An amince da magungunan rigakafi na monoclonal (mAbs) lecanemab da donanemab don magance cutar Alzheimer ta farko a Burtaniya da Amurka bi da bi, yayin da aka ƙi amincewa da lecanemab a Tarayyar Turai saboda bayanan lafiya da inganci "marasa gamsarwa" daga gwaje-gwajen asibiti. NICE, ƙungiyar jama'a a Burtaniya da ke da alhakin tantance shaidun sabbin fasahohin kiwon lafiya don tabbatar da darajar mai biyan haraji, tana ganin cewa fa'idodin lecanemab sun yi ƙanƙanta don ba da hujjar farashin ga NHS. Ganin cewa cutar Alzheimer cuta ce ta gama gari da ke haifar da raguwar ƙwaƙwalwa kuma kusan kashi 4% na mutanen da ke da shekaru 60+ a duk duniya suna fama da ita (5.4% a Yammacin Turai da kashi 6.4% a Arewacin Amurka), amincewa da magungunan rigakafi guda biyu na monoclonal don maganin cutar Alzheimer ta farko yana ba da bege ga inganta rayuwar mutanen da abin ya shafa (QoL).
A ranar 22 ga Agusta 2024, Hukumar Kula da Magunguna da Kayayyakin Kula da Lafiya (MHRA) ta Burtaniya ta amince da amfani da lecanemab a farkon matakan cutar Alzheimer (AD). Wannan ita ce maganin farko da aka ba da lasisi don amfani a Burtaniya.
Lecanemab wani maganin rigakafi ne na monoclonal (mAbs). Yana jinkirta daɗaɗa alamun cutar Alzheimer ta hanyar haɗawa da amyloid beta don rage plaques a cikin kwakwalwa. Ya nuna wasu shaidun inganci a cikin jinkirin ci gaba da cutar a cikin gwaji na asibiti.
Koyaya, Cibiyar Kula da Lafiya ta Kasa (NICE), ƙungiyar jama'a da ke da alhakin tantance shaidar sabbin fasahohin kiwon lafiya don tabbatar da ƙimar mai biyan haraji, tana tunanin cewa fa'idodin lecanemab kaɗan ne don tabbatar da farashin ga NHS.
Hukumar Lafiya ta Ƙasa (NHS) wani tsari ne na duniya baki ɗaya wanda gwamnati ke ba da kuɗaɗen shiga daga haraji na gabaɗaya. Yana ba da ayyukan kiwon lafiya ga kowa, kyauta a wurin haihuwa bisa ga buƙatar kiwon lafiya (kuma ba bisa ga ikon biyan kuɗi ba). NICE tana gudanar da nazarin ingancin farashi (CEA) don sabon magani kuma tana ba da jagororin asibiti ga NHS. Fa'idodin sabon magani ya kamata su isa su tabbatar da farashin kafin a amince da shi a NHS. Tsarin shawarar NICE game da lecanemab (watau, "fa'idodin sabon maganin Alzheimer's lecanemab sun yi ƙanƙanta don tabbatar da farashin ga NHS" ) yana nuna cewa lecanemab ba zai samu ga marasa lafiya na NHS ba. Duk da haka, marasa lafiya masu zaman kansu za su iya samun maganin lecanemab bayan sun biya kuɗin kula da su ta hanyar aljihu.
Tun da farko a ranar 25 ga Yuli 2024, Hukumar Magunguna ta Turai (EMA) ta ƙi amincewa da izinin tallata Leqembi (abu mai aiki: lecanemab) don maganin cutar Alzheimer . EMA tana da damuwa game da aminci da inganci. Gabaɗaya, hukumar ta gano cewa fa'idodin magani ba su da yawa waɗanda za su fi ƙarfin haɗarin da ya sa aka ƙi. Ya zuwa ranar 5 ga Agusta 2024, kamfanin Leqembi ya nemi sake yin nazari kan ra'ayin ƙin yarda.
A Amurka, an amince da Kisunla (donanemab-azbt; kamar lecanemab, donanemab shima wani maganin rigakafi ne na monoclonal wanda ke ɗaure ga amyloid a cikin kwakwalwa kuma yana rage alamun) don maganin cutar Alzheimer a ranar 02 ga Yuli 2024. Ana ba da shi ga marasa lafiya da ke da ɗan rauni na fahimta ko kuma ɗan ƙaramin matakin cutar Alzheimer.
Cutar Alzheimer cuta ce ta gama gari wacce ke da saurin raguwar ƙwaƙwalwa. Ayyukan fahimi kamar tunani, koyo da tsara iyawa suna shafar. Kimanin kashi 4% na mutane masu shekaru 60+ a duniya suna fama da cutar. Yaduwar Yammacin Turai da Arewacin Amurka shine 5.4% da 6.4% bi da bi. Amincewa da ƙwayoyin rigakafi guda biyu, Lecanemab a Burtaniya da donanemab a Amurka, don maganin farkon cutar Alzheimer yana ba da zaɓi da bege don inganta ingancin rayuwa (QoL) ga mutanen da abin ya shafa. Ko da “wasu” shaida na inganci mafari ne na maraba.
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References:
- van Dyck, CH et al. Lecanemab a farkon Cutar Alzheimer. N. Engl. J. Med. 388, 9-21 (2023). DOI: https://doi.org/10.1056/NEJMoa2212948
- MHRA. Sakin labarai - Lecanemab lasisi ga manya marasa lafiya a farkon matakan cutar Alzheimer. An buga 22 Agusta 2024. Akwai a https://www.gov.uk/government/news/lecanemab-licensed-for-adult-patients-in-the-early-stages-of-alzheimers-disease
- NICE. Labarai - Fa'idodin sabon lecanemab na maganin Alzheimer sun yi ƙanƙanta don tabbatar da farashin NHS. An buga 22 Agusta 2024. Akwai a https://www.nice.org.uk/news/articles/benefits-of-new-alzheimer-s-treatment-lecanemab-are-too-small-to-justify-the-cost-to-the-nhs
- Hukumar Kula da Magunguna ta Turai. Leqembi. Sabunta kamar na 5 ga Agusta 2024. Akwai a https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi
- FDA ta amince da magani ga manya masu cutar Alzheimer https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease
- KISUNLA (donanemab-azbt) allura, don amfani da cikin jijiya Amincewar Amurka ta farko: 2024 https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761248s000lbl.pdf
- Espay AJ, Kepp KP, Herrup K. Lecanemab da Donanemab a matsayin Magunguna don Cutar Alzheimer: Halin da aka kwatanta akan Bayanan. eNeuro. 2024 Jul 1;11 (7): ENEURO.0319-23.2024. DOI: https://doi.org/10.1523/ENEURO.0319-23.2024
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 lecanemab and donanemab have been approved for the treatment of early Alzheimer’s disease in the UK and USA respectively while lecanemab has been refused marketing authorisation in the EU in view of “unsatisfactory” safety and efficacy data from the clinical trials. NICE, the public body in the UK responsible for assessing evidence for new health technologies for ensuring value for the taxpayer, thinks that benefits of lecanemab are too small to justify the cost to the NHS. Given, Alzheimer’s disease is a common neurodegenerative disorder characterised by progressive decline in memory and about 4 % people aged 60+ years worldwide are affected (5.4 % in Western Europe and 6.4 % North America), approval of the two monoclonal antibodies for the treatment of early Alzheimer’s disease offers hope for improvement in quality of life (QoL) of the affected people.){kind=link}