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
What are CGTs?
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.
What is the CGT Access Model?
This model aims to improve and streamline access to life-changing CGT medications for Medi-Cal members in both the fee-for-service (FFS) and managed care delivery systems with rare and severe diseases. The initial focus of Medi-Cal’s CGT Access Model, in alignment with Centers for Medicaid and Medicare Services (CMS) requirements, will be for CGT medications for Medi-Cal members with SCD. For more information on CMS’ CGT Access Model, you can visit this website: https://www.cms.gov/priorities/innovation/innovation-models/cgt.
When does Medi-Cal’s CGT Access Model start?
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.
Why does Medi-Cal’s CGT Access Model begin with a focus on 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.
Will the CGT Access Model be expanded in the future to include other diseases beyond 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.
What drugs will be covered under 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.
What does a typical member’s CGT treatment journey look like?
- 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
What benefits and services are covered under 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 by Vertex Pharmaceuticals, Inc. – effective October 1, 2025.
- LYFGENIA by bluebird bio, Inc. – effective July 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.
What benefits and services are not included within the 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.
- For LYFGENIA, members receive services from Qualified Treatment Centers (QTCs). There are currently eight (8) QTCs in California. For more information, please visit LYFGENIA’s website.
- FOR CASGEVY, members receive services from Authorized Treatment Centers (ATCs). There are currently six (6) ATCs in California. For more information, please visit CASGEVY’s website.
Yog xav paub ntxiv, thov xa mus rau Tus Tswv Cuab FAQ kom paub ntau ntxiv.
Kev tsim nyog
Who is eligible to participate in Medi-Cal’s CGT Access Model?
To be eligible for Medi-Cal’s CGT Access Model, Medi-Cal members must meet all of the following criteria:
- 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.
How do you access CGT medications under Medi-Cal’s GCT Access Model?
Medi-Cal FFS members should consult their treating health care provider to determine eligibility and learn more as well as for information on accessing CGT SCD medications. Medi-Cal FFS providers can assist members with accessing one of the two CGT SCD medications. Medi-Cal managed care members should contact their treating health care provider or Medi-Cal managed care plan (MCP) to determine eligibility and learn more about CGT services. Medi-Cal MCPs are responsible for care coordination and assisting members with accessing one of the two CGT sickle cell disease medications. For more information on Medi-Cal MCP care coordination and other requirements, please review the applicable All Plan Letter on DHCS’ website. Each Medi-Cal MCP also includes a point of contact, which can be found in the Medi-Cal Managed Care Health Plan Directory.
Hu rau Cov Lus Qhia & Cov Lus Qhia
Where can you learn more about Medi-Cal’s CGT Access Model and/or provide feedback?
Information about Medi-Cal’s CGT Access Model is available on DHCS’ website. Feedback, questions, and comments may also be submitted to DHCS via email at dhcscgt@dhcs.ca.gov.