ModifiedmedimpactPolicy N/A

New specialty drug product coverage additions — Initial and renewal criteria, PA and documentation requirements

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Defines initial and renewal coverage criteria, prescriber and documentation requirements, age and quantity limits, and approval durations for newly marketed specialty drugs reviewed by the P&T Advisory Committee. Applies to MedImpact-managed Medicaid pharmacy benefits and providers seeking coverage for the listed products.

Policy Summary

Payermedimpact

PolicyNew specialty drug product coverage additions — Initial and renewal criteria, PA and documentation requirements

Policy CodePolicy N/A

Change TypeAdded new product-specific criteria and class-level PA rules

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation (diagnostic tests, genetic results, labs, and specialist consultation notes) per drug-specific criteria.

SourceLink

POLICY UPDATE CHANGES

Approval and renewal criteria for Zycubo (copper histidinate) for Menkes disease including genetic and laboratory requirements and specialist prescribing.

Approval criteria for Cardamyst (etripamil) for acute conversion of PSVT requiring ECG confirmation and specialist prescribing.

Approval and renewal criteria for Myqorzo (aficamten) for obstructive hypertrophic cardiomyopathy including imaging and functional thresholds and prior trial of beta-blocker or non-dihydropyridine CCB.

Itvisma (onasemnogene abeparvovec-brve) intrathecal SMA criteria specifying age >=2, genetic confirmation, anti-AAV9 titer threshold, steroid prophylaxis, and contraindications with other SMN1 therapies.

Class-level formulary selection and PA requirements for several drug classes (Bone resorption agents, DPP-4 inhibitors, GLP-1 receptor agonists) with guidance that new chemical entities require PA until P&T review.

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ModifiedmedimpactPolicy N/A

New specialty drug product coverage additions — Initial and renewal criteria, PA and documentation requirements

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Sign up for all medimpact policy alerts

Know when medimpact releases new policies or updates existing guidance.

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Policy Summary

Payermedimpact

PolicyNew specialty drug product coverage additions — Initial and renewal criteria, PA and documentation requirements

Policy CodePolicy N/A

Change TypeAdded new product-specific criteria and class-level PA rules

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation (diagnostic tests, genetic results, labs, and specialist consultation notes) per drug-specific criteria.

SourceLink

POLICY UPDATE CHANGES

Approval and renewal criteria for Zycubo (copper histidinate) for Menkes disease including genetic and laboratory requirements and specialist prescribing.

Approval criteria for Cardamyst (etripamil) for acute conversion of PSVT requiring ECG confirmation and specialist prescribing.

~12distinct new products listed or described in this part

multiplecontain both initial and renewal criteria

variedapproval durations (1–12 months) stated

PA requirednew chemical entities require prior authorization until P&T review

multiple classesdocument lists preferred/non-preferred agent rules

Coverage Criteria by Product

Initial Therapy — Palsonify

Covered when ALL of the following are met

Palsonify initial criteria: Documented diagnosis of acromegaly requiring medical therapy; prescribed by, or in consultation with, an endocrinologist, neurosurgeon, or specialist experienced in acromegaly management; inadequate response to pituitary surgery or surgery is not an option; documentation of inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue after a trial of at least 30 days; historical or current IGF-1 above the upper limit of normal for age/sex or prior elevation requiring somatostatin-based therapy; provider attestation that the patient has been counseled on and can comply with empty-stomach administration instructions.

Initial approval duration 12 months

Continuation Therapy — Palsonify

Renewal requires ALL of the following

Palsonify renewal criteria: Documentation of positive response such as IGF-1 reduced to ≤1.0 × ULN or clinically meaningful reduction from baseline; improvement or stabilization of acromegaly signs and symptoms (e.g., headache, soft tissue swelling, sweating, joint pain).

Approval duration 12 months renewal

Initial Therapy — Voyxact

Covered when ALL of the following are met

Voyxact initial criteria: Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy; prescriber is a nephrologist or appropriate specialist; meets high-risk definition with proteinuria ≥ 0.5 g/day OR UPCR ≥ 0.8 g/g; patient is stable on a maximally tolerated ACEI or ARB unless contraindicated.age ≥ 18

Initial approval 3 months

Continuation Therapy — Voyxact

Renewal requires ALL of the following

Voyxact renewal criteria: Patient remains on a maximally tolerated ACEI/ARB unless contraindicated; prescribed by or in consultation with a nephrologist or appropriate specialist; prescriber submits documentation of clinical benefit compared to baseline (reduction in proteinuria or UPCR or stabilization/improvement in eGFR).age ≥ 18

Renewal approval 12 months

Initial Therapy — Redemplo

Covered when ALL of the following are met

Redemplo initial criteria: Diagnosis of familial chylomicronemia syndrome (FCS) confirmed by pathogenic mutation in LPL, APOA5, GPIHBP1, LMF1, or APOC2; prescribed by, or in consultation with, an endocrinologist or FCS specialist; fasting triglycerides ≥ 880 mg/dL; patient will follow a low-fat diet (≤20 g fat/day).age ≥ 18

Initial approval 12 months

Continuation Therapy — Redemplo

Renewal requires ALL of the following

Redemplo renewal criteria: Prescribed by, or in consultation with, an endocrinologist or other FCS specialist; documentation of clinically significant improvement or stabilization (e.g., reduction in fasting triglycerides, decreased frequency or severity of pancreatitis).age ≥ 18

Renewal approval 12 months

Initial Therapy — Attruby

Covered when ALL of the following are met

Attruby initial criteria: Documented transthyretin-mediated cardiomyopathy (ATTR-CM), wild-type or variant, confirmed by appropriate diagnostics (e.g., Tc99m PYP, cardiac MRI, biopsy, and/or genetic testing); prescribed by, or in consultation with, a cardiologist, geneticist, or specialist experienced in ATTR management; documentation of symptomatic cardiomyopathy (e.g., heart failure symptoms); documentation that the patient is receiving optimized guideline-directed medical therapy or reasons why not fully optimized.age ≥ 18

Initial approval 12 months

Continuation Therapy — Attruby

Renewal requires at least ONE of the following

Attruby renewal criteria: At least ONE: stabilization or improvement in functional status (e.g., NYHA class, 6-minute walk), reduction in cardiovascular hospitalizations versus baseline, stabilization or improvement in cardiac biomarkers or imaging, OR cardiologist's clinical impression of meaningful benefit; prescribed by or in consultation with a cardiologist/geneticist or specialist.age ≥ 18

Renewal approval 12 months

Initial Therapy — Forzinity

Covered when ALL of the following are met

Forzinity initial criteria: Diagnosis of Barth syndrome documented by genetic test demonstrating a pathogenic TAZ variant; patient weight ≥ 30 kg; prescriber attests patient is ambulatory and able to complete a 6-minute walk test; documentation of baseline muscle strength (e.g., handheld dynamometry); prescribed by, or in consultation with, a cardiologist, hematologist, or specialist experienced in Barth syndrome.

Initial approval 12 months

Continuation Therapy — Forzinity

Renewal requires ALL of the following

Forzinity renewal criteria: Clinical documentation demonstrating improvement or stabilization of muscle strength measured by handheld dynamometry; prescribed by, or in consultation with, a cardiologist, hematologist, or specialist experienced in Barth syndrome.

Renewal approval 12 months

Initial Therapy — Aqvesme

Covered when ALL of the following are met

Aqvesme initial criteria: Diagnosis of anemia due to alpha or beta thalassemia; AND patient meets ONE: recent hemoglobin ≤ 10.0 g/dL OR prescriber attestation patient required ≥6 RBC units within the last 24 weeks; prescribed by or in consultation with a hematologist or specialist; patient is not on concurrent Reblozyl or Pyrukynd.age > 12

Initial approval 6 months

Continuation Therapy — Aqvesme

Renewal requires ALL of the following

Aqvesme renewal criteria: Prescriber submits clinical documentation that the patient has experienced clinical benefit compared to baseline.

Renewal approval 12 months

Initial Therapy — Pivya

Covered when ALL of the following are met

Pivya initial criteria (uUTI): Patient is female; documented clinical diagnosis of uncomplicated urinary tract infection with at least 2 signs/symptoms; urinalysis confirming pyuria and/or positive nitrites; urine culture confirming or showing high clinical suspicion of uUTI caused by Escherichia coli, Proteus mirabilis, or Staphylococcus saprophyticus; documented allergy, intolerance, contraindication, or therapeutic failure to ≥2 first-line oral agents appropriate to organism susceptibilities; provider attests Pivya is not being used as step-down therapy after IV antibiotics.age ≥ 18

Approval duration 1 month; quantity limit 21 tablets per 7-day course

Initial Therapy — Pivya (detailed) + restrictions

Additional Pivya requirements and restrictions

Pivya restrictions: Provider must attest Pivya is not being used as step-down therapy for infections that previously required IV antibiotics; requests for non-female patients or without required urinalysis/urine culture or without documented failure/intolerance to ≥2 first-line oral agents may be denied.

Quantity limit 21 tablets per 7-day course

Pivya initial therapy — core requirements (step/failure rules)

Core Pivya requirements (step/failure rules)

Pivya core requirements: Documented clinical diagnosis of uUTI with urinalysis and urine culture showing organism susceptibility as appropriate; documented allergy/intolerance/therapeutic failure to at least two first-line oral agents prior to approval; provider attestation Pivya is not step-down from IV antibiotics.age ≥ 18

Must fail or be intolerant to ≥2 first-line oral uUTI agents prior to approval

Zycubo initial therapy — Menkes disease criteria

Covered when ALL of the following are met

Zycubo initial criteria: Diagnosis of Menkes disease; documented ATP7A gene mutation; serum copper < 75 mcg/dL; prescriber attests to baseline and ongoing monitoring (serum copper and ceruloplasmin, serum electrolytes, kidney and liver function, CBC); medication will not be used concomitantly with other copper-containing therapies; documentation of response to therapy compared to baseline; prescribed by or in consultation with a pediatric neurologist, geneticist, or other Menkes specialist.age ≤ 18

Initial approval duration 6 months; quantity limit 2 vials per day

Zycubo renewal — renewal criteria for Zycubo

Renewal requires ALL of the following

Zycubo renewal criteria: Documentation of response to therapy compared to baseline; prescribed by or in consultation with a pediatric neurologist, geneticist, or other Menkes specialist.age ≤ 18

Renewal duration 6 months; quantity limit 2 vials per day

Cardamyst initial therapy — etripamil criteria

Covered when ALL of the following are met

Cardamyst initial criteria: Diagnosis of paroxysmal supraventricular tachycardia (PSVT) confirmed by ECG; prescriber attests history of sustained symptomatic episodes (e.g., typically ≥20 minutes); concurrent oral medications will be used for ventricular rate control or rhythm regulation as clinically appropriate; medication used for conversion of acute symptomatic PSVT; prescribed by, or in consultation with, a cardiologist or PSVT specialist.age > 18

Initial and renewal approval 12 months; quantity limit 4 nasal spray devices per month

Myqorzo initial therapy — aficamten initial criteria

Covered when ALL of the following are met

Myqorzo initial criteria: Diagnosis of obstructive hypertrophic cardiomyopathy (oHCM); documentation of left ventricular hypertrophy with maximal wall thickness ≥15 mm (or ≥13 mm with familial HCM); NYHA Class II or III symptoms; LVEF ≥ 55%; peak LVOT gradient ≥ 30 mmHg at rest or ≥ 50 mmHg after provocation; prescribed by or in consultation with a cardiologist or oHCM specialist; prior adequate trial and failure of a beta blocker OR a non-dihydropyridine calcium channel blocker.age ≥ 18

Initial approval 6 months

Myqorzo renewal — aficamten renewal

Renewal requires ALL of the following

Myqorzo renewal criteria: Left ventricular ejection fraction (LVEF) ≥ 50% for renewal; prescriber submits clinical documentation of disease improvement and/or stabilization from baseline (e.g., at least 1 NYHA class decrease, specified pVO2 improvements); prescribed by or in consultation with a cardiologist or oHCM specialist.age ≥ 18

Renewal duration 12 months; quantity limit 1 tablet per day

Itvisma initial therapy — intrathecal onasemnogene abeparvovec-brve criteria

Covered when ALL of the following are met

Itvisma initial criteria: Prescribed by or in consultation with a neurologist or specialist experienced in SMA; SMA diagnosis confirmed by medical records demonstrating SMN1 mutation/deletion (e.g., homozygous deletion of exon 7 or compound heterozygous mutation); patient is ≥ 2 years of age at time of treatment; has not received prior onasemnogene abeparvovec (e.g., IV Zolgensma); baseline anti-AAV9 antibody titer ≤ 1:50 with documentation; does not have advanced SMA (permanent invasive ventilation or chronic noninvasive ventilation ≥16 hrs/day not expected to improve, or complete paralysis of all extremities with no residual motor function); patient is clinically stable with no active/recent serious infection at planned dosing; baseline labs (LFTs, creatinine, CBC, anti-AAV9 antibody) obtained; must be administered as a one-time intrathecal injection via lumbar puncture by an appropriate specialist or trained healthcare professional with access to monitoring and supportive care; must be used with systemic corticosteroids beginning 1 day prior and continued ≥ 30 days with taper and monitoring; provider attests immunizations are up to date and prophylaxis considered; not to be used in combination with other SMN1 gene replacement therapies, Spinraza, or Evrysdi.age ≥ 2

One-time intrathecal administration; all PA requests to MedImpact

Aqvesme (mitapivat) is exclusionary for members who are currently receiving Reblozyl (luspatercept-aamt) or Pyrukynd (luspatercept) — concurrent treatment with either agent disqualifies coverage. This requirement applies at initiation and renewal and must be documented by the prescriber.

Itvisma (intrathecal onasemnogene abeparvovec-brve) must not be used in combination with any other SMN1 gene replacement therapy. This includes no repeat or sequential AAV9‑based SMN1 gene therapy (for example, IV onasemnogene abeparvovec [Zolgensma]) and no concurrent use with Spinraza (nusinersen) or Evrysdi (risdiplam).

Pivya (pivmecillinam) is not approved as step‑down therapy following prior intravenous antibiotic treatment. The prescriber must attest that Pivya is not being used as step‑down therapy for infections that previously required IV antibiotics; use in that scenario does not meet the approval criteria.

Clinical Thresholds and Measured Values

Proteinuria / UPCR thresholds used for Voyxact initial approval

Proteinuria threshold≥ 0.5 g/day

UPCR thresholdUrine protein-to-creatinine ratio (UPCR) ≥ 0.8 g/g

ContextRequired to meet Voyxact high-risk definition for IgAN initial approval (kidney‑biopsy confirmed).

Fasting triglycerides threshold for Redemplo

Fasting triglycerides threshold≥ 880 mg/dL

Genetic confirmationDiagnosis of FCS must be confirmed by mutation in LPL, APOA5, GPIHBP1, LMF1, or APOC2

Dietary requirement

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Palsonify prior authorization

Palsonify (paltusotine) requires prior authorization. Initial approvals are authorized for 12 months; renewals are also authorized for 12 months when renewal criteria are met.

Initial approval duration: 12 months
Renewal approval duration: 12 months (requires documentation of clinical response)

Prior Authorization

Voyxact prior authorization

Voyxact (sibeprenlimab-szsi) requires prior authorization. Initial approval is for 3 months; renewals may be approved for 12 months contingent on documentation of clinical benefit at renewal.

Initial approval duration: 3 months
Renewal approval duration: 12 months (requires documentation of clinical benefit vs baseline)

Product Initial Therapy Criteria (Grouped)

Palsonify initial therapy criteria (detailed block)

Covered when ALL of the following are met

Palsonify initial criteria (detailed): Documented acromegaly requiring medical therapy; prescribed by or in consultation with endocrinologist/neurosurgeon or specialist experienced in acromegaly; inadequate response to surgery or surgery not an option; documentation of inadequate response, intolerance, or contraindication to at least one injectable SSA after ≥30 days; historical or current IGF-1 above ULN or prior elevation; provider attestation patient counseled on and able to comply with empty-stomach administration; initial approval duration 12 months.

Detailed initial requirements and documentation

Voyxact initial therapy criteria (detailed block)

Covered when ALL of the following are met

Voyxact initial criteria (detailed): Diagnosis of primary IgA nephropathy confirmed by kidney biopsy; prescriber is nephrologist or appropriate specialist; patient meets high-risk definition (proteinuria ≥0.5 g/day OR UPCR ≥0.8 g/g); patient stable on maximally tolerated ACE inhibitor or ARB unless contraindicated; initial approval duration 3 months.

Renewal / Continuation Criteria

Voyxact continuation criteria (renewal)

Renewal requires ALL of the following

Voyxact continuation: Patient is stable on maximally tolerated ACE inhibitor or ARB unless contraindicated; prescribed by or in consultation with a nephrologist or appropriate specialist; prescriber submits documentation of clinical benefit compared to baseline (e.g., reduction in proteinuria/UPCR or stabilization/improvement in eGFR).

Renewal approval 12 months

Attruby continuation criteria (renewal)

Renewal requires ANY of the following (at least one)

Attruby continuation: At least ONE: stabilization or improvement in functional status (e.g., NYHA class, 6-minute walk), reduction in cardiovascular-related hospitalizations versus baseline, stabilization/improvement in cardiac biomarkers or imaging, or cardiologist's clinical impression of meaningful benefit.

Renewal approval 12 months

Required Prior Trials and Step Therapy

Drug	Step requirement
Palsonify (paltusotine)	Trial of at least one injectable somatostatin analogue (e.g., octreotide, lanreotide, Sandostatin, Somatuline) for ≥30 days with documentation of inadequate response, intolerance, or contraindication prior to approval.

Drug	Step requirement
Pivya (pivmecillinam)	Documented allergy, intolerance, contraindication, or therapeutic failure to at least 2 first-line oral agents for uncomplicated UTI (examples: sulfamethoxazole/trimethoprim, amoxicillin‑clavulanate, cefdinir, fosfomycin, cefpodoxime, nitrofurantoin) prior to approval.

Descriptor	Requirement
Pivya — alternative descriptor	Must fail or be intolerant to ≥2 first-line oral uUTI agents appropriate to organism susceptibilities before Pivya will be approved.

Drug	Required prior therapy
Myqorzo (aficamten)	Adequate trial and failure of a beta blocker OR a non‑dihydropyridine calcium channel blocker is required prior to initiation.

Quantity Limits and Dispensing Controls

Quantity limit — Palsonify (paltusotine)

Palsonify quantity limit2 tablets per day

Approval duration contextInitial approval 12 months; renewals 12 months when renewal criteria met

Most actionableQuantity limit: 2 tablets/day

Quantity limit — Voyxact (sibeprenlimab-szsi)

Voyxact quantity limit1 (syringe) per month

Initial approval duration3 months initial; 12 months renewal

Prescribing context

Prescribing and Administration Settings

Note

Infusion center: specialist prescribing and product‑label administration

For infusion‑center administered products, ensure the drug is prescribed by or in consultation with the appropriate specialist (e.g., nephrologist for Voyxact) and administered per product labeling.

Note

Home administration: Zycubo subcutaneous route to bypass GI absorption

For Menkes disease, Zycubo is administered subcutaneously to bypass gastrointestinal absorption; home subcutaneous administration is permitted per product labeling when appropriate.

Note

Hospital outpatient: Itvisma intrathecal administration by specialist

Itvisma must be administered as a one‑time intrathecal injection via lumbar puncture by an appropriate specialist or trained healthcare professional with access to monitoring and supportive care (hospital outpatient setting).

Definitions and Mechanisms

Definition — High risk of disease progression for IgAN (proteinuria/UPCR threshold)

DefinitionHigh risk of disease progression in IgAN is defined as proteinuria ≥ 0.5 g/day or UPCR ≥ 0.8 g/g

ApplicationThis definition is required documentation for Voyxact initial approval (kidney biopsy confirmed IgAN)

Prescriber requirementPrescribed by or in consultation with a nephrologist or appropriate specialist

Definition — Genetic confirmation requirements for familial chylomicronemia syndrome (FCS)

Genetic confirmation requirementPathogenic mutation in one of the following genes: LPL, APOA5, GPIHBP1, LMF1, or APOC2

PrescriberPrescribed by or in consultation with an endocrinologist or FCS specialist

Policy Summary

Payermedimpact

PolicyNew specialty drug product coverage additions — Initial and renewal criteria, PA and documentation requirements

Policy CodePolicy N/A

Change TypeAdded new product-specific criteria and class-level PA rules

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation (diagnostic tests, genetic results, labs, and specialist consultation notes) per drug-specific criteria.

SourceLink

On This Page

Patient will follow a low‑fat diet (≤ 20 g fat/day)

Hemoglobin threshold for thalassemia (Aqvesme)

Hemoglobin threshold (thalassemia)Recent hemoglobin ≤ 10.0 g/dL

Alternate transfusion criterionOr prescriber attestation of ≥ 6 RBC units transfused within last 24 weeks

Age/contextApplies to anemia due to alpha or beta thalassemia per Aqvesme initial criteria

Serum copper threshold relevant to Menkes disease / Zycubo

Serum copper threshold< 75 mcg/dL

Genetic requirementDocumented ATP7A gene mutation required for Menkes disease diagnosis

Administration route contextZycubo (copper histidinate) given subcutaneously to bypass GI absorption

LVEF thresholds (initial and renewal) for Myqorzo

Initial LVEF thresholdLeft ventricular ejection fraction (LVEF) ≥ 55% for initial Myqorzo approval

Renewal LVEF thresholdLVEF ≥ 50% required for renewal

Context for renewalRenewal also requires documentation of clinical improvement or stabilization (e.g., ≥1 NYHA class decrease or specified pVO2 improvements)

Left ventricular wall thickness threshold for Myqorzo

Left ventricular wall thicknessMaximal LV wall thickness ≥ 15 mm (or ≥ 13 mm with familial HCM)

Use contextRequired documentation of LV hypertrophy for Myqorzo initial approval

Prescriber requirementPrescribed by or in consultation with a cardiologist or oHCM specialist

LVOT gradient thresholds for Myqorzo

LVOT gradient (rest)Peak LVOT gradient ≥ 30 mmHg at rest

LVOT gradient (provocation)Peak LVOT gradient ≥ 50 mmHg after provocation (e.g., Valsalva or exercise)

RoleRequired for Myqorzo initial approval along with LV hypertrophy and symptom criteria

Baseline anti-AAV9 antibody titer threshold for Itvisma

Baseline anti‑AAV9 antibody titer≤ 1:50 (measured by a validated assay)

DocumentationResult must be documented in medical records prior to Itvisma intrathecal administration

ContextApplies to Itvisma (intrathecal onasemnogene) initial eligibility

Zycubo serum copper monitoring threshold

Monitoring serum copper thresholdSerum copper < 75 mcg/dL at baseline

Required monitoringPrescriber must attest to baseline and ongoing monitoring of serum copper and ceruloplasmin, electrolytes, kidney/liver function, and CBC

Renewal contextDocumentation of response compared to baseline required for renewal

Prior Authorization

Redemplo prior authorization

Redemplo (plozasiran) requires prior authorization. Initial approvals are for 12 months and renewals for 12 months when clinical benefit is documented.

Initial approval duration: 12 months
Renewal approval duration: 12 months (requires documentation of clinically significant improvement or stabilization)

Prior Authorization

Forzinity prior authorization

Forzinity (elamipretide) requires prior authorization. Both initial and renewal approvals are for 12 months when renewal criteria are met.

Initial approval duration: 12 months
Renewal approval duration: 12 months (requires documentation of improvement or stabilization)

Prior Authorization

Pivya prior authorization

Pivya (pivmecillinam) requires prior authorization for uncomplicated UTI; approval is limited to a 1-month duration (7-day course quantity limit when criteria met).

Approval duration: 1 month
Quantity limit: 21 tablets per 7-day course

Prior Authorization

Itvisma PA submission requirement

All prior authorization requests for Itvisma (onasemnogene abeparvovec-brve) must be submitted to MedImpact for review.

All PA requests must be sent to MedImpact

Prior Authorization

Class‑level PA for new agents

New chemical entities in listed therapeutic classes require prior authorization until reviewed by the P&T Committee; this includes specified classes such as Bone Resorption agents, DPP‑4 inhibitors, and GLP‑1 receptor agonists.

PA required for any new chemical entity in the specified classes until P&T review

Prior Authorization

PA requirement for non‑preferred and new agents

Non‑preferred agents require prior authorization. New chemical entities in specified classes also require PA until P&T Committee review.

Agents not selected as preferred are considered non‑preferred and require PA
New chemical entities require PA until reviewed by P&T

Step Therapy

Palsonify step requirement

Palsonify approval requires documentation of a prior trial of at least one injectable somatostatin analogue for a minimum of 30 days before approval is granted.

Trial requirement: ≥ 30 days of an injectable SSA (e.g., octreotide, lanreotide)

Step Therapy

Pivya step requirement

Pivya requires documented failure, allergy, intolerance, or contraindication to at least two first‑line oral agents for uncomplicated UTI prior to approval.

Must document allergy/intolerance/therapeutic failure to ≥ 2 first‑line oral uUTI agents appropriate to organism susceptibilities

Step Therapy

Pivya step therapy (emphasis)

Pivya prior authorization requires evidence of trials or failures of at least two first‑line oral uUTI agents (emphasizing that approval is contingent on these documented trials).

Documented trials/failures to ≥ 2 first‑line oral agents required before Pivya approval

Documentation Required

Palsonify documentation requirements

For Palsonify prior authorization requests, include documentation of inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue, and supporting IGF‑1 data or prior elevations; include provider attestation regarding empty‑stomach administration counseling.

Document inadequate response/intolerance/contraindication to ≥1 injectable SSA after ≥30 days
Provide historical or current IGF‑1 above ULN or prior elevation
Provider attestation patient counseled on empty‑stomach administration

Documentation Required

Voyxact documentation requirements

Voyxact prior authorization must include kidney biopsy confirming IgAN, documentation that the patient meets high‑risk proteinuria thresholds (≥0.5 g/day or UPCR ≥0.8 g/g), evidence the patient is on maximally tolerated ACEI/ARB unless contraindicated, and clinical benefit documentation at renewal.

Provide kidney biopsy confirming IgA nephropathy
Document proteinuria ≥0.5 g/day OR UPCR ≥0.8 g/g
Document use of maximally tolerated ACEI or ARB unless contraindicated
At renewal, submit documentation of clinical benefit vs baseline

Documentation Required

Forzinity documentation requirements

Forzinity documentation must include genetic testing showing a pathogenic TAZ variant, baseline muscle strength measurement (e.g., handheld dynamometry), patient weight ≥30 kg, ability to perform a 6‑minute walk test at baseline, and progress notes documenting improvement or stabilization.

Genetic test demonstrating pathogenic TAZ variant
Baseline muscle strength documentation and ambulatory status/6‑minute walk ability
Patient weight ≥ 30 kg
Progress notes showing improvement or stabilization for renewal

Documentation Required

Zycubo documentation requirements

Zycubo prior authorization requests must include documentation of ATP7A mutation and serum copper <75 mcg/dL, baseline labs (serum copper/ceruloplasmin, electrolytes, kidney and liver function, CBC), and progress notes or lab reports documenting response compared to baseline; prescribe in consultation with a pediatric neurologist, geneticist, or Menkes specialist.

Genetic confirmation of ATP7A mutation
Serum copper < 75 mcg/dL
Baseline and ongoing monitoring labs (copper/ceruloplasmin, electrolytes, kidney/liver function, CBC)
Documentation of response vs baseline and specialist involvement

Documentation Required

Zycubo documentation (monitoring & progress)

Zycubo documentation (expanded): include genetic testing confirming ATP7A mutation, serum copper and monitoring labs, progress notes or lab reports demonstrating response vs baseline, and specialist consultation notes.

Genetic test confirming ATP7A mutation
Serum copper and ceruloplasmin with monitoring plan
Progress notes or labs documenting response vs baseline
Prescriber consultation with pediatric neurologist/geneticist

Documentation Required

Pivya documentation requirements

Pivya prior authorization must include clinical diagnosis documentation of uUTI, urinalysis and urine culture results (with organism susceptibility), and documentation of prior agent failures, allergies, or intolerances to at least two first‑line oral agents.

Clinical diagnosis with ≥2 signs/symptoms of uUTI
Urinalysis confirming pyuria and/or positive nitrites
Urine culture confirming or showing high suspicion of susceptible organism
Evidence of allergy/intolerance/therapeutic failure to ≥2 first‑line oral agents

Documentation Required

Itvisma documentation & administration requirements

Itvisma prior authorization must include SMA diagnostic genetic records confirming SMN1 mutation/deletion, baseline anti‑AAV9 antibody titer ≤1:50 with documentation, baseline liver/renal/CBC labs, documentation of immunization status and steroid prophylaxis plan, and evidence that administration will occur by an appropriate specialist with monitoring.

SMA genetic confirmation (SMN1 mutation/deletion) in medical records
Baseline anti‑AAV9 antibody titer ≤1:50 with documented result
Baseline labs (LFTs, creatinine, CBC) and immunization/steroid plan
Administration plan: one‑time intrathecal injection by trained specialist

Prior Authorization

PA for new chemical entities

For any new chemical entity in specified classes (e.g., GLP‑1 receptor agonists, Colony Stimulating Factors, topical steroids, Bone Resorption agents), prior authorization is required until the product is reviewed by the P&T Committee.

PA required for new chemical entities in listed classes until P&T review

Denial Risk

Palsonify prior therapy denial risk

Palsonify requests that lack documentation of an inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue (after a ≥30‑day trial) may be denied.

Denial risk if no documentation of ≥30‑day trial and inadequate response/intolerance to an injectable SSA

Denial Risk

Voyxact diagnostic and risk denial triggers

Voyxact requests without kidney‑biopsy confirmation of IgAN or without documentation of proteinuria ≥0.5 g/day or UPCR ≥0.8 g/g may be denied.

Denial risk if kidney biopsy confirming IgAN or proteinuria/UPCR thresholds are not provided

Denial Risk

Redemplo diagnostic and lab denial risks

Redemplo requests lacking genetic confirmation of familial chylomicronemia syndrome (mutations in LPL, APOA5, GPIHBP1, LMF1, or APOC2) or without fasting triglycerides ≥880 mg/dL and documentation of low‑fat diet adherence risk denial.

Denial risk if genetic confirmation or fasting TG ≥880 mg/dL and low‑fat diet plan are not documented

Denial Risk

Pivya indication and prior therapy denial risks

Pivya requests for non‑female patients, or without documented uUTI signs/symptoms plus urinalysis and culture showing a susceptible organism, or without documented trial/failure/allergy/intolerance to ≥2 first‑line oral agents may be denied.

Denial triggers: male patients, missing urinalysis/urine culture, missing documentation of ≥2 first‑line agent failures/allergies/intolerances

Denial Risk

Pivya explicit denial triggers

Pivya requests without documentation of failure or intolerance to at least two first‑line oral uUTI agents, or lacking urinalysis and urine culture confirmation, or used as step‑down after IV antibiotics will be denied.

Denial triggers include: no documentation of ≥2 failed/intolerant first‑line agents; missing urinalysis/urine culture; use as step‑down from IV antibiotics

Denial Risk

Zycubo denial triggers

Zycubo requests lacking documentation of ATP7A genetic confirmation, serum copper <75 mcg/dL, baseline and monitoring labs, or specialist prescribing/consultation may be denied.

Denial risk if ATP7A mutation, serum copper <75 mcg/dL, monitoring labs, or specialist involvement are missing

Denial Risk

Myqorzo denial triggers

Myqorzo requests without required imaging/functional criteria (LV wall thickness, LVOT gradient, LVEF ≥55%, NYHA II–III) or without prior trial and failure of a beta‑blocker or non‑dihydropyridine calcium channel blocker may be denied.

Denial risk if imaging/functional thresholds or required prior therapy trial are not documented

Denial Risk

Itvisma denial triggers

Itvisma requests without SMA genetic confirmation, baseline anti‑AAV9 titer ≤1:50 with documentation, required baseline labs, evidence of clinical stability, or documentation that administration will be by an appropriate specialist may be denied.

Denial triggers: missing SMA genetic confirmation, anti‑AAV9 titer result >1:50 or undocumented, missing baseline labs, lack of clinical stability, or no specialist administration plan

Prior Authorization

Non‑preferred agents require PA

Agents not selected as preferred will be considered non‑preferred and will require prior authorization.

Non‑preferred status = PA required

Detailed diagnostic and risk thresholds required

Redemplo initial therapy criteria (detailed block)

Covered when ALL of the following are met

Redemplo initial criteria (detailed): Genetic confirmation of FCS with pathogenic mutation in LPL, APOA5, GPIHBP1, LMF1, or APOC2; prescribed by or in consultation with an endocrinologist or FCS specialist; fasting triglycerides ≥880 mg/dL; patient will adhere to a low-fat diet ≤20 g/day; initial approval duration 12 months.

Genetic and laboratory confirmation required

Initial therapy rules — generic top-level rules across products (3 top-level nodes)

Initial therapy rule 1: Zycubo initial approval requires ATP7A genetic confirmation and serum copper <75 mcg/dL with specialist prescribing and monitoring protocols.age ≤ 18

Initial approval 6 months; renewal 6 months

Initial therapy rule 2: Myqorzo initial approval requires imaging and functional criteria including LV wall thickness thresholds, LVOT gradient thresholds, LVEF ≥55%, NYHA II–III, and prior trial/failure of beta blocker or non-dihydropyridine CCB.age ≥ 18

Initial approval 6 months

Initial therapy rule 3: Itvisma (intrathecal onasemnogene) requires genetic confirmation of SMA, baseline anti-AAV9 titer ≤1:50, baseline labs, steroid prophylaxis regimen, administration intrathecally by trained specialist, and not used with other SMN1 gene replacement therapies.age ≥ 2

One-time intrathecal administration; PA to MedImpact

Redemplo continuation criteria (renewal)

Renewal requires ALL of the following

Redemplo continuation: Prescribed by, or in consultation with, an endocrinologist or other FCS specialist; documentation of clinically significant improvement or stabilization such as reduction in fasting triglycerides or decreased pancreatitis frequency/severity.

Renewal approval 12 months

Myqorzo renewal — renewal requirements for Myqorzo

Renewal requires ALL of the following

Myqorzo continuation: Left ventricular ejection fraction (LVEF) ≥50%; prescriber submits clinical documentation of disease improvement and/or stabilization from baseline (e.g., ≥1 NYHA class decrease or specified pVO2 improvements); prescribed by, or in consultation with, a cardiologist.age ≥ 18

Renewal duration 12 months; quantity limit 1 tablet per day

Zycubo renewal — renewal requirements for Zycubo

Renewal requires ALL of the following

Zycubo continuation: Documentation of response to therapy compared to baseline; prescribed by, or in consultation with, a pediatric neurologist, geneticist, or other Menkes specialist.age ≤ 18

Renewal duration 6 months; quantity limit 2 vials per day

Prescribed by or in consultation with nephrologist for IgAN

Quantity limit — Redemplo (plozasiran)

Redemplo (oral) quantity limit4 tablets per day

Injectable presentation quantity limit1 syringe per 3 months for injectable formulation

Initial approval duration12 months initial; 12 months renewal

Quantity limit — Aqvesme (mitapivat)

Aqvesme quantity limit4 vials per 28 days

Indication contextFor anemia due to alpha or beta thalassemia (age >12) meeting hemoglobin or transfusion criteria

RenewalRenewal requires clinical benefit documentation

Quantity limit — Pivya (pivmecillinam) course (21 tablets / 7 days)

Pivya course quantity21 tablets per 7‑day course

Approval duration1 month for uncomplicated UTI when criteria satisfied

Patient restrictionApproved for adult females with documented uUTI and prior failure/intolerance to ≥2 first‑line agents

Quantity limit — Redemplo injectable presentation

Redemplo injectable quantity limit1 syringe per 3 months

RenewalRequires documentation of clinically significant improvement or stabilization

PrescriberPrescribed by or in consultation with an endocrinologist or FCS specialist

Quantity limit — Zycubo (copper histidinate) unspecified details block

Zycubo quantity notePolicy lists quantity limits for Zycubo; renewal guidance requires monitoring and documentation of response

Baseline requirementSerum copper < 75 mcg/dL and ATP7A mutation documented

Administration routeSubcutaneous injection to bypass GI absorption

Quantity limit — Pivya (duplicate key_value for emphasis)

Pivya quantity limit (duplicate)21 tablets per 7‑day course

Use restrictionProvider attests Pivya not used as step‑down after IV antibiotics

AgeAdults ≥ 18 years

Quantity limit — Zycubo renewal quantity limit (2 vials/day)

Zycubo renewal quantity limit2 vials per day

Renewal age limitApplies to patients ≤ 18 years of age for renewal

Renewal requirementDocumentation of response compared to baseline required

Quantity limit — Cardamyst (etripamil) nasal spray

Cardamyst quantity limit4 nasal spray devices per month

IndicationFor acute conversion of PSVT confirmed by ECG with history of sustained symptomatic episodes

AgeAdults > 18 years

Quantity limit — Myqorzo (aficamten) 1 tablet/day

Myqorzo quantity limit1 tablet per day

Initial/renewal durationsInitial approval 6 months; renewal 12 months when renewal criteria met

Indication contextFor obstructive hypertrophic cardiomyopathy in adults meeting imaging and symptom thresholds

Additional requirementFasting triglycerides ≥ 880 mg/dL and commitment to low‑fat diet (≤ 20 g/day)

Definition — Menkes disease brief mechanism (ATP7A mutation causing copper transport defect)

Mechanism summaryMenkes disease is an X‑linked disorder caused by mutations in ATP7A leading to defective copper transport across the GI tract and blood–brain barrier

Therapeutic implicationRequires bypassing GI absorption; copper histidinate (Zycubo) given subcutaneously

Diagnostic requirementATP7A genetic mutation and serum copper < 75 mcg/dL documented prior to treatment

Definition — Aficamten mechanism of action

Mechanism of actionAficamten is an allosteric, reversible cardiac myosin inhibitor that reduces myosin‑generated force to alleviate LVOT obstruction in HCM

Clinical effectReduces cardiac contractility and left ventricular outflow tract obstruction to improve symptoms in oHCM

Indication contextUsed in adults with symptomatic obstructive hypertrophic cardiomyopathy meeting imaging and functional criteria