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Commissioner selections for preferred drugs (Kentucky)

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Summary of the Commissioner for the Department for Medicaid Services' Preferred Drug List selections and coverage criteria for several specialty and pharmacy agents affecting Medicaid members in Kentucky. Covers initial and renewal authorization criteria, age/quantity limits, and monitoring requirements for listed products.

Policy Summary

Payermedimpact

PolicyCommissioner selections for preferred drugs (Kentucky)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit product-specific prior authorization with required diagnostic confirmation, baseline labs and supporting documentation per drug criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MultiplePDL selections summarized

6 mo–1 yrAuthorization durations

Some agentsAge-restricted coverage

PresentQuantity limits

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Commissioner selections for preferred drugs (Kentucky)

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Policy Summary

Payermedimpact

PolicyCommissioner selections for preferred drugs (Kentucky)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit product-specific prior authorization with required diagnostic confirmation, baseline labs and supporting documentation per drug criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MultiplePDL selections summarized

6 mo–1 yrAuthorization durations

Some agentsAge-restricted coverage

PresentQuantity limits

≥6 moVyjuvek min age

Product-specific Coverage Criteria

Filspari (sparsentan) Initial Therapy

Covered when ALL of the following are met for Filspari (sparsentan):

Filspari initial criteria: Biopsy-proven primary immunoglobulin A nephropathy (IgAN); AND presence of proteinuria; AND patient is at risk of rapid disease progression, generally UPCR ≥ 1.5 g/g; AND no hypersensitivity to any component of the product; AND adequate trial of an ACE inhibitor or ARB at ≥50% of the maximum labeled dose; AND avoidance of concomitant therapy with major interacting drugs including RAAS inhibitors/ERAs/aliskiren, strong CYP3A inhibitors, strong CYP3A inducers, H2 receptor antagonists, proton pump inhibitors, and sensitive substrates of P-gp and BCRP; AND prescriber has confirmed aminotransferases (ALT, AST) are < 3x ULN; AND prescriber will monitor ALT, AST and total bilirubin monthly for the first 12 months after initiation (or when restarting after interruption for elevated aminotransferases), then every 3 months for duration of treatment; AND prescriber will monitor renal function and serum potassium regularly during treatment; AND female patients have a negative pregnancy test prior to start and patients of reproductive potential have been advised to use an effective contraceptive method during treatment; AND prescriber has assessed hypotension risk and discontinued or adjusted other antihypertensive medications as needed.UPCR ≥ 1.5 g/g; ALT/AST <3x ULN

Monitoring and avoidance of specified interacting drugs required

Filspari Renewal Therapy

Renewal covered when ALL of the following are met for Filspari:

Filspari renewal criteria: Patient continues to meet initial criteria; AND patient has reduction or stabilization in proteinuria; AND patient has not experienced any treatment-restricting adverse effects (e.g., hepatotoxicity, acute kidney injury, severe hypotension, hyperkalemia).clinical response or stability

Adverse effects preclude renewal

Joenja (leniolisib) Initial Therapy

Covered when ALL of the following are met for Joenja (leniolisib):

Joenja initial criteria: Confirmed diagnosis of activated PI3Kδ syndrome (APDS) with documented pathogenic variant in PIK3CD or PIK3R1; AND evidence of nodal and/or extranodal lymphoproliferation with ≥1 measurable nodal lesion on CT or MRI OR clinical findings compatible with APDS (e.g., recurrent otosinopulmonary infections, organ dysfunction); AND pregnancy status confirmed in females of reproductive potential with use of highly effective contraception during treatment; AND avoidance of concomitant strong or moderate CYP3A4 inducers and strong CYP3A4 inhibitors; AND patient is NOT on concurrent immunosuppressive therapy.genetic confirmation and clinical manifestations

Concomitant interacting drugs prohibited; no concurrent immunosuppression

Joenja Renewal Therapy

Renewal covered when ALL of the following are met for Joenja:

Joenja renewal criteria: Patient continues to meet initial criteria; AND patient has disease response defined by stabilization or improvement of disease signs and symptoms (e.g., decreased infection frequency/severity, decreased lymphadenopathy, increased percentage of naïve B cells, decreased disease-related hospitalizations); AND patient has not experienced treatment-restricting adverse effects (e.g., severe neutropenia with ANC < 500 cells/µL).clinical improvement or stabilization

Safety parameters for renewal include absence of severe neutropenia

Miebo (perfluorohexyloctane) Approval

Covered when ALL of the following are met for Miebo:

Miebo approval criteria: Trial and failure of ≥1 over-the-counter ophthalmic lubricant (e.g., polyvinyl alcohol); AND at least a 1-month trial and therapeutic failure, allergy, contraindication (including potential drug–drug interactions), or intolerance of 2 preferred agents.1 month trial where specified

Quantity limit 0.4 mL (8 drops) per day

Ngenla (somatrogon-ghla) Initial Therapy

Covered when ALL of the following are met for Ngenla:

Ngenla initial criteria: Diagnosis of growth hormone deficiency; AND pediatric patient aged ≥ 3 years with open epiphyses if used for longitudinal growth promotion; AND no hypersensitivity to somatrogon-ghla or excipients; AND no active malignancy; AND no active proliferative or severe non‑proliferative diabetic retinopathy; AND not Prader‑Willi syndrome with specified high‑risk features (severe obesity, history of upper airway obstruction or sleep apnea, severe respiratory impairment, unidentified respiratory infection); AND trial and therapeutic failure, allergy, contraindication, or intolerance of 2 preferred agents.age ≥ 3 years

Quantity limit: none

Olpruva (sodium phenylbutyrate) Initial Therapy

Covered when ALL of the following are met for Olpruva:

Olpruva initial criteria: Diagnosis of a urea cycle disorder involving deficiency of CPS, OTC, or AS; AND patient weighs ≥ 20 kg with body surface area ≥ 1.2 m²; AND prescribed by or in consultation with a specialist experienced in UCD treatment; AND requested drug is not being used for acute hyperammonemia.weight ≥ 20 kg and BSA ≥ 1.2 m²

Length of authorization: 1 year

Skyclarys (omaveloxolone) Initial Therapy

Covered when ALL of the following are met for Skyclarys:

Skyclarys initial criteria: Diagnosis of Friedreich's ataxia confirmed by molecular genetic testing with detection of biallelic pathogenic FXN variants and clinical signs/symptoms consistent with FA; AND patient retains meaningful voluntary motor function; AND patient does not have pes cavus as defined; AND no history of clinically significant left‑sided heart disease or clinically significant cardiac disease (excluding mild‑moderate FA‑associated cardiomyopathy); AND no signs of very advanced disease (e.g., cardiomyopathy by transthoracic echocardiogram); AND B‑type natriuretic peptide (BNP) ≤ 200 pg/mL prior to initiating therapy with periodic monitoring during treatment; AND prescriber will assess liver function (ALT, AST, bilirubin) and lipid parameters prior to and periodically during therapy; AND patient does not have severe hepatic impairment (Child‑Pugh C); AND patient can swallow capsules; AND avoidance of concomitant moderate/strong CYP3A4 inhibitors and inducers (monitor/adjust if unavoidable).BNP ≤ 200 pg/mL; no severe hepatic impairment

Baseline and periodic monitoring per product label required

Skyclarys — Initial approval

Skyclarys (omaveloxolone) — Initial approval: Covered when ALL of the following are met

Skyclarys initial criteria: Molecular genetic confirmation of Friedreich's ataxia (biallelic pathogenic FXN variant) with consistent clinical signs; AND patient retains meaningful voluntary motor function; AND no pes cavus (as defined); AND no history of clinically significant left‑sided heart disease/clinically significant cardiac disease (excluding mild‑moderate FA‑associated cardiomyopathy); AND no signs of very advanced disease (e.g., cardiomyopathy by TTE); AND BNP ≤ 200 pg/mL prior to initiating therapy; AND prescriber will assess liver function and lipid parameters prior to and periodically during therapy; AND no severe hepatic impairment (Child‑Pugh C); AND ability to swallow capsules; AND avoid concomitant moderate/strong CYP3A4 inhibitors or inducers (monitor if unavoidable).BNP ≤ 200 pg/mL

Provider must perform baseline and periodic monitoring per product label.

Skyclarys — Renewal Therapy

Skyclarys — Renewal criteria: Covered when ALL of the following are met

Skyclarys renewal criteria: Patient continues to meet initial criteria; AND patient has disease improvement defined by stabilization OR slowed progression of disease signs and symptoms from pretreatment baseline; AND patient has not experienced any treatment‑restricting adverse effects (e.g., fluid overload, heart failure; ALT or AST >5x ULN or >3x ULN with signs of liver dysfunction).

Renewal length: 1 year; quantity limit 90 capsules per 30 days; age ≥ 16 years.

Vyjuvek (beremagene geperpavec-svdt) Initial Therapy

Vyjuvek (beremagene geperpavec-svdt) — Initial approval: Covered when ALL of the following are met

Vyjuvek initial criteria: Age ≥ 6 months; AND no skin graft within the past 3 months; AND prescribed by or in consultation with a dermatologist or specialist with expertise in DEB; AND genetically confirmed dystrophic epidermolysis bullosa with COL7A1 mutation (documentation required); AND treated cutaneous wounds are clean with adequate granulation tissue, excellent vascularization, and are not infected; AND patient is receiving standard‑of‑care wound therapy; AND patient has not received and is not being considered for other gene therapy or investigational cellular therapy.

Initial length: 6 months.

Vyjuvek — Renewal Therapy

Vyjuvek — Renewal criteria: Covered when ALL of the following are met

Vyjuvek renewal criteria: Patient continues to meet initial criteria; AND patient has not experienced unacceptable toxicity requiring discontinuation; AND patient demonstrates disease response defined by improvement (healing) of treated wounds, reduction in skin infections, etc.; AND patient requires continued treatment for new and/or existing open wounds.

Renewal length: 1 year; quantity limit: 4 vials per 28 days; no age limit.

This policy includes several product-specific coverage exclusions and clinical-use limits. Olpruva is restricted to chronic management of urea cycle disorders and is not covered for treatment of acute hyperammonemia (acute use excluded) and must be prescribed by or in consultation with a UCD specialist for patients meeting weight/BSA thresholds. Skyclarys (omaveloxolone) requires molecular confirmation of Friedreich's ataxia and baseline/periodic cardiac and hepatic assessment; patients with severe hepatic impairment (Child-Pugh C) or a history of clinically significant left‑sided heart disease/clinically significant cardiac disease are excluded from therapy. Agents not designated as preferred within class listings are treated as non-preferred and will require prior authorization per class guidance.

Patients with severe hepatic impairment (Child-Pugh C) are specifically excluded from Skyclarys therapy. Prescribers must confirm absence of Child‑Pugh C level hepatic dysfunction before initiation and follow the product label for ongoing hepatic monitoring (ALT/AST, bilirubin) during treatment.

Skyclarys is not appropriate for patients with a history of clinically significant left‑sided heart disease or clinically significant cardiac disease. The exclusion is intended to avoid treating individuals with advanced cardiac disease — mild to moderate FA‑associated cardiomyopathy is not automatically excluded, but clinically significant left‑sided heart disease is a contraindication per the criteria and baseline cardiac evaluation is required.

Class-selection guidance designates agents not selected as preferred as non-preferred and subject to prior authorization (PA). For multiple therapeutic classes (for example, GLP‑1 receptor antagonists, growth hormones, immunomodulators, multiple sclerosis agents, ophthalmic immunomodulators), the policy requires at least a minimum number of unique preferred chemical entities; any products outside those preferred lists will require PA and documentation consistent with the product-specific criteria.

Clinical exclusions applied across products include examples such as: active malignancy (precludes pediatric growth hormone replacement with Ngenla), active proliferative or severe non‑proliferative diabetic retinopathy (excludes Ngenla use for growth promotion), and features of certain syndromes that increase risk (e.g., specific high‑risk Prader‑Willi features exclude use of Ngenla). Additionally, devices or clinical states that make a product unsuitable are excluded — for example, Vyjuvek is not appropriate for infected or poorly granulating wounds (see Vyjuvek exclusions) and Skyclarys is excluded in severe hepatic impairment or clinically significant cardiac disease.

Examples of specific clinical exclusion scenarios: active malignancy excludes initiation of pediatric growth hormone (Ngenla); proliferative diabetic retinopathy or severe non‑proliferative diabetic retinopathy also exclude Ngenla; and in the context of Vyjuvek, wounds that are infected, lack adequate granulation tissue or vascularization, or are within 3 months of a skin graft are not eligible for treatment.

Skyclarys initial approval requires molecular genetic confirmation of Friedreich's ataxia with biallelic pathogenic FXN variants and that the patient retains meaningful voluntary motor function (able to manipulate objects or ambulate). Documentation of genetic testing and a pretreatment motor-function baseline are required; patients without genetic confirmation or without meaningful voluntary motor function do not meet coverage criteria.

Initial Therapy Requirements (Overview and Product Examples)

Initial therapy overview — product-specific requirements, diagnostic confirmation, baseline labs, contraindication screening

Initial therapy requirements are product-specific and require diagnostic confirmation, baseline labs, contraindication screening, and avoidance of interacting drugs when specified.

See individual product initial criteria: Refer to individual product sections for specific diagnostic confirmation, baseline laboratory thresholds, contraindication screening, and required avoidance of interacting drugs: Filspari (sparsentan), Joenja (leniolisib), Ngenla (somatrogon), Olpruva (sodium phenylbutyrate), Skyclarys (omaveloxolone).

Initial Therapy — product-specific initial criteria examples (Skyclarys, Vyjuvek)

Initial drug-specific criteria examples:

Skyclarys example: Molecular genetic confirmation of Friedreich's ataxia (biallelic FXN pathogenic variants), retention of meaningful voluntary motor function, BNP ≤ 200 pg/mL prior to initiation, baseline and periodic assessment of liver function and lipids, and avoidance of moderate/strong CYP3A4 inhibitors/inducers.

Renewal / Continuation Requirements

Product renewal/continuation nodes

Renewal/continuation requirements per product:

Filspari renewal: Patient continues to meet initial criteria; AND reduction or stabilization in proteinuria; AND no treatment‑restricting adverse effects (e.g., hepatotoxicity, AKI, severe hypotension, hyperkalemia).

Joenja renewal: Patient continues to meet initial criteria; AND disease response (stabilization or improvement of signs/symptoms); AND no treatment‑restricting adverse effects (e.g., severe neutropenia ANC <500/µL).

Ngenla renewal: Patient continues to meet initial criteria; AND no unacceptable toxicity; AND positive response compared to pre‑treatment baseline.

Olpruva renewal: Documented response to therapy; AND no treatment‑limiting adverse effects.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Obtain product-specific prior authorization

Prior authorization is required for each listed product and must follow the product-specific initial and renewal criteria as detailed in the policy (e.g., Filspari: 6-month initial authorization with biopsy confirmation, UPCR threshold, ACE/ARB trial, baseline LFTs and monitoring; Joenja: genetic confirmation and avoidance of CYP3A modulators; Skyclarys and Vyjuvek: product-specific baseline and renewal requirements).

Authorizations follow the product-specific initial and renewal nodes in the policy.
Length of initial and renewal authorizations vary by product (examples: Filspari 6 months initial/1 year renewal; Skyclarys 1 year; Vyjuvek 6 months initial/1 year renewal).

Prior Authorization

Submit PA with age, diagnosis, and baseline labs as required

Prior authorization is required for specialty agents and will be granted only when the policy’s specified initial requirements are met, including applicable age limits, diagnostic confirmation, baseline laboratory assessments, and prescriber specialty where required.

Clinical Thresholds and Key Numeric Criteria

Urine protein-to-creatinine ratio (UPCR) — Filspari eligibility

UPCR thresholdUrine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g

ContextUsed to define patients 'at risk of rapid disease progression' for Filspari (sparsentan) initial eligibility

Source requirementPresence of proteinuria and UPCR ≥ 1.5 g/g required alongside biopsy-proven primary IgA nephropathy

B-type natriuretic peptide (BNP) — coverage-related threshold

BNP thresholdB-type natriuretic peptide (BNP) ≤ 200 pg/mL prior to initiating therapy

UseRequired baseline assessment for Skyclarys (omaveloxolone) and to be monitored periodically during treatment

Quantity Limits and Dispense Maximums

Joenja (leniolisib) — quantity limit (initial)

Joenja initial quantity limit1 per day

Authorization lengthLength of authorization: 1 year

Age limit (initial block)Listed age limit information present in initial/renewal sections (see policy)

Miebo (perfluorohexyloctane) — quantity limit

Miebo quantity limit0.4 mL (8 drops) per day

Indication contextQuantity limit tied to approval for dry eye disease after required trials of OTC and preferred agents

Trial requirement

Step Therapy and Preferred Agent Trials

Product / Class	Required trial(s) of preferred agent(s) before coverage	Acceptable failure definition / exceptions
Miebo (perfluorohexyloctane) — Ophthalmic immunomodulator	Trial and failure of ≥1 over-the-counter ophthalmic lubricant (e.g., polyvinyl alcohol); AND at least a 1-month trial and therapeutic failure, allergy, contraindication, or intolerance of 2 preferred ophthalmic agents.	Therapeutic failure, allergy, contraindication (including potential drug-drug interactions), or intolerance documented by prescriber; age limit: none; quantity limit 0.4 mL (8 drops) per day.
Ngenla (somatrogon-ghla) — Growth hormones class	Trial and therapeutic failure, allergy, contraindication, or intolerance of 2 preferred growth hormone agents.	Failure defined as inadequate clinical response or intolerance as documented by prescriber; pediatric-specific exclusions apply (e.g., active malignancy, certain Prader-Willi features).
Other listed specialty agents (class-level guidance)	Agents not selected as preferred will be considered non-preferred and require prior authorization; for new chemical entities in a class PA is required until P&T review.	Exceptions allowable for documented allergy, contraindication, or intolerance to all preferred agents; new chemical entities treated as non-preferred until reviewed.

Drug class	Preferred agent minimum (DMS guidance)	Policy action for non-preferred / new chemical entities
Diabetes: GLP-1 Receptor Antagonists	At least 3 unique chemical entities should be preferred.	Agents not selected as preferred are non-preferred and will require prior authorization; new chemical entities require PA until reviewed by the P&T Advisory Committee.
Growth hormones	At least 2 unique chemical entities should be preferred.	Non-preferred growth hormones require prior authorization; new chemical entities require PA pending P&T review.
Ophthalmic immunomodulators	At least 1 unique chemical entity should be preferred (class examples: Restasis, Xiidra).	Non-preferred ophthalmic immunomodulators require prior authorization; new chemical entities require PA until P&T review.
Multiple listed classes (class selection guidance)	DMS will select preferred agents based on economic evaluation; minimum preferred counts vary by class (see above).	Agents not selected as preferred are considered non-preferred and will require PA; new chemical entities require PA until P&T Advisory Committee review.

Background and Policy Scope

Background: the selections summarize FDA‑indicated uses for multiple specialty products and link coverage to diagnostic confirmation and monitoring. Examples include reduction of proteinuria in biopsy‑proven primary IgA nephropathy for Filspari (UPCR eligibility threshold commonly ≥ 1.5 g/g), genetic confirmation requirements for targeted therapies such as Joenja (PI3Kδ mutation) and Skyclarys (biallelic FXN pathogenic variants), and wound‑status requirements for Vyjuvek. Coverage decisions uniformly require appropriate baseline assessments and ongoing monitoring (for example, liver tests and BNP for Skyclarys) as described in each product section.

Key Definitions and Clinical Terms

Definition: UPCR ≥ 1.5 g/g (Filspari eligibility)

UPCR threshold definitionUPCR ≥ 1.5 g/g defines patients 'at risk of rapid disease progression' for Filspari eligibility

Associated requirementsRequirement accompanies biopsy-proven primary IgA nephropathy and presence of proteinuria

Monitoring/denial noteFailure to meet UPCR ≥ 1.5 g/g may trigger denial of sparsentan coverage

APDS — genetic confirmation requirement for Joenja

APDS genetic requirementConfirmed diagnosis of APDS requires documented PI3Kδ mutation in either PIK3CD or PIK3R1

Clinical manifestationsPlus nodal/extranodal lymphoproliferation (≥1 measurable nodal lesion) OR compatible clinical findings (e.g., recurrent otosinopulmonary infections)

Policy Revision Timeline

2023-11-16P&T meeting / recommendations

Pharmacy & Therapeutics Advisory Committee review and resulting Commissioner recommendations summarized for the Kentucky Preferred Drug List selections (source meeting date for the recommendations).

2023-11-16Policy publication (PDL selections)Latest

MedImpact published the Commissioner for the Department for Medicaid Services' selections for preferred products, listing new products to market and class reviews including Filspari, Joenja, Miebo, Ngenla, Olpruva, Skyclarys, and Vyjuvek with associated authorization lengths and criteria.

Policy Summary

Payermedimpact

PolicyCommissioner selections for preferred drugs (Kentucky)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit product-specific prior authorization with required diagnostic confirmation, baseline labs and supporting documentation per drug criteria.

SourceLink

On This Page

Vyjuvek example: Genetically confirmed dystrophic epidermolysis bullosa with COL7A1 mutation, age ≥ 6 months, no skin graft within past 3 months, wounds clean with adequate granulation and vascularization, and concurrent standard‑of‑care wound therapy required.

Continuation Therapy — summarize clinical response and safety monitoring needed for renewal

Continuation (renewal) requirements summarize clinical response and safety monitoring.

Skyclarys continuation: Continue only if stabilization or slowed progression from baseline and no treatment‑limiting adverse effects; AND monitor liver enzymes and cardiac status as indicated.

Renewal length 1 year; 90 capsules/30 days.

Vyjuvek continuation: Continue only if wound healing response or need for ongoing treatment of new/existing open wounds and no unacceptable toxicity.

Renewal length 1 year; 4 vials/28 days.

Examples: Skyclarys requires molecular genetic confirmation of Friedreich’s ataxia and BNP ≤ 200 pg/mL prior to initiation; Vyjuvek requires genetically confirmed COL7A1 mutation and prescription by or consultation with a dermatologist or DEB specialist.

Age limits are enforced where listed (e.g., Skyclarys ≥ 16 years; Vyjuvek ≥ 6 months).

Prior Authorization

PA required for non‑preferred GLP‑1 RAs

Non-preferred GLP-1 receptor agonists require prior authorization; the policy specifies that the DMS will select at least three unique chemical entities as preferred and agents not selected as preferred will require PA until P&T review.

Preferred GLP-1 RAs listed include Byetta, Ozempic, Trulicity, and Victoza; non-preferred examples include Adlyxin, Bydureon BCise, Mounjaro, Rybelsus.
New chemical entities in the GLP-1 RA class require PA until reviewed by the P&T Advisory Committee.

Prior Authorization

PA required for non‑preferred glucagon agents

Non-preferred glucagon agents require prior authorization; the policy directs selection of at least one preferred chemical entity and treats agents not selected as preferred as non‑preferred requiring PA.

Preferred glucagon agents (examples) include Baqsimi and Proglycem; non-preferred examples include Gvoke and Zegalogue.
New chemical entities in the Glucagon Agents class require PA until P&T review.

Prior Authorization

PA required for non‑preferred growth hormones

Non-preferred growth hormone products require prior authorization; the policy states at least two unique chemical entities should be selected as preferred, and agents not selected as preferred will require PA.

Preferred growth hormones listed include Genotropin, Norditropin FlexPro, and Nutropin AQ; non-preferred examples include Humatrope and Ngenla (listed non‑preferred).
New chemical entities in the Growth Hormones class require PA until P&T review.

Prior Authorization

PA required for non‑preferred atopic dermatitis agents

Immunomodulators for atopic dermatitis that are not selected as preferred require prior authorization; the policy requires at least one unique chemical entity to be preferred and treats other agents as non‑preferred requiring PA.

Preferred examples include Adbry and Dupixent; non-preferred examples include Opzelura.
New chemical entities in this class require PA until reviewed by the P&T Advisory Committee.

Prior Authorization

PA required for non‑preferred multiple sclerosis agents

Multiple sclerosis agents not selected as preferred will require prior authorization; the policy indicates at least five unique chemical entities should be preferred and all others will be treated as non‑preferred requiring PA.

Preferred MS agents listed include Avonex, Betaseron, Copaxone 20 mg, Gilenya, and others.
New chemical entities in the Multiple Sclerosis class require PA until P&T review.

Prior Authorization

PA required for non‑preferred ophthalmic immunomodulators

Non-preferred ophthalmic immunomodulators require prior authorization; the policy requires at least one unique chemical entity to be preferred and treats other ophthalmic immunomodulators as non‑preferred requiring PA.

Preferred ophthalmic agents include Restasis and Xiidra; Cequa is listed as a non-preferred ophthalmic immunomodulator in the class list.
For Miebo (ophthalmic perfluorohexyloctane), approval also requires trial and failure of OTC lubricants and trials of preferred agents per its product-specific criteria.

Step Therapy

Document trials and failures of preferred agents (step therapy)

For specified products a trial and therapeutic failure of preferred agents is required prior to PA approval; for example, Miebo requires trial/failure of ≥1 OTC lubricant and a 1-month trial and failure (or intolerance/contraindication/allergy) of 2 preferred ophthalmic agents.

Miebo approval criteria: trial and failure of ≥1 OTC ophthalmic lubricant and 1-month trials and failure/intolerance/contraindication to 2 preferred agents.
Ngenla requires trial and therapeutic failure (or allergy/contraindication/intolerance) of 2 preferred growth hormone agents prior to approval.

Step Therapy

Confirm concurrent standard‑of‑care wound therapy for Vyjuvek

Vyjuvek initial authorization requires that the patient be receiving standard‑of‑care wound therapy concurrently; the policy explicitly lists this as an initial criterion for coverage.

Initial approval criteria include: genetically confirmed COL7A1 mutation, clean wounds with adequate granulation and vascularization, no infection, prescriber specialty (dermatologist or DEB specialist), and concurrent standard‑of‑care wound therapy.
Do not submit PA unless documentation shows standard‑of‑care wound therapy is in place for treated wounds.

Step Therapy

When step therapy is unspecified, PA still required for non‑preferred agents

For several listed classes the policy does not specify step therapy sequences; instead, agents not selected as preferred are treated as non‑preferred and will require PA per class selection guidelines.

When step therapy is not detailed, submit PA for non‑preferred agents and include required supporting documentation.
New chemical entities in any listed class require PA until reviewed by the P&T Advisory Committee.

Documentation Required

Include diagnostic confirmation and baseline labs in PA

The PA request must include supporting clinical documentation: diagnostic confirmation (e.g., biopsy‑proven IgAN for Filspari; molecular genetic confirmation for Joenja, Skyclarys, Vyjuvek), prior trials of specified agents where required, and relevant baseline laboratory assessments (e.g., ALT/AST, total bilirubin, renal function, serum potassium, BNP where indicated).

Filspari initial criteria require biopsy‑proven IgAN, UPCR ≥ 1.5 g/g, documentation of an adequate ACE inhibitor or ARB trial, and baseline ALT/AST <3x ULN with monitoring plan.
Skyclarys requires molecular genetic testing confirming biallelic FXN variants and BNP ≤ 200 pg/mL prior to initiation; prescriber must assess liver function and lipids prior to and periodically during therapy.

Documentation Required

Attach required molecular genetic test documentation

Molecular genetic testing results must be submitted where required: Skyclarys requires documentation of biallelic pathogenic FXN variants for Friedreich’s ataxia and Vyjuvek requires genetically confirmed COL7A1 mutation; Joenja requires documented PI3Kδ mutation (PIK3CD or PIK3R1).

Skyclarys initial criteria: molecular genetic confirmation of FA with detection of biallelic pathogenic FXN variants.
Vyjuvek initial criteria: documentation of genetically confirmed DEB with COL7A1 mutation.
Joenja initial criteria: documented PI3Kδ mutation in PIK3CD or PIK3R1.

Prior Authorization

Expect PA and documentation for non‑preferred and new chemical entities

PA is required for non‑preferred agents and for any new chemical entity in a listed class until the P&T Advisory Committee reviews the agent; providers should be prepared to submit standard documentation described elsewhere in the policy with PA requests for these agents.

Agents not selected as preferred will be considered non‑preferred and require PA.
New chemical entities in any listed class require PA until reviewed by the P&T Advisory Committee.

Denial Risk

Missing Filspari entry criteria can trigger denial

Sparsentan (Filspari) PA may be denied if required initial criteria are missing, including absence of biopsy‑proven primary IgA nephropathy, UPCR below the eligibility threshold, failure to document an adequate ACE inhibitor or ARB trial, contraindicated concomitant medications, elevated aminotransferases, or missing pregnancy testing for females of reproductive potential.

Denial triggers listed: no biopsy‑proven IgAN; UPCR < 1.5 g/g; no adequate trial of ACE inhibitor or ARB at ≥50% of max labeled dose; concurrent prohibited medications; ALT/AST ≥3x ULN on baseline.
Prescribers must document negative pregnancy test and contraception counseling for females of reproductive potential to avoid denial.

Denial Risk

Missing baseline confirmation, severity exclusions, or failed monitoring can cause denial

Therapies may be denied if diagnostic confirmation or required baseline assessments are not provided, if listed severity or comorbid exclusions apply (e.g., severe hepatic impairment, clinically significant left‑sided heart disease), or if monitoring/response criteria required for renewal are not met.

Skyclarys exclusions and denial risks include lack of molecular genetic confirmation, BNP > 200 pg/mL, severe hepatic impairment (Child‑Pugh C), or clinically significant left‑sided heart disease.
Renewals can be denied if patients have not demonstrated stabilization/improvement or have experienced treatment‑restricting adverse effects per the product renewal nodes.

Prior Authorization

Non‑preferred selections require PA

Agents not selected as preferred by the DMS are treated as non‑preferred and require prior authorization; providers should submit PA for any non‑preferred selection and include the product‑specific documentation requested in the policy.

Class guidance repeatedly states non‑preferred agents require PA; confirm whether prescribed agent is preferred before dispensing.
For many classes the policy lists preferred and non‑preferred examples to guide selection.

Prior Authorization

New chemical entities require PA until P&T review

Any new chemical entity in the listed drug classes requires prior authorization until reviewed by the P&T Advisory Committee; include complete documentation with the PA submission as for other non‑preferred agents.

Policy language: new chemical entities require PA until reviewed by the P&T Advisory Committee.
Providers should expect to supply the same documentation elements (diagnosis confirmation, labs, prior therapy history) when requesting PA for new agents.

Renewal relevanceBNP monitoring is part of baseline and periodic safety assessments for continuation

BNP threshold (numeric)

BNP numeric valueBNP ≤ 200 pg/mL

Applies toSkyclarys (omaveloxolone) — required prior to initiation and monitored periodically

Clinical noteBNP threshold used to help exclude patients with advanced cardiac disease prior to treatment

Requires trial and failure of ≥1 OTC lubricant and 1-month trials of 2 preferred agents prior to approval

Joenja — quantity referenced in renewal

Joenja renewal quantity referenceRenewal section lists quantity as 2 per day

Contrast with initial limitInitial section lists 1 per day while renewal section references 2 per day — both appear in policy

ActionRefer to prior authorization determination for applicable quantity to apply (initial vs renewal)

Skyclarys (omaveloxolone) — quantity limit

Skyclarys quantity limit90 capsules per 30 days

Renewal lengthRenewal authorization length: 1 year

Age requirementAge ≥ 16 years for Skyclarys

Vyjuvek (beremagene geperpavec-svdt) — quantity limit

Vyjuvek quantity limit4 vials per 28 days

Initial/renewal lengthsInitial length: 6 months; Renewal length: 1 year

Age requirementIndicated for patients ≥ 6 months of age

Therapy exclusionsPatients must avoid strong/moderate CYP3A4 inducers and strong CYP3A4 inhibitors and not be on concurrent immunosuppressive therapy

Definition: Biallelic pathogenic variant (Friedreich's ataxia — Skyclarys)

Biallelic FXN variant requirementMolecular genetic testing confirming biallelic pathogenic FXN variants is required to support Skyclarys coverage

Clinical correlationRequirement coupled with clinical signs/symptoms and retention of meaningful voluntary motor function

Documentation for renewalContinuation requires ongoing clinical benefit and absence of treatment-restricting adverse effects

Definition: Clean wound suitable for Vyjuvek

Clean wound definitionCutaneous wound(s) that are clean, have adequate granulation tissue, exhibit excellent vascularization, and do not appear infected

ApplicabilityRequired for Vyjuvek initial eligibility and must be receiving standard-of-care wound therapy concurrently

Exclusion exampleInfected wounds, wounds without adequate granulation/vascularization, or within 3 months of a skin graft do NOT meet initial coverage criteria