Off-label coverage on Cellcept and Mabthera expanded

MOHW partially revises ‘Reimbursement Standard and Application Details (Pharmaceuticals)’

From next month, the off-label reimbursement would be expanded on Roche Korea’ immunosuppressant Cellcept Capsule (mycophenolate mofetil) and chronic lymphocytic leukemia and rheumatoid arthritis treatment Mabthera injection (rituximab).

 

Lilly Korea’s psoriatic arthritis and ankylsoing spondylitis treatment Taltz Prefilled Syringe Injection (ixekizumab) would receive reimbursement as a second-line treatment on severe case of ankylsoing spondylitis.

 

South Korea’s Ministry of Health and Welfare (MOHW) has partially revised the ‘Healthcare Reimbursement Standard and Application Details (Pharmaceuticals)’ to reflect the said changes as of Oct.

 

1.

 

First, an oral mycophenolate mofetil Cellcept would expand the coverage based on indications approved in South Korea and overseas, textbooks, clinical guideline, clinical literature, and related academic recommendations.

 

The new coverage on Cellcept would apply on patients with advanced diffuse cutaneous systemic sclerosis and systemic sclerosis associated interstital lung disease.

 

The reimbursement would be granted for patients with diffuse cutaneous systemic sclerosis, who have not sufficiently responded to one or more types of other immunosuppressant, such as azathioprine, and scored over 12 points in modified Rodnan Skin Score (mRSS).

 

Also, patients with systemic sclerosis associated interstital lung disease, who have not sufficiently responded to one or more types of other immunosuppressant, such as azathioprine, and their Forced Vital Capacity (FVC) ranging from 45 percent to under 80 percent.

 

For both diseases, 250 mg to 3,000 mg of the drug would be administered daily.

 

The off-label use of the rituximab injection would obtain reimbursement, when treating children with chronic nephritic syndrome.

 

The new off-label coverage would be available to patients with steroid-dependent nephritic syndrome frequently relapsing regardless of receiving steroid and immunosuppressant (cyclosporine, cyclophosphamide, tacrolimus or mycophenolate mofetil), patients with steroid-dependent nephritic syndrome who do not demonstrate remission or frequently relapsing regardless of receiving steroid and immunosuppressant (cyclosporine, cyclophosphamide, tacrolimus or mycophenolate mofetil), and patient who cannot use steroid or immunosuppressant (cyclosporine, cyclophosphamide, tacrolimus or mycophenolate mofetil).

 

The reimbursement would be provided for an initial administration of 375 mg/ m2 (maximum 500 mg), and another follow-up administration after three to six months (maximum twice a year).

 

The treatment can be re-administered, if the patient relapses.

 

However, patients with chronic or acute infection, who received live attenuated vaccine within a month, or who test absolute neutrophil count (ANC) under 500/ mm³ would not be eligible for the administration.

 

The reimbursement on an ixekizumab treatment, Taltz Prefilled Syringe Injection would be additionally granted as a second-line treatment on patients with severe case of ankylsoing spondylitis by referring to the reimbursement standard on interleukin-17 inhibitors (IL-17i).

 

Patients with severe and active ankylsoing spondylitis, who do not respond well to one or more types of tumor necrosis factor-α (TNF-α) inhibitor or halted treatment due to adverse reaction, would be eligible for the coverage.

 

The sustained administration of six months with reimbursement would be approved to patients scoring 50% on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) or reduced more than two (scale 0 to 10) after using the treatment for 16 weeks.

 

The evaluation would be conducted every six months from then on, and the sustained administration would be allowed if the patient maintains the evaluation result from the first 16 weeks.

 

Also the coverage would be granted for patients, who do not respond to the treatment or have to halt the administration due to adverse reaction, but switching to a TNF-α inhibitor (etanercept, adalimumab, infliximab or golimumab injection) that has not been used before or to a secukinumab injection.

 

However, in such case, the patient has to submit a doctor’s recommendation on the switch.

 

As the reimbursement on Taltz Prefilled Syringe Injection has been expanded to patients with ankylsoing spondylitis, the treatment’s substance name would be added to golimumab’s reimbursement standard as an option for switch.

 

Janssen Korea’s Simponi Prefilled Syringe Injection 50 mg is the most famous brand name for golimumab.