CurrentIndependent HealthPolicy N/A

Medicare Part D Prior Authorization Criteria (selected drugs)

Lists prior authorization requirements for specified drugs on Independent Health's 2026 Medicare Advantage Standard Part D formulary; governs prescribers, pharmacies, and coverage determinations for affected Medicare members.

Policy Summary

PayerIndependent Health

PolicyMedicare Part D Prior Authorization Criteria (selected drugs)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with required diagnostic tests, prior therapy history, and prescriber specialty attestation before dispensing listed specialty drugs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6/1/2026document effective or update date referenced

1 yeartypical coverage duration for many products

~20+products listed in this part

restrictedprescriber restrictions common

Product-Specific Coverage Criteria

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inv-09: Dupilumab — Initial Authorization (disease-specific)

inv-09: Dupilumab — Initial Authorization (disease-specific) — Covered when ALL of the following are met (disease-specific):

ALL of the following

Diagnosis consistent with an FDA-approved indication for dupilumab for the disease submitted (e.g., atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis), with documentation of current and previous therapies used to treat the condition as specified below.
Disease-specific requirements
- Atopic dermatitis (AD): patient tried and failed, or had a contraindication or intolerance to, at least a moderate strength topical corticosteroid for at least 4 weeks, or documentation why topical corticosteroids are not advisable; provider attests to continuation of topical regimen where applicable.
- Asthma: patient on guideline-directed therapy prior to biologic (at minimum maximally tolerated inhaled corticosteroid [ICS] plus long-acting beta-agonist [LABA] and long-acting muscarinic antagonist [LAMA] as indicated); submission of pre-bronchodilator FEV1 <80% predicted (adults) or <90% (children) and either blood eosinophil count ≥150 cells/mcL within 6 weeks of initiation or documentation that asthma requires daily oral corticosteroids for control; provider attestation that background inhaled therapy will be continued.
- COPD: patient on stable standard-of-care COPD medications including ICS, LABA, and LAMA for ≥90 days unless contraindicated; documentation of symptomatic COPD defined by mMRC ≥2 or CAT score ≥10; submission of blood eosinophil count per thresholds.
- Chronic rhinosinusitis with nasal polyps (CRSwNP): patient tried an intranasal corticosteroid for ≥2 months (or has contraindication) and provider attests intranasal corticosteroid will be continued after starting dupilumab; documentation of nasal polyps and symptomatic nasal congestion.
- Eosinophilic esophagitis (EoE): submission of upper endoscopy with biopsy showing ≥15 eosinophils per high-power field (or ≥60 eos/mm²) and documentation of signs/symptoms (dysphagia, food impaction, etc.); for initial authorization, patient tried and failed at least an 8-week PPI and other indicated therapies as applicable.
- Prurigo nodularis (PN): documentation of pruritus for ≥6 weeks and presence of pruriginous firm nodular lesions; prior topical/systemic therapies documented as tried/failed or contraindicated.
For initial authorization: submission of current and previous therapies used to treat the condition, per the disease-specific items above. Provider must attest background standard-of-care therapies will be continued where required (e.g., inhalers, intranasal corticosteroids).
For reauthorization: documentation of clinical benefit (disease-specific examples: reduction in exacerbation rate, improvement/maintenance of FEV1 for asthma; reduction in nasal congestion or polyp score for CRSwNP; reduction in itch severity or lesion count for AD/PN; histologic remission or symptom improvement for EoE), or maintenance of previously achieved benefit.
Coverage duration: initially 6 months then 1 year for subsequent authorizations.

inv-26: Mepolizumab criteria

inv-26: Mepolizumab criteria — Covered when ALL of the following are met (indication-specific):

ALL of the following

Diagnosis consistent with an FDA-approved indication for mepolizumab (examples: severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome), with submission of current and previous therapies used to treat the condition where applicable.
Indication-specific requirements
- Asthma: patient on GINA-recommended regimen prior to biologic (minimum maximally-tolerated ICS plus LABA and LAMA where indicated); pre-bronchodilator FEV1 <80% predicted (adults) or <90% (children); blood eosinophil count ≥150 cells/mcL within 6 weeks of initiation or ≥300 cells/mcL within 12 months; provider attests to continuation of background inhaled therapy.
- COPD: patient on stable standard-of-care COPD medications including ICS, LABA, and LAMA for ≥90 days unless contraindicated; blood eosinophil thresholds as above; documentation patient is symptomatic (mMRC ≥2 or CAT ≥10).
- CRSwNP: documentation of nasal polyps, symptomatic nasal congestion, and trial of intranasal corticosteroid for ≥2 months or documentation of contraindication; provider attestation intranasal corticosteroid will be continued.
- Eosinophilic granulomatosis with polyangiitis (EGPA): eos percentage ≥10% or absolute eos count ≥1000 cells/mm³ in previous 6 weeks and disease duration ≥6 months relapsed/refractory to oral corticosteroids and/or immunosuppressive therapy.
- Hypereosinophilic syndrome (HES): history of ≥2 flares requiring systemic therapy in past 12 months and absolute eos ≥1000 cells/mcL in previous 6 weeks; attestation disease not secondary to non-hematologic cause.
For initial authorization: documentation of trials and failures or contraindications to appropriate prior therapies as specified above; for HES, prior use of oral corticosteroids, cytotoxic, or immunosuppressive therapy for ≥4 weeks required.
For reauthorization: confirmation patient remains on required background therapies where applicable and documentation of clinical benefit (e.g., reduction in exacerbations, systemic corticosteroid dose, symptom scores, or maintenance of previously achieved benefit).
Coverage duration: 1 year.

inv-28: Prolastin-C criteria

inv-28: Prolastin-C criteria — Covered when ALL of the following are met:

ALL of the following

Pre-treatment alpha-1 antitrypsin (AAT) level below 11 mmol/L (80 mg/dL) documented.
Clinically evident emphysema attributable to congenital alpha-1 proteinase inhibitor deficiency demonstrated by pulmonary function testing (e.g., spirometry or body plethysmography), chest imaging, or reduced DLCO.
Prescriber specialty: pulmonology.
For each reauthorization: confirmation of symptomatic or clinical improvement, or maintenance of previously achieved improvement, is required.
A description of how the drug will be used and/or obtained may be required to determine Medicare Part B vs Part D coverage. If medication will be self-administered after proper training or delivered to the provider by the patient for administration, Part D coverage may apply; otherwise Part B may apply.

inv-40: Sofosbuvir-velpatasvir

inv-40: Sofosbuvir-velpatasvir — Covered when ALL of the following are met:

ALL of the following

Laboratory confirmation of hepatitis C virus (HCV) infection and submission of HCV genotype.
Attestation that patients with decompensated cirrhosis will receive concomitant ribavirin unless ribavirin is contraindicated.
Coverage duration: 12 weeks.
Documentation as required by indication and prescribing information; no prerequisite or prior therapy required under this policy unless specified for a particular case.

inv-64: Example product-specific initial criteria

inv-64: Example product-specific initial criteria — Covered when ALL of the following are met (example: TURALIO / VANFLYTA):

ALL of the following

Diagnosis of the covered use confirmed according to product labeling (e.g., biopsy, genetic testing, imaging) with submission of required baseline labs and test results as specified per product.
Prescriber restriction to appropriate specialty as listed for the product (e.g., immunology and nephrology for VANFLYTA; specialty per product for TURALIO).
For initial authorization: documentation of current or previous therapies used to treat the condition and demonstration of intolerance, contraindication, or inadequate response to required prior therapies when the product's criteria specify prior therapy requirement.
Submission of baseline organ function testing where required (e.g., liver function tests or Child-Pugh score when hepatic safety is relevant).
For reauthorization: documentation of clinically relevant response to therapy or maintenance of previously achieved benefit; coverage durations per product (commonly 1 year).

inv-65: VANFLYTA criteria

inv-65: VANFLYTA criteria — Covered when ALL of the following are met for VANFLYTA:

ALL of the following

Diagnosis of primary IgA nephropathy confirmed by renal biopsy.
Submission of 24-hour urine protein ≥0.5 g/day or urine protein-to-creatinine ratio (UPCR) ≥0.8 g/g.
Submission of liver function testing or Child-Pugh score; pregnancy status for females of childbearing potential.
Prescriber restricted to immunology or nephrology.
For initial authorization: patient is currently using (or has contraindication/intolerance to) a maximally tolerated dose of an ACE inhibitor or ARB.
For annual reauthorization: documentation of clinically relevant response to therapy (stabilization or improvement of UPCR or reduction in 24-hour urine protein from baseline) is required.

inv-66: VIJOICE criteria

inv-66: VIJOICE criteria — Covered when ALL of the following are met for VIJOICE:

ALL of the following

Diagnosis of the covered genetic or inborn error of metabolism with at least one target lesion on imaging and requesting provider attestation that the patient has severe or life-threatening disease.
Submission of test confirming presence of mutation in PIK3CA gene (or other required molecular confirmation per product labeling) and pregnancy status for females of childbearing potential.
Prescriber restricted to specialists in genetic diseases or inborn errors of metabolism.
Coverage duration: initially 6 months then 1 year.
For each reauthorization: submission of objective documentation of symptomatic or clinical benefit (e.g., reductions in target lesion size, pain, vascular malformations, limb enlargements) or maintenance of previously achieved improvement is required.

inv-68: VERQUVO background therapy requirement

inv-68: VERQUVO background therapy requirement — Covered when ALL of the following are met for VERQUVO (example HFrEF requirement):

ALL of the following

For initial authorization, the patient's HFrEF regimen must be submitted and must include all of the following at maximally-tolerated doses: (1) an ACE inhibitor, angiotensin II receptor blocker (ARB), or sacubitril/valsartan; (2) a beta-blocker (BB); and (3) a mineralocorticoid receptor antagonist (MRA). Recommended dosing of each component to treat HFrEF is required.
If doses of any of these three components have not been optimized or any therapy is not being used, prescriber must submit documentation explaining why (e.g., intolerances, physiologic parameters, contraindications).
If the patient is using a beta-blocker not indicated for HFrEF, patient will be required to switch to one of the FDA-approved options (bisoprolol, carvedilol, or metoprolol succinate) unless contraindicated; prescriber must document rationale.
For each annual reauthorization: confirmation of symptomatic or clinical improvement (or maintenance of previously achieved improvement) is required.

inv-71: XPOVIO criteria

inv-71: XPOVIO criteria — Covered when ALL of the following are met (indication-specific):

ALL of the following

Diagnosis of the covered hematologic malignancy consistent with FDA-approved indications for selinexor (XPOVIO), with submission of pregnancy status for females of childbearing potential.
Indication-specific prior therapy requirements
- Multiple myeloma in combination with bortezomib and dexamethasone: documented failure of at least one previous therapy.
- Relapsed or refractory multiple myeloma: documented failure of at least four previous lines of systemic therapy including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
- Relapsed or refractory diffuse large B-cell lymphoma: documented failure of at least two previous lines of systemic therapy.
Prescriber restricted to hematology and oncology.
Coverage duration: 1 year.

inv-72: XPOVIO — Prior therapy requirements

inv-72: XPOVIO — Prior therapy requirements — Additional prior therapy details:

ALL of the following

For relapsed/refractory multiple myeloma: documentation must list prior lines of therapy and demonstrate inclusion of the required classes (≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-CD38 monoclonal antibody); exceptions for clinical trial participation or contraindications must be documented.
For multiple myeloma combined regimens: when used with bortezomib and dexamethasone, documentation of prior therapies and rationale for current regimen must be provided; documented failure of at least one prior therapy is required for this combination.
For relapsed/refractory DLBCL and other indications: documentation of prior systemic therapies and reasons for discontinuation (progression, intolerance) must be submitted.

Procedure, Diagnostic and Threshold Codes / Key Values

No explicit procedure or billing codes in this partmixed

No codes listed

Products listed (doses)mixed

LENVIMA (4 MG DAILY DOSE)	Product listing as affected
LENVIMA (8 MG DAILY DOSE)	Product listing as affected
LENVIMA (10 MG DAILY DOSE)	Product listing as affected
LENVIMA (12 MG DAILY DOSE)	Product listing as affected
LENVIMA (14 MG DAILY DOSE)	Product listing as affected
LENVIMA (18 MG DAILY DOSE)	Product listing as affected
LENVIMA (20 MG DAILY DOSE)	Product listing as affected
LENVIMA (24 MG DAILY DOSE)	Product listing as affected

Products (examples)mixed

LIVTENCITY	Product listing as affected
LONSURF	Product listing as affected
LORBRENA ORAL TABLET 100 MG, 25 MG	Product listing as affected
LUMAKRAS	Product listing as affected

Biologicsmixed

NUCALA SUBCUTANEOUS SOLUTION PREFILLED SYRINGE 100 MG/ML	Product listing as affected
NUCALA SUBCUTANEOUS SOLUTION AUTOINJECTOR	Product listing as affected

Mean pulmonary arterial pressure

Mean pulmonary arterial pressure (mPAP)> 20 mm Hg

Evidence sourceRight heart catheterization at rest confirming mPAP >20 mm Hg

Applies toPAH and CTEPH diagnostic hemodynamics per policy

Pulmonary arterial wedge pressure

Pulmonary arterial wedge pressure (PAWP)≤ 15 mm Hg

Measurement methodObtained at right heart catheterization

ContextUsed with mPAP and PVR to confirm pre-capillary pulmonary hypertension

Pulmonary vascular resistance (PAH WHO Group 1)

PVR threshold — PAH (WHO Group 1)> 2 Wood units

MeasurementCalculated from right heart catheterization hemodynamics

UseRequired for PAH diagnosis and ADEMPAS coverage criteria

Pulmonary vascular resistance (CTEPH WHO Group 4)

PVR threshold — CTEPH (WHO Group 4)> 3 Wood units

Additional requirementImaging evidence of chronic pulmonary embolism and attestation patient is inoperable or has persistent/recurrent disease

Measurement methodRight heart catheterization

Maximum aTTP recurrences on caplacizumab for continued coverage

Maximum aTTP recurrences on caplacizumab for continued coverage≤ 2 recurrences

Documentation requiredIf not first use, submit previous aTTP recurrences while on caplacizumab

Coverage implicationCoverage will not be authorized if >2 recurrences while on therapy

Platelet count thresholds for DOPTELET

Platelet threshold — chronic liver disease with planned procedure< 50 x 10^9/L

Platelet threshold — ITP< 30 x 10^9/L OR < 50 x 10^9/L with symptomatic bleeding

Prior therapy/documentation for ITPDocument splenectomy OR tried and failed ≥2 ITP therapies from different classes if no splenectomy

Blood eosinophil thresholds (dupilumab)

Asthma — blood eosinophil threshold (dupilumab)≥ 150 cells/mcL within 6 weeks

COPD — blood eosinophil threshold (dupilumab)≥ 300 cells/mcL within 6 weeks

TimingEosinophil count obtained within 6 weeks of therapy initiation

Eosinophil count threshold (EoE)

EoE histologic threshold>= 15 eosinophils per high-power field (or 60 eosinophils/mm2)

Additional requirementDocumentation of signs/symptoms and failure of an ≥8-week PPI trial

SpecimenUpper endoscopy with biopsy

mMRC dyspnea score

mMRC dyspnea score threshold>= 2

UseDefines symptomatic COPD for biologic eligibility (e.g., dupilumab/mepolizumab)

AlternativeCAT score >=10 also defines symptomatic COPD per policy

COPD Assessment Test (CAT) score

COPD Assessment Test (CAT) score threshold>= 10

UseAlternative definition of symptomatic COPD for biologic eligibility

ContextRequired along with spirometric criteria and eosinophil counts for COPD indications

ITP platelet count

ITP platelet count for treatment eligibility< 30 x 10^9/L (or < 50 x 10^9/L with increased bleeding risk)

Reauthorization requirementUpdated platelet count showing improvement from baseline required for reauthorization

Related thresholdFor chronic hepatitis C thrombocytopenia: < 75 x 10^9/L

Chronic hepatitis C thrombocytopenia platelet count

Chronic hepatitis C thrombocytopenia threshold< 75 x 10^9/L

DocumentationAttestation patient will receive interferon therapy to treat HCV

Prescriber restrictionsGastroenterology, hematology, hepatology, infectious diseases

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for drugs listed with 'PA' on Independent Health formularies. Approval must be obtained before filling prescriptions or initiating therapy; failure to obtain PA may result in non-coverage.

Drugs listed with 'PA' on the formularies require prior authorization.
If medication will be administered in-office, document plan for Part B vs Part D billing (e.g., patient-delivered pharmacy supply vs provider-administered).

Documentation Required

Documentation and Denial Triggers

Many specialty and biologic agents require submission of diagnostic testing, prior therapy history, baseline labs and monitoring data, pregnancy status for females of childbearing potential, and prescriber attestation. Missing required documentation (e.g., biomarker testing, baseline labs, prior-treatment history) is a common trigger for denial.

Submit pregnancy status for females of childbearing potential when required.
Provide baseline labs and ECG where specified (e.g., potassium, magnesium, QTc).
Include prior-treatment history and documentation of contraindications/intolerance where required.
Missing prerequisite therapy documentation or missing laboratory/test results may result in denial.

Prior Authorization

Prior Authorization and Duration

Initial authorization durations vary by drug and indication (examples: many biologics — initial 6 months then annual; select agents — 30 days for hyponatremia formulations; tolvaptan hyponatremia limited to 30 days; caplacizumab 3 months; zurzuv ae 14 days single course per plan year). Reauthorization typically requires documentation of clinical benefit or maintenance of previously achieved benefit and any required repeat testing (e.g., annual TB screen for biologics where applicable).

Initial duration examples: Dupilumab — initially 6 months then 1 year; Caplacizumab (CABLIVI) — 3 months; Tolvaptan (hyponatremia) — 30 days.
Reauthorization generally requires evidence of clinical benefit and any specified repeat labs or screenings (e.g., TB screening, liver tests).

Step Therapy

Biologic Prior Therapy Requirement

For drugs in the biologic/immunomodulator group (excluding specified exceptions), initial authorization requires trial and failure or intolerance to at least two preferred agents where applicable (examples include adalimumab biosimilar, Cosentyx, Enbrel, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz/Xeljanz XR). Providers must submit prior therapy history or attest contraindications.

Preferred-agent trial requirement: documented trials of at least two preferred agents or documentation of contraindication/intolerance.
Submit prior therapy history with dates, doses, and reasons for discontinuation.

Prior Authorization

Butalbital Combinations — PA for Older Patients

PA required for listed butalbital combination products only when patients are 65 years of age or older; documentation must show trial and failure of a preferred alternative (e.g., ibuprofen or rizatriptan) or contraindication to alternatives. PA does not apply to patients 64 years or younger.

Applies to listed butalbital combination NDCs for patients ≥65 years.
Provide documentation of preferred-alternative trial or contraindication.

Prior Authorization

Caplacizumab (CABLIVI) — PA Requirements

Caplacizumab (CABLIVI) requires diagnosis of the covered use and confirmation that therapy will be administered with plasma exchange and immunosuppressive therapy. Prescriber must be in an allowed specialty (cardiology, hematology, immunology). Coverage for initial course is limited (3 months). If the request is not for first use, submit prior recurrence history; coverage will be denied if patient experienced >2 aTTP recurrences while on caplacizumab.

Required documentation that caplacizumab will be given with plasma exchange and immunosuppression.
If not first use, submit prior aTTP recurrences while on caplacizumab; coverage denied if >2 recurrences.
Prescriber restriction: cardiology, hematology, immunology.

Note

PA and Prescriber Restrictions; PA Exemptions by Specialist

Some agents are restricted to certain specialists and may be exempt from PA when prescribed by those specialists per policy (examples vary by product). Where prescriber restrictions exist, include specialty and contact info; exemptions and specialist-based waivers are applied as specified in product entries.

Prescriber restrictions are listed per product (e.g., oncology, nephrology, hematology).
PA may be exempted when prescribed by listed specialists — follow product-specific guidance.

Documentation Required

EGFR-Targeted and Other Oncology Therapy PA — Required Testing

Oncology and targeted agents frequently require submission of mutation/biomarker testing (e.g., EGFR exon 19 deletions or exon 21 L858R for EGFR-targeted therapy; ALK testing for ZYKADIA; FLT3 for XOSPATA; BRCA for ZEJULA). Missing required genetic or biomarker test results will result in non-approval.

Submit required diagnostic/genetic test results (EGFR, ALK, FLT3, BRCA, FGFR2, MET exon 14, etc.) as specified for each agent.
Attest prescriber specialty (oncology/hematology) where restricted.

Prior Authorization

Lenalidomide PA Requirements

Lenalidomide and related immunomodulators require pregnancy exclusion (female patients of childbearing potential — submit pregnancy status) and meet disease-specific prerequisites: examples include ANC ≥1,000/mcL and platelets ≥75,000/mcL for maintenance post-auto-HSCT multiple myeloma; documentation of prior therapies for mantle cell lymphoma, follicular and marginal zone lymphomas; exclusions for CLL outside clinical trials.

Submit pregnancy status for females of childbearing potential.
For post-auto-HSCT maintenance myeloma: submit ANC and platelet counts meeting stated thresholds.
Provide prior treatment history per indication (e.g., mantle cell lymphoma requires ≥2 prior therapies including bortezomib or documented contraindication).

Prior Authorization

Mepolizumab — PA and Background Therapy Requirements

Mepolizumab requires that patients be on recommended background inhaler/COPD therapy or intranasal corticosteroids where applicable, with provider attestation that background therapy will continue. Initial authorizations and reauthorizations require documentation of prior therapies and clinical benefit or maintenance of benefit.

For asthma: attestation patient is on ICS + LABA ± LAMA per GINA and will continue background therapy.
For CRSwNP: documentation of intranasal corticosteroid trial for ≥2 months or contraindication.
Reauthorization requires evidence of clinical benefit (e.g., exacerbation reduction, steroid-sparing, FEV1 improvement).

Prior Authorization

Tolvaptan (ADPKD and Hyponatremia) — PA Requirements

Tolvaptan for ADPKD (ADPKD-specific formulation) requires criteria confirming rapidly progressing ADPKD (Mayo classification 1C–1E, historical eGFR decline, or PROPKD score >6) and submission of baseline serum sodium and assessments. The hyponatremia formulation is limited to short-course use and exclusions apply for hepatic impairment and desmopressin coadministration.

For ADPKD: submit imaging classification or documented eGFR decline or PROPKD score supporting rapidly progressing disease.
Hyponatremia formulation: limited to 30 days; initiate in a monitored setting and submit evidence of clinically significant hyponatremia.
Exclude patients with significant liver disease or inability to sense thirst; avoid strong CYP3A inhibitors/inducers.

Prior Authorization

Selected Product-Specific PA Requirements (XOSPATA, XPOVIO, XURIDEN, ZEJULA, ZTALMY, ZURZUVAE, ZYDELIG, ZYKADIA)

XOSPATA (gilteritinib) requires submission of FLT3 mutation testing and baseline potassium and magnesium levels; XPOVIO (selinexor) requires documentation of prior therapy failures per indication (e.g., multiple myeloma — failure of specified numbers and classes of prior therapies). XURIDEN, ZEJULA, ZTALMY, ZURZUVAE, ZYDELIG, and ZYKADIA each have product-specific required baseline labs, genetic tests, pregnancy status, prescriber restrictions, and co-therapy attestations — submit those items per product entry.

XOSPATA: submit FLT3 mutation test, baseline potassium and magnesium.
XPOVIO: document required prior lines of systemic therapy and pregnancy status.
XURIDEN: baseline CBC, neutrophil count, MCV, urine orotic acid; annual reauthorization requires stabilization/improvement documentation.
ZEJULA: document response to platinum-based chemotherapy and BRCA testing when applicable.
ZTALMY: genetic confirmation of CDKL5 pathogenicity/deficiency required.
ZURZUVAE: attest postpartum status within 12 months; single 14-day course per plan year.
ZYDELIG: attestation therapy will be coadministered with rituximab and documentation of prior systemic therapy.
ZYKADIA: submit ALK testing; avoid strong CYP3A inducers.

Denial Risk

Drug Interactions, Hepatic Impairment, and Baseline Safety Exclusions

Drug-drug interactions and hepatic impairment exclusions are common denial triggers. Coadministration with strong CYP3A4 inducers or inhibitors, CYP3A/P-gp dual inducers, or other specified interacting drugs may preclude approval. Severe hepatic impairment and certain baseline safety parameters (QTc, potassium, magnesium, WBC) outside acceptable ranges may also lead to denial.

CYP3A4 inducer/ inhibitor exclusions: many agents require avoidance of strong CYP3A4 inducers (e.g., KISQALI, XOSPATA, ZYKADIA) or moderate/strong inhibitors per product guidance.
Baseline safety parameter exclusions: QTc thresholds, uncorrected hypokalemia/hypomagnesemia, WBC limits — submit recent ECG and electrolyte labs where requested.
Severe hepatic impairment exclusions apply for listed drugs (e.g., specific CF/TRIKAFTA formulations, Skyclarys, others).

Denial Risk

Population and Indication Exclusions — Denial Triggers

Population exclusions and other indication-specific exclusions must be checked for each product (examples: pregnancy exclusions for many oncology and immunomodulatory agents; dementia-related psychosis exclusion for certain antipsychotics; age-based PA applicability for some agents). Requests may be denied if exclusion criteria are present.

Verify and document absence of exclusion criteria (pregnancy, dementia-related psychosis, age-based restrictions, hepatic failure, etc.).
Examples: pregnancy exclusion for lenalidomide and many agents; dementia-related psychosis exclusion for INQOVI; age-based PA for butalbital products and PREVYMIS/PREVENT criteria.

Initial Authorization Requirements

Reauthorization / Continuation Requirements

Required Trials and Step Edges

Requirement	Details
Trial of at least two preferred agents
Required prior to initial authorization for drugs managed by this policy (exceptions: Otezla and Velsipity); preferred agents include adalimumab biosimilar, Cosentyx, Enbrel, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz/Xeljanz XR

Requirement	Details
Prior medication trials from at least two different classes
For apomorphine subcutaneous initial authorization the patient must have tried and failed or had intolerance to medications from at least two different classes that reduce 'off' episodes (COMT inhibitors, dopamine agonists, MAO‑B inhibitors), unless contraindicated; submit diagnosis, current/previous therapies, attestation of 'off' episodes

Requirement	Details
Documented trial and failure or contraindication required
For migraine acute treatment, must have tried and failed one triptan or have documented contraindication; for episodic prevention, Emgality requires prior failure of Aimovig where specified — submit prior therapy history and baseline headache days per month

Requirement	Details
Trial and failure or intolerance to at least one bisphosphonate
Initial authorization for teriparatide requires prior trial and failure or intolerance to ≥1 bisphosphonate; therapeutic failure defined as fracture or decrease in BMD while on bisphosphonate ≥3 months; submit documentation of prior bisphosphonate use and evidence of high fracture risk

Requirement	Details
Trial and failure or intolerance to armodafinil or modafinil
Sunosi initial authorization requires that the patient has tried and had inadequate response to, or was intolerant/contraindicated for, armodafinil or modafinil; submit baseline blood pressure and current/previous therapies

Requirement	Details / Examples
Maximally-tolerated background therapy required
Many products require optimized background regimens before approval. Examples: VERQUVO requires ACEi/ARB or sacubitril‑valsartan + beta‑blocker + MRA each at maximally‑tolerated doses; WINREVAIR requires at minimum a nitric oxide pathway mediator plus an endothelin receptor antagonist (with or without prostacyclin pathway agent). If components not used, prescriber must document rationale (intolerance, contraindication)

Requirement

Details / Examples

Maximally-tolerated background therapy required

Many products require optimized background regimens before approval. Examples: VERQUVO requires ACEi/ARB or sacubitril‑valsartan + beta‑blocker + MRA each at maximally‑tolerated doses; WINREVAIR requires at minimum a nitric oxide pathway mediator plus an endothelin receptor antagonist (with or without prostacyclin pathway agent). If components not used, prescriber must document rationale (intolerance, contraindication)

Requirement	Details
Prior therapy failure documentation required
For initial authorization of many specialty agents, submit documentation of prior therapy failures or intolerances as specified for the indication (examples: XPOVIO requires documented failure of prior lines of therapy per indication); absence of required prior‑therapy documentation may lead to denial

Administration Site and Medicare Coverage Determination

Billing Rule

Specify site of care (Part B vs Part D may be affected)

Coverage classification (Medicare Part B vs Part D) may depend on site of administration and how the medication is obtained/ administered; specify intended site of care and whether the medication will be pharmacy‑filled and delivered to the office or self‑administered.

Indicate site of care (home, infusion center, office) and whether patient will self‑administer after training or the provider will administer.
If IV/home administration for primary immunodeficiency, note Part B might apply for IVIG home infusions.

Note

Policy Background and Scope

This portion of the policy lists prior authorization criteria for selected high‑cost, specialty, and certain conventional drugs on the Independent Health Medicare Advantage Part D formulary. It specifies required documentation (for example, diagnostic test results, hemodynamics for PAH, baseline labs, pregnancy status), prescriber specialty restrictions, age limits, prior therapy requirements, and exclusionary conditions that together determine medical necessity and coverage decisions.

Key Definitions and Thresholds

Policy Summary

PayerIndependent Health

PolicyMedicare Part D Prior Authorization Criteria (selected drugs)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with required diagnostic tests, prior therapy history, and prescriber specialty attestation before dispensing listed specialty drugs.

SourceLink

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