【News】Insurance coverage approved for the treatment of HAM and Hereditary Spastic Paraplegia using Medical HAL

CYBERDYNE Inc. (Tsukuba, Ibaraki; President & CEO: Yoshiyuki Sankai, the “Company”) announced today that its application for public insurance coverage for the treatment of HTLV-1 Associated Myelopathy (HAM) (*1) and Hereditary Spastic Paraplegia (*2) was approved by the letter of announcement on the website of MHLW that was posted on October 1, 2023.

Based on the clinical trial data obtained from the NCY2001 study (*3), the Company filed an application in 2021 for partial change of the manufacturing and marketing approval to include spastic paraplegia due to spinal cord lesions of different causes (viral disease HAM and hereditary spastic paraplegia caused by genetic abnormality). MHLW approved the application in October 2022. Following the approval, the Company applied for public health insurance coverage so that the medical institutions retrieve reimbursement when treating patients with HAM and hereditary spastic paraplegia using Medical HAL. The notice posted on the website of MHLW confirmed the public health insurance coverage for treating those two diseases using Medical HAL.

As soon as the revision of the Guide for Appropriate Use is completed, medical institutions will be able to calculate the following reimbursements when treating patients with spinal cord diseases (HAM and hereditary spastic paraplegia) with Medical HAL as well as neuromuscular diseases (*4) that have already been covered by the insurance.

J118-4 Ambulatory exercise treatment (with robot suit) (per day) 1100 points

With this insurance coverage, the Company will accelerate the spread of Medical HAL as a new treatment option for the estimated 4,500 spinal cord disease (HAM and hereditary spastic paraplegia) patients nationwide in Japan and promote efforts to establish Medical HAL as the standard treatment for these spinal cord diseases worldwide.

＜Comment from Dr. Takashi Nakajima, Director of National Hospital Organization Niigata Hospital＞
With the new insurance coverage, the “J118-4 Gait Movement Procedure (by Robot Suit)” insurance points can now be applied to HAM and hereditary spastic paraplegia. As a result, the number of diseases that Medical HAL Lower Limb Type could treat under public health insurance has increased from eight to ten conditions. The applicable lesion sites have also been expanded from the motor unit area to the spinal cord area. It is wonderful that patients with HAM and hereditary spastic paraplegia with spinal cord lesions can now enjoy this treatment as an insured treatment and improve their walking and mobility function, which significantly impacts daily life. This is an achievement of Japan’s efforts to combat intractable diseases (including HTLV-1). It is also proof that researchers, specialized medical institutions, and HAM patient groups worked together on this project in a clinical trial conducted as an investigator-initiated clinical trial.
This insurance coverage is based on the results obtained through the clinical trial (NCY-2001 study) and is considered a significant basis for expanding public insurance coverage overseas, where there is a great need for such coverage in the future. Furthermore, suppose the development of a virological treatment for HAM and a genetic medicine treatment for hereditary spastic paraplegia progresses. In that case, it will be possible to aim for further clinical efficacy by combining HAL with these therapies. Research and development in many fields, including these areas, is highly anticipated.

*1 HTLV-1-associated myelopathy (HAM):
It is a rare disease, with an estimated 3,000 patients nationwide, and it is one of the designated intractable diseases. It is an intractable disease that progressively damages the spinal cord, causing symptoms such as difficulty walking, urination, defecation, numbness, and leg pain. The condition eventually forces patients to live in wheelchairs or bedridden, leading to a severe decline in quality of life.

*2 Hereditary spastic paraplegia:
It is a rare genetic disorder that causes gradual muscle weakness with spasticity in the legs and is one of the designated intractable diseases. It can occur at any age and causes excessive reflexes, increased tendon reflexes or muscle tone in both lower extremities and paralysis, making walking difficult.

*3 NCY-2001 trial
This study is a part of the “Practical Application Research Project for Intractable Diseases” funded by Grant-in-Aid for Scientific Research from Ministry of Health, Labour and Welfare (FY 2012-2014), “Investigator-Initiated Clinical Study of Wearable Assistive Robot for Lower Limbs Controlled Voluntarily by Bioelectric Signals etc., (Hybrid Assistive Limb [HAL]-HN01) as a New Medical Device to Delay Progression of Intractable Rare Neuromuscular Diseases” (Principal Investigator: Takashi Nakajima), and a part of the research funded by the Japan Agency for Medical Research and Development (hereinafter referred to as AMED) from FY2007 to FY2008, ” Multicenter clinical trials on efficacy and safety of cybernic treatment using cyborg-type robot HAL-HNO1 for the patients with gait dysfunction due to rare/intractable brain & spinal cord diseases ” (Principal Investigator: Takashi Nakajima).
The study was conducted at the National Hospital Organization Niigata Hospital, St. Marianna University Hospital, Kyoto Prefectural University of Medicine Hospital, Fukuoka University Hospital, National Hospital Organization Tokushima Hospital, University of Tsukuba Hospital, Kagoshima University Hospital, Kirishima Rehabilitation Center, and National Hospital Organization Murayama Medical Center as an investigator-initiated clinical trial. The research was conducted at the National Hospital Organization Murayama Medical Center. The Company participated as a research partner of the Grant-in-Aid for Scientific Research from the Ministry of Health, Labour and Welfare, and also as a research and development entrusted by the National Hospital Organization Niigata Hospital (Principal Investigator: Takashi Nakajima) based on a contract research and development agreement signed by the National Hospital Organization Niigata Hospital and AMED as of April 1, 2017.
(jRCT1092220257, jRCT1092220204)

*4 Progressive neuromuscular incurable diseases (8 diseases):
Spinal muscular atrophy (SMA), Spinal and bulbar muscular atrophy (SBMA), Amyotrophic lateral sclerosis (ALS), Charcot-Marie-Tooth disease, Distal myopathy, Inclusion body myositis, Congenital myopathy, Muscular dystrophy.