harvard pilgrim prior auth specialty drugs Policy Update

Prior Authorization, Documentation & Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for many specialty and product-specific medications. Requests must include a documented diagnosis consistent with the requested drug's FDA indication or accepted clinical use, relevant prior therapy trials or reasons for not using them (failure/intolerance/contraindication), prescriber specialty when specified, and supporting medical or laboratory evidence (e.g., mutation testing, right heart catheterization). Coverage durations and prescriber restrictions vary by product; incomplete documentation of required prior therapies, mutations, or medical evidence may result in denial or delay.

Prior authorization required with documented diagnosis and specified prior therapy failure/contraindication per product.
Prescriber specialty restrictions apply where noted (e.g., oncologist, neurologist, hematologist, pulmonologist, gastroenterologist).
Include treatment history, objective testing (e.g., genetic/mutation testing, right heart catheterization), and prior trial durations where required.
Coverage duration commonly 2 years unless otherwise specified (product-specific exceptions apply).

Prior Authorization

GLP‑1 / Diabetes Agents Prior Authorization

GLP‑1 receptor agonists and related antidiabetic agents (e.g., Mounjaro, Ozempic, Rybelsus, Trulicity) require prior authorization. Initial requests must document Type 2 diabetes. If step therapy is required, include documentation of a trial and failure, contraindication, or intolerance to at least a 90‑day supply of one agent from an appropriate comparator class (examples: metformin-containing agents, DPP‑4 inhibitors, SGLT2 inhibitors, alpha‑glucosidase inhibitors, meglitinides, sulfonylureas). Reauthorization requires clinical response.

Documented diagnosis of Type 2 Diabetes OR documentation of trial and failure/intolerance/contraindication to an appropriate comparator for a minimum 90 days.
Subsequent approvals require evidence of clinical benefit (e.g., improved A1c, weight benefit) as noted in product-specific criteria.

Prior Authorization

Lidocaine Patch Prior Authorization

Lidocaine 5% patches require prior authorization for conditions such as postherpetic neuralgia or diabetic neuropathy. Approval typically requires documentation of trial and failure, adverse reaction, or contraindication to first‑line oral neuropathic agents (e.g., gabapentin) unless clinically contraindicated.

Document trial and failure or intolerance to gabapentin (or justification for not using gabapentin).
Specify diagnosis (e.g., postherpetic neuralgia, diabetic neuropathy) and symptom duration.

Documentation Required

Product‑Specific Prior Authorization & Required Medical Information

Some products require additional, product‑specific documentation or prescriber qualifications. Examples include oncology agents requiring oncologist prescribers, neurologic agents requiring a neurologist, and transplant or CMV prophylaxis agents requiring transplant documentation. Genetic or molecular testing results are mandatory when the indication depends on a biomarker.

Oncology agents: document cancer type, prior systemic therapies, and prescriber specialty (oncologist).
Drugs requiring biomarkers: submit approved test results (e.g., BRCA, FGFR2, EGFR, FLT3) per the indication.
Transplant products (e.g., Prevymis): document allogeneic HSCT or kidney transplant and CMV risk status.

Prior Authorization

Radicava Prior Authorization

Radicava (edaravone) requires prior authorization. Requests must document a diagnosis of amyotrophic lateral sclerosis (ALS) and the prescribing physician should be a neurologist.

Documented ALS diagnosis.
Prescriber: neurologist.

Prior Authorization

Sirturo (bedaquiline) Prior Authorization

Sirturo (bedaquiline) prior authorization requires documentation of pulmonary multi‑drug resistant tuberculosis (MDR‑TB) and that bedaquiline will be used in combination with an appropriate multidrug regimen. If in‑vitro susceptibility testing is available, provide results; if not, document empiric regimen rationale.

Documented MDR‑TB diagnosis.
Bedaquiline used with at least three other drugs shown susceptible in vitro, or with at least four other likely‑susceptible drugs when testing is unavailable.
Provide susceptibility testing when available and treatment plan.

Prior Authorization

Migraine Agents Prior Authorization

CGRP and other migraine agents require prior authorization. Initial approval typically requires a documented migraine diagnosis and a documented inadequate response, intolerance, or contraindication to a prior preventive medication trial (for many products this is a 4‑week trial of an antidepressant, antiepileptic agent, or beta blocker). Subsequent approvals often require evidence of clinically significant reduction in migraine days.

Initial: documented migraine diagnosis and inadequate response/intolerance/contraindication to a 4‑week trial of at least one agent from antidepressants, antiepileptics, or beta blockers.
Subsequent: documentation of clinically significant reduction in migraine frequency vs baseline for continued coverage.
Products noted: Aimovig, Emgality, products requiring triptan trial (see Steqeyma/Yesintek denial trigger).

Prior Authorization

Zurzuvae — Prior Authorization & Duration

Zurzuvae (postpartum depression) prior authorization requires documentation of the diagnosis and is authorized for a limited duration.

Diagnosis: postpartum depression.
Coverage duration: 14 days.

Prior Authorization

Zydelig — Prior Authorization & Criteria

Zydelig (idelalisib) prior authorization requires a documented diagnosis of relapsed chronic lymphocytic leukemia (CLL) and that Zydelig is being used in combination with rituximab. Prescriber must be a hematologist or oncologist.

Documented relapsed CLL diagnosis.
Concomitant use with rituximab must be documented.
Prescriber: hematologist or oncologist.

Prior Authorization

Zykadia TABS — Prior Authorization & Criteria

Zykadia (ceritinib) tablets prior authorization requires documentation of ALK‑positive metastatic non‑small cell lung cancer and that the prescribing physician is an oncologist.

Documented ALK‑positive metastatic NSCLC.
Prescriber: oncologist.

Denial Risk

Denial Triggers & Exclusions (Examples)

Provide complete documentation to avoid denials: absence of required prior therapy trials, missing mutation or biomarker testing, lack of prescriber specialty documentation, or insufficient indication detail are common denial triggers. Some explicit exclusions and contraindications are also enforced.

Denial triggers include missing documentation of required prior therapies or biomarker tests, and lack of required prescriber specialty.
Examples of explicit exclusions: Dupixent not approved for relief of acute bronchospasm or status asthmaticus; Icatibant not approved for acquired angioedema or concurrent ACE inhibitor use; Kalydeco not effective for CF patients homozygous for F508del.
Requests for indications that are explicitly excluded (e.g., cosmetic uses) will be denied.

Denial Risk

Indication Exclusions

Certain indications are specifically excluded from coverage. Examples: Dupixent is not approved for relief of acute bronchospasm or status asthmaticus; TIRF products are not covered for non‑cancer pain; Kalydeco is excluded for CF patients homozygous for F508del.

Dupixent: not for acute bronchospasm or status asthmaticus.
TIRF products: not covered for any non‑cancer pain indication.
Kalydeco: not effective and not covered for patients homozygous for F508del mutation.

Denial Risk

Contraindications

Contraindications and use restrictions must be observed. Example: Icatibant will not be approved for members with acquired angioedema or who are concurrently taking ACE inhibitors.

Icatibant contraindication: acquired angioedema or concurrent ACE inhibitor therapy.

Documentation Required

Icatibant — Documentation & Exclusion

Icatibant prior authorization requires a documented diagnosis of hereditary angioedema (HAE) with recent severe attacks and laboratory confirmation for Types 1 and 2 when applicable. Prescriber should be an allergist, hematologist, or immunologist. Icatibant is not approved for acquired angioedema or concurrent ACE inhibitor therapy.

Diagnosis: HAE with at least one severe attack in the past 6 months.
For HAE Types 1 & 2: provide laboratory confirmation (low C4, reduced C1 esterase inhibitor level or function).
Prescriber: allergist, hematologist, or immunologist.
Excluded: acquired angioedema and concurrent ACE inhibitor use.

Documentation Required

Kalydeco — Genetic Testing & Exclusion

Kalydeco (ivacaftor) requires documentation of cystic fibrosis and a CFTR mutation responsive to ivacaftor via clinical or in vitro data. If genotype is unknown, submit an FDA‑cleared CF mutation test and follow up with sequencing when recommended. Kalydeco is not effective in patients homozygous for F508del.

Document CF diagnosis and presence of a CFTR mutation responsive to ivacaftor per clinical/in vitro assay.
If genotype unknown: submit FDA‑cleared CF mutation test and sequence verification when indicated.
Exclusion: patients homozygous for F508del mutation.

Denial Risk

Missing Prior Therapy or Mutation Testing — Risk of Denial

Missing documentation of prior therapies or required testing is a common cause of denial. Ensure that prior lines of therapy, durations, reasons for discontinuation, and relevant lab or genetic test reports are included with the request.

For oncology and specialty agents: list prior chemotherapy/biologic agents and document progression or intolerance.
For biomarker‑driven therapies: attach laboratory or genetic test reports that meet the product criteria.

Denial Risk

Common Exclusions (Cosmetic, Quinine, TIRF)

Cosmetic‑use and other explicit exclusions apply (e.g., topical acne retinoids for cosmetic purposes). Quinine is not approved for nocturnal leg cramps. Transmucosal immediate‑release fentanyl (TIRF) products are not covered for non‑cancer pain.

Cosmetic exclusions: topical acne retinoids for cosmetic use will be denied.
Quinine: excluded for treatment/prevention of nocturnal leg cramps.
TIRF: not covered for non‑cancer pain.

Denial Risk

Concurrent Chemotherapy Exclusion

Concurrent chemotherapy restrictions: some agents (e.g., Rubraca) are not approvable for concurrent use with other chemotherapy agents. Verify allowed combinations and sequencing in the product criteria.

Rubraca: not approved for concurrent use with other chemotherapy agents.
Confirm required sequencing or monotherapy requirements on the product's criteria.

Documentation Required

Continuation‑Only Note

Some products are designated for continuation of prior therapy only; indicate prior authorization/benefit history to support continuation requests.

Example: Revuforj may be approvable for continuation only when previously authorized.
Include prior authorization details and evidence of ongoing benefit for continuation approvals.

Denial Risk

Exclusion for Erectile Dysfunction

Certain drugs are explicitly excluded for specific indications. Example: Tadalafil is excluded when prescribed for erectile dysfunction.

Tadalafil: excluded for treatment of erectile dysfunction (ED).

Denial Risk

Steqeyma / Yesintek — Denial Trigger

Steqeyma and Yesintek (CGRP antagonists/antibody products) require documentation of a migraine diagnosis and trial/failure/intolerance/contraindication to at least one triptan. Lack of this documentation is a denial trigger.

Document prior trial and inadequate response, intolerance, or contraindication to at least one triptan medication for migraine.
Provide migraine frequency and prior preventive therapy history.

Prior Authorization

Vowst — Prior Authorization & Required Antibiotic Course

Vowst prior authorization requires diagnosis of recurrent Clostridioides difficile infection and documentation that the patient completed an appropriate antibiotic regimen (oral vancomycin or fidaxomicin) 2–4 days prior to initiating Vowst. Prescriber specialty is typically gastroenterology or infectious disease. Coverage duration is 14 days.

Diagnosis: recurrent C. difficile infection.
Documentation: completion of oral vancomycin or fidaxomicin 2–4 days prior to Vowst initiation.
Prescriber: gastroenterologist or infectious disease specialist.
Coverage duration: 14 days.

Denial Risk

CDKL5 / Rare Seizure Disorder — Denial Risk & Documentation

For products treating rare seizure disorders (e.g., CDKL5‑associated seizures / Epidiolex‑like agents), denial risk increases when trials of required anticonvulsants are not documented. Prior authorization requires documentation of diagnosis and trials of formulary anticonvulsants.

CDKL5 (CDD): document diagnosis and trial and failure, contraindication, or intolerance to two formulary anticonvulsants (examples: valproic acid, levetiracetam, lamotrigine).
Epidiolex: diagnosis of seizures associated with LGS, DS, or TSC and prescriber must be a neurologist.

Documentation Required

Seizure Disorder Documentation & Prescriber Requirement

Seizure disorder medications requiring prior authorization must include a documented diagnosis requiring acute or chronic treatment and often require neurologist prescribers. For acute rescue products (e.g., Valtoco), document the seizure disorder and that prescriber is a neurologist.

Valtoco: document seizure disorder requiring acute treatment and prescriber must be a neurologist.
Epidiolex and other seizure agents: require neurologist prescriber and diagnosis of the specific syndrome (LGS, DS, TSC).

Documentation Required

Teriparatide — Documentation & Cumulative Use Limit

Teriparatide prior authorization requires documentation of osteoporosis (postmenopausal or male primary/hypogonadal osteoporosis, or glucocorticoid‑induced) with T‑score ≤ -2.0 or prior osteoporotic fracture, plus inadequate response or intolerance to at least one traditional osteoporosis therapy. Coverage is limited by cumulative duration of parathyroid hormone analogs (combined teriparatide and other PTH analogs > 2 years is not authorized).

Document osteoporosis diagnosis, T‑score ≤ -2.0 or history of osteoporotic fracture.
Document inadequate response or intolerance to at least one traditional osteoporosis agent.
Coverage limits: cumulative PTH analog use (including teriparatide) > 2 years is not authorized.

Prior Authorization

TIRF Products — Documentation & Restriction

Transmucosal immediate‑release fentanyl (TIRF) products are covered only for breakthrough cancer pain in opioid‑tolerant adult cancer patients. Approval requires documentation that the patient is opioid tolerant on around‑the‑clock opioids; TIRF is not covered for non‑cancer pain.

Indication: breakthrough cancer pain in adult cancer patients.
Patient must be opioid tolerant (examples of opioid tolerance defined in policy).
Not covered for non‑cancer pain indications.

Documentation Required

Vanflyta / Venclexta / Molecular Marker Documentation

Vanflyta and other hematology/oncology agents require documentation of specific molecular markers or disease characteristics and specialist prescribers. For example, Vanflyta requires documented newly diagnosed AML with FLT3‑ITD positive status as detected by an FDA‑approved test and prescriber specialty (oncologist/hematologist) is typically required.

Vanflyta: document newly diagnosed AML with FLT3‑ITD positive status by an FDA‑approved test.
Prescriber: oncologist or hematologist as specified.
Attach molecular test reports when required.

Documentation Required

Venclexta — Documentation & Prescriber Requirement

Venclexta (venetoclax) prior authorization requires indication‑specific documentation (e.g., AML first‑line in combination with azacitidine/decitabine/low‑dose cytarabine for patients ≥75 years or medically unfit for intensive chemo; CLL/SLL per indication) and prescriber specialty (hematologist/oncologist).

Document diagnosis and the combination regimen per indication.
Prescriber: hematologist or oncologist.

Documentation Required

Voriconazole INJ — Documentation

Voriconazole injection prior authorization requires documentation of specified invasive fungal infections or intolerance/refractoriness to other therapies. Provide indication and prior antifungal treatment history.

Document serious invasive fungal infection (e.g., invasive aspergillosis, candidemia) and prior antifungal therapy failures or intolerance when applicable.

Documentation Required

Required Medical Information & Prescriber Details; Part B vs Part D Documentation

Required medical information and prescriber details must accompany requests for many specialty drugs: documented diagnosis, prior therapy trials and outcomes, relevant laboratory or genetic testing, and prescriber specialty or consultation notes when specified. Provide setting/use details for Medicare Part B vs Part D determinations.

Attach clinical notes, prior authorization history, test reports (genetic, pathology, hemodynamic), and specialty prescriber information.
If Medicare status is uncertain, include information on the care setting and drug administration to permit Part B vs Part D coverage determination.

Requirement	Example / Notes
Prior trials and failures of other medication classes are required before approval
Examples: Aimovig — inadequate response after a 4-week trial of antidepressants, antiepileptic drugs (AEDs), or beta blockers; Cosentyx and similar biologics — failure/intolerance of listed topical/systemic therapies or NSAID trials for axial disease

Requirement	Example / Notes
Trial and failure, contraindication, or intolerance to one or more specified conventional therapies is required prior to specialty biologic approval
Examples: Rheumatoid arthritis and PJIA — trial and failure of methotrexate, leflunomide, or sulfasalazine; Plaque psoriasis — failure/intolerance to listed topical agents

Requirement	Example / Notes
Documented trial and failure (or contraindication/intolerance) of prior therapies as specified for the indication must be provided
Examples: PJIA — trial and failure of one conventional therapy (methotrexate, leflunomide, or sulfasalazine); Lonsurf (mCRC) — prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and specified biologic therapies

Requirement	Example / Notes
Trial of at least one triptan (or documentation of inadequate response, intolerance, or contraindication to a triptan) is required for certain migraine agents
Examples: Nurtec — inadequate response/intolerance/contraindication to at least one triptan for acute migraine; Steqeyma/Yesintek — require trial/failure/intolerance/contraindication to at least one triptan

Requirement	Example / Notes
Documented CFTR genotype is required when eligibility is genotype-dependent
Example: Orkambi — member must have cystic fibrosis and documentation of homozygosity for the F508del mutation on both CFTR alleles

Requirement	Example / Notes
Document trials of prior therapies per product-specific criteria; provide documentation of prior agents tried and reasons for discontinuation
Examples: Biologics and immunomodulators — trials and failures (or intolerance/contraindication) of conventional therapies and, where listed, trial/failure of TNF inhibitors prior to approval

Requirement	Example / Notes
Must document prior trial and failure, intolerance, or contraindication to specified conventional therapies before biologic or advanced therapy is authorized
Applies across multiple indications (e.g., IBD, dermatology, rheumatology) — documentation should specify therapies tried, durations, and clinical response

Requirement	Example / Notes
Prior trial of specified conventional agents (and biologics where indicated) must be documented before approval
Examples: RA/PJIA — methotrexate, leflunomide, or sulfasalazine; Crohn's disease — 6-mercaptopurine, azathioprine, or corticosteroids and inadequate response to TNF inhibitors when required

Requirement	Example / Notes
For Ztalmy in CDKL5 deficiency disorder: member must have diagnosis of seizures associated with CDKL5 deficiency disorder and prior trials as specified
Specific requirement: trial and failure, contraindication, or intolerance to two formulary anticonvulsants (examples: valproic acid, levetiracetam, lamotrigine); prescriber must be a neurologist or in consultation with one

Requirement	Example / Notes
Must document trials of two formulary anticonvulsants (trial and failure, intolerance, or contraindication) prior to coverage
Applies to therapies for seizures associated with CDKL5 deficiency disorder (e.g., Ztalmy) — examples of formulary anticonvulsants include valproic acid, levetiracetam, lamotrigine

Key Terms & Molecular Markers

BRAF V600E/V600K — mutation status required

Required markerBRAF V600E or V600K mutation

Indications referencedUnresectable or metastatic melanoma (with binimetinib), metastatic colorectal cancer (with cetuximab), metastatic NSCLC (with binimetinib)

Prescriber restrictionPrescribing physician must be an oncologist

FGFR3 susceptible alterations — Balversa eligibility

Susceptible alterationsFGFR3 genetic alterations (susceptible FGFR3 alterations)

IndicationLocally advanced or metastatic urothelial carcinoma

Prior therapy requirementProgression during/after at least one line of systemic therapy and prior PD‑1/PD‑L1 inhibitor therapy or not a candidate for such therapy

Prescriber restrictionPrescribing physician must be an oncologist or urologist

Non-radiographic axial spondyloarthritis (nr-axSpA)

DefinitionActive axial spondyloarthritis with objective signs of inflammation (elevated CRP and/or sacroiliitis on MRI) but without definitive radiographic sacroiliac joint structural damage

Therapy prerequisiteMinimum 1 month trial and failure, contraindication, or intolerance to two NSAIDs at maximally indicated doses

Example indicationNon-radiographic axial spondyloarthritis (nr-axSpA)

Initial vs Subsequent Approval (Emgality) — requirements

Initial approval requirementFailure/intolerance to a 4‑week trial of at least one preventive medication class (antidepressant, antiepileptic, or beta blocker)

Subsequent approval requirementDemonstration of clinically significant reduction in migraine days or frequency of cluster attacks from baseline

Initial coverage duration6 months (initial)

Hereditary Angioedema (HAE) — laboratory confirmation required

Diagnostic confirmationHAE Types 1 & 2 require laboratory confirmation (e.g., low C4, reduced C1 esterase inhibitor level or function)

Clinical historyDocumented history of at least one severe attack in the past six months

Prescriber restrictionPrescribing physician must be an allergist, hematologist, or immunologist

HER2 overexpressing — prior therapies required

Tumor characteristicBreast cancer that overexpresses HER2

Prior therapiesPrior therapy with an anthracycline and a taxane and prior trastuzumab required per criteria

Concurrent therapyOften required to be used concurrently with capecitabine in specified scenarios

Pulmonary arterial hypertension (PAH) — confirmation required

Diagnostic confirmationPulmonary arterial hypertension must be confirmed by right heart catheterization

Prescriber restrictionPrescribing physician must be a cardiologist or pulmonologist

Related conditionCTEPH: persistent/recurrent disease after surgery or inoperable status

Molecular markers — documented mutation/fusion status required

Required documentationDocumented tumor mutation or fusion status (examples: BRCA, FGFR2, BRAF, KRAS G12C, ALK, PIK3CA)

Use caseSelection for several oncology agents depends on these molecular markers

Opioid tolerant — definition used for TIRF products

Opioid tolerant definitionAround‑the‑clock opioids equivalent to morphine 60 mg/day or more (or fentanyl transdermal 25 mcg/hr or more, oxycodone 30 mg/day or more, hydromorphone 8 mg/day or equianalgesic doses) for ≥1 week

ContextRequired for TIRF products: patient must be opioid tolerant and remain on around‑the‑clock opioids when taking transmucosal fentanyl

FLT3 ITD positive AML — definition

Molecular findingFLT3 internal tandem duplication (ITD) mutation positive

Testing requirementDetected by an FDA‑approved test

Indication contextUsed to identify patients with AML eligible for specific therapies

NTRK gene fusion-positive solid tumors — eligibility

Tumor featureNTRK gene fusion-positive solid tumor

Clinical contextMetastatic or surgically unresectable tumors without acquired resistance mutation and lacking satisfactory alternatives

Prescriber restrictionPrescribing physician must be an oncologist

CDKL5 — CDKL5 deficiency disorder (CDD)

DisorderCDKL5 deficiency disorder (CDD)

Indication contextSeizures associated with CDKL5 deficiency disorder

Step requirementTrial and failure, contraindication, or intolerance to two formulary anticonvulsants required prior to coverage

Prescriber restrictionPrescribed by or in consultation with a neurologist

OpenPayer

Prior authorization medical necessity guidelines for specialty drugs (partial list)

Drug-specific Coverage Criteria

Prior Authorization, Documentation & Denial Triggers

Coverage Determination Codes & Age Limits

Initial Authorization Requirements

Reauthorization / Continuation Rules

Required Prior Trials and Step Therapy Tables

Key Terms & Molecular Markers

Setting / Coverage Determination (Part B vs Part D)