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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty Drugsmedimpact new specialty drug coverage update | Ope…
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    ModifiedmedimpactPolicy N/A

    New products to market — Preferred Drug List selections and coverage criteria

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    Summarizes PDL selections and establishes coverage, initial and renewal authorization criteria, quantity limits, and approval durations for several new specialty products affecting PAH, PNH, PH1, IBD, and related therapies for Medicaid managed by MedImpact.

    Policy Summary
    Payermedimpact
    PolicyNew products to market — PDL selections & utilization criteria
    Policy CodePolicy N/A
    Change TypeAdds coverage and PA criteria for 5 new specialty products
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization with required specialist documentation and prior-trial evidence per product-specific criteria.
    SourceLink
    POLICY UPDATE CHANGES

    Adds coverage and specific prior authorization criteria for new agents including Opsynvi, sotatercept-csrk, danicopan (Voydeya), nedosiran (Rivfloza), and infliximab-dyyb (Zymfentra).

    5new products with documented criteria
    1 yearOpsynvi approval duration
    3 monthsVoydeya initial duration

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    ≥9
    Rivfloza age limit
    1/dayOpsynvi quantity limit

    Coverage and Initial Placement Criteria

    Opsynvi Initial Therapy

    Opsynvi (macitentan/tadalafil combination) — Initial Approval

    ALL of the following

    • diagnosis: Diagnosis of pulmonary arterial hypertension (PAH) World Health Organization (WHO) Group 1
    • functional_class: Patient is WHO functional class (FC) 2 or 3
    • prescriber: Prescribed by, or in consultation with, a cardiologist, pulmonologist, or other specialist in the treatment of pulmonary arterial hypertension (PAH)
    • prior_trials: Patient has had at least a 30-day trial and failure, allergy, contraindication, or intolerance of ambrisentan AND sildenafil or tadalafil
    • age: Patient meets the minimum age recommended by the package insert for use in PAH
    • concomitant_medications: Patient will not be using with other phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil)

    ALL of the following

    • quantity_limit: Quantity limit: 1 tablet per day

    ALL of the following

    • renewal: Renewal requires prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms

    Sotatercept-csrk Initial Therapy

    Sotatercept-csrk — Initial Approval

    ALL of the following

    • diagnosis: Diagnosis of pulmonary arterial hypertension (PAH) World Health Organization (WHO) Group 1
    • prescriber: Prescribed by, or in consultation with, a cardiologist, pulmonologist, or other specialist in the treatment of PAH
    • prior_trials: Patient has had at least a 30-day trial and failure, allergy, contraindication, or intolerance of Adempas AND ambrisentan AND sildenafil or tadalafil
    • age: Patient meets the minimum age recommended by the package insert for use in PAH

    Voydeya Initial Therapy

    Voydeya (danicopan) — Initial Approval

    ALL of the following

    • diagnosis: Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) with extravascular hemolysis (EVH)
    • prescriber: Prescribed by, or in consultation with, a hematologist or other specialist in the treatment of PNH with EVH
    • age: Patient meets the minimum age recommended by the package insert for use in PNH with EVH
    • concomitant_use: Patient will be using as add-on therapy to ravulizumab (Ultomiris) or eculizumab (Soliris)

    ALL of the following

    Rivfloza Initial Therapy

    Rivfloza (nedosiran) — Initial Approval

    ALL of the following

    • diagnosis: Patient has a diagnosis of primary hyperoxaluria type 1 (PH1)
    • prescriber: Prescribed by, or in consultation with, a nephrologist, urologist, or other applicable specialist in PH1
    • renal_function: Patient does not have severe renal impairment (eGFR < 30 mL/min/1.73 m2)
    • hepatic_function: Patient does not have moderate or severe hepatic impairment

    Zymfentra Initial Therapy

    Zymfentra (infliximab-dyyb) — Initial Approval

    ALL of the following

    • diagnosis: Diagnosis of moderate to severe Crohn's disease (CD) or ulcerative colitis (UC)
    • induction: Patient has undergone induction therapy with intravenous infliximab
    • prescriber: Prescribed by, or in consultation with, a gastroenterologist or other specialist in the treatment of CD or UC
    • prior_conventional: Patient has had a trial and failure of ≥ 1 conventional therapies (oral/rectal 5-ASA agents, oral/rectal steroids, immunosuppressants) OR is high-risk for intestinal complications or post-operative recurrence

    Initial Therapy (Crohn's disease or ulcerative colitis)

    Covered when ALL of the following are met

    CD/UC initial criteria: Diagnosis of moderate to severe Crohn's disease (CD) or ulcerative colitis (UC); AND patient has undergone induction therapy with intravenous infliximab; AND prescribed by, or in consultation with, a gastroenterologist or other specialist in the treatment of CD or UC; AND patient has had a trial and failure of >= 1 conventional therapies (oral/rectal 5-ASA agents, oral/rectal steroids, immunosuppressant) OR patient is deemed high-risk for intestinal complications or post-operative recurrence; AND not used in combination with any other biologic agent; AND patient has had a 3-month trial and failure of, or contraindication or intolerance to, >= 1 preferred cytokine or CAM antagonist indicated for CD or UC; AND patient meets the minimum age recommended by the package insert for use in CD or UC.

    Exact step therapy: conventional therapies and preferred cytokine/CAM antagonist requirement included.

    Initial Therapy (Filsuvez for dystrophic/junctional EB)

    Covered when ALL of the following are met

    Filsuvez initial criteria: Patient has a diagnosis of dystrophic or junctional epidermolysis bullosa; AND prescribed by, or in consultation with, a dermatologist or other specialist in the treatment of epidermolysis bullosa; AND patient has partial-thickness wounds (does not extend beyond the dermis layer) which are clean with adequate granulation tissue, excellent vascularization, and do not appear infected; AND patient's wound has persisted for at least 3 weeks; AND patient wound size is at least 10 cm; AND patient is receiving standard-of-care wound therapy; AND patient has not received or is being considered for other gene therapy, stem cell transplant, or investigational cellular therapy; AND patient has not received immunosuppressive therapy or cytotoxic chemotherapy within the past 60 days; AND patient meets the minimum age recommended by the package insert for use in dystrophic or junctional epidermolysis bullosa.

    Also see renewal criteria for response.

    Initial Therapy (Eohilia for EoE)

    Covered when ALL of the following are met

    Eohilia initial criteria: Diagnosis of eosinophilic esophagitis; AND prescribed by, or in consultation with, an allergist, immunologist, gastroenterologist, or other specialist in the treatment of eosinophilic esophagitis; AND meets age requirement (>=11 years).

    Approval duration is 12 weeks; quantity limit 20 mL/day for 12 weeks.

    Initial Therapy (Eltrombopag / Alvaiz)

    Covered when ALL of the following are met

    Eltrombopag initial criteria: Prescribed by, or in consultation with, a hematologist or liver disease specialist; AND patient has one of the following indications: persistent or chronic immune thrombocytopenia (ITP) with an insufficient response to corticosteroids, immunoglobulins, or splenectomy; OR used for thrombocytopenia in chronic hepatitis C to allow interferon-based therapy; OR diagnosis of severe aplastic anemia with an insufficient response to immunosuppressive therapy; AND patient meets the minimum age recommended by the package insert for respective indications.

    Quantity limits provided by strength.

    Initial Therapy (Resmetirom / Rezdiffra for NASH)

    Covered when ALL of the following are met

    Resmetirom initial criteria: Diagnosis of noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (F2-F3); AND prescribed by, or in consultation with, a gastroenterologist or hepatologist; AND prescriber attests that member does not have excessive alcohol consumption.

    Approval duration 1 year; quantity limit 1 per day; renewal requires documentation of response and no treatment-limiting adverse effects.

    Coverage for Rivfloza (nedosiran) is denied for patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) or with moderate or severe hepatic impairment. Requests are also excluded when nedosiran is to be used concomitantly with lumasiran (Oxlumo). These exclusions align with the product-specific initial and renewal criteria requiring preserved renal and hepatic function and avoidance of concurrent lumasiran use.

    Biologic and combination use is restricted: for Crohn's disease or ulcerative colitis, infliximab-dyyb (Zymfentra) is not approved when used in combination with any other biologic agent and requires prior induction with intravenous infliximab plus failure of conventional therapies and a preferred cytokine/CAM antagonist trial. For Filsuvez initiation in dystrophic or junctional EB, patients who are receiving or are being considered for gene therapy, stem cell transplant, or investigational cellular therapy are excluded from coverage.

    The document does not present a comprehensive list of explicit, standalone coverage exclusions for all products; many class and product entries are shown with utilization tags such as QL (quantity limit) and AE (additional evaluation/authorization) rather than discrete exclusion statements. Refer to individual product criteria for specific exclusions where provided.

    Use of listed agents contrary to configured utilization controls may be considered not medically necessary. Examples include dispensing above specified quantity limits (QL) (e.g., Opsynvi limited to 1 tablet per day) or initiating biologic therapy without required induction (for infliximab-dyyb, lack of prior intravenous infliximab induction or failure of required conventional therapies and preferred biologic trials may render the request not medically necessary). Renewal requests must include documentation of clinical response compared to baseline.

    Filsuvez is limited to wounds that meet product-specific wound criteria. Coverage is not supported for wounds that are not partial-thickness, are infected, lack adequate granulation tissue or vascularization, have persisted for less than 3 weeks, or are smaller than 10 cm. Additionally, patients who recently received immunosuppressive therapy or cytotoxic chemotherapy within the past 60 days, or who are receiving gene/stem cell/investigational cellular therapies, are excluded from initiation under the criteria.

    Key Coding and Age/Clinical Thresholds

    inv-16: Age limit — Rivfloza (nedosiran) minimum age
    Rivfloza minimum age>= 9 years of age
    Indication age supportNedosiran indicated for children 9 years and older and adults with PH1
    Source contextAge limit specified in renewal and product description
    inv-17: Renal function exclusion — Rivfloza eGFR cutoff
    eGFR cutoff for exclusioneGFR < 30 mL/min/1.73 m2 (severe renal impairment) excludes coverage
    Renewal confirmationRenewal criteria reiterate patient must not have severe renal impairment (eGFR < 30 mL/min/1.73 m2)
    Related contraindication

    Prior Authorization, Documentation, and Denial Risk

    Prior Authorization

    Opsynvi prior authorization

    Opsynvi (macitentan/tadalafil) requires prior authorization. Submit documentation confirming a diagnosis of pulmonary arterial hypertension (WHO Group 1), WHO functional class 2 or 3 status, that the prescriber is a PAH specialist (or consultation occurred), evidence of a ≥30-day trial and failure/allergy/contraindication/intolerance to ambrisentan AND sildenafil or tadalafil, the patient meets the package‑insert minimum age, and that the drug will not be used with other phosphodiesterase‑5 inhibitors.

    • Diagnosis: PAH WHO Group 1
    • WHO FC: 2 or 3
    • Specialist prescriber or consultation (cardiologist/pulmonologist/PAH specialist)
    • Prior trial/failure of ambrisentan AND sildenafil or tadalafil (≥30 days or intolerance/allergy/contraindication)
    • Meets package‑insert minimum age
    • Not to be used concomitantly with other PDE‑5 inhibitors
    Prior Authorization

    Sotatercept‑csrk prior authorization

    Initial Therapy Criteria (Grouped)

    INITIAL THERAPY CRITERIA

    Initial therapy criteria require diagnosis confirmation, specialist involvement, prior trials/failures of listed agents, age per PI, and other product-specific conditions.

    ALL of the following

    • product_specific: Refer to individual product initial approval criteria sections for diagnosis, prescriber specialty, prior trial/failure requirements, age per package insert, and any product-specific restrictions (e.g., concomitant medication exclusions or monitoring).

      See product-specific criteria blocks.

    ALL of the following

    • class_rules: For class-level placement: DMS to select preferred agent(s) based on economic evaluation; agents not selected as preferred will be considered non-preferred and require prior authorization; new chemical entities in a class require prior authorization until reviewed by the P&T Committee.

    Renewal and Continuation Requirements

    CONTINUATION CRITERIA

    Renewal requires documentation of clinical benefit or stabilization.

    ALL of the following

    • prescriber_attestation: Prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms (or documentation such as progress notes/labs) for renewal
    product_specific_renewal: Renewal requires documentation of response to therapy compared to baseline; product-specific measures include: hemoglobin increase for Voydeya, reduction/stabilization in serum oxalate for Rivfloza, wound healing/improvement for Filsuvez, and no treatment-limiting adverse effects for Resmetirom and eltrombopag.

    Renewal durations vary by product.

    Renewal/Continuation

    Renewal criteria require clinical documentation of response and ongoing need.

    Step Therapy and Preferred Ordering

    RequirementNotes / Evidence
    Document prior trial and failure (or allergy/contraindication/intolerance) of enumerated preferred agents
    For PAH agents: at least a 30-day trial and failure (or allergy/contraindication/intolerance) of ambrisentan AND sildenafil or tadalafil required prior to coverage
    RequirementNotes / Evidence
    Trial and failure of ≥1 conventional therapies for CD or UC
    Plus a 3‑month trial and failure of, or contraindication/intolerance to, ≥1 preferred cytokine or CAM antagonist prior to approval
    Policy statementSource / Clarification
    At least two unique chemical entities should be designated preferred within each drug class
    Preferred selection determined by DMS economic evaluation; agents not selected as preferred will be considered non‑preferred and require PA
    InterpretationSource example / Implementation note
    Numbered sequences (1, 2, 3) indicate preferred order or sequence within a class
    Products listed with markers such as '1 =' , '2 =' , '3 =' imply tiered preference and can be implemented as step order in the formulary
    Meaning of group numbersOperational guidance
    Group numbering (e.g., '1 =', '2 =', '3 =') defines preferred sequence or tiers within the class
    Use group numbering to implement step‑preference logic where available; map '1 =' as first‑line preferred, subsequent numbers as later tiers
    Numeric indicatorsImplication for utilization management
    Numeric indicators adjacent to product names imply preferred groupings or step tiers
    Where numeric groupings appear, configure edits to require trials of lower‑numbered (preferred) group agents before higher‑tier agents
    Class listing implicationNote
    Class lists imply tiering/selection (AE vs QL) that can inform step therapy even when explicit step rules are not stated
    Use class AE/QL markers and preferred/non‑preferred designation to derive step logic where explicit failure criteria are absent
    OrganizationEvidence in source
    Products are organized into class selection with QL and AE flags which indicate utilization controls
    The excerpt lists many products with QL/AE designations but does not provide explicit step edit algorithms in these class tables
    StatementSource
    No explicit step therapy requirements are defined in these chunks (class lists show QL/AE but not required step failures)
    Where explicit step rules are absent, rely on product‑specific initial approval criteria for required prior trials/failures
    Preferred agent listingImplication
    Preferred agents are explicitly identified in class lists (example: Ritalin LA, Ritalin tablet, Strattera capsule, Xelstrym patch)
    Although preferred agents are listed and likely favored in utilization management, explicit step‑therapy rules for these products are not provided in the extracted text

    Quantity Limits and Dispense Restrictions

    inv-118: Opsynvi quantity limit — Opsynvi QL value
    Opsynvi quantity limitQuantity Limit: 1 tablet per day
    Formulary tagListed among PAH agents with CC and QL designations
    Approval duration referenceOpsynvi appears in new products list with 1 year approval context
    inv-119: Voydeya (danicopan) quantity limits — 50 mg and 100 mg tablet daily allowances
    Voydeya 50 mg daily allowance50 mg tablet: up to 9 tablets per day
    Voydeya 100 mg daily allowance100 mg tablet: up to 6 tablets per day
    Approval duration

    Site of Care and Prescriber Requirements

    Note
    Note

    Background and Therapeutic Context

    Background: these agents represent targeted specialty therapies across several disease areas. The macitentan/tadalafil combination (Opsynvi) addresses pulmonary arterial hypertension and is placed alongside other PAH agents with utilization controls. Sotatercept-csrk is an activin signaling inhibitor developed for PAH and requires specialist prescribing and laboratory monitoring. Danicopan (Voydeya) is a Factor D inhibitor for paroxysmal nocturnal hemoglobinuria with extravascular hemolysis and is intended as add-on therapy to terminal complement inhibitors. Nedosiran (Rivfloza) is an siRNA therapy that lowers urinary oxalate in primary hyperoxaluria type 1 and is restricted to patients with preserved renal and hepatic function (age and eGFR thresholds apply). Finally, infliximab-dyyb (Zymfentra) is a TNF-α inhibitor for moderate to severe Crohn's disease or ulcerative colitis with specific induction and prior-therapy requirements.

    Definitions and Tag Glossary

    inv-81: Definition — sotatercept-csrk description and class
    sotatercept-csrk definitionAn activin signaling inhibitor used in the treatment of pulmonary arterial hypertension (PAH)
    Therapeutic classActivin signaling inhibitor for PAH management
    Approval contextListed as a new product with initial and renewal criteria in the document
    inv-82: Definition — danicopan (Voydeya)
    danicopan (Voydeya) definitionA selective Factor D inhibitor used to treat paroxysmal nocturnal hemoglobinuria (PNH) with extravascular hemolysis (EVH)
    Use contextIndicated as add-on to ravulizumab or eculizumab per initial criteria
    Policy Summary
    Payermedimpact
    PolicyNew products to market — PDL selections & utilization criteria
    Policy CodePolicy N/A
    Change TypeAdds coverage and PA criteria for 5 new specialty products
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization with required specialist documentation and prior-trial evidence per product-specific criteria.
    SourceLink
    On This Page
    Coverage and Initial Placement CriteriaKey Coding and Age/Clinical ThresholdsPrior Authorization, Documentation, and Denial RiskInitial Therapy Criteria (Grouped)Renewal and Continuation RequirementsStep Therapy and Preferred OrderingQuantity Limits and Dispense RestrictionsSite of Care and Prescriber RequirementsBackground and Therapeutic ContextDefinitions and Tag Glossary
    monitoring: Prescriber attests that hemoglobin and platelet will be monitored

    ALL of the following

    • renewal: Renewal requires prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms
    • quantity_limit: Quantity limit: 50 mg tablet: 9 tablets per day; 100 mg tablet: 6 tablets per day
    • renewal: Renewal requires prescriber attestation of clinically significant improvement or stabilization (e.g., increase in hemoglobin)
    concomitant_medications: Patient will not use nedosiran concomitantly with lumasiran (Oxlumo)

    ALL of the following

    • age: Patient is ≥ 9 years of age>= 9 years
    • quantity_limit: Quantity limit: 1 syringe per month
    • renewal: Renewal requires documentation of reduction or stabilization in serum oxalate levels and continued absence of severe renal or moderate/severe hepatic impairment
    no_combination: NOT used in combination with any other biologic agent
  1. 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 CD or UC
  2. age: Patient meets the minimum age recommended by the package insert for use in CD or UC

    3. ALL of the following

    • renewal: Renewal requires documentation (e.g., progress notes) of response to therapy compared to baseline
    Also not for use with moderate or severe hepatic impairment
    inv-18: Wound size — Filsuvez minimum wound size requirement
    Minimum wound size>= 10 cm
    Wound type requirementPartial-thickness wounds (does not extend beyond dermis)
    Additional wound conditionsWounds must be clean with adequate granulation tissue and excellent vascularization and not infected
    inv-19: Wound duration — Filsuvez minimum wound duration requirement
    Minimum wound duration>= 3 weeks
    Renewal noteRenewal requires documentation of improvement and continued need for treatment
    Exclusion relatedRecent immunosuppressive or cytotoxic chemotherapy within past 60 days excludes initiation
    inv-20: Eohilia age — Eohilia minimum age
    Eohilia minimum age>= 11 years
    Approval duration contextInitial approval duration noted in product section (12 weeks) with quantity limit
    Renewal criteriaRenewal requires prior positive response and documentation of histologic relapse for retreatment
    inv-21: Filsuvez age — Filsuvez minimum age
    Filsuvez minimum age>= 6 months of age
    Renewal requirementRenewal requires clinical documentation showing improvement and no treatment-limiting adverse effects
    Indication contextFor dystrophic or junctional epidermolysis bullosa wounds meeting criteria

    Sotatercept‑csrk requires prior authorization. Provide documentation of PAH WHO Group 1 diagnosis, specialist prescriber or consultation, evidence of a ≥30‑day trial and failure/allergy/contraindication/intolerance to Adempas, ambrisentan, AND sildenafil or tadalafil, that the patient meets the package‑insert minimum age, and prescriber attestation that hemoglobin and platelet monitoring will occur.

    • Diagnosis: PAH WHO Group 1
    • Specialist prescriber (cardiologist/pulmonologist) or consultation
    • Prior trial/failure of Adempas, ambrisentan, AND sildenafil or tadalafil (≥30 days or intolerance/allergy/contraindication)
    • Meets package‑insert minimum age
    • Prescriber attestation to monitor hemoglobin and platelets
    Prior Authorization

    Voydeya prior authorization

    Voydeya (danicopan) requires prior authorization. Include documentation of a diagnosis of PNH with extravascular hemolysis (EVH), that the prescriber is a hematologist or PNH specialist (or consultation), the patient meets the package‑insert minimum age, and that the drug will be used only as add‑on therapy to ravulizumab or eculizumab.

    • Diagnosis: PNH with EVH
    • Specialist prescriber or consultation (hematologist/PNH specialist)
    • Meets package‑insert minimum age
    • Will be used as add‑on to ravulizumab (Ultomiris) or eculizumab (Soliris)
    Prior Authorization

    Rivfloza prior authorization

    Rivfloza (nedosiran) requires prior authorization. Provide documentation of a PH1 diagnosis, specialist prescriber or consultation, evidence the patient does not have severe renal impairment (eGFR ≥ 30 mL/min/1.73 m2) or moderate/severe hepatic impairment, the patient meets the age requirement (≥9 years), and that nedosiran will not be used concomitantly with lumasiran (Oxlumo).

    • Diagnosis: primary hyperoxaluria type 1 (PH1)
    • Specialist prescriber or consultation (nephrologist/urologist)
    • No severe renal impairment (eGFR < 30 mL/min/1.73 m2 excludes coverage)
    • No moderate or severe hepatic impairment
    • Age ≥ 9 years
    • Not used concomitantly with lumasiran (Oxlumo)
    Prior Authorization

    Zymfentra prior authorization

    Zymfentra (infliximab‑dyyb) requires prior authorization. Submit documentation of a diagnosis of moderate‑to‑severe Crohn's disease or ulcerative colitis, evidence the patient underwent induction therapy with intravenous infliximab, that the prescriber is a gastroenterologist or specialist (or consultation), prior trial/failure of ≥1 conventional therapies (or high‑risk designation), a 3‑month trial and failure (or contraindication/intolerance) of ≥1 preferred cytokine or CAM antagonist, and that it will not be used in combination with another biologic.

    • Diagnosis: moderate to severe CD or UC
    • Induction therapy with IV infliximab documented
    • Specialist prescriber or consultation (gastroenterologist)
    • Trial/failure of ≥1 conventional therapies (5‑ASA, steroids, immunosuppressant) or high‑risk designation
    • 3‑month trial and failure (or contraindication/intolerance) of ≥1 preferred cytokine or CAM antagonist
    • Not used in combination with any other biologic agent
    Prior Authorization

    Crohn's/UC prior authorization

    Prior authorization is required for moderate‑to‑severe Crohn's disease or ulcerative colitis biologic therapy. Document diagnosis, induction with IV infliximab, specialist involvement, trial/failure of ≥1 conventional therapies (or high‑risk status), and trial/failure (or intolerance/contraindication) of ≥1 preferred cytokine or CAM antagonist for 3 months as applicable.

    • Diagnosis of moderate to severe CD or UC
    • Induction with IV infliximab must be documented
    • Specialist prescriber or consultation required
    • Trial/failure of ≥1 conventional therapies or high‑risk designation
    • 3‑month trial and failure (or contraindication/intolerance) of ≥1 preferred cytokine or CAM antagonist
    Prior Authorization

    Filsuvez prior authorization

    Filsuvez requires prior authorization. Include diagnosis of dystrophic or junctional epidermolysis bullosa, specialist prescriber or consultation, wound characteristics showing partial‑thickness wounds that are clean with adequate granulation and vascularization, wound duration ≥3 weeks and size ≥10 cm, evidence of standard‑of‑care wound therapy, absence of recent gene/stem cell/investigational cellular therapy or immunosuppressive/cytotoxic chemotherapy within 60 days, and that the patient meets the package‑insert minimum age.

    • Diagnosis: dystrophic or junctional EB
    • Specialist prescriber or consultation (dermatologist)
    • Partial‑thickness wound (not beyond dermis), clean, adequate granulation, excellent vascularization, not infected
    • Wound persisted ≥ 3 weeks
    • Wound size ≥ 10 cm
    • Receiving standard‑of‑care wound therapy
    • No gene therapy/stem cell/investigational cellular therapy; no immunosuppressive/cytotoxic chemotherapy within 60 days
    • Meets package‑insert minimum age
    Prior Authorization

    Other products prior authorization

    Prior authorization is required for other new or specialty products listed (e.g., Eohilia, Alvaiz/eltrombopag, Rezdiffra/resmetirom). Provide specialty prescriber attestation or consultation and documentation supporting the indicated diagnosis per each product's initial criteria.

    • Eohilia: diagnosis of eosinophilic esophagitis; specialist prescriber/consultation; age ≥11 years where applicable
    • Eltrombopag (Alvaiz): prescribed by/with hematologist or liver disease specialist and meets indication criteria
    • Resmetirom (Rezdiffra): gastroenterologist/hepatologist prescriber and attestation of no excessive alcohol use
    Prior Authorization

    PA required for non‑preferred and new agents

    Prior authorization is required for agents designated as non‑preferred and for any new chemical entity in the listed classes until P&T Committee review. Requests for non‑preferred or newly listed agents must include PA documentation.

    • Agents not selected as preferred are non‑preferred and require PA
    • New chemical entities require PA until reviewed by the P&T Committee
    Prior Authorization

    Prior authorization required for non‑preferred and new chemical entities

    Agents not selected as preferred will be considered non‑preferred and require prior authorization. For any new chemical entity in a class, PA is required until P&T Committee review; configure PA workflows accordingly.

    • Non‑preferred classification triggers PA
    • New chemical entities remain PA‑required until formal P&T placement
    Billing Rule

    Prior authorization and quantity limits

    Where CC (clinical criteria) or QL (quantity limit) tags are applied, prior authorization or adjudication will be required. Expect PA when CC is assigned and enforcement of quantity limits for QL‑tagged medications.

    • CC = clinical criteria implies PA/coverage criteria must be met
    • QL = quantity limits will be enforced at claim adjudication
    Billing Rule

    Quantity limits and authorization

    Many stimulant and related products are assigned quantity limits and some AE/CC tags; configure authorization rules to enforce QL and to prompt PA or additional edits where AE or CC are indicated.

    • Products with QL will have quantity enforcement applied
    • Products marked AE or CC may require PA or prescriber documentation
    Billing Rule

    Utilization controls (QL/AE/CC) applied

    Utilization controls such as QL (quantity limit), AE (additional evaluation/age exception), and CC (clinical criteria) are applied across listed stimulant and ADHD products; expect claims edits and authorization requirements aligned with these tags.

    • AE indicates additional authorization or age‑based exception editing
    • CC indicates clinical criteria must be met for coverage
    • QL enforces dispensing limits
    Billing Rule

    Prior authorization and quantity limits

    Certain products are designated AE (additional evaluation/authorization) and require prior authorization; many products are marked QL indicating quantity limits will be applied at claims adjudication.

    • AE‑marked products will trigger additional authorization review
    • QL‑marked products will have quantity limits enforced
    Note

    Prior authorization noted

    Multiple stimulant products are marked with AE indicating an authorization/adjudication review may apply; specific product PA criteria may not be listed here, so prescribers should prepare supporting documentation when AE is present.

    • AE flags indicate additional authorization review
    • Prepare clinical justification to support requests for AE products
    Prior Authorization

    AE (authorization) required for select products

    Products marked AE (examples include Mydayis ER capsule, QuilliChew ER tablet, Relexxii tablet) require additional authorization review; prescribers should expect to provide supporting documentation.

    • Mydayis ER, QuilliChew ER, Relexxii and similar AE‑flagged products require additional review
    • Submit clinical rationale and prior therapy history as applicable
    Note

    AE = prior authorization; QL = quantity limit

    AE designation denotes prior authorization or additional evaluation and QL denotes quantity limit; when these tags appear next to a methylphenidate or related agent, expect the corresponding authorization or quantity‑limit processes to apply.

    • AE = prior authorization/additional evaluation
    • QL = quantity limit enforcement
    Step Therapy

    Product‑specific step requirements

    Product approvals commonly require documentation of prior trials and failures of specified preferred agents; ensure PA submissions include evidence of the required prior agents and trial durations per each product's criteria.

    • Document prior agent names, trial duration (e.g., ≥30 days where specified), and reasons for failure/intolerance/contraindication
    • Include specialty consultation or prescriber attestation when required
    Step Therapy

    Step therapy for Crohn's/UC

    For Crohn's/UC biologic coverage, the patient must have trialed and failed ≥1 conventional therapies and must have had a 3‑month trial and failure of (or be intolerant/contraindicated to) ≥1 preferred cytokine or CAM antagonist prior to approval.

    • Trial/failure of ≥1 conventional therapies (5‑ASA, steroids, immunosuppressants) OR high‑risk designation
    • 3‑month trial and failure (or contraindication/intolerance) to ≥1 preferred cytokine or CAM antagonist
    Note

    Step therapy — no details

    Step‑therapy specifics are not fully detailed in the class listings; class guidance identifies preferred agents and notes that non‑preferred or new agents will require PA, but explicit step sequences or failure criteria beyond product‑specific rules are not provided in this excerpt.

    • Class lists indicate preferred vs non‑preferred placement but do not define a full step algorithm here
    • Follow product‑specific prior‑trial requirements where provided
    Note

    Implied step sequences

    Numbered groupings (e.g., '1 =', '2 =', '3 =') in class listings imply an order of preferred agents and suggest tiered or step‑preference sequencing within drug classes; use these groupings to infer preferred first‑line agents when implementing step logic.

    • Group numbering implies preferred order among agents in the class
    • At least two unique chemical entities should be preferred per class
    Note

    Implied step ordering

    Class listings include grouped numbering (1=, 2=, 3=) which suggests tiered preferred sequencing among agents within the class; adopt these groupings as step‑preference tiers where specific step therapy edits are not otherwise defined.

    • Use numeric groupings to determine preferred first/second/third agents
    • Where product criteria specify prior trials, those requirements supersede inferred ordering
    Note

    Step therapy grouping indicators

    Step therapy grouping indicators (numeric '1 =', '2 =', '3 =') appear across class lists, indicating preferred product groupings or tiered selection; however, explicit failure rules or required step durations are not provided in these class excerpts.

    • Numeric groupings imply tiering but lack explicit failure criteria in this extract
    • Implement product‑specific steps when supplied
    Note

    Step therapy not specified

    No explicit universal step therapy algorithm is specified in the provided class excerpts; individual product pages contain specific prior‑trial requirements that must be followed for authorization.

    • Follow product‑level initial criteria for required prior trials/failures
    • Class lists alone do not define complete step sequences
    Step Therapy

    Preferred agents — step implications

    Preferred agents are identified in class listings (e.g., Ritalin LA, Ritalin tablet, Strattera capsule, Xelstrym patch) and imply preferred‑first placement in utilization management; prescribers should trial preferred agents per policy before non‑preferred alternatives.

    • Preferred agents are listed and should be considered first‑line within class selection
    • Non‑preferred alternatives will require PA
    Documentation Required

    Required documentation for renewal/continuation

    For renewal/continuation requests, submit progress notes or prescriber attestation documenting diagnosis, prior therapy trials/failures, specialty consultation when applicable, monitoring (if specified), and clinical response or stabilization compared to baseline.

    • Progress notes demonstrating clinical improvement or stabilization
    • Laboratory data or objective measures where relevant (e.g., serum oxalate reduction for Rivfloza)
    • Prescriber attestation of monitoring (e.g., hemoglobin/platelets for sotatercept‑csrk)
    Documentation Required

    Renewal documentation

    Renewal requests must include clinical documentation showing response compared to baseline (progress notes, labs) to justify continued coverage and meet renewal criteria.

    • Progress notes or lab results demonstrating improvement or stabilization
    • Product‑specific renewal evidence as noted (e.g., hemoglobin increase for Voydeya; oxalate reduction for Rivfloza)
    Documentation Required

    Initial request documentation

    Initial prior authorization requests must include clinical documentation of the diagnosis, evidence of specialist involvement or consultation as required, and documentation of prior therapy trials, contraindications, or intolerances per the product's initial criteria.

    • Diagnosis consistent with the product's indication
    • Specialist prescriber or documented consultation when specified
    • Prior trials and documented failures/intolerance/contraindications for required agents
    Documentation Required

    Documentation for PA

    No single standardized PA form is specified in these excerpts; however, PA is required for non‑preferred agents and new chemical entities and supporting documentation of medical necessity should be provided with the request.

    • Include clinical rationale and supporting records when submitting PA for non‑preferred/new agents
    • Follow product‑specific documentation guidance where present
    Documentation Required

    PA documentation (general)

    PA documentation should support medical necessity for non‑preferred agents and new chemical entities; while specific forms are not listed here, include clinical notes, prior therapy history, and any specialty attestation required by the product criteria.

    • Clinical notes, prior medication trials, and specialty consultation/attestation
    • Monitoring plans or lab results where required by product criteria
    Billing Rule

    Required claim tagging

    Pharmacies must apply formulary class and utilization management tags (CC, QL, AE) to claims as listed for each product; correct claim tagging supports appropriate adjudication and triggers required prior authorization or quantity‑limit enforcement.

    • Apply CC for clinical criteria requirements
    • Apply QL for quantity‑limit enforcement
    • Apply AE to flag for additional authorization or age‑based exceptions
    Documentation Required

    AE/CC documentation

    When AE (additional edit) or CC (clinical criteria) tags are present, prescribers must supply documentation to support use; these tags indicate extra review and may trigger PA or claims edits.

    • Provide clinical justification and prior‑therapy evidence when AE or CC flags appear
    • Expect additional review time when AE/CC are applied
    Documentation Required

    Exception documentation

    Class entries include AE (access exception) and QL (quantity limit) designations; when requesting exceptions to AE or QL controls, provide documentation that supports the exception request consistent with the product's indication and dosing.

    • Exception requests should include rationale and supporting clinical records
    • Documentation must align with indication and dosing under the AE/QL designation
    Documentation Required

    Documentation to justify use

    Documentation should justify indication and dosing consistent with product placement under QL/AE designations; include records demonstrating the need for the requested quantity or exception.

    • Show indication supports requested dose/quantity
    • Provide prior‑trial history and reasons for deviation from preferred agents when applicable
    Documentation Required

    Documentation expectations

    Providers should expect authorization edits when QL or AE markers are present on product listings; plan to submit supporting documentation and follow the plan's AE/QL processes for methylphenidate and related formulations.

    • QL markers will enforce quantity limits at claim time
    • AE markers will prompt authorization or additional review
    Denial Risk

    Opsynvi denial triggers

    Denials may be issued for Opsynvi requests lacking documentation of WHO Group 1 PAH diagnosis, WHO functional class 2–3, required prior trials of ambrisentan and a PDE‑5 inhibitor, specialty prescriber/consultation, or assurance it will not be used with other PDE‑5 inhibitors.

    • Missing PAH WHO Group 1 diagnosis or WHO FC 2–3
    • No documented prior trials/failures of required agents
    • No specialist prescriber or consultation
    • No documentation excluding concomitant PDE‑5 inhibitor use
    Denial Risk

    Sotatercept‑csrk denial triggers

    Sotatercept‑csrk requests may be denied if documentation is missing for required prior trials/failures (Adempas, ambrisentan, and sildenafil/tadalafil) or if there is no prescriber attestation of hemoglobin and platelet monitoring.

    • Absence of documented prior trials/failures of Adempas, ambrisentan, AND sildenafil or tadalafil
    • No prescriber attestation for hemoglobin and platelet monitoring
    Denial Risk

    Voydeya denial triggers

    Voydeya requests may be denied if the diagnosis of PNH with EVH is not documented, if the prescriber is not a specialist or no consultation is provided, or if documentation does not show it will be used as add‑on to ravulizumab or eculizumab.

    • Missing PNH with EVH diagnosis
    • No specialist prescriber or documented consultation
    • No documentation that therapy will be add‑on to ravulizumab or eculizumab
    Denial Risk

    Rivfloza denial triggers

    Rivfloza requests may be denied for patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2), moderate or severe hepatic impairment, or for concomitant use with lumasiran (Oxlumo); ensure these exclusions are documented and considered before submission.

    • eGFR < 30 mL/min/1.73 m2 excludes coverage
    • Moderate or severe hepatic impairment excludes coverage
    • Concomitant use with lumasiran (Oxlumo) is not permitted
    Denial Risk

    Zymfentra denial triggers

    Zymfentra requests may be denied if induction with IV infliximab is not documented, if the patient has not trialed and failed ≥1 conventional therapies, if trial/failure of ≥1 preferred cytokine or CAM antagonist is not shown, or if the product is requested in combination with another biologic.

    • No documentation of IV infliximab induction
    • No trial/failure of ≥1 conventional therapies (5‑ASA, steroids, immunosuppressant)
    • No 3‑month trial/failure (or contraindication/intolerance) of ≥1 preferred cytokine or CAM antagonist
    • Requested use in combination with another biologic
    Denial Risk

    Triggers for denial (Filsuvez)

    Filsuvez requests may be denied if wounds are not partial‑thickness, are infected, lack adequate granulation/vascularization, have existed for less than 3 weeks, are smaller than 10 cm, or if the patient received recent immunosuppressive or cytotoxic chemotherapy within 60 days.

    • Wound not partial‑thickness or extends beyond dermis
    • Wound infected or lacks adequate granulation/vascularization
    • Wound duration < 3 weeks
    • Wound size < 10 cm
    • Recent immunosuppressive therapy or cytotoxic chemotherapy within 60 days
    Prior Authorization

    Non‑preferred agents require PA

    Agents not selected as preferred will be considered non‑preferred and require prior authorization; expect PA denials if non‑preferred status is not addressed in the request.

    • Non‑preferred designation triggers PA requirement
    • Failure to submit PA for a non‑preferred agent may result in denial
    Prior Authorization

    New chemical entities require PA

    For any new chemical entity in a class, prior authorization is required until the product is reviewed by the P&T Committee; requests for new entities lacking PA will be subject to denial.

    • New chemical entities remain PA‑required pending P&T review
    • Ensure PA submission references new‑entity status and clinical justification
    Denial Risk

    Formulary tag mismatch

    Coverage or claim denial risk exists if a drug is used outside its formulary class or without meeting utilization management tags (QL, CC, AE); ensure the drug aligns with the formulary class and that required tags are satisfied in the PA submission.

    • Confirm formulary class alignment for requested product
    • Address CC/QL/AE tags in documentation to avoid claim denial
    Denial Risk

    Formulary mismatch

    Requests for products that do not meet formulary class selection or utilization management tags (AE/QL/CC) may be denied; include documentation showing alignment with class selection and any exceptions requested.

    • Demonstrate product meets class selection or provide rationale for exception
    • Include prior‑trial and dosing justification when AE/QL/CC tags apply
    Denial Risk

    General denial risk

    Coverage may be denied if product‑specific class selection rules and quantity limits (QL) are not met; verify quantity limits and class rules before submitting PA to reduce denial risk.

    • Check QL values assigned to the product (e.g., Opsynvi 1 tablet/day; Rivfloza 1 syringe/month)
    • Ensure prior‑trial requirements and specialist involvement are documented per product criteria
    Denial Risk

    Denial risk for non‑class products or QL exceedance

    Coverage may be restricted or denied if a medication is not in the approved class selection or if the requested quantity exceeds assigned quantity limits (QL); address class placement and provide justification when requesting exceptions.

    • Requests exceeding established QL may be denied
    • Non‑class or off‑formulary requests need strong clinical justification
    Billing Rule

    QL / AE enforcement

    Claims for stimulant and related agents may be subject to quantity‑limit enforcement (QL) or AE review; ensure PA submissions include required documentation to satisfy AE/QL controls and avoid claim denials.

    • QL flags will trigger quantity enforcement at claim adjudication
    • AE flags will prompt additional authorization review—include clinical rationale
    Denial Risk

    AE/QL designation implies potential denial risk

    AE or QL designation indicates utilization management controls that may trigger denial if requirements are not met; treat AE/QL markers as potential denial triggers and submit supporting evidence accordingly.

    • AE = additional authorization/age exception—prepare attestation and monitoring plans
    • QL = quantity limits—confirm requested quantity aligns with policy
    Note
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    Initial therapy overarching

    Initial approval requires meeting product-specific diagnostic, prescriber specialty, prior therapy, and age criteria.

    Product-specific initial therapy: See individual product criteria: Crohn's/UC (infliximab-dyyb), Filsuvez for EB, Eohilia for EoE, eltrombopag (Alvaiz) for thrombocytopenia, resmetirom (Rezdiffra) for NASH. Each requires specialist prescribing/consultation, indication-specific prior therapy or condition, and adherence to package insert age recommendations.

    Detailed criteria captured in product sections.

    Class-level initial placement rules

    Class Selection & Guidelines

    ALL of the following

    • preferred_selection: DMS to select preferred agent(s) based on economic evaluation; at least 2 unique chemical entities should be preferred
    • pa_new_entities: For any new chemical entity in the class, require prior authorization until reviewed by the P&T Committee
    General renewal: Documentation (progress notes, laboratory reports) showing clinical response compared to baseline and ongoing need for therapy; for Filsuvez, documentation must show wound improvement and absence of treatment-limiting adverse effects; for Resmetirom and eltrombopag, documentation of response and tolerability is required.

    Renewal durations and documentation specifics vary by product.

    Initial approval noted as 3 months with 6 months renewal in product section
    inv-120: Rivfloza (nedosiran) quantity limit — 1 syringe
    Rivfloza quantity limit1 syringe per month
    Quantity contextQuantity limit listed in renewal/quantity section for nedosiran
    Age linkageAge limit for use is >= 9 years (see age item)
    inv-121: Unspecified biologic(s) listed in quantity limit section — quantity '2' referenced
    Unspecified biologic quantity2 syringes per month
    ContextListed in biologic quantity limit section alongside multiple biologics
    UsageApplies to biologic products referenced in that quantity limits block
    inv-122: Eohilia quantity limit — 20 (mL/day for 12 weeks noted in inventory)
    Eohilia quantity limit20 mL per day for 12 weeks
    Approval durationInitial/short-course therapy duration referenced as 12 weeks
    Age requirementMinimum age 11 years (see Eohilia age)
    inv-123: Eltrombopag (Alvaiz) strengths and per-day limits
    Eltrombopag (Alvaiz) strength limits9 mg: 1 per day; 18 mg: 1 per day; 36 mg: 3 per day; 54 mg: 2 per day
    Age contextAge limit for some eltrombopag formulations noted as 6 years or older in product section
    RenewalRenewal requires documentation of response to therapy
    inv-124: Resmetirom (Rezdiffra) quantity limit — 1
    Resmetirom quantity limit1 per day
    Approval durationApproval duration listed as 1 year in product section
    Renewal requirementRenewal requires documentation of response and no treatment-limiting adverse effects
    inv-125: methylphenidate ER 10 mg, 20 mg tablet — QL designation indicated in class list
    methylphenidate ER 10 mg, 20 mg tabletDesignated with QL in stimulant class listings (10 mg, 20 mg ER tablets)
    Formulary tagAppears repeatedly with QL and CC tags across class lists
    Step groupingsListed within numbered groupings implying preferred/tier placement (1,2,3) where shown
    inv-126: Multiple listed stimulants — subject to QL where indicated
    Stimulants subject to QLMultiple listed stimulant products are subject to quantity limits where indicated (QL)
    AE/CC flagsSeveral stimulant entries also include AE (additional evaluation) or CC tags indicating extra review or clinical criteria
    Implementation noteQuantity limits enforced per plan configuration for each product tagged QL
    inv-127: multiple listed stimulant products — quantity limits applied (QL)
    Quantity limits applied to stimulant productsMultiple listed stimulant products are designated with QL (quantity limits)
    ScopeIncludes various methylphenidate and related stimulant formulations across class lists
    EnforcementClaims may be subject to QL enforcement or AE review as indicated
    inv-128: multiple methylphenidate and stimulant products — designated as QL (specifics not listed here)
    Methylphenidate/stimulant products designated QLMultiple methylphenidate and stimulant products are designated as QL (specific numeric limits not listed in these excerpts)
    Product formsIncludes CD, ER, sprinkle, LA, OROS, capsule, tablet, chewable, patch formulations
    Reference noteSpecific per-product limits appear elsewhere in the quantity limits module where provided
    inv-129: Multiple stimulant formulations — designated as QL
    Stimulant formulations as QLMultiple stimulant formulations are designated as QL across class listings
    ExamplesIncludes methylphenidate ER, LA, OROS, chewable, patch, and others as listed
    PA implicationNon-preferred or AE-marked products may require prior authorization in addition to QL enforcement
    inv-130: multiple listed stimulant products — QL designation
    Listed stimulant products with QLMultiple listed stimulant products are marked QL in the class selection entries
    RepetitionQL designation reiterated across several chunks indicating broad application
    ActionProviders should expect quantity-limit enforcement for these products
    Approval durationsInitial approval 3 months with 6 months renewal noted in product section
    inv-83: Definition — nedosiran (Rivfloza)
    nedosiran (Rivfloza) definitionAn LDHA-directed small interfering RNA indicated to lower urinary oxalate in PH1 for patients >= 9 years with preserved kidney function
    Key exclusionsNot for patients with severe renal impairment (eGFR <30) or moderate/severe hepatic impairment; avoid concomitant lumasiran
    Quantity limit1 syringe per month listed in quantity limits
    inv-84: Definition — conventional therapies for Crohn's/UC
    Conventional therapies for CD/UCIncludes oral/rectal 5-aminosalicylic acid agents, oral/rectal steroids, and immunosuppressants such as azathioprine and mercaptopurine
    Role in step therapyPatients must have trialed and failed >=1 conventional therapies before biologic use per criteria
    Induction requirementAlso requires prior induction with IV infliximab for infliximab-dyyb initiation
    inv-85: Definition — partial-thickness wound
    Partial-thickness wound definitionA wound that does not extend beyond the dermis layer
    Clinical wound requirementsMust be clean with adequate granulation tissue, excellent vascularization, and not infected
    Policy useUsed to define eligible wounds for Filsuvez therapy
    inv-86: Definition — preferred agent
    Preferred agent definitionAn agent selected by DMS based on economic evaluation to be placed on the preferred formulary list
    Operational impactPreferred placement reduces need for PA compared to non-preferred agents
    Policy ruleAt least two unique chemical entities should be preferred within each class
    inv-87: Definition — non-preferred agent
    Non-preferred agent definitionAn agent not selected as preferred which will require prior authorization (PA)
    PA requirementNew chemical entities and non-preferred agents require PA until P&T review
    Formulary implicationNon-preferred status triggers utilization management controls
    inv-88: Definition — CC (Clinical Criteria)
    CC definitionClinical Criteria — documented requirement for coverage
    UseApplied to products requiring clinical documentation to meet coverage rules
    Relation to PACC-tagged items often require prior authorization or review
    inv-89: Definition — QL (Quantity Limit)
    QL definitionQuantity Limit — restrictions on dispensed amount or frequency for a product
    ApplicationUsed across many stimulant and specialty product listings to limit supply
    EnforcementClaims may be enforced to this limit or trigger AE/PA if exceeded
    inv-90: Definition — AE (Additional Evaluation)
    AE definitionAdditional Evaluation / Additional Edit — indicates extra authorization or clinical edit applies
    ImplicationAE-marked products may require prior authorization or further adjudication
    ExamplesAE is used for select stimulant products (e.g., Mydayis, QuilliChew ER) in listings
    inv-91: Definition — QL (Quantity Limit, product-level)
    QL (product-level) definitionQuantity Limit — product is subject to a limit on quantity dispensed or a utilization control at the product level
    EvidenceMany methylphenidate formulations and stimulant products are marked QL in product lists
    System impactPharmacy systems must enforce per-product QL settings
    inv-92: Definition — AE (Additional Edit/Authorization)
    AE (Additional Edit/Authorization) definitionAn indicator that additional authorization review or clinical edit applies to the product
    Operational noteAE flags prompt prescribers to supply supporting documentation for use
    ExamplesAE applied to select stimulant entries like Jornay PM, Mydayis ER
    inv-93: Definition — CC (Clinical Criteria/Care Coordination)
    CC (Clinical Criteria/Care Coordination) definitionIndicates coverage may require meeting defined clinical criteria or care coordination activities
    UsageApplied across class lists to denote products needing documented clinical justification
    Relation to renewalCC-tagged products often require clinical documentation for renewal
    inv-94: Definition — QL (Quantity Limit, product-level, additional reference)
    QL reiterationQuantity Limit — product-level limit reiterated across class listings
    PurposeUsed to control volume dispensed and manage utilization across therapies
    CatalogingMultiple chunks repeat QL designation indicating consistent policy application
    inv-95: Definition — AE (Age Exception or Additional Evaluation)
    AE (Age Exception / Additional Evaluation) definitionAE may denote age exception or additional authorization/exception review depending on context
    ExampleSome products show AE indicating prior authorization or age-based exception processes
    Provider actionPrescribers should provide documentation when AE is present
    inv-96: Definition — CC (Care Coordination)
    CC (Care Coordination) definitionCare Coordination — additional management or review process associated with coverage
    ApplicationUsed where coordinated care or specialist involvement is required
    RelationOften applied alongside QL/AE markers in class lists
    inv-97: Definition — QL (reiteration in later inventory)
    QL (reiteration) definitionQuantity Limit — reiterated as primary utilization control across stimulant class entries
    Operational implicationMultiple chunks confirm QL as the dominant control in these class listes
    Provider expectationExpect quantity enforcement for QL-tagged stimulant products
    inv-98: Definition — AE (reiteration)
    AE (reiteration) definitionAdditional Evaluation — reiterated as an authorization/exception marker for select stimulant products
    ExamplesMydayis ER, QuilliChew ER, Jornay PM listed with AE in class entries
    ImpactTriggers additional review during claims adjudication
    inv-99: Definition — QL (reiteration)
    QL (reiteration) definitionQuantity limit indicator applied to the listed product — reiterated across multiple chunks
    ContextRepeated in stimulant and other class lists to denote usage limits
    System notePharmacy systems must code and enforce these QL flags
    inv-100: Definition — AE (reiteration)
    AE (reiteration) definitionAE indicates products subject to additional authorization review or access exception processes
    Provider requirementDocumentation should be supplied when AE is present to justify use
    ExamplesAE used for select ADHD/stimulant products in lists
    inv-101: Definition — AE (short form)
    AE short formAE — Additional Evaluation / Additional Edit indicating extra review required
    UsageUsed across class lists for certain products to denote need for prior authorization or extra adjudication
    Relation to QLAE often appears alongside QL in stimulant entries
    inv-102: Definition — QL (short form)
    QL short formQL — Quantity Limit (product or class-level limit on dispensed quantity)
    Practical effectLimits supply and may require PA or denial if exceeded
    DocumentationProviders should reference specific QL entries for numeric limits per product