Valbenazine (Ingrezza, Ingrezza Sprinkle) coverage
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Clinical coverage and prior authorization criteria for valbenazine (Ingrezza, Ingrezza Sprinkle) for treatment of tardive dyskinesia and chorea associated with Huntington disease for Delaware First Health lines of business.
Added newly approved FDA indication: chorea associated with Huntington's disease and added Appendix H with UHDRS details.
Added Ingrezza Sprinkle formulation as an approved product formulation.
Revised continued approval duration from 6 months to 12 months for VMAT2 inhibitors to align criteria.
Added step therapy bypass for IL HIM per IL HB 5395 and added HIM line of business.
Coverage Criteria
Initial Therapy — Tardive Dyskinesia
Covered when ALL of the following are met
TD initial criteria
- Diagnosis of tardive dyskinesia secondary to a centrally acting dopamine receptor blocking agent (see Appendix F).
- Prescribed by or in consultation with a psychiatrist or neurologist.
- Age ≥ 18 years.
- Evidence of moderate to severe TD supported by an Abnormal Involuntary Movement Scale (AIMS) score of 3 or 4 on any one of items 1 through 9 (see Appendix G).
- Failure of tetrabenazine (e.g., no improvement in any one of AIMS items 1 through 9) at up to 200 mg per day, unless contraindicated or clinically significant adverse effects are experienced; (Illinois HIM requests: step therapy requirement does not apply as of 1/1/2026).
- Valbenazine (Ingrezza/Ingrezza Sprinkle) is not prescribed concurrently with Austedo/Austedo XR or tetrabenazine.
- Dose does not exceed both: a) 80 mg per day; and b) 1 capsule per day.
- Approval duration: 12 months.
Initial Therapy — Chorea Associated with Huntington Disease
Covered when ALL of the following are met
Huntington chorea initial criteria
- Diagnosis of chorea associated with Huntington disease.
- Prescribed by or in consultation with a neurologist.
- Age ≥ 18 years.
- Targeted mutation analysis demonstrating HTT CAG trinucleotide expansion of ≥ 36 repeats.
- Evidence of chorea supported by a Unified Huntington Disease Rating Scale (UHDRS) score of 1 to 4 on any one of chorea items 1 through 7 (see Appendix H).
- Failure of tetrabenazine (e.g., no improvement on any one of UHDRS chorea items 1 through 7) at up to 100 mg per day, unless contraindicated or clinically significant adverse effects are experienced; (Illinois HIM requests: step therapy requirement does not apply as of 1/1/2026).
- Valbenazine (Ingrezza/Ingrezza Sprinkle) is not prescribed concurrently with Austedo/Austedo XR or tetrabenazine.
- Dose does not exceed both: a) 80 mg per day; and b) 1 capsule per day.
- Approval duration: 12 months.
Continued Therapy — All Indications
Covered when ALL of the following are met
Continued therapy criteria
Member status
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria.
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state-specific addendums).
Evidence of response
- For TD: Member is responding positively to therapy as evidenced by a reduction since baseline in any one of AIMS items 1 through 9 (see Appendix G).
- For Huntington disease: Member is responding positively as evidenced by a reduction since baseline in any one of the UHDRS chorea items 1 through 7 (see Appendix H).
- Valbenazine (Ingrezza/Ingrezza Sprinkle) is not prescribed concurrently with Austedo/Austedo XR or tetrabenazine.
- If request is for a dose increase, new dose does not exceed both: a) 80 mg per day; and b) 1 capsule per day.
- Approval duration: 12 months.
Other Diagnoses/Off‑label Uses
Covered when ONE of the following applies
Other uses
- If the drug has had a label change within the last 6 months that is not yet reflected in this policy (e.g., newly approved indication, age expansion, new dosing), follow the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (references provided).
- If the requested use (diagnosis, age, dosing regimen) is not specifically listed under Section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business.
Dosing / Indication statements
Dosing and coverage-related statements present in document parts:
Document lists available strengths 40 mg, 60 mg, 80 mg and maximum dose 80 mg/day; Ingrezza Sprinkle formulation and related updates noted in review history.
Requests for uses that are not FDA‑approved and are not specifically addressed in this policy are not authorized for coverage unless the requestor provides sufficient documentation of safety and efficacy consistent with the applicable off‑label use policies (see HIM.PA.154 for Health Insurance Marketplace/ICHRA and CP.PMN.53 for Medicaid).
During the 2Q 2024 review the policy was updated to add Austedo XR as an additional drug excluded from concurrent use with valbenazine; this concurrent treatment exclusion is noted in the review history entry for that review cycle.
This portion of the document does not enumerate specific "not medically necessary" (NMN) statements. Review history entries record template and warning updates applied during periodic reviews, but do not add discrete NMN determinations in the text covered here.
Coding
| G24.01 | Tardive dyskinesia |
| G24.01 | Tardive Dyskinesia (ICD-10 G24.01) referenced |
Provider Actions & Authorization Rules
Prior authorization required — meet all listed criteria
Prior authorization is required. Approval is contingent on documented diagnosis, specialist involvement, age ≥ 18, baseline severity measurement (AIMS for TD or UHDRS for Huntington chorea), prior tetrabenazine trial unless contraindicated, no concurrent VMAT2 inhibitor use, and adherence to dose limits (≤ 80 mg/day and 1 capsule/day).
- Diagnosis of TD secondary to a centrally acting DRBA (see Appendix F) or diagnosis of chorea associated with Huntington disease.
- Prescribed by or in consultation with a psychiatrist (TD) or neurologist (TD/Huntington chorea).
- Age ≥ 18 years.
- Baseline severity: AIMS score 3–4 on any one of items 1–9 (TD) or UHDRS chorea score 1–4 on any one of chorea items 1–7 (Huntington chorea).
- Failure of tetrabenazine unless contraindicated or intolerant.
- Not prescribed concurrently with Austedo/Austedo XR or tetrabenazine.
- Dose limits: does not exceed 80 mg per day and 1 capsule per day.
Authorization timelines and periodic review
The policy enforces prior authorization with defined approval durations and periodic reviews; continued approval duration has been revised to 12 months. Initial and continued approval periods are reflected in the criteria sets.
- Approval duration for initial and continued therapy is 12 months as specified in the criteria.
- Review history documents operational changes to approval durations and periodic policy reviews.
Step therapy: tetrabenazine trial required before valbenazine
A trial and failure of tetrabenazine is required prior to approval: up to 200 mg/day for tardive dyskinesia and up to 100 mg/day for Huntington chorea, unless contraindicated or clinically intolerant.
- TD: failure of tetrabenazine at up to 200 mg per day (no improvement in any one of AIMS items 1–9).
- Huntington chorea: failure of tetrabenazine at up to 100 mg per day (no improvement in any one of UHDRS chorea items 1–7).
- For Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395.
Illinois HIM step therapy bypass (IL HB 5395)
Per IL HB 5395, the tetrabenazine step therapy requirement is bypassed for Illinois HIM requests effective 1/1/2026; the HIM line of business was added to the policy.
- Explicit note in both TD and Huntington chorea initial criteria that the step therapy requirement does not apply for Illinois HIM requests as of 1/1/2026.
- Policy review history records addition of HIM line of business and the IL HIM step therapy bypass.
Submit clinical documentation to support PA
Submit supporting documentation with the PA request, such as office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria.
- Documentation must show diagnosis, specialist consultation or prescriber, age, prior treatment history (including tetrabenazine trial if applicable), and baseline severity assessments.
- Include any lab results or other records referenced in the clinical assessment (e.g., CYP2D6 testing when relevant for tetrabenazine dosing per Appendix).
Use AIMS and UHDRS for assessment and documentation
Document baseline and follow-up assessments using the AIMS for tardive dyskinesia and the UHDRS chorea subscore for Huntington disease to support severity and treatment response.
- AIMS: items 1–10 rated 0–4; evidence of moderate–severe TD is an AIMS score of 3 or 4 on any one of items 1–9.
- UHDRS chorea subscore: rating of 7 body regions on a 0–4 scale; evidence of chorea is a score 1–4 on any one of chorea items 1–7.
Incomplete documentation may trigger denial or information request
Failure to submit required documentation (office notes, labs, or clinical information) demonstrating that the member meets the approval criteria may result in a denial or a request for additional information.
- Ensure PA submissions include prior treatment details, severity scales, and specialist consultation to avoid delays or denials.
- Incomplete documentation may trigger a request for more information prior to decision.
Off‑label requests require sufficient supporting evidence
Requests for non‑FDA approved (off‑label) indications require sufficient supporting documentation per the plan's off‑label policies; lacking adequate evidence may lead to denial.
- Non‑FDA indications not addressed in this policy require documentation of efficacy and safety according to HIM.PA.154 (Marketplace/ICHRA) or CP.PMN.53 (Medicaid) or other evidence of coverage documents.
- Confirm the requested indication is covered by this policy; if not, reference off‑label policy requirements in the submission.
No other significant provider action changes noted
No additional notable provider actions or new denial triggers were identified in the recent reviews for this portion of the policy.
- Review history records multiple annual reviews with no significant changes noted in several cycles.
- Operational changes documented elsewhere (e.g., additions of indications, appendices, or formulations) are recorded but do not add new provider action items here.
Definitions
Initial Therapy Criteria
Initial therapy — Initial approval requires meeting all listed indication-specific criteria including specialist prescriber, age, severity measurement, prior therapies, etc.
Initial approval requires meeting all listed indication-specific criteria including specialist prescriber, age, severity measurement, prior tetrabenazine trial (unless contraindicated), no concurrent VMAT2 inhibitor, and dose limits.
Initial therapy requirements summary
- Prescriber: must be prescribed by or in consultation with a psychiatrist (TD) or neurologist (TD/Huntington chorea) as specified in the indication criteria (see Initial Therapy sections).
- Age: member must be ≥ 18 years.
- Severity measurement: TD requires AIMS score of 3 or 4 on any one of items 1-9; Huntington chorea requires UHDRS score 1-4 on any one of chorea items 1-7 (see Appendices G and H).
- Prior therapy: documented failure of tetrabenazine (TD up to 200 mg/day; Huntington chorea up to 100 mg/day) unless contraindicated or intolerant; Illinois HIM exception to step therapy applies as of 1/1/2026.
- Concurrent VMAT2 inhibitor use: not permitted (no concurrent Austedo/Austedo XR or tetrabenazine).
- Dose limits: must not exceed both 80 mg/day and 1 capsule/day.
- Approval duration: 12 months.
Initial therapy / dosing — Initial dosing instructions present in document
Initial dosing instructions present in document
Appendix H lists dosing regimens and titration schedules; product strengths include 40/60/80 mg.
Continuation Therapy Criteria
Continued therapy — Continuation requires evidence of clinical response and adherence to dose limits
Continuation requires evidence of clinical response and adherence to dose limits
Continuation requirements
Member eligibility
- Member currently receiving medication via Centene benefit or previously met initial approval criteria.
- Continuity of care provisions apply for members enrolled in applicable state/product addendums.
Clinical response
- For TD: documented reduction since baseline in any one of AIMS items 1-9.
- For Huntington disease: documented reduction since baseline in any one of UHDRS chorea items 1-7.
- No concurrent use with Austedo/Austedo XR or tetrabenazine.
- Dose increases must not exceed both 80 mg/day and 1 capsule/day.
- Approval duration: 12 months.
Continued therapy duration — Continued therapy/approval duration (revised to 12 months for VMAT2 inhibitors)
Continued therapy/approval duration
Change applied during 2Q 2025 annual review and noted in review history.
Step Therapy
| Step | Requirement | Failure criteria / dose limits | Coverage status |
|---|---|---|---|
| 1 | |||
| Trial and failure of tetrabenazine required prior to approval for both indications (unless contraindicated or intolerant). | |||
| TD: failure at up to 200 mg/day; Huntington chorea: failure at up to 100 mg/day. Valbenazine dose must not exceed 80 mg/day and 1 capsule/day. | |||
| Covered when step met (subject to full prior authorization criteria) |
| State / Line of business | Policy change | Effective date / reference | Coverage status |
|---|---|---|---|
| Illinois — HIM line of business | |||
| Step therapy requirement (trial and failure of tetrabenazine) does not apply for Illinois HIM per IL HB 5395; step therapy bypass added. | |||
| Applies to requests from 1/1/2026 onward per IL HB 5395 (documented in policy review history). | |||
| Covered without tetrabenazine step for IL HIM requests per statute |
Quantity Limits
Background
Valbenazine is a VMAT2 inhibitor approved for the treatment of tardive dyskinesia and for chorea associated with Huntington disease in adults; the policy’s review history records the addition of the chorea indication and Appendix H (UHDRS) when that FDA approval occurred.
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