CurrentSelectHealthPolicy N/A

ACTIMMUNE_Medication_Criteria

This document section lists multiple medications with their prior authorization (PA) indication indicators, exclusion criteria, required medical information, coverage duration, prescriber/age restrictions, and Part B prerequisites as applied by SelectHealth. It is part 2 of 5 and contains drug-specific PA rules used to determine coverage and reauthorization requirements.

Policy Summary

PayerSelectHealth

PolicyACTIMMUNE_Medication_Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit diagnosis, prior therapy history, relevant genotype/mutation testing (when required), lab values, and rationale for contraindications/intolerance as specified in Required Medical Information.

POLICY UPDATE CHANGES

No material clinical/coverage changes — has_material_change = false.

100+Medications listed in section

MultipleRequire genetic/molecular testing

SeveralRequire prior therapy failure documentation

manyPA Indication: All FDA-Approved

Coverage Summary

General pattern for each medication

This policy section covers SelectHealth pharmacy clinical policy criteria across multiple medications that require prior authorization. It includes FDA‑approved indication confirmation, required supporting medical information (often genetic/molecular test results or documented prior therapy failures), exclusion criteria, prescriber and age limits where applicable, Part B prerequisites when relevant, and typical coverage durations. Many drugs in the formulary have step‑therapy or trial-of-therapy requirements and may require documentation of intolerance or contraindication to alternatives.

For each medication, ALL of the following general elements apply unless explicitly noted in the drug-specific criteria:

- FDA indication: request must be for an FDA‑approved indication for the product.

- Required medical information: provide clinical diagnosis, relevant lab/imaging/genetic or molecular test results, staging or performance status where relevant, and documentation of prior therapies or intolerance when required.

- Exclusion criteria: known hypersensitivity or contraindicated comorbid conditions must be documented; combination use exclusions are enforced where specified.

- Prescriber and age restrictions: if the policy specifies a required specialty prescriber (e.g., neurologist) or an age limit, documentation must show qualification.

- Part B prerequisite: when a Part B infusion or physician‑administered treatment is listed as a prerequisite, documentation must show the Part B therapy was attempted if required.

- Coverage duration: initial and reauthorization durations are applied as listed (e.g., Plan Year, 6 months, Initial: 6 mo with Reauthorization: Plan Year).

- Operational note: prior authorization may be denied if required genetic testing, prior therapy, or documentation of intolerance/contraindication is not provided.

Initial Therapy Criteria (selected examples)

ACTIMMUNE / Diabetes agents (representative)

Covered when ALL of the following are met:

Diabetes agents (example: MOUNJARO, TRULICITY)

Diagnosis of Type 2 diabetes mellitus (T2DM)
Trial of SGLT2/DPP4 criteria: Patient has tried and failed a 90-day trial of a sodium-glucose cotransporter-2 (SGLT2) inhibitor as evidenced by an A1c >= 7% in last 3 months OR patient has ONE of the following: reduced renal function (eGFR 45 mL/min/1.73m2 or less), recurrent genital fungal infection, recurrent urinary tract infection, intolerance to an SGLT2/DPP4 inhibitorA1c >= 7% (within last 3 months); eGFR <= 45 mL/min/1.73m2
A1c threshold: AND patient has an A1c >= 7% in the last 3 months>= 7% (within last 3 months)
Exclusion: Type 1 diabetes mellitus

ref”: “b1_0

title”: “Example: ACTIMMUNE (implicit earlier section) - Diabetes agents (MOUNJARO, TRULICITY)“

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Example: GOMEKLI (MEK inhibitor)

Covered when ALL of the following are met:

GOMEKLI (MEK inhibitor)

Diagnosis of documented NF1 mutation or diagnosis of NF1 using NIH Consensus Conference criteria inclusive of presence of a plexiform neurofibroma (PN)
Inoperable PN: PN is inoperable (cannot be completely surgically removed without substantial morbidity due to encasement/close proximity to vital structures, invasiveness, or high vascularity)
Bone marrow function: Patient has adequate bone marrow function
Prior therapy (Koselugo): Intolerance, contraindication, or documentation explaining why treatment with Koselugo is inappropriate

Example: Growth hormone products (GENOTROPIN, OMNITROPE, etc.)

Covered when ALL of the following are met according to the indication:

Growth hormone products (GENOTROPIN, OMNITROPE)

Indications (one of)
- Adult GHD: Patient has failed two stimulation tests OR has at least two other pituitary hormone deficiencies plus low IGF-1 (below age-appropriate level) OR patient established on growth hormone as a pediatric
- Pediatric GHD/ISS: Pediatric GHD or ISS: meet listing including chronic renal insufficiency criteria, height more than 2 SD below mean or less than 3rd percentile, failed to catch up by age 2 for SGA
- Turner Syndrome: confirmed by karyotype/fibroblast studies and height criteria and growth velocity <4 cm/yr or <10th percentileheight velocity <4 cm/yr

Continuation / Reauthorization Criteria

Reauthorization requirements (aggregated)

Reauthorization is required for several medications — evidence of benefit, stability, or lack of progression must be provided as specified below:

GOMEKLI reauthorization: Reauthorization: Patient must not have centrally confirmed radiographic disease progressionNo radiographic progression
TAVALISSE reauthorization: Reauthorization: Platelet count is greater than 50,000/microL> 50,000/microL
Initial platelet count requirement < 50,000/microL
TAVNEOS reauthorization: Reauth: Patient has experienced improvement in BVAS scoreImproved BVAS score
Exclusion: patient requiring dialysis
VONJO reauthorization: Reauthorization: CBC and platelet count required; if platelets > 50,000/mm3, Vonjo is no longer indicatedPlatelets <= 50,000/mm3 to continue
Initial requirement: platelets below 50,000/mm3
VORANIGO reauthorization: Reauthorization: Patient does not have imaging-based (MRI) disease progressionNo MRI progression
Initial: MRI-evaluable, measurable, non-enhancing disease required
Other reauthorization nodes: Additional drugs require reauthorization evidence of clinical benefit or stability as listed (e.g., WELIREG: patient stable on therapy; Chond examples)
Providers must submit follow-up labs/imaging or clinical scores where required

Exclusion Criteria & Not Covered Scenarios

Common exclusion criteria (aggregated)

Common exclusions called out across multiple medication entries — aggregated as branch nodes:

Aggregated exclusions

Type 1 diabetes exclusion: Exclusion: Type 1 diabetes mellitus (applies to GLP-1/diabetes agent entries)
Referenced for MOUNJARO/TRULICITY and other diabetes agents
Previous MEK inhibitor exclusion: Exclusion: Previous treatment with a prior MEK inhibitor (applies to GOMEKLI)
Combination biologic/JAK inhibitor exclusions: Exclusion: Combination therapy with another biologic medication, JAK inhibitor, or Otezla (applies to multiple biologic entries)
Examples include Amjevita/Hadlima, Xolair, Pyzchiva/Tyenne, etc.
Pregnancy exclusion: Exclusion: Pregnancy (e.g., VERQUVO excludes pregnancy)
Dialysis exclusion: Exclusion: Patient currently requires dialysis (e.g., TAVNEOS)
Other per-drug exclusions: Other drug-specific exclusions aggregated (e.g., impaired responsiveness to PTH for YORVIPATH; use in combination with Onpattro/Tegsedi for VYNDAMAX)
See Required Medical Information/Exclusion sections per drug

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for each listed medication. Approvals are contingent on meeting the medication-specific required medical information and criteria documented in the policy.

PA required for all medications in this policy (e.g., Actimmune, Akeega, Alecensa, Radicava ORS, Alunbrig, etc.).
Approval depends on submission of medication-specific required medical information outlined in the policy.

Documentation Required

Submit required documentation for PA

Submit the following documentation with the prior authorization request. Lack of complete documentation may delay or result in denial of the request.

Relevant diagnosis and supporting clinical notes.
Prior therapy history including dates, doses, response, and reasons for discontinuation (failure, intolerance, or contraindication).
Genotype/mutation testing and laboratory results when required by the medication-specific criteria (must include test name, result, and date).
Relevant laboratory values (e.g., serum testosterone levels, LDL, triglycerides, SARA scores, ECOG status) where specified by the medication criteria.
Clinical rationale when a medication is being used because of contraindication or intolerance to preferred agents.

Billing Rule

Part B prerequisite

Satisfy Part B billing prerequisites when indicated and follow plan-specific billing rules prior to or at time of claim submission.

When a medication or administration is covered under Part B, confirm Part B eligibility and document any prerequisite steps or approvals before billing.

Billing Rule

Coverage duration enforcement

Coverage durations specified in the policy will be applied and enforced at approval and during adjudication.

Examples: many agents default to Plan Year duration; some agents specify Initial and Reauthorization durations (e.g., Juxtapid: Initial 6 months, Reauthorization Plan Year; Aqneursa: 6 months).

Documentation Required

Reauthorization requirements

For reauthorization, submit objective evidence demonstrating continued benefit or stability as required by the medication-specific reauthorization criteria.

Provide follow-up labs, imaging, validated scale scores, or clinical notes showing lack of disease progression or clinical improvement (for example: RECIST measurements, SARA scores, stable/improved testing results).
Include documentation of ongoing tolerability and adherence.

Denial Risk

Exclusion criteria enforcement

Requests meeting one or more exclusion criteria will be denied. Verify exclusions before submitting a PA request.

Example exclusions: hypersensitivity to the drug or its production source (e.g., Actimmune or E. coli–derived products), combination with prohibited agents (e.g., ArcAlyst with TNF-inhibitors), or specific comorbid conditions listed in the medication section (e.g., significant hepatic disease or alcohol abuse for Juxtapid).
Claims that meet an exclusion criterion will be denied per policy.

Denial Risk

Claims will be denied if exclusion criteria are met

Claims will be denied if exclusion criteria are met or required supporting documentation is not provided.

Denial risks include missing genotype confirmation when required, absent prior therapy failure documentation, or lack of specified laboratory values.

Documentation Required

Mutation/genotype and testing documentation

When a medication requires molecular confirmation (mutation, genotype, or specific biomarker), provide FDA‑approved test results or equivalent validated testing documentation.

Include the test name, method, laboratory performing the test, date, and the specific mutation or genotype result (e.g., ALK-positive, PDGFRA D842V, FGFR3 alteration, BRCA mutation).
If alternate testing was used, provide validation or rationale if acceptable per policy.

Documentation Required

Trial and failure documentation

Document prior therapy failures, intolerances, or contraindications as required by medication-specific criteria. Provide dates, durations, and reasons for discontinuation.

Examples: trial and failure of specific agents (e.g., prior Lynparza required before Akeega approval if indicated), documented failure/intolerance to Alecensa before Alunbrig, prior statin therapy and documented intolerance before Juxtapid, or prior therapy including platinum agents for certain ovarian cancer regimens.
Include objective evidence when available (clinical notes, lab/imaging results, or specialist consultation).

Documentation Required

Specialty prescriber required for some indications

Some indications require a specialty prescriber. Verify and document prescriber type when required by the medication-specific section.

Example: Neurologist required for Aqneursa; other agents may require oncology, geneticist, or other specialty prescribers per the medication criteria.

Clinical Evidence Notes

The brief contains no structured evidence entries (the evidence array is empty) but many medication-specific criteria rely on required diagnostic testing, genotype/mutation confirmation, and numeric laboratory thresholds (for examples see genotype/testing and numeric thresholds such as A1c >= 7% (within last 3 months), eGFR <= 45 mL/min/1.73m2, UPCR >= 1.5 g/g, platelets < 50,000/microL, serum K > 5.1 mmol/L, UFC >= 1.5x ULN).

Guidance for populators: surface trial- and study‑specific numeric thresholds from the brief's thresholds[] into key_value fields or embed them directly as numeric criteria nodes inside each medication's criteria tree. Do not duplicate these numbers as separate metric_cards; instead embed the concrete thresholds within the drug-specific criteria where they are used for decisioning.

Referenced clinical thresholds

A1c (diabetes agents)>= 7% (within last 3 months)

eGFR (SGLT2 contraindication / VELTASSA criterion)<= 45 mL/min/1.73m2 (SGLT2 contraindication); VELTASSA eGFR 15–60 mL/min for eligibility

Proteinuria (FILSPARI / TARPEYO)UPCR >= 1.5 g/g

Platelet counts (TAVALISSE initial / reauth)Initial: < 50,000/microL; Reauth: > 50,000/microL

BMI (WEGOVY) / ZEPBOUND BMI requirementWEGOVY: BMI >= 27; ZEPBOUND: BMI >= 30 kg/m2

ZURZUVAE timing and durationInitiation <= 12 months after delivery; Maximum duration = 14 days per pregnancy

ZEPBOUND OSA severity (AHI) and prescriptive thresholdAHI >= 15 events/hour (laboratory or home sleep study)

YORVIPATH hypoparathyroidism duration and labs>= 26 weeks duration; 25(OH) vitamin D 20–80 ng/mL; albumin-adjusted serum calcium > 7.8 mg/dL

Serum potassium (VELTASSA)> 5.1 mmol/L on two separate screenings

Myalept baseline leptin< 8 ng/mL (males) or < 12 ng/mL (females)

Livtencity CMV DNA threshold> 2730 IU/mL in whole blood or > 910 IU/mL in plasma

XTANDI PSA doubling timePSA doubling time < 10 months (nmCRPC)

XOLAIR allergic asthma IgE and weight limitsIgE >= 30 IU/mL; weight < 330 lbs (150 kg) for allergic asthma dosing

Background

Background: This text is part of a broader SelectHealth pharmacy clinical policy that enumerates medications requiring prior authorization. It is labeled as part 2 of 5 and contains drug-specific PA rules used to determine initial coverage decisions and reauthorization requirements.

This section organizes each medication entry to state PA indication indicators, exclusion criteria, required medical information (diagnosis, testing, prior trials, labs), coverage duration, and prescriber/age restrictions; it is intended to be used operationally to adjudicate PA requests and to instruct providers on documentation needed for approval.

Definitions: Key terms used in this policy include: PA Indication Indicator — the label that indicates which indications are subject to prior authorization (examples: 'All FDA-Approved Indications', 'Some FDA-Approved Indications', 'All Medically-Accepted Indications'); and NIA — notation meaning 'Not Indicated / Not Applicable' used throughout the document to mark absent or not-applicable fields.

MOUNJARO	Tirzepatide (listed as medication in policy)
TRULICITY	Dulaglutide
GOMEKLI	MEK inhibitor (policy entry)
GENOTROPIN	Growth hormone
HAEGARDA	Hereditary angioedema prophylaxis
ORLADEYO	Hereditary angioedema prevention
LEDIPASVIR-SOFOSBUVIR	Hepatitis C antiviral
IBRANCE	Palbociclib
IMBRUVICA	Ibrutinib
KALYDECO	Ivacaftor

XGEVA	denosumab
XHANCE	fluticasone propionate exhalation delivery system (nasal)
XIFAXAN	rifaximin
XOLAIR	omalizumab
XOSPATA	gilteritinib
XPOVIO	selinexor
XTANDI	enzalutamide
YORVIPATH	recombinant parathyroid hormone (1-34) - teriparatide analog (brand specific)
NEUPOGEN	filgrastim
RELEUKO	biosimilar filgrastim

OpenPayer

ACTIMMUNE_Medication_Criteria

Coverage Summary

Initial Therapy Criteria (selected examples)

Continuation / Reauthorization Criteria

Exclusion Criteria & Not Covered Scenarios

Applicable Codes

Provider Actions & Prior Authorization Requirements

Clinical Evidence Notes

Background

Revision History