standard of healthcare reimbursement would be established for the risankizumab injection based on the existing biological therapy options for psoriasis treatment.

 

The coverage on the treatment would be granted to patients (age over 18) with chronic (expressed for over six months) psoriasis at a severe level, who qualify all following conditions—showing symptoms of plague psoriasis on 10 percent and more of their body surface area; scoring 10 or higher on Psoriasis Area and Severity Index (PASI); and demonstrating no reaction despite receiving UVB phototherapy for over three months or cannot maintain the therapy due to adverse reaction.

 

However, those patients who cannot receive both photochemotherapy (PUVA) and UVB phototherapy should qualify following conditions—showing symptoms of plague psoriasis on 10 percent and more of their body surface; scoring 10 or higher on PASI; and demonstrating no reaction to three months of or longer administration of methotrexate (MTX) or cyclosporine, or cannot maintain the therapy due to adverse reaction.

 

If the patient shows reduction of PASI by 75 percent or more after taking the treatment for 16 weeks (three doses), the coverage status is maintained for another six months.

 

The PASI would be evaluated every six months and the coverage would be maintained if the patient shows the initial evaluation result.

 

Risankizumab was added as an alternative option of TNF-α inhibitors like adalimumab, etanercept and infliximab or guselkumab, ixekizumab, secukinumab and ustekinumab have added risankizumab with the new reimbursement approval.

 

◆ Strensiq 40 mg/ mL injection and other: Handok’s Strensiq injection (asfotase alfa), the only enzyme replacement therapy indicated to treat infantile- and juvenile-onset hypophosphatasia (HPP).

 

The injection would also be listed from June 1 for patients with infantile- and juvenile-onset HPP, who started treatment before the age of 19.

 

Accordingly, provisional approval procedure and other reimbursement standards were added to manage careful use of the treatment with standard of initial administration and suspension.

 

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.

 

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

 

The treatment has to be administered at a healthcare institute by principle, but self-administration would be allowed only when a properly trained patient demonstrates stable disease activity and no sign of adverse reaction.

 

For a long-term prescription, a single dose is for maximum of four weeks.

 

The patient also has to document ‘medication log’ to keep track of administration period and management for the responsible healthcare institute to follow.

 

◆ Lemtrada injection: Sanofi-Aventis Korea’s Lemtrada injection (alemtuzumab) indicated to treat relapsing remitting multiple sclerosis (RRMS) in adult patients is extending its reimbursement to cover third cycle for patients qualifying acceptable disease activity level after the second cycle.

 

Patients, who have relapsed at least once, are eligible for the coverage if they meet two conditions out of following three; brain or spinal MRI detects new or enlarged T2 lesion, or new Gadolinium-enhanced lesion.

 

◆ Cyclosporine oral and injection and mycophenolate mofetil: The reimbursed indications are expanding for Cipol-N soft capsule and Sandimmun injection (cyclosporine), Cellcept capsule (mycophenolate mofetil), cyclophosphamides, Mabthera Injection (rituximab) and IV-Globulin SN injection (human immunoglobulin G).

 

Specifically, the healthcare reimbursement would be granted for the off-label use of the drugs in immune tolerance induction as immunosuppressant to treat hemophilia A or B patients, if pre-approved by Health Insurance Review and Assessment Service (HIRA).

 

The President of HIRA is stipulated to decide prerequisite conditions of the pre-approval, such as forming a committee, standard, procedure and method of the pre-approval.

 

But the reimbursed off-label use of Pfizer Pharmaceutical Korea’s Benefix injection (Recombinant Blood Coagulation Factor Ⅸ) cleared is only for hemophilia B patients.

 

◆Desmopressin acetate and mirabegron: As Ferring Korea’s Nocdurna 25 μg sublingual tablet is to get listed, desmopressin acetate items exempted from reimbursement due to the revised standard would be stipulated.

 

Also, the reimbursement standard for mirabegron would be revised with the listing of overactive bladder treatment by Hanmi Pharmaceutical, Mirabeg 50 mg SR tablet.