Drugs That Require Prior Authorization — Pharmacy & Specialty Drugs
Customize your policy alerts
Sign up for all Hawaii Medical Service Association (HMSA) policy alerts
Know when Hawaii Medical Service Association (HMSA) releases new policies or updates existing guidance.
Monitor payer policy activity
List of prescription drugs that require prior authorization from HMSA Akamai Advantage (PPO) and the clinical/administrative criteria used to approve coverage for those drugs; applies to members and prescribers seeking coverage for medications shown in this portion of the policy.
No material clinical or coverage changes in this revision.
Coverage Criteria (Per Drug / Group)
BIMZELX (bimekizumab) — Psoriasis and Axial Spondyloarthritis
Covered when ALL of the following are met:
ALL of the following
- BIMZELX (bimekizumab) — moderate to severe plaque psoriasis (new starts): patient has disease affecting crucial body areas (hands, feet, face, scalp, neck, genitals/groin, intertriginous areas) OR ≥10% BSA OR ≥3% BSA with either inadequate response/intolerance to phototherapy or methotrexate/cyclosporine/acitretin OR contraindication to those agents.
- BIMZELX — active ankylosing spondylitis or non-radiographic axial spondyloarthritis (new starts): patient has inadequate response or intolerance to at least one NSAID OR contraindication to NSAIDs.
DANZITEN — CML / Ph+ ALL (Tyrosine Kinase Inhibitor Group)
Covered when ALL of the following are met:
ALL of the following
- DANZITEN (ponatinib or policy group for ponatinib-like agents) — chronic myeloid leukemia (CML): diagnosis confirmed by presence of Philadelphia chromosome or BCR-ABL gene; if resistance to an alternative TKI occurred, patient is negative for specified mutations (T315I, Y253H, E255K/V, F359V/C/I or other listed per agent).
- DANZITEN — acute lymphoblastic leukemia (ALL) (Ph+): diagnosis confirmed by detection of the Philadelphia chromosome or BCR-ABL gene; if resistant to prior TKI, documented mutation testing per agent-specific list.
- For CML/ALL new starts: prior therapy requirements apply as specified (e.g., prior intolerance or resistance to specific TKIs) and mutation testing results must be provided.
Oncology / Targeted Therapy — Mutation/Stage/Prior Therapy Requirements (Group)
Coverage for oncology and targeted therapy agents requires demonstration of tumor molecular status, disease stage, and prior therapy where applicable. Covered when ALL of the following are met:
ALL of the following
- Requested targeted oncology drug is prescribed for an FDA‑approved or medically accepted tumor type listed in the policy.
- For agents with mutation- or biomarker-specific indications (e.g., RET, EGFR, ALK, BRAF, FGFR2, HER2, NTRK, ROS1, IDH2, RET fusions), documentation of the relevant positive genomic alteration is provided from an FDA-cleared test or validated laboratory (e.g., NGS, PCR, FISH) including the specific alteration(s).
- Disease is advanced, recurrent, unresectable, or metastatic when required by the indication, or other stage-specific criteria (e.g., adjuvant/neoadjuvant) are met per the specific drug guidance.
- Prior systemic therapies or sequencing requirements have been met for subsequent-line indications (e.g., prior platinum-containing chemotherapy, prior EGFR TKI, prior PD-(L)1 therapy) as specified for the product.
- Where resistance mutation testing is required (e.g., T790M, T315I, RET fusion confirmation, FGFR2 fusions), results are provided and support the use of the requested agent.
Ivermectin and IVIG — Indication-specific Criteria
Covered when ALL of the following are met:
ALL of the following
- IVERMECTIN — approved parasitic indications only (e.g., strongyloidiasis, onchocerciasis, scabies, lice, ascariasis, gnathostomiasis, pediculosis). The requested use is NOT for prevention or treatment of COVID-19 (explicit exclusion).
- IVERMECTIN — required medical information: diagnosis and supporting documentation (e.g., stool exam, skin scraping, microscopy) appropriate to the indicated infection.
- IVIG (intravenous immunoglobulin) — covered for medically accepted indications when indication-specific IgG thresholds or clinical criteria are met (examples): B-cell CLL: serum IgG <500 mg/dL or history of recurrent bacterial infections; BMT/HSCT: within first 100 days post-transplant OR serum IgG <400 mg/dL; pediatric HIV: serum IgG <400 mg/dL or recurrent bacterial infections; dermatomyositis/polymyositis: failure/intolerance of standard first-line agents; PRCA: secondary to parvovirus B19 infection.
IVIG — Diagnostic & Laboratory Criteria
IVIG is covered when ALL of the following diagnostic or laboratory criteria relevant to the requested indication are met:
ANY of the following
- For B‑cell chronic lymphocytic leukemia (CLL): serum IgG less than 500 mg/dL OR documented history of recurrent bacterial infections.
- For bone marrow transplant / hematopoietic stem cell transplant (BMT/HSCT): request is within the first 100 days post-transplant OR serum IgG less than 400 mg/dL.
- For pediatric HIV infection: serum IgG less than 400 mg/dL OR history of recurrent bacterial infections.
- For dermatomyositis or polymyositis: trial and failure or intolerance of at least one standard first‑line therapy (corticosteroid or immunosuppressant) OR contraindication to those therapies.
- For pure red cell aplasia (PRCA): PRCA is secondary to parvovirus B19 infection (documented).
LUMIZYME — Diagnostic Coverage Criteria (Pompe Disease)
Covered when ALL of the following diagnostic criteria are met:
ALL of the following
- LUMIZYME (alglucosidase alfa) — Pompe disease (acid alpha‑glucosidase deficiency): diagnosis confirmed by either an enzyme assay demonstrating deficient acid alpha‑glucosidase activity OR pathogenic GAA gene mutation(s) on genetic testing.
- Documentation of clinical manifestations consistent with Pompe disease (e.g., hypotonia, motor delay in infants; progressive limb‑girdle weakness, respiratory insufficiency in late‑onset) and baseline functional measures as applicable.
LIVTENCITY — Prescriber / Age Criteria
Covered when ALL of the following are met:
ALL of the following
- LIVTENCITY (ganciclovir implant or policy group for LIVTENCITY) — prescriber and age criteria: prescribed by or in consultation with a qualified specialist experienced in management of the specific indication (e.g., pediatric infectious disease, transplant infectious disease, or pediatric hepatology as applicable).
- Age restrictions per product labeling are met (document age and indication).
LENVIMA (lenvatinib) — Disease‑Specific Coverage Criteria
Covered when ALL of the following disease‑specific criteria are met:
ALL of the following
- LENVIMA (lenvatinib) — disease-specific coverage: indication-specific documentation supplied (e.g., radioactive iodine‑refractory differentiated thyroid cancer, unresectable hepatocellular carcinoma [HCC] as per label, or other approved indications).
- For HCC: disease is unresectable; prior systemic therapy documented if required by the indication; liver function and Child‑Pugh status documented and consistent with product labeling.
- For thyroid cancer and other indications: tumor histology, prior therapies, and evidence of disease progression as required by indication are provided.
LYTGOBI — Cholangiocarcinoma (FGFR2‑altered) Criteria
Covered when ALL of the following are met:
ALL of the following
- LYTGOBI (futibatinib) — cholangiocarcinoma: patient has unresectable, locally advanced, or metastatic cholangiocarcinoma AND the requested drug is being used as subsequent therapy AND tumor harbors an FGFR2 fusion or rearrangement documented by an appropriate molecular test.
MAVYRET — Hepatitis C Virus (HCV) Coverage Criteria
Covered when ALL of the following are met:
ALL of the following
- MAVYRET (glecaprevir/pibrentasvir) — HCV: active HCV infection confirmed by detectable HCV RNA prior to initiation; planned regimen, genotype, prior treatment history, cirrhosis status (compensated vs decompensated/CTP B or C), HIV coinfection status, resistance‑associated substitutions and transplant status as applicable are documented.
- MAVYRET is excluded for patients with decompensated cirrhosis (Child‑Turcotte‑Pugh class B or C) — requests for such patients should be denied per policy.
- Coverage consistent with current AASLD‑IDSA guidance for genotype and prior treatment scenarios; durations determined per guideline algorithms.
MEKINIST / MEKTOVI — BRAF‑Targeted Therapy Criteria
Covered when ALL of the following are met:
ALL of the following
- MEKINIST (trametinib) and MEKTOVI (binimetinib) — BRAF V600‑mutant melanoma or other labeled indications: tumor is positive for BRAF V600 activating mutation (e.g., V600E or V600K) documented by an appropriate molecular test.
- When used in combination (MEKINIST + TAFINLAR or MEKTOVI + encorafenib per labeling), documentation supports combination use for metastatic/unresectable or for adjuvant/neoadjuvant indications per labeling.
Omnipod (Insulin Pump) — Coverage Criteria
Covered when ALL of the following are met:
ALL of the following
- Omnipod (insulin pump) — patient has diabetes mellitus requiring intensive insulin management and documented need for continuous subcutaneous insulin infusion for improved glycemic control (e.g., recurrent severe hypoglycemia, wide glycemic variability despite optimized multiple daily injections), with documentation of diabetes education and pump training plan.
- Prescriber is an endocrinologist, diabetologist, or clinician experienced in insulin pump management or documented endocrinology consultation.
OPSUMIT (macitentan) — Pulmonary Arterial Hypertension Criteria
Covered when ALL of the following are met:
ALL of the following
- OPSUMIT (macitentan) — pulmonary arterial hypertension (PAH, WHO Group 1): diagnosis confirmed by right heart catheterization; for PAH new starts: pretreatment mean pulmonary arterial pressure >20 mmHg, pulmonary capillary wedge pressure ≤15 mmHg, and pulmonary vascular resistance >2 Wood units; documentation of WHO Group 1 classification provided.
- OPSUMIT is used in accordance with labeled indication and has appropriate prior therapy documentation when required (e.g., inadequate response or intolerance to alternative endothelin receptor antagonists if specified).
OPIPZA (cariprazine) — Neuropsychiatric Indications Criteria
Covered when ALL of the following are met:
ALL of the following
- OPIPZA (cariprazine) — schizophrenia, adjunctive treatment for major depressive disorder (MDD), irritability associated with autistic disorder, or Tourette's disorder: diagnosis confirmed by a qualified mental health provider and indication consistent with FDA‑approved labeling.
- For schizophrenia and Tourette's: documentation of prior treatment trials as appropriate per standard of care. For adjunctive MDD: inadequate response to at least one antidepressant at an adequate dose/duration unless contraindicated. For autism‑related irritability: behavioral interventions trial documented if age/setting appropriate.
NURTEC (rimegepant) — Migraine Criteria
Covered when ALL of the following are met:
ALL of the following
- NURTEC ODT (rimegepant) — acute treatment of migraine and preventive therapy as labeled: for prevention/continuation, documentation of clinical benefit or reduction in monthly migraine days per baseline is required; acute use requires diagnosis of migraine and appropriate dosing limits.
- For continuation of preventive therapy: patient had clinical improvement (e.g., reduction in monthly migraine days) after an initial trial (per product guidance).
MEPRON (atovaquone) — Coverage Criteria
Covered when ALL of the following are met:
ALL of the following
- MEPRON (atovaquone) — indicated infections per labeling (e.g., Pneumocystis jirovecii pneumonia treatment or prophylaxis when TMP‑SMX contraindicated/intolerant): documentation of intolerance or contraindication to first‑line agent (e.g., TMP‑SMX) and relevant diagnostic evidence is provided.
Antipsychotics — Schizophrenia / MDD Adjunct / Autism Irritability / Tourette's
Covered when ALL of the following are met:
ALL of the following
- Antipsychotics (including but not limited to cariprazine, aripiprazole, risperidone, olanzapine, etc.) — for schizophrenia, adjunctive treatment for MDD, irritability in autism, or Tourette's: diagnosis confirmed and prescriber documents prior trials or contraindications as appropriate per indication; dosing and monitoring consistent with labeling.
- For adjunctive MDD: inadequate response to at least one antidepressant at adequate dose/duration unless contraindicated.
POSACONAZOLE — Oral Use and Prophylaxis Criteria
Covered when ALL of the following are met:
ALL of the following
- POSACONAZOLE — oral formulation: requested for treatment or prophylaxis per labeled indications (e.g., prophylaxis in high‑risk neutropenic patients, treatment of invasive fungal infections); documentation of indication, prior antifungal therapy response/intolerance, and relevant risk factors provided.
- For invasive fungal disease treatment: patient has had inadequate response, intolerance, or contraindication to first‑line antifungal therapy when applicable; duration per indication and product labeling.
PREGABALIN (including Lyrica oral solution) — Coverage Criteria
Covered when ALL of the following are met:
ALL of the following
- PREGABALIN (including Lyrica oral solution) — for neuropathic pain, fibromyalgia, seizure adjuncts, or other labeled indications: diagnosis confirmed and prior trials of appropriate alternatives or contraindications documented where required; dosing consistent with labeling and renal function documented for dose adjustment.
Erythropoietin Agents (PROCRIT) — Anemia Criteria
Covered when ALL of the following are met:
ALL of the following
- Erythropoietin agents (e.g., PROCRIT) — anemia treatment: documented hemoglobin level and underlying cause (e.g., chronic kidney disease, chemotherapy‑induced anemia) consistent with labeled indications; prior iron repletion and appropriate workup performed; dosing and monitoring plan described.
Biologics (e.g., REMICADE, RENFLEXIS) — Indication‑Specific New‑Start Requirements
For new starts of biologic infused or injected agents (e.g., REMICADE, RENFLEXIS, HUMIRA, etc.) coverage is provided when ALL of the following are met:
ALL of the following
- Indication is consistent with FDA‑approved or medically accepted uses specified in the policy and documentation of disease severity is provided (e.g., plaque psoriasis BSA or PASI, RA activity scores).
- Patient has had inadequate response, intolerance, or contraindication to specified conventional systemic therapies (e.g., methotrexate, cyclosporine, phototherapy for psoriasis; conventional DMARDs for RA) unless biologic is first‑line per indication guidance.
- Prescriber is a specialist in the disease area or there is documented specialist consultation when required.
QULIPTA — Migraine Prevention Continuation Criteria
Covered when ALL of the following are met:
ALL of the following
- QULIPTA (atugotriptan?) — for migraine prevention continuation: patient experienced clinical benefit during an initial trial as evidenced by reduction in monthly migraine days or other meaningful improvement documented by prescriber.
RELISTOR INJ — Opioid‑Induced Constipation Criteria
Covered when ALL of the following are met:
ALL of the following
- RELISTOR INJ (methylnaltrexone) — opioid‑induced constipation (OIC): diagnosis of OIC with inadequate response to laxatives; patient is receiving opioid therapy for chronic non‑cancer pain or advanced illness as appropriate; dosing per labeling and safety screening performed.
RETEVMO — RET Fusion‑Positive Cancers
Covered when ALL of the following are met:
ALL of the following
- RETEVMO (selpercatinib) — RET fusion‑positive cancers: tumor documents RET fusion or RET‑mutant alteration via validated molecular testing and indication is consistent with labeled or medically accepted uses; prior therapy requirements met if applicable.
Moderate to Severe Plaque Psoriasis — New‑Start Criteria
Covered when ALL of the following are met:
ALL of the following
- Moderate to severe plaque psoriasis (new starts) — for biologic therapy: crucial body areas affected OR ≥10% BSA OR ≥3% BSA with prior failure/intolerance/contraindication to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin), unless biologic is clinically warranted as first‑line for severe disease.
CML / Ph+ Leukemias — Tyrosine Kinase Inhibitor Criteria
Covered when ALL of the following are met:
ALL of the following
- Chronic myeloid leukemia and related leukemias (TKI group including IMATINIB, BOSULIF, ICLUSIG, etc.): diagnosis confirmed by detection of Philadelphia chromosome or BCR‑ABL gene; prior therapy sequencing and mutation testing (e.g., T315I, other listed mutations) are documented; product‑specific requirements for failure, intolerance, or mutation presence are met.
Sapropterin — PKU Coverage Criteria
Covered when ALL of the following are met:
ALL of the following
- Sapropterin (for phenylketonuria, PKU) — diagnosis of PKU confirmed and patient demonstrated responsiveness to sapropterin during prior supervised trial or meets prespecified criteria per guideline/labeling.
PAH / PH Hemodynamic & Agent Initiation Requirements
Covered when ALL of the following hemodynamic or diagnostic requirements are met:
ALL of the following
- Pulmonary arterial hypertension (PAH) agents (e.g., sildenafil, treprostinil, epoprostenol, macitentan, riociguat): diagnosis confirmed by right heart catheterization; for PAH new starts: mean pulmonary arterial pressure >20 mmHg, pulmonary capillary wedge pressure ≤15 mmHg, and pulmonary vascular resistance >2 Wood units (adult thresholds); documentation of WHO Group 1 classification.
- Agent selection consistent with guideline‑recommended therapy and product labeling; prior therapy requirements met when applicable (e.g., failure/intolerance to other class agent).
SYNAREL — Central Precocious Puberty Initial Therapy
Covered when ALL of the following are met:
ALL of the following
- SYNAREL (nafarelin) — central precocious puberty (CPP) initial therapy: diagnosis confirmed by appropriate endocrine testing and clinical assessment; therapy initiated by or in consultation with a pediatric endocrinologist; dosing per pediatric labeling.
TAFINLAR — BRAF‑Targeted Indications
Covered when ALL of the following are met:
ALL of the following
- TAFINLAR (dabrafenib) — BRAF‑mutant melanoma and other labeled indications: tumor documents BRAF V600 activating mutation; when combined with MEKINIST or other approved partner, combination use aligns with labeled indication and disease status (adjuvant, metastatic, unresectable) is met.
TETRABENAZINE — Chorea / Tardive Dyskinesia Criteria
Covered when ALL of the following are met:
ALL of the following
- TETRABENAZINE — chorea in Huntington disease or tardive dyskinesia: diagnosis confirmed; prior assessment with standardized scales (e.g., AIMS for tardive dyskinesia) documented where applicable; benefit/risk discussed and monitored per labeling.
TOBI / Inhaled Tobramycin — Coverage Criteria
Covered when ALL of the following are met:
ALL of the following
- TOBI / Inhaled Tobramycin — cystic fibrosis or bronchiectasis: documentation of indication (e.g., Pseudomonas aeruginosa chronic infection in CF) and prior airway culture results; dosing and inhaled delivery plan provided.
Topical Tacrolimus — Atopic Dermatitis Criteria
Covered when ALL of the following are met:
ALL of the following
- Topical tacrolimus — moderate to severe atopic dermatitis: diagnosis confirmed; trial and inadequate response or contraindication to topical corticosteroids documented or use in areas where corticosteroids are inappropriate (e.g., face, intertriginous areas).
TREMFYA — Coverage Criteria
Covered when ALL of the following are met:
ALL of the following
- TREMFYA (guselkumab) — covered per indication‑specific criteria analogous to other biologics for plaque psoriasis, psoriatic arthritis, or axial spondyloarthritis: documentation of disease severity, prior therapy trials, or contraindications as required.
TRIKAFTA — Cystic Fibrosis Coverage Criteria
Covered when ALL of the following are met:
ALL of the following
- TRIKAFTA (elexacaftor/ivacaftor/tezacaftor) — cystic fibrosis: patient meets genotype eligibility per labeling (CFTR mutations indicated) and age requirements; not used concurrently with contraindicated CFTR modulators; baseline and monitoring plan provided.
VENCLEXTA — Hematology Oncology Criteria
Covered when ALL of the following are met:
ALL of the following
- VENCLEXTA (venetoclax) — hematologic malignancies: diagnosis and mutation status (e.g., CLL, AML with IDH/BCL2 considerations) documented; prior therapy and combination regimens aligned with labeling; tumor response/monitoring plan provided.
VERQUVO — Heart Failure Criteria
Covered when ALL of the following are met:
ALL of the following
- VERQUVO (vericiguat) — heart failure: patient meets labeled criteria (e.g., symptomatic chronic heart failure with reduced ejection fraction despite optimized therapy); concomitant heart failure treatment optimized per guideline and prescriber documents appropriateness of vericiguat.
VITRAKVI — NTRK Fusion‑Positive Tumors
Covered when ALL of the following are met:
ALL of the following
- VITRAKVI (larotrectinib) — NTRK fusion‑positive solid tumors: tumor harbors an NTRK gene fusion confirmed by validated testing; indication matches labeled uses; prior therapies documented if applicable.
VOSEVI — HCV Coverage Conditions
Covered when ALL of the following are met:
ALL of the following
- VOSEVI (sofosbuvir/velpatasvir/voxilaprevir) — HCV: active HCV RNA documented; genotype, prior treatment history, cirrhosis status, and resistance‑associated substitutions documented as applicable; duration consistent with AASLD‑IDSA guidance.
VOWST — Recurrent C. difficile Prevention Criteria
Covered when ALL of the following are met:
ALL of the following
- VOWST (fecal microbiota, live-jslm) — prevention of recurrent C. difficile infection: patient meets recurrent CDI criteria per labeling and guideline (e.g., multiple documented recurrences) and standard-of-care antimicrobial therapy completed as required before administration.
VYNDAMAX — ATTR‑CM Initial and Continuation Therapy
Covered when ALL of the following are met:
ALL of the following
- VYNDAMAX (tafamidis) — transthyretin amyloid cardiomyopathy (ATTR‑CM): diagnostic criteria per ATTR group (cardiac involvement by imaging or scintigraphy, biopsy or genetic confirmation when variant ATTR suspected, and exclusion of light‑chain amyloidosis) are met; documentation of clinical manifestations and baseline measures provided for initiation and continuation.
PAH Agents — Initiation Requirements (Group)
Covered when ALL of the following are met:
ALL of the following
- PAH/PH Agent Initiation — hemodynamic requirements: right heart catheterization confirming WHO Group and hemodynamics (mPAP >20 mmHg, PCWP ≤15 mmHg, PVR >2 WU) for Group 1 therapy initiation; therapy selection and sequencing documented per guideline.
XOLAIR — Indications and Criteria
Covered when ALL of the following are met:
ALL of the following
- XOLAIR (omalizumab) — allergic asthma and chronic spontaneous urticaria indications: documented diagnosis, IgE levels and dosing calculations when applicable, prior therapy trials (e.g., high‑dose inhaled corticosteroids plus controllers for asthma) and clinical response criteria for continuation.
ZARXIO — Administration Timing & FN Prophylaxis Criteria
Covered when ALL of the following operational and administration criteria are met:
ALL of the following
- ZARXIO (filgrastim-sndz) — administration timing for febrile neutropenia prophylaxis: dosing schedule aligns with chemotherapy regimen (e.g., started 24–72 hours after cytotoxic chemotherapy) and intended use is for FN prophylaxis; documentation of planned chemotherapy with FN risk provided.
- For prophylactic use, documentation of neutropenia risk and intent (primary vs secondary prophylaxis) is provided.
ZELBORAF — BRAF‑Mutant Melanoma Criteria
Covered when ALL of the following are met:
ALL of the following
- ZELBORAF (vemurafenib) — melanoma: tumor positive for BRAF V600 mutation; indication consistent with labeling; prior therapy requirements documented where applicable.
ZONISADE — Adjunctive Partial‑Onset Seizures Criteria
Covered when ALL of the following are met:
ALL of the following
- ZONISADE (zonisamide) — adjunctive therapy for partial‑onset seizures: diagnosis confirmed and prior trials of at least one appropriate anticonvulsant unless contraindicated; dosing and monitoring plan provided.
Postpartum Depression Therapy Coverage
Covered when ALL of the following are met:
ALL of the following
- Postpartum depression therapies — coverage per product labeling and behavioral/medical evaluation: documented diagnosis of postpartum depression and prior trials of standard antidepressant therapy or documented contraindication/intolerance when required; safety monitoring plan provided.
ZYDELIG — CLL / SLL Criteria
Covered when ALL of the following are met:
ALL of the following
- ZYDELIG (idelalisib) — CLL/SLL: indication and prior therapy requirements per labeling documented; laboratory and infection risk monitoring plan in place.
ZYKADIA — ALK‑Positive NSCLC Criteria
Covered when ALL of the following are met:
ALL of the following
- ZYKADIA (ceritinib) — ALK‑positive NSCLC and other labeled indications: disease is ALK‑positive by validated test; prior therapy sequencing documented (e.g., prior ALK inhibitors) when applicable; dosing and safety monitoring consistent with labeling.
ZYPREXA RELPREVV — Long‑Acting Injectable Antipsychotic Criteria
Covered when ALL of the following are met:
ALL of the following
- ZYPREXA RELPREVV (olanzapine pamoate) — criteria for use: diagnosis of schizophrenia; patient preference or documented adherence issues that justify long‑acting injectable antipsychotic; appropriate monitoring and follow‑up arranged per safety recommendations.
Provider Actions — Prior Authorization, Documentation, and Denial Risks
Prior authorization request — how to request
You will need authorization by your HMSA Akamai Advantage (PPO) plan before filling prescriptions for the drugs listed below. Coverage is provided only after HMSA determines the drug is prescribed according to the policy criteria. You, your appointed representative, or your prescriber can request prior authorization by calling HMSA at 1 (855) 479-3659, 24 hours a day, 7 days a week. Customer service is available in English and other languages. TTY/TDD users should call 711.
Coverage duration / renewal
Coverage durations vary by drug and indication. Examples in this policy include: many specialty and oncology agents — Plan Year; select vaccines and short-term agents — 3 months or 1 month (see specific drug entries). Some drugs have an initial authorization period (for example, EMGALITY initial 3 months with continuation requiring documented response), others specify Initial/Continuation durations (e.g., HETLIOZ initial 6 months, continuation Plan Year). Prior authorization renewals require documentation of treatment benefit or continued clinical need as specified in each drug entry.
- Examples: Plan Year; 3 months; 1 month; Initial: 3 months / Continuation: Plan Year (EMGALITY); Initial: 6 months / Continuation: Plan Year (HETLIOZ)
Group prior authorization requirement
Many drugs in this list are grouped and require prior authorization. Examples of groups requiring PA include (but are not limited to) ABIRATERONE, ARCALYST, AREXVY/ABRYSVO, ARIKAYCE, select oncology groups (e.g., GILOTRIF, COTELLIC, CRESEMBA), high-risk medication groups for older adults, HRM-hypnotics, HRM-anticholinergics (meclizine, promethazine), and numerous specialty biologics and oncology agents. For grouped entries, follow the group-specific required medical information, age/prescriber restrictions, prerequisite therapy, and coverage duration.
- Grouped examples: ABIRATERONE, ARCALYST, AREXVY/ABRYSVO, ARIKAYCE, GILOTRIF, COTELLIC, CRESEMBA, HIGH RISK MEDICATION, HRM-HYPNOTICS, HRM-MECLIZINE, HRM-PROMETHAZINE
BIMZELX prior authorization
BIMZELX: Prior authorization required. Follow the biologic psoriasis/psoriatic arthritis group criteria — document prior treatment history, failures/intolerances to indicated conventional systemic therapies or phototherapy as specified in the psoriasis biologic criteria. Coverage duration: Plan Year.
BOSENTAN prior authorization
BOSENTAN: Prior authorization required. Ensure PA documentation includes indication-specific required medical information and hemodynamic documentation when applicable for pulmonary arterial hypertension (PAH) agents. Coverage duration typically Plan Year.
PA required per drug entry — summary of required clinical info, age restrictions, durations
For each drug entry that requires prior authorization, the policy lists the specific required clinical information, any age or prescriber restrictions, the coverage duration, prerequisite therapy requirements, and other criteria (for example: tumor biomarker or mutation testing for targeted oncology agents; prior trials and intolerances for specialty biologics; lab thresholds for iron chelators; documentation of HCV RNA for HCV therapies). Failure to include the required documentation may result in denial.
- Required elements per drug: indication, prior therapy history or failures, lab or biomarker confirmation (where applicable), age/prescriber restrictions, and intended regimen/setting (especially for Medicare Part A/B vs Part D determination)
EMGALITY PA — initial duration 3 months and continuation rules
EMGALITY (galcanezumab) prior authorization: Initial approval limited to 3 months for preventive migraine (and 3 weeks for episodic cluster headache initial). Continuation criteria require documentation of treatment response: for migraine, at least 3 months of therapy with reduction in monthly migraine days from baseline; for episodic cluster headache, at least 3 weeks with reduced weekly attack frequency. Concurrent use with another CGRP antagonist is not allowed.
- Initial: 3 months (preventive migraine) — Continuation: Plan Year with documented response
- Episodic cluster headache: initial 3 weeks; continuation requires reduced weekly attacks
- No concurrent CGRP antagonists
EPIDIOLEX PA — age restriction and Plan Year duration example
EPIDIOLEX (cannabidiol) prior authorization: Covered for FDA-approved indications with age restriction of 1 year and older. Coverage duration: Plan Year. Provide required documentation per indication.
- Age restriction: ≥ 1 year
- Coverage Duration: Plan Year
Prior authorization required — group examples (oncology/specialty)
Examples of other prior authorization-required agents (select oncology/specialty examples): GILOTRIF, KADCYLA, KESIMPTA, KEYTRUDA, KINERET, KISQALI, LENVIMA, LUMAKRAS, LYNPARZA, MAVYRET, MONJUVI, OFEV, ORGOVYX/ORKAMBI, PULMOZYME, TRIKAFTA, VENCLEXTA, VERQUVO, VITRAKVI, XALKORI, XOLAIR, XTANDI, YESCARTA/VITRAKVI—each entry includes indication-specific required medical information such as tumor mutation status, prior lines of therapy, or hemodynamic documentation for PAH agents. Always include diagnostic confirmation and prior therapy history when submitting PA requests for oncology and specialty drugs.
- Oncology/specialty examples: GILOTRIF, KADCYLA, KEYTRUDA, KISQALI, LENVIMA, LUMAKRAS, LYNPARZA, MAVYRET, MONJUVI, TRIKAFTA, VENCLEXTA, VITRAKVI, XALKORI, XTANDI
HRM-hypnotics PA for age ≥65 — prescriber alternatives and acknowledgement
For High Risk Medications (HRM) and older adults (≥65 years): HRM-HYPNOTICS (eszopiclone, zaleplon, zolpidem) — PA applies only to patients 65 years and older and requires prescriber acknowledgement that benefit outweighs risk, documentation of trial or contraindication to non-HRM alternatives (doxepin 3/6 mg or ramelteon), and restriction to cumulative >90 days/year. HRM-MECLIZINE and HRM-PROMETHAZINE require prescriber acknowledgement and anticholinergic-therapy justification; PA applies to patients ≥65 with shorter duration thresholds (meclizine prior auth >30 days/year, promethazine >30 days/year). Diazepam and other benzodiazepines require prescriber acknowledgement and alternatives/steps where indicated.
- HRM-HYPNOTICS: Applies to patients ≥65; prescriber acknowledgement required; trial/contraindication to doxepin/ramelteon; PA applies > cumulative 90 days/year
- HRM-MECLIZINE: Applies to patients ≥65; prescriber must acknowledge risks with anticholinergic polypharmacy; PA applies > cumulative 30 days/year; prior auth duration example: 3 months
- HRM-PROMETHAZINE: Applies to patients ≥65; prescriber acknowledgement required; PA applies > cumulative 30 days/year
Initial Therapy Criteria (New Starts)
Continuation Therapy Criteria (Reauthorization)
Step Therapy / Prior Trial Requirements
| Example | Requirement |
|---|---|
| Arcalyst (gout flare prevention) | Inadequate response, intolerance, or contraindication to maximum tolerated NSAID and colchicine; must be used concurrently with urate-lowering therapy; ≥2 gout flares in prior 12 months required for new starts. |
| Alvaiz (chronic/persistent ITP) | Inadequate response or intolerance to prior therapy (e.g., corticosteroids or immunoglobulins) prior to approval; platelet-count thresholds specified for initiation/continuation. |
| Example | Requirement |
|---|---|
| BOSULIF (CML, Ph+ B-ALL) | Diagnosis confirmed by Philadelphia chromosome/BCR‑ABL; prior resistance or intolerance to imatinib, dasatinib, or nilotinib required; mutation testing required when prior TKI resistance noted. |
| Oncology targeted agents (general) | Prior-line therapy and documented tumor biomarker/mutation status required as specified per agent and indication (e.g., RET, ALK, BRAF), with prior therapy failures documented where indicated. |
| Example | Documentation required |
|---|---|
| DHE Nasal (dihydroergotamine) | Documentation of inadequate response, intolerance, or contraindication to at least one triptan; exclusion if used with potent CYP3A4 inhibitors. |
| DARAPRIM (pyrimethamine) | Documentation that patient is immunocompromised and intolerant/contraindicated to TMP‑SMX for prophylaxis or treatment indications. |
| DOPTELET (avatrombopag) | For procedure use: untransfused platelet count <50,000/mcL documented; for ITP new starts: prior therapy failure/intolerance and platelet thresholds documented. |
| EMGALITY (migraine/cluster) | Document prior therapies and that drug will not be used concurrently with another CGRP receptor antagonist; continuation requires documented reduction in migraine/cluster frequency after specified trial period. |
| Example | Prior trial requirement |
|---|---|
| EPRONTIA (topiramate) — partial-onset seizures | Requires prior trial/failure/intolerance to a generic anticonvulsant and to specified alternatives (Aptiom/Xcopri/Spritam) per age/indication before approval. |
| EPRONTIA — migraine prevention/primary generalized tonic-clonic seizures | Requires trial of generic topiramate immediate release OR documentation of inability to swallow solid oral dosage forms as applicable. |
| Example | Step requirement |
|---|---|
| FANAPT (schizophrenia, bipolar mania) | Requires inadequate response, intolerance, or contraindication to specified generic antipsychotics AND to specified brand comparators prior to approval. |
| Example | Requirement |
|---|---|
| Selected biologics and systemic agents (example: RA, psoriasis) | Trial of specified first‑line agents (e.g., methotrexate for RA; phototherapy or methotrexate/cyclosporine/acitretin for psoriasis) or documented contraindication/intolerance required prior to biologic initiation for many indications. |
| HRM‑Amitriptyline and related groups (older adults) | Require documented trials of listed alternative agents (SSRIs/SNRIs/bupropion/mirtazapine/trazodone) and prescriber acknowledgement of benefit vs risk when applied to patients ≥65 years. |
| Example | Requirement |
|---|---|
| Kineret (anakinra) — rheumatoid arthritis, systemic JIA | For new starts in moderately to severely active RA: inadequate response/intolerance/contraindication to two specified agents required; for systemic JIA new starts, trial/failure of tocilizumab required. |
| Example | Authorization note |
|---|---|
| Livtencity (fusidic/antiviral entry) — initial authorization | Age ≥12 years and must be prescribed by or in consultation with ID/transplant/hematology/oncology specialist; initial authorization limited to 3 months. |
| Example | Prerequisite trials |
|---|---|
| LIVTENCITY — limited-duration initial authorization example | Initial coverage duration 3 months with prescriber specialty and age restrictions documented for new starts. |
| Example | Requirement |
|---|---|
| OPIPZA (long‑acting risperidone) — schizophrenia, adjunctive MDD, autism irritability, Tourette's | Requires prior inadequate response, intolerance, or contraindication to specified generic and brand antipsychotic comparators before approval; prerequisite therapy required per entry. |
| Example | Requirement |
|---|---|
| MEPRON (atovaquone) | For PCP treatment/prophylaxis: intolerance or contraindication to sulfamethoxazole‑trimethoprim required; for babesiosis, used concurrently with azithromycin per entry. |
| Example | Requirement |
|---|---|
| Many biologics/targeted therapies (examples: REMICADE, RENFLEXIS, others) | Require prior trials of specified standard therapies (e.g., methotrexate for RA; phototherapy/systemic agents for psoriasis) or documentation of contraindication/intolerance prior to approval for many new starts. |
| Example | Step requirement |
|---|---|
| RINVOQ (certain autoimmune indications) | Requires inadequate response, intolerance, or contraindication to at least one TNF inhibitor prior to approval in specified indications (e.g., RA, PsA, AS, UC per setting). |
| Example | Requirement |
|---|---|
| Biologic initiation for psoriasis (e.g., SKYRIZI, STELARA) — new starts | New starts require either crucial body‑area involvement, ≥10% BSA, or ≥3% BSA plus prior inadequate response/intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) or contraindication to those agents. |
| Example | Requirement |
|---|---|
| TERIPARATIDE (osteoporosis) | Prior trial and documented failure/intolerance to prior therapies or meeting fragility‑fracture/FRAX high‑risk criteria required prior to authorization; initial authorization 24 months. |
| TETRABENAZINE (chorea/tardive dyskinesia) | Requires prior inadequate response or intolerable adverse event to deutetrabenazine before initiation; initial authorization 6 months with continuation criteria based on documented benefit. |
| Example | Prerequisite therapy |
|---|---|
| Topical tacrolimus (moderate‑severe atopic dermatitis) | Prerequisite trial of at least one medium‑ or higher‑potency topical corticosteroid required, or documentation of disease affecting sensitive areas as an alternative; age‑specific formulations noted. |
| Example | Requirement |
|---|---|
| Assorted agents across entries (examples) | Prior trial, failure, intolerance, or contraindication to specified therapies documented in each drug entry is required where indicated (e.g., tacrolimus, Tremfya, Trintellix, Verquvo, vigabatrin). |
| Example | Requirement |
|---|---|
| XELJANZ (new starts in RA, AS, JIA, UC, PsA) | Requires prior inadequate response, intolerance, or contraindication to at least one TNF inhibitor for specified indications (trial of at least one TNF inhibitor is a step requirement). |
| Example | Requirement |
|---|---|
| Oncology agents with prior‑line requirements (example: LONSURF, XPOVIO) | Prior lines of therapy required as specified per drug and indication (e.g., Lonsurf for gastric/esophageal cancers requires at least two prior lines of chemotherapy; XPOVIO and others specify prior therapies). |
| Example | Prerequisite therapy |
|---|---|
| ZONISADE (adjunctive partial‑onset seizures) | Must have tried and failed or be intolerant/contraindicated to a generic anticonvulsant AND to listed alternatives (Aptiom, Xcopri, Spritam) prior to approval unless unable to swallow solid oral forms. |
| Example | Prerequisite therapy |
|---|---|
| ZYKADIA (ALK‑positive NSCLC and others) | For NSCLC: prior inadequate response, intolerance, or contraindication to Alecensa (alectinib) or Alunbrig (brigatinib) required before approval in many settings per entry. |
Coding, Thresholds, and Key Clinical Numeric Criteria
| ZELBORAF | ZELBORAF (vemurafenib) |
| ZIRABEV | ZIRABEV |
| ZOLINZA | ZOLINZA |
| ZONISADE | ZONISADE |
| ZTALMY | ZTALMY |
| ZURZUVAE | ZURZUVAE |
| ZYDELIG | ZYDELIG |
| ZYKADIA | ZYKADIA |
| ZYPREXA RELPREVV | ZYPREXA RELPREVV |
Quantity Limits and Duration Restrictions
Site of Care / Medicare Part A vs B vs D Considerations
Submit setting/use (infusion center | outpatient | pharmacy) for Part B/Part D determination
When requesting coverage for drugs that may be administered in different settings (infusion center, outpatient clinic, or dispensed by pharmacy), submit the use/setting details with the PA to allow HMSA to determine Medicare Part B vs Part D applicability.
- Include whether drug is to be administered in an infusion center, physician office (incident to), outpatient clinic, or dispensed to the patient via pharmacy.
Part D denied if Part A/B covers the medication
Coverage under Part D will be denied if coverage is available under Part A or Part B as the medication is prescribed and dispensed or administered for the individual; this rule is repeatedly applied across affected entries.
Part D denial when covered under Part A/B — repeated policy guidance
The policy reiterates that Part D coverage will be denied when the medication is covered under Part A or Part B as prescribed/dispensed/administered; include documentation of setting/use to support Part D coverage requests.
Biosimilar Notes and Exclusions
KANJINTI / biosimilar intolerance rule — prior intolerable AE to Trazimera excludes coverage
For KANJINTI and related biosimilars (e.g., Trazimera), coverage is excluded if the patient previously experienced an intolerable adverse event to Trazimera that was NOT attributed to the active ingredient; document prior AE details if claiming intolerance to an originator or biosimilar.
- All indications require prior intolerable AE to Trazimera not attributed to the active ingredient to qualify for coverage of specified biosimilars.
ORKAMBI combination exclusion — no use with other CFTR potentiators
ORKAMBI (and related CFTR modulators) must not be used in combination with other CFTR potentiating agents; PA requests must document that the requested CFTR modulator will not be co‑administered with other potentiators.
- Examples of excluded combinations: ORKAMBI or TRIKAFTA with ivacaftor or other CFTR potentiators.
Background and Scope
This document lists prescription drugs and drug groups that require prior authorization from HMSA Akamai Advantage (PPO). For each product the policy summarizes the clinical and administrative criteria used to determine coverage, including required diagnostic confirmation, prior therapy trials or contraindications, age and prescriber restrictions, duration limits, and any explicit exclusions.
Coverage decisions are criteria‑driven: approval is provided only when the submitted documentation demonstrates that the drug will be used for an indicated diagnosis and that all applicable authorization requirements are met (for example, right‑heart catheterization and hemodynamic thresholds for pulmonary arterial hypertension, tumor mutation documentation for targeted oncology therapies, or specified laboratory thresholds for IVIG and HCV agents).
Providers must request prior authorization using the HMSA contact provided and include the clinical information listed for the specific drug (diagnostic test results, prior therapy history, labs, and the site/setting of administration when relevant) because failure to supply required documentation may result in denial.
Definitions and Clinical Terms
Drug Lists / Coding Table (Drug Groups and Codes)
| ZELBORAF | ZELBORAF (vemurafenib) |
| ZIRABEV | ZIRABEV |
| ZOLINZA | ZOLINZA |
| ZONISADE | ZONISADE |
| ZTALMY | ZTALMY |
| ZURZUVAE | ZURZUVAE |
| ZYDELIG | ZYDELIG |
| ZYKADIA | ZYKADIA |
| ZYPREXA RELPREVV | ZYPREXA RELPREVV |
Revision History
Policy current status indicated as CURRENT with prior authorization procedures and phone number for PA requests
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.