ModifiedmedimpactPolicy N/A

New specialty drug additions to PDL — coverage criteria for Vowst, Bimzelx, Velsipity, Omvoh, and related agents

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Defines initial and renewal coverage criteria, age and quantity limits, approval durations, and prescribing requirements for newly reviewed specialty drugs added to the Preferred Drug List (PDL). Affects prescribers and pharmacists managing Medicaid-covered specialty medications.

Policy Summary

Payermedimpact

PolicyCoverage criteria for new specialty PDL additions (Vowst, Bimzelx, Velsipity, Omvoh)

Policy CodePolicy N/A

Change TypeNon-Preferred additions with PA and quantity limits

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation (diagnosis, specialist consult, prior therapy trials, and timing for Vowst) to request coverage.

SourceLink

POLICY UPDATE CHANGES

Vowst added as Non-Preferred with specific initial and renewal criteria, age and quantity limits, and a 30-day approval duration.

Bimzelx (bimekizumab) added as Non-Preferred for moderate to severe plaque psoriasis with defined initial and renewal criteria, 6-month initial approval and 1-year renewal.

Velsipity (etrasimod) added as Non-Preferred for moderate to severe ulcerative colitis with defined prior therapy requirements, 6-month initial approval and 1-year renewal.

Omvoh (mirkizumab) added as Non-Preferred for moderate to severe ulcerative colitis with approval durations specified.

30 days

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ModifiedmedimpactPolicy N/A

New specialty drug additions to PDL — coverage criteria for Vowst, Bimzelx, Velsipity, Omvoh, and related agents

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Sign up for all medimpact policy alerts

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Policy Summary

Payermedimpact

PolicyCoverage criteria for new specialty PDL additions (Vowst, Bimzelx, Velsipity, Omvoh)

Policy CodePolicy N/A

Change TypeNon-Preferred additions with PA and quantity limits

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation (diagnosis, specialist consult, prior therapy trials, and timing for Vowst) to request coverage.

SourceLink

POLICY UPDATE CHANGES

Vowst added as Non-Preferred with specific initial and renewal criteria, age and quantity limits, and a 30-day approval duration.

Bimzelx (bimekizumab) added as Non-Preferred for moderate to severe plaque psoriasis with defined initial and renewal criteria, 6-month initial approval and 1-year renewal.

Velsipity (etrasimod) added as Non-Preferred for moderate to severe ulcerative colitis with defined prior therapy requirements, 6-month initial approval and 1-year renewal.

Omvoh (mirkizumab) added as Non-Preferred for moderate to severe ulcerative colitis with approval durations specified.

30 days

Vowst approval duration (initial)

6 mo / 1 yrInitial / renewal approval durations

≥18Age minimum specified

12Vowst quantity limit

2 inj/28dBimzelx quantity limit

2 tabs/dayTenapanor quantity limit

Coverage Criteria for Newly Reviewed Specialty Drugs

Initial Therapy - Vowst

Covered when ALL of the following are met

Vowst Initial Approval: Diagnosis of recurrent Clostridioides difficile infection (CDI)

Prescriber: Prescribed by, or in consultation with, a gastroenterologist or infectious disease specialist

Prior antibiotic courses: Patient has completed at least 3 full courses of antibiotic treatment with two or more guideline-recommended agents (e.g., oral vancomycin, fidaxomicin (Dificid), or oral metronidazole)>=3 courses

Specific agents listed in document

Timing of initiation: Treatment with Vowst will be initiated between 48 and 96 hours of completion of the most recent course of antibiotics48-96 hours

Bowel preparation: At least 8 hours prior to the first dose of Vowst, the patient will receive an appropriate bowel cleansing regimen (e.g., magnesium citrate or polyethylene glycol)>=8 hours before dose

Renewal Therapy - Vowst

Covered for renewal when ALL of the following are met

Diagnosis of recurrent Clostridioides difficile infection (CDI)

Prescriber: Prescribed by, or in consultation with, a gastroenterologist or infectious disease specialist

Treatment failure: Patient had treatment failure defined as presence of CDI diarrhea within 8 weeks of the first dose of Vowst AND a positive stool test for C. difficilewithin 8 weeks

Prior Vowst exposure: Patient has not previously received more than 1 treatment course of Vowst<=1 prior course

Initial Therapy - Bimzelx (bimekizumab)

Covered when ALL of the following are met

Diagnosis of moderate to severe plaque psoriasis

Prescriber: Prescribed by or in consultation with a dermatologist, rheumatologist, or other specialist in the treatment of psoriasis

Duration and severity: Symptoms persistent for >= 6 months with at least one of: >=3% BSA involvement OR PASI >=10 OR incapacitating plaque location (e.g., head/neck, palms, soles, genitalia)>=6 months

Examples of incapacitating locations listed in document

Conventional therapy trial: Trial and failure (at least 3 months) of >=1 conventional therapy (e.g., methotrexate, cyclosporine, acitretin)>=3 months

Renewal Therapy - Bimzelx

Covered for renewal when documentation of response is provided

Response documentation: Documentation (e.g., progress note) of response to therapy compared to baseline, such as improvement in redness, thickness, scaliness, amount of surface area involvement, and/or PASI score

Initial Therapy - Velsipity (etrasimod)

Covered when ALL of the following are met

Diagnosis of moderate to severe ulcerative colitis (UC)

Prescriber: Prescribed by, or in consultation with, a gastroenterologist or other specialist in the treatment of UC

Conventional therapy trial OR high-risk: Patient has had a trial and failure of >=1 conventional therapies (oral/rectal 5-ASA, oral/rectal steroids, or an immunosuppressant) OR is deemed high-risk for intestinal complications or post-operative recurrence

No combination biologics: Not used in combination with any other biologic agent

Preferred biologic failure: 3-month trial and failure of, or contraindication or intolerance to, >=1 preferred cytokine or CAM antagonist indicated for the treatment of UC

Renewal Therapy - Velsipity

Covered for renewal when response documented

Response documentation: Documentation (e.g., progress notes) of response to therapy compared to baseline

Omvoh (mirkizumab) - Coverage (partial)

Covered when criteria met per product indication

Approval duration: Initial approval 6 months; renewal 1 year

Specific clinical initiation and renewal criteria not included in this partial document

Mirkizumab-mrkz (UC) — Initial and Renewal

Covered when ALL of the following are met:

Diagnosis of moderate to severe ulcerative colitis (UC)

Prescriber: Prescribed by, or in consultation with, a gastroenterologist or other specialist in the treatment of UC

Prior therapies: Patient has had a trial and failure of >=1 conventional therapy (oral/rectal 5-ASA, oral/rectal steroids, or an immunosuppressant) OR patient is deemed high-risk for intestinal complications or post‑operative recurrence>=1 failed conventional therapy or high-risk

Preferred biologic trial: Patient has had a 3-month trial and failure of, or contraindication or intolerance to, >=1 preferred cytokine or CAM antagonist indicated for UC3 months

Zuranolone (Zurzuvae) — Initial

Covered when ALL of the following are met:

Diagnosis of postpartum depression (PPD) in adults

Timing: Treatment initiated within one year of giving birth<=1 year from delivery

Quantity/Duration: Approval duration six months with limit of 2 courses of treatment (28 days); quantity limit maximum 14 day supply per fill, maximum 2 fills per 180 days

Tenapanor (Xphozah) — Initial and Renewal

Covered when ALL of the following are met:

Diagnosis of chronic kidney disease with elevated serum phosphorus

Dialysis: Patient is on dialysis

Prior therapies: Patient has had a trial and failure, contraindication, intolerance, or inadequate response to at least 2 preferred phosphate binders>=2 preferred phosphate binders

Age/Quantity: Patient is >= 18 years of age; quantity limit 2 tablets daily; approval duration 1 year

The criteria for Bimzelx (bimekizumab) and Velsipity (etrasimod) explicitly prohibit concurrent use with other biologic agents. Requests for these products must document that therapy is NOT being used in combination with any other biologic agent, consistent with the initial approval requirements for plaque psoriasis and ulcerative colitis in the source document.

The policy states that these agents are not to be used in combination with any other biologic agent. Documentation must confirm the patient is not receiving another biologic concomitantly as a condition of coverage.

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior authorization required; approvals are time-limited

Prior authorization is required for initial and renewal requests; approvals are time-limited (Vowst initial approval duration 30 days; most specialty agents require initial approval of 6 months and renewals of 1 year).

Vowst: initial approval limited to 30 days (quantity limit 12 capsules over 3 days).
Most listed specialty agents (e.g., Bimzelx, Velsipity, Omvoh/mirkizumab) use initial approvals of 6 months with renewals up to 1 year.

Prior Authorization

Product-specific approval durations (e.g., 6 months initial, 1 year renewal)

Initial authorization durations and renewal durations are specified per product: Mirkizumab‑mrkz initial approval 6 months with renewal approvals of 1 year; similar 6‑month initial / 1‑year renewal durations are noted for other listed agents.

Mirkizumab‑mrkz: initial approval 6 months; renewal 1 year (quantity limit 2 mL per 28 days).
Renewal requests require documentation of continued response compared to baseline.

Initial Therapy Criteria (Drug-Specific)

inv-37: Initial therapy (drug-specific)

Initial therapy requires meeting diagnosis, prescriber, prior therapy, and product-specific conditions.

See individual product criteria: Refer to the product-specific coverage criteria entries for detailed initial therapy requirements (diagnosis, prescriber, required prior therapies, timing and preparation where applicable)

inv-38: Mirkizumab-mrkz initial

Initial approval criteria for Mirkizumab-mrkz

Specialist: Prescribed by, or in consultation with, a gastroenterologist or other UC specialist

Conventional therapy trial: Trial and failure of >=1 conventional therapy: oral/rectal 5-ASA agents, oral/rectal steroids, or an immunosuppressant; OR patient is high‑risk for intestinal complications or post‑operative recurrence

Continuation / Renewal Criteria

inv-41: Continuation / Renewal

Renewal requires documented response and meeting timing/prior-use limits where specified.

Vowst renewal: See Vowst renewal criteria for required documentation of treatment failure and timing since prior course

Bimzelx renewal: Documentation of clinical response compared to baseline (e.g., redness, thickness, scaliness, area involvement, and/or PASI)

Velsipity renewal: Documentation of clinical response compared to baseline (progress notes) is required for renewal

inv-42: Renewal documentation

Renewal requires evidence of continued benefit.

Step Therapy Requirements

Scope	Required prior trials / conditions
Vowst (fecal microbiota spores) — prevention of recurrent Clostridioides difficile infection	Patient has completed at least 3 full courses of antibiotic treatment including two or more guideline‑recommended agents (e.g., oral vancomycin, fidaxomicin [Dificid], oral metronidazole); treatment with Vowst will be initiated between 48 and 96 hours after completion of the most recent antibiotic course; and appropriate bowel cleansing (e.g., magnesium citrate or polyethylene glycol) at least 8 hours prior to first dose.
Bimzelx (bimekizumab) — moderate to severe plaque psoriasis	Trial and failure (≥3 months) of ≥1 conventional therapy (e.g., methotrexate, cyclosporine, acitretin); and 3‑month trial and failure of, or contraindication/intolerance to, ≥1 preferred cytokine or CAM antagonist indicated for this condition; not to be used in combination with another biologic.
Velsipity (etrasimod) — moderate to severe ulcerative colitis	Patient has had trial and failure of ≥1 conventional therapies (5‑ASA, steroids, immunosuppressant) or is high‑risk for complications; and a 3‑month trial and failure of, or contraindication/intolerance to, ≥1 preferred cytokine or CAM antagonist for UC; not to be used in combination with another biologic.

Policy area	Requirement
Ulcerative colitis (class-level step) — Mirkizumab-mrkz and other non-preferred UC agents	Patient must have had a 3‑month trial and failure of, or contraindication/intolerance to, ≥1 preferred cytokine or CAM antagonist indicated for UC prior to approval of a non‑preferred agent; documentation that the prescriber is a gastroenterologist or that treatment was in consultation with a gastroenterologist is required.

Indication	Required prior trials
Elevated serum phosphorus in adults with chronic kidney disease on dialysis (Tenapanor/Xphozah)	Patient has had trial and failure, contraindication, intolerance, or inadequate response to at least 2 preferred phosphate binders prior to approval.

Quantity Limits and Dosing Constraints

Vowst — Quantity Limit

Quantity limit12 capsules over 3 days (limit to 1 fill per approval)

Age limit>= 18 years of age

Approval duration30 days (initial approval duration)

Bimzelx — Quantity Limit

Quantity limit2 injections per 28 days

Age limit>= 18 years of age

Renewal requirementDocumentation of response to therapy compared to baseline (e.g., redness, thickness, scaliness, area involvement, and/or PASI)

Definitions and Abbreviations

rCDI — Indication and Required Prior Antibacterial Therapy

DefinitionRecurrent Clostridioides difficile infection (rCDI): prevention indication for Vowst after antibacterial treatment for recurrent CDI

Prior antibiotic requirementPatient has completed at least 3 full courses of antibiotic treatment with two or more guideline-recommended agents (e.g., oral vancomycin, fidaxomicin, oral metronidazole)

Timing of initiationTreatment with Vowst initiated between 48 and 96 hours after completion of the most recent antibiotic course

Bowel preparationAt least 8 hours prior to first dose, patient receives an appropriate bowel cleansing regimen (e.g., magnesium citrate or polyethylene glycol)

PASI — Definition and Use

Definition

Site of Care and Prescribing Locale

Note

Background and Context

Use of other biologic agents in combination is specifically excluded for certain products in this policy. For Bimzelx and Velsipity the initial approval language requires the medication to be NOT used in combination with any other biologic agent, and the Commissioner’s selections reiterate that combination biologic therapy is not permitted. Prior authorization decisions may be denied if combination biologic use is documented or not explicitly ruled out in the submitted documentation.

Policy Summary

Payermedimpact

PolicyCoverage criteria for new specialty PDL additions (Vowst, Bimzelx, Velsipity, Omvoh)

Policy CodePolicy N/A

Change TypeNon-Preferred additions with PA and quantity limits

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation (diagnosis, specialist consult, prior therapy trials, and timing for Vowst) to request coverage.

SourceLink

On This Page

Timing since prior course: Previous course of Vowst was at least 12 days ago but no more than 8 weeks ago12-56 days

No combination biologics: Not used in combination with any other biologic agent

Preferred biologic failure: 3-month trial and failure of, or contraindication or intolerance to, >=1 preferred cytokine or CAM antagonist indicated for this condition>=3 months

Age requirement: Patient meets the minimum age recommended by the package insert for use in UC (policy lists >= 18 years)>=18 years

Documented age requirement

Not to be used in combination with any other biologic agent

Age: Patient meets the minimum age recommended by the package insert (policy lists >=18 years)>=18 years

Quantity/Duration: Initial approval duration 6 months; renewal 1 year; quantity limit 2 mL per 28 days

Renewal requires documentation of response compared to baseline

Prior Authorization

Class‑level prior authorization for non‑preferred agents

Agents in a drug class that are not selected as preferred will be considered non‑preferred and require prior authorization.

DMS selects preferred agents; non‑preferred agents require PA.
At least two or three unique chemical entities should be preferred per class depending on class guidance.

Prior Authorization

PA required for non‑preferred and new chemical entities

Any agent not selected as preferred, and any new chemical entity in a class, requires prior authorization until reviewed by the P&T Committee.

New chemical entities in listed classes (e.g., Hepatitis C, Macrolides, Oxazolidinones, Tetracyclines) require PA until P&T review.

Step Therapy

Required prior therapy (step requirements before approval)

Documented trial and failure of specified prior therapies is required before approval: Vowst requires completion of at least 3 full antibiotic courses (including two or more guideline agents); Bimzelx and Velsipity require trial/failure of conventional systemic therapies and trial/failure of preferred cytokine/CAM antagonists.

Vowst: ≥3 full courses of antibiotic treatment with two or more guideline agents (e.g., oral vancomycin, fidaxomicin, oral metronidazole).
Bimzelx (psoriasis): trial/failure ≥3 months of ≥1 conventional therapy (e.g., methotrexate, cyclosporine, acitretin) and 3‑month trial/failure/intolerance/contraindication to ≥1 preferred cytokine or CAM antagonist.
Velsipity (UC): trial/failure of ≥1 conventional therapy OR high‑risk designation, and 3‑month trial/failure/intolerance/contraindication to ≥1 preferred cytokine or CAM antagonist.

Step Therapy

Ulcerative colitis: conventional therapy and preferred biologic trial required

For Mirkizumab‑mrkz (UC) initial approval, the patient must have trial and failure of ≥1 conventional therapy (5‑ASA, steroids, or immunosuppressant) or be high‑risk for complications, and must have trial/failure/intolerance/contraindication to ≥1 preferred cytokine or CAM antagonist.

Conventional therapies: oral/rectal 5‑ASA agents, oral/rectal steroids, or immunosuppressants (e.g., azathioprine, mercaptopurine).
Preferred cytokine/CAM antagonist trial: 3‑month trial and failure or documented contraindication/intolerance.

Step Therapy

Phosphate binders: trial of ≥2 preferred binders required before Tenapanor

Tenapanor (Xphozah) requires a documented trial and failure, contraindication, intolerance, or inadequate response to at least two preferred phosphate binders prior to approval.

Patient must be on dialysis with elevated serum phosphorus and have tried ≥2 preferred phosphate binders without adequate response or with intolerance/contraindication.

Note

No other explicit step therapy requirements stated

No additional explicit step therapy requirements beyond those specified for individual products are detailed in these sections.

Refer to individual product criteria for product‑specific step requirements.

Documentation Required

Required documentation for PA and renewals

Providers must submit documentation that supports diagnosis, prescriber specialty or consultation, prior treatment trials/failures, and timing of prior antibiotic therapy (for Vowst); renewals must include documentation of clinical response compared to baseline.

For Vowst initial requests: documentation of ≥3 prior antibiotic courses, timing that initiation is 48–96 hours after last antibiotic, and evidence of bowel cleansing ≥8 hours prior to first dose.
For renewals: progress notes demonstrating response compared to baseline (e.g., symptom improvement, PASI, stool testing as specified).

Documentation Required

Renewal: documentation of clinical response required

Renewal requests must include progress notes documenting response to therapy compared with baseline to support continued coverage.

Examples: symptom improvement measures, PASI change for psoriasis, or stool testing/clinical response for CDI and UC.

Documentation Required

Specialist prescribing or documented consultation required

Initial approvals for certain agents require that the prescriber be a specialist (e.g., gastroenterologist for Vowst/Mirkizumab/Velsipity) or that treatment be documented as in consultation with the relevant specialist.

Vowst: prescribed by or in consultation with a gastroenterologist or infectious disease specialist.
UC agents (Velsipity, Mirkizumab): prescribed by or in consultation with a gastroenterologist or other UC specialist.

Denial Risk

Denial triggers: missing diagnosis, specialist, prior trials, or Vowst timing/prep

Prior authorization requests may be denied for missing or insufficient documentation of diagnosis, lack of required specialist prescribing/consultation, failure to document required prior antibiotic or conventional/biologic therapy trials, missing timing requirements for Vowst (initiation 48–96 hours after antibiotics), or missing bowel cleansing prior to Vowst.

Specific Vowst denial triggers: absent documentation of ≥3 prior antibiotic courses, incorrect timing of initiation, or no bowel prep documented.
For biologic/UC agents: absent documentation of required conventional or preferred biologic trials, or lack of specialist involvement.

Denial Risk

Prohibited combination therapy — do not combine biologics

Requests for use of these agents in combination with another biologic agent are explicitly not permitted and may result in denial.

Bimzelx and Velsipity criteria explicitly state 'NOT used in combination with any other biologic agent.'
Mirkizumab/UC criteria also state not to be used in combination with another biologic.

Denial Risk

Denial risk: missing phosphate binder trials for Tenapanor

If documentation of trial/failure, contraindication, intolerance, or inadequate response to at least two preferred phosphate binders is not provided for dialysis patients with hyperphosphatemia, the Tenapanor request may be denied.

Ensure records show trials of ≥2 preferred phosphate binders and reasons for failure/intolerance if applicable.

Prior Authorization

Non‑preferred agent requests require PA and supporting justification

Requests for agents not selected as preferred will be processed as non‑preferred and require PA; absence of justification or required step therapy documentation for non‑preferred agents increases the risk of denial.

Provide documented failure/intolerance/contraindication to preferred agents where required.

Prior Authorization

New chemical entities: PA required until P&T Committee review

New chemical entities in listed classes require prior authorization until reviewed by the P&T Committee; submit PA documentation accordingly until P&T status changes.

Examples: new entries in Hepatitis C, Macrolides/Ketolides, Oxazolidinones, and Tetracyclines classes require PA until committee review.

>=1 failed conventional therapy or high-risk

Preferred cytokine/CAM trial: 3-month trial and failure of, or contraindication or intolerance to, >=1 preferred cytokine or CAM antagonist for UC3 months

inv-39: Zuranolone initial

Initial approval criteria for Zuranolone

Diagnosis timing: Diagnosis of postpartum depression (PPD) in adults with treatment initiated within one year of giving birth<=1 year

Quantity/Duration: Approval duration six months with limit of 2 courses (28 days); quantity limit maximum 14 day supply per fill, maximum 2 fills per 180 days

inv-40: Tenapanor initial

Initial approval criteria for Tenapanor

CKD on dialysis: Patient on dialysis with elevated serum phosphorus

Prior binder trials: Trial and failure, contraindication, intolerance, or inadequate response to at least 2 preferred phosphate binders>=2

Age/Quantity: Patient is >= 18 years of age; quantity limit 2 tablets daily; approval duration 1 year

Response documentation: Documentation (e.g., progress notes) of response to therapy compared to baseline is required for renewal

Velsipity — Quantity Limit

Quantity limit1 tablet per day

Age limit>= 18 years of age

Renewal requirementDocumentation (e.g., progress notes) of response to therapy compared to baseline

Mirkizumab-mrkz — Quantity Limit

Quantity limit2 mL per 28 days

Approval durations6 months initial; 1 year renewal

Age limit>= 18 years of age

Tenapanor (Xphozah) — Quantity Limit

Quantity limit2 tablets daily

Age limit>= 18 years of age

Prior therapy requirementTrial and failure, contraindication, intolerance, or inadequate response to at least 2 preferred phosphate binders

Zuranolone (Zurzuvae) — Quantity Limit

Quantity/FillMaximum 14 day supply per fill

Fill limitMaximum 2 fills per 180 days

Approval duration/limitsSix months with limit of 2 courses of treatment (28 days)

PASI: Psoriasis Area and Severity Index — used as a criterion for severity assessment in plaque psoriasis (PASI >= 10 qualifies)

Severity thresholdPASI score of 10 or greater as one option for defining moderate to severe plaque psoriasis

Context of usePASI is used alongside BSA and incapacitating plaque location to establish duration/severity requirements (symptoms >= 6 months)

Mirkizumab-mrkz — Description and Key Coverage Notes

Drug class/descriptionMirkizumab-mrkz: a humanized IgG4 monoclonal antibody indicated for treatment of moderate to severe ulcerative colitis (UC)

Approval durationsInitial approval 6 months; renewal 1 year

Use constraintsNot to be used in combination with any other biologic agent; prior trials of conventional therapies and preferred cytokine/CAM antagonists required

Tenapanor (Xphozah) — Description and Required Prior Therapy

Mechanism/indicationTenapanor (Xphozah): a sodium/hydrogen exchanger 3 (NHE3) inhibitor used to reduce serum phosphorus in adults with CKD on dialysis

Prior therapy requirementRequires trial and failure, contraindication, intolerance, or inadequate response to at least 2 preferred phosphate binders before approval

Quantity/age limitsQuantity limit 2 tablets daily; age >= 18 years

Zuranolone (Zurzuvae) — Description, Timing, and Limits

Mechanism/indicationZuranolone (Zurzuvae): a neuroactive steroid GABAA receptor positive modulator indicated for treatment of postpartum depression (PPD) in adults within one year of giving birth

Timing requirementTreatment initiated within one year of delivery (PPD diagnosis within 1 year postpartum)

Quantity/fill limitsMaximum 14 day supply per fill; maximum 2 fills per 180 days; approval duration six months with limit of 2 courses (28 days)