Prior Authorization Required — How to Request

You need prior authorization (PA) from HMSA Akamai Advantage (PPO) before filling many specialty and selected non‑specialty drugs. To request PA, the patient, an appointed representative, or the prescriber must call HMSA at 1-855-479-3659 (TTY/TDD 711). Customer service is available 24/7 in English and other languages. Failure to obtain PA may result in denial of coverage.

• Call 1-855-479-3659 to request prior authorization (TTY/TDD 711).
• PA must be obtained before coverage; denial may result if PA not obtained.

Drug‑Specific Prior Authorization Details

Drug-specific PA requests must include the clinical details required for the requested agent and indication. Examples: molecular or genetic test results (EGFR, BRAF, RET, FGFR3, PIK3CA, MET, BRCA, RET fusion status), histology or stage (e.g., recurrent/advanced/metastatic), and prior systemic therapy history. If a drug requires documentation of a specific genetic alteration or biomarker, include the test name, result, date, and laboratory.

• Include molecular testing results when required (EGFR, BRAF V600E, RET fusion, FGFR3, MET exon 14 skipping, PIK3CA, BRCA, etc.).
• Provide pathology/histology and disease stage (e.g., recurrent, metastatic) when requested.
• List prior therapies, dates, and reason for discontinuation (progression, intolerance).

BESREMI Prior Authorization — Hematologic Indications

BESREMI (ropeginterferon alfa-2b) PA requires documentation appropriate to the requested hematologic indication. For polycythemia vera, documentation of diagnosis and prior therapy status is required. Some indications may require specialty prescribers (e.g., hematology/oncology) or consultation.

• Ensure prescriber is hematologist/oncologist or consults with one when applicable.
• Provide diagnostic documentation and prior therapy history relevant to the hematologic indication.

BOSENTAN Prior Authorization — PAH and Dermatologic Criteria

BOSENTAN PA requirements vary by indication. For pulmonary arterial hypertension (PAH) the diagnosis must be confirmed by right heart catheterization with hemodynamic thresholds documented (pretreatment mean pulmonary arterial pressure >20 mmHg; pulmonary capillary wedge pressure ≤15 mmHg; pulmonary vascular resistance thresholds as specified). For dermatologic indications (e.g., plaque psoriasis, ankylosing spondylitis) include BSA, involved crucial body area information, prior phototherapy or systemic therapy trials or contraindications, and intolerance documentation when applicable.

• For PAH: include right heart catheterization report and hemodynamics (mPAP, PCWP, PVR).
• For psoriasis: document BSA, affected crucial body areas, prior phototherapy or systemic agent trials (methotrexate, cyclosporine, acitretin) or contraindications.
• For ankylosing spondylitis/axial spondyloarthritis: document trial/intolerance to NSAIDs or contraindication to NSAIDs.

CAYSTON Prior Authorization — Cystic Fibrosis/Pseudomonas Documentation

CAYSTON (inhaled aztreonam) PA requires evidence of Pseudomonas aeruginosa in the airways. Acceptable documentation includes positive airway culture for Pseudomonas or a documented history of airway infection/colonization.

• Provide airway culture showing Pseudomonas aeruginosa OR documented history of airway Pseudomonas infection/colonization.

Clinical Prior Authorization Conditions — Examples

Clinical prior authorization conditions commonly require specific laboratory values, diagnostic confirmation, or evidence of prior therapy failure or intolerance. Examples include eosinophil thresholds for biologics, opioid treatment history for extended‑release opioids, and serologic or virologic confirmation for infectious disease therapies.

• Eosinophil counts or systemic steroid dependence for severe asthma biologics.
• Opioid history and monitoring documentation for extended‑release opioids (cancer, sickle cell, palliative, or chronic severe pain plus opioid history).
• HCV: HCV RNA prior to therapy, planned regimen, genotype, cirrhosis and HIV coinfection status.

HETLIOZ (Tasimelteon) Prior Authorization Criteria

HETLIOZ (tasimelteon) prior authorization requires documentation of total blindness with no light perception for Non-24-Hour Sleep-Wake Disorder: diagnosis of total blindness in both eyes and inability to perceive light. For Smith-Magenis Syndrome (SMS) use, confirm the diagnosis and document improvement on therapy for continuation. Age and prescriber specialty restrictions apply (sleep disorder specialist, neurologist, or psychiatrist).

• Non‑24: document total blindness in both eyes and no light perception; age ≥18 years.
• SMS: confirm SMS diagnosis; for continuation, document sleep quality improvement.
• Prescribed by or in consultation with a sleep disorder specialist, neurologist, or psychiatrist.

HUMIRA Prior Authorization — Prerequisite Therapy for Inflammatory Indications

HUMIRA (adalimumab) and many inflammatory biologics require documentation of prior or concomitant therapy. For rheumatoid arthritis new starts, document an inadequate response or intolerance to methotrexate (MTX) unless MTX is contraindicated or the biologic will be used in combination with MTX per indication-specific rules. Hidradenitis suppurativa and other inflammatory indications may have separate severity or prior‑therapy requirements.

• For RA new starts: trial of MTX or documented contraindication/intolerance OR prior biologic/targeted synthetic DMARD failure as specified.
• For psoriasis and hidradenitis suppurativa: document BSA, affected areas, and failure/intolerance to topical, phototherapy, or systemic agents as required.

IMBRUVICA Prior Authorization — Hematologic Indications and Prior Therapy

IMBRUVICA (ibrutinib) PA is limited to specific hematologic indications. For certain diseases it is restricted to subsequent‑line therapy, combination regimens, or single‑agent use per indication. Provide disease‑specific documentation and prior therapy history (for mantle cell lymphoma, marginal zone lymphoma, hairy cell leukemia, CNS lymphoma, diffuse large B‑cell lymphoma, etc.).

• Document indication, prior lines of therapy, and whether use is first‑line, subsequent, or combination as required by the indication.
• Provide supporting pathology and staging as appropriate.

KANJINTI Prior Authorization — Trastuzumab Biosimilar Requirements

KANJINTI (trastuzumab biosimilar) PA requires documentation consistent with trastuzumab use: HER2‑positive disease confirmation, prior HER2 inhibitor adverse event history if applicable, and indication‑specific combination therapy details. Coverage under Medicare Part D will be denied when administration/dispensing is covered under Part A or B.

• Document HER2 testing and result (IHC/FISH) and disease stage (neoadjuvant, metastatic, etc.).
• If switching due to adverse event to another trastuzumab product, document intolerable adverse event not attributed to the active ingredient.
• Be aware Part D denial risk if Part A/B covers administration.

JAKAFI Prior Authorization — Indication and Prerequisite Therapy Requirements

JAKAFI (ruxolitinib) requires indication-specific documentation and, for some indications like polycythemia vera, evidence of inadequate response or intolerance to first‑line therapies (e.g., hydroxyurea). For select leukemias and myeloproliferative disorders, provide mutation status and combination therapy details when required.

• For polycythemia vera: document inadequate response/intolerance to hydroxyurea and other required conditions.
• Provide mutation or pathway activation details (e.g., JAK/STAT pathway) for ALL or other malignancy indications when requested.

JAYPIRCA Prior Authorization — Prior BTK/BCL‑2 Therapy Requirements

JAYPIRCA (pirtobrutinib) PA requires prior BTK inhibitor exposure for CLL/SLL and prior BCL‑2 inhibitor exposure for some CLL indications. For mantle cell and marginal zone lymphoma, document prior covalent BTK inhibitor therapy. Provide prior therapy dates and reasons for discontinuation.

• For CLL/SLL: documentation of prior BTK inhibitor and prior BCL‑2 inhibitor when required.
• For mantle cell lymphoma and MZL: document prior covalent BTK inhibitor therapy.

Prior Authorization Requirement — General Guidance and Part D Denial Risk

Many specialty drugs and selected agents require PA before coverage. Requests must include indication‑specific clinical information and any required diagnostic testing, prior therapy documentation, and prescriber specialty attestation. When Part A or B covers administration or dispensing of a medication, Part D coverage may be denied.

• Include required medical information and diagnostics for the requested drug and indication.
• Verify whether the drug and its administration are covered under Medicare Part A/B to avoid Part D denial risk.

Prerequisite Therapy for Inflammatory Indications — Biosimilars and Biologics

For many inflammatory biologics and biosimilars (including Renflexis, Remicade biosimilars, and others), prerequisite therapy rules include trials of methotrexate or documentation of intolerance/contraindication, combination therapy requirements, or prior biologic failure. Specify whether the request is a new start (may have stricter rules) or continuation. Prescriber specialty and documentation of severe/refractory disease may be required for hidradenitis suppurativa and uveitis.

• For RA: combination with MTX or MTX intolerance/contraindication documentation.
• For hidradenitis suppurativa and uveitis (new starts): document severe/refractory disease and prior immunosuppressive therapy trials or contraindications.

Psoriasis Prior Authorization — BSA and Prior Therapy Requirements

Psoriasis prior authorizations commonly require documentation of body surface area (BSA), involvement of crucial body areas (hands, feet, face, scalp, neck, genitals/groin, intertriginous areas), and prior trials of topical, phototherapy, or systemic agents (methotrexate, cyclosporine, acitretin) unless contraindicated. Some biologics require minimum BSA thresholds (e.g., ≥10%) or at least 3% with other qualifying conditions.

• Document BSA percentage and note whether crucial body areas are affected.
• Report prior phototherapy or systemic therapy trials and reasons for failure or intolerance, or document contraindications.

Tadalafil (BPH) Prior Authorization — Prerequisite Therapy

For benign prostatic hyperplasia (BPH) coverage with tadalafil, document an inadequate response, intolerance, or contraindication to both an alpha blocker and a 5‑alpha reductase inhibitor (5‑ARI) before approving tadalafil for BPH.

• Document trials of an alpha blocker AND a 5‑ARI with dates and reasons for discontinuation/ intolerance, unless contraindicated.

Molecular Testing and Prior Therapy Requirements — Oncology Agents

Oncology and other targeted agents frequently require molecular testing and prior therapy documentation. Provide tumor biomarker test results (mutation, fusion, amplification, exon skipping) with laboratory name, test date, and result. Also include prior systemic therapies, lines of therapy, and whether the requested agent is being used as first‑line, adjuvant/neoadjuvant, or subsequent therapy.

• Attach molecular testing reports for required biomarkers (BRAF V600E, RET fusions, EGFR, MET exon 14, FGFR3, PIK3CA, BRCA, etc.).
• List prior systemic therapies, number of lines, dates, and reasons for discontinuation.

Psoriasis Prior Authorization Criteria — Initial and Continuation Therapy

Psoriasis biologic continuation criteria require demonstration of benefit (reduction in BSA, improved symptoms, or other clinical response) and documentation of prior trials when needed. Initial therapy criteria are stricter and often require trials of topical therapy, phototherapy, or specific systemic agents before biologic approval unless contraindicated or area involvement justifies first‑line biologic.

• For continuation: document clinical improvement and ongoing benefit.
• For initial starts: document prior topical, phototherapy, or systemic therapy trials or justify first‑line biologic with severe disease or crucial area involvement.

TRULICITY Prior Authorization — Age Restriction and Clinical Documentation

TRULICITY (dulaglutide) PA applies for glycemic control in type 2 diabetes mellitus; age restriction applies — coverage is for patients 10 years of age or older. Provide diagnosis and prior diabetes therapy documentation as requested.

• Document diagnosis of type 2 diabetes and patient age (≥10 years).
• Include prior antidiabetic therapy trials and rationale for use if required.

Diagnostic Confirmation Required — HAE, PAH, Cystinosis, HCV, etc.

Diagnostic confirmation is required for many indicated therapies. Examples include HAE therapies (BESREMI, icatibant, others) requiring laboratory confirmation of C1 inhibitor deficiency/dysfunction or documented genetic mutation/family history; PAH therapies requiring right heart catheterization with specific hemodynamic criteria; cystinosis requiring leukocyte cystine, genetic testing, or corneal cystine crystals; and HCV therapies requiring HCV RNA confirmation prior to treatment.

• HAE: C1 inhibitor deficiency/dysfunction confirmed by laboratory testing OR genetic testing/family history per agent requirements.
• PAH: right heart catheterization report with mean pulmonary arterial pressure, PCWP, and PVR as applicable.
• Cystinosis: leukocyte cystine level, genetic testing, or slit‑lamp demonstration of corneal crystals.
• HCV: HCV RNA in serum prior to treatment; include genotype, cirrhosis status, prior treatments, and planned regimen.

HAE Diagnostic Documentation — Laboratory and Genetic Confirmation

When diagnostic or lab documentation is missing for hereditary angioedema (HAE) therapies, PA may be denied. For acute HAE treatment agents (e.g., icatibant, Sajazir), provide laboratory confirmation of C1 inhibitor deficiency/dysfunction or, for normal C1 inhibitor HAE, positive genetic testing (F12, ANGPT1, plasminogen, KNG1, HS3ST6, MYOF) or family history plus refractoriness to high‑dose antihistamine trial.

• Provide C4 and C1 inhibitor quantitative and functional testing when available.
• For HAE with normal C1‑INH, attach genetic testing results or family history and documentation of high‑dose antihistamine trial failure.

Required Medical Information — Examples

Provide required examples of medical information with PA requests: diagnosis confirmation (pathology, imaging, or diagnostic tests), prior therapy trials with dates and reasons for discontinuation, laboratory values or biomarker reports, prescriber specialty and consultation notes when required, and documentation of clinical benefit for continuation requests.

• Diagnosis confirmation: pathology report, imaging (HRCT), or standardized diagnostic testing.
• Prior therapy history: drugs tried, dates, response, intolerance or contraindication.
• Labs/biomarkers: molecular test reports, viral RNA, eosinophil counts, IGF‑1, testosterone levels, etc.
• Provider: prescriber specialty, consultation notes, and prescriber attestations when required.

Cystinosis Prior Authorization — Diagnostic Documentation

Cystinosis PA requires diagnostic confirmation by one of: increased leukocyte cystine concentration, genetic testing showing pathogenic CTNS variants, or slit‑lamp demonstration of corneal cystine crystals plus evidence of corneal accumulation.

• Attach leukocyte cystine level, genetic testing report, or slit‑lamp exam documenting corneal cystine crystals.
• Document clinical features consistent with cystinosis.

IVIG Prior Authorization — Indication‑Specific Documentation

IVIG (intravenous immunoglobulin) PA requires indication‑specific criteria: examples include low serum IgG thresholds for CLL or HIV pediatrics, timing post‑transplant, history of recurrent infections, or failure/intolerance to standard first‑line immunosuppressive therapies for dermatomyositis/polymyositis. Provide serum IgG values, infection history, transplant dates, and prior therapy trials.

• For CLL: serum IgG <500 mg/dL or recurrent bacterial infections.
• For BMT/HSCT: requested within first 100 days post‑transplant or serum IgG <400 mg/dL.
• For dermatomyositis/polymyositis: trial and failure/intolerance of corticosteroid or immunosuppressant, or documented contraindication.

Extended‑Release Opioid Prior Authorization — Required Documentation

Extended‑release (ER) opioid PA requires documentation that use is for cancer pain, sickle cell disease, a terminal condition, or palliative care, or that the patient has severe persistent pain requiring daily opioids and an established opioid history. Include evaluation and monitoring plans for opioid use disorder, prior opioid exposure (at least one week of immediate‑release or 30 days of ER agent for continuation), and clinician expertise.

• Document diagnosis (cancer, sickle cell, terminal/palliative) OR severe persistent non‑cancer pain plus prior opioid use.
• Provide monitoring and evaluation plan for opioid use disorder.
• For continuation: document prior ER opioid use ≥30 days or immediate‑release opioid ≥1 week.

Central Precocious Puberty (CPP) — Required Medical Information

For central precocious puberty (CPP) and GnRH agonist therapy (e.g., leuprolide), required medical information includes a pubertal response to a GnRH agonist test or a pubertal third‑generation LH assay, bone age versus chronological age supporting CPP, and age of onset criteria (females <8 years, males <9 years). Age limits for treatment continuation are specified (females <12, males <13).

• Attach GnRH agonist stimulation test or third‑generation LH assay results.
• Provide bone age assessment and documentation of secondary sexual characteristics onset.
• Confirm patient meets age criteria for initiation and continuation.

HCV Prior Authorization — Required Medical Information and Guidance

HCV antiviral therapy requests (e.g., EPCLUSA, MAVYRET, VOSEVI, VOSEVI) require confirmation of HCV infection with HCV RNA prior to treatment, plus planned regimen, genotype, prior treatment history, cirrhosis status (compensated vs decompensated/CTP class), HIV coinfection status, resistance‑associated substitutions when applicable, and transplant status. Approvals will follow current AASLD‑IDSA guidance.

• Provide HCV RNA test result, genotype, and planned antiviral regimen.
• Document cirrhosis status, prior HCV treatments, HIV coinfection, resistance testing when applicable, and transplant status.

OFEV and Diagnostic Documentation — Acromegaly and Fibrosing Lung Disease

OFEV and other agents used for acromegaly or fibrosing lung disease require disease‑specific labs and imaging: for acromegaly, provide elevated IGF‑1 for age/gender and prior surgery/radiotherapy response or rationale for not performing; for idiopathic pulmonary fibrosis and related indications provide HRCT or biopsy showing UIP pattern or multidisciplinary support when biopsy not performed.

• Acromegaly: pretreatment IGF‑1 level above lab reference for age/gender and prior surgery/radiotherapy history or rationale.
• Pulmonary fibrosis: HRCT showing UIP or biopsy results, or multidisciplinary documentation supporting diagnosis.

Required Diagnostic Documentation — Imaging, Biopsy, Molecular and Lab Reports

Required diagnostic documentation examples include imaging (HRCT), biopsy, mutation or fusion testing, IGF‑1 levels, and pathology reports as applicable to the requested drug and indication. Ensure reports include test dates, laboratory/pathology source, and numeric/qualitative results.

• Attach HRCT or biopsy reports when requested.
• Provide molecular testing with lab name, date, and result.
• Include numeric laboratory values (IGF‑1, eosinophils, testosterone) with reference ranges.

NASH Prior Authorization — Fibrosis Staging and Continuation Monitoring

For noncirrhotic NASH therapies, initial approval requires biopsy or MRE confirmation of moderate to advanced fibrosis (F2–F3). Continuation requires objective evidence of benefit (decrease in ALT, reduction in liver fat by MRI‑PDFF or CAP, or other documented improvement). Prescriber should be a gastroenterologist or hepatologist.

• Provide liver biopsy or MRE showing fibrosis stage F2–F3 for initiation.
• For continuation: supply objective response data (ALT trend, MRI‑PDFF, FibroScan/CAP improvement).
• Prescriber: gastroenterologist or hepatologist or consult note.

Testosterone Prior Authorization — Laboratory Confirmation

Testosterone therapy requires two low morning serum total testosterone concentrations (confirmed by reference lab ranges) for primary hypogonadism or hypogonadotropic hypogonadism prior to initiation. For continuation, document prior baseline low morning total testosterone. Age‑related (late‑onset) hypogonadism use is not established.

• Attach two separate morning total testosterone measurements below lab reference range.
• Document indication (primary hypogonadism, hypogonadotropic hypogonadism) and rationale for therapy.

Terbinafine Prior Authorization — Duration and Documentation

Oral terbinafine for onychomycosis is limited to non‑continuous use and PA applies to cumulative therapy duration limits (e.g., 12‑week course, and prior authorization applies to cumulative therapy >90 days per year). Provide indication, prior topical/systemic therapy trials, and treatment duration.

• Document diagnosis of onychomycosis and the planned duration (typically 12 weeks).
• PA may apply when cumulative therapy exceeds defined annual limits.

H. pylori Prior Authorization — Diagnostic and Regimen Documentation

For H. pylori treatment with VOQUEZNA, provide proof the infection is proven or strongly suspected to be caused by susceptible bacteria via culture and susceptibility testing or local epidemiology/susceptibility patterns. Include regimen and duration (typically 14 days).

• Attach culture & susceptibility or documentation of likely susceptibility based on local patterns.
• Specify the planned eradication regimen and duration.

Coverage Duration Examples

Standard coverage duration examples: IBS‑D and SIBO: 14‑day courses; small intestinal bacterial overgrowth (SIBO) and IBS‑D recurring treatment documentation required for retreatment; hepatic encephalopathy (HE) recurrence reduction: 6 months. Other agents list initial vs continuation durations per indication.

• IBS‑D and SIBO: typical approval duration = 14 days.
• HE recurrence reduction: typical duration = 6 months.
• Refer to the agent‑specific entry for initial vs continuation durations.

Prerequisite Therapy / Step Therapy Requirements — Documentation of Failures

Many PA entries require documentation of prior trials or failures to standard therapies before approval (step therapy). This includes specialty agents, oncology targeted therapies where prior lines are specified, biologics for inflammatory diseases, and HRM (high‑risk medication) substitutions for older adults. Document trials, dates, reasons for failure or intolerance, and any contraindications.

• List prior medications tried, treatment dates, clinical response, and reason for discontinuation (inefficacy, adverse event, intolerance).
• For oncology: list lines of systemic therapy and whether requested agent is subsequent or first‑line per policy.

Prerequisite Therapy for Specialty Agents — Required Documentation

Some specialty agents require specified prerequisite therapy (for example LORBRENA, NEXAVAR, PIQRAY, and others). If a policy indicates prerequisite therapy = Yes, include full prior therapy history showing adherence, dosing, and reasons for discontinuation, or documentation of contraindication/intolerance.

• When prerequisite therapy is required, attach records showing trials and outcomes or contraindication documentation.
• If prior targeted therapy is required (e.g., prior BRAF inhibitor, BTK inhibitor), include treatment names and dates.

Step/Alternative Therapy and High‑Risk Medication (HRM) Requirements

Step/alternative therapy requirements are common for HRM and other agents targeted at older adults; prescriber must often attest that benefits outweigh risks. For HRM medications, document trials of non‑HRM alternatives when required and provide prescriber risk acknowledgement for patients 65+.

• Document trials of non‑HRM alternatives where applicable and provide prescriber risk acknowledgement when the PA applies to patients ≥65.
• Include clinical rationale when alternative trials are contraindicated or not feasible.

KINERET Step Therapy — Prior Biologic/DMARD Requirements

KINERET (anakinra) new starts often require prior trials of specified biologics or targeted agents for rheumatoid arthritis and related indications; document failed or intolerant therapies (listed agents) or contraindications.

• For RA: document failure/intolerance to two specified biologics/DMARDs as listed in policy or a contraindication to those agents.
• Provide dates and clinical outcomes of prior biologic/DMARD use.

Therapy Sequence Requirements — Oncology and Specialty Agents

Therapy sequence requirements in oncology and specialty areas are enforced — many approvals depend on progression after specific prior agents, prior mutation‑directed therapy, or documented resistance. Review indication‑specific sequence rules (e.g., RET, BRAF, EGFR, ALK, ROS1) and attach required molecular reports and prior therapy history.

• Confirm molecular eligibility (RET fusion, BRAF V600E, EGFR sensitizing mutations, etc.) with test reports.
• Provide prior systemic therapy sequence and dates demonstrating progression or intolerance as required.

Prerequisite Therapy or Age Restriction Noncompliance — Denial Risk and Exception Documentation

If prerequisite therapy requirements or age restrictions are not met, the PA may be denied. Provide justification or supporting clinical documentation when requesting exceptions (e.g., contraindication, intolerance, severe disease that warrants deviation from step therapy).

• When prior therapy requirements are unmet, include contraindication or intolerance documentation to support approval.
• For age‑based restrictions, provide clinical rationale if requesting an exception.

Required Prior/Concomitant Therapies and Timing Rules

Provide required prior or concomitant therapy documentation (e.g., combination with GnRH analog for prostate cancer agents, concurrent urate‑lowering therapy with gout prophylaxis agents), tolerability data, and specific administration timing when relevant (e.g., myeloid growth factors ≥24 hours after chemotherapy).

• Document required concomitant therapies (example: GnRH analog with androgen receptor pathway agents).
• Follow timing rules (e.g., myeloid growth factors at least 24 hours after chemotherapy).
• Provide tolerability history or contraindication documentation when required.