Drugs That Require Prior Authorization (PA)
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Lists prescription drugs that require prior authorization from HMSA Akamai Advantage (PPO) and summarizes indication-specific PA criteria, exclusions, required documentation, and coverage durations for prescribers, patients, and appointed representatives.
No material clinical or coverage changes in this revision.
Drug-Specific Coverage Criteria
Abiraterone (ABIRATERONE) — Coverage criteria
Covered when criteria listed are met
Coverage duration: Plan Year
Acitretin — Psoriasis prerequisite
Covered when ALL of the following are met
Coverage duration: Plan Year
Actimmune — Mycosis fungoides / Sezary syndrome
Covered per FDA‑approved and some medically‑accepted indications
Coverage duration: Plan Year
Adempas — PAH and CTEPH criteria
Covered when ALL hemodynamic and disease‑specific criteria are met
For CTEPH: persistent/recurrent disease after pulmonary endarterectomy (PEA) or inoperable CTEPH confirmed by RHC and imaging
Aimovig — Migraine prophylaxis
Covered when criteria are met
Initial: 3 months; Continuation: Plan Year
Arcalyst — Prevention of gout flares
Covered when ALL of the following are met
Continuation requires demonstrated clinical benefit and continued urate‑lowering therapy; Coverage duration: Plan Year
Ayvakit — Tardive dyskinesia and chorea
Covered when specific diagnostic and response criteria are met
Avapritinib / related — PDGFRA / GIST / systemic mastocytosis criteria
Covered when disease‑specific molecular and prior therapy criteria are met
Coverage duration: Plan Year
Hereditary angioedema (HAE) — acute attack
Covered when ALL of the following are met (example: HAE acute attack treatment)
Prescriber should be an immunologist, allergist, or rheumatologist or consult such specialist
Pulmonary arterial hypertension (PAH)
Covered when ALL of the following are met (PAH — when required)
Applies to WHO Group 1 PAH; Coverage duration: Plan Year
BRAF V600E targeted therapy (BRAFTOVI)
Covered when ALL of the following are met (examples for specific tumor types)
Coverage duration: Plan Year
Coverage duration: Plan Year
Coverage duration: Plan Year
Gaucher disease therapies
Covered when ALL of the following are met
For CERDELGA, CYP2D6 metabolizer status must be established; Coverage duration: Plan Year
Multiple sclerosis initial and continuation
Continuation requires improvement in walking speed or other objective walking measure
Coverage duration: Plan Year
AML (DAURISMO) coverage criteria
Acute myeloid leukemia — Daunorubicin/other (DAURISMO) requirements
Coverage duration: Plan Year
Deferasirox
Chronic iron overload (Deferasirox)
Required before initiation; Coverage duration: Plan Year
Migraine/cluster headache: ergot/dihydroergotamine
Ergotamine/Dihydroergotamine migraine therapy
Coverage will be denied if used with potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin)
Fasenra coverage
Fasenra (benralizumab) — severe asthma and EGPA
Continuation requires improved control (reduced exacerbations/symptoms or reduced maintenance oral corticosteroid dose)
Continuation requires beneficial response (fewer relapses, reduced steroid dose, or no active vasculitis)
Fentanyl patch criteria
Fentanyl patch coverage
OR for chronic opioid requirement: patient has been taking an extended‑release opioid ≥30 days OR immediate‑release opioid ≥1 week and can safely take requested dose; prescriber monitors for opioid use disorder
IPF diagnostic criteria
Idiopathic pulmonary fibrosis (Esbriet/pirfenidone)
Coverage duration: Plan Year
Step therapy for neuropsychiatric agents
Anticonvulsant and antipsychotic prior trials
Perampanel (FYCOMPA) requires documentation of these prior trials
See individual drug rows for comparator lists
Everolimus oncology coverage
Everolimus cancer indications
Coverage duration: Plan Year
Coverage duration: Plan Year
Perampanel (FYCOMPA) approval criteria
Covered when ALL of the following are met
Applies to partial‑onset seizures; Coverage duration: Plan Year
Applies to adjunctive primary generalized tonic‑clonic seizures
GAVRETO — RET rearrangement-positive disease
Covered when ALL of the following are met
Age restrictions by tumor type (see policy); Coverage duration: Plan Year
GILOTRIF — EGFR-positive NSCLC
Covered when ALL of the following are met
Prerequisite therapy required per entry; Coverage duration: Plan Year
HADLIMA — indication-specific coverage criteria
Covered for indicated diagnoses when the following indication‑specific prior therapy or diagnostic criteria are met
New starts only; Coverage duration: Plan Year
New starts only
New starts only
Prescriber specialty and documentation per policy
HETLIOZ / TASIMELTEON coverage criteria
Covered when ALL of the following are met
Initial: 6 months; Continuation: Plan Year; prescriber specialty required
Initial: 6 months; Continuation: Plan Year
High-Risk Medication (HRM) approval criteria (65+)
Covered for patients 65 years or older only when the following conditions are satisfied
Applies to HRM entries; PA applies when cumulative therapy exceeds specified days/year
Prior authorization applies to cumulative day limits (see individual entries)
Examples: 30 days/year or 90 days/year per agent
HER2-targeted therapies — indication-specific criteria & exclusions
Covered for FDA and some medically‑accepted indications when indication‑specific criteria are met
Coverage under Part D denied if Part A or B covers administration; Coverage duration: Plan Year
Intolerance to comparator (Trazimera) considered only per prescribing info
High-Risk Medication (HRM) PA criteria
Covered when ALL of the following are met (pattern used across several HRM drug entries):
Applies to HRM entries; Coverage duration examples: 3 months or Plan Year
See individual drug rows for exact alternatives
Mitigates risk of cognitive decline or falls in older adults
HUMIRA coverage criteria
Covered for specific FDA‑approved and some medically‑accepted indications when criteria met:
New starts only for many indications; Coverage duration: Plan Year
New starts only
ICATIBANT coverage criteria
Covered when ALL of the following are met:
Prescriber should be immunologist/allergist/rheumatologist or consult; age ≥18 for listed entry
Imatinib and kinase inhibitor criteria
Covered when ALL applicable diagnostic and prior therapy conditions are met:
For CML: criteria include resistance/intolerance to prior TKIs or specific mutations as noted
Coverage duration: Plan Year
Progression required
INCRELEX coverage criteria
Covered when ALL of the following are met for pediatric patients:
Patient ≥2 years old; prescriber endocrinologist or consult; continuation requires documented growth benefit
Imatinib and related requirements
Imatinib‑related and related agents — covered when the following are met
See imatinib-specific entry for detailed mutation and prior‑therapy rules
INCRELEX
INCRELEX (severe primary IGF‑1 deficiency) initial therapy covered when ALL listed criteria met
Patient ≥2 years; prescriber endocrinologist or consult; continuation requires improvement
IVIG
IVIG coverage criteria vary by indication
Coverage duration: Plan Year
Opioids and ketoconazole
Opioid extended‑release analgesics and ketoconazole have specific eligibility and risk documentation
Prescriber knowledgeable in potent opioid management; Coverage duration: Plan Year
See drug‑specific contraindications list
Kineret step requirements
Kineret initiation criteria for certain rheumatologic indications
Coverage duration: Plan Year
LORBRENA
Lorlatinib (LORBRENA) coverage criteria for ALK/ROS1‑positive diseases
Prior therapy required per entry; Coverage duration: Plan Year
Lumizyme (Pompe disease) coverage criteria
Covered when the following are met for Pompe disease with Lumizyme:
Prior authorization required; Coverage duration: Plan Year
Atovaquone (Mepron) coverage criteria
Atovaquone (Mepron) coverage conditions by indication:
For PCP treatment/prophylaxis: intolerance/contraindication to SMX‑TMP required; for babesiosis use concurrently with azithromycin
Nuedexta (PBA) coverage criteria
Nuedexta (pseudobulbar affect) criteria:
Continuation: decrease in PBA episodes since starting therapy; Coverage duration: Initial 4 months then Plan Year
Nurtec coverage criteria
Nurtec coverage rules for migraine:
For preventive therapy: not to be used concurrently with another CGRP antagonist; continuation requires ≥3 months of treatment and reduction in migraine days
Ofev (nintedanib) coverage criteria
Ofev (nintedanib) criteria for pulmonary fibrosis indications:
Coverage duration: Plan Year
Coverage duration: Plan Year
ONTRUZANT and related HER2 agents — coverage conditions
Covered when the following HER2‑specific conditions are met for listed indications
Coverage under Part D will be denied if Part A or B covers administration when applicable; Coverage duration: Plan Year
PREVYMIS — CMV prophylaxis coverage
Covered when ALL of the following are met
Coverage duration: 7 months; age thresholds apply by transplant type
Coverage duration: 7 months; age thresholds apply
OPSUMIT — PAH coverage (new starts)
Covered when ALL of the following hemodynamic criteria are documented for pulmonary arterial hypertension (WHO Group 1)
Coverage duration: Plan Year
Omega-3-acid ethyl esters — hypertriglyceridemia
Covered when ALL of the following are met
Required before initiation; Coverage duration: Plan Year
Psychiatric agents requiring prior therapy or alternatives
Covered when specified step/alternative therapy criteria are met
See individual drug entries for exact comparator lists; Coverage duration: Plan Year
Rheumatologic and Dermatologic Biologic Agents — New starts
Covered when ALL of the following are met for specific indications (examples extracted):
New starts only; Coverage duration: Plan Year
New starts only
New starts only
REZLIDHIA / REZDIFFRA (NASH) Initial and continuation
Coverage requires specific baseline and response criteria:
Continuation: beneficial response (e.g., ALT reduction); Coverage duration: Plan Year
RETEVMO (RET fusion-positive tumors)
Covered when ALL of the following are met:
For solid tumors: recurrent/persistent/progressive/unresectable/locally advanced/metastatic with prior systemic treatment or no satisfactory alternatives AND tumor RET fusion‑positive
Pulmonary Arterial Hypertension — Sildenafil
Covered when ALL of the following hemodynamic criteria are met (for PAH starts):
Coverage duration: Plan Year
Benign Prostatic Hyperplasia (Tadalafil)
Covered when ALL of the following are met:
Coverage duration: 26 weeks; prerequisite therapy required
Central Precocious Puberty (GnRH agonist e.g., Synarel)
Covered when ALL of the following are met for patients not currently receiving therapy:
Age limits: female <12 years; male <13 years for coverage; Coverage duration: Plan Year
CPP
Examples of coverage criteria present in this segment include:
Coverage duration: Plan Year
Mutation-dependent oncology coverage
Coverage for several oncology drugs is contingent on tumor mutation or diagnostic test results and indication‑specific conditions.
Coverage duration: Plan Year
Coverage duration: Plan Year
PAH (tadalafil)
Covered for WHO Group 1 PAH when hemodynamic criteria are met (new starts only).
Coverage duration: Plan Year
Tetrabenazine
Tetrabenazine is covered for tic disorders and tardive dyskinesia with prior therapy requirements.
Initial duration: 6 months; continuation: Plan Year
Topical tacrolimus
Topical tacrolimus is authorized for certain dermatologic indications with prior‑treatment rules and age limits.
Prerequisite therapy: Yes; Coverage duration: Plan Year
Testosterone enanthate coverage criteria
Covered when ALL of the following are met
Continuation requires confirmed low morning serum total testosterone prior to starting therapy; Safety/efficacy not established for age‑related hypogonadism
Coverage duration: Plan Year
TRIKAFTA coverage criteria
Covered when ALL of the following are met
Coverage duration: Plan Year
PAH agents coverage criteria
Covered when ALL of the following are met for new starts
Applies to Treprostinil, Uptravi, and other PAH agents; Coverage duration: Plan Year
VOQUEZNA coverage criteria
Covered when ALL of the following are met
Duration of therapy: 14 days
VITRAKVI coverage criteria
Covered when ALL of the following are met
Includes non‑metastatic indication; Coverage duration: Plan Year
Oncology molecular/line-of-therapy criteria
Examples of required criteria for oncology indications (NSCLC and ALCL):
Coverage duration: Plan Year; see individual drug entries for exact prior‑therapy sequencing
Plaque psoriasis biologic initiation
Plaque psoriasis biologic initiation criteria (Y‑series example):
Applies to new starts only; Coverage duration: Plan Year
IBS-D and SIBO treatment courses
IBS‑D and SIBO antibiotic course rules (XIFAXAN):
Coverage durations vary by indication (initial 14 days etc.)
Coverage duration: 14 days where applicable
ZARXIO timing and indication criteria
ZARXIO neutropenia chemotherapy timing rule:
Coverage duration: per indication
This prior authorization policy lists drugs that may fall under either Medicare Part B or Part D depending on the clinical setting, route of administration, or who dispenses/administers the medication. When the same medication and administration scenario is payable under Medicare Part A or B, Part D coverage will be denied. To determine the correct benefit, the reviewer may require documentation describing the site-of-care or how the drug will be used (for example, infusion or physician‑administered versus outpatient pharmacy dispensing).
When submitting a request for coverage determination, include the clinical details that establish the setting of use (e.g., inpatient/hospital outpatient infusion, physician administration, or outpatient pharmacy dispensing) so the reviewer can determine whether the claim should be processed under Medicare Part A/B or Part D.
Some drug entries include explicit exclusions or indicate that coverage depends on circumstance-specific criteria; many entries have empty exclusion fields in this extract. Examples include diagnostic- or mutation-driven restrictions, contraindications listed by the manufacturer, pregnancy- or syndrome-specific exclusions, and exclusions based on concomitant interacting drugs.
Where an exclusion is listed for a drug, the exclusion must be verified against the submitted clinical information. If an exclusion applies (for example, pregnancy or a specific genetic syndrome), the request should be denied per the exclusion language.
Ergot-derived migraine therapies (e.g., dihydroergotamine, ergotamine products) include a clear exclusion for concomitant use with potent CYP3A4 inhibitors (examples cited include ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin). Coverage will be denied when the patient is taking a listed potent CYP3A4 inhibitor.
Prior to approval, verify the patient’s current medication list for interacting agents; if a potent CYP3A4 inhibitor is present, the request should be declined per the exclusion.
Several HER2-targeted agent entries reference Trazimera intolerance language: coverage is excluded when the patient had an intolerable adverse event to Trazimera unless the adverse event was explicitly NOT attributed to the active ingredient per the prescribing information. For biosimilar or related-agent substitution, the presence or attribution of the prior adverse event must be documented.
When a prescriber requests a HER2 agent because of prior Trazimera intolerance, the documentation must specify the adverse event and state whether it was attributed to Trazimera’s active ingredient to determine eligibility under this exception.
IMPAVIDO (and other listed products in that segment) carries specific exclusions such as pregnancy and Sjogren‑Larsson syndrome for the indicated uses in the extract. Confirm pregnancy status and applicable syndromic exclusions when evaluating requests for these agents.
If an exclusion (for example, pregnancy) is present in the record for the member, the request should be denied consistent with the stated exclusion.
Ivermectin entries explicitly state that the requested drug must not be prescribed for the prevention or treatment of COVID‑19. Requests where the indication or clinical notes document use for COVID‑19 should be denied.
Ensure indication documentation is specific; if the clinical record cites COVID‑19 prevention or treatment as the reason for prescribing ivermectin, the request does not meet coverage criteria in this policy.
KANJINTI and other HER2-related entries reference intolerances to comparator agents: coverage is excluded where the member had an intolerable adverse event to Trazimera that was attributed to the active ingredient. If a prior adverse event occurred but the event was not attributed to the active ingredient, the exclusion may not apply and coverage can be considered per other criteria.
For KANJINTI requests citing prior trastuzumab (Trazimera) intolerance, documentation must describe the adverse event and attribution to permit appropriate application of this exclusion.
When drug administration or dispensing is covered under Medicare Part A or Part B (for example, physician‑administered drugs in a hospital outpatient setting or infusion services), Part D coverage will be denied. The policy repeats this Part D denial rule across multiple entries: if the same medication and administration scenario are payable under Part A or B, do not authorize Part D coverage.
Reviewers must confirm the anticipated site of care and who will bill for the service; if the administration is expected to be billed to Part A or Part B, deny Part D coverage and redirect the provider to the appropriate benefit for authorization.
Part D coverage is not appropriate when the medication is administered or dispensed in a manner that would be payable under Medicare Part A or Part B. Examples in the document reiterate that coverage under Part D will be denied in those circumstances — the clinical submission must document setting/use to determine the correct benefit.
If a request lacks sufficient information to establish that the medication will be dispensed under Part D (outpatient pharmacy) rather than administered under Part A/B, request additional information about the planned setting before issuing a coverage decision.
Conflicts between Part D coverage and Part A/B applicability also arise when the claim involves physician administration or facility-based infusion. The policy reiterates that Part D will deny coverage if Part A or B covers the medication for the individual under the same administration/dispensing scenario.
Document whether the drug will be billed by an outpatient pharmacy or as a physician-administered drug; when administration will be performed and billed under Part A/B, do not approve Part D prior authorization requests.
Some entries include explicit product‑use exclusions unrelated to Medicare benefit conflicts. For example, the BPH formulation of tadalafil specifically lists erectile dysfunction as an exclusion for that formulation and indication — requests for ED should be managed under the appropriate tadalafil/ED coverage rules rather than the BPH indication.
When an exclusion such as erectile dysfunction is documented, the request should be denied for the BPH formulation and the prescriber advised to submit the appropriate indication‑specific documentation if coverage under a different indication is being sought.
Tadalafil for benign prostatic hyperplasia (BPH) is explicitly limited to the BPH indication; erectile dysfunction is listed as an exclusion for the BPH formulation entry. Approval requires meeting the BPH‑specific prior therapy rules and not using the drug for ED under that entry.
Confirm the indication on the request. If the prescriber indicates erectile dysfunction as the reason for tadalafil, process under the appropriate ED policy rather than the BPH PA criteria.
For colorectal cancer, the policy requires the tumor to be HER2‑amplified and RAS and BRAF wild‑type, and it specifies that HER2‑targeted therapy must be used in combination with agents such as pertuzumab, tucatinib, or lapatinib. Coverage for these colorectal indications is contingent on those molecular and combination requirements.
Ensure documentation includes molecular testing results (HER2 amplification plus RAS/BRAF wild‑type status) and the planned combination agent before approving HER2‑directed therapy for colorectal cancer.
For hepatobiliary malignancies, HER2‑targeted therapy coverage requires that the disease be HER2‑positive and that the requested agent be used in combination with pertuzumab or tucatinib as specified. These combination requirements appear consistently across the HER2‑agent entries.
When evaluating hepatobiliary HER2 requests, require confirmation of HER2 positivity and the treating plan showing the specified combination partner to meet coverage criteria.
Initial Authorization Requirements
Requirements for Ongoing Therapy
Prior Trial / Step Therapy Requirements
| Coverage requirement | Example / policy language |
|---|---|
| Prior trial of specified therapies required | Prior trial or intolerance to listed prior therapies is required for many drugs before authorization (examples throughout policy). |
| Documentation of inadequate response, intolerance, or contraindication required | Policy requires documentation that prior therapies produced inadequate response, intolerance, or are contraindicated before approval (see multiple drug entries). |
| Documentation required | Policy note / examples |
|---|---|
| Prior trial history and reason for failure/intolerance | Requests must document prior trial(s) and the reason therapy failed, was intolerant, or contraindicated (step_therapy and documentation modules). |
| Prescriber attestation when applicable | For HRM/older adults, prescriber must acknowledge benefit outweighs risk and document concomitant medications where applicable (see HRM entries). |
| Required alternatives | Example agents / policy text |
|---|---|
| Generic anticonvulsant(s) then branded alternatives | For anticonvulsant indications (e.g., perampanel, other seizure agents) policy requires failure/intolerance to a generic anticonvulsant AND listed branded alternatives (Aptiom, Xcopri, Spritam). |
| Generic antipsychotics then brand alternatives | For schizophrenia/mania the patient must have inadequate response/intolerance/contraindication to specified generic antipsychotics AND to listed brand products before coverage. |
| Non-HRM alternatives required | Policy example / wording |
|---|---|
| Trial of specified non-HRM alternatives | HRM anticholinergic entries require trials of specified non-HRM alternatives (e.g., amantadine for EPS) before approval; prescriber must document trial and outcome. |
| Two non-HRM alternatives for rhinitis or similar indications | For rhinitis, policy requires trial and inadequate response/intolerance to two listed non-HRM alternatives (levocetirizine, azelastine nasal, fluticasone nasal, flunisolide nasal). |
| Hadlima prior trial | Policy requirement / examples |
|---|---|
| Prior conventional therapy trial required for indication-specific starts | Hadlima new starts require prior trial or intolerance to indicated therapies depending on indication (e.g., methotrexate for RA; NSAID for ankylosing spondylitis; phototherapy or methotrexate/cyclosporine/acitretin for psoriasis). |
| Documentation of trial/failure/intolerance | Requests must document inadequate response, intolerance, or contraindication to the listed prior therapies per indication. |
| Alternative / non-HRM or SOC agent trials | Policy examples |
|---|---|
| Trials of specified alternatives required | For many entries the policy requires trials of specified alternative non‑HRM or standard-of-care agents and documentation of inadequate response/intolerance prior to approval. |
| Number/type of alternatives varies by indication | Examples: depression/anxiety/insomnia entries require trials of two alternative agents; psoriasis biologics require prior phototherapy/systemic therapy unless contraindicated. |
| Are prior therapies required? | Policy stance / note |
|---|---|
| [{"text":"Yes — prior therapies required for many drugs","status":"covered"},{"text":"The policy indicates 'Yes' for prior therapies required in multiple drug entries; prior trial/failure/intolerance is commonly required before approval.','status':''}] |
| Step therapy present | Policy summary |
|---|---|
| Yes | Step therapy requirements are present for many agents; prior trial(s) and documentation are required as specified per drug. |
| Lorlatinib prior use/intolerance requirement | Policy text / example |
|---|---|
| Prior use or intolerance to specific ALK inhibitors required | For lorlatinib (Lorbrena) in recurrent/advanced ALK-positive NSCLC, prior use or intolerance to alectinib (Alecensa) or brigatinib (Alunbrig) is required per policy. |
| HER2 regimen prior therapy / combination | Policy requirement |
|---|---|
| Prior therapy or combination requirements vary by tumor type | HER2-targeted regimens require indication-specific prior therapy or combination rules (e.g., colorectal requires HER2-amplified and use in combination with pertuzumab/tucatinib/lapatinib; prior HER2 inhibitor exposure rules apply). |
| Trial and failure/intolerance required | Policy wording / examples |
|---|---|
| Trial and documented failure/intolerance required | Multiple entries require trial and documented inadequate response, intolerance, or contraindication to specified alternatives before coverage. Examples include psychiatric, seizure, and biologic agents. |
| Prior trial(s) required generally | Policy summary |
|---|---|
| Prior trials required for many new starts | Policy repeatedly states prior trial(s) are required for new starts; details depend on drug and indication (see step therapy module). |
| Prior trial(s) required (oncology / other) | Policy examples |
|---|---|
| Yes — prior trials required for selected oncology and other agents | Examples: certain oncology TKIs require prior kinase inhibitor exposure or demonstration of progression on prior lines; other specialty agents also require prior therapy trials. |
| Document prior trial / failure / contraindication | Policy requirement |
|---|---|
| Documentation required | Policy requires documentation of prior trial, failure, intolerance, or contraindication to listed agents for many authorizations (document the agent, duration, and reason). |
| Documentation of prior failure/intolerance/contraindication required | Policy note / examples |
|---|---|
| Yes — document prior failure/intolerance/contraindication | Authorization requires evidence that the patient failed, was intolerant of, or has contraindication to listed prior agents (this requirement is repeated across many drug entries). |
How Providers Request Authorization and Required Documentation
How to request prior authorization
Prior authorization requests must be initiated by the member, an appointed representative, or the prescriber by calling HMSA at 1 (855) 479-3659 (TTY/TDD 711). Support is available 24 hours a day, 7 days a week.
Coverage setting may affect determination
Provide information about the drug use setting (e.g., outpatient pharmacy dispensing vs. facility administration) when requested, because coverage determination may depend on whether the drug is payable under Medicare Part B or Part D.
Prior authorization requirement (general)
Prior authorization is required for the specialty drugs listed in this policy; approval depends on meeting the drug- and indication-specific clinical, diagnostic, and prerequisite therapy criteria shown in each drug entry.
PAH prior authorization — right heart catheterization requirement
For PAH agents, prior authorization for new starts requires confirmation of pulmonary arterial hypertension by right heart catheterization and documentation of pretreatment hemodynamics per the policy thresholds.
- Document pretreatment mean pulmonary arterial pressure (mPAP) > 20 mmHg
- Document pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg
- For adults, document pulmonary vascular resistance (PVR) ≥ 3 Wood units when required
Fasenra PA criteria (eosinophil threshold etc.)
Initial Fasenra requests must include baseline blood eosinophil count ≥150 cells/µL or documentation that the patient is systemic corticosteroid–dependent, and history of severe asthma despite medium‑to‑high‑dose inhaled corticosteroid plus an additional controller unless contraindicated.
- Asthma initial: baseline blood eosinophils ≥150 cells/µL OR systemic corticosteroid dependence
- Document history of severe asthma despite medium-to-high dose inhaled corticosteroid plus an additional controller
Fentanyl patch PA criteria
Prior authorization for fentanyl transdermal patches requires the indication to be cancer‑related pain, sickle cell disease, a terminal condition/palliative care, or evidence patient requires daily opioid therapy with prior opioid exposure and a monitoring plan for opioid use disorder.
- Eligible indications: cancer, sickle cell disease, terminal condition, or palliative care
- Or documented chronic daily opioid requirement with prior opioid exposure (ER ≥30 days or IR ≥1 week) and monitoring plan
Deferasirox PA requirement (serum ferritin threshold)
Deferasirox for chronic transfusional iron overload requires a pretreatment serum ferritin level greater than 1000 mcg/L to meet PA criteria.
- Submit pretreatment serum ferritin > 1000 mcg/L
FYCOMPA / PERAMPANEL PA
Perampanel (FYCOMPA) prior authorization requires documentation of seizure‑specific prior therapy failures/intolerance/contraindications per indication (e.g., failed generic anticonvulsant plus listed branded agents); follow administration timing rules when given with chemotherapy as specified.
- For partial‑onset seizures: failed generic anticonvulsant AND failed/intolerant/contraindicated to Aptiom, Xcopri, and Spritam
- For adjunctive primary generalized tonic‑clonic seizures: failed generic anticonvulsant AND failed/intolerant/contraindicated to Spritam
Plan Year coverage durations (common administrative note)
Many agents list 'Plan Year' as the standard coverage duration for initial or continuation approvals; include any drug‑specific initial-duration documentation if required (e.g., short initial courses shown elsewhere).
- Expect Plan Year as the usual coverage duration for many drugs
- Follow drug-specific initial duration when specified (see individual drug entry)
HRM prior authorization
High‑Risk Medication (HRM) PAs apply when cumulative therapy exceeds the stated days per year and/or for patients aged 65 or older; prescriber must acknowledge that benefits outweigh risks and document required alternative trials or contraindications.
- Prescriber acknowledgement that benefit outweighs risk for patients ≥65
- PA applies when cumulative therapy exceeds specified limits (commonly >30 days/year; some agents >90 days/year)
- Document trials/intolerance/contraindication to non‑HRM alternatives as required
Specialty biologics prior authorization (HUMIRA example)
Specialty biologic agents (e.g., HUMIRA) require prior authorization and submission of indication‑specific supporting information, including prerequisite therapy trials or intolerance documentation where listed.
- Document prior therapy trials or reasons for intolerance/contraindication for new starts
- Provide indication‑specific clinical information per drug entry
Imatinib-related requirements (diagnostic confirmation)
For imatinib and related kinase inhibitor requests, document inability to use imatinib tablets when applicable and provide diagnostic confirmation (Philadelphia chromosome/BCR‑ABL) for CML/Ph+ ALL as required.
- Confirm Philadelphia chromosome or BCR‑ABL gene for CML/Ph+ ALL
- Document intolerance or inability to use imatinib tablets when claimed
Lidocaine patches coverage
Lidocaine patches are prior‑authorization listed for pain associated with diabetic neuropathy and cancer‑related neuropathy; include indication documentation when requesting PA.
- Document indication: diabetic neuropathy or cancer‑related neuropathy (including treatment‑related neuropathy) as applicable
IVIG documentation and thresholds
IVIG requests must include indication‑specific IgG laboratory values or timing after transplant per policy thresholds (e.g., serum IgG <500 mg/dL for CLL; <400 mg/dL within 100 days post‑BMT).
- For CLL: submit serum IgG < 500 mg/dL or history of recurrent bacterial infections
- For BMT/HSCT within first 100 days: submit serum IgG < 400 mg/dL or other transplant timing rationale
Lidocaine patches (PA requirement)
Lidocaine patches require prior authorization for the indicated pain conditions and should be submitted under the designated PA group with supporting indication documentation.
Lumizyme prior authorization (Pompe disease diagnostic confirmation)
Lumizyme prior authorization requires documentation confirming Pompe disease diagnosis by acid alpha‑glucosidase (GAA) enzyme assay or genetic testing.
- Submit GAA enzyme assay results or genetic testing demonstrating pathogenic variants consistent with Pompe disease
Segment PA note — many drugs require PA with specific documentation
This PA segment includes numerous drugs that require prior authorization with drug‑specific documentation; review each listed drug row and submit the required clinical information for the requested agent.
OGSIVEO PA requirement
OGSIVEO requires prior authorization for its FDA‑approved indications; submit the specified required clinical information for the drug's PA group.
ONTRUZANT PA requirement
ONTRUZANT requires prior authorization for listed HER2‑positive oncology indications; include tumor HER2 status and any indication‑specific combination or prior therapy documentation per the entry.
- Provide HER2‑positive / HER2‑amplified documentation and any required companion diagnostic results
- Document combination therapy or prior HER2 inhibitor exposure where applicable
PREVYMIS PA requirement (CMV prophylaxis — serostatus & transplant type)
PREVYMIS prior authorization for CMV prophylaxis requires documentation of CMV serostatus and transplant type: HSCT recipients must be CMV‑seropositive allogeneic HSCT recipients; kidney prophylaxis requires CMV‑seronegative high‑risk kidney transplant recipients.
- HSCT prophylaxis: patient CMV‑seropositive AND recipient of an allogeneic HSCT
- Kidney transplant prophylaxis: patient CMV‑seronegative AND high‑risk kidney transplant recipient
Prior authorization required — drug-specific (general reminder)
Reminder: prior authorization is required for the drugs and indications listed throughout this document; approvals require submission of the required medical information, prerequisite therapy status, and indicated coverage duration per drug row.
Coverage duration notes (initial vs continuation examples)
Some drugs have defined initial durations that differ from continuation durations (for example, certain agents specify short initial courses); check the drug row for any initial‑vs‑continuation duration requirements and submit initial‑period justification when requested.
- Examples: SAPROPTERIN initial: 2 months (see entry); many agents list Plan Year for continuation
PA required for listed agents (segment reminder)
Prior authorization is required for the agents listed in this segment; ensure submission includes any required tumor mutation, diagnostic testing, prior therapy trials, or age‑limit documentation indicated for the drug and indication.
Tetrabenazine PA requirement
Tetrabenazine initial authorization requires documentation of inadequate response or intolerability to deutetrabenazine and clinical evaluation (e.g., AIMS) for tardive dyskinesia or characteristic motor features for chorea.
- Submit evidence of failure/intolerance to deutetrabenazine
- Provide clinical exam or structured assessment (e.g., AIMS or DISCUS) documenting disease severity
Testosterone enanthate PA
Testosterone enanthate initial PA requires at least two confirmed low morning serum total testosterone concentrations per reference range or guidelines for primary or hypogonadotropic hypogonadism; continuation requires a confirmed low morning testosterone prior to therapy.
- Initial: ≥2 low morning serum total testosterone measurements
- Continuation: documentation of a low morning serum total testosterone prior to starting therapy
TRIKAFTA PA guidance
TRIKAFTA prior authorization requires that the drug not be used concomitantly with other CFTR potentiators (e.g., ivacaftor) and documents age ≥2 years for eligible patients.
- Do not combine with other CFTR potentiators
- Confirm patient age ≥ 2 years
PAH agents PA (Treprostinil, Uptravi etc.)
PAH agents (e.g., treprostinil, selexipag/Uptravi) require prior authorization for new starts with right heart catheterization confirmation and documentation of pretreatment hemodynamic thresholds as stated for WHO Group 1 PAH.
- Provide right heart catheterization confirming PAH
- Include pretreatment mPAP >20 mmHg, PCWP ≤15 mmHg, and PVR ≥3 Wood units (for adults when required)
VOQUEZNA PAK PA (H. pylori treatment rules)
VOQUEZNA PAK prior authorization for H. pylori requires proof or strong suspicion that infection is caused by susceptible bacteria based on culture/susceptibility or local epidemiology; therapy duration is 14 days.
- Provide culture/susceptibility or local epidemiology support for susceptible H. pylori
- Duration of therapy: 14 days
XDEMVY requires PA
XDEMVY is listed as requiring prior authorization; submit the requested drug's PA group documentation per the entry.
XIFAXAN requires PA
XIFAXAN prior authorization requires indication‑specific prerequisite therapy and duration documentation (e.g., IBS‑D and SIBO courses, hepatic encephalopathy recurrence reduction), and follow the specified course lengths.
- IBS‑D/SIBO: document prior course history and adherence to 14‑day course rules
- HE recurrence reduction: duration and indication per entry (e.g., 6 months for HE recurrence reduction)
ZTALMY requires PA
ZTALMY requires prior authorization and has an age restriction documented (approved for patients 2 years of age or older); include age documentation when requesting PA.
- Confirm patient age ≥ 2 years
Prerequisite therapy / failure requirements — general
Many drugs require evidence of prior trials, inadequate response, intolerance, or contraindication to specified alternatives before approval; provide documentation of prior therapy trials and reason for failure or intolerance.
- Document specific prior agents tried, durations, and clinical outcome (inadequate response, intolerance, or contraindication)
- Reference the drug row for exact comparator lists required
Step therapy / prior trial requirements — general
Step therapy: many agents require documented prior trials of one or more specified alternatives (examples include psoriasis, psychiatric, and anticonvulsant agents); include dates, agents, and reasons for failure/intolerance on the PA submission.
- Provide dates and duration of prior trials and clinical rationale for failure/intolerance
- Follow indication‑specific comparator lists in the drug entry
Step therapy / required trials — anticonvulsant and antipsychotic examples
Several anticonvulsant and antipsychotic agents require prior trials of specified generic agents and, in some cases, failure/intolerance to listed branded alternatives; include prior medication names and documented treatment outcomes.
- List generic anticonvulsants tried and outcomes for seizure indications
- For antipsychotics, document trials of required generic and brand alternatives or inability to swallow oral formulations if applicable
Step/alternative therapy requirements (HRM examples)
For High‑Risk Medication (HRM) entries, prior trials of specified non‑HRM alternatives are required (e.g., amantadine for EPS); prescriber must acknowledge benefit vs risk and document alternative trial outcomes.
- Document trial and failure/intolerance to required non‑HRM alternatives (name agents and dates)
- Prescriber acknowledgement that benefits outweigh risks for patients ≥65
Trial of alternatives required — general
When alternatives are required, submit documentation of trials and clinical rationale for failure or intolerance to those alternatives (commonly two alternative agents for specified indications).
- Provide dates and outcomes for each alternative tried
- State clinical reason for not using an alternative if claiming contraindication
Kineret prerequisite therapy
Kineret initiation for moderately to severely active rheumatoid arthritis requires inadequate response/intolerance/contraindication to two listed products prior to starting therapy; include prior therapy details in the PA.
- Document trials and outcomes for the two required comparator products
Lorlatinib prerequisite therapy
Lorlatinib (LORBRENA) prior authorization for recurrent/advanced ALK‑positive NSCLC requires prior use or intolerance to alectinib (Alecensa) or brigatinib (Alunbrig); include prior ALK inhibitor history.
- Provide prior ALK inhibitor therapy details (agent, dates, reason for discontinuation)
HER2 agents prerequisite therapy
HER2‑targeted oncology agents may require prior HER2 inhibitor exposure or specific combination therapy per tumor type; include prior therapy history and tumor molecular status when requesting PA.
- Document prior HER2 inhibitor exposure or rationale for starting the requested HER2 agent
- Provide tumor HER2 status and any required companion molecular testing
Psychiatric step/failure requirements
Many psychiatric drug entries require documented prior failure, intolerance, or contraindication to specified generic and/or brand alternatives before approval; include those prior treatment details in the PA submission.
- List prior psychiatric medications tried with dates and reasons for failure/intolerance
- If unable to swallow oral formulations, document reason
Step therapy / prerequisite therapy — biologics examples
Biologics often require prerequisite therapy for new starts (e.g., methotrexate co‑therapy or failure of conventional systemic agents); confirm and document prior use or contraindications to required agents per the drug entry.
- Provide prior conventional systemic therapy trials (names, durations, outcomes)
- Document any contraindications to required concomitant agents (e.g., methotrexate)
Prior therapy requirements — oncology and other examples
Certain oncology and other specialty agents require documentation of prior therapies, line‑of‑therapy status, or specific mutation testing before approval; include test reports and prior regimen history with the PA.
- Attach molecular test reports (e.g., RET, BRAF V600E, MET exon 14) when required
- Provide prior systemic therapy history and progression details
Trintellix step therapy
Trintellix prior authorization for MDD requires documentation of inadequate response, intolerance, or contraindication to one of the listed generic antidepressants; include prior antidepressant trial details.
- Document which generic antidepressant(s) were tried and the clinical outcome
Prerequisite therapy / failure required — multiple examples
Multiple drugs require documented inadequate response, intolerance, or contraindication to specified prior agents before approval; ensure PA submissions include explicit prior treatment timelines and outcomes.
Required supporting clinical information (general)
Submit all required supporting clinical information listed in the drug entry (diagnostic confirmation, prior therapy history, lab/genetic testing, and structured assessment tools where specified).
- Include diagnostic test results (e.g., right heart cath, enzyme assays, mutation testing) when required
- Provide prior therapy trial dates, agents, and reasons for failure/intolerance
HAE required documentation
HAE drug requests require laboratory confirmation of C1‑INH deficiency/dysfunction or documentation of HAE with normal C1‑INH (including specified genetic testing or family history) and prescriber specialty (immunologist/allergist/rheumatologist) or consult.
- Provide C1‑INH laboratory test results or genetic testing for F12, ANGPT1, PLG, KNG1, HS3ST6, or MYOF as applicable
- Indicate prescriber is an immunologist/allergist/rheumatologist or include specialist consult
PAH required documentation
PAH prior authorization submissions must include right heart catheterization results confirming PAH and the pretreatment hemodynamic values (mPAP, PCWP, and, when required for adults, PVR) per policy thresholds.
- Include right heart catheterization report with pretreatment mPAP, PCWP, and PVR (if required)
- If requesting after ambrisentan failure/intolerance, document prior therapy details
Oncology required documentation
Oncology PA submissions must include disease stage, relevant molecular testing (e.g., RET, BRAF V600E, MET exon 14), and prior systemic therapy history including number and type of prior regimens when required by the drug entry.
- Attach pathology and molecular diagnostic reports supporting targetable mutations
- Provide prior systemic therapy lines and dates
Gaucher disease testing
For Gaucher disease therapies, include enzyme assay or genetic testing confirming beta‑glucocerebrosidase deficiency; for CERDELGA also provide CYP2D6 metabolizer status when required.
- Submit enzyme assay or genetic test confirming Gaucher disease
- Provide CYP2D6 metabolizer status for CERDELGA
HCV required pretreatment documentation
HCV treatment PAs must include HCV RNA confirmation prior to starting therapy, planned regimen, genotype, prior treatment history, cirrhosis status, HIV coinfection status, and any resistance‑associated substitutions as applicable.
- Provide HCV RNA result, genotype, planned regimen, and cirrhosis status (CTP class if applicable)
- Document prior antiviral treatment history and transplant status if applicable
IPF diagnostic documentation
IPF new‑start requests must document exclusion of other causes of pulmonary fibrosis and provide HRCT pattern results or lung biopsy/multidisciplinary discussion supporting a UIP or alternative pattern as specified.
- Attach HRCT report showing UIP or non‑UIP pattern and biopsy or multidisciplinary discussion if biopsy not performed
- Document exclusion of other causes of pulmonary fibrosis
Required medical information — seizures
For seizure‑related PA requests, document prior inadequate response/intolerance/contraindication to required generic anticonvulsants and named branded comparators (e.g., Aptiom, Xcopri, Spritam) per indication.
- List prior anticonvulsant trials with dates and outcomes
- Specify which required branded comparators were tried and reasons for failure/intolerance
Required medical information — Hadlima
Hadlima requests must include documentation of prior inadequate response/intolerance or contraindication to specified prior therapies (e.g., methotrexate, prior biologics, phototherapy) per indication.
- Document prior MTX, biologic DMARD, or other comparator trials as required by indication
Required documentation — Tasimelteon
Tasimelteon PA must include confirmed diagnosis for Non‑24 (total blindness in both eyes unable to perceive light) or Smith‑Magenis syndrome, and for continuation document objective improvement in sleep measures.
- For Non‑24: confirm total blindness in both eyes and inability to perceive light
- For continuation: document increased total nighttime sleep or decreased daytime naps (Non‑24) or improved sleep quality (SMS)
Required documentation — HRM classes (65+)
For HRM PAs in patients aged 65+, prescriber must acknowledge that benefit outweighs risk and document prior trials or contraindications to specified non‑HRM alternatives and any concomitant anticholinergic/CNS‑active medications.
- Prescriber acknowledgement of benefit vs risk for the older adult
- Document trials or contraindications to non‑HRM alternatives
- List concomitant anticholinergic or CNS‑active medications if present and justify combined use
Prescriber acknowledgement and concomitant medication documentation (HRM)
When prescribing HRM agents, the prescriber must acknowledge benefit outweighs risks and document any concomitant anticholinergic or CNS‑active medications and justification for combined use.
- Prescriber signed acknowledgement
- List and justify concomitant medications that increase anticholinergic or CNS burden
ICATIBANT required testing
For icatibant PA, provide laboratory confirmation of HAE subtype (C1‑INH deficiency/dysfunction or HAE with normal C1‑INH with required genetic testing or family history) as specified in the entry.
- Submit C1‑INH functional/antigen testing or required genetic test results
Kinase inhibitor diagnostics and prior therapy
Kinase inhibitor PA submissions must include mutation status (BCR‑ABL, Philadelphia chromosome, c‑KIT, RET, MET, etc.) and prior therapy history/failure or intolerance to prior kinase inhibitors where required.
- Attach mutation testing reports (e.g., BCR‑ABL, c‑KIT, RET, MET exon 14) when relevant
- Document prior kinase inhibitor therapies and reasons for discontinuation
Diagnostic confirmation (CML/Ph+ ALL)
For CML or Philadelphia chromosome–positive ALL, diagnostic confirmation by detection of the Philadelphia chromosome or BCR‑ABL gene is required with PA submissions.
- Provide cytogenetic or molecular test confirming Philadelphia chromosome/BCR‑ABL
Pompe disease diagnostic confirmation (Lumizyme)
Pompe disease (Lumizyme) PA must include diagnostic confirmation by GAA enzyme assay or genetic testing demonstrating acid alpha‑glucosidase deficiency.
- Submit GAA enzyme assay or genetic testing confirming Pompe disease
PA required before filling (denial risk)
Many drug requests require PA before filling; failure to obtain PA from HMSA Akamai Advantage (PPO) prior to dispensing may result in denial of coverage.
HAE diagnostic confirmation and prescriber specialty (denial risk)
HAE requests may be denied if laboratory confirmation of the HAE subtype is not provided or if the prescriber specialty requirement (immunologist/allergist/rheumatologist) is not met or documented.
PAH diagnostic hemodynamics (denial risk)
PAH requests risk denial if right heart catheterization pretreatment hemodynamics (mPAP >20 mmHg, PCWP ≤15 mmHg, PVR ≥3 Wood units when required) are not documented.
CYP3A4 inhibitor contraindication (denial risk)
Coverage will be denied for ergot/ergotamine therapies when used with potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin); do not submit PA for concurrent use.
- Do not combine with potent CYP3A4 inhibitors
Part D denial when other Parts cover (denial risk)
Medicare Part D coverage will be denied when the medication or its administration is properly covered under Medicare Part A or Part B for the individual; provide setting/use details when requested to determine correct coverage part.
Age restriction for HRM drugs (denial risk)
PA for HRM entries applies only to patients 65 years of age or older; requests for younger patients or those not meeting age criteria risk denial unless the drug row specifies otherwise.
RETEVMO denial risk if tumor not RET fusion‑positive
Requests for RETEVMO in NSCLC risk denial if the tumor is not RET fusion–positive or if disease does not meet the recurrent/advanced/metastatic criteria required by the policy.
CPP and BPH denial risks (age and prior therapy)
For CPP and BPH indications, PA requests may be denied if age criteria or prior therapy requirements are not met (e.g., BPH tadalafil requires inadequate response/intolerance/contraindication to BOTH an alpha blocker and a 5‑ARI).
- CPP: confirm age cutoffs (female <12, male <13) and bone age assessment as required
- BPH (tadalafil): document failure/intolerance/contraindication to an alpha blocker and a 5‑ARI
Key Clinical Thresholds and Diagnostic Criteria
Quantity and Duration Limits
Policy Background and Scope
Background: This document enumerates prescription drugs that require prior authorization from HMSA Akamai Advantage (PPO) and summarizes the clinical and administrative criteria used to determine medical necessity. It covers multiple therapeutic areas (oncology, pulmonary hypertension, autoimmune disease, rare genetic disorders, infectious disease, neurology, and others) and includes indications, prerequisite therapies, required diagnostic testing, exclusions, and coverage durations.
The policy requires prescribers, members, or appointed representatives to request prior authorization by calling HMSA (contact details are provided in the full policy). Reviewers should apply indication‑specific criteria such as diagnostic confirmation, mutation testing, prior therapy trials, age limits, and site‑of‑care considerations described in each drug entry when adjudicating requests.
Definitions and Diagnostic Confirmations
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