デジタルセラピューティクス(DTx)とは

デジタルセラピューティクス(DTx)とは

アプリなどソフトウエアを活用して治療する「デジタルセラピューティクス」(Digital Therapeutics:DTx、デジタル治療)は、例えばスマートフォンのアプリやIoTデバイスなどを高血圧や糖尿病、精神神経疾患などへの治療介入に活用するものである。
2010年に米国のWellDoc社が「Bluestar」という2型糖尿病患者向けの治療補助アプリで米国のFDA(Food and Drug Administration/米国食品医薬品局)の認証を得たことで注目を集めるようになった。

DTxは、単独利用あるいは付加的利用によって治療アウトカムが向上するソフトウェアによる治療であり、先行する米国では既にいくつか実用化されている。
DTxは10年くらい前に誕生した新規の医療機器製品である。
DTxにより、患者や医師にとって治療の選択肢が増えることになる。現状では3時間待ちの5分診療が慢性化している。しかしながら、DTxを利用すれば、医療機関に行かなくとも自宅で治療や診療、指導を受けることが可能だ。
患者はリアルタイムに症状や測定データなどを入力し、医師は”すきま時間”を利用して患者の診察や指導が出来る。

産業界では、DTxを開発する新興ベンチャーが増加しつつある。筆者のもとにも、多くのベンチャー企業や、これから医療機器業界に進出したいソフトウェア開発企業からの問合せが尽きない。

一方において、製薬企業にとっては医薬品以外の収益源になる可能性がある。これまでの製薬企業では、10年から15年間莫大な資金を投入して新薬を開発しなければならなかった。しかも開発途中において中止を余儀なくされることも少なからずあり得る。いわば”一か八か”の勝負の様なものである。しかも、運よく上市できたとしても、特許期間の問題などからジェネリック品が登場するため、常に新薬の開発を繰り返さなければならなかった。
DTxにおいては、医薬品とは異なり、比較的短期間の開発が可能だ。しかも、上市後の機能追加・変更なども比較的容易に行うことが出来る。

DTxの先駆け:「処方されるアプリ」 Bluestar (WellDoc)

2型糖尿病の自己管理を補助するための「処方されるアプリ」として2010年にFDAがWellDoc社が開発したBluestarと呼ばれる医療機器ソフトウェアを承認したことで、DTxが一躍注目されるようになった。
「処方されるアプリ」というのは、医師が”解除キー”と呼ばれるコードを患者に発行し、当該コードをアプリに入力することによって使用が可能となるものである。つまり、処方箋の代わりとなるものである。
Bluestarは、大規模な臨床試験において、糖尿病新薬などの医薬品と同等以上の効果があったという結果が示され、2010年にFDAからの承認取得した。
実は、Bluestarは後発品である。2型糖尿病向けのDTxとしては先行品があったが、パソコン上で動くものであった。Bluestarは、スマートフォンに搭載したことが革新的となった。つまり患者は常に医療機器ソフトウェアを持ち歩くことが出来るようになったわけだ。

BlueStarの機能は、患者が自宅で血糖値を記録し、入力情報をもとに適切なタイミングで疾患指導や生活習慣・モチベーション維持に関するアドバイスを表示する。またアプリ上での専門家への質問が出来る。
さらに、薬物療法や食事療法、運動療法といった血糖コントロールの方法の学習ができる。 一方で、医師向けには診断サポートシステムとなり、毎回の診察前の血糖値や服薬・体調の記録、進行状況のレポートを医療チームへの提供することが可能である。

「治療のために処方される世界初のDTx」 reSETPear Therapeutics社)

Pear Therapeutics社が開発したreSETは、アプリによる認知行動療法を通して、 薬物乱用・依存に対する治療効果を示すものである。
上述のBlueStarは自己管理を補助するものとして承認されたものであるのに対し、reSETは治療手段として承認された点に違いがある。
reSETの承認された適応症は、外来治療を受けている18歳以上の大麻、コカイン、 アルコールなどの依存症患者である。
12週(90日)の治療期間が設定されており、全部で61種類のコンテンツ(therapy lesson)が用意されているが、自分の症状に関連するものや医師から勧められたものを週に4つほどのペースで進めることが推奨されている。
多施設非盲検ランダム化比較試験が行われ、オピオイド依存症を除いた集団(399例)において、 標準的な対面カウンセリングを受けた群(対照群) と、対面カウンセリングを減らしてreSETを利用した群で比較したところ、 reSET利用群が対照群の2倍、薬物中断成功率が高いというエビデンスを示した。 この臨床試験中、 reSET利用による副作用の報告はなかった。

日本におけるデジタルセラピューティクス

日本では2014年11月、薬事法が改正されて「医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律(薬機法)」に衣替えした際、対象の医療機器に「単体プログラム(ソフトウェア)」が加えられた。それにより治療アプリが医師に処方されたり、健康保険が適用される道が開けた。
2017年10月、医療ベンチャー・キュア・アップ社が「ニコチン依存症治療アプリ(禁煙治療アプリ)」の治験の開始を発表した。
2019年5月30日、ニコチン依存症を治療するスマートフォン向けアプリについて、薬事承認に向けた申請を行ったと発表。治療用アプリの申請は国内初で禁煙治療向けでは世界初であった。2020年11月11日保険適用が承認された。

国内31医療機関と臨床試験(治験)を実施し、その結果も発表した。禁煙外来による12週間の治療にアプリを併用し、6ヶ月後の禁煙継続率がどれだけ高まるかを調べた。584人のニコチン依存症患者を対象に実施。アプリを併用した患者は禁煙継続率が64%と13ポイント高まった。 アプリはキュア・アップ社が慶応義塾大学医学部と共同開発したもので、患者がたばこを吸いたい気持ちの強さなどをアプリに入力すると「ガムをかんでください」などのアドバイスを表示する。

患者にとって禁煙や糖尿病の改善は、自分との闘いである。禁煙は一人では中々難しいこともある。また糖尿病は自覚症状がなく、忙しい場合など、つい治療や服薬を失念してしまうこともある。
このように治療中に”心が折れる”場合に、DTxの支援があれば継続する可能性が高まる。 このようにDTxには夢があるようにも思える。しかしながら、有効性を証明するための臨床試験の実施や、保険収載における問題点も少なからず耳にする。それら問題点については別の配信で解説したい。

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