Addition of Kevzara® to category of drugs subject to guidance and management fee for self-injection at home and lift of ban on long-term prescription
2018-12-03
Asahi Kasei Pharma Corp.
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Asahi Kasei Pharma Open new window announces that on December 1, 2018, Kevzara® 150 mg Syringe and 200 mg Syringe Subcutaneous Injection [generic name: sarilumab (rDNA origin)] were added to the category of drugs subject to a guidance and management fee for self-injection at home, and that their treatment by self-injection was included in Japan's National Health Insurance (NHI) coverage. On the same day, the ban on their long-term prescription was lifted.*

  • In accordance with Ordinance No. 107 of the Ministry of Health, Labour and Welfare (March 6, 2006), prescription of a new drug is limited to a 14-day portion until the end of the month in which one year passes from the date the NHI drug price was listed.
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Developed jointly by Sanofi and Regeneron Pharmaceuticals, Kevzara® is a human monoclonal antibody that binds to interleukin-6 (IL-6) receptors and thereby blocks the action of IL-6, which is known to play an important role in inflammation of the synovial membrane of joints. Kevzara® is available in 19 countries including the US, Canada, and various countries in Europe (as of December 3, 2018). Sanofi and Regeneron obtained manufacturing and marketing approval for Kevzara® in Japan as a treatment for rheumatoid arthritis not responding well to conventional treatments on September 27, 2017. Kevzara® was listed in Japan's NHI drug price standard on November 22, 2017, and Asahi Kasei Pharma launched its sale on February 5, 2018.

As treatment of rheumatoid arthritis may become long-term, patients' quality of life can be improved by reducing the frequency of hospital visits. Asahi Kasei Pharma believes that the inclusion of NHI coverage for Kevzara® by self-injection and the removal of the prescription limit will further benefit both patients and healthcare providers in Japan.

Product outline

Product name

Kevzara® 150 mg Syringe Subcutaneous Injection
Kevzara® 200 mg Syringe Subcutaneous Injection

Generic name

Sarilumab (rDNA origin)

Indication

Rheumatoid arthritis not responding well to conventional treatments

Dosage and administration

For adults, ordinarily subcutaneous administration of 200 mg of sarilumab (rDNA origin) once every 2 weeks. Reduced to 150 mg depending on patient condition.

Manufacture

Sanofi K.K.

Sale

Asahi Kasei Pharma Corp.

Approval

September 27, 2017

NHI price listing

November 22, 2017

Launch of sale

February 5, 2018

NHI price

¥44,556 per 150 mg syringe
¥59,120 per 200 mg syringe

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