The approval of Roche / Chugai Pharmaceutical’s Evrysdi (risdiplam) as the first ever oral therapy in Japan for the treatment of spinal muscular atrophy (SMA) in June 2021 has a strong potential to disrupt the Japanese SMA market. This can be further bolstered if Roche builds up its digital presence in Japan, says GlobalData, a leading data and analytics company.

Spinraza (Nusinersen) from Biogen and Zolgensma (onasemnogene abeparvovec-xioi) from Novartis, both survival motor neuron (SMN) enhancing treatments, were the only other approved therapies available in Japan prior to Evrysdi.

Ms. Sasmitha Sahu, Pharma Analyst at GlobalData, comments: “All are SMN-enhancing treatments but the key differentiating factor for Evrysdi is the oral route of administration. Both Spinraza and Zolgensma are based on invasive options and mandate visits to hospitals. Evrysdi fulfils this unmet need of an ‘at-home’ convenient therapy.”

GlobalData forecasts the SMA market size in Japan to touch US$645m in 2028 at an annual growth rate of 9.5%.

According to the GlobalData’s Pharma intelligence center, valproate sodium from Kowa Company was the only other asset in pipeline development in Japan for SMA. It is a generic oral therapy, which is in Phase III development. Branaplam from Novartis and amifampridine from Catalyst Pharma are the other two innovator oral therapies, which are currently in Phase II development in the US and EU but do not have any ongoing trials in Japan.

Ms. Sahu adds: “Based on results from the Phase III trial of valproate sodium in childhood onset SMA patients, GlobalData observed that there are no apparent improvements in motor function although there were no significant safety issues. Moreover, there are no further updates from Kowa on further development of valproate sodium for SMA treatment in Japan. With no other innovator oral therapy in sight at least until 2025 in Japan, Evrysdi is likely to dominate the Japanese SMA market share.”

SMA is listed in the national intractable disease list in Japan and is eligible for medical expenses subsidy system.  Spinraza and Zolgensma are already included in the National Health Insurance (NHI) reimbursement price list.

Ms. Sahu continues: “Zolgensma is currently the most expensive therapy reimbursed in Japan. Evrysdi is expected to be automatically listed in the NHI reimbursement price list following its recent approval. Although pricing is not clear at this point, it is expected to be lower than that for Zolgensma owing to the reduced hospitalization costs.”

Currently, Biogen and Novartis have a predominant presence in digital media through their unbranded websites Togetherinsma.jp, Moshikashite-nmd.jp and smarteyes.baby apart from the websites of their respective brands, Spinraza.jp and Zolgensma.jp. Roche has not initiated any unbranded digital activities ahead of the launch of Evrysdi in Japan.

Ms. Sahu concludes: “The approval of Evrysdi in Japan ahead of the SMA awareness month in August provides Roche a great opportunity to drive its promotion through branded and unbranded digital promotional activities in Japan.”