Cell thiab Gene Therapy (CGT) Access Model
Cov Lus Nug Tseem Ceeb (FAQs)
Hloov kho Lub Yim Hli 1, 2025
Cov FAQs hauv qab no muab cov lus qhia dav dav thiab qhia meej txog CGT Access Model. Raws li Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv (DHCS) tau txais cov lus nug ntxiv, FAQ no yuav raug hloov kho.
General
CGTs yog dab tsi?
CGTs yog ib chav kawm ntawm kev kho mob ib zaug, ntau yam uas tau tsim los kho cov kab mob tsawg thiab hnyav, xws li kab mob mob hlwb (SCD). CGTs tuaj yeem kho cov kab mob hauv qab no, hais txog cov tsos mob, thiab qeeb lossis nres kev kis kab mob.
CGT Access Model yog dab tsi?
Cov qauv no yog tsim los txhim kho thiab ua kom yooj yim rau kev nkag mus rau cov tshuaj CGT hloov lub neej rau Medi-Cal cov tswv cuab hauv ob qho tib si tus nqi-rau-kev pabcuam (FFS) thiab kev tswj xyuas cov kab mob uas tsis tshua muaj thiab hnyav. Thawj qhov tseem ceeb ntawm Medi-Cal's CGT Access Model, nyob rau hauv kev ua raws li Lub Chaw rau Medicaid thiab Medicare Services (CMS) cov cai, yuav yog rau cov tshuaj CGT rau Medi-Cal cov tswv cuab nrog SCD. Yog xav paub ntxiv txog CMS 'CGT Access Model, koj tuaj yeem mus saib lub vev xaib no: https://www.cms.gov/priorities/innovation/innovation-models/cgt .
Thaum twg Medi-Cal's CGT Access Model pib?
Cov tswv cuab tsim nyog Medi-Cal tuaj yeem pib nkag mus rau CGT kev kho mob tsis pub dhau lub Xya Hli 1, 2025. Medi-Cal cov tswv cuab yuav tsum tham nrog lawv cov kws kho mob los txiav txim seb lawv puas tsim nyog tau txais cov tshuaj CGT thiab seb lawv puas tsim nyog los daws lawv cov kev xav tau kev noj qab haus huv, raws li tau piav qhia ntau ntxiv hauv nqe lus nug #9 hauv qab no.
Vim li cas Medi-Cal tus CGT Access Model pib nrog kev tsom mus rau SCD?
Nruab nrab ntawm 50% thiab 60% ntawm cov neeg nyob nrog SCD muaj kev pab them nqi kho mob Medicaid (Medi-Cal hauv California) thiab tus nqi siab ntawm cov kev kho mob no yuav ua rau lub xeev cov koom haum Medicaid '(DHCS hauv California) pob nyiaj siv. CGT Access Model yuav pab ua kom yooj yim rau lub xeev Medicaid cov koom haum muab kev nkag mus rau CGT cov tshuaj rau cov tib neeg tsim nyog tau txais Medicaid.
DHCS puas tuaj yeem ntxiv lossis nws twb tau ntxiv cov ntshav-dependent beta thalassemia (TDT) raws li tus mob tsim nyog rau kev kho mob raws li CGT Access Model?
Tsis yog, TDT tsis suav nrog hauv CGT Access Model. Raws li CMS CGT Access Model, J3392 (Casgevy) thiab J3394 (Lyfgenia) raug muab tshem tawm ntawm kev tswj xyuas kev noj qab haus huv thaum siv tsuas yog siv rau kev kho mob mob qog noj ntshav (SCD). Yog li, Medi-Cal cov phiaj xwm tswj hwm kev saib xyuas (MCPs) tsis raug nqi ncaj qha thiab tsis muaj lub luag haujlwm them nyiaj rau cov tshuaj no thaum siv rau SCD. Rau tag nrho lwm cov tshuaj tsis yog SCD, suav nrog TDT, J3392 (Casgevy) thiab J3394 (Lyfgenia) tseem yog lub luag haujlwm ntawm Medi-Cal MCPs. Qhov no yuav qhia meej nyob rau hauv Phau Ntawv Qhia Txog Tus Kws Kho Mob Medi-Cal.
Puas yog CGT Access Model yuav nthuav dav ntxiv rau yav tom ntej kom suav nrog lwm yam kab mob dhau SCD?
Thaum lub hom phiaj tseem ceeb ntawm tus qauv yog nyob rau ntawm SCD, CMS tej zaum yuav xaiv nthuav CGT Access Model kom suav nrog lwm yam uas tsis tshua muaj thiab hnyav rau yav tom ntej; Txawm li cas los xij, DHCS tsis paub txog kev nthuav dav nyob rau lub sijhawm no.
Cov tshuaj twg yuav raug them raws li Medi-Cal's CGT Access Model?
Medi-Cal's CGT Access Model yuav them rau ob lub tseemfwv qibsiab Food and Drug Administration (FDA)-pom zoo CGT tshuaj uas tau txheeb xyuas los ntawm CMS rau kev kho mob SCD. Qhov no suav nrog, CASGEVY ™ , uas yog tsim los ntawm Vertex Pharmaceuticals, Inc., thiab LYFGENIA ™ , uas yog tsim los ntawm bluebird bio, Inc.
Tus tswvcuab zoo li cas CGT txoj kev kho mob zoo li cas?
- Ib tug tswv cuab txoj kev taug kev tau txais kev kho mob CGT yuav suav nrog cov hauv qab no:
- Kev sab laj nrog hematologists thiab lwm tus kws kho mob tshwj xeeb
- Kev ntsuam xyuas thoob plaws hauv lub chaw kho mob suav nrog kev xav tau ntawm lub cev, kev xav tau kev noj qab haus huv ntawm tus cwj pwm, thiab kev xav tau kev txhawb nqa kev sib raug zoo
- Kev sib koom tes ntawm kev saib xyuas thiab kev pab txhawb nqa rau cov tswv cuab thiab tsev neeg taug txoj kev kho mob
- Kev tswj kab mob hauv kev npaj rau CGT
- Fertility preservation Services
- Gene therapy infusion thiab kev pabcuam rov qab
- Kev kho mob tom qab kev kho mob
Cov txiaj ntsig
Cov txiaj ntsig thiab kev pabcuam dab tsi raug them raws li Medi-Cal's CGT Access Model?
Raws li CGT Access Model, cov nqi hauv qab no raug them:
- Ib qho ntawm ob cov tshuaj CGT rau SCD
- CASGEVY los ntawm Vertex Pharmaceuticals, Inc. - pib lub Kaum Hli 1, 2025.
- LYFGENIA los ntawm bluebird bio, Inc. - pib lub Xya hli ntuj 1, 2025.
- Fertility Preservation Services
- Raws li ib feem ntawm kev them nyiaj rov qab rau cov tshuaj CGT SCD, cov neeg muab kev pab them nqi:
- Txog li peb ntu ntawm kev sau thiab khaws cia cov ntaub ntawv khaws cia, txog li kaum tsib xyoos rau cov tswv cuab tsim nyog.
- Kev tsim nyog qhov chaw nyob, zaub mov, thiab cov nqi mus ncig kuj yuav raug them, yog tias tsim nyog kom tau txais cov kev pabcuam fertility preservation.
Cov txiaj ntsig thiab kev pabcuam dab tsi uas tsis suav nrog hauv Medi-Cal's CGT Access Model?
Lwm yam kev kho mob thiab tsis yog kev kho mob hauv qab no tsis raug them raws li CGT Access Model tab sis yuav tsum tau muab thiab them nyob ntawm tus tswv cuab txoj kev tsim nyog thiab kev tso npe rau hauv Medi-Cal FFS lossis kev tswj xyuas kev xa tawm:
Medi-Cal FFS: - Cov kws kho mob FFS yuav tsum xa thiab xa daim nqi DHCS ncaj qha rau tag nrho lwm yam kev kho mob thiab tsis yog kev kho mob CGT cov kev pabcuam, suav nrog kev thauj mus los (sab nraum tus nqi ntawm cov tshuaj, kev tiv thaiv kev xeeb tub, thiab kev tsim nyog qhov chaw nyob, pluas noj, thiab kev mus ncig uas tsim nyog tau txais kev pabcuam fertility preservation raws li tau sau tseg saum toj no).
Medi-Cal Managed Care:
- Tus tswv cuab ntawm Medi-Cal txoj kev npaj saib xyuas yuav tsum them rau tag nrho lwm yam kev kho mob thiab tsis yog kev kho mob CGT, suav nrog kev thauj mus los (sab nraum tus nqi ntawm cov tshuaj, kev txuag kev xeeb tub, thiab qhov chaw nyob tsim nyog, pluas noj, thiab kev mus ncig uas tsim nyog tau txais kev pabcuam fertility preservation, raws li tau hais saum toj no).
Cov tswv cuab tau txais kev kho CGT SCD qhov twg?
CGT SCD kev kho mob tsuas yog muaj thiab tswj hwm ntawm cov chaw kho mob uas muaj kev kho mob tsim nyog thiab kev cob qhia kom ua tau.
- Rau LYFGENIA, cov tswv cuab tau txais kev pabcuam los ntawm Chaw Kho Mob Tsim Nyog (QTCs). Tam sim no muaj yim (8) QTCs hauv California. Yog xav paub ntxiv, thov mus saib LYFGENIA's Lub vev xaib .
- RAU CASGEVY, cov tswvcuab tau txais kev pabcuam los ntawm Chaw Khomob Tso Cai (ATCs). Tam sim no muaj rau (6) ATCs hauv California. Yog xav paub ntxiv, thov mus saib CASGEVY's Lub vev xaib .
Yog xav paub ntxiv, thov xa mus rau Tus Tswv Cuab FAQ kom paub ntau ntxiv.
Kev tsim nyog
Leej twg tsim nyog koom nrog Medi-Cal's CGT Access Model?
Txhawm rau tsim nyog rau Medi-Cal's CGT Access Model, Medi-Cal cov tswv cuab yuav tsum ua raws li tag nrho cov hauv qab no:
- Muaj cov ntaub ntawv kho mob ntawm SCD;
- Nkag mus rau npe rau hauv Medi-Cal puv npo thaum lub sijhawm tau txais cov tshuaj CGT (ceeb toom: ob qho tib si Medi-Cal tswj hwm kev saib xyuas thiab tus nqi-rau-kev pabcuam (FFS) cov tswvcuab yuav tsim nyog tau txais kev kho CGT);
- Muaj Medi-Cal ua lawv tus thawj them nyiaj;
- Tau txais ib qho ntawm ob qho tshuaj CGT los ntawm tus kws kho mob koom nrog; thiab
- Txaus siab rau tag nrho cov CGT Access Model raws li txoj cai tau tshaj tawm Medi-Cal, raws li tau teev tseg hauv Medi-Cal Tus Kws Kho Mob Phau Ntawv Qhia thiab siv tau Txhua Daim Ntawv Npaj.
Koj nkag mus rau CGT cov tshuaj li cas raws li Medi-Cal's GCT Access Model?
Medi-Cal FFS cov tswv cuab yuav tsum sab laj nrog lawv tus kws kho mob kom txiav txim siab txog kev tsim nyog thiab kawm ntxiv nrog rau cov ntaub ntawv ntawm kev nkag mus rau CGT SCD cov tshuaj. Medi-Cal FFS cov chaw muab kev pabcuam tuaj yeem pab cov tswvcuab nkag mus rau ib qho ntawm ob qho tshuaj CGT SCD. Medi-Cal tswj xyuas cov tswv cuab yuav tsum hu rau lawv tus kws kho mob lossis Medi-Cal tswj hwm txoj kev npaj kho mob (MCP) txhawm rau txiav txim siab tsim nyog thiab kawm paub ntxiv txog cov kev pabcuam CGT. Medi-Cal MCPs yog lub luag haujlwm rau kev saib xyuas kev sib koom tes thiab pab cov tswvcuab nkag mus rau ib qho ntawm ob qho tshuaj CGT mob cell. Yog xav paub ntxiv txog Medi-Cal MCP kev saib xyuas kev sib koom tes thiab lwm yam uas yuav tsum tau ua, thov tshuaj xyuas Daim Ntawv Qhia Tag Nrho uas siv tau ntawm DHCS lub vev xaib. Txhua Medi-Cal MCP kuj suav nrog cov ntsiab lus ntawm kev sib cuag, uas tuaj yeem pom nyob rau hauv Medi-Cal Managed Care Health Plan Directory.
Hu rau Cov Lus Qhia & Cov Lus Qhia
Koj tuaj yeem kawm paub ntau ntxiv txog Medi-Cal's CGT Access Model thiab/los yog muab cov lus qhia txog qhov twg?
Cov ntaub ntawv hais txog Medi-Cal's CGT Access Model muaj nyob rau ntawm DHCS lub vev xaib. Cov lus teb, cov lus nug, thiab cov lus pom kuj tuaj yeem xa mus rau DHCS ntawm email ntawm dhcscgt@dhcs.ca.gov .
