CurrentHawaii Medical Service Association (HMSA)Policy N/A
Drugs Requiring Prior Authorization — Pharmacy & Specialty Drugs Coverage Criteria
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Lists drugs that require prior authorization from HMSA Akamai Advantage (PPO) and the criteria/documentation required for coverage; applies to members and prescribers seeking coverage for medications shown in the chart.
Policy Summary
PayerHawaii Medical Service Association (HMSA)
PolicyDrugs Requiring Prior Authorization — Pharmacy & Specialty Drugs Coverage Criteria
Policy CodePolicy N/A
Change TypeNo material changes
Effective DateN/A
Next Review DateN/A
Key ActionPrior authorization must be requested from HMSA at 1 (855) 479-3659 prior to dispensing.
SourceLink
POLICY UPDATE CHANGES
No material clinical or coverage changes in this revision.
24/7PA phone availability
20+Drugs listed (partial)
Plan YearTypical coverage duration
Coverage Criteria and Drug-specific Requirements
inv-01: General PA rule
General prior authorization rules and documentation requirements applicable across drug-specific criteria.
Prior authorization is required for the drugs and indications listed in this section. Requests must include supporting clinical documentation as specified under each drug entry and any additional required information (e.g., diagnostic testing, mutation status, prior therapy trials).
Coverage durations shown are default; exceptions (e.g., chemotherapy cycles, surgical prophylaxis) are listed with specific drug entries.
Prescriber restrictions: when a drug entry requires prescribing by or in consultation with a specialist (e.g., oncologist, hepatologist, immunologist), the request should include documentation of specialist involvement.
Age restrictions: age limits specified under individual drug entries apply. If none specified, no age restriction is documented.
Exclusion criteria: therapies listed as excluded or not covered for certain indications are noted in the corresponding drug-specific entries.
Step-therapy and prior treatment requirements: when a drug requires prior failure/intolerance/contraindication to specified agents or classes, documentation of trials (drug names, dates, doses, and reasons for failure/intolerance) must be provided.
Diagnostic confirmation: for many oncology, genetic, infectious disease, and rare disease therapies, requests must include relevant test results (e.g., mutation testing, enzyme assays, HCV RNA, right heart catheterization) with dates and values where applicable.
inv-02: ADEMPAS (riociguat) PA criteria for PAH and CTEPH
Selected pulmonary arterial hypertension (PAH) and related agents — diagnostic and hemodynamic criteria required for World Health Organization (WHO) Group 1 and Group 4 disease.
For PAH (WHO Group 1) initial therapy with agents such as riociguat (Adempas), bosentan, sildenafil, treprostinil, and selexipag (Uptravi): right heart catheterization confirming mean pulmonary arterial pressure (mPAP) >20 mmHg AND pulmonary capillary wedge pressure (PCWP) ≤15 mmHg. When specified, pretreatment pulmonary vascular resistance (PVR) thresholds apply (e.g., >2 Wood units).
For chronic thromboembolic pulmonary hypertension (CTEPH) and riociguat (Adempas): patient must have persistent/recurrent CTEPH after pulmonary endarterectomy (PEA) OR inoperable CTEPH confirmed by right heart catheterization and imaging (CT, MRI, or pulmonary angiography).
Treprostinil and Uptravi (selexipag): new starts require PAH diagnosis by right heart catheterization; document WHO group, hemodynamics, and prior therapy trials or contraindications if applicable.
Sildenafil for PAH: confirm PAH diagnosis by right heart catheterization; age and dosing per product labeling. Continuation approvals require evidence of clinical benefit or stable hemodynamics.
For PAH agents, specify whether therapy is initial or continuation; for new starts, include baseline hemodynamics and prior therapies tried or contraindicated.
inv-03: Thrombopoietin receptor agonist / platelet-related criteria (examples in document)
Platelet and thrombopoietin receptor agonist (TPO-RA) indications and thresholds.
For chronic immune thrombocytopenia (ITP) new starts: inadequate response or intolerance to prior therapy (e.g., corticosteroids, IVIG) AND untransfused platelet count <30,000/mcL OR 30,000–50,000/mcL with symptomatic bleeding or bleeding risk factors (procedures, anticoagulation, comorbidities).
For ITP continuation: platelet response criteria — current platelet count ≤200,000/mcL OR >200,000 to ≤400,000/mcL with dosing adjusted to avoid clinically important bleeding.
For thrombocytopenia associated with chronic hepatitis C: use for initiation/maintenance of interferon-based therapy; continuation limited to patients receiving interferon-based therapy.
For severe aplastic anemia (AA): new starts require insufficient response to immunosuppressive therapy; continuation criteria include specified platelet count ranges and duration of appropriately titrated therapy (e.g., 16 weeks before deeming inadequate response).
Thrombopoietin receptor agonists used for chronic liver disease-associated thrombocytopenia: documentation of pre-procedure platelet count <50,000/mcL and planned procedure timing for periprocedural use.
inv-04: Selected medication-specific criteria (examples)
Selected medication-specific criteria and required documentation (consolidated examples across the source).
Imatinib (all formulations): For chronic myeloid leukemia (CML) and other BCR-ABL–positive neoplasms, diagnosis must be confirmed by detection of Philadelphia chromosome or BCR-ABL gene. Prior therapy requirements depend on agent and line of therapy — if resistance to other TKIs is claimed, provide mutation testing (e.g., T315I, Y253H, E255K/V, F359V/C/I, G250E) and prior TKI trial history.
CML / ABL1-rearranged neoplasms: Agent-specific criteria apply. For patients with resistant disease, mutation testing and documentation of prior kinase inhibitor exposure are required; certain agents (e.g., ponatinib, ibrutinib alternatives) reserved for T315I or other resistant mutations.
Monjuvi (tafasitamab-cxix): For indicated B-cell lymphomas, document pathology and prior lines of therapy per FDA labeling; include CD19-positive disease confirmation when applicable.
Lorbrema/Lorlatinib / Lumakras sequencing note (targeted therapies): ensure appropriate sequential use per labeling and mutation status; include documentation of prior targeted therapies and tumor genotyping (e.g., KRAS G12C for Lumakras, ALK for Lorbrena/lorlatinib).
Venclexta (venetoclax): For hematologic malignancies, documentation of diagnostic testing (e.g., BCL-2 dependency context per indication), combination regimens, and tumor mutation status as required by indication. Monitor for tumor lysis and provide dosing/monitoring plan.
Qinlock (ripretinib) and other GIST agents: specify prior therapy history (number and names of prior FDA-approved therapies), mutation testing if required, and disease status (residual, unresectable, recurrent/metastatic).
Xalkori (crizotinib), Rozlytrek (entrectinib), Retevmo (selpercatinib), Vitrakvi (larotrectinib), and other targeted agents: require tumor genotyping confirming the actionable alteration (e.g., ROS1, NTRK fusions, RET rearrangement) and document prior therapy lines as applicable.
Mavyret, Harvoni, and other HCV direct-acting antivirals: HCV RNA confirmation prior to therapy, genotype, cirrhosis status (compensated vs decompensated), prior treatment history, HIV coinfection, and transplant status; apply AASLD-IDSA guidance for regimen selection and duration.
Zykadia (ceritinib), Zykadia coverage criteria: for ALK-positive NSCLC ensure ALK rearrangement testing and prior therapy exposure as required by indication.
TibSOVO (ivosidenib) and other IDH agents: indicate off-label or specific cancer uses require mutation confirmation (IDH1/IDH2) and disease context documentation.
SkyRizi (risankizumab) and Tremfya (guselkumab) for plaque psoriasis (new starts): document BSA (≥3% or crucial areas) or severe disease criteria, and prior inadequate response/intolerance/contraindication to specified conventional systemic therapies or phototherapy; continuation requires documented benefit.
Biologics such as Renflexis and other infliximab products for rheumatologic, dermatologic, and immune-mediated diseases: follow disease-specific prior therapy rules (e.g., methotrexate trial for RA unless contraindicated) and note additional exclusions (e.g., interchangeability exceptions, prior hypersensitivity to reference or biosimilar).
IVIG indications: document specific indication (e.g., primary immunodeficiency, immune thrombocytopenia, CIDP), relevant diagnostic test results, prior therapies, and dosing plan; coverage duration typically per plan year or indication-specific (e.g., acute vs chronic).
Erythropoietin agents (e.g., Procrit): initial and reauthorization criteria require documentation of hemoglobin level, underlying cause (chemotherapy-induced anemia vs chronic kidney disease), intent of therapy, dosing plan, and monitoring strategy; follow ESA labeling for hemoglobin thresholds and risks.
Increlex (mecasermin) new starts: for severe primary insulin-like growth factor-1 (IGF-1) deficiency, document IGF-1 levels, growth hormone status, prior GH testing and trials, and specialist prescribing (endocrinology).
Naglazyme (galsulfase) for MPS VI: confirm diagnosis with enzyme assay demonstrating deficient arylsulfatase B activity and/or genetic testing; document disease severity and specialist involvement.
Mavyret (glecaprevir/pibrentasvir): see HCV DAAs guidance above — genotype-inclusive 8–12 week options per AASLD-IDSA where appropriate.
Modafinil and other wake-promoting agents for narcolepsy, idiopathic hypersomnia, and excessive daytime sleepiness: document diagnosis per sleep specialist evaluation, sleep study results where applicable, prior stimulant trials or contraindications, and for narcolepsy provide cataplexy documentation if treating cataplexy-specific agents.
Posaconazole (oral): for prophylaxis in high-risk neutropenic patients and treatment of invasive fungal disease, document indication (prophylaxis vs treatment), immunosuppression status, relevant cultures/biopsy/imaging, dosing formulation appropriateness (delayed-release tablets vs oral suspension) and therapeutic drug monitoring when indicated.
Quetiapine XR/ER: specify indication (schizophrenia, bipolar disorder, adjunctive major depressive disorder), document prior therapies tried/intolerated, and for older adults note risks (e.g., increased mortality in dementia-related psychosis) and dosing considerations.
Quinine sulfate: indication-specific coverage (e.g., severe malaria) — require diagnosis and appropriateness; chronic or unapproved uses typically excluded.
Relistor (methylnaltrexone injectable) for opioid-induced constipation: document chronic opioid use, inadequate response to conventional laxatives, and goal of therapy (palliative vs chronic) and prescriber specialty when applicable.
Sapropterin and related agents for phenylketonuria (PKU): document metabolic testing, baseline phenylalanine levels, dietary management plan, responsiveness testing to sapropterin where applicable, and specialist (metabolic/genetics) involvement.
Omnipod insulin pump systems (initial): requirements include diabetes requiring insulin management, current self-monitoring of blood glucose or CGM use, prior trial of multiple daily injections with inadequate control or inability to perform multiple injections, and patient education/counseling plan.
Uceris (budesonide ER) for ulcerative colitis induction: document diagnosis, extent/severity, prior therapy trials if applicable, and planned induction vs maintenance use per labeling.
Temazepam and other benzodiazepine-hypnotics in older adults: prior authorization applies for older adults due to appropriateness concerns; prescriber must acknowledge risks and document alternatives tried or contraindications to non-HRM options (e.g., doxepin low-dose).
Topical lidocaine (including compounded): coverage depends on indication (e.g., postherpetic neuralgia) and limits on compounded topical agents may apply; include diagnosis and prior therapy trials.
Terbinafine for onychomycosis: document clinical diagnosis with supporting microscopy/culture or failed topical therapy; duration per label (e.g., 6–12 weeks) and hepatic monitoring when indicated.
Teriparatide and other PTH analogs for osteoporosis: initial therapy criteria include diagnosis of severe osteoporosis (T-score thresholds or fragility fractures), prior therapy trials or contraindications, and reauthorization requires bone density improvement or other clinical rationale.
Uptravi (selexipag) for PAH: follow PAH diagnostic criteria above; document right heart catheterization and prior therapy trials or contraindications when required.
Skyrizi (risankizumab) and Tremfya (guselkumab) for plaque psoriasis: initial therapy requires BSA or crucial area involvement and prior systemic therapy failure/intolerance unless severe disease warrants biologic as first-line.
Xeljanz (tofacitinib) and other Janus kinase inhibitors for rheumatologic indications: document prior csDMARD (e.g., methotrexate) failure/intolerance for RA new starts, and monitor for boxed warnings; other indications follow respective labeling.
Xalkori and other ALK/ROS1 inhibitors: require tumor genotyping confirming ALK or ROS1 alterations and documentation of disease stage and prior therapies as applicable.
inv-05: BOSENTAN (PAH) — Initial therapy (new starts)
Bosentan (Tracleer) — PAH initial therapy specifics for new starts.
For pulmonary arterial hypertension (WHO Group 1): diagnosis must be confirmed by right heart catheterization. For new adult starts only, pretreatment hemodynamics must include mPAP >20 mmHg, PCWP ≤15 mmHg, and PVR >2 Wood units. Additionally, patient must have experienced inadequate response, intolerance, or have a contraindication to ambrisentan (Letairis) prior to initiating bosentan, unless contra-indicated or not tolerated.
Provide baseline liver function tests prior to initiation and monitor per product labeling due to hepatotoxicity risk.
Age restrictions and prescriber specialty requirements: none specified beyond standard labeling. Coverage duration: Plan Year.
inv-06: BRAFTOVI — Indication-specific criteria
Targeted therapy criteria — examples for BRAFTOVI and sequencing requirements for kinase inhibitors and mutation-driven oncology therapies.
BRAFTOVI (encorafenib) coverage criteria: For colorectal cancer (including appendiceal adenocarcinoma), tumor must be BRAF V600E mutation-positive and disease advanced/metastatic or unresectable; for melanoma, tumor must harbor BRAF V600 activating mutation and use may be as single agent or in combination with binimetinib for unresectable/metastatic or adjuvant systemic therapy; for NSCLC, BRAF V600E mutation and advanced/recurrent/metastatic disease when used with binimetinib.
QINLOCK (ripretinib), CML/ABL1-related agents and other targeted therapies: document prior therapy exposures (number and agents), relevant mutation testing, and disease status (residual, unresectable, recurrent/metastatic).
Lorbrena/Lumakras sequencing: ensure appropriate mutation confirmation (ALK or KRAS G12C respectively) and document prior targeted therapy trials or contraindications as per indication.
MONJUVI (tafasitamab-cxix) and similar B-cell lymphoma agents: document histologic diagnosis, prior lines of therapy, CD19 expression if required, and intent (monotherapy vs combination) per labeling.
Alternate oncology indications or uses outside label require detailed rationale, mutation testing confirmation, and evidence that use aligns with current oncology standards.
inv-07: BRIVIACT — Partial-onset seizures
Briviact (brivaracetam) partial-onset seizure coverage rules.
For treatment of partial-onset (focal-onset) seizures: patient must have experienced inadequate response, intolerance, or contraindication to a generic anticonvulsant AND inadequate response/intolerance/contraindication to listed alternatives (e.g., aptiom, cenobamate where age-appropriate).
Age: 1 month of age or older for some indications — confirm product-specific age approvals. Coverage duration: Plan Year. For other seizure and epilepsy indications, follow specific required-medical-information entries in the drug table.
inv-08: CERDELGA — Type 1 Gaucher disease
Cerdelga (eliglustat) — Type 1 Gaucher disease criteria.
Diagnosis must be confirmed by enzyme assay demonstrating deficiency of beta-glucocerebrosidase activity or by genetic testing.
Prior to initiation, patient's CYP2D6 metabolizer status must be established using an FDA-cleared test and documented; patient must be an extensive, intermediate, or poor metabolizer (per labeling guidance for eliglustat dosing).
Coverage duration: Plan Year.
inv-09: Cystinosis therapies (CYSTADROPS, CYSTAGON, CYSTARAN)
Cystinosis therapies — initiation criteria and diagnostic confirmation.
For systemic cystinosis (Cystagon/Cystaran/Cystadrops): diagnosis confirmed by increased cystine concentration in leukocytes OR genetic testing OR slit-lamp demonstration of corneal cystine crystals as applicable.
For corneal cystine crystal accumulation, topical cysteamine (Cystaran/Cystadrops) indicated; systemic therapy (Cystagon) for nephropathic cystinosis requires systemic diagnostic confirmation.
Coverage duration: Plan Year.
inv-10: COSENTYX — New starts for dermatologic and rheumatologic indications
Cosentyx (secukinumab) — new starts for dermatologic and rheumatologic indications.
Moderate to severe plaque psoriasis (new starts): at least 3% BSA affected OR crucial body areas affected AND prior inadequate response, intolerance, or contraindication to specified prior products (e.g., adalimumab biosimilars, etanercept, ustekinumab, risankizumab, deucravacitinib) unless severe disease warrants biologic first-line.
Active ankylosing spondylitis / non-radiographic axial spondyloarthritis (new starts): prior inadequate response/intolerance to NSAIDs or contraindication to NSAIDs.
Psoriatic arthritis: inadequate response/intolerance to specified prior agents as listed for biologics group. Coverage duration: Plan Year.
inv-11: DALFAMPRIDINE — Multiple sclerosis
Dalfampridine ER for improvement of walking in MS — objective impairment required for initiation and documented benefit for continuation.
New starts: documented sustained walking impairment prior to initiating therapy (e.g., timed 25-foot walk) as per product labeling.
Continuation: objective improvement in walking speed or other objective measures of walking ability since starting therapy. Coverage duration: Plan Year.
inv-12: PYRIMETHAMINE (DARAPRIM) — Prophylaxis and treatment indications
Pyrimethamine (Daraprim) prophylaxis and treatment criteria for toxoplasmosis, PCP, and cystoisosporiasis.
Primary toxoplasmosis and PCP prophylaxis: patient has intolerance or contraindication to trimethoprim-sulfamethoxazole (TMP-SMX) AND CD4 count <200 cells/mm3 within past 3 months.
Secondary toxoplasmosis prophylaxis: CD4 count <200 cells/mm3 within past 6 months.
Cystoisosporiasis treatment or prophylaxis: intolerance or contraindication to TMP-SMX; for secondary prophylaxis, CD4 <200 cells/mm3 within past 6 months as applicable.
Coverage durations vary by indication (e.g., acute toxoplasmosis treatment Plan Year, certain prophylaxis durations 3–6 months per drug table).
inv-13: BOSULIF (bosutinib) — CML and Ph+ B-ALL
Bosulif (bosutinib) for CML and Ph+ B-ALL — mutation and prior TKI requirements.
For CML (including post-transplant): diagnosis confirmed by Philadelphia chromosome or BCR-ABL gene detection. If resistance to an alternative TKI is claimed, mutation testing for T315I, G250E, V299L, and F317L is required and patient must be negative for those mutations if specified. Patient must have experienced resistance or intolerance to imatinib, dasatinib, or nilotinib unless T315I or other specific mutation/labeled indication applies.
For Ph+ B-ALL: diagnosis confirmed by Philadelphia chromosome or BCR-ABL gene detection; provide prior therapy history and mutation testing as applicable.
inv-14: CABOMETYX — Indication-specific criteria
Cabometyx (cabozantinib) — indication-specific required information and prior therapy history.
For renal cell carcinoma: disease advanced/relapsed/refractory or Stage IV AND patient has received two or more prior systemic therapies.
For other labeled indications (e.g., hepatocellular carcinoma), follow FDA labeling and document prior therapies, tumor staging, and liver function status.
inv-15: Pyrimethamine (toxoplasmosis/PCP/cystoisosporiasis) criteria
Pyrimethamine (toxoplasmosis/PCP/cystoisosporiasis) — detailed prophylaxis/treatment criteria (additional).
See inv-12 for toxoplasmosis and PCP prophylaxis/treatment thresholds and TMP-SMX intolerance criteria.
Specify durations: congenital toxoplasmosis treatment: Plan Year; acquired toxoplasmosis treatment, primary toxoplasmosis prophylaxis, PCP prophylaxis: typically 3 months; secondary toxoplasmosis prophylaxis and cystoisosporiasis treatment/prophylaxis: typically 6 months per drug table.
inv-16: Thrombocytopenia indications (DOPTELET / related group)
Thrombocytopenia and related drug group (DOPTELET and similar) — indications and per-indication duration.
For thrombocytopenia in chronic liver disease prior to procedure: unftransfused platelet count <50,000/mcL. Coverage duration typically 1 month per procedure.
Chronic ITP initial: 6 months; reauthorization: Plan Year. Chronic liver disease: 1 month. Severe aplastic anemia: initial 6 months; reauth per APR-Plan Year or IPR-16 weeks logic as specified in drug table.
inv-17: Dupixent coverage criteria (indication-specific)
Dupixent (dupilumab) coverage rules across approved indications.
Atopic dermatitis (initial): moderate-to-severe disease and inadequate response to topical corticosteroids or calcineurin inhibitors OR topical options not advisable. Continuation requires maintained clinical response. Age thresholds per indication (e.g., AD ≥6 months).
Oral corticosteroid–dependent asthma: inadequate control despite high-dose inhaled corticosteroid plus an additional controller; for severe asthma initial therapy either baseline blood eosinophils ≥150 cells/µL or systemic corticosteroid dependence and prior controller trial history required. Continuation requires improved asthma control.
Chronic rhinosinusitis with nasal polyposis: used as add-on maintenance treatment; for adults, inadequate response to Xhance (fluticasone) required.
Eosinophilic esophagitis: biopsy-confirmed diagnosis (≥15 eosinophils per HPF), clinical manifestations, weight ≥15 kg, and inadequate response/intolerance/contraindication to topical corticosteroids for initial therapy.
Prescribing specialties and age limits vary by indication; coverage durations vary (initial vs continuation periods as listed).
inv-18: Topiramate-containing product criteria (EPRONTIA/TOPIRAMATE)
Topiramate-containing products — indications and age limits.
For epilepsy and seizures: age thresholds vary by indication (epilepsy 2 years or older; adjunctive or monotherapy contexts per product labeling). Prior trials of generic topiramate immediate-release may be required for certain formulations or migraine prevention.
For migraine prevention in pediatrics: age ≥12 years for preventive indication as stated in drug table.
Coverage duration: Plan Year.
inv-19: Idiopathic pulmonary fibrosis (new starts)
Idiopathic pulmonary fibrosis (IPF) — diagnostic imaging and pathology requirements for antifibrotic therapy initiation.
For new starts: HRCT demonstrating usual interstitial pneumonia (UIP) pattern OR HRCT non-UIP supported by lung biopsy OR multidisciplinary discussion between experienced radiologist and pulmonologist when lung biopsy not performed. Document pulmonary function tests and clinical course where available.
inv-20: Etanercept — rheumatoid arthritis, ankylosing spondylitis, psoriasis, hidradenitis suppurativa (new starts)
Etanercept and other biologic DMARDs — rheumatoid arthritis, ankylosing spondylitis, psoriasis, hidradenitis suppurativa (new starts)
Rheumatoid arthritis (moderate to severe, new starts): inadequate response/intolerance/contraindication to methotrexate OR prior biologic/targeted synthetic DMARD as specified.
Ankylosing spondylitis and non-radiographic axial spondyloarthritis (new starts): inadequate response/intolerance to NSAIDs or contraindication.
Moderate to severe plaque psoriasis (new starts): ≥3% BSA or crucial areas affected AND prior inadequate response/intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) unless severe disease warrants biologic first-line.
Hidradenitis suppurativa (new starts): severe refractory disease and prior inadequate response to specified therapies.
inv-21: Fasenra — severe asthma and EGPA
Fasenra (benralizumab) — severe eosinophilic asthma and EGPA criteria.
Severe asthma initial therapy: baseline blood eosinophils ≥150 cells/µL OR systemic corticosteroid dependence AND history of severe asthma despite medium-to-high-dose inhaled corticosteroid plus additional controller. Continuation requires documented clinical benefit.
EGPA initial therapy: history or presence of eosinophil count >1000 cells/µL or >10% blood eosinophils. Continuation requires beneficial response (reduced relapses, steroid-sparing effect, or no active vasculitis). Age restrictions apply (as listed).
inv-22: Fulphila — prophylaxis of chemotherapy-induced febrile neutropenia and stem cell transplantation
Fulphila and other supportive oncology biologics — prophylaxis of chemotherapy-induced febrile neutropenia and stem cell transplantation use.
For prophylaxis of febrile neutropenia with myelosuppressive chemotherapy: patient must have solid tumor or non-myeloid cancer and be receiving myelosuppressive anti-cancer therapy; administer at least 24 hours after chemotherapy.
Coverage duration commonly 6 months for prophylaxis indications; dosing and timing per oncology standards.
inv-23: Perampanel (Fycompa) — seizure disorders
Perampanel (Fycompa) seizure disorder criteria.
Treatment of partial-onset seizures: inadequate response/intolerance/contraindication to a generic anticonvulsant AND to listed alternatives where age-appropriate. Age limits: partial-onset seizures ≥4 years; primary generalized tonic-clonic seizures ≥12 years for adjunctive use per table.
Coverage duration: Plan Year.
inv-24: GATTEX — short bowel syndrome
GATTEX (teduglutide) — short bowel syndrome criteria.
Adult SBS initial therapy: dependence on parenteral support for at least 12 months. Pediatric SBS: dependence on parenteral support. Continuation requires reduction in parenteral support from baseline while on therapy.
Prescriber: gastroenterologist, GI surgeon, or nutritional support specialist involvement expected. Coverage duration: Plan Year.
inv-25: Growth hormone and related endocrine therapies
Growth hormone and related endocrine therapies — pediatric and adult diagnostic and stimulation testing requirements.
Pediatric growth hormone deficiency (GHD): diagnostic criteria include neonatal diagnosis or specific height/velocity criteria with failed stimulation testing (two failed GH stimulation tests with peak <10 ng/mL) or structural/genetic causes and low IGF-1.
Adult GHD: failed stimulation testing or organic hypothalamic-pituitary disease with low IGF-1 and other pituitary hormone deficiencies. Continuation requires demonstration of clinical benefit.
Prescriber restrictions: endocrinologist or appropriate specialist; coverage duration: Plan Year.
inv-26: Haegarda — hereditary angioedema prophylaxis
Haegarda (C1 esterase inhibitor subcutaneous) for hereditary angioedema prophylaxis.
Prophylaxis requires laboratory confirmation of HAE with C1 inhibitor deficiency/dysfunction OR HAE with normal C1 inhibitor with confirmatory genetic testing or family history and refractoriness to high-dose antihistamine trial.
Prescribing by or in consultation with immunologist/allergist/rheumatologist; age 6 years or older for Haegarda. Coverage duration: Plan Year.
inv-27: HER2-directed agents (Herceptin, Herceptin Hylecta, Trazimera, others) — oncology indications
HER2-directed agents — Herceptin, Herceptin Hylecta, Trazimera, others — oncology indications and required tumor testing.
All HER2-directed therapy requests require tumor HER2 testing documentation (IHC and/or ISH as appropriate) and indication-specific staging and prior therapy history. For colorectal cancer, require HER2 amplification with RAS/BRAF wild-type when specified and combination regimens per indication.
For certain agents, prior intolerance to an alternate trastuzumab biosimilar (e.g., Trazimera) may be a requirement for coverage of a replacement biosimilar or brand product; provide documentation of the adverse event and attribution.
Coverage under Part D may be denied when drug is appropriately covered under Part A or B based on administration/dispensing context.
inv-28: Fentanyl patch — chronic severe pain
Fentanyl patch coverage for chronic severe pain — high-risk opioid prescribing requirements.
Fentanyl patch requests must document cancer-, sickle cell–, or palliative-level pain OR severe persistent pain requiring daily opioid therapy, prior opioid exposure and safety evaluation, monitoring plan for opioid use disorder, and prescriber expertise in potent opioid management.
Continuation requires documentation of benefit and monitoring. Coverage duration: Plan Year.
inv-29: Trazimera-related interchange/exceptions
Trazimera and related interchange/exceptions.
When requesting alternate trastuzumab products due to intolerance to a prior biosimilar, document intolerable adverse event and attribution not due to active ingredient per prescribing information. Provide tumor HER2 status and prior therapy history for oncology indications.
inv-30: Tasimelteon (HETLIOZ) — Non-24 and SMS
Tasimelteon (Hetlioz) — Non-24 and Smith-Magenis Syndrome (SMS) criteria.
Non-24: diagnosis of total blindness in both eyes with inability to perceive light; for initial and continuation therapy document improved nighttime sleep or decreased daytime napping if currently on therapy. Age ≥18 years for Non-24.
SMS: confirmed Smith-Magenis Syndrome diagnosis; continuation must show improvement in quality of sleep. Age thresholds apply (e.g., SMS ≥16 years). Prescriber specialty: sleep disorder specialist, neurologist, or psychiatrist; initiation coverage 6 months, renewal Plan Year.
inv-31: HRM (High Risk Medication) prior authorization cluster
High Risk Medications (HRM) prior authorization cluster — older adult appropriateness and drug-specific exceptions.
Multiple HRM groups require prescriber acknowledgement that benefit outweighs risks for patients 70 years or older and documentation of alternatives tried/intolerated where specified (e.g., hypnotics, anticholinergics, antipsychotics, promethazine).
Duration limits and cumulative day caps apply for many HRM groups (e.g., >30 days/year for certain anticholinergics or >90 days/year for hypnotics).
For specific HRM groups (e.g., HYPNOTICS, PROMETHAZINE), initial indication-specific criteria such as prior doxepin trial for insomnia may be required.
inv-32: Humira and other biologic indications (new starts)
Humira and other TNF/biologic agents — rheumatologic and dermatologic indications (new starts).
For RA (new starts): inadequate response/intolerance/contraindication to methotrexate OR to prior biologic/targeted synthetic DMARDs as specified. For psoriasis and PsA, document BSA/crucial area involvement and prior systemic therapy trials per biologic class criteria.
Age and prescriber restrictions vary by product; coverage duration Plan Year.
inv-33: Icatibant (SAJAZIR) — acute HAE attacks
Icatibant (SaJazir) for acute hereditary angioedema attacks.
Treatment requires laboratory confirmation of HAE with C1 inhibitor deficiency/dysfunction OR HAE with normal C1 inhibitor with confirmatory testing and either positive genetic testing for listed genes or family history and refractoriness to high-dose antihistamines.
Prescribed by or in consultation with immunologist/allergist/rheumatologist; age ≥18 years. Coverage duration: Plan Year.
inv-34: ICLUSIG (ponatinib) — hematologic and GIST criteria
Iclusig (ponatinib) — CML, Ph+ leukemias, and GIST criteria.
For CML: available for accelerated or blast phase when no other kinase inhibitor is indicated, or chronic phase with resistance/intolerance to at least two prior kinase inhibitors including imatinib, dasatinib, or nilotinib, or for T315I mutation–positive disease. Provide mutation testing and prior TKI exposure documentation.
For GIST: disease residual/unresectable/recurrent/metastatic/tumor rupture with progression after at least two FDA-approved therapies; provide prior therapy history and mutation testing if applicable.
inv-35: Enasidenib (IDHIFA) — AML with IDH2 mutation
Enasidenib (IDHIFA) — AML with IDH2 mutation criteria.
For AML with IDH2 mutation: newly diagnosed patients not candidates for intensive induction therapy, post-induction/post-consolidation uses per labeling, or relapsed/refractory AML. Mutation confirmation required. Coverage duration: Plan Year.
inv-36: Moderately to severely active rheumatoid arthritis (new starts)
Moderately to severely active rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis biologic/targeted therapy sequencing summary.
New starts for these indications require documented inadequate response/intolerance/contraindication to conventional systemic therapies (e.g., methotrexate for RA, NSAIDs for axial spondyloarthritis, phototherapy or systemic agents for psoriasis) unless disease severity justifies biologic as first-line. Document prior trials, doses, durations, and reasons for failure/intolerance. Continuation requires documented clinical benefit.
inv-37: Ankylosing spondylitis and non-radiographic axial spondyloarthritis (new starts)
Ankylosing spondylitis and non-radiographic axial spondyloarthritis (new starts) summary.
Patients must have inadequate response or intolerance to NSAIDs or a contraindication to NSAIDs before initiating certain biologic/targeted agents. Document trial details and symptom burden. Coverage duration: Plan Year.
inv-38: Moderate to severe plaque psoriasis (new starts)
Moderate to severe plaque psoriasis (new starts) — biologic initiation prerequisites.
At least 3% BSA affected or crucial body areas involved AND prior inadequate response/intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) OR severe disease warranting biologic first-line (≥10% BSA or crucial areas). Document BSA, prior therapies, and reasons for failure/intolerance. Coverage duration: Plan Year.
Clinical Thresholds and Diagnostic Values
inv-112: PAH hemodynamic thresholds
Mean pulmonary arterial pressure (mPAP)> 20 mmHg
Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg
Pulmonary vascular resistance (PVR) — adults> 2 Wood units (some agent criteria specify ≥3 Wood units)
inv-113: Platelet count thresholds (ITP/AA)
ITP new starts — platelet countUntransfused platelet count < 30,000/mcL OR 30,000–50,000/mcL with symptomatic bleeding or bleeding risk factors
ITP continuation — platelet responseCurrent platelet ≤200,000/mcL OR >200,000 to ≤400,000/mcL with dosing adjusted to avoid clinically important bleeding
Severe aplastic anemia (new starts)Insufficient response to immunosuppressive therapy required
inv-114: Mean pulmonary arterial pressure
Mean pulmonary arterial pressure (mPAP)> 20 mmHg
ContextRequired as part of right heart catheterization confirmation for PAH (WHO Group 1) — applies to new starts per agent-specific rules
Source noteReferenced across PAH agent entries (e.g., ADEMPAS, BOSENTAN, SILDENAFIL)
inv-115: Pulmonary capillary wedge pressure
Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg
ContextMeasured during right heart catheterization as part of PAH confirmation for WHO Group 1
Agent applicationListed in multiple PAH agent criteria (e.g., ADEMPAS, BOSENTAN, UPTRAVI)
inv-116: Pulmonary vascular resistance (adults)
Pulmonary vascular resistance (PVR) — adults> 2 Wood units (some PAH agent entries specify ≥3 Wood units for adult new starts)
Measured during RHCUsed with mPAP and PCWP to confirm PAH hemodynamics
Agent-specific noteCertain drugs (e.g., SILDENAFIL, OPSUMIT examples) require PVR ≥3 Wood units in adults
inv-117: CD4 count
CD4 threshold for primary PCP/toxoplasmosis prophylaxisCD4 count < 200 cells/mm3 within the past 3 months
CD4 threshold for secondary toxoplasmosis prophylaxisCD4 count < 200 cells/mm3 within the past 6 months
ContextRequired documentation when TMP‑SMX intolerance/contraindication exists
inv-118: Platelet count
ITP new starts platelet thresholdUntransfused platelet count < 30,000/mcL
Procedure-related thrombocytopenia (chronic liver disease)Untransfused platelet count prior to scheduled procedure < 50,000/mcL
Continuation targetCurrent platelet ≤200,000/mcL or >200,000 to ≤400,000/mcL with dose adjustment
inv-119: Blood eosinophil count (asthma/COPD criteria)
Asthma baseline eosinophil threshold (Fasenra)>= 150 cells/µL (baseline) or systemic corticosteroid dependence for severe asthma
COPD initial therapy eosinophil threshold>= 300 cells/µL (absolute blood eosinophils) prior to initiating therapy
Agent contextEosinophil counts used for eligibility for biologic therapies (e.g., Fasenra, Dupixent criteria)
inv-120: EoE diagnostic eosinophils
EoE diagnostic threshold>= 15 intraepithelial eosinophils per high-power field on esophageal biopsy
Clinical correlationPlus clinical manifestations (e.g., dysphagia) and weight/age minimums as specified
Continuation noteResponse to topical corticosteroid therapy considered for continuation decisions
inv-121: Baseline blood eosinophil count for Fasenra
Fasenra baseline eosinophils (severe asthma)>= 150 cells per microliter
Alternate criterionOr systemic corticosteroid dependence with inadequate control despite high-dose ICS + additional controller
ContinuationClinical improvement (reduced exacerbations or OCS dose) required for reauthorization
inv-122: EGPA eosinophil threshold for Fasenra
EGPA eosinophil threshold for Fasenra>1000 cells per microliter OR >10% blood eosinophils
Continuation criteriaDemonstrated benefit: fewer relapses, reduced OCS dose, or no active vasculitis
Age restrictionEGPA: 18 years of age or older (per agent entry)
inv-123: Psoriasis body surface area (BSA)
Moderate-to-severe plaque psoriasis — BSA threshold>= 3% body surface area OR involvement of crucial body areas
Severe disease warranting biologic first-line>= 10% BSA or crucial areas affected
DocumentationMust document BSA or crucial-area involvement and prior therapy status per biologic criteria
inv-124: SGA birthweight threshold
Small for gestational age (SGA) birthweight thresholdBirth weight < 2500 g at gestational age > 37 weeks OR birth weight/length < 3rd percentile or ≥2 SD below mean
Age requirement for GH therapyNo catch-up growth by age 2 for SGA indication
DocumentationKaryotype, growth measurements, and specialty consultation often required
inv-125: Psoriasis body surface area (BSA)
Psoriasis BSA (moderate/severe) — threshold>= 3% BSA or crucial body areas involvement
Severe disease threshold>= 10% BSA or crucial areas affected (may justify biologic first-line)
Use caseApplied to new-start biologic approvals and required documentation
inv-126: INCRELEX height/IGF-1 thresholds
INCRELEX height thresholdHeight ≥ 3 standard deviations (SD) below the mean for age/gender
Baseline IGF‑1 thresholdBasal IGF‑1 level ≥ 3 SD below the mean for age/gender
Provocative GH testProvocative GH test shows normal or elevated GH (required for certain indications)
inv-127: Idiopathic hypersomnia diagnostic thresholds
Idiopathic hypersomnia — daytime sleepiness durationDaily excessive sleepiness for at least 3 months
MSLT / sleep testing thresholdsAverage sleep latency ≤ 8 minutes on MSLT OR total 24‑hour sleep time ≥ 11 hours
SOREMPsFewer than 2 SOREMPs or absent when overnight REM latency ≤15 minutes, and rule out other causes
inv-128: Neurogenic orthostatic hypotension
Neurogenic orthostatic hypotension diagnostic thresholdPersistent decrease in systolic BP ≥20 mmHg OR diastolic BP ≥10 mmHg within 3 minutes of standing or tilt test
Indication contextUsed to determine eligibility for initial therapy (e.g., droxidopa/NORTHERA)
DocumentationOrthostatic vitals or tilt-table test results required
inv-129: Weight for posaconazole prophylaxis
Weight threshold for posaconazole prophylaxisPatient weighs greater than 40 kilograms
Route requirementRequested posaconazole must be used orally for certain indications
Oropharyngeal candidiasis noteOral use for oropharyngeal candidiasis requires prior fluconazole failure/intolerance
inv-130: Self-testing frequency for insulin pump
Insulin pump self-testing frequencyPatient self-testing glucose levels 4 or more times per day (or using CGM) required for initial Omnipod approval
Clinical needPlus inadequate glycemic control, recurrent hypoglycemia, or severe glycemic excursions as justification
DocumentationRecord of self-monitoring or CGM use typically required with PA request
inv-131: Erythropoietin hemoglobin threshold (initial approval)
Erythropoietin initial hemoglobin thresholdPretreatment hemoglobin (Hgb) < 10 g/dL (except surgical settings)
Iron stores requirementAdequate iron stores (e.g., TSAT ≥ 20%) required prior to initiation (except certain uses)
MDS-specific EPOFor MDS: pretreatment serum erythropoietin ≤ 500 IU/L
inv-132: Psoriasis BSA threshold
Psoriasis BSA threshold (summary)>= 3% BSA (moderate to severe) — biologic threshold often >= 10% or crucial-area involvement
Documentation requirementRecord BSA or crucial-area involvement and prior therapy failures/intolerance per biologic criteria
Severe disease>=10% BSA or crucial areas may permit biologic first-line without prior systemic failure
inv-133: Phenylalanine level for PKU pretreatment
Phenylalanine pretreatment threshold for PKU therapy> 6 mg/dL (360 micromol/L)
Treatment trial responseDocumentation of improvement in blood phenylalanine levels or clinical benefit may be required
Use contextApplies to sapropterin and related agents for PKU
inv-134: PAH hemodynamic thresholds
Mean pulmonary arterial pressure (mPAP)> 20 mmHg (required for PAH confirmation)
Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg
Pulmonary vascular resistance (PVR)≥ 3 Wood units for adults in many agent criteria (some agent entries allow >2 Wood units)
inv-135: Topical therapy threshold for plaque psoriasis
Topical therapy threshold for plaque psoriasis<= 20% BSA AND prior inadequate response or intolerance to at least one topical corticosteroid
Use caseApplies when considering escalation from topical therapy to systemic/targeted agents
DocumentationRecord prior topical therapy and response per PA request
inv-136: FRAX high fracture probability
FRAX high fracture probability — major fracture>= 20% 10‑year probability (major osteoporotic fracture)
FRAX high fracture probability — hip fracture>= 3% 10‑year probability (hip fracture)
Continuation implicationHigh FRAX may be used to justify continuation beyond initial authorization period
inv-137: Pulmonary hemodynamics thresholds for PAH
PAH confirmation — mPAP> 20 mmHg (right heart catheterization)
PAH confirmation — PCWP≤ 15 mmHg
PAH confirmation — PVR≥ 3 Wood units (some entries note >2 Wood units for specific agents)
inv-138: Mean pulmonary arterial pressure
Mean pulmonary arterial pressure> 20 mmHg
Measurement contextFrom right heart catheterization required for PAH confirmation
Applies toMultiple PAH drug entries (ADEMPAS, BOSENTAN, SILDENAFIL, UPTRAVI, etc.)
inv-139: Pulmonary capillary wedge pressure (PCWP)
Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg
RolePart of hemodynamic triad confirming pre-capillary pulmonary hypertension (PAH)
Required documentationRight heart catheterization report including PCWP must be submitted
inv-140: Pulmonary vascular resistance (PVR)
Pulmonary vascular resistance (PVR)≥ 3 Wood units for adult PAH new starts (some entries reference >2 Wood units for specific agents)
MeasurementCalculated from right heart catheterization hemodynamics
Agent-specific varianceCheck individual drug entry — thresholds may vary by agent (e.g., >2 vs ≥3 Wood units)
inv-141: Body surface area (psoriasis)
Psoriasis body surface area (BSA) — moderate threshold>= 3% BSA or crucial-area involvement
Severe threshold>= 10% BSA or crucial areas (may permit biologic first-line)
DocumentationRecord BSA and prior therapy failures/intolerance per PA requirements
Prior Authorization Steps, Documentation & Denial Risks
Prior Authorization
Prior Authorization Required
Prior authorization is required for many specialty, biologic, and select oral therapies. Requests must include diagnosis-specific documentation and any required testing or prior treatment history; coverage durations vary by drug (initial approvals range from 1 month to 24 months; many are Plan Year). Prescribers, patients, or representatives may request PA by calling HMSA at 1 (855) 479-3659 (TTY 711).
- General PA required for drugs listed in the formulary chart
- Coverage duration varies by drug (initial and continuation periods specified per drug)
- Call HMSA for PA: 1 (855) 479-3659 (TTY 711)
Billing Rule
Medicare Part A/B Coordination
Some medications may be covered under Medicare Part A or Part B depending on the setting of administration. When Part A/B coverage applies, Part D requests will be denied. Provide information about dispensing/administration setting to allow appropriate Part A/B vs Part D determination.
- If drug is administered in a facility or physician office (Part A/B) submit site-of-care information
- Coverage under Part D will be denied if Part A or B coverage is available for that use
Documentation Required
Diagnostic & Molecular Testing — Required Documentation
Provide required diagnostic confirmation, laboratory, molecular, or genetic testing results where specified. Missing diagnostic or mutation confirmation is a common reason for denial.
- Cystinosis (CYSTAGON, CYSTARAN, CYSTADROPS): leukocyte cystine concentration, genetic testing, or slit-lamp evidence of corneal crystals
- HCV agents (EPCLUSA, HARVONI, MAVYRET, VOSEVI): HCV RNA prior to treatment, genotype, cirrhosis status, prior treatment history; approvals follow current AASLD‑IDSA guidance
- NTRK therapies (VITRAKVI): documentation tumor is NTRK gene fusion-positive and absence of acquired resistance mutations
- IDHIFA (AML): IDH2 mutation documented
- ZYKADIA/ZYKADIA NSCLC: ALK-positive NSCLC documentation per indication
- Sildenafil/PAH agents (ADEMPAS, SILDENAFIL, etc.): right heart catheterization hemodynamics (mPAP, PCWP, PVR) for WHO Group 1 PAH
Documentation Required
Tumor Mutation & Resistance Testing (Oncology Agents)
Many oncology and targeted agents require tumor mutation or resistance testing and explicit mutation status. For some TKIs and targeted therapies, PA requires demonstration of absence or presence of specific mutations or prior resistance to other agents.
- BOSULIF (bosutinib): For CML/Ph+ B-ALL provide Philadelphia chromosome/BCR‑ABL confirmation; if prior TKI resistance, submit mutation testing showing negative for T315I, G250E, V299L, F317L when required and documentation of resistance/intolerance to imatinib, dasatinib, or nilotinib
- ROZLYTREK, XALKORI, ZELBORAF, TABRECTA, others: submit tumor mutation testing (e.g., ALK, ROS1, BRAF, MET exon 14, MET amplification, RET, NTRK, MET) per drug-specific requirements
- Requests missing required mutation or molecular confirmation may be denied
Step Therapy
Step Therapy & Prior Treatment Documentation
For biologic and immunologic therapies, include prior therapy history showing trials and failures, intolerance, or contraindications where required. Failure-to-document prior therapy or step requirements may result in denial.
- Biologics for psoriasis, RA, IBD, axial spondyloarthritis: document prior systemic, phototherapy, methotrexate/cyclosporine/acitretin, or prior biologic/targeted DMARD failures per drug-specific criteria
- TNF inhibitor failure requirement: many agents require prior inadequate response/intolerance to at least one TNF inhibitor for certain indications
- Document dates, doses, durations, and reasons for discontinuation of prior therapies
Prior Authorization
Drug-Specific Prior Authorization & Administration Notes
Drug-specific PA examples and special documentation/administration rules to watch for (consolidated, non-exhaustive).
- HUMIRA: PA requires documentation of indication-specific step therapy (e.g., RA: MTX failure/intolerance or prior biologic/targeted DMARD failure) and BSA or joint counts for dermatologic/rheumatologic indications
- DUPIXENT: PA required — include indication, prior topical/systemic therapy for atopic dermatitis or eosinophil counts/criteria for asthma/COPD/EGPA when applicable; age- and indication-specific age limits and initial vs continuation durations apply
- TREMFYA, COSENTYX, SKYRIZI, YESINTEK, and other psoriasis biologics: for new starts document >=3% BSA or involvement of crucial areas and prior failure/intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) unless criteria for first‑line biologic are met
- TERBINAFINE ORAL: PA for onychomycosis requires diagnostic confirmation (fungal test) and is limited to non-continuous use; prior authorization applies if treatment exceeds cumulative limits
- PARATHYROID HORMONE ANALOGS (e.g., TERIPARATIDE, BONSITY): initial approvals commonly 24 months; continuation requires high fracture risk (FRAX) and benefit vs risk documentation
- INHALED TOBRAMYCIN/TOBI PODHALER: require airway culture showing Pseudomonas aeruginosa or history of Pseudomonas infection/colonization; Part D denied if Part A/B coverage applies
- POSACONAZOLE: PA required; oral use specified and oropharyngeal candidiasis requires prior fluconazole failure; age limits apply (>=13)
- VORICONAZOLE: PA required for oral or IV; typical coverage 6 months; note hepatic impairment exclusion (decompensated cirrhosis)
- ZARXIO: PA required for myelosuppressive chemotherapy FN prophylaxis — administer at least 24 hours after chemo and document solid tumor or non-myeloid cancer and chemo regimen
- XYREM (sodium oxybate): PA required — diagnosis confirmation by sleep study for narcolepsy or cataplexy, and prior stimulant/wakefulness agent trials as applicable
- OMNIPOD/OMNIPOD GO systems: PA required for initial pumps/pods; initial criteria include multiple daily injections failure/need and self-monitoring or CGM use; document prior trial of basal insulin for Omnipod GO when specified
- LEN VIMA (LENVIMA): PA requires indication-specific disease state documentation (e.g., thyroid, HCC, RCC, endometrial cancer — combination with pembrolizumab for EC) and prior therapy status where listed
- QUININE SULFATE: PA for babesiosis requires use in combination with clindamycin; coverage duration typically 1 month
Denial Risk
Exclusions, Interactions & Contraindications — Denial Risks
Requests may be excluded or denied when exclusion criteria or baseline tests are not met, when Part A/B coverage exists, for contraindicated combinations, or when drug–drug interactions pose safety risks.
- Exclusion / baseline test examples: voriconazole — decompensated cirrhosis/CTP B or C exclusion; many oncology agents require specific prior lines of therapy or absence of acquired resistance mutations
- Drug interaction denial risk: ergotamine and potent CYP3A4 inhibitors — coverage will be denied for concomitant use (e.g., ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin)
- Contraindicated combination therapy: ivacaftor‑containing CF modulators not to be used in combination with certain agents as specified (e.g., SYMDEKO should not be combined with other ivacaftor-containing medications)
- Requests may be excluded if exclusion criteria are present (e.g., Part A/B site-of-care exclusions)
Denial Risk
Part D Denial Risk When Part A/B Coverage Available
When Part D may be denied because Part A or B coverage is available, include documentation about setting and administration. Conversely, if Part D denial risks exist for available Part A/B coverage, consider coordination of benefits.
- Many infused or physician‑administered drugs (e.g., HERCEPTIN/HERCEPTIN HYLECTA, TOBRAMYCIN inhaled administered in clinic, certain oncology infusions) may be covered under Part B or Part A; submit site-of-care and administration details to support correct coverage determination
- Coverage under Part D will be denied if coverage is available under Part A or Part B for the medication as prescribed and administered
Documentation Required
Required Laboratory, Culture & Prescriber Documentation
Provide indication-specific laboratory, culture, or other test results per drug instructions and include prescriber specialty when required.
- Fulphila (pegfilgrastim biosimilar): if given with chemotherapy, administer at least 24 hours after chemo and document indication (solid tumor or non‑myeloid cancer)
- Fentanyl patch: documentation must support severe, persistent cancer pain, palliative care or chronic severe pain requiring daily opioid therapy and safe opioid dosing history
- ICATIBANT (SAJAZIR): for HAE attacks include laboratory confirmation of C1 inhibitor deficiency/dysfunction or genetic testing when applicable and specialist consultation notes
- INCRELEX: for severe primary IGF-1 deficiency provide height/IGF-1 baseline, GH stimulation test results, and endocrinology consultation
- Omalizumab (XOLAIR) and other allergic/asthma agents: include IgE levels, weight-based dosing data, and prior controller therapy history
Step Therapy
Psychiatric & Geriatric Step Therapy Requirements
When reviewing PA criteria for psychiatric and other CNS agents, ensure step therapy and generic trials are documented (dates, doses, responses). Older‑adult safety acknowledgements are required where noted.
- Psychiatric agents (e.g., QUETIAPINE XR, FANAPT, etc.): document trials of specified generic and brand alternatives, intolerance or contraindications, or inability to swallow oral formulations when listed
- Be mindful of geriatric restrictions: certain PA requirements apply only to patients ≥70 years (HRM lists) and prescriber acknowledgment of risk when multiple CNS‑active drugs or anticholinergics are used
Documentation Required
Oncology & Rare Disease — Biomarker, Enzyme & Prior Therapy Documentation
For oncology and rare-disease therapies, include tumor type, prior systemic therapies, transplant status, and any relevant mutation/biomarker testing or enzyme assays.
- AML agents (e.g., IDHIFA, VENCLEXTA): document mutation status (IDH2, FLT3, t(11;14) where relevant), prior therapies, transplant history, and intended combination regimens
- ZYKADIA/ZYKADIA NSCLC: document ALK‑positive disease and prior trial/failure of alectinib or brigatinib when required; for brain metastases include CNS involvement documentation
- Enzyme/genetic confirmations: e.g., CERDELGA & CEREZYME require enzyme assay or genetic testing to confirm Gaucher disease; MPS VI requires arylsulfatase B deficiency testing
Initial Therapy — New Start Requirements
Continuation and Reauthorization Requirements
Prior Trials and Step Therapy Tables
| Requirement | Documentation needed |
|---|---|
| Documentation of prior therapy failure, intolerance, or contraindication | |
| Clinical notes describing the prior agent(s) tried, duration, and reason for discontinuation (lack of efficacy, adverse event, or contraindication) | |
| When applicable, objective measures demonstrating treatment failure (e.g., continued disease activity, lab or imaging results) |
| COSENTYX indication (new starts) | Prior trial / exception |
|---|---|
| Moderate to severe plaque psoriasis (new starts) | |
| Document inadequate response, intolerance, or contraindication to listed biologic or systemic agents (examples: adalimumab, etanercept, ustekinumab, risankizumab, methotrexate, cyclosporine, acitretin) OR severe disease (≥10% BSA or crucial areas) where biologic may be first-line |
| Anticonvulsant alternative | Documentation required |
|---|---|
| Generic anticonvulsant trial (e.g., generic topiramate or other standard agent) | |
| Evidence of inadequate response, intolerance, or contraindication to the generic anticonvulsant | |
| If relevant, trial and failure/intolerance to specified branded alternatives (Aptiom if ≥4 yrs, Xcopri if ≥18 yrs, Spritam if ≥4 yrs) |
| Seizure/migraine setting | Step requirement |
|---|---|
| Partial‑onset (focal) seizures and migraine prevention | |
| Trial of a generic immediate‑release topiramate (or inability to swallow solids) required prior to coverage of branded/topiramate‑containing products |
| Indication / drug group | Prior agent trials required |
|---|---|
| Rheumatoid arthritis and other inflammatory conditions (new starts) | |
| Document inadequate response, intolerance, or contraindication to methotrexate OR to a prior biologic/targeted synthetic DMARD before approval (or used with methotrexate as specified) |
| Requirement | What to document |
|---|---|
| Prior trials or contraindications to listed alternatives | |
| Clinical record noting which alternatives were tried, treatment duration, and reason for failure/intolerance/contraindication |
| Drug/indication | Prior treatment requirement |
|---|---|
| Moderately to severely active rheumatoid arthritis (new starts) | |
| Inadequate response, intolerance, or contraindication to methotrexate OR to a prior biologic DMARD/targeted synthetic DMARD; document methotrexate trial or reason it was not used |
| Required prior therapy | Documentation detail |
|---|---|
| For targeted therapies in NSCLC (e.g., LORBRENA) where specified | |
| Document prior progression on or inadequate response to the listed prior agents (e.g., Alecensa, Alunbrig) or specify exception if not applicable |
| Scenario | Required documentation |
|---|---|
| ROS1‑positive or ALK‑positive NSCLC prior therapy sequencing | |
| Document progression on listed agents (e.g., crizotinib, entrectinib, ceritinib) where the policy requires prior exposure before approval |
| Therapy class / indication | Trial requirement or exception |
|---|---|
| Psychiatric agents (e.g., quetiapine XR) and related indications | |
| Trials of listed generic and/or brand alternatives required prior to approval unless documented exception (e.g., inability to swallow oral forms) |
| Requirement | Documentation examples |
|---|---|
| Document prior trial(s) and reason for failure/intolerance/contraindication | |
| Examples: trial dates and outcome notes, adverse event reports, lab or imaging supporting intolerance, or clinician statement of contraindication |
| Psoriasis biologic context | Prior therapy documentation |
|---|---|
| Moderate to severe plaque psoriasis (biologic new starts) | |
| Document inadequate response, intolerance, or contraindication to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) unless severe disease (≥10% BSA or crucial areas) warrants biologic first‑line |
| RA / biologic prerequisite | Required documentation |
|---|---|
| Rheumatoid arthritis — methotrexate trial requirement | |
| Document trial of methotrexate (monotherapy or in combination) or provide reason (intolerance/contraindication) for not using methotrexate prior to biologic approval |
| TNF inhibitor prerequisite | What to show |
|---|---|
| New starts of certain targeted or small‑molecule immunomodulators (e.g., XELJANZ) | |
| Document inadequate response, intolerance, or contraindication to at least one TNF inhibitor (e.g., adalimumab, etanercept) prior to authorization |
| AED requirement | Documentation |
|---|---|
| Some seizure indications requiring multiple AED trials | |
| Document trial and inadequate response/intolerance to two antiepileptic drugs (dates, doses, and outcomes) where policy mandates two AED failures prior to approval |
| Psoriasis (non-severe) prior therapy | Required trials |
|---|---|
| Moderate to severe plaque psoriasis (new starts, non‑severe) | |
| Required prior trial of phototherapy or specified systemic agents (methotrexate, cyclosporine, acitretin) unless contraindicated or severe disease warrants biologic first‑line |
| ZYKADIA NSCLC requirement | Documentation |
|---|---|
| ALK‑positive NSCLC prior to ZYKADIA | |
| Document prior inadequate response, intolerance, or contraindication to alectinib or brigatinib prior to ZYKADIA approval unless disease is ROS1‑positive |
Quantity and Duration Limits
inv-312: Flucytosine
Flucytosine quantity limit6 weeks
ContextCoverage duration listed for FLUCYTOSINE entry
UnitCourse (per entry)
inv-313: Growth hormone entries (where specified)
Growth hormone coverage duration (where specified)Plan Year (coverage duration generally)
Indication-specific numeric thresholdsSGA and pediatric GHD criteria (birthweight, height velocity) required per entry
Prescriber requirementOften prescribed by or in consultation with an endocrinologist
inv-314: Fycompa
Fycompa (perampanel) coverage durationPlan Year
Initial criteria noteInitial: age and seizure-type specific requirements; continuation requires demonstrated benefit
Age limitsPartial-onset seizures: ≥4 years; primary GTC seizures: ≥12 years
inv-315: LYNPARZA
LYNPARZA quantity/coverage notesCoverage durations and required medical information specified per indication (e.g., retreatment and BRCA status) — see LYNPARZA entry
Indication examplesUterine leiomyosarcoma requires prior therapy and BRCA‑altered disease for some uses
Coverage durationPlan Year for many indications; some uses have specific shorter durations
inv-316: OMNIPOD GO 10-40 UNITS/DAY variants
OMNIPOD GO variants — dosing variants listedOMNIPOD GO 10–40 units/day variants listed as product-specific items
Initial criteriaPatient requires insulin management and self-testing ≥4 times/day or CGM use
Coverage durationPlan Year
inv-317: TERBINAFINE TABS
TERBINAFINE TABS quantity/duration12 weeks; prior authorization applies to cumulative >90 days per year
Use contextOral therapy for onychomycosis prescribed as non-continuous use
PA triggerPA required when cumulative therapy >90 days/year
inv-318: Terbinafine
Terbinafine quantity limit summaryCumulative ≤90 days without prior authorization; 12‑week course typical
IndicationOnychomycosis due to dermatophytes when oral therapy is used
PA conditionPrior authorization applies if cumulative days exceed specified limits
Definitions and Diagnostic Criteria
inv-239: Pulmonary arterial hypertension (PAH) confirmation
PAH confirmation — right heart catheterizationDiagnosis confirmed by right heart catheterization with required hemodynamics (mPAP >20 mmHg, PCWP ≤15 mmHg, PVR thresholds)
Agent examplesRequired for ADEMPAS, BOSENTAN, UPTRAVI, SILDENAFIL, treprostinil and other PAH agents
DocumentationSubmit right heart catheterization report with the numeric hemodynamic values
inv-240: FGFR3/PDGFRA testing
FGFR3 / PDGFRA molecular testingDocumentation of PDGFRA or FGFR3 alterations required for specific oncology indications (e.g., AYVAKIT, RYDAPT)
Use caseRequired to qualify for targeted therapies in GIST, myeloid/lymphoid neoplasms with eosinophilia, and select solid tumors
Test reportingSubmit molecular test results with PA request (mutation/exon details as specified)
inv-241: PAH confirmation
PAH confirmation — hemodynamic triadmPAP >20 mmHg, PCWP ≤15 mmHg, and PVR ≥3 Wood units for adults (agent-specific variance applies)
Required testRight heart catheterization report
Applies toMultiple PAH drug approvals (ADEMPAS, BOSENTAN, UPTRAVI, SILDENAFIL, treprostinil, etc.)
inv-242: Cystinosis diagnostic criteria
Cystinosis diagnostic criteriaDiagnosis confirmed by increased leukocyte cystine concentration OR genetic testing OR slit‑lamp demonstration of corneal cystine crystals
Product-specific requirementCYSTADROPS requires corneal cystine crystal accumulation
DocumentationProvide enzyme/genetic or slit-lamp findings with PA request
inv-243: CD4 threshold
CD4 threshold for prophylaxis (primary)CD4 < 200 cells/mm3 within past 3 months (with TMP‑SMX intolerance/contraindication)
CD4 threshold for secondary prophylaxisCD4 < 200 cells/mm3 within past 6 months
Use contextsApplies to PCP, toxoplasmosis, and cystoisosporiasis prophylaxis/treatment entries
inv-244: Platelet thresholds for ITP
Platelet thresholds for ITP new startsUntransfused platelet count <30,000/mcL OR 30,000–50,000/mcL with symptomatic bleeding or bleeding risk factors
Chronic liver disease procedure thresholdUntransfused platelet count <50,000/mcL prior to scheduled procedure
Continuation responseCurrent platelet ≤200,000/mcL OR >200,000 to ≤400,000/mcL with dose adjustment
inv-245: Usual interstitial pneumonia (UIP) pattern
Usual interstitial pneumonia (UIP) pattern — IPF diagnosisHRCT showing UIP pattern OR non‑UIP HRCT supported by lung biopsy or multidisciplinary discussion
DocumentationHRCT images/reports or lung biopsy and multidisciplinary evaluation required for new‑start antifibrotic approval
Applies toIdiopathic pulmonary fibrosis (ESBRIET) new starts
inv-246: HRM
High-resolution manometry (HRM) — example usageHRCT/HRM referenced where specialty diagnostic testing is required (e.g., IPF or esophageal disorders) — provide study report
Alternative testsIf biopsy not performed, multidisciplinary discussion with experienced radiologist and pulmonologist acceptable
Documentation requirementAttach HRM/HRCT or biopsy reports with PA request as applicable
inv-247: non-HRM alternative
Non‑HRM alternative — diagnostic approachWhen HRM/biopsy unavailable, multidisciplinary review (radiologist + pulmonologist) may substitute for biopsy in IPF diagnosis
DocumentationProvide documentation of multidisciplinary discussion and consensus diagnosis
ContextApplied to idiopathic pulmonary fibrosis and other complex diagnostic situations
inv-248: IDH2 mutation (AML)
IDH2 mutation requirement (AML) — IDHIFAPresence of an IDH2 mutation confirmed for AML indications
Usage contextsNewly‑diagnosed (unfit for intensive induction), post‑induction maintenance, or relapsed/refractory AML per entry
DocumentationSubmit molecular testing results confirming IDH2 mutation with PA request
inv-249: Philadelphia chromosome / BCR-ABL
Philadelphia chromosome / BCR‑ABL confirmationCytogenetic or molecular detection of Philadelphia chromosome / BCR‑ABL required for CML or Ph+ ALL targeted therapies
ContextRequired for imatinib, bosutinib, and other ABL‑directed agents prior to PA approval
DocumentationSubmit cytogenetics or PCR results with PA request
inv-250: Central precocious puberty (CPP) criteria
Central precocious puberty (CPP) diagnostic criteriaPubertal response to GnRH agonist test OR pubertal third‑generation LH level; bone age vs chronological age supporting CPP; onset of secondary sexual characteristics before age thresholds
Age thresholdsFemales: onset < 8 years; Males: onset < 9 years; patient must be <12 years (female) or <13 years (male) for CPP therapy entries
DocumentationProvide GnRH stimulation results, LH level, and bone‑age assessment with PA request
inv-251: Decompensated cirrhosis (CTP class B or C)
Decompensated cirrhosis exclusion (MAVYRET)Moderate or severe hepatic impairment (Child‑Turcotte‑Pugh class B or C) is an exclusion for MAVYRET
Required baseline testHCV RNA in serum must be documented prior to starting HCV therapy
Guideline alignmentCoverage and durations applied consistent with AASLD‑IDSA guidance
inv-252: PAH confirmation hemodynamics
PAH confirmation hemodynamicsRight heart catheterization showing mPAP >20 mmHg, PCWP ≤15 mmHg, and PVR ≥3 Wood units (adult new starts unless agent specifies >2)
DocumentationSubmit RHC report with numeric values for PA authorization
Applies toMultiple PAH agents (e.g., OPSUMIT, SILDENAFIL, TREPROSTINIL, UPTRAVI)
inv-255: Psoriasis severity criteria
Psoriasis severity criteria>= 3% BSA or crucial body areas involvement defines moderate‑to‑severe disease; >=10% BSA or crucial areas defines severe disease
ImplicationSevere disease threshold may allow biologic first‑line without prior systemic failure
DocumentationBSA measurement and prior therapy history required with PA
inv-256: PAH confirmation
PAH confirmation (summary)Right heart catheterization with mPAP >20 mmHg, PCWP ≤15 mmHg, and PVR thresholds as specified (commonly ≥3 Wood units)
Documentation requirementAttach RHC report and hemodynamic values for PAH drug PA requests
Agent varianceSome agent entries specify >2 Wood units instead of ≥3 — verify per drug
inv-257: PA Indication Indicator
PA Indication Indicator — definitionSpecifies whether a drug is for all FDA‑approved indications and/or some medically‑accepted indications (noted on individual entries)
Implication for PACheck PA Indication Indicator on drug row to determine if off‑label uses are considered
DocumentationProvide indication‑specific required medical information per entry
inv-258: Required Medical Information
Required medical information — generalDiagnostic confirmation, prior therapy history, and relevant molecular or laboratory test results must be submitted with PA requests
ExamplesRight heart catheterization for PAH; BCR‑ABL/Philadelphia chromosome for CML; HCV RNA for HCV therapies
ConsequenceMissing required documentation may lead to denial of coverage
Policy Background
This document defines HMSA's pharmacy prior authorization requirements for a broad set of specialty and non‑specialty medications. Prior authorization must be requested from HMSA at 1 (855) 479‑3659 before dispensing, and coverage is provided only after HMSA determines the request meets the drug‑ and indication‑specific criteria listed in the policy chart (see callout and authorization instructions). [[chunk 0]]
The policy groups drugs by indication and specifies the clinical evidence or documentation required with PA requests — examples include diagnostic confirmation (for pulmonary arterial hypertension, right heart catheterization hemodynamics are required), molecular or enzyme testing for targeted oncology or lysosomal disease indications, platelet/CD4 thresholds for hematologic and infectious prophylaxis uses, and prior‑therapy trials or documented intolerance when step therapy is applicable. Requests lacking required documentation risk denial. [[chunk 191]] [[chunk 192]]
Many entries indicate a default coverage duration of Plan Year, while some therapies have explicit initial or induction durations (examples: certain antifungals, hepatic or transplant prophylaxis, or short induction courses). The policy also highlights exclusions that commonly result in noncoverage — for example, medications that are appropriately billed under Medicare Part A or Part B rather than Part D, certain hepatic impairment exclusions for antiviral agents, or drug–drug interaction exclusions (e.g., ergotamines with potent CYP3A4 inhibitors). [[chunk 2]] [[chunk 116]]
Operationally, the policy emphasizes two practical risks for prescribers and pharmacies: failure to obtain PA before dispensing may result in denial of coverage, and requests that omit required diagnostic or prior‑therapy evidence (for example, PAH hemodynamics, genotype/mutation results, enzyme assay results, or documented prior treatment failures) may be denied. Providers should submit the specific tests, mutation or enzyme reports, prior‑therapy dates/outcomes, and any prescriber attestations requested in the chart to support timely adjudication. [[chunk 0]] [[chunk 191]]
Policy Summary
PayerHawaii Medical Service Association (HMSA)
PolicyDrugs Requiring Prior Authorization — Pharmacy & Specialty Drugs Coverage Criteria
Policy CodePolicy N/A
Change TypeNo material changes
Effective DateN/A
Next Review DateN/A
Key ActionPrior authorization must be requested from HMSA at 1 (855) 479-3659 prior to dispensing.
SourceLink
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