State Drugs and Therapeutics Advisory Board minutes — formulary preference and PA recommendations (Jan 13, 2022)
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Minutes documenting board discussions and recommendations to place several drugs on the preferred drug list with prior authorization and related coverage considerations (e.g., tolerability requirements, therapy limits).
Recommended Qelbree (viloxazine HCl ER) be made preferred on the PDL with prior authorization.
Recommended Lybalvi (olanzapine-samidorphan) be made preferred with prior authorization.
Recommended Invega Hafyera be made preferred with prior authorization.
Recommended Myfembree (relugolix-estradiol-norethindrone acetate) be made preferred with prior authorization, limited to parity with comparable PDL product and noting a 2-year therapy limitation for bone density concerns.
Recommended Qulipta (atogepant) be made preferred with prior authorization for migraine prevention.
Formulary Recommendations and Coverage Notes
Board-recommended preferred-with-PA decisions
Preferred on PDL with prior authorization when recommended by the board
Board motion carried to make Qelbree preferred with a PA; guanfacine and clonidine were noted as existing preferred non-stimulant ADHD options.
Board motion carried; contraindication for patients on opioids was noted and consideration of drug testing in PA criteria was requested.
Board emphasized that tolerability must be demonstrated prior to initiation and that use is recommended after stability on shorter‑acting formulations; motion carried (abstention noted).
Placed on equal footing with a comparable PDL product; therapy limited to 2 years due to bone density concerns.
Motion carried with some nay/abstain votes noted.
There were no PDL drug appeals
Provider Requirements, Prior Authorization, and Documentation
Prior authorization required for newly preferred agents
Qelbree, Lybalvi, Invega Hafyera, Myfembree, and Qulipta were recommended by the board to be made preferred on the PDL but only with prior authorization; providers should expect PA requirements to apply when prescribing these agents.
ADHD non-stimulant preferred options and Qelbree PA
Within ADHD non-stimulant choices the board noted guanfacine and clonidine as preferred options; Qelbree was voted to be preferred only with a prior authorization, indicating PA will be required for its use despite preferred placement.
- Guanfacine and clonidine are identified as preferred non-stimulant ADHD options.
- Qelbree (viloxazine HCl ER) was recommended to be preferred with a PA.
Myfembree indication and 2-year therapy documentation
For Myfembree, document that the indication is heavy menstrual bleeding due to uterine fibroids and note the therapy duration limitation; the board placed Myfembree as preferred with prior authorization and limited to 2 years of therapy because of bone density concerns.
- Indication to document: heavy menstrual bleeding due to uterine fibroids.
- Therapy duration: limited to 2 years due to bone density concerns; PA should reflect this limit.
Demonstrate tolerability before starting Invega Hafyera
Before initiating Invega Hafyera, document demonstration of tolerability on shorter-acting antipsychotic formulations; the board emphasized that tolerability must be shown prior to initiation and that Hafyera is appropriate after stability on shorter-acting forms.
- Tolerability must be demonstrated prior to initiation of this very long-acting injectable.
- Use after documented stability on shorter-acting formulations and adherence is recommended; avoid dosing without interim follow-up.
Drug-specific Notes
Initiation Constraints and Criteria
Initiation constraints for long-acting injectables
Considerations noted for initiation
Board emphasized not dosing without interim follow‑up and noted no antidote is available for severe reactions.
Preferred Step Therapy Positioning
| Step | Preferred non‑stimulant options | Placement / prior authorization note |
|---|---|---|
| 1 | Guanfacine | Preferred non‑stimulant option (no PA noted) |
| 1 | Clonidine | Preferred non‑stimulant option (no PA noted) |
| 2 | Qelbree (viloxazine HCl ER) | Recommended to be made preferred with prior authorization; positioned after preferred non‑stimulant options per board motion |
Advisory Board Role and Meeting Context
The advisory board reviews new drug entries and class monographs to recommend preferred status and prior authorization requirements on the PDL. During the January 13, 2022 meeting the board discussed clinical considerations such as alternative preferred agents within classes (for example, guanfacine and clonidine as preferred non-stimulant ADHD options), tolerability and stability requirements for very long‑acting injectables, and safety limits (for example, bone density considerations for relugolix‑containing therapy).
When the board favored making a product preferred on the PDL, members frequently specified that prior authorization (PA) should be required; examples from this meeting include motions to make Qelbree, Lybalvi, Invega Hafyera, Myfembree, and Qulipta preferred with PA. The board’s recommendations also included operational details that inform PA design — for example, requiring documentation of prior tolerability before initiating very long‑acting injectables and limiting Myfembree therapy to 2 years due to bone density concerns.
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