HealthPartners Part D Prior Auth Coverage | OpenPayer
CurrentHealthPartnersPolicy N/A
2026 Medicare Part D Prior Authorization Requirements — Part D formulary coverage criteria
Lists prior authorization requirements, criteria, and coverage details for multiple prescription drugs on the HealthPartners 2026 Medicare Part D formulary; applies to Part D benefits and prescribers/providers submitting PA requests.
Policy Summary
PayerHealthPartners
PolicyMedicare Part D prior authorization and coverage criteria for selected drugs (Part D formulary)
Policy CodePolicy N/A
Change TypeTechnical/periodic review (no material changes)
Effective DateApr 1, 2026
Next Review DateN/A
Key ActionSubmit prior authorization with required diagnostic documentation and evidence of prior therapy trials or contraindications as specified for the requested drug.
No material clinical or coverage changes in this revision.
26132formulary FID
04/01/2026effective date
12 monthscommon duration
Yesprerequisite therapy
multiplePA drugs shown
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Coverage Criteria (Per-Drug Entries)
Dalfampridine — Initial therapy criteria
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for dalfampridine (e.g., improvement of walking in multiple sclerosis)
Patient is currently able to walk 25 feet
Physician attestation that the patient has difficulty walking
Deferasirox — Initial therapy criteria
Covered when ALL of the following are met:
ANY of the following
Diagnosis of chronic iron overload due to a non‑transfusion dependent thalassemia syndrome with BOTH: (a) liver iron concentration (LIC) ≥ 5 mg Fe/g dry weight, and (b) serum ferritin > 300 mcg/L
OR diagnosis of chronic iron overload due to blood transfusions with BOTH: (a) ongoing regular blood transfusions for conditions such as thalassemia syndromes, MDS, chronic anemia, or sickle cell disease, and (b) serum ferritin > 1,000 mcg/L prior to starting therapy
Enbrel — Coverage criteria
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for Enbrel (etanercept)
For rheumatoid arthritis: moderate–severe disease with medical contraindication or inadequate response to methotrexate, hydroxychloroquine, leflunomide, or sulfasalazine for at least 3 months
For juvenile idiopathic arthritis: medical contraindication or inadequate response to one NSAID or methotrexate for 1 month (as applicable)
For plaque psoriasis: ≥3% BSA or involvement of palms/soles/face/scalp/genital regions or pustular psoriasis with inadequate response to topical corticosteroids for 4 weeks or systemic therapies as appropriate
Patient does not have an FDA‑labeled limitation of use or contraindication to therapy
Glutamine — Coverage criteria
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for oral glutamine
Documentation supporting the intended use (e.g., management of chemotherapy‑induced mucositis as per labeled/compendia guidance)
Epidiolex — Coverage criteria
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for cannabidiol (Epidiolex)
Documentation of the specific seizure disorder (e.g., Lennox‑Gastaut syndrome, Dravet syndrome, tuberous sclerosis complex) with prior trials of appropriate standard therapies or contraindication/intolerance to them
Teriparatide — Initial and renewal criteria
Covered when ALL of the following are met:
ALL of the following
Diagnosis of osteoporosis in a patient at high risk for fracture (or other FDA‑approved indication for teriparatide)
Documentation of prior fracture or failure/intolerance to conventional osteoporosis therapies (e.g., bisphosphonates) unless contraindicated
Diagnosis of an FDA‑approved indication for the immunoglobulin product (e.g., primary immunodeficiency, CIDP maintenance, MMN, ITP as specified per product)
Confirmatory diagnostic testing or documentation supporting the indication (e.g., immunoglobulin deficiency testing for primary immunodeficiency; electrophysiologic and clinical confirmation for CIDP/MMN)
Patient does not have an FDA‑labeled limitation of use or contraindication to therapy
GATTEX — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of short bowel syndrome with intestinal failure requiring parenteral support, with documentation of malabsorption and need for intestinal rehabilitation (GATTEX [teduglutide] indication)
Documentation that patient is being managed in an appropriate multidisciplinary program and goals for reducing parenteral support are established
GLP‑1 receptor agonists — Coverage criteria
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for a GLP‑1 receptor agonist (e.g., type 2 diabetes; other FDA‑approved uses)
Documentation confirming diagnosis of type 2 diabetes (ICD‑10 code, medical records, chart notes, A1C or lab results) when used for diabetes
Hadlima — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis consistent with an FDA‑approved indication for Hadlima (adalimumab) or biosimilar
Documentation of prior therapy or contraindication per indication and any relevant step‑therapy (as required)
Ibrutinib (Imbruvica) — Coverage criteria
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for ibrutinib (Imbruvica/Imbruvica tablets) such as CLL/SLL, mantle cell lymphoma, WM, cGVHD after failure of at least one systemic therapy, consistent with product labeling
For tablet formulations (140 mg, 280 mg) provide rationale if unable to use preferred capsules/tablets or listed preferred strengths/forms
Ibrance — Coverage criteria
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for palbociclib (Ibrance) or other indicated agent
Documentation supporting indication (e.g., HR+/HER2‑ advanced/metastatic breast cancer) and use in accordance with labeled/compendia guidance
Diabetes supplies — Part D coverage condition
Part D coverage condition: covered when ALL of the following are met:
ALL of the following
Supplies are for use by a patient enrolled in the Part D plan and consistent with a covered outpatient medication under Part D (e.g., insulin administration supplies when insulin is covered under Part D)
Documentation supports that the supplies are necessary for administration or monitoring of a Part D‑covered drug (e.g., syringes, sharps disposal, glucose test strips when Part D covers the associated medication under plan rules)
Kerendia — Initial and renewal
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for Kerendia (finerenone), such as chronic kidney disease associated with type 2 diabetes per labeling
Documentation of baseline eGFR and albuminuria consistent with labeled indication and that patient is on optimized renin‑angiotensin system therapy as appropriate
Kesimpta — Initial
Covered when ALL of the following are met:
ALL of the following
Diagnosis consistent with an FDA‑approved indication for Kesimpta (ofatumumab) and documentation of prior therapies or contraindications per disease‑specific requirements
Kineret — Initial and renewal
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for anakinra (Kineret) such as rheumatoid arthritis or other labeled inflammatory disorders
Documentation of prior therapies and medical necessity where applicable
Kisqali / Femara — Initial and renewal
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication requiring combination endocrine therapy such as HR+ advanced/metastatic breast cancer where ribociclib (Kisqali) and letrozole (Femara) use is indicated
Documentation supporting indication and prior/concurrent therapies per guideline or compendia recommendations
Lidocaine patch & Linezolid — Initial and renewal
Covered when ALL of the following are met:
ALL of the following
Diagnosis and intended use consistent with labeled indications for lidocaine patch or linezolid
Documentation of prior therapies, medical necessity, and appropriate monitoring (e.g., for linezolid: duration limits, drug interaction review) as clinically indicated
LIVTENCITY — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for Livtencity (maribavir) such as treatment of post‑transplant CMV infection that is refractory to or resistant to available antivirals
Documentation of CMV viremia and prior antiviral therapy/resistance testing as appropriate per labeling
MAVYRET — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of chronic hepatitis C infection for which MAVYRET (glecaprevir/pibrentasvir) is indicated per labeling
Documentation of genotype and prior treatment history per labeling/compendia and absence of contraindications
LYNPARZA — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for olaparib (LYNPARZA) such as BRCA‑mutated ovarian or breast cancer per labeling
Documentation of genetic testing results when indicated and prior therapy history consistent with labeled use
Nitazoxanide — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of nitazoxanide‑responsive condition per FDA or compendia (e.g., cryptosporidiosis in certain populations) and documentation supporting need
Nitisinone — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for nitisinone and supporting confirmatory testing (e.g., hereditary tyrosinemia type 1) per labeling
Otezla — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of psoriasis or psoriatic arthritis where apremilast (Otezla) is indicated, or other FDA‑approved indication
Documentation of prior topical and/or systemic therapy trials or contraindications per indication
Pirfenidone — Initial therapy for IPF
Covered when ALL of the following are met:
ALL of the following
Diagnosis of idiopathic pulmonary fibrosis (IPF) where pirfenidone is indicated
Documentation of pulmonary function testing and prior therapies as appropriate
Repatha — Hyperlipidemia (HeFH/ASCVD/HoFH)
Covered when ALL of the following are met:
ALL of the following
Diagnosis of hyperlipidemia consistent with FDA‑labeled indications for Repatha (evolocumab) such as HeFH, clinical ASCVD requiring additional LDL lowering, or HoFH
Documentation of baseline lipid values and prior trial of maximally tolerated statin therapy (and ezetimibe when appropriate) unless contraindicated
Rezdiffra — Initial and renewal therapy
Initial therapy criteria (covered when ALL are met):
ALL of the following
Diagnosis of nonalcoholic steatohepatitis (NASH)/MASH with moderate–advanced fibrosis when Rezdiffra (investigational/approved as per labeling) is indicated per labeling or compendia
Documentation of fibrosis stage and other baseline evaluations supporting therapy selection
Signifor (Cushing's disease) — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of Cushing disease where pasireotide (Signifor) is indicated per labeling
Documentation of biochemical and clinical findings supporting need for therapy and prior surgical/other therapy status per guidelines
Sildenafil (PAH) — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of pulmonary arterial hypertension (WHO Group 1) where sildenafil is indicated per labeling, with right heart catheterization confirmation when required
Documentation that patient does not have contraindications and is managed by a cardiologist or pulmonologist
Sirturo (MDR‑TB) — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of multidrug‑resistant tuberculosis (MDR‑TB) for which bedaquiline (Sirturo) is indicated per guidelines
Documentation of prior TB treatment history, drug susceptibility testing, and specialist (infectious disease/pulmonology) management
Rubraca — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for rucaparib (Rubraca) and supporting genetic testing where indicated
Documentation of prior therapies per labeling/compendia
NORDITROPIN — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis and documentation supporting growth hormone use per FDA‑approved indications for Norditropin (e.g., growth hormone deficiency)
NORDITROPIN — Renewal
Covered when ALL of the following are met:
ALL of the following
For renewal of NORDITROPIN: documentation of continued clinical benefit, growth velocity or other appropriate markers, and specialist follow‑up
SOMAVERT — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of acromegaly where pegvisomant (Somavert) is indicated per labeling
Documentation of prior therapies, IGF‑1 levels, and specialist management
STELARA — Initial therapy and step therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for ustekinumab (Stelara) and documentation of prior therapies or contraindications per step‑therapy requirements
For initial therapy, failure or intolerance to preferred agents as specified in disease‑specific criteria (step therapy) must be documented
TRIKAFTA — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of cystic fibrosis with at least one F508del mutation or other mutation responsive to elexacaftor/tezacaftor/ivacaftor (Trikafta) per labeling
Documentation of genetic testing confirming mutation(s) and prior therapy history as appropriate
TRIKAFTA — Renewal
Renewal criteria (covered when ALL are met):
ALL of the following
For Trikafta renewal: documentation that patient has been seen by prescriber within the past 12 months and that medication has demonstrated efficacy (e.g., stabilized or improved pulmonary function)
Tadalafil (PAH) — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of PAH where tadalafil is indicated and right heart catheterization confirmation provided when required by indication
Documentation of prior/contraindicated therapies and specialist management
VENCLEXTA — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for venetoclax (VENCLEXTA) with appropriate disease and molecular testing as required (e.g., CLL with 17p deletion, AML with IDH mutation where indicated)
Documentation of prior therapies and treatment plan including dose ramp‑up and tumor lysis prophylaxis as clinically required
VERQUVO — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis of heart failure with reduced ejection fraction where Verquvo (vericiguat) is indicated per labeling
Documentation of guideline‑directed medical therapy trials or intolerance to components and specialist/cardiology involvement
Voriconazole — Indications
Covered when ALL of the following are met:
ALL of the following
Diagnosis of an FDA‑approved indication for voriconazole and documentation of invasive fungal infection requiring therapy
Prior therapy trials or contraindications documented per indication (e.g., intolerance to other azoles) when required
Vosevi — Initial therapy
Covered when ALL of the following are met:
ALL of the following
Diagnosis and documentation supporting use of Vosevi (sofosbuvir/velpatasvir/voxilaprevir) per labeled hepatitis C treatment indications
Documentation of prior DAA therapy and resistance profile when applicable
Initial coverage criteria — rifaximin / DIFICID
Covered when ALL of the following are met:
ALL of the following
Diagnosis of recurrent C. difficile infection where rifaximin or fidaxomicin (DIFICID) criteria apply
Documentation of prior therapies and clinical course per product‑specific initial coverage criteria
Initial coverage criteria — XOLAIR (omalizumab)
Covered when ALL of the following are met:
ALL of the following
Diagnosis of eosinophilic or allergic disease for which omalizumab (Xolair) is indicated and documentation of prior therapies or biomarkers as required (e.g., IgE levels, eosinophil counts) per labeling
Initial coverage criteria — YESINTEK
Covered when ALL of the following are met:
ALL of the following
Diagnosis and documentation supporting use of YESINTEK per labeled indications
Initial coverage criteria — Zejula
Covered when ALL of the following are met:
ALL of the following
Diagnosis and documentation supporting use of Zejula (niraparib) per labeled indications, including genetic testing when indicated
Initial coverage criteria — Zurzuvae
Covered when ALL of the following are met:
ALL of the following
Diagnosis and documentation supporting use of Zurzuvae per labeled indications
Initial Therapy Criteria (Grouped Examples)
Imbruvica — Initial and Renewal
Covered when ALL of the following are met:
Imbruvica initial: Diagnosis of an FDA‑approved indication not otherwise excluded from Part D.
For some entries prescriber must be or consult a hematologist; renewal requires seen within last 12 months and positive response
Imbruvica dosing and renewal: Limited to dose within FDA‑labeled dosing guidelines; renewal requires patient seen within last 12 months and positive response.
Coverage duration varies by entry (6 or 12 months)
Inqovi — Initial and Renewal
Covered when ALL of the following are met:
Inqovi initial criteria:
Continuation and Renewal Criteria
Abiraterone continuation
Renewal/continuation rules noted where specified.
Abiraterone continuation: Renewal requires positive response to therapy and documentation per policy.
Coverage duration: six months per authorization
Prolastin-C continuation
Prolastin‑C continuation requirements
Prolastin-C continuation: Patient must have been seen within the past 12 months and show positive response to therapy for renewal.
Prior authorization required. Initial requests must document diagnosis of an FDA‑approved indication not excluded from Part D, completion of genetic testing if required with results supporting abiraterone use (when applicable), and absence of any FDA‑labeled limitation of use or contraindication unless supported by NCCN. If requesting the 500 mg tablet provide rationale why the 250 mg tablet cannot be used. Limit dosing to within FDA‑labeled guidelines; coverage duration: six months. Renewal requires documented positive response to therapy.
Step Therapy
Actemra — step therapy and PA
Prior authorization required. Initial approval requires diagnosis of one of the listed indications and inadequate response or medical contraindication to preferred drugs as specified (e.g., RA or polyarticular JIA: inadequate response to at least two preferred agents). Prescriber should be or consult a rheumatologist or pulmonologist. Do not use concurrently with other biologic therapies. Coverage duration: 12 months.
Coding and Affected Products
Part D / Covered NDCs and drug productsmixedCovered
GAMUNEX-C
GAMUNEX-C immune globulin
GATTEX 30-VIAL
GATTEX (alpha-1 proteinase inhibitor) 30-vial
GATTEX ONE-VIAL
GATTEX one-vial presentation
HADLIMA
HADLIMA biosimilar (adalimumab)
HADLIMA PUSHTOUCH
HADLIMA PushTouch device
HADLIMA(CF)
HADLIMA cystic fibrosis presentation
HADLIMA(CF) PUSHTOUCH
HADLIMA(CF) with PushTouch
HIZENTRA
HIZENTRA subcutaneous immune globulin
IBRANCE
IBRANCE (palbociclib)
INBRIJA INHALATION CAPSULE
INBRIJA levodopa inhalation capsules
1–10 of 42
1/5
Step Therapy Requirements
Step requirement
Details
Step through preferred agents before Actemra
Actemra initial criteria require inadequate response or medical contraindication to at least two preferred drugs for the indicated condition (examples: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis — preferred drugs listed include Hadlima, Simlandi, Rinvoq; giant cell arteritis requires inadequate response to at least one preferred drug). Prescriber restriction: prescribed by or in consultation with a rheumatologist or pulmonologist. Coverage duration: 12 months.
Step requirement
Details
Step through preferred antidepressants before listed agents
For new starts of certain antidepressant products, approval requires diagnosis of an FDA‑approved indication and prior inadequate response or medical contraindication to two preferred alternative antidepressants (examples: trials of two listed alternatives such as SSRI/SNRI/class agents). Prescriber: typically neurology/psychiatry as indicated. Coverage duration: 12 months.
Requirement
Examples / Notes
Required prior trials of specified alternatives before approval
Several products require documented inadequate response or contraindication to specified alternative therapies prior to approval. Examples: antipsychotics require failure/contraindication to two alternatives (lurasidone, risperidone, ziprasidone, olanzapine, quetiapine, aripiprazole); CIMZIA and similar biologics require failure or contraindication to at least two preferred drugs specific to each indication (preferred lists enumerated per disease). Documentation of prior trials must be submitted with initial PA.
Documentation requirement
What to include
Documentation of prior therapy trials or contraindications required as part of initial PA.
Initial prior authorization requests must include evidence of prior inadequate response or medical contraindication to the specified preferred or first‑line therapies (e.g., CIMZIA, COSENTYX, DUPIXENT). For biologics and specialty agents include therapy names, durations, and reason for discontinuation (failure or intolerance). Prescriber specialty consultation/notes should be included when required.
Prior therapy requirement
Examples / Thresholds
Failure or contraindication to specified prior therapies required before coverage.
Examples: Enbrel — inadequate response to at least one preferred adalimumab agent (Hadlima, Simlandi) or specified conventional therapies; Glutamine (sickle cell) — ≥2 painful crises in prior 12 months despite hydroxyurea unless contraindicated; Epidiolex — inadequate response to two antiseizure medications; Teriparatide — inadequate response to another osteoporosis therapy (e.g., bisphosphonates). Documentation of prior trials and durations required.
Requirement
Details
Trial of specified conventional therapies prior to biologic (Hadlima)
Hadlima initial approval requires prior trial and inadequate response or contraindication to specified conventional therapies depending on indication (examples: methotrexate, hydroxychloroquine, leflunomide, or sulfasalazine for rheumatoid arthritis; NSAID or methotrexate for juvenile idiopathic arthritis; topical/systemic therapy durations noted). Documentation of trials and durations must be provided with PA.
Requirement
Policy detail
Use preferred Imbruvica strengths/forms unless intolerance or contraindication documented
Imbruvica authorization specifies preferred strengths/formulations (capsules 70 mg/140 mg, 420 mg tablet, 70 mg/mL suspension). Requests for certain tablet strengths (140 mg and 280 mg) require documentation of intolerance or medical contraindication to preferred strengths/forms. Renewal requires recent visit and positive response; coverage duration typically six months.
Requirement
Examples
Proof of prior therapy failure or contraindication required before approval.
Examples: Inqovi (MDS) — inadequate response or contraindication to azacitidine (Part B before Part D for some beneficiaries); Jaypirca entries — prior therapies including BTK/BCL‑2 inhibitors as specified; Kisqali — prior inadequate response or contraindication to a preferred drug such as Verzenio or Ibrance. Providers must submit documentation of prior trials/failures or contraindications with the PA request.
Requirement
Details
Trial of high-intensity statin plus ezetimibe for minimum 8 weeks or documented statin intolerance
For PCSK9/adjunct lipid therapies (example NEXLETOL, Repatha), prior trial of a high‑intensity statin plus ezetimibe concomitantly for at least 8 weeks with LDL remaining above goal (e.g., >70 mg/dL) is required unless documented statin intolerance (e.g., rhabdomyolysis to one statin or unresolved muscle symptoms to both atorvastatin and rosuvastatin). Documentation of statin/ezetimibe trial duration and LDL values must be provided.
Requirement
Details
Required prior antibiotic trial or documented resistance
For travelers' diarrhea due to noninvasive E. coli, approval of rifaximin (or related agents) requires trial and failure or contraindication to one of ciprofloxacin, levofloxacin, ofloxacin, or azithromycin, or documented resistance to all listed antibiotics. Documentation of antibiotic trials or resistance must be submitted with PA. Coverage duration for travelers' diarrhea is typically 3 days; IBS‑D and hepatic encephalopathy have different duration rules.
Quantity Limits and Duration
inv-469: abiraterone dose restriction
Quantity restrictionAbiraterone dosing must be limited to doses within FDA-labeled dosing guidelines.
Provider actionIf 500 mg tablet requested, provide rationale why 250 mg tablet cannot be used.
Coverage duration noteInitial authorization: six months when criteria met.
inv-470: Adempas dose restriction
Quantity restrictionAdempas dosing limited to doses within FDA-labeled dosing guidelines.
Clinical documentationPrior authorization requires right heart catheterization confirmation for Group 1 PAH (mPAP ≥20 mmHg, PCWP ≤ 15 mmHg, PVR >2 WU).
Site of Care & Part B vs Part D Determinations
Note
Site‑of‑care — Part B vs Part D may affect coverage
Confirm whether administration or dispensing setting affects benefit (Part B vs Part D). For some drugs (e.g., certain immunoglobulins, amphotericin products, Gammagard Liquid, Vivtencity, Xatmep) providers must supply the setting/use details to determine correct coverage.
Note
Site‑of‑care — provide setting when requested
Some drugs may be covered under Part B or Part D depending on setting; provide information about the administration/dispensing setting when requested to determine the correct benefit (examples include immunoglobulins and certain injectables/infusion drugs).
Note
Immunoglobulins — setting may determine Part B vs Part D
Certain immunoglobulin products may be covered under Part B or Part D depending on circumstance and setting; submit setting details (infusion center vs home) and indication to support correct benefit determination.
Background and Rationale
This policy provides clinical context and documentation expectations tied to specific drug indications. It is intended to guide the information required for prior authorization rather than offer full clinical guidance. Key elements include hemodynamic criteria for pulmonary arterial hypertension (right heart catheterization thresholds), pretreatment laboratory thresholds (e.g., alpha‑1 antitrypsin levels), and specialty prescriber recommendations. Providers should supply indication‑specific diagnostics, evidence of prior therapies or contraindications where required, and attestations (for example, inhaler education or diet/exercise counseling) to support PA requests.
Definitions and Diagnostic Thresholds
inv-397: Right heart catheterization confirmation for Group 1 PAH
RequirementRight heart catheterization confirmation for Group 1 PAH defined by: mean PAP ≥20 mmHg, PCWP ≤ 15 mmHg, and PVR >2 Wood units.
Use in policiesNeeded for PAH agents (e.g., Adempas, Opsumit, Winrevair) as part of prior authorization documentation.
PrescriberPrescribed by or in consultation with a cardiologist or pulmonologist per product-specific requirements.
ThresholdsPretreatment serum alpha-1 antitrypsin (AAT) level thresholds: <11 micromoles/L; or <80 mg/dL by radial immunodiffusion; or <57 mg/dL by nephelometry.
ContextRequired for Prolastin-C initial authorization in AAT deficiency with clinically evident emphysema.
Policy Summary
PayerHealthPartners
PolicyMedicare Part D prior authorization and coverage criteria for selected drugs (Part D formulary)
Policy CodePolicy N/A
Change TypeTechnical/periodic review (no material changes)
Effective DateApr 1, 2026
Next Review DateN/A
Key ActionSubmit prior authorization with required diagnostic documentation and evidence of prior therapy trials or contraindications as specified for the requested drug.
Diagnosis of an FDA‑approved indication AND genetic testing completed if required with results supporting use; AND for MDS inadequate response or contraindication to azacitidine (Part B before Part D may apply for MA‑PD beneficiaries).
Renewal requires positive response; coverage duration six months; limited to FDA dosing
NOH initial criteria summary: (1) Diagnosis of symptomatic neurogenic orthostatic hypotension due to specified causes; (2) orthostatic BP drop ≥20 mmHg systolic OR ≥10 mmHg diastolic within 3 minutes of standing; (3) trial/failure of at least two first‑line therapies; (4) prescriber cardiology/neurology consult recommended.see thresholds
Coverage one month then three months if renewal criteria met
Inbrija — Initial and Renewal
Covered when ALL of the following are met:
Inbrija initial criteria: Parkinson's disease with OFF episodes AND patient is taking carbidopa/levodopa AND trial and failure of at least one adjunct agent for ≥4 weeks in combination with carbidopa/levodopa AND provider attestation of inhaler education and documentation of pulmonary status (no underlying lung disease or FEV <50% with attestation benefits outweigh risks).
Prescribed by or in consultation with a neurologist; renewal requires positive response; coverage 12 months
Tolvaptan — Initial
Covered when ALL of the following are met:
Tolvaptan initial criteria: Diagnosis of ADPKD with prescriber attestation of rapidly‑progressing disease (examples: declining renal function, increasing total kidney volume) AND nephrology consultation where indicated.
Exclusions: concurrent use with Samsca (tolvaptan tablets) and patients with stage 5 CKD; prescribed by or in consultation with nephrology
INCRELEX - Initial therapy
Covered when ALL of the following are met:
INCRELEX initial criteria: Diagnosis of an FDA‑approved indication AND for severe primary IGF‑1 deficiency or GH gene deletion with neutralizing antibodies to GH: height SDS ≤ -3.0 AND basal IGF‑1 SDS ≤ -3.0.height SDS <= -3.0; basal IGF-1 SDS <= -3.0
Prescribed by or in consultation with an endocrinologist; coverage 12 months
NEXLETOL - Initial therapy
Covered when ALL of the following are met:
NEXLETOL initial criteria: Diagnosis of an FDA‑approved indication AND for HeFH or ASCVD with LDL above goal despite therapy: trial of a high‑intensity statin plus ezetimibe concomitantly for at least 8 weeks with LDL remaining >70 mg/dL OR documented statin intolerance (defined per policy).8 weeks trial; LDL >70 mg/dL
Prescriber preferably cardiology/endocrinology; coverage 12 months; limited to FDA dosing
Nucala (mepolizumab) severe asthma initial criteria
Covered when ALL of the following are met
Nucala severe asthma initial: Diagnosis of severe asthma AND pre‑treatment serum eosinophil count ≥150 cells/mcL within prior 12 months AND inadequate asthma control despite medium/high‑dose inhaled corticosteroid plus at least one other maintenance medication AND inadequate control defined by exacerbation or hospitalization criteria.>=150 cells/mcL
Renewal requires evidence of response
OFEV (nintedanib) initial criteria
Covered when ALL of the following are met (per indication):
OFEV IPF criteria: For IPF: exclusion of other ILD causes and HRCT UIP pattern OR HRCT/histopathology combinations indicative of IPF; baseline FVC ≥50% and %DLCO ≥30%; AND inadequate response or contraindication to pirfenidone.FVC >=50%; %DLCO >=30%
Prescribed by or in consultation with pulmonology/rheumatology; coverage 12 months; renewal requires visit within 14 months and positive response
OFEV progressive ILD criteria: For chronic fibrosing ILD with progressive phenotype: >10% fibrotic features on HRCT and clinical progression (FVC decline ≥10% OR FVC decline ≥5% plus worsening symptoms/imaging) with baseline FVC ≥45% and %DLCO ≥30%.FVC >=45%; %DLCO >=30%
Renewal: positive response
Modafinil and related agents - Initial therapy
Modafinil and related agents covered with criteria for multiple indications:
Modafinil initial criteria (selected): Diagnosis of an FDA‑approved indication AND for OSA: either ≥15 obstructive events/hour on sleep study OR ≥5 events/hour plus at least one qualifying symptom (unless sleep study not feasible); for narcolepsy: confirmatory polysomnography and MSLT unless not feasible; for shift‑work disorder: sleep study demonstrating disturbed sleep‑wake pattern with exclusion of other causes; adjunctive uses require prior therapy trials as specified.OSA thresholds per sleep study
Initial coverage 6 months then 12 months if renewal criteria met; may not be used concurrently with armodafinil
General renewal: Renewal generally requires positive response to therapy and documentation of recent follow‑up visit (examples: BENLYSTA within 14 months; ATTRUBY within 12 months; many products require evidence of efficacy).
Coverage durations commonly 12 months on renewal
Renewal requirements
Renewal conditions across listed biologics:
Biologic renewal: Renewal typically requires evidence that treatment goals have been met or positive clinical response as judged by the provider; typical renewal interval is 12 months for many biologics such as CIMZIA and COSENTYX.
CRESEMBA continuation
CRESEMBA renewal:
CRESEMBA renewal: Positive response to therapy to extend coverage from initial 3 months to 6 months.
General renewal requirements
Renewal/continuation commonly requires:
Renewal common requirements: Positive response to therapy documented and periodic clinician follow‑up (examples: OFEV requires seen within last 14 months); coverage durations commonly 12 months on renewal.
Venclexta continuation
Venclexta renewal
Venclexta renewal: Renewal requires documented positive response to therapy.
Coverage duration six months
Renewal rules
Renewal/continuation requirements where specified
Imbruvica renewal: Patient has been seen within the last 12 months and demonstrates positive response to therapy.
Coverage duration varies by entry
Kalydeco renewal: Patient has been seen within the last 12 months and demonstrates positive response to therapy.
Coverage duration 12 months
CONTINUATION CRITERIA
RETACRIT renewal rules
Retacrit renewal: Indication‑specific renewal criteria (examples include hemoglobin thresholds for CKD, pediatric and cancer contexts) and evidence of continued benefit.
See product page for details
Verzenio continuation
Verzenio renewal
Verzenio renewal: Renewal requires positive response to therapy per prescriber documentation.
Coverage duration six months
Voriconazole continuation
Voriconazole renewal
Voriconazole renewal: Renewal requires positive response to therapy; coverage duration varies by indication (1 month for esophageal candidiasis; 6 months for other indications).
Prescriber specialist consultation recommended
Xdemvy continuation
Xdemvy renewal
Xdemvy renewal: Renewal requires positive response to therapy as documented by prescriber.
Coverage duration six weeks
Prior Authorization
Adempas — hemodynamics & PA
Prior authorization required for PAH/CTEPH. Submit diagnostic confirmation (right heart catheterization showing mean PAP ≥20 mmHg, PCWP ≤15 mmHg, PVR >2 Wood units for Group 1 PAH) and prescriber specialty (cardiology or pulmonology). Do not use concurrently with nitrates, nitric oxide donors, PDE inhibitors, or non‑specific PDE inhibitors. Coverage duration: 12 months.
Documentation Required
Armodafinil — sleep study & concurrency
Prior authorization required. For OSA, provide sleep study showing ≥15 obstructive events/hour or ≥5 events/hour plus qualifying symptoms (or prescriber statement if study not feasible). Do not use concurrently with modafinil or other target agents. Initial coverage 6 months; renewal to 12 months if response.
Prior Authorization
ATTRUBY — diagnostic confirmation & exclusions
Prior authorization required for ATTR‑CM. Provide cardiac biopsy or noninvasive diagnostic evidence (serum/urine immunofixation and free light chain ratio within 0.26–1.65 and myocardial 99mTc‑PYP uptake heart‑to‑contralateral ratio >1.5 or visual grade ≥2), HF history and NYHA class I–III documentation, and prescriber cardiology involvement. Do not use concurrently with ONPATTRO or TEGSEDI. Coverage: 12 months; renewal requires seen within 12 months and demonstrated efficacy.
Documentation Required
BENLYSTA — serology, prior therapy & renewal
Prior authorization required for BENLYSTA SC. Provide serologic evidence (anti‑dsDNA >30 IU/mL, low complement C3/C4, or anti‑Smith), documentation of continuation of standard‑of‑care therapy, and inadequate response or contraindication to two listed alternatives. Do not use concurrently with another biologic agent. Renewal requires positive response and visit within 14 months; coverage duration: 12 months.
Documentation Required
Bosentan — hemodynamics & liver labs
Prior authorization required for bosentan. Provide right heart catheterization hemodynamics confirming Group 1 PAH (mean PAP ≥20 mmHg, PCWP ≤15 mmHg, PVR >2 Wood units) and liver tests showing ALT/AST ≤3×ULN and bilirubin not ≥2×ULN prior to start. Do not use concurrently with cyclosporine A or glyburide. Coverage duration: 12 months.
Step Therapy
CIMZIA — step therapy, prescriber restriction
Prior authorization required. Initial CIMZIA requests must document the indication and failure or contraindication to at least two preferred drugs for that indication, and be prescribed by or in consultation with an appropriate specialist (rheumatologist, dermatologist, gastroenterologist). Concurrent use with other biologic therapies is prohibited; dose limited to FDA labeling; coverage: 12 months.
Prior Authorization
COSENTYX — PA, prescriber restriction
Prior authorization required. COSENTYX requests must document the FDA‑approved indication, prescriber specialty (dermatologist or rheumatologist), and prior therapy failures per indication. Do not use concurrently with other biologic therapies. Limit to FDA‑labeled dosing; coverage duration: 12 months.
Prior Authorization
CRESEMBA — prior therapy & coverage duration
Prior authorization required for oral isavuconazole (CRESEMBA). Document the FDA‑approved diagnosis and inadequate response or contraindication to voriconazole or posaconazole as indicated. Initial coverage is 3 months and may be extended to 6 months with positive response; prescriber should be or consult ID/transplant/hematology/oncology specialist.
Prior Authorization
Prior authorization — general requirement
Prior authorization is required for many products; initial and renewal approvals require indication‑specific clinical criteria (diagnosis, severity, required labs, prior therapy failures or contraindications) and dosing limited to FDA‑labeled guidelines.
Prior Authorization
GAMMAGARD LIQUID — PA & site‑of‑care note
PA applies to GAMMAGARD LIQUID. Submit documentation of the FDA‑approved indication (e.g., primary immunodeficiency, CIDP maintenance) and meet product‑specific exclusions; coverage duration: 12 months. Note: Part B vs Part D determination may be required based on setting.
Prior Authorization
GAMUNEX‑C — PA & documentation
PA required for GAMUNEX‑C. Provide diagnosis consistent with FDA‑approved indication (primary immunodeficiency, CIDP maintenance, ITP after intolerance to conventional therapy) and required clinical details; coverage duration: 12 months. Part B vs Part D setting may affect coverage.
Documentation Required
GATTEX — SBS documentation & dose limit
Prior authorization required for GATTEX. Document short bowel syndrome with ≥1 year parenteral nutrition dependence, inability or plan to taper PN, required colonoscopy/FOBT per age, and limit dose to 0.05 mg/kg/day (FDA dose). Coverage: 12 months.
Documentation Required
GLP‑1 agonists — diabetes documentation
PA required for GLP‑1 receptor agonists. Provide documentation confirming diagnosis of type 2 diabetes (ICD‑10, chart notes, A1C or labs). Coverage duration: 12 months.
Step Therapy
Hadlima — step therapy & concurrency
Hadlima requires prior authorization. Initial requests must meet disease‑specific criteria and document inadequate response or contraindication to required conventional therapies (step therapy). Do not use concurrently with other biologics; limit dose to FDA‑labeled dosing.
Prior Authorization
Imbruvica — formulation preference & PA
Imbruvica requires prior authorization. Provide diagnosis consistent with FDA‑approved hematologic or cGVHD indications; for certain tablet strengths (140 mg, 280 mg) document intolerance or contraindication to preferred strengths/forms. Coverage duration: six months; dose limited to FDA‑labeled dosing.
Documentation Required
Tolvaptan — ADPKD attestation & exclusions
Prior authorization required for tolvaptan (ADPKD). Submit prescriber attestation of rapidly‑progressing disease, nephrology consultation, and note exclusions (concurrent Samsca use, stage 5 CKD).
Documentation Required
Kalydeco — genetic requirement & prescriber
Kalydeco prior authorization: document diagnosis of cystic fibrosis, presence of at least one responsive CFTR mutation per in vitro data, and that patient is not homozygous for F508del. Prescriber should be or consult CF specialist/pulmonologist. Renewal requires visit within 12 months and positive response; coverage 12 months.
Documentation Required
Kerendia — labs & prior ACE/ARB trial
Kerendia prior authorization: document UACR ≥30 mg/g, eGFR ≥25 mL/min/1.73 m2, serum potassium ≤5.0 mEq/L prior to start, and trial of (or intolerance to) an ACE inhibitor or ARB. Renewal requires positive response and continued ACE intolerance or continuation; coverage 12 months.
Prior Authorization
LIVTENCITY — CMV prior therapy & concurrency
Prior authorization required for LIVTENCITY. Document active CMV infection in HSCT or SOT patients and inadequate response or contraindication to ganciclovir, valganciclovir, foscarnet, or cidofovir; prescriber must be or consult transplant/ID specialist. Do not use concurrently with those antivirals. Coverage duration: eight weeks.
Documentation Required
MAVYRET — HCV labs & drug interactions
MAVYRET prior authorization: ensure adherence to AASLD/IDSA guidance, HCV RNA within past 6 months, and that patient is not concurrently taking listed interacting drugs (e.g., carbamazepine, rifampin, certain statins, cyclosporine >100 mg/day). Prescriber should be or consult GI/hepatology/ID/transplant specialist; coverage 8–16 weeks per guideline.
Prior Authorization
LYNPARZA — indication‑specific testing & PA
LYNPARZA requires prior authorization. Initial requests must document the FDA‑approved indication and indication‑specific requirements (e.g., BRCA/HRD status or prior therapy responses). Limit dosing to FDA labeling; coverage duration: six months.
Prior Authorization
Nucala — eosinophil threshold & prior therapy
For severe eosinophilic asthma (Nucala), prior authorization requires pre‑treatment eosinophil ≥150 cells/µL within prior 12 months, inadequate control despite medium/high‑dose inhaled steroid plus another maintenance med, and defined exacerbation history; renewal requires evidence of response.
Documentation Required
Rezdiffra — diagnostic confirmation & renewal
Rezdiffra prior authorization: confirm diagnosis of MASH/NASH with moderate‑advanced fibrosis (stage F2 or F3) by liver biopsy or elastography/CT/MRI, document prescriber counseling on diet and exercise, and prescribe by or consult endocrinology/gastro/hepatology. Renewal requires ≥1 year therapy without fibrosis worsening or progression to F4.
General prior authorization requirement: providers must submit indication‑specific clinical documentation (diagnosis, labs/imaging, prior therapy trials or contraindications, specialist consults where specified) and requests are generally limited to doses within FDA‑labeled guidelines; many approvals default to 12 months.
Prior Authorization
Venclexta — PA & contraindication check
Venclexta prior authorization: document FDA‑approved diagnosis (e.g., CLL/SLL or AML in combination regimens), confirm no FDA‑labeled contraindication, and limit dosing to FDA labeling. Renewal requires documented positive response; initial coverage up to six months.
Prior Authorization
Verquvo — HF criteria & specialist consult
Verquvo prior authorization: document EF <45%, NYHA II–IV, and either ≥1 HF hospitalization in past 6 months or outpatient IV diuretics in past 3 months, plus inadequate response or contraindication to at least two guideline therapies (ACE/ARB/ARNI, beta‑blocker, aldosterone antagonist, or SGLT2). Prescriber should be or consult a cardiologist. Coverage duration: 12 months.
Documentation Required
Xalkori — genetic testing & PA
Xalkori prior authorization: provide FDA‑approved indication documentation and completion of required genetic testing with supportive results when applicable (e.g., ROS1 or ALK). Patient must not have unsupported FDA‑labeled limitations; coverage duration: six months; dose limited to FDA labeling.
Step Therapy
Xeljanz — step therapy & concurrency exclusion
Xeljanz prior authorization: document diagnosis per indication and inadequate response or contraindication to at least two preferred drugs specific to each indication. Do not use concurrently with other biologic therapies. Prescriber should be or consult rheumatology/dermatology/gastroenterology; coverage duration: 12 months.
Prior Authorization
Xifaxan/rifaximin — indication‑specific PA & dosing limits
Rifaximin (Xifaxan) PA required per indication. For hepatic encephalopathy document lactulose dose‑limiting side effects and prescriber follow‑up; for IBS‑D document inadequate response/contraindication to first‑line therapies and limit dosing to 550 mg TID for 14 days (retreatment limited to patients with prior positive response, max two 14‑day courses); for travelers' diarrhea document trial/failure or resistance to listed antibiotics (duration 3 days).
Documentation Required
Xolair — IgE testing & concurrency exclusion
Xolair prior authorization: initial requests must document the FDA‑approved indication and, for severe asthma, positive allergy testing and baseline IgE ≥30 IU/mL plus inadequate control on inhaled corticosteroid and another maintenance med. Xolair may not be used concurrently with another monoclonal antibody therapy.
Prior Authorization
Zejula & Zurzuvae — indication‑specific PA
Zejula and Zurzuvae require prior authorization. Zejula: document FDA‑approved indication and population‑specific eligibility (maintenance after response to platinum chemo); coverage six months. Zurzuvae (postpartum depression): document onset timing (third trimester or within 4 weeks postpartum) and prescriber attestation about driving/operating machinery counseling; coverage 14 days.
Note
Index — consult individual drug pages
This index lists drugs and page references only; providers must consult each drug's policy page for specific prior authorization, step therapy, documentation, and denial rules.
Requests may be denied if the patient has an FDA‑labeled limitation of use or a contraindication to the requested therapy; verify product‑specific labeled limitations/contraindications before submission.
Denial Risk
Denial risk — concurrent biologic/monoclonal antibody use
Do not approve concurrent use of listed biologic/monoclonal antibody therapies — e.g., Actemra, BENLYSTA, CIMZIA, COSENTYX, DUPIXENT, Nucala, Xolair, YESINTEK and others — unless policy explicitly allows it; concurrent biologic use is an exclusion and may trigger denial.
Denial Risk
Denial risk — missing/unsupported genetic testing
Denial risk: requests for targeted oncology agents that require genetic testing (e.g., Xalkori) will be denied if required genetic testing is not completed or results do not support use.
Documentation Required
Genetic testing — documentation required
If genetic testing is required for the requested oncology agent, include completed test results demonstrating the appropriate mutation or biomarker prior to PA submission; lack of supporting results may preclude approval (examples: Xalkori, LYNPARZA where BRCA/HRD status is required).
Coverage duration
Authorization duration: 12 months when criteria met.
inv-471: Multiple listed products dose limits
General ruleMultiple listed products: dose is limited to within FDA-labeled dosing guidelines.
Applies toBiologics, oncology agents, specialty drugs referenced throughout the policy (product-specific exceptions noted in entries).
Authorization implicationRequests exceeding FDA dosing limits require rationale and may be denied absent supporting evidence.
inv-472: Sirturo coverage duration 24 weeks
Coverage durationSirturo (bedaquiline) coverage duration specified as 24 weeks.
Use contextAuthorized for MDR-TB as part of combination regimen when resistance or adverse reactions to standard agents exist.
Prescriber requirementPrescribed by or in consultation with an infectious disease specialist.
inv-473: Signifor duration (3 months then 12 months if renewal criteria met)
RenewalThen 12 months if renewal criteria are met (for Cushing's disease: 12 months).
ContraindicationPatient must not have severe hepatic impairment for Signifor use.
inv-475: XIFAXAN dosing
Dose and regimenXIFAXAN (rifaximin) dosing for IBS-D: 550 mg three times daily for 14 days.
Other indications/durationsHepatic encephalopathy: coverage 12 months (with lactulose intolerance); travelers' diarrhea: 3 days dosing per label.
Retreatment limitsIBS-D retreatment limited to patients with prior positive response, up to two 14-day treatments.
inv-476: Rifaximin (for IBS-D) dosing limit
IBS-D dosing limitRifaximin for IBS-D: 550 mg three times daily for 14 days (retreatment limited to patients with prior positive response; max two 14-day courses).
Hepatic encephalopathyRifaximin coverage for hepatic encephalopathy requires lactulose dose-limiting side effects; coverage 12 months.
Travelers' diarrheaFor travelers' diarrhea due to noninvasive E. coli: regimen limited to 3 days with prior antibiotic trial/failure or documented resistance as specified.
inv-477: Zurzuvae 14-day treatment course
Treatment courseZurzuvae (brexanolone) limited to a 14-day treatment course for postpartum depression per policy.
Initiation requirementsOnset of symptoms must be in the third trimester or within four weeks of delivery; prescriber attestation about driving/operating machinery counseling is required.
Dose limitsDose limited to FDA-labeled dosing guidelines.
Note
Mixed Part B/Part D coverage — provide setting details
Some drugs have mixed site‑of‑care determinations; for products such as paricalcitol, PULMOZYME, or Retacrit, submit details of the dispensing/administration setting to establish benefit responsibility.
Note
Mixed coverage — document use & setting for benefit determination
Coverage may be under Part B or Part D depending on circumstances (e.g., Xatmep); documentation of the clinical use and setting may be requested to determine the correct benefit.
Documentation Required
Vowst — bowel prep & single‑course administration
Vowst administration requires completion of bowel preparation (magnesium citrate) the day before and at least 8 hours prior to initiation; confirm patient completed antibiotic therapy 2–4 days prior. Coverage limited to a single 10‑day treatment course.
RenewalRenewal requires patient seen within past 12 months and positive response to therapy.
OSA diagnostic thresholdsObstructive sleep apnea (OSA) diagnosis: >=15 obstructive respiratory events/hour on sleep study, OR >=5 events/hour plus at least one symptom (daytime sleepiness, unintentional sleep episodes, unrefreshing sleep, fatigue, insomnia, waking with breath-holding/gasping/choking, loud snoring, or breathing interruptions).
DocumentationSleep study results are required unless prescriber documents study is not feasible for armodafinil PA requests.
ApplicationUsed to determine eligibility for armodafinil for OSA per policy.
inv-400: Narcolepsy confirmation
ConfirmationNarcolepsy confirmation requires polysomnography and multiple sleep latency test (MSLT) unless prescriber documents that sleep study is not feasible.
ContextRequired for armodafinil and modafinil prior authorization when narcolepsy is the indication.
RenewalRenewal requires positive response to therapy per product criteria.
inv-401: Positive response to therapy
DefinitionPositive response to therapy: clinical improvement as judged by provider (e.g., symptom control, reduction in exacerbations, objective measures as appropriate).
Use for renewalMany products require documented positive response for renewal (e.g., BENLYSTA, Inqovi, multiple biologics).
DocumentationProvider attestation and recent visit documentation usually required (timing varies by product).
inv-402: Inadequate asthma control
Clinical definitionInadequate asthma control is defined as at least one exacerbation requiring oral systemic corticosteroids >=3 days within the last 12 months, OR at least one serious exacerbation requiring hospitalization or ER visit in the last 12 months.
ApplicationUsed for eligibility for biologics like DUPIXENT and XOLAIR requiring inadequate control despite maintenance therapy.
DocumentationProvider must document exacerbation history or hospital/ER events when requesting biologic therapy for asthma.
inv-403: Atopic dermatitis severity
Severity thresholdAtopic dermatitis considered moderate to severe when BSA >= 10% or involvement of face, neck, hands, feet, genitals, or intertriginous areas with intractable pruritus or cracking/oozing/bleeding.
UseApplied to DUPIXENT initial authorization for atopic dermatitis.
DocumentationProvider must document BSA or involvement of critical areas and prior topical therapy failures as specified.
inv-404: Eosinophilic asthma pre-treatment lab
Pre-treatment labEosinophilic asthma pre-treatment serum eosinophil count >=150 cells/mcL within the previous 12 months.
PurposeRequired for initial authorization of biologics for eosinophilic asthma (e.g., DUPIXENT, Nucala).
RenewalRenewal requires evidence of positive clinical response per product-specific criteria.
inv-405: Short Bowel Syndrome (SBS)
DefinitionShort bowel syndrome (SBS): clinical condition of insufficient intestinal length/function requiring dependence on parenteral nutrition; GATTEX initial PA requires ≥1 year PN dependence and inability or planned inability to taper PN.
DocumentationColonoscopy or fecal occult blood testing required per age group prior to GATTEX initiation.
PrescriberPrescribed by or in consultation with a gastroenterologist.
Confirmatory testsHAE diagnostic testing includes C1-INH antigenic level, C1-INH functional level, and C4 level; genetic mutations (e.g., factor XII, PLG) may establish diagnosis.
ApplicationRequired for prophylaxis (HAEGARDA) and acute treatment (icatibant) authorizations.
PrescriberPrescribed by or in consultation with hematology/allergy/immunology specialists as indicated.
inv-407: FVC
FVC baseline thresholdsForced vital capacity (FVC) baseline thresholds for antifibrotic therapy: >=50% for IPF; >=45% for certain progressive ILD.
UseRequired for OFEV and pirfenidone initial authorizations and monitoring.
RenewalRenewal commonly requires evidence of positive response and recent prescriber follow-up per product policy.
inv-408: Right heart catheterization parameters
Right heart cath parametersFor PAH confirmation: mean PAP ≥20 mmHg; PCWP ≤ 15 mmHg; PVR >2 Wood units (policy references these as required hemodynamics).
ApplicationUsed for eligibility documentation for multiple PAH therapies (Adempas, Opsumit, Winrevair, etc.).
PrescriberPrescribed by or in consultation with cardiology or pulmonology specialists per product-specific requirements.
inv-409: MASH/NASH with fibrosis staging
DefinitionMASH/NASH with fibrosis staging: diagnosis confirmed by liver biopsy or elastography/CT/MRI showing stage F2 or F3 fibrosis for Rezdiffra initial approval.
Treatment requirementMust be used in combination with diet and exercise counseling (prescriber confirmation required).
RenewalRenewal requires >=1 year of therapy without fibrosis worsening or progression to F4 (cirrhosis).
inv-410: WHO Group 1 PAH diagnostic criteria
WHO Group 1 PAH diagnostic criteriaRight heart catheterization with mean pulmonary arterial pressure ≥20 mmHg, PCWP ≤ 15 mmHg, and PVR ≥3 Wood units (policy notes PVR thresholds for some agents).
UseRequired for certain PAH agent approvals (e.g., sildenafil requires PVR ≥3 WU per policy).
DocumentationRight heart catheterization report must be submitted with PA requests when required by product-specific criteria.