Prior Authorization Required — How to Request

You will need authorization by your HMSA Akamai Advantage (PPO) plan before filling prescriptions for the drugs listed below. HMSA will provide coverage only after it determines the drug is prescribed according to the criteria shown. To request prior authorization, the prescriber, member, or appointed representative must call HMSA at 1 (855) 479-3659 (TTY/TDD 711). Be prepared to provide clinical details and supporting documentation described in each drug's required medical information. Coverage under Medicare Part D will be denied when coverage is available under Part A or Part B for the same indication or setting; therefore prescribers should confirm whether the drug will be billed as a medical (Part A/B) or pharmacy (Part D) benefit prior to submitting a Part D PA request.

• Prior authorization (PA) is required before dispensing many specialty, oncology, and targeted agents; PA is generally granted for a Plan Year when criteria are met.
• Medicare Part B vs Part D: drugs billed/dispensed or administered in a setting covered under Part A or Part B may not be covered under Part D — coverage will be denied under Part D if Part A or B applies.
• If a requested drug is usually covered under the medical benefit (Part A/B) rather than the pharmacy benefit (Part D), the PA request may be denied — confirm billing pathway up front.

Required Documentation and Denial Risks

Coverage is contingent on submission of the required clinical documentation. Lack of required prior therapy, diagnostic testing, mutation testing, hemodynamic confirmation, or intolerance documentation may result in denial.

• Provide complete chart notes, prior treatment history (including dates, doses, and reasons for discontinuation), and relevant lab or diagnostic reports (e.g., HCV RNA, BRAF mutation, FGFR3, leukocyte cystine, NAGS testing).
• Examples of required documentation: mutation or biomarker testing for targeted oncology agents (e.g., BRAF fusion/rearrangement or V600 for OJEMDA/ORJEMDA), right heart catheterization and hemodynamics for PAH agents (e.g., UPTRAVI, Tadalafil for PAH), fungal diagnostic testing for oral itraconazole onychomycosis, and confirmation of NAGS deficiency for CARBAGLU.
• Missing documentation (for example: hemodynamic confirmation for PAH, CD4 counts and TMP–SMX intolerance for DARAPRIM prophylaxis, or leukocyte cystine/genetic testing for cystinosis drugs) may cause denial.

Prior Therapy / Step Requirements

Some approvals require demonstration of prior therapy failure, intolerance, or contraindication to specified alternatives. Include trial dates, doses, and reasons for failure/intolerance.

• Prior therapy requirements commonly apply to biologics, targeted immunomodulators, and certain oral agents (examples: RA, psoriasis, hidradenitis suppurativa, uveitis, Cosentyx/Cosentyx-related step therapy).
• A documented trial of and inadequate response or intolerance to listed alternatives (or contraindication) is required where specified — absence of this will delay or deny PA.
• TNF inhibitor trial absence or failure to document alternatives will commonly result in denial for agents that require step therapy to TNF inhibitors or other listed agents.

HRM Age-based Prior Authorization and Duration Limits

Several High-Risk Medication (HRM) groups require PA only for older adults and may have cumulative duration limits. Prescribers must acknowledge risk-benefit for older patients and document alternatives/trials when indicated.

• HRM age-based PA: For many HRM groups (for example HRM-Anticonvulsants, HRM-Hypnotics, HRM-Hydroxyzine, HRM-Skeletal Muscle Relaxants, HRM-Promethazine, HRM-Scopolamine), the PA requirement applies only to patients age 70 or older (or age 65+ where specified).
• Examples of duration/limits: HRM-Hypnotics PA applies to cumulative >90 days/year; several HRM PAs apply when cumulative therapy exceeds 30 days/year.
• When HRM alternatives are required (e.g., doxepin before hypnotics, buspirone/SSRIs/SNRIs for hydroxyzine anxiety), document trials, responses, or contraindications.

Drug Interaction and Contraindication Denial Risks

Certain drugs have specific drug–drug contraindications or interaction-related denial risks that must be checked prior to prescribing.

• DHE Nasal and ergotamine products: coverage will be denied if used with potent CYP3A4 inhibitors (examples: ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin).
• Ergotamine tartrate/caffeine: denied when used in conjunction with potent CYP3A4 inhibitors.
• Prescribers should review the patient's medication list and document why concomitant interacting agents are not present or are clinically necessary.

Dupixent (dupilumab) Prior Authorization

Dupixent (dupilumab): PA is required and criteria include disease-specific assessments and prior therapy where applicable.

• For moderate-to-severe atopic dermatitis, document severity (body surface area, impact on daily living), prior topical/systemic therapy trials or contraindications, and response or intolerance.
• For asthma, chronic rhinosinusitis with nasal polyps, or other approved indications, include relevant diagnostic testing (e.g., eosinophil counts, IgE where applicable) and prior controller therapy trials or contraindications.
• Continuation approvals require documentation of clinical benefit since initiation.

Fentanyl Patch Prior Authorization Requirements

Fentanyl transdermal systems (patches): prior authorization is required; document opioid tolerance, indication, dosing plan, and monitoring.

• Document that the patient is opioid-tolerant (as defined by accepted dosing equivalents) prior to initiating a fentanyl patch.
• Provide indication (typically chronic, severe pain requiring continuous opioid therapy), prior analgesic trials and reasons for escalation to transdermal fentanyl, and plans for monitoring and risk mitigation (e.g., opioid agreement, naloxone).

Icatibant PA and Diagnostic Requirements

Icatibant (Sajazir): PA is required for acute hereditary angioedema (HAE) attacks and specific diagnostic confirmation must be provided.

• For acute angioedema due to HAE: provide laboratory confirmation of HAE with C1 inhibitor deficiency/dysfunction OR confirm HAE with normal C1 inhibitor with relevant genetic testing (F12, ANGPT1, PLG, KNG1, HS3ST6, MYOF) or family history and failed high-dose antihistamine trial.
• Age restriction: 18 years or older. Prescriber should be an immunologist, allergist, or rheumatologist or consult with one.

ICLUSIG Prior Authorization

Iclusig (ponatinib): PA required for specified hematologic malignancies and rearrangement-confirmed indications.

• Indications include myeloid/lymphoid neoplasms with eosinophilia and FGFR1 or ABL1 rearrangement; provide cytogenetic/molecular confirmation as applicable.
• For other oncology uses, include disease state documentation, prior therapies, and rationale for use.

IDACIO and Adalimumab Biosimilars Prior Authorization

Idacio and other adalimumab biosimilars: PA applies with the same clinical criteria as originator biologics; document prior therapy and indication-specific requirements.

• For plaque psoriasis, RA, PsA, AS and other autoimmune indications, document severity measures (e.g., BSA for psoriasis), prior conventional DMARD trials (e.g., methotrexate) or contraindications, and previous biologic history where required.
• Biosimilars are reviewed under the same step-therapy and prior authorization rules as the reference product; note interchangeability or prior adverse event history where relevant.

INBRIJA Prior Authorization

INBRIJA (levodopa inhalation) and other dopaminergic agents: PA is required with documentation of diagnosis and prior therapy trials.

• Document diagnosis of Parkinson's disease, current oral levodopa regimen and motor fluctuation history (e.g., 'off' episodes), and rationale for inhaled levodopa.
• Provide prior therapy history, adverse reactions, and evidence that INBRIJA is medically necessary for the patient's symptom control.

Itraconazole Prior Authorization and Diagnostic Requirements

Itraconazole (oral) requires PA and condition-specific diagnostic confirmation for onychomycosis and duration limits apply.

• The requested itraconazole must be oral. For onychomycosis due to dermatophytes, a fungal diagnostic test (e.g., KOH, fungal culture, or nail biopsy) confirming dermatophyte infection is required.
• PA applies when cumulative oral therapy exceeds 90 days/year; document intended duration (typically up to 12 weeks for fingernails/toenails as applicable) and non-continuous use where required.

LAZCLUZE (Lapatinib) Prior Authorization

Lapatinib (Lazcluze) and other targeted oncology therapies: PA requires mutation testing and regimen documentation per indication.

• For HER2-targeted indications, provide HER2 testing results and treatment plan; for other tumor types, include relevant molecular biomarker testing and line of therapy justification.
• Include prior treatments, combination regimens, and disease staging as applicable.

LENVIMA Prior Authorization

Lenvima (lenvatinib): PA required with indication-specific documentation including tumor type and prior therapy history.

• For approved indications (e.g., hepatocellular carcinoma, thyroid carcinoma, endometrial carcinoma in combination), provide tumor type, prior systemic therapies, relevant biomarkers, and rationale for lenvatinib use.
• Include baseline labs and monitoring plan given toxicity profile.

LUPRON (CPP) Prior Authorization

Leuprolide acetate (LUPRON and other CPP agents): PA required for specific indications and duration limits.

• Document indication (for example, advanced prostate cancer, central precocious puberty), relevant baseline labs, and prior therapies where applicable.
• Provide anticipated duration of therapy and monitoring plans.

Posaconazole Prior Authorization

Posaconazole (oral) PA requirements: oral formulation only and minimum weight for prophylaxis; duration limits apply.

• Posaconazole must be used orally. For prophylaxis of invasive Aspergillus and Candida infections, patient weight must be greater than 40 kilograms.
• Age and indication-specific limits: treatment of invasive aspergillosis (13+ years), prophylaxis (2+ years); typical approval up to 6 months.

Erythropoiesis-stimulating Agent Prior Authorization

Erythropoiesis-stimulating agents (e.g., Procrit): PA requires hemoglobin thresholds, iron status, and indication-specific criteria.

• Initial approval generally requires pretreatment hemoglobin (Hgb) <10 g/dL (except for anemia due to chemotherapy or MDS), adequate iron stores (TSAT ≥20%), and absence of recent erythropoietin use.
• For MDS, pretreatment serum erythropoietin ≤500 IU/L may be required. Reauthorization requires documented response after ≥12 weeks of therapy and current Hgb thresholds per policy.

RENFLEXIS Prior Authorization

Renflexis and other infliximab biosimilars: PA criteria mirror reference biologic; document indication, prior therapy trials, and infusion plan.

• For IBD, RA, and other approved uses, include prior conventional therapy trials (e.g., corticosteroids, immunomodulators), previous biologic history, and dosing/infusion schedule.
• For medical benefit-administered infusions, confirm billing pathway (Part A/B) to avoid Part D denial.

REPATHA Prior Authorization

Repatha (evolocumab) and other PCSK9 inhibitors: PA required with LDL-C thresholds and prior maximal tolerated statin therapy.

• Document diagnosis (heterozygous familial hypercholesterolemia, clinical atherosclerotic cardiovascular disease), baseline LDL-C despite maximally tolerated statin ± ezetimibe, and lipid panel results.
• Specify prior lipid-lowering therapies tried, intolerance documentation, and treatment goals.

REVLMID (Lenalidomide) Prior Authorization and REMS

Lenalidomide (Revlimid) and other agents with REMS/restricted distribution: PA requires disease-specific criteria and adherence to distribution program requirements.

• For multiple myeloma, MDS, and other indications, provide diagnostic confirmation, prior lines of therapy where indicated, and compliance with REMS (pregnancy prevention programs) when applicable.
• Include prior therapy history, cytogenetic/molecular testing if required, and monitoring plans.

RINVOQ / ROMVIMZA Prior Authorization

Rinvoq (upadacitinib) and Romluz (monoclonal therapeutics) class agents: PA requires prior therapy trials and safety monitoring documentation.

• For RA, PsA, and related indications, document prior conventional DMARD trials (e.g., methotrexate) or biologic history per the specific criteria.
• Provide baseline labs, screening for infections (e.g., TB, hepatitis), and rationale for targeted therapy selection.

Targeted Oncology and Specialty Agents — Documentation Requirements

Targeted oncology and specialty agents: PA is required with supporting pathology, staging, biomarker/mutation testing, prior regimen history, and intended regimen documentation.

• Include tumor histology, biomarker or mutation testing (e.g., BRAF, FGFR3, EGFR, ALK), line of therapy, prior systemic treatments, and combination regimens.
• For many agents, coverage is limited to FDA-approved indications and specified medically-accepted indications; off-label uses require strong supporting evidence and documentation.

Tadalafil (BPH) Prior Authorization and Step Requirement

Tadalafil for benign prostatic hyperplasia (BPH): PA requires prior therapy trials with both an alpha blocker and a 5-alpha reductase inhibitor.

• For BPH, document inadequate response, intolerance, or contraindication to BOTH an alpha blocker and a 5‑ARI prior to tadalafil approval for BPH symptoms.
• Typical coverage duration noted in policy (e.g., 26 weeks) should be included in the request.

SYNAREL Prior Authorization Criteria

Synarel (nafarelin) and other gonadotropin-releasing hormone analogs: PA criteria require indication-specific documentation.

• Document indication (e.g., endometriosis, central precocious puberty), prior therapies tried, and diagnostic confirmation if applicable.
• Provide age, pubertal status, growth parameters (for pediatric use), and monitoring plan.

TECENTRIQ Prior Authorization Criteria

Tecentriq (atezolizumab) and other immune checkpoint inhibitors: PA requires tumor type, PD-L1 or other biomarker testing when required, and prior therapy history.

• Provide indication-specific biomarkers (e.g., PD-L1), prior chemotherapy or targeted therapy history, performance status, and line of therapy justification.
• Include documentation of any immune-related contraindications or autoimmune disease considerations.

Testosterone Product Prior Authorization Criteria

Testosterone products: PA requires documented hypogonadism with supporting labs and symptom documentation; abuse, contraindications, and monitoring plan must be provided.

• Confirm diagnosis of hypogonadism with at least two low morning total testosterone measurements and clinical signs/symptoms.
• Provide prior therapy history, fertility considerations, and plans for monitoring adverse effects (hematocrit, PSA where appropriate).

TREMFYA Prior Authorization

Tremfya (guselkumab) prior authorization: PA required with indication-specific severity and prior therapy documentation.

• For plaque psoriasis new starts: document BSA ≥3% or involvement of crucial body areas and prior inadequate response, intolerance, or contraindication to specified biologics or systemic therapies as listed in policy.
• For PsA and other indications, include prior DMARD trials and disease activity measures where applicable.

TRIKAFTA Prior Authorization

Trikafta (elexacaftor/tezacaftor/ivacaftor): PA required for CF with eligible mutations and weight/age criteria; include genotype and prior CFTR modulator history.

• Provide documented CFTR mutation genotype that is responsive to Trikafta, patient age and weight per label, and prior CFTR modulator therapy and response if applicable.
• Include baseline liver function tests and monitoring plan.

Rifaximin — IBS‑D and SIBO Prior Authorization

Rifaximin for IBS-D and rifaximin for SIBO: PA requires indication-specific documentation and prior therapy trials.

• For IBS-D: document diagnosis consistent with IBS-D criteria and prior inadequate response or intolerance to conventional therapies per policy.
• For suspected SIBO: provide diagnostic testing results when available or detailed clinical rationale and prior antibiotic trial history; duration limits may apply.

XOLAIR Prior Authorization and Diagnostic Requirements

Xolair (omalizumab): PA requires confirmation of perennial aeroallergen sensitivity, baseline IgE ≥30 IU/mL for asthma indications, and prior controller therapy trials where specified.

• For moderate-to-severe persistent asthma: positive skin or blood test to at least one perennial aeroallergen, baseline IgE ≥30 IU/mL, and inadequate control despite medium-to-high dose inhaled corticosteroid plus an additional controller unless contraindicated.
• For chronic spontaneous urticaria: document symptom duration (≥6 weeks), evaluation for other causes, and inadequate response to H1 antihistamines; continuation requires evidence of benefit.

XYREM Prior Authorization and REMS Requirements

Sodium oxybate (Xyrem) has specialized PA and REMS/program requirements; provide diagnosis, prior therapy history, and compliance with distribution program.

• For narcolepsy with cataplexy or excessive daytime sleepiness: document diagnosis, prior stimulants or other therapies tried, and patient enrollment in the REMS/specialty distribution program.
• Include dosing plan, home safety considerations, and monitoring for misuse/diversion.

Medicare Part A/B vs Part D Coverage and Denial Risk

Coverage determinations: Part D denials may occur if the same medication is available under Part A/B for the patient’s setting or if payment is the responsibility of the medical benefit. Prescribers should confirm the appropriate billing route and provide evidence if the request is for the pharmacy benefit.

• If the medication will be administered in a facility or physician office and billed to Part A or Part B, Part D PA will be denied — document why pharmacy benefit is appropriate if requesting Part D coverage.
• Medicare Part denial risk increases when documentation does not clarify the site-of-care or presence of medical benefit coverage.

Diagnostic Confirmation Requirements for Select Rare Diseases

Special diagnostic confirmations referenced elsewhere in this policy include but are not limited to CARBAGLU (NAGS deficiency enzymatic/biochemical/genetic testing), cystinosis drugs (leukocyte cystine elevation, genetic testing, or corneal crystals), DARAPRIM (document TMP‑SMX intolerance and recent CD4 counts for prophylaxis), Pompe disease, and other lysosomal/rare disease diagnostics — include the specific test results in the PA submission.

• CARBAGLU: provide enzymatic, biochemical, or genetic confirmation of NAGS deficiency.
• Cystinosis drugs (CYSTAGON/CYSTARAN): provide leukocyte cystine concentration, genetic testing, or slit-lamp demonstration of corneal cystine crystals.
• DARAPRIM (pyrimethamine): for prophylaxis/treatment in immunocompromised patients, include CD4 counts within specified lookback periods and documentation of TMP‑SMX intolerance/contraindication.

Examples of Required Medical Documentation by Condition

Condition- and age-specific examples of required documentation (not exhaustive): psoriasis severity and prior biologic/DMARD history; RA prior therapy and combination therapy documentation; hidradenitis suppurativa and uveitis baseline severity; osteoporosis baseline bone density and prior therapy; onychomycosis fungal testing; HCV genotype, RNA, prior treatment and cirrhosis status; GATTEX parenteral nutrition dependence; HAE diagnostic confirmation and attack history.

• Provide objective measures where applicable (BSA for psoriasis, DAS28 or other RA activity metrics, bone density scans for osteoporosis).
• For continuation requests, show documented clinical benefit compared to baseline (symptom reduction, lab improvement, reduced exacerbations) and adherence to monitoring.