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Commissioner selections for Kentucky Preferred Drug List (PDL) — selected specialty drugs

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Summarizes the Commissioner of the Department for Medicaid Services' final Preferred Drug List selections and coverage criteria for several specialty drugs (vutrisiran/Amvuttra, sodium phenylbutyrate/taurursodiol/Relyvrio, eflapegrastim/Rolvedon, lenacapavir/Sunlenca) as reviewed by the P&T Committee on March 16, 2023; applies to Kentucky Medicaid formulary decisions and prescribers seeking prior authorization.

Policy Summary

Payermedimpact

PolicyCommissioner selections for Kentucky Preferred Drug List (PDL) — selected specialty drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewMar 16, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation (diagnosis, baseline labs, resistance profile or trial of preferred agents) as specified for each product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4New or non-preferred products listed in this excerpt

1 yearTypical length of authorization

≥400Sunlenca baseline requirement

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Commissioner selections for Kentucky Preferred Drug List (PDL) — selected specialty drugs

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Policy Summary

Payermedimpact

PolicyCommissioner selections for Kentucky Preferred Drug List (PDL) — selected specialty drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewMar 16, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation (diagnosis, baseline labs, resistance profile or trial of preferred agents) as specified for each product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4New or non-preferred products listed in this excerpt

1 yearTypical length of authorization

≥400Sunlenca baseline requirement

Vutrisiran quantity limit example

5/tabLenacapavir tablet limit

Coverage Criteria by Product

Initial Therapy

Covered when ALL of the following are met for initial approval:

Vutrisiran initial criteria: Patient will receive supplementation with vitamin A at the recommended daily allowance during therapy; AND vutrisiran is NOT used in combination with other transthyretin (TTR) reducing agents (e.g., inotersen, tafamidis, patisiran); AND patient has a definitive diagnosis of hereditary transthyretin-mediated (hATTR) amyloidosis/FAP documented by amyloid deposition on tissue biopsy OR identification of a pathogenic TTR variant; AND polyneuropathy is demonstrated by ≥ 2 of: subjective symptoms suggestive of neuropathy; abnormal nerve conduction studies consistent with polyneuropathy; abnormal neurological examination suggestive of neuropathy; AND peripheral neuropathy is attributed to hATTR/FAP with other causes excluded; AND baseline strength/weakness documented using an objective clinical measurement tool (e.g., MRC muscle strength); AND patient has NOT received an orthotopic liver transplant (OLT).

From Initial Approval Criteria

Continuation Therapy

Renewal covered when ALL of the following are met:

Vutrisiran renewal criteria: Patient continues to meet initial criteria; AND patient is absent of unacceptable toxicity from the drug; AND patient has experienced disease response compared to pretreatment baseline as evidenced by stabilization or improvement in ≥ 1 of: signs and symptoms of neuropathy; MRC muscle strength.

From Renewal Criteria

Initial Therapy

Covered when ALL of the following are met for initial approval:

Relyvrio initial criteria: Diagnosis of amyotrophic lateral sclerosis (ALS) based on validated criteria (e.g., revised El Escorial, Awaji, Gold Coast); AND no hypersensitivity to any component of the product; AND adequate trial of riluzole for ≥ 8 weeks; AND baseline disease severity assessed with an objective tool (e.g., ALSFRS-R); AND patient does not require permanent assisted ventilation; AND prescribed by or in consultation with a neurologist; AND prescriber attests to reviewing medical history and evaluating for potential drug and disease interactions.

From Initial Approval Criteria

Continuation Therapy

Renewal covered when ALL of the following are met:

Relyvrio renewal criteria: Patient continues to meet initial criteria; AND patient demonstrates disease stabilization OR improvement in the slope of decline as shown on an objective measure/tool; AND patient has not experienced any unacceptable toxicity from treatment (e.g., worsening hypertension or heart failure).

From Renewal Criteria

Initial Therapy

Covered when ALL of the following are met for initial approval:

Rolvedon initial criteria: Medication is being used for chemotherapy-induced neutropenia prophylaxis to decrease incidence of febrile neutropenia; AND patient has a nonmyeloid malignancy and is receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia; AND patient has had at least a 7-day trial and therapeutic failure, allergy, contraindication or intolerance of 2 preferred colony stimulating factor agents.

From Initial Approval Criteria

Initial Therapy

Covered when ALL of the following are met for initial approval:

Sunlenca (lenacapavir) initial criteria: Patient has a diagnosis of HIV-1 infection; AND prescribed by, or in consultation with, an infectious disease specialist or HIV specialist (AAHIVS); AND patient is heavily treatment-experienced with multidrug-resistant HIV-1 (documented resistance to ≥ 2 ARVs from each of at least 3 of the 4 main classes); AND patient has ≤ 2 fully active ARVs remaining that can be effectively combined; AND documentation of baseline viral load ≥ 400 copies/mL on current antiretroviral regimen; AND no history of treatment failure or known/suspected resistance to lenacapavir; AND will be taken with other antiretrovirals (optimized background regimen); AND NOT used in combination with strong CYP3A inducers.

From Criteria for Approval

Initial Therapy

Covered when ALL of the following are met for initial approval:

Initial Lenacapavir Approval: Patient has HIV-1 infection; AND prescribed by or in consultation with an infectious disease specialist or AAHIVS; AND is heavily treatment-experienced with multidrug resistance (resistance to ≥ 2 ARVs from each of ≥ 3 of the 4 main classes); AND has ≤ 2 fully active ARVs remaining; AND documentation of baseline viral load ≥ 400 copies/mL on current regimen; AND no history of treatment failure or known/suspected resistance to lenacapavir; AND will take lenacapavir with other ARVs (optimized background regimen); AND lenacapavir will NOT be used with strong CYP3A inducers.

Quantity limits apply: 300 mg tablets: 5 tablets per fill; 463.5 mg/1.5 mL vial: 2 vials per 6 months

Continuation Therapy

Renewal covered when ALL of the following are met:

Lenacapavir renewal criteria: Patient has been adherent to their ARV treatment regimen; AND patient has NOT experienced virologic failure of lenacapavir and has documented clinical improvement and/or stabilization (e.g., decreased viral load from pretreatment baseline; increased or stabilized CD4+ counts); AND patient has NOT experienced any treatment-restricting adverse effects; AND age > 18 years.

From Renewal Criteria

Initial Therapy

Covered when ALL of the following are met

Initial Lenacapavir: Patient meets initial lenacapavir criteria as specified: HIV-1 diagnosis; specialist prescriber; heavily treatment-experienced with multidrug resistance; ≤ 2 fully active ARVs remaining; baseline viral load ≥ 400 copies/mL; no lenacapavir resistance; used with optimized background regimen; not with strong CYP3A inducers; AND quantity limits apply per product labeling/PDL (300 mg tablets: 5 tablets per fill; 463.5 mg/1.5 mL vial: 2 vials per 6 months).

From Initial Therapy and Quantity Limits

Formulary selection and PA criteria

Formulary placement and prior authorization requirements:

Class selection rules: DMS will select preferred agent(s) based on economic evaluation and will select at least 2 unique chemical entities as preferred per class.at least 2 unique chemical entities

operational rule

Non-preferred agents require PA: Agents not selected as preferred will be considered non-preferred and will require prior authorization.N/A

PA required for non-preferred agents

New chemical entities temporary PA: Any new chemical entity in the Intranasal Antihistamines and Anticholinergics class requires prior authorization until reviewed by the P&T Advisory Committee.P&T review

Use of vutrisiran (Amvuttra) in combination with other transthyretin (TTR)‑reducing agents is prohibited. Specifically, vutrisiran must NOT be used with inotersen, tafamidis, or patisiran. Requests for coverage that propose concurrent use with any other TTR‑reducing agent will be denied.

Sunlenca (lenacapavir) must not be used in combination with strong CYP3A inducers. Requests proposing concomitant use with strong CYP3A inducers will be excluded from approval.

Repeatedly emphasized in the approval criteria for lenacapavir: concomitant use with strong CYP3A inducers is excluded. Lenacapavir will only be approved when it is not prescribed with strong CYP3A inducers.

There is no change in PDL status for multiple listed classes; the document lists a range of antibiotic subclasses, antifungals, antiviral and respiratory classes, and common respiratory and allergy agents where Preferred Drug List status remains unchanged.

Eligibility for lenacapavir (Sunlenca) requires that the patient be heavily treatment‑experienced with multidrug resistance as defined by documented resistance to ≥ 2 ARVs from each of at least 3 of the 4 main ART classes, and have ≤ 2 fully active ARVs remaining that can be effectively combined. In addition, a baseline viral load of ≥ 400 copies/mL on the current antiretroviral regimen must be documented. Requests for patients who are not heavily treatment‑experienced, who have >2 fully active ARVs available, who have a baseline viral load <400 copies/mL, or who have known or suspected lenacapavir resistance will be considered not medically necessary.

Initial Therapy — Product-specific Requirements

Renewal / Continuation Requirements

Prior Authorization, Documentation, and Operational Rules

Prior Authorization

Vutrisiran (Amvuttra) prior authorization

Prior authorization is required for Amvuttra (vutrisiran). Submit documentation of definitive hATTR/FAP diagnosis (amyloid on tissue biopsy OR identification of a pathogenic TTR variant), baseline objective strength/weakness measurement (e.g., MRC), exclusion of other causes of peripheral neuropathy, confirmation patient will receive vitamin A supplementation at RDA during therapy, and that the patient has not received an orthotopic liver transplant.

Definitive diagnosis: amyloid on tissue biopsy OR pathogenic TTR variant
Baseline strength/weakness documented with objective tool (e.g., MRC)
Other causes of neuropathy excluded
Vitamin A supplementation at RDA during therapy required
No prior orthotopic liver transplant

Prior Authorization

Relyvrio prior authorization

Prior authorization is required for Relyvrio. Provide documentation of an ALS diagnosis based on validated criteria, evidence of an adequate trial of riluzole for ≥ 8 weeks, baseline disease severity measured with an objective tool (e.g., ALSFRS-R), and that the drug is prescribed by or in consultation with a neurologist.

Coding and Baseline Values

Self-Injectable Epinephrine entries - preferredmixed

epinephrine 0.3 mg	Self-injectable epinephrine 0.3 mg (generic EpiPen®, Mylan)
epinephrine 0.15 mg	Self-injectable epinephrine 0.15 mg (generic EpiPen Jr.®, Mylan)

Self-Injectable Epinephrine entries - non-preferredmixed

epinephrine 0.3 mg	Self-injectable epinephrine 0.3 mg (generic Adrenaclick®)
epinephrine 0.15 mg	Self-injectable epinephrine 0.15 mg (generic Adrenaclick®)
epinephrine 0.3 mg	Self-injectable epinephrine 0.3 mg (generic EpiPen®)
epinephrine 0.15 mg	Self-injectable epinephrine 0.15 mg (generic EpiPen Jr.®)
Symjepi	Symjepi™

inv-17: Baseline viral load — Required baseline viral load

Required baseline viral load>= 400 copies/mL

Product Quantity Limits

inv-46: Amvuttra (vutrisiran) — quantity limit example: 1 syringe

Quantity limit example1 syringe per 3 months

inv-47: Rolvedon (eflapegrastim) — quantity limit: 60 packets

Quantity limit (packets)60 packets per 30 days

inv-48: Rolvedon (eflapegrastim) — alternate quantity limit: 1 syringe

Alternate quantity limit (syringe)1 syringe per 14 days

inv-49: lenacapavir — 300 mg tablets: 5 tabs/fill; 463.5 mg/1.5 mL vial: 2 vials/6 months

Step Therapy Rules

Step	Requirement	Notes
1	Failure, allergy, contraindication, or intolerance of 2 preferred colony stimulating factor agents	Required prior to Rolvedon approval; applies to chemotherapy‑induced neutropenia prophylaxis for adults with nonmyeloid malignancy receiving myelosuppressive therapy

Step	Requirement	Notes
1	Prior authorization required for any new chemical entity in the Intranasal Antihistamines and Anticholinergics class	Temporary PA requirement in effect until the P&T Advisory Committee reviews the agent

Key Definitions

inv-37: hATTR amyloidosis/FAP — disease definition and context

DefinitionHereditary transthyretin-mediated amyloidosis/familial amyloidotic polyneuropathy (hATTR amyloidosis/FAP) — disease caused by pathogenic TTR variants leading to amyloid deposition and progressive polyneuropathy.

Clinical contextVutrisiran (Amvuttra) is a transthyretin-directed small interfering RNA indicated for treatment of the polyneuropathy of hATTR amyloidosis in adults.

Diagnostic requirementDefinitive diagnosis required by tissue biopsy showing amyloid OR identification of a pathogenic TTR variant (per authorization documentation).

inv-38: Heavily treatment-experienced (HIV-1) — definition describing documented resistance and remaining active ARVs

Heavily treatment-experienced (HIV-1) — core definitionPatient with documented resistance to ≥ 2 ARVs from at least 3 of the 4 main ART classes and limited fully active ARVs remaining (≤ 2).

Clinical Background

Hereditary transthyretin-mediated (hATTR) amyloidosis is a progressive disorder characterized by pathogenic TTR variants that lead to amyloid deposition and polyneuropathy. Vutrisiran is an siRNA therapy directed at transthyretin to reduce TTR production; coverage requires a definitive diagnosis of hATTR/FAP (tissue amyloid or pathogenic TTR variant), objective documentation of polyneuropathy, exclusion of other causes, baseline strength measurement, and avoidance of concurrent TTR-reducing agents such as inotersen, tafamidis, and patisiran.

Policy Summary

Payermedimpact

PolicyCommissioner selections for Kentucky Preferred Drug List (PDL) — selected specialty drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewMar 16, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation (diagnosis, baseline labs, resistance profile or trial of preferred agents) as specified for each product.

SourceLink

On This Page

Temporary PA requirement

ALS diagnosis per validated criteria (revised El Escorial, Awaji, Gold Coast)
Riluzole trial ≥ 8 weeks
Baseline objective disease severity assessment (e.g., ALSFRS-R)
Prescribed by or in consultation with a neurologist

Prior Authorization

Rolvedon (eflapegrastim) prior authorization

Prior authorization is required for Rolvedon when used for chemotherapy-induced neutropenia prophylaxis. Document the nonmyeloid malignancy, receipt of myelosuppressive chemotherapy associated with significant febrile neutropenia risk, and at least a 7-day trial with therapeutic failure, allergy, contraindication, or intolerance to 2 preferred colony stimulating factors.

Indication: chemotherapeutic prophylaxis for febrile neutropenia in nonmyeloid malignancy
Receiving myelosuppressive anti-cancer drugs with clinically significant febrile neutropenia risk
Trial and failure/intolerance/allergy/contraindication to 2 preferred CSF agents (≥7 days)

Prior Authorization

Sunlenca (lenacapavir) prior authorization

Prior authorization is required for Sunlenca (lenacapavir). Provide evidence the patient is heavily treatment-experienced with multidrug-resistant HIV‑1 (documented resistance to ≥2 ARVs from each of ≥3 of the 4 main classes), has ≤2 fully active ARVs remaining, baseline viral load ≥400 copies/mL on current regimen, specialist involvement, and that lenacapavir will not be used with strong CYP3A inducers.

Documented multidrug resistance: ≥2 ARVs resistant from each of ≥3 of 4 main classes
≤2 fully active ARVs remaining
Baseline viral load ≥ 400 copies/mL on current regimen
Prescribed by/in consultation with infectious disease or HIV specialist
Not to be used with strong CYP3A inducers

Prior Authorization

Lenacapavir prior authorization and quantity limits

Prior authorization is required for lenacapavir and quantity limits apply. Authorizations must reflect the specified limits: 300 mg tablets — 5 tablets per fill; 463.5 mg/1.5 mL vials — 2 vials per 6 months.

300 mg tablets: 5 tablets per fill
463.5 mg/1.5 mL vial: 2 vials per 6 months

Prior Authorization

Prior authorization required for non-preferred/new chemical entities

Non-preferred agents require prior authorization; additionally, new chemical entities in some classes require temporary PA until P&T review. Submit PA for any agent listed as non-preferred or for a new chemical entity as specified.

Agents not selected as preferred will require prior authorization
New chemical entities (e.g., intranasal antihistamines/anticholinergics or antiretrovirals per class guidance) require PA until P&T review

Step Therapy

Rolvedon step therapy requirement

Before Rolvedon approval, document trial and therapeutic failure, allergy, contraindication, or intolerance to two preferred colony stimulating factors. Absence of these prior trials may preclude coverage.

At least a 7-day trial and therapeutic failure (or allergy/contraindication/intolerance) to 2 preferred CSF agents

Prior Authorization

Class-level prior authorization for non-preferred ARVs

Agents in the Antiretrovirals: HIV/AIDS class that are not selected as preferred are considered non-preferred and require prior authorization before coverage is granted.

Non-preferred ARV agents require PA
Class-level selection based on economic evaluation determines preferred vs non-preferred status

Note

Step therapy — none specified

No step therapy rules are specified in this policy excerpt for other classes beyond the specific Rolvedon requirement; do not apply additional step edits absent explicit policy language.

Documentation Required

Required diagnostic and baseline documentation

Documentation must include definitive diagnostic evidence and baseline tests as specified by product: for vutrisiran, tissue biopsy or pathogenic TTR variant and baseline objective strength measure; for lenacapavir (Sunlenca), baseline viral load ≥400 copies/mL and resistance profile demonstrating multidrug resistance.

Vutrisiran: amyloid on tissue biopsy OR pathogenic TTR variant; baseline strength/weakness (e.g., MRC)
Lenacapavir: baseline viral load ≥ 400 copies/mL and documented resistance profile meeting heavily treatment-experienced definition

Documentation Required

Relyvrio documentation requirements

For Relyvrio PA requests, include documentation of an adequate riluzole trial of ≥ 8 weeks and baseline disease severity measured with an objective tool such as the ALSFRS-R.

Riluzole trial ≥ 8 weeks
Baseline disease severity using an objective tool (e.g., ALSFRS-R)

Documentation Required

Documentation to support lenacapavir (Sunlenca) requests

Submit clinical documentation (progress notes, lab reports) demonstrating HIV‑1 diagnosis, resistance testing showing multidrug resistance per the policy definition, baseline viral load ≥400 copies/mL on current regimen, prescriber specialty (infectious disease or AAHIVS), and evidence of adherence for renewals.

Progress notes or lab reports showing resistance testing and baseline viral load ≥400 copies/mL
Prescriber is infectious disease/HIV specialist (AAHIVS) or in consultation
Evidence of adherence and clinical response for renewal

Prior Authorization

PA required for new chemical entities (intranasal class)

New chemical entities in the Intranasal Antihistamines & Anticholinergics class require prior authorization until reviewed by the P&T Advisory Committee; submit PA for such agents per the temporary requirement.

PA required for any new chemical entity in the intranasal antihistamines/anticholinergics class until P&T review

Denial Risk

Vutrisiran combination exclusion — denial risk

Vutrisiran will be denied if used in combination with other transthyretin-reducing agents (for example inotersen, tafamidis, patisiran); concurrent use is explicitly prohibited and will preclude approval.

Do not use vutrisiran with other TTR-reducing agents (inotersen, tafamidis, patisiran)

Denial Risk

Sunlenca CYP3A interaction — denial risk

Sunlenca (lenacapavir) must NOT be used with strong CYP3A inducers; requests where lenacapavir would be combined with strong CYP3A inducers will be precluded from approval.

Concurrent use with strong CYP3A inducers is prohibited

Denial Risk

Rolvedon missing step trials — denial risk

Rolvedon requests lacking documentation of trials and failure/intolerance/allergy/contraindication to two preferred colony stimulating factors may be denied; ensure prior-step documentation is included.

Evidence of prior trials and failure/intolerance/allergy/contraindication to 2 preferred CSF agents required

Denial Risk

Lenacapavir denial triggers

Lenacapavir (Sunlenca) requests may be denied if the patient is not heavily treatment-experienced per the policy, has >2 fully active ARVs available, has baseline viral load <400 copies/mL, has prior lenacapavir resistance, or if lenacapavir would be used with strong CYP3A inducers.

Denial triggers: not heavily treatment-experienced; >2 fully active ARVs available; baseline viral load <400 copies/mL; known/suspected lenacapavir resistance; concurrent strong CYP3A inducers

Prior Authorization

Non-preferred agents require prior authorization

Agents not selected as preferred in a class will be considered non-preferred and require prior authorization before coverage is approved.

Non-preferred status triggers PA requirement

Tablet quantity limit300 mg tablets: 5 tablets per fill

Vial quantity limit463.5 mg/1.5 mL vial: 2 vials per 6 months

Prescriber requirement

Prescribed by or in consultation with an infectious disease or HIV specialist (AAHIVS).

Baseline viral load requirementDocumentation of baseline viral load ≥ 400 copies/mL on current antiretroviral regimen is required for approval.

inv-39: Heavily treatment-experienced with multidrug resistance — documented resistance across classes

Multidrug resistance definitionDocumented resistance to ≥ 2 antiretroviral (ARV) medications from each of at least 3 of the 4 main classes (NRTIs, NNRTIs, PIs, INSTIs).

Implication for therapyMeets criteria for lenacapavir (Sunlenca) eligibility when combined with ≤ 2 fully active ARVs and specialist oversight.