HMSA Pharmacy & Specialty Drugs Prior Auth Policy

Selected oncology and specialty drug criteria

Coverage is provided when the listed drug-specific criteria are met as specified in the chart.

Abiraterone (abiraterone acetate): The requested drug will be used in combination with a gonadotropin-releasing hormone (GnRH) analog or after bilateral orchiectomy for node-positive (N1), non-metastatic (M0) or very-high-risk/non-metastatic high-risk prostate cancer or PSA persistence/recurrence after radical prostatectomy.

All FDA-approved and some medically-accepted indications included.

PAH criteria

Pulmonary arterial hypertension (PAH) and related agents — coverage requirements

PAH diagnostic confirmation: PAH must be confirmed by right heart catheterization; for new starts pretreatment mean pulmonary arterial pressure (mPAP) >20 mmHg AND pulmonary capillary wedge pressure (PCWP) ≤15 mmHg AND pulmonary vascular resistance (PVR) >2 Wood units (≥3 Wood units required for certain agents).mean PAP >20 mmHg; PCWP ≤15 mmHg; PVR >2 (or ≥3) Wood units

Applies to multiple PAH agents (e.g., Adempas, ambrisentan, bosentan, OPSUMIT, UPTRAVI, treprostinil).

ITP / severe AA criteria

Immune thrombocytopenia (ITP) and severe aplastic anemia (AA) criteria for thrombopoietic agents

ITP new starts: Patient experienced inadequate response or intolerance to prior therapy (e.g., corticosteroids or IVIG) AND untransfused platelet count prior to initiation <30,000/mcL OR 30,000–50,000/mcL with symptomatic bleeding or bleeding risk factors (e.g., planned procedure, anticoagulation, comorbidity, high bleeding risk).Platelet count <30,000/mcL OR 30,000–50,000/mcL with bleeding/risk factors

Continuation criteria specify platelet response targets (current plt ≤200,000/mcL or dosing adjusted if 200k–400k/mcL).

Severe AA new starts: Patient had an insufficient response to immunosuppressive therapy prior to initiating therapy for severe aplastic anemia.

Continuation criteria include specified platelet count ranges and APR/IPR definitions.

Oncology mutation-specific coverage

Targeted oncology therapies — mutation and prior-therapy requirements

Ayvakit (avapritinib) — myeloid/lymphoid neoplasms with eosinophilia: Disease is FIP1L1–PDGFRA rearrangement–positive AND harbors PDGFRA D842V mutation AND disease is resistant to imatinib (or for GIST: PDGFRA exon 18 mutation including D842V OR failure of ≥2 FDA-approved therapies).

Genetic/mutation testing required.

Balversa (erdafitinib) — urothelial carcinoma: Tumor harbors susceptible FGFR3 genetic alterations AND requested use is as subsequent therapy for locally advanced/recurrent/metastatic or stage II–IV recurrent/persistent bladder cancer.

Genetic testing required.

Braftovi / Mektovi (encorafenib ± binimetinib) — BRAF-targeted uses: Tumor is positive for BRAF V600 (or other activating V600) mutation AND requested use is for advanced/recurrent/unresectable disease or adjuvant setting as specified; combination use required for some tumor types (e.g., with binimetinib in NSCLC).

Mutation confirmation required and prior-therapy rules per indication.

Neurology criteria

Neurology and symptom-confirmation requirements

Amphetamine-class agents: Patient has a diagnosis of attention-deficit hyperactivity disorder (ADHD) OR a diagnosis of narcolepsy confirmed by sleep study (for narcolepsy).

Applies to amphetamine/dextroamphetamine products.

Briviact / Zonisade / other anticonvulsants — adjunctive/monotherapy criteria: For partial-onset (focal) seizures: inadequate response, intolerance, or contraindication to a generic anticonvulsant AND inadequate response/intolerance/contraindication to specified named alternatives (e.g., Aptiom, Xcopri, Spritam) unless swallowing difficulty documented.

Age and specific comparator requirements apply per product.

Modafinil / narcolepsy/idiopathic hypersomnia criteria: Diagnosis confirmed by sleep lab evaluation and diagnostic criteria (e.g., MSLT, total 24-hour sleep time, exclusion of other causes); continuation requires decreased daytime sleepiness from baseline.

Applies to modafinil and related daytime-sleepiness agents.

Dupixent: Indication-specific initial and continuation criteria

Dupixent is covered when indication-specific clinical criteria are met.

Atopic dermatitis — initial therapy: Patient has moderate-to-severe disease AND inadequate response or intolerance to a topical corticosteroid or topical calcineurin inhibitor, OR topical corticosteroids and topical calcineurin inhibitors are not advisable.

Continuation requires maintained or improved clinical response.

Atopic dermatitis — continuation: Patient achieved or maintained a positive clinical response on therapy.

Oral-corticosteroid–dependent asthma — initial: Inadequate asthma control despite high-dose inhaled corticosteroid AND an additional controller (unless intolerant/contraindicated).

Moderate-to-severe eosinophilic asthma — initial: Baseline blood eosinophils >=150 cells/µL AND inadequate control despite medium-to-high-dose inhaled corticosteroid AND an additional controller (unless intolerance/contraindication).

Cosentyx: New-start coverage criteria

Coverage for Cosentyx for new starts requires disease severity and prior therapy failure or intolerance per indication.

Plaque psoriasis (new starts): At least 3% body surface area affected OR crucial body areas involved AND inadequate response, intolerance, or contraindication to specified biologic/targeted products or prior systemic/phototherapy as required.>=3% BSA

Per policy, severe disease (>=10% BSA or crucial areas) may justify biologic first-line.

Ankylosing spondylitis (new starts): Inadequate response, intolerance, or contraindication to specified alternatives (e.g., TNF inhibitors, others listed).

Non-radiographic axial spondyloarthritis (new starts): Inadequate response to an NSAID OR intolerance/contraindication to NSAIDs.

Psoriatic arthritis (adult new starts):

Cabometyx: Oncology-specific PA criteria

Cabometyx covered for multiple oncology indications when disease stage and prior therapy conditions are met.

Renal cell carcinoma: Disease is advanced, relapsed, or stage IV (including brain metastases).

Non-small cell lung cancer (RET+): Tumor is RET-positive AND disease is recurrent, advanced, or metastatic.

Hepatocellular carcinoma: Requested drug used as subsequent therapy after prior lines per indication.

GIST: Residual/unresectable/recurrent/metastatic disease AND progression after at least two FDA-approved therapies.

Differentiated thyroid cancer:

CARBAGLU: Diagnostic confirmation

Coverage for CARBAGLU requires diagnostic confirmation.

NAGS deficiency: Diagnosis confirmed by enzymatic, biochemical, or genetic testing prior to authorization.

Required documentation: enzymatic/biochemical/genetic confirmation.

DARAPRIM: Indication-specific requirements

DARAPRIM coverage tied to TMP-SMX intolerance and CD4 thresholds for prophylaxis.

Primary toxoplasmosis and PCP prophylaxis: Intolerance or contraindication to trimethoprim-sulfamethoxazole (TMP-SMX) AND a recent CD4 cell count <200 cells/mm3 (within past 3 months).CD4 <200 cells/mm3

Coverage durations vary by indication (e.g., 3–6 months per policy).

Secondary toxoplasmosis prophylaxis: CD4 count <200 cells/mm3 within past 6 months as specified for secondary prophylaxis.CD4 <200 cells/mm3

Cystoisosporiasis treatment/prophylaxis: Intolerance or contraindication to TMP-SMX and meeting CD4 criteria where applicable per indication.

Doptelet: Platelet count-based coverage criteria

Doptelet covered for specific platelet thresholds and response criteria depending on indication.

Chronic liver disease — procedure support: Untransfused platelet count prior to a scheduled procedure is <50,000/mcL.<50,000/mcL

Coverage duration: 1 month for procedure indication.

Chronic ITP (new starts): Inadequate response or intolerance to prior therapy (e.g., corticosteroids or IVIG) AND untransfused platelet count <30,000/mcL OR 30,000–50,000/mcL with symptomatic bleeding or bleeding risk factors.<30,000/mcL or 30–50k with bleeding/risk

Initial approval durations apply per indication.

ITP continuation/reauthorization: Current platelet count is ≤200,000/mcL OR is >200,000 and ≤400,000/mcL with dose adjustment to avoid clinically important bleeding.

Dupixent — Atopic dermatitis initial therapy

Covered when ALL of the following are met

Dupixent AD initial criteria: 1) Patient has moderate-to-severe disease; AND 2) Patient had an inadequate response to either a topical corticosteroid or topical calcineurin inhibitor, OR topical corticosteroids and topical calcineurin inhibitors are not advisable for the patient.

Initial approval durations vary by indication (AD initial: 4 months).

Dupixent — Eosinophilic esophagitis (EoE) initial therapy

Covered when ALL of the following are met

Dupixent EoE initial criteria: 1) Diagnosis confirmed by esophageal biopsy with >=15 intraepithelial esophageal eosinophils per high power field; AND 2) Patient exhibits clinical manifestations (e.g., dysphagia); AND 3) Patient weighs at least 15 kg; AND 4) Patient experienced an inadequate response, intolerance, or has a contraindication to a topical corticosteroid.>=15 eos/hpf; weight >=15 kg

Continuation requires maintained positive clinical response.

Fasenra — Severe asthma initial therapy

Covered when ALL of the following are met

Fasenra severe asthma initial criteria: 1) Either a) baseline blood eosinophil count >=150 cells/µL OR b) patient is systemic corticosteroid-dependent; AND 2) Severe asthma despite medium-to-high-dose inhaled corticosteroid AND an additional controller (LABA, LAMA, leukotriene modifier, or sustained-release theophylline) unless intolerant/contraindicated.>=150 cells/µL

Continuation requires demonstrated improvement in control or reduction in oral steroid dose.

Ergotamine — migraine indication

Covered when ALL of the following are met

Ergotamine (migraine) criteria: Patient has experienced inadequate response, intolerance, or contraindication to at least one triptan (5‑HT1 agonist).

Use with potent CYP3A4 inhibitors is a coverage denial—requests will be denied if coadministered with agents like ritonavir, nelfinavir, indinavir, erythromycin, or clarithromycin.

EPCLUSA — Hepatitis C virus treatment

Coverage consistent with guidance

EPCLUSA (sofosbuvir/velpatasvir) HCV criteria: HCV infection confirmed by presence of HCV RNA in serum prior to treatment; planned regimen, genotype, prior treatment history, cirrhosis status (compensated/decompensated), HIV coinfection status, resistance-associated substitutions when applicable, and transplant status must be provided. Coverage and durations follow current AASLD‑IDSA guidance.HCV RNA confirmation

Documentation required per policy.

Erivedge — adult medulloblastoma

Covered when ALL of the following are met

Erivedge — adult medulloblastoma: Patient received prior systemic therapy AND tumor(s) have mutations in the sonic hedgehog pathway.

Documentation of prior systemic therapy and tumor mutation required.

Everolimus — specified oncology and rare indications

Covered when ALL of the following are met

Everolimus covered indications: Indications include classic Hodgkin lymphoma, thymomas/thymic carcinomas, previously treated Waldenstrom's macroglobulinemia, specified soft tissue sarcomas, gastrointestinal stromal tumors, certain neuroendocrine tumors, thyroid carcinoma, endometrial carcinoma, uterine sarcoma, breast cancer in combination regimens, histiocytic neoplasms, meningiomas — specific per‑indication criteria apply.

Indication-specific documentation required per policy.

Growth hormone — pediatric GHD, Turner syndrome, SGA

Covered when specified diagnostic thresholds are met

Pediatric growth hormone criteria (GHD, Turner, SGA): Pediatric GHD: neonatal diagnosis OR specific age, height and growth velocity criteria AND failed two GH stimulation tests (peak <10 ng/mL) OR pituitary/CNS disorder with low IGF‑1. Turner syndrome: confirmed by karyotype AND pre‑treatment height <5th percentile. SGA: birth weight <2500 g at GA >37 weeks OR birth wt/length <3rd percentile or ≥2 SD below mean and no catch‑up growth by age 2 (SGA therapy age ≥2 years).failed GH stim tests (peak<10 ng/mL); birth wt <2500 g (SGA)

Prescriber specialty guidance and age limits apply.

Growth hormone-related indications (Genotropin and similar)

Covered when the listed clinical criteria for pediatric/adult growth hormone deficiency, Turner syndrome, and small for gestational age are met.

Adult and pediatric GH-related indications: Adult GHD: failed two GH stimulation tests OR IGF‑1 >2 SD below mean with failed stimulation OR organic hypothalamic‑pituitary disease with ≥3 pituitary hormone deficiencies OR genetic/structural defects OR childhood‑onset GHD with congenital abnormality. Continuation requires evidence of improvement.failed stimulation tests or IGF‑1 thresholds

Documentation required; specialist involvement recommended.

Hereditary angioedema (HAE) agents

Coverage for prophylaxis or treatment of HAE when laboratory confirmation and additional genetic or clinical criteria are met.

HAEGARDA prophylaxis: Laboratory confirmation of HAE subtype: C1 inhibitor deficiency/dysfunction OR HAE with normal C1 inhibitor confirmed by lab testing AND either positive mutation in specified genes OR family history with refractory symptoms to high‑dose antihistamine trial ≥1 month; age ≥6 years; prescriber specialty required.age >=6 years

Prescribed by or in consultation with immunologist/allergist/rheumatologist.

Icatibant (acute HAE attack): Laboratory-confirmed HAE subtype as above OR HAE with normal C1‑INH plus genetic/family‑history criteria; prescriber specialty required; age ≥18 years for icatibant.age >=18 years

Acute attack treatment criteria apply.

Humira (adalimumab) indications and prior therapy requirements

Coverage for specified inflammatory and autoimmune indications when prior therapy requirements are met for new starts.

Rheumatoid arthritis (moderate–severe, new starts): Inadequate response, intolerance, or contraindication to methotrexate OR inadequate response/intolerance to a prior biologic DMARD or targeted synthetic DMARD; combination therapy documentation may be required.

May require use with MTX or leflunomide or documentation of intolerance/contraindication.

Ankylosing spondylitis / non-radiographic axial spondyloarthritis (new starts): Inadequate response or intolerance to an NSAID OR contraindication to NSAID trial (per indication).

Plaque psoriasis (moderate–severe, new starts): >=3% BSA or crucial body areas affected AND inadequate response/intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) OR contraindication to those agents OR severe disease (>=10% BSA or crucial areas) justifying biologic first‑line.BSA >=3% (or >=10% for severe)

Ibrance (palbociclib) selective criteria

Coverage for breast cancer when disease and prior therapy/resistance criteria are met.

IBRANCE (palbociclib) — HR+ HER2- advanced/recurrent/metastatic breast cancer: Disease is advanced/recurrent/metastatic AND hormone receptor–positive and HER2‑negative AND meets ONE of: a) requested use with an aromatase inhibitor or fulvestrant AND patient had intolerable adverse event to Kisqali (ribociclib) or Verzenio (abemaciclib) or has contraindication to both; OR b) endocrine‑resistant, PIK3CA‑mutated and requested use with inavolisib and fulvestrant.

Documentation of prior adverse events, resistance, or mutation status required.

Hypnotics and insomnia (HRM group)

PA for eszopiclone, zaleplon, zolpidem tartrate in older adults and for long-duration use.

Hypnotics (HRM) — insomnia criteria: Patient has contraindication to doxepin 3 mg or 6 mg OR tried doxepin with inadequate response/intolerance; prescriber acknowledges benefits outweigh risks; if patient uses two or more additional CNS‑active meds, prescriber documents medical necessity. Applies to patients ≥70 years and to cumulative >90 days/year use.Applies to patients >=70 years; >90 cumulative days/year triggers PA

Prescriber must document necessity given HRM risk profile in older adults.

IBRANCE - breast cancer (initial/coverage criteria)

Covered when ALL of the following are met for HR+ HER2- advanced/recurrent/metastatic breast cancer:

IBRANCE breast cancer criteria (detailed): 1) Disease is advanced, recurrent, or metastatic; AND 2) Patient has HR‑positive and HER2‑negative disease; AND 3) Patient meets ONE of: a) requested drug will be used with an aromatase inhibitor or fulvestrant AND patient experienced an intolerable adverse event to Kisqali or Verzenio OR has contraindication to both; OR b) patient is endocrine‑resistant, PIK3CA‑mutated AND requested drug will be used with inavolisib and fulvestrant.

Prior intolerance or mutation documentation required.

ICATIBANT - hereditary angioedema

Covered when ALL of the following are met for acute HAE attacks:

ICATIBANT diagnostic options: HAE with C1‑inhibitor deficiency/dysfunction confirmed by laboratory testing OR HAE with normal C1‑INH confirmed by lab testing AND one of: a) positive test for specified gene mutations (F12, ANGPT1, PLG, KNG1, HS3ST6, MYOF), b) family history of angioedema and refractoriness to high‑dose antihistamine for ≥1 month. Prescriber must be or consult immunologist/allergist/rheumatologist; age ≥18 years.age >=18

Acute attack treatment criteria; documentation required.

ICLUSIG - hematologic and GIST indications

Covered when ANY of the following disease-specific criteria are met:

ICLUSIG — CML criteria: Accelerated or blast phase CML with no other kinase inhibitor indicated; OR chronic phase with resistance/intolerance to ≥2 prior kinase inhibitors including at least one of imatinib, dasatinib, or nilotinib; OR T315I mutation positive.

Indication‑specific mutation and prior therapy documentation required.

ICLUSIG — ALL criteria: Diagnosis confirmed by Philadelphia chromosome or BCR‑ABL gene detection for ALL indications.

ICLUSIG — GIST criteria: Residual, unresectable, recurrent, metastatic, or tumor rupture AND progression after at least two FDA‑approved therapies (e.g., imatinib, sunitinib, regorafenib, ripretinib).

IDACIO - indication-specific prior therapy requirements for adalimumab biosimilars

For new starts, covered when the following indication-specific prior therapy requirements are met:

IDACIO — rheumatoid arthritis (new starts): Inadequate response, intolerance, or contraindication to methotrexate OR inadequate response/intolerance to a prior biologic DMARD or targeted synthetic DMARD.

New starts only; similar prior‑therapy rules apply for other indications (psoriasis, ankylosing spondylitis, uveitis).

IDACIO — plaque psoriasis (new starts): At least 3% BSA or crucial body areas affected AND inadequate response/intolerance to phototherapy or methotrexate/cyclosporine/acitretin OR contraindication to those agents OR severe disease warranting biologic (>=10% BSA or crucial areas).BSA >=3%

Documentation required.

INBRIJA - initial and continuation criteria for off episodes in Parkinson's disease

Covered when ALL of the following are met for initial treatment of off episodes:

INBRIJA initial criteria: Patient is currently treated with oral carbidopa/levodopa AND patient does not have asthma, COPD, or other chronic underlying lung disease.

Continuation coverage requires documented improvement on therapy.

Itraconazole - required route and diagnostic confirmation

Covered when indication-specific documentation and route requirements are met:

Itraconazole route and testing: Requested drug will be used orally; for onychomycosis due to dermatophytes diagnosis must be confirmed by a fungal diagnostic test (KOH, culture, or nail biopsy); for allergic bronchopulmonary aspergillosis initiate with systemic corticosteroids.fungal diagnostic confirmation required

PA durations vary by indication (e.g., 12 months for disseminated/CNS histo; others 6 months).

LAZCLUZE — Indication-specific criteria

LAZCLUZE (lapatinib) covered when ALL of the following are met

Breast cancer criteria (LAZCLUZE): Disease is recurrent, advanced, or metastatic (including brain metastases) AND disease is HER2‑positive AND requested drug will be used in combination with an aromatase inhibitor, capecitabine, OR trastuzumab.

Colorectal cancer criteria (LAZCLUZE): Requested drug will be used in combination with trastuzumab AND patient has not had previous treatment with a HER2 inhibitor; tumor must be HER2‑amplified and RAS/BRAF wild‑type per colorectal criteria.

LENVIMA — Indication-specific criteria

LENVIMA (lenvatinib) covered when ALL of the following per-indication criteria are met

Differentiated thyroid cancer (LENVIMA): Disease not amenable to radioactive iodine therapy AND unresectable, locally recurrent, persistent, or metastatic disease.

Hepatocellular carcinoma (LENVIMA): Disease is unresectable or inoperable (local, metastatic or extensive liver tumor burden).

Endometrial carcinoma (LENVIMA + pembrolizumab): Disease is advanced, recurrent, or metastatic AND requested drug will be used in combination with pembrolizumab AND patient experienced progression following prior systemic therapy.

LUMIZYME — Diagnostic confirmation

LUMIZYME (alglucosidase alfa) covered when ALL of the following are met

Pompe disease confirmation (LUMIZYME): Diagnosis confirmed by enzyme assay demonstrating acid alpha‑glucosidase (GAA) deficiency OR by genetic testing prior to initiation.

Diagnostic confirmation required (enzyme assay or genetic testing).

LUPRON DEPOT-PED — CPP criteria

LUPRON DEPOT‑PED (for CPP) covered when ALL of the following are met

CPP diagnostic criteria for new therapy: Diagnosis confirmed by pubertal response to a GnRH agonist test OR pubertal level on a third‑generation LH assay AND bone age assessment supports CPP AND onset of secondary sexual characteristics occurred before age 8 (females) or before age 9 (males).

Age restriction: patient must be <12 yrs if female, <13 yrs if male for CPP indication.

BRAF-targeted therapy — mutation and indication criteria

MEKINIST / MEKTOVI (BRAF-targeted drugs) covered when ALL of the following are met

BRAF mutation requirement: Tumor is positive for a BRAF V600 activating mutation (e.g., V600E or V600K) prior to use.

Use scenarios and combination requirements vary by tumor type (e.g., combination with dabrafenib/encorafenib or binimetinib).

Use scenarios: Requested drug used as single agent or in combination for unresectable, metastatic, or adjuvant systemic therapy as specified per indication.

Mutation confirmation required.

MAVYRET — HCV coverage criteria

MAVYRET (hepatitis C) covered when ALL of the following are met

HCV confirmation: HCV infection confirmed by presence of HCV RNA in serum prior to starting treatment.HCV RNA confirmation

Planned regimen, genotype, prior treatment history, cirrhosis status, HIV coinfection, RAS where applicable, and transplant status must be provided; durations per AASLD‑IDSA guidance.

Required documentation: Provide planned regimen, genotype, prior treatment history, presence/absence of cirrhosis (CTP class), HIV coinfection status, resistance‑associated substitutions where applicable, and transplantation status; decompensated cirrhosis (CTP B or C) is an exclusion for some HCV agents as noted.

Coverage and duration consistent with current guidance.

OGIVRI — HER2 indication-specific criteria

OGIVRI (trastuzumab biosimilar) covered when ALL of the following are met for indication-specific uses

Colorectal cancer criteria (OGIVRI): For colorectal cancer: disease is HER2‑amplified and RAS and BRAF wild‑type AND requested drug used in combination with pertuzumab, tucatinib, or lapatinib AND patient has not had previous treatment with a HER2 inhibitor.

Documentation of HER2 amplification and RAS/BRAF wild‑type status required.

Hepatobiliary carcinoma criteria (OGIVRI): Disease is HER2‑positive AND requested drug used in combination with pertuzumab.

Endometrial cancer criteria (OGIVRI): Disease is HER2‑positive AND requested drug used in combination with paclitaxel and continued as single‑agent maintenance.

Neoadjuvant/other uses (OGIVRI): For all indications: patient had an intolerable adverse event to Trazimera and that adverse event was NOT attributed to the active ingredient per prescribing information when relevant for biosimilar interchange rules.

NITISINONE — HT-1 diagnostic confirmation

NITISINONE covered when ALL of the following are met

HT‑1 diagnostic confirmation (NITISINONE): Diagnosis of hereditary tyrosinemia type 1 confirmed by biochemical testing (e.g., detection of succinylacetone in urine) OR by DNA mutation analysis prior to initiating therapy.

Diagnostic confirmation required.

NUBEQA — combination therapy requirement

NUBEQA coverage condition

NUBEQA combination requirement: Requested drug will be used in combination with a gonadotropin‑releasing hormone (GnRH) analog or after bilateral orchiectomy as specified in prostate cancer indications.

Combination therapy documentation required.

NUPLAZID — diagnostic timing requirement

NUPLAZID coverage condition

NUPLAZID diagnostic timing requirement: For hallucinations and delusions associated with Parkinson's disease psychosis, the diagnosis of Parkinson's disease must have been made prior to onset of psychotic symptoms.

Documentation of PD diagnosis timing required.

NURTEC — acute and preventive criteria

NURTEC coverage conditions

NURTEC acute migraine: Patient experienced inadequate response, intolerance, or contraindication to one triptan (5‑HT1 receptor agonist) for acute migraine treatment.

NURTEC preventive continuation: Patient received at least 3 months of treatment with the requested drug and had a reduction in migraine days per month from baseline for continuation approval.3 months

Initial and continuation durations specified in policy.

OFEV — idiopathic pulmonary fibrosis diagnostic criteria

OFEV (nintedanib) new-start criteria

IPF diagnostic requirements (OFEV): For new starts: HRCT showing usual interstitial pneumonia (UIP) pattern OR HRCT non‑UIP supported by lung biopsy OR HRCT non‑UIP supported by multidisciplinary discussion between experienced radiologist and pulmonologist if no biopsy performed.

Documentation of HRCT and multidisciplinary review or biopsy required for new starts.

OGIVRI / ONTRUZANT oncology indications and exclusions

Covered when the following indication-specific conditions are met

OGIVRI / ONTRUZANT — HER2‑positive oncology indications: Indications include multiple HER2‑positive cancers (neoadjuvant/adjuvant and metastatic settings, leptomeningeal and brain metastases, esophageal/gastric, endometrial, hepatobiliary, HER2‑amplified colorectal with RAS/BRAF wild‑type, etc.); specific combination and prior‑treatment rules apply per indication.

Documentation of HER2 status, prior adverse event to biosimilar (where relevant), and combination regimen required.

OPSUMIT (PAH) requirements

Covered when ALL of the following are confirmed

OPSUMIT (PAH) requirements: PAH confirmed by right heart catheterization with pretreatment mean PAP >20 mmHg, PCWP ≤15 mmHg, and PVR ≥3 Wood units for new starts.mean PAP >20 mmHg; PCWP ≤15 mmHg; PVR ≥3 Wood units

Hemodynamic confirmation required for OPSUMIT new starts.

OJEMDA pediatric low-grade glioma

Covered for relapsed or refractory pediatric LGG when the following is documented

OJEMDA pediatric LGG: Tumor is positive for either a BRAF fusion/rearrangement OR a BRAF V600 mutation prior to use in relapsed/refractory pediatric low‑grade glioma.

Molecular tumor testing required for authorization.

Pimecrolimus (atopic dermatitis) criteria

Covered for mild to moderate atopic dermatitis when ONE of the following is met

Pimecrolimus criteria: Disease affects sensitive skin areas (face, genitals, skin folds) OR inadequate response/intolerance/contraindication to at least one first‑line therapy (e.g., medium or higher potency topical corticosteroid); prescribed for short‑term or non‑continuous chronic use.

Age >=2 years for pimecrolimus.

PROCRIT (erythropoiesis-stimulating agent) initial and reauthorization criteria

Covered when specified hematologic and treatment-response conditions are met

PROCRIT initial approval criteria: For initial approval (except anemia due to chemotherapy or MDS): adequate iron stores (e.g., TSAT ≥20%) AND pretreatment hemoglobin <10 g/dL AND no erythropoietin in prior month; for MDS: pretreatment serum erythropoietin ≤500 IU/L.Hgb <10 g/dL; TSAT >=20%; EPO <=500 IU/L for MDS

Reauthorization requires ≥12 weeks of therapy with response and current Hgb <12 g/dL for most uses.

PYZCHIVA (psoriasis) new start criteria

Covered for moderate to severe plaque psoriasis (new starts) when BOTH of the following are met

PYZCHIVA psoriasis new-start criteria: At least 3% BSA affected OR crucial body areas affected; AND inadequate response/intolerance/contraindication to phototherapy or methotrexate/cyclosporine/acitretin OR severe psoriasis warranting biologic as first‑line (≥10% BSA or crucial areas).BSA >=3% (>=10% for severe first‑line)

Documentation of BSA and prior therapy required.

Posaconazole oral use and age/weight requirements

Covered when administration route and patient weight/age criteria met

Posaconazole oral prophylaxis: Requested drug will be used orally; for prophylaxis of invasive Aspergillus and Candida infections patient weight must be >40 kg; age restrictions apply by indication.weight >40 kg

Coverage duration for posaconazole prophylaxis: 6 months.

RELISTOR injection criteria for opioid-induced constipation

Covered for opioid-induced constipation in chronic non-cancer pain when ONE of the following is met

RELISTOR injection criteria: Patient is unable to tolerate oral medications OR experienced inadequate response/intolerance to an oral drug indicated for opioid‑induced constipation (e.g., Movantik) OR has contraindication to an oral trial.

Coverage duration for injection: 4 months where indicated.

QINLOCK (GIST / melanoma) prior treatment requirements

Covered for specified indications when the following alternative therapy history or mutation status is present

QINLOCK — GIST prior therapy: For advanced/residual/unresectable/rupture/recurrent/progressive GIST: patient has received prior treatment with ≥3 kinase inhibitors including imatinib OR has progressed after avapritinib and dasatinib OR received imatinib and is intolerant to second‑line sunitinib.

Documentation of prior kinase inhibitor lines required.

QINLOCK — cutaneous melanoma criteria: Disease metastatic or unresectable AND KIT activating mutation positive AND requested drug used as subsequent therapy with prior progression/intolerance to BRAF‑targeted therapy as applicable.

Mutation testing required for melanoma KIT‑mutated cases.

REMICADE / RENFLEXIS biologic interchange and criteria

Covered for multiple autoimmune and inflammatory indications when indication-specific criteria and prior therapy conditions are met

REMICADE / RENFLEXIS — listed indications: Indications include Behcet's syndrome, hidradenitis suppurativa, juvenile idiopathic arthritis, pyoderma gangrenosum, sarcoidosis, Takayasu's arteritis, uveitis, and others as listed; indication‑specific prior therapy rules apply.

For biosimilar interchange: documentation of prior intolerable adverse event to a biosimilar and attribution assessment may be required.

RA new starts (REMICADE/RENFLEXIS): Requested drug used in combination with methotrexate or leflunomide OR intolerance/contraindication to both, AND inadequate response/intolerance/contraindication to methotrexate OR prior biologic/targeted synthetic DMARD.

Documentation of combination therapy or contraindication required.

Moderately to severely active rheumatoid arthritis (new starts)

Covered when ALL of the following are met:

Moderately to severely active rheumatoid arthritis (new starts): 1) Patient will use the requested drug in combination with methotrexate or leflunomide OR has intolerance/contraindication to both; AND 2) Patient has inadequate response, intolerance, or contraindication to methotrexate OR inadequate response/intolerance to a prior biologic DMARD or targeted synthetic DMARD.

Combination therapy documentation or intolerance proof required.

Moderate to severe plaque psoriasis (new starts)

Covered when ALL of the following are met:

Moderate to severe plaque psoriasis (new starts): 1) At least 3% BSA affected OR crucial body areas affected; AND 2) ANY of: inadequate response/intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin), OR contraindication to those agents, OR severe psoriasis warranting biologic first‑line (>=10% BSA or crucial areas).BSA >=3% (>=10% for severe)

Documentation of BSA and prior therapy required.

Autoimmune diseases requiring prior TNF inhibitor trial (new starts)

Covered when ALL of the following are met (indication-specific):

Autoimmune diseases requiring prior TNF inhibitor trial (new starts): For RA, psoriatic arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, non‑radiographic axial spondyloarthritis: patient had inadequate response, intolerance, or contraindication to at least one TNF inhibitor (examples listed). For atopic dermatitis new starts: refractory moderate‑to‑severe disease AND inadequate response to at least one other systemic drug including biologics.

TNF inhibitor trial documentation required where indicated.

Hidradenitis suppurativa and uveitis (new starts)

Covered when indicated:

Hidradenitis suppurativa: For hidradenitis suppurativa (new starts): patient has severe, refractory disease and has had inadequate response/intolerance to specified prior therapies.

Specialist documentation and prior therapy history required.

Uveitis: For non‑infectious uveitis (new starts): inadequate treatment response, intolerance, or contraindication to a trial of immunosuppressive therapy for uveitis.

Documentation required.

REPATHA — oncology / specialty coverage stance

REPATHA coverage stance: REPATHA and REPATHA SURECLICK: prior authorization applies to all FDA‑approved indications per policy.

PA required for all indications.

REVLMID — hematologic/oncology criteria (selected)

REVLMID (lenalidomide) selected hematologic criteria: For indications such as myelodysplastic syndrome (MDS): patient meets disease‑specific diagnostic and symptomatic thresholds (e.g., lower‑risk MDS with symptomatic anemia per IPSS/IPSS‑R/WPSS) as specified in policy.

Indication‑specific documentation required.

RUBRACA — selected oncology criteria

RUBRACA selected oncology criteria: For BRCA‑mutated metastatic castration‑resistant prostate cancer: prior androgen‑receptor–directed therapy and prior taxane chemotherapy (or unfit for chemo) AND requested use with GnRH analog or after orchiectomy. For maintenance BRCA‑mutated ovarian cancer: in complete or partial response to primary therapy or recurrent disease in response to platinum‑based chemo.

Mutation testing and prior‑therapy documentation required.

RUBRACA uterine leiomyosarcoma / pancreatic adenocarcinoma: Indication‑specific mutation requirements apply (e.g., BRCA/PALB2) and prior‑therapy sequencing as detailed in policy.

PAH agents (sildenafil, tadalafil) coverage

PAH agents (sildenafil, tadalafil) coverage: For WHO Group 1 PAH: confirmation by right heart catheterization required; for adults pretreatment mean PAP >20 mmHg AND PCWP ≤15 mmHg AND PVR ≥3 Wood units for many agents (some entries use PVR >2 Wood units); specific hemodynamic thresholds noted per agent entry.mean PAP >20 mmHg; PCWP ≤15 mmHg; PVR ≥3 (or >2) Wood units

Hemodynamic confirmation critical for authorization; applies to sildenafil, tadalafil (PAH formulation), treprostinil, UPTRAVI, and others.

SYNAREL — Central Precocious Puberty

Covered when ALL of the following are met for patients not currently receiving therapy:

SYNAREL — Central precocious puberty (CPP): Diagnosis of CPP confirmed by pubertal response to GnRH agonist test OR pubertal level on third‑generation LH assay AND bone age assessment supports CPP AND onset of secondary sexual characteristics occurred before age 8 (females) or before age 9 (males); age restrictions apply (<12 yrs female, <13 yrs male).onset age thresholds specified

Diagnostic testing and bone age documentation required prior to initiation.

MET-altered NSCLC agents

Covered when ALL of the following are met for recurrent/advanced/metastatic NSCLC:

MET‑altered NSCLC agents (Tabrecta/Tepmetko): Tumor is positive for MET exon 14 skipping mutation (or high‑level MET amplification where specified) confirmed by molecular testing prior to therapy.molecular confirmation required

Molecular testing and documentation required for authorization.

Tadalafil — BPH

Covered when ALL of the following are met:

Tadalafil for BPH: Patient has experienced inadequate response, intolerance, or contraindication to BOTH an alpha blocker AND a 5‑alpha reductase inhibitor prior to tadalafil for BPH; duration and trial documentation required.failure/intolerance to both classes

Coverage duration example: 26 weeks.

Teriparatide — Osteoporosis initial therapy

Initial therapy covered when ANY of the following (disease-specific) conditions are met:

Teriparatide — osteoporosis initial criteria: Postmenopausal osteoporosis, primary male osteoporosis, or glucocorticoid‑induced osteoporosis: history of fragility fracture OR pre‑treatment T‑score ≤‑2.5 OR T‑score between ‑2.5 and ‑1 with high FRAX probability AND additional risk indicators or prior injectable/oral bisphosphonate trial failure/intolerance as specified.T‑score/FRAX thresholds; Initial duration 24 months

Initial approval typically 24 months; continuation requires documented ongoing high fracture risk per FRAX.

Tetrabenazine — coverage criteria

Covered when ALL of the following are met for tardive dyskinesia or Huntington's chorea:

Tetrabenazine criteria: Patient experienced inadequate response or intolerable adverse event to deutetrabenazine prior to tetrabenazine initiation for tardive dyskinesia or chorea associated with Huntington's disease.prior agent failure/intolerance

Step‑therapy requirement documented in policy.

Topical tacrolimus — Covered when ANY of the following are met

Covered when ANY of the following are met:

Topical tacrolimus criteria: For moderate to severe atopic dermatitis: disease affects sensitive skin areas (face, genitals, skin folds) OR inadequate response/intolerance/contraindication to at least one first‑line agent (e.g., medium or higher potency topical corticosteroid). For all indications, drug prescribed for short‑term or non‑continuous chronic use. Age restrictions apply (0.03% >=2 yrs; 0.1% >=16 yrs).age restrictions as specified

Coverage duration: Plan Year; documentation of prior therapy or sensitive‑area involvement required.

TREMFYA — Psoriasis initiation

TREMFYA — Psoriasis initiation: Covered when ALL of the following are met for new starts:

TREMFYA initial therapy for moderate-to-severe plaque psoriasis: At diagnosis at least 3% BSA affected OR crucial body areas affected AND patient has inadequate response/intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) OR those agents are contraindicated OR severe psoriasis (>=10% BSA or crucial areas) justifies biologic first‑line.BSA >=3% (>=10% for severe)

Documentation of BSA and prior therapy required; coverage duration Plan Year.

TREMFYA Initial Therapy

TREMFYA Initial Therapy — moderate to severe plaque psoriasis (new starts)

TREMFYA psoriasis detailed criteria: ALL of the following: (1) At least 3% BSA affected OR crucial body areas affected at diagnosis; AND (2) ANY of: a) inadequate response/intolerance to phototherapy or methotrexate/cyclosporine/acitretin; b) contraindication to those systemic agents; c) severe psoriasis warranting biologic first‑line (>=10% BSA or crucial areas).

Applies to new starts only; documentation required.

PAH Agents — Treprostinil / UPTRAVI initial therapy criteria

Treprostinil/UPTRAVI — pulmonary arterial hypertension (new starts)

PAH hemodynamic confirmation for treprostinil/UPTRAVI: ALL of the following for new starts: (1) PAH confirmed by right heart catheterization; (2) pretreatment mean pulmonary arterial pressure >20 mmHg; (3) pretreatment pulmonary capillary wedge pressure <=15 mmHg; (4) pretreatment pulmonary vascular resistance >2 Wood units (or ≥3 where specified).mean PAP >20 mmHg; PCWP <=15 mmHg; PVR >2 (or >=3) Wood units

Right heart cath documentation required for authorization.

HCV Therapy

Hepatitis C treatment entries — coverage requires diagnostic confirmation and regimen documentation

HCV treatment documentation (e.g., Vosevi/EPCLUSA/MAVYRET): HCV infection confirmed by HCV RNA in serum prior to starting treatment; planned regimen, genotype, prior treatment history, presence/absence of cirrhosis (CTP class), HIV coinfection status, resistance‑associated substitutions where applicable, and transplant status must be provided. Coverage and durations follow current AASLD‑IDSA guidance.HCV RNA confirmation

Documentation required to determine regimen and duration.

Verquvo Criteria

Verquvo — symptomatic chronic heart failure

Verquvo initiation: ALL of the following for symptomatic chronic heart failure: left ventricular ejection fraction (LVEF) <45%. For initial therapy, ANY of: hospitalization for heart failure within past 6 months OR use of outpatient IV diuretics for heart failure within past 3 months.LVEF <45%

Documentation of LVEF and recent hospitalization or outpatient IV diuretic use required.

Versacloz Criteria

Versacloz — treatment‑resistant schizophrenia

Versacloz initiation: ALL of the following: patient severely ill with schizophrenia who failed to respond adequately to standard antipsychotic treatment; inadequate response/intolerance/contraindication to one of specified generic antipsychotics (aripiprazole, asenapine, lurasidone, olanzapine, quetiapine, risperidone, ziprasidone); AND inadequate response/intolerance/contraindication to one of specified brand agents (Caplyta, Lybalvi, Rexulti, Secuado, Vraylar).

Treatment‑resistant criteria and documentation required.

Voriconazole Criteria

Voriconazole — route requirement and coverage duration

Voriconazole use and duration: Patient will use the requested drug orally or intravenously as indicated; coverage duration for typical courses: up to 6 months where specified.

Oral or IV route documentation required; duration limits apply.

IBS-D and SIBO PA criteria

Rifaximin for IBS‑D and SIBO — covered when the following requirements are met:

IBS‑D initial or retreatment: (1) Patient has not previously received treatment with the requested drug; OR (2) Patient previously received the drug and is experiencing recurrence AND has not already received an initial 14‑day course plus two additional 14‑day courses; for SIBO either recurrence after successful course or confirmatory testing (upper gut aspirate culture or breath testing) required.14 days course

Initial course duration typically 14 days; retreatment rules specified.

XOLAIR (omalizumab) criteria

Omalizumab (XOLAIR) — covered when ALL of the following are met for initial moderate‑to‑severe persistent asthma:

XOLAIR asthma initial: (1) Positive skin or blood test to ≥1 perennial aeroallergen; (2) Baseline IgE ≥30 IU/mL; (3) Inadequate control despite medium‑to‑high‑dose inhaled corticosteroid AND an additional controller unless contraindicated. Continuation requires demonstrated clinical improvement.IgE >=30 IU/mL

Age restriction: asthma ≥6 years; CSU age ≥12 years; documentation of allergen testing and IgE required.

XOLAIR CSU initial: Evaluation for other causes of urticaria; spontaneous wheals/angioedema for ≥6 weeks; symptomatic despite H1 antihistamine therapy. Continuation requires benefit demonstrated.

Age restriction: CSU ≥12 years.

Yesintek psoriasis criteria

Yesintek for moderate to severe plaque psoriasis — covered when ALL of the following are met for new starts:

Yesintek psoriasis initial: (1) ≥3% BSA affected OR crucial body areas affected; AND (2) Either prior inadequate response or intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin), OR those agents are contraindicated, OR severe psoriasis warrants biologic first‑line (≥10% BSA or crucial areas).BSA >=3% (>=10% for severe)

Documentation required; coverage duration Plan Year.

Xyrem (sodium oxybate) criteria

Xyrem (sodium oxybate) for narcolepsy — covered when the following are met:

Xyrem initial (excessive daytime sleepiness): Diagnosis confirmed by sleep lab evaluation; if ≤17 years inadequate response/intolerance to at least one CNS stimulant OR contraindication to stimulants; if ≥18 years inadequate response/intolerance to at least one CNS wakefulness‑promoting drug (e.g., modafinil/armodafinil) OR contraindication to such agents. Continuation requires decreased daytime sleepiness or cataplexy episodes on therapy.

Prescriber specialty and sleep lab documentation required.

Zonisade criteria

Zonisade for adjunctive partial‑onset seizures — covered when ALL of the following are met:

Zonisade initiation criteria: (1) Inadequate response, intolerance, or contraindication to a generic anticonvulsant; AND (2) inadequate response, intolerance, or contraindication to Aptiom, Xcopri, or Spritam unless documented difficulty swallowing solid oral dosage forms.

Age restriction: ≥16 years; documentation of prior failures required.

Some medications in this PA list may be covered under Medicare Part B (medical benefit) or Part D (pharmacy benefit) depending on the drug, how it is supplied, and the site of care. HMSA will require information about the setting of administration (e.g., physician office/infusion center, hospital outpatient, or retail pharmacy) and how the medication will be dispensed to determine whether coverage is evaluated under Part B or Part D. If the drug is payable under Part A or Part B for the member’s specific use or site of care, Part D coverage will be denied.

Dihydroergotamine (DHE) nasal spray is contraindicated with potent CYP3A4 inhibitors. Coverage will be denied when DHE Nasal is used in conjunction with known potent CYP3A4 inhibitors (for example: ritonavir, nelfinavir, indinavir, erythromycin, or clarithromycin). PA requests must document prior adequate trials of and intolerance/contraindication to at least one triptan as required by the DHE Nasal entry.

Ergotamine (ergotamine tartrate/caffeine) is not covered when administered concurrently with potent CYP3A4 inhibitors. The policy explicitly states that coverage will be denied if ergotamine is used in conjunction with potent CYP3A4 inhibitors (examples include ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin). Prior authorization requests must confirm prior inadequate response/intolerance to at least one triptan.

When a medication is payable under Medicare Part A or Part B for the member’s specific use and site of care (for example, physician‑administered infusions in an outpatient setting), HMSA will deny the request under Part D. Part D coverage will be denied if coverage is available under Part A or Part B; PA submissions should include documentation of the intended site of care and supply/administration setting to allow the appropriate Medicare benefit determination.

Ivacaftor‑containing products must not be used in combination with other ivacaftor‑containing regimens. The policy excludes concomitant use of ivacaftor products — requests for ivacaftor combinations will be denied. Requests must not propose combining ivacaftor-containing products; prior authorization for cystic fibrosis therapies will require documentation that the requested regimen does not duplicate ivacaftor exposure.

MAVYRET ( glecaprevir/pibrentasvir) is not authorized for patients with decompensated hepatic impairment. The policy lists decompensated cirrhosis (Child‑Turcotte‑Pugh class B or C) as an exclusion for MAVYRET; PA requests for HCV therapy must include HCV RNA confirmation, cirrhosis status (CTP class) and other required documentation per HCV entries.

How to Request Authorization and Required Documentation

Prior Authorization

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.

Documentation Required

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.

Step Therapy

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.

Prior Authorization

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.

Denial Risk

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.

Prior Authorization

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.

Prior Authorization

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).

Documentation Required

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.

Prior Authorization

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.

Prior Authorization

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.

Prior Authorization

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.

Documentation Required

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.

Prior Authorization

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.

Prior Authorization

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.

Prior Authorization

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.

Prior Authorization

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.

Documentation Required

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.

Prior Authorization

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.

Prior Authorization

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.

Prior Authorization

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.

Prior Authorization

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.

Documentation Required

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.

Step Therapy

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.

Prior Authorization

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.

Prior Authorization

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.

Documentation Required

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).

Prior Authorization

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.

Prior Authorization

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.

Prior Authorization

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.

Documentation Required

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.

Prior Authorization

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.

Denial Risk

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.

Documentation Required

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.

Documentation Required

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.

Requirement	Details
Prior trials or documentation of intolerance/contraindication required	Prior trials of specified agents or documentation of intolerance/contraindication are required before coverage; specifics vary by drug and indication (see individual entries).
What to document	Clinical record of prior medication trials (drug names, dates, doses), reason for discontinuation (failure, intolerance, or contraindication), and relevant diagnostic confirmation when applicable.

Indication group	Step therapy requirement
Plaque psoriasis (Cosentyx new starts)	>=3% BSA or crucial body areas affected AND prior inadequate response, intolerance, or contraindication to listed biologic/targeted products (examples: adalimumab-aacf, etanercept, Humira, Idacio, Pyzchiva, Skyrizi, Sotyktu, Stelara, Tremfya, Yesintek).
Ankylosing spondylitis / non-radiographic axial spondyloarthritis	Prior inadequate response, intolerance, or contraindication to listed products (e.g., adalimumab-aacf, etanercept, Humira, Idacio; NSAID trial required for non-radiographic axial spondyloarthritis).
Psoriatic arthritis (adult)	Prior inadequate response, intolerance, or contraindication to specified biologic/targeted products before Cosentyx approval.

Situation	Required alternative trials/failures
Adjunctive/second-line anticonvulsants	Trial of a generic anticonvulsant AND failure/intolerance/contraindication to listed alternatives (e.g., Aptiom, Xcopri, Spritam) required prior to approval for branded agents. For monotherapy or intolerance to solids, exceptions apply.
Migraine/ergotamine	Patient must have experienced inadequate response, intolerance, or contraindication to at least ONE triptan (5-HT1 agonist) before ergotamine is considered; concurrent use with potent CYP3A4 inhibitors is a denial.

Drug/Indication	Prior trial requirement
Rheumatoid arthritis (biologics/targeted agents)	Document inadequate response, intolerance, or contraindication to methotrexate OR prior biologic/targeted synthetic DMARD as specified for new starts. Combination therapy documentation often required.
Hypnotics (eszopiclone, zaleplon, zolpidem) — older adults	Contraindication to non-HRM alternative doxepin (3 or 6 mg) OR trial and inadequate response/intolerance to doxepin; prescriber must document benefit outweighs risk; applies to patients ≥70 yrs and cumulative >90 days/year.

OpenPayer

Drugs Requiring Prior Authorization — Pharmacy & Specialty Drugs Coverage Criteria

Drug-specific Coverage Criteria

Key Diagnostic and Numeric Thresholds

How to Request Authorization and Required Documentation

Criteria for New Starts

Criteria for Continued Coverage

Required Prior Trials and Step Requirements

Dosing, Duration and Quantity Limits

Coverage Determination by Setting

Biosimilar-specific Notes

Policy Background