One method CMS has is the Cell and Gene Therapy (CGT) Access Model. Under the CGT Access Model, CMS (on the federal stage) will negotiates outcomes primarily based agreements (OBAs) with producers, which is able to embrace pricing phrases and outcomes to be evaluated. Then states can elect to take part within the contract phrases negotiated by CMS or they will choose out and negotiate on their very own. From CMS’s perspective, they’re hoping that the elevated buying energy will result in decrease costs (or equivalently, extra negotiated rebates). For producers, they’re hoping that the CGT entry mannequin will expedite entry for sufferers and scale back transaction prices since producers must negotiate with a lot fewer than 50 State Medicaid Agencies. For each events, outcomes-based contracts are burdensome to implement; having CMS will help states in implementing, monitoring, reconciling, and evaluating the monetary and medical outcomes outlined in OBAs
What CGTs are at present deliberate for inclusion within the CGT Access mannequin and the way a lot will they price?
Two CGTs for the therapy of sickle cell illness are deliberate for inclusion within the mannequin. Both have been accepted in December 2023. “Casgevy” from Vertex Pharmaceuticals and CRISPR Therapeutics had an inventory value of $2.2 million per affected person; “Lyfgenia” from bluebird bio was listed at $3.1 million per affected person.
What varieties of rebates may State Medicaid Agencies obtain beneath the CGT Access Model?
These would come with not solely the usual Medicaid Drug Rebate Program (MDRP) rebate (a.okay.a. Medicaid finest value) but in addition extra assured rebates and quantity rebates in addition to rebates paid sooner or later primarily based on affected person and inhabitants outcomes.
When would the rebates be paid?
The timing of the rebates depends upon the kind of rebate. Statutory Rebate (MDRP) and the negotiated assured rebate will probably be paid instantly after therapy. At the top of the yr, volume-based rebates may come into impact. Finally, patient-outcome and population-outcome rebates will probably be paid years after therapy administration. Note that the affected person consequence rebates may be paid yearly over time to account for instances the place sufferers reply to remedy however maybe not indefinitely.
What does the method seem like from the affected person perspective?
The CGT Access Model: Overview for States presentation has a useful timeline.
If a state chooses to take part within the mannequin, can it try to barter extra reductions or phrases aside from these negotiated by CMS?
If a state opts to take part within the mannequin, it should enter into an settlement with the producer that displays the phrases negotiated by CMS. Some restricted state-to-state variation could also be permitted, as could also be essential to comport with state legislative and regulatory necessities.
What do states have to do to take part within the CGT Access Model?
Requirements embrace:
- Execute value-based buying supplemental rebate agreements (VBP SRAs) with producers that replicate the Key Terms negotiated by CMS
- Pursue state plan amendments (SPAs) the place applicable
- Establish a standardized entry coverage for included gene therapies
- Carve included gene therapies out of any inpatient fee bundle
- Require suppliers to observe necessities for knowledge reporting and claims submissions
- Ensure beneficiaries have entry to care with instate or out-of-state certified gene remedy supplier(s)
- Ensure needed transportation and associated journey bills to beneficiaries (NEMT)
- Meet minimal T-MSIS knowledge necessities
What laws created the CGT Access Model?
CMS states that:
The CGT Access Model was developed in response to President Biden’s Executive Order 14087, “Lowering Prescription Drug Costs for Americans” and was first proposed in a report responding to the manager order directed by the Secretary of the Department of Health and Human Services.
https://www.cms.gov/priorities/innovation/innovation-models/cgt
How can I be taught extra?
Some useful reference materials on the CMS CGT Access Model webpage consists of: