Currentharvard pilgrim health carePolicy N/A

Harvard Pilgrim Part D specialty drug coverage (products list, indications, requirements)

Defines coverage indications, required clinical information, prescriber restrictions, coverage durations, and prerequisite Part D drug requirements for a list of specialty and Part D drugs for Harvard Pilgrim members.

Policy Summary

Payerharvard pilgrim health care

PolicyHarvard Pilgrim Part D specialty drug coverage (products list, indications, requirements)

Policy CodePolicy N/A

Change TypeMinor / no material changes

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documented diagnosis, required medical information (including mutation or biomarker results when specified), and prescriber specialty when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~20+drugs listed in this excerpt

2 yearstypical coverage duration for most products

Prescriber restrictionsmany drugs require specialist prescriber

Mixedprerequisite Part D drugs

NCapplicable state

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Product-specific Coverage Criteria

Product-specific coverage criteria

Covered when ALL of the following are met:

ALL of the following

Lynparza: The member has a documented diagnosis that matches the specific indication being requested (select one of the following per request): Breast cancer, ovarian cancer, pancreatic cancer, or prostate cancer.
For Lynparza - Breast Cancer: Deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting; if hormone receptor-positive, prior endocrine therapy or documented contraindication/intolerance to endocrine therapy OR high-risk early breast cancer treated with neoadjuvant or adjuvant chemotherapy.
For Lynparza - Ovarian Cancer: Maintenance treatment for deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy OR maintenance in combination with bevacizumab for HRD-positive disease in complete or partial response to first-line platinum-based chemotherapy OR maintenance for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to platinum-based chemotherapy.
For Lynparza - Pancreatic Cancer: Deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma with no disease progression after at least 16 weeks of first-line platinum-based chemotherapy.
For Lynparza - Prostate Cancer: Deleterious or suspected deleterious germline or somatic HRR gene-mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide or abiraterone; or deleterious or suspected deleterious BRCA-mutated mCRPC when used in combination with abiraterone and prednisone/prednisolone as specified.
Lytgobi: The member has a documented diagnosis of previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or rearrangements.
Vigafyde: The member has a documented diagnosis of infantile spasms and is age 1 month to 2 years.
Vitrakvi: The member has a documented diagnosis of metastatic or surgically unresectable solid tumor that is NTRK gene fusion-positive without a known acquired resistance mutation, with no satisfactory alternative treatments or disease progression following treatment.
Vizimpro: The member has a documented diagnosis of metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
Vonjo: The member has a documented diagnosis of intermediate- or high-risk primary or secondary (post-PV or post-ET) myelofibrosis with platelet count < 50 x 10^9/L.
Xalkori: The member has a documented diagnosis of one of the following: metastatic NSCLC that is ALK-positive or ROS1-positive; relapsed/refractory systemic ALCL that is ALK-positive; or unresectable, recurrent, or refractory IMT that is ALK-positive.
Xdemvy: The member has a documented diagnosis of Demodex blepharitis and the medication is prescribed by or in consultation with an ophthalmologist or optometrist.
Alectinib / ALK-targeted examples: For ALK-positive metastatic NSCLC, documentation of ALK rearrangement is required; use is for unresectable or metastatic disease and must be prescribed by an oncologist. Prior ALK inhibitor exposure or line of therapy requirements should follow the specific indication requested.
Tofacitinib / Xeljanz examples: For indications such as RA, PsA, UC, or AS, the member must meet disease-specific criteria including prior trial and failure or intolerance to conventional therapies and/or TNF inhibitors as specified for each diagnosis, and therapy should be prescribed by or in consultation with the appropriate specialist (rheumatologist or gastroenterologist).
Ztalmy (CDKL5): The member has a documented diagnosis of seizures associated with CDKL5 deficiency disorder (CDD) and therapy is prescribed by or in consultation with a neurologist.
Idelalisib / Zydelig: The member has a documented diagnosis of relapsed CLL and Zydelig is being used in combination with rituximab, with the prescribing physician a hematologist or oncologist.
Prescriber restriction: Where indicated above, the prescribing physician must be the specialist listed (e.g., oncologist, neurologist, ophthalmologist, hematologist).
Coverage duration: Unless otherwise specified in the product-specific entry, authorization is for up to 2 years per the policy standard; follow reauthorization requirements and outcome documentation as applicable.

Prior Authorization, Documentation & Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for many specialty products listed in this policy. Providers must submit a complete prior authorization request including the documented diagnosis, relevant prior therapies or trials, and any required laboratory, mutation or biomarker testing. Requests lacking required diagnosis, molecular testing, prior therapy documentation, or required monitoring data (for example, liver tests for certain agents) will be delayed or denied.

PA required for many specialty drugs — confirm product-specific rules before prescribing.
Include prescriber specialty when required (e.g., oncologist, pulmonologist, allergist, rheumatologist).
If the drug criterion specifies a prerequisite Part D drug, that Part D trial must be documented in the request.

Documentation Required

Everolimus — Prior & Required Medical Information

Everolimus for Advanced HR+ HER2- breast cancer requires documentation of postmenopausal status, concurrent exemestane use, and documented failure of letrozole or anastrozole prior to approval. For other everolimus indications (e.g., ARCC, NET, SEGA, TSC-related conditions) submit the specific diagnosis and prior therapy as noted in product-specific criteria.

Initial Authorization Requirements

Initial therapy — general initial authorization examples

Initial authorization examples

Emgality initial: Documented diagnosis of migraine or episodic cluster headache

Initial approval 6 months; subsequent approval life of plan

GLP-1 initial therapy — Type 2 Diabetes

Initial therapy requirements for Type 2 Diabetes GLP-1 agents

GLP-1 initial conditions: Documented Type 2 Diabetes OR trial and failure of a minimum 90-day supply, contraindication, or intolerance to one product from specified classes (metformin, DPP-4, SGLT2, alpha-glucosidase inhibitors, meglitinides, sulfonylureas)

Prerequisite Part D drug required for initiation; coverage duration 2 years

Initial therapy requirements — per-drug variation

Reauthorization / Continuation Requirements

Continuation therapy examples

Continuation/reauth criteria where specified

Continuation examples: Approve for continuation of prior therapy when continuation criteria in the product-specific entry are met

Typical coverage duration for continuation commonly 2 years unless otherwise noted

Continuation therapy requirements

Continuation/renewal notes present for some products

Genotropin continuation: Continuation requires medical history related to growth, test results, growth chart, continuing care plan, and improvement in annualized pre-treatment growth rate after first 6 months

Coverage duration 2 years

Jakafi continuation:

Prior Trials, Step Requirements & Optimization

Requirement	Details
Must document prior trials/failures as specified	Examples include prior topical/conventional therapies for plaque psoriasis and trial/failure/contraindication/intolerance to two NSAIDs at maximally indicated doses for non‑radiographic axial spondyloarthritis (minimum 1 month) — documentation of specific prior therapies and durations required per indication.
Prior authorization and documentation	Prior authorization is required with documented diagnosis, required clinical information, and evidence of the specified prior trials/failures where listed (e.g., Cosentyx indications).

Product / Example	Prior trial / failure requirement
Everolimus (Advanced HR+ HER2‑)	Documented failure of letrozole or anastrozole while on exemestane combination; prerequisite Part D drug required.
Jakafi (selected hematology indications)	For myelofibrosis and other indications, prior lines of systemic therapy required; subsequent authorizations require demonstrated clinical benefit (e.g., spleen size reduction or symptomatic improvement).

Scenario	Step requirement
Kineret — Rheumatoid arthritis (initial)	Requires TF/C/I (trial and failure, contraindication, or intolerance) to TWO of: etanercept (Enbrel), one formulary adalimumab product, abatacept (Orencia), upadacitinib (Rinvoq), tofacitinib (Xeljanz), OR attestation that trials are inappropriate — unless continuing prior therapy.

Product	Statin requirement
Nexletol / Nexlizet	Must have elevated LDL‑C while on maximally tolerated statin therapy OR statin contraindication/intolerance documented prior to approval.

Product example	Required prior biologic/systemic step
Rinvoq (selected indications)	Many indications require inadequate response/intolerance to TNF inhibitors or other specified systemic therapies prior to approval (e.g., RA requires conventional therapy plus prior TNF inhibitor failure).
Stelara / related biologics	For specified indications, trial, intolerance, or contraindication to alternative biologics or systemic therapies (e.g., Yesintek or Steqeyma for Stelara where listed) must be documented prior to approval.

Product(s)	Prior trial / intolerance requirement
Stelara (example)	Requires trial of, intolerance to, or contraindication to Yesintek or Steqeyma prior to approval where specified (document per product criteria).
Teriparatide / Osteoporosis agents	Denosumab and other osteoporosis therapies require inadequate response/intolerance to at least one traditional osteoporosis treatment (e.g., bisphosphonates) documented prior to approval.

Biologic	Required step through
Ustekinumab	Requires trial, intolerance, or contraindication to Yesintek or Steqeyma prior to approval for listed indications; prescriber must be appropriate specialist (dermatologist, gastroenterologist, or rheumatologist).

Product family / Indication	Required prior therapies
Voquezna family — H. pylori	Requires documented trial and failure, contraindication, or intolerance to bismuth quadruple therapy prior to approval for H. pylori (Dual/Triple Pak).
Voquezna — HRH / MHRH / NERD	For erosive esophagitis or NERD, requires trial and inadequate response/intolerance/contraindication to TWO generic PPIs prior to approval; coverage durations vary by indication (see product criteria).

Requirement	Notes
Document prior therapy trials/failures as specified per product	Several products across indications require documentation of prior trials and failures, contraindications, or intolerances to specified therapies (examples include TNF inhibitors for autoimmune diseases and multiple prior systemic therapies for certain oncology agents).

Key Definitions & Coding Notes

Pre-treatment serum IgE level — Xolair

Pre-treatment serum IgE range>= 30 IU/mL and <= 1,300 IU/mL

Indication contextRequired for Xolair when used for moderate-to-severe persistent asthma with definitive perennial allergen sensitivity

Associated prior therapy requirementFailure of a regimen including two or more of: inhaled corticosteroids, oral corticosteroids, leukotriene modifiers, inhaled long-acting bronchodilators, or intolerance to these therapies

Non-radiographic axial spondyloarthritis — definition

DefinitionActive disease with objective signs of inflammation (e.g., elevated CRP and/or MRI sacroiliitis) without definitive radiographic structural damage

Required prior therapyTrial and failure, contraindication, or intolerance to two NSAIDs at maximally indicated doses for at least one month

Recommended Prescribing Setting / Specialist Requirement

Prior Authorization

Specialist prescriber required for Valtoco (neurologist)

Valtoco for acute seizure rescue must be prescribed by a neurologist per the product entry; include neurologist prescriber information on the authorization form.

Ensure the prescribing physician is a neurologist or include neurologist consultation documentation.
Attach seizure disorder diagnosis and acute-treatment rationale.

Documentation Required

Ensure gastroenterology or ID specialist involvement and antibiotic pre‑treatment for Vowst

Vowst must be prescribed by or in consultation with a gastroenterologist or infectious disease specialist; include the specialist's documentation and required antibiotic pre-treatment evidence.

Provide gastroenterology or infectious disease specialist notes supporting the Vowst request.
Attach documentation of completing oral vancomycin or fidaxomicin 2–4 days prior to Vowst.

Policy Scope & Background

This section of the policy lists specialty drugs and the clinical diagnoses for which coverage will be considered. It provides the purpose and scope of the indexed coverage rules, and notes that many products require documentation of the diagnosis, relevant laboratory or molecular test results, prior therapy trials or failures where specified, and frequently a specialist prescriber. Coverage durations and prerequisite Part D drug requirements are specified per product in the detailed entries.

Policy Summary

Payerharvard pilgrim health care

PolicyHarvard Pilgrim Part D specialty drug coverage (products list, indications, requirements)

Policy CodePolicy N/A

Change TypeMinor / no material changes

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documented diagnosis, required medical information (including mutation or biomarker results when specified), and prescriber specialty when required.

SourceLink

On This Page

Advanced HR+ BC: postmenopausal, on exemestane, documented failure of letrozole or anastrozole.
Other everolimus indications: attach diagnosis and prior therapy/progression documentation per indication.

Documentation Required

Fasenra — Prior Therapy & Diagnosis Documentation

Fasenra (including Fasenra Pen) requires a documented diagnosis of either severe eosinophilic asthma with an eosinophilic phenotype despite current inhaled corticosteroid plus an additional controller, or eosinophilic granulomatosis with polyangiitis (EGPA). Document prior controller therapy (LABA, leukotriene modifier, or sustained‑release theophylline) and specialty prescriber (asthma specialist or rheumatologist) when applicable.

Severe eosinophilic asthma: documentation of inhaled corticosteroid use plus additional controller and inadequate control.
EGPA: diagnosis documentation and specialist prescriber required.

Step Therapy

GLP-1 Class — Prior Therapy Requirement

For initial Type 2 diabetes indications of GLP-1 receptor agonists (where listed), document either a diagnosis of Type 2 diabetes or trial and failure/intolerance/contraindication to at least one agent from a listed class (e.g., metformin, DPP-4 inhibitors, SGLT2 inhibitors, sulfonylureas, meglitinides, alpha‑glucosidase inhibitors). Reauthorization requires demonstration of clinical benefit.

Initial use: diagnosis of Type 2 diabetes OR trial/failure of a listed oral/other injectable antidiabetic class (90-day minimum where specified).
Reauth: evidence of positive clinical response to therapy.

Prior Authorization

Jynarque — Prior Authorization & Liver Monitoring

Jynarque (tolvaptan) prior authorization is required for ADPKD and must include documentation of rapidly progressing ADPKD. Liver function testing (ALT, AST, bilirubin) must be measured and documented per the monitoring schedule: prior to initiation, at 2 and 4 weeks after initiation, then monthly for the first 18 months; if on therapy >18 months, ALT/AST/bilirubin at least every 3 months. Do not approve if a history of significant liver impairment or injury is present (excluding uncomplicated polycystic liver disease).

Diagnosis: rapidly progressing ADPKD.
Liver monitoring: baseline, 2 weeks, 4 weeks, then monthly for ≤18 months; thereafter at least every 3 months.
Do not approve for patients with significant prior liver injury (except uncomplicated polycystic liver disease).

Prior Authorization

Prior Authorization and Prerequisite Part D Drug

Some criteria require a prerequisite Part D drug trial prior to approval. When the policy indicates 'Criteria DOES require use of a prerequisite Part D drug,' the provider must document the Part D agent(s) used, dates, and response or reason for discontinuation.

Document Part D product name(s), dates of therapy, and trial outcome or intolerance.
Examples include many oncology and specialty agents (see product-specific entries such as Lynparza, Jaypirca, Ibrance, etc.).

Prior Authorization

Specialty Drug Prior Authorization — Prescriber Requirements

Specialty drug prior authorization rules frequently require that the prescribing clinician be a specialist (e.g., oncologist for oncology agents, pulmonologist or CF specialist for cystic fibrosis therapies, allergist/immunologist for immunologic biologics). Ensure the request includes prescriber specialty or documentation of consultation with the appropriate specialist.

Attach specialist documentation when required by the product criteria.
For continuation requests, include documentation of ongoing specialist involvement as specified.

Documentation Required

Genotype-Confirmed Indications — Molecular Test Documentation

Genotype- or biomarker-confirmed indications (e.g., BRCA, HRR, EGFR exon 20 insertions, FGFR2 fusions, IDH1 mutations, BRAF V600, ROS1, NTRK fusions, CFTR mutations) must include the specific test result and test method. Approval is contingent on submission of the relevant molecular test report or FDA-cleared assay documentation.

Include mutation/fusion name, test date, and laboratory report.
If genotype is unknown, perform an FDA‑cleared mutation test and include verification when recommended by the test instructions.

Prior Authorization

Tyenne — Prior Authorization & Prior Therapy

Tyenne (if listed) requires indication-specific prior therapy trials or failures per the product criteria. Document diagnosis, prior treatments attempted, response, and reason for discontinuation or intolerance when applicable.

Provide line-of-therapy history and evidence of trial/failure as specified in the Tyenne criteria.

Note

Index — Prior Auth Not Included

This section is an index-level provider note: the document's index lists drugs and their page references; the index itself does not include prior authorization decisions. Refer to each product's criteria in the main sections for coverage rules.

Index entries are for navigation only; prior authorization requirements appear in each product's criteria section.

Denial Risk

Missing Required Diagnostic Documentation — Denial Risk

Missing required diagnostic documentation (for example, confirmation of CFTR genotype for CF therapies, BRCA/HRR for PARP inhibitors, FLT3 or IDH1 mutation reports for AML agents) is a common cause for denial or delay. Providers should attach the lab/pathology/molecular report that demonstrates the required marker or mutation.

CF products (e.g., Kalydeco, Trikafta): include CFTR mutation report; approvals are mutation-specific.
Oncology agents requiring BRCA/HRR/FGFR2/IDH1/FLT3/etc.: attach molecular pathology results.

Billing Rule

TIRF Exclusion — Non-Cancer Pain

Transmucosal Immediate-Release Fentanyl (TIRF) products are excluded for any non-cancer pain indication. Approvals are limited to adult cancer patients who are opioid tolerant and receiving around-the-clock opioid therapy; documentation of opioid tolerance and oncology indication is required.

TIRF products will not be covered for non-cancer pain.
Document opioid tolerance (e.g., morphine ≥60 mg/day or equianalgesic) and cancer diagnosis.

Documentation Required

CF Mutation Documentation Required (Orkambi/Trikafta/Kalydeco)

Cystic fibrosis therapies (e.g., Kalydeco, Trikafta, Orkambi-type agents) require genotype documentation. If the genotype is unknown, an FDA-cleared CFTR mutation test must be performed and reported. Requests without mutation documentation will be denied.

CF initial authorization: include CF diagnosis and CFTR mutation(s) responsive to the requested drug.
If genotype unknown: perform and include an FDA-cleared mutation assay and bi-directional sequencing where recommended.

Documentation Required

Tukysa — Biomarker and Prior Therapy Requirement

Tukysa (and similar agents) require documentation of tumor biomarker status and prior therapies where specified. For example, indications may require HER2 status, PIK3CA/AKT1/PTEN alterations, or other biomarkers plus documentation of prior endocrine-based regimens or other systemic therapies.

Attach biomarker test reports and line-of-therapy history per Tukysa criteria.
Denial risk if biomarker or prior therapy documentation is absent.

Denial Risk

Voquezna — Prerequisite Therapy Requirement

Voquezna and other H. pylori or erosive esophagitis therapies require documentation of prior PPI trials or failure of bismuth quadruple therapy as specified. Failure to document prerequisite PPI or bismuth quadruple therapy will result in denial.

H. pylori: document trial and failure/intolerance/contraindication to bismuth quadruple therapy when required.
Erosive esophagitis: document trial and inadequate response or intolerance to two generic PPIs when specified.

Denial Risk

Missing Prior Therapy Documentation — Denial Risk

Requests that lack documentation of prior therapy trials or failures (when required by the product criteria) are subject to denial. Providers must include dates, agents, doses, and reason for failure/intolerance/contraindication.

Include trial duration, agent names, and clinical response or intolerance.
Examples include biologic step therapy, targeted oncology agent prerequisites, and specialty therapy line-of-treatment requirements.

Note

Index — No Denial Criteria (Info)

Some products list no denial criteria in their index entries; however, absence of denial language in the index does not remove the need to meet the product-specific medical necessity criteria. Always review the full product criteria.

Index 'no denial criteria' entries are informational; follow the product detail section for coverage rules.

Documentation Required

Required Clinical Documentation

Providers must submit required clinical documentation for all specialty prior authorization requests: diagnosis, pertinent history, prior therapy trials with dates and outcomes, relevant lab results, imaging, and molecular/pathology reports when applicable. Incomplete clinical records risk denial or request for additional information.

Minimum submission: diagnosis, prior therapy history with dates, lab/imaging reports, mutation/biomarker test results when indicated.
For reauthorizations include response metrics (symptom improvement, lab trends, imaging, PPFEV1, etc.).

Documentation Required

Exkivity — Required Medical Information

Exkivity requires documentation of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations and progression on or after platinum-based chemotherapy. Attach the molecular report confirming the exon 20 insertion.

Molecular confirmation of EGFR exon 20 insertion is required.
Document prior platinum-based chemotherapy and disease progression.

Documentation Required

Ibrance — Required Medical Information

Ibrance (palbociclib) and similar CDK4/6 inhibitors require documentation of HR-positive, HER2-negative advanced or metastatic breast cancer and use in combination with an aromatase inhibitor or fulvestrant as specified. For some indications, prior endocrine therapy failure must be documented.

Document HR+/HER2- status, planned combination agent (aromatase inhibitor or fulvestrant), and prior endocrine therapy history when applicable.
Prescriber specialty: oncologist.

Documentation Required

Jaypirca — Required Medical Information

Jaypirca prior authorization requires diagnosis documentation (e.g., relapsed/refractory MCL or CLL/SLL) and evidence of at least two prior lines of systemic therapy including required targeted agents (e.g., BTK inhibitor for MCL; BTK inhibitor and BCL-2 inhibitor for CLL/SLL). Include prescriber oncology consultation documentation.

Document prior lines of therapy and inclusion of required agents (BTK, BCL-2 where applicable).
Prescriber: oncologist (or consultation).

Documentation Required

Jubbonti (Denosumab) — Required Medical Information

Jubbonti (denosumab for osteoporosis) approvals require fracture risk documentation or failure/intolerance to at least one traditional osteoporosis treatment, or specific cancer-related bone loss scenarios (e.g., adjuvant aromatase inhibitor therapy). Provide prior therapy history and fracture risk assessment.

High fracture risk or prior treatment failure documentation required.
If used for aromatase inhibitor-related bone loss, document concurrent AI therapy.

Documentation Required

Kalydeco — Required Medical Information

Kalydeco requires a documented diagnosis of cystic fibrosis and at least one CFTR mutation responsive to ivacaftor based on clinical or in vitro data. If genotype is unknown, an FDA‑cleared CFTR mutation test should be used and include verification per test instructions.

Provide CF diagnosis and CFTR mutation report showing responsiveness to Kalydeco.
If genotype unknown: perform FDA‑cleared mutation testing and include results.

Step Therapy

Kineret — Required Medical Information & Step Therapy

Kineret requires indication-specific documentation. For rheumatoid arthritis, document diagnosis and prior conventional therapy trials (methotrexate, leflunomide, sulfasalazine) or clinician attestation why trials are inappropriate. For NOMID, include genetic testing (NLRP3 mutation) or clinical symptom constellation plus elevated acute-phase reactants.

RA: trial/failure/intolerance to one conventional DMARD and specialist prescriber (rheumatologist).
NOMID: NLRP3 mutation OR clinical criteria plus elevated ESR/CRP/SAA.

Documentation Required

Diagnostic & Molecular Test Documentation

Diagnostic and molecular test documentation is required for many targeted therapies (e.g., BRCA for Lynparza, FGFR2 for Lytgobi, ROS1/ALK for certain lung agents, IDH1 for Tibsovo). Submit the laboratory/pathology report with the specific mutation/fusion and testing method to support approval.

Include gene/mutation name, testing method, laboratory, and date.
Absence of test results may trigger denial or request for additional information.

Documentation Required

Orkambi-Type Requirement — CF Genotype Documentation

Orkambi-type requirements: products for cystic fibrosis often require demonstration of specific CFTR genotypes (e.g., F508del homozygosity or other responsive mutations). Denials occur if the patient is homozygous for mutations known to be non-responsive or if mutation documentation is absent.

Document CFTR genotype (e.g., F508del status) and applicability to the requested product.
Denial risk if genotype incompatible with product efficacy.

Documentation Required

Otezla — Required Medical Information

Otezla requests must include diagnosis-specific details (e.g., psoriatic arthritis, plaque psoriasis, Behcet's disease) and prior topical/systemic therapy failures where specified. Prescriber documentation (dermatologist or rheumatologist) is recommended.

Provide prior topical/systemic treatment history for psoriasis indications.
Document active oral ulcers for Behcet's disease.

Documentation Required

Rezdiffra — Baseline Documentation

Rezdiffra baseline documentation is required per product criteria (attach baseline assessments as specified in the product section).

Include baseline efficacy/safety measures required for reauthorization.

Documentation Required

Rydapt — Required Medical Information & Exclusions

Rydapt requires documentation of FLT3 mutation-positive AML when used as first-line therapy in combination with standard induction (cytarabine/daunorubicin) and consolidation, or other approved indications. Note: Rydapt is not approved as single-agent induction therapy.

Attach FLT3 mutation report and treatment plan showing combination induction/consolidation.
Single-agent induction use is excluded.

Documentation Required

Sapropterin — Required Medical Information

Sapropterin approval requires documentation of hyperphenylalaninemia due to BH4‑responsive PKU. Provide metabolic/genetic testing and specialist prescriber details. Initial authorizations are time-limited with reauthorization contingent on clinical improvement.

Document BH4 responsiveness and baseline/early treatment metabolic data.
Prescriber should be a metabolic disease specialist or geneticist.

Documentation Required

Tibsovo — Required Medical Information

Tibsovo (ivosidenib) requires documentation of a susceptible IDH1 mutation for AML, cholangiocarcinoma, or other indicated uses. Include mutation testing reports and indication-specific prior therapy details where applicable.

Attach IDH1 mutation report and indication rationale (relapsed/refractory AML, newly diagnosed AML where appropriate).
Prescriber: hematologist/oncologist.

Documentation Required

CF Diagnostic & Mutation Documentation — Initial & Reauth

CF diagnostic and mutation documentation is required for CF therapies across the formulary (Trikafta, Kalydeco, etc.). Reauthorization requires evidence of clinical benefit (e.g., PPFEV1 improvement, reduced exacerbations).

Initial: CF diagnosis and CFTR mutation(s) responsive to the requested therapy.
Reauth: demonstrate clinical benefit (lung function, exacerbation reduction).

Documentation Required

Tukysa — Required Clinical Information

Tukysa required clinical information includes the specific cancer diagnosis, biomarker status (e.g., HER2, PIK3CA/AKT1/PTEN alterations where applicable), and prior systemic therapy history (e.g., endocrine regimens, chemotherapy). Include mutation reports and prior treatment timelines.

Document biomarker/alteration reports and prior endocrine or systemic treatment history.
Prescriber specialty and line-of-therapy rationale required.

Documentation Required

Required Diagnosis Documentation

Providers must document the diagnosis that supports the requested therapy. Absent or unclear diagnostic information will result in denial or request for additional clinical data.

Include ICD-10 diagnosis and supporting clinical notes, imaging, labs, or pathology.

Documentation Required

Combination Therapy Documentation

Combination therapy documentation is required when the requested product is approved only in combination with another agent (e.g., Xermelo with a somatostatin analog). Provide documentation of the concomitant agent and rationale for combination use.

Attach current medication list showing combination partner and indication.
Document inadequate control on monotherapy when required.

Documentation Required

Pre-Treatment IgE & Prior Therapy (Xolair)

For products requiring pre-treatment IgE levels and prior therapy trials (e.g., Xolair/omalizumab), include documented serum IgE and evidence of prior antihistamine or controller therapy trials as specified. Failure to include IgE and prior therapy data may lead to denial.

Pre-treatment IgE: include numeric result and date.
Document prior trials of H1 antihistamines or other specified controllers and outcomes.

Note

Index Usage — Locate Full Product Criteria

This index usage note: use the index to locate the full product criteria and required documentation. The index itself is not a substitute for reading product-specific coverage rules and required provider actions.

Refer to the product's detailed section for exact prior authorization and documentation requirements.

Step Therapy

Step Therapy & Trial/Failure Requirements

Step therapy and trial/failure requirements apply to many biologics and autoimmune agents. Providers must document prior use and failure, contraindication, or intolerance to required first-line therapies (e.g., TNF inhibitors, conventional DMARDs, specific topical/systemic agents).

Include dates, agents, doses, and reasons for discontinuation of prior therapies.
Examples: biologic step requirements, TNF inhibitor failures, conventional DMARD trials.

Documentation Required

Jakafi — Continuation/ Reauthorization Requirement

Jakafi continuation (reauthorization) requires documentation of ongoing benefit and specific parameters as noted in Myelofibrosis/other Jakafi indications (e.g., spleen size reduction or symptomatic improvement). Include objective measures when available.

Provide evidence of positive clinical response (spleen size reduction, symptom improvement, lab trends) for continuation.

Step Therapy

Kineret — Step Therapy / Trials Required

Kineret may require step therapy or trials depending on the indication (RA vs NOMID). Ensure prior conventional therapy trials are documented where required and include specialist prescriber details.

Document conventional therapy trials for RA or genetic/clinical confirmation for NOMID.

Step Therapy

Statin Optimization Requirement

Statin optimization is required before approving certain LDL‑C lowering agents (e.g., Nexletol/Nexlizet). Document use of maximally tolerated statin therapy or a statin intolerance/contraindication.

Provide lipid panel results and documentation of maximally tolerated statin or reason for statin intolerance.

Step Therapy

Step Therapy for Biologics — Prior TNF or Specified Agents

Step therapy for biologics: some agents require prior TNF inhibitor failure or intolerance, or trials of specific agents (Yesintek, Steqeyma) before approval. Document prior biologic exposures and responses.

Attach prior biologic trial history and reason for failure/intolerance.
Confirm prescriber specialty per product requirements.

Step Therapy

Prerequisite Therapy or Trial Requirements

Prerequisite therapy or trial requirements (e.g., Stelara, teriparatide examples) must be documented in the prior authorization request. When multiple products are listed as prerequisite options, document trial of at least one listed agent with dates and outcomes.

List which prerequisite agent was used, duration, and outcome.
If trials are clinically inappropriate, include an attestation explaining why.

Step Therapy

Required Prior Therapy Trials — Consolidated

Required prior therapy trials (consolidated examples) across the formulary include trials of conventional DMARDs for rheumatologic diseases, TNF inhibitors for certain GI/dermatologic agents, and specific endocrine or chemotherapy regimens for oncology agents. Always provide clear trial documentation.

Provide line-of-therapy timeline including agent names, durations, and outcomes.
Include attestation if a trial is not clinically appropriate.

Note

Index — Step Therapy Not Included (Info)

This index note: the policy index may include entries that indicate 'step therapy not included' for some listings — consult the product detail for any step therapy requirements, as the index alone may not reflect all limitations.

Index entries are directional; verify step therapy in each product's criteria.

Initial coverage requirements vary by drug

Lynparza initial: Diagnosis and mutation status as specified per indication (e.g., BRCA/HRR) and prior chemotherapy/endocrine therapy as applicable; prescriber oncology

Prior authorization required with documentation of mutation status and prior therapies; coverage duration 2 years

Piqray initial therapy

Initial authorization rules when specified

Piqray initial: Patient has documented HR-positive, HER2-negative, PIK3CA-mutated advanced/metastatic breast cancer, progressed on or after endocrine-based regimen, and Piqray will be used with fulvestrant; prescriber must be an oncologist

Coverage duration 2 years; prerequisite Part D drug required

Initial therapy — oncology

Initial therapy — oncology examples

Rydapt initial therapy: Used as first-line therapy in combination with standard cytarabine and daunorubicin induction for FLT3 mutation-positive AML

Single-agent induction not approved; prescriber hematologist/oncologist

Tibsovo initial therapy: New diagnosis of AML with susceptible IDH1 mutation AND used as monotherapy or with azacitidine for patients >=75 years or unfit for intensive induction chemotherapy

Also covers relapsed/refractory AML with IDH1 mutation and cholangiocarcinoma previously treated; prescriber oncologist; coverage duration 2 years

Initial therapy examples

Examples of initial therapy requirements

RA Tyenne initial: Diagnosis of moderately to severely active RA AND TF/C/I to two listed agents or attestation that trial inappropriate

Prescribed by or in consultation with a rheumatologist; coverage duration 1 year

For myelofibrosis, subsequent authorization requires documentation of spleen size reduction or symptomatic improvement

Prerequisite Part D drug may be required per product; coverage duration 2 years

Continuation of prior therapy examples

Continuation allowed where specified

Modeyso continuation: Approve for continuation of prior therapy for diffuse midline glioma with H3 K27M mutation and progressed disease after prior therapy

Coverage duration 2 years

Continuation therapy examples

Continuation/renewal rules when specified

Revuforj continuation: Approve for continuation of prior therapy as specified in product entry

Coverage duration 2 years for continuation

Rezdiffra - Continuation

Rezdiffra reauthorization

Rezdiffra reauth: Patient demonstrates positive response to therapy and has not progressed to cirrhosis

Subsequent authorization typically 2 years

Continuation therapy

Continuation/reauthorization rules observed for select products

Sapropterin continuation: Subsequent authorization for sapropterin is for 2 years if the member has experienced improvement

Initial authorization 8 weeks; prescriber specialist in metabolic diseases or geneticist

Trikafta reauthorization: Patient demonstrates positive clinical response to therapy (e.g., improved PPFEV1 or decreased pulmonary exacerbations)

Prescriber pulmonologist or CF center specialist; coverage duration 2 years

Continuation/Reauthorization — examples

Reauthorization requirements (examples)

Tyenne reauth (RA/PJIA/SJIA/GC/SSc-ILD): Patient demonstrates positive clinical response to therapy as evidenced by reduction in swollen/tender joint count or improvement in symptoms or clinical features depending on indication

Coverage durations and reauth evidence vary by indication

Continuation — example

Continuation example

Voranigo continuation: Approve for continuation of therapy for grade 2 astrocytoma or oligodendroglioma with susceptible IDH1/2 mutation and prior biopsy/resection history

Coverage duration 2 years

Objective evidence examplesElevated C-reactive protein (CRP) and/or sacroiliitis on MRI

deleterious or suspected deleterious BRCA-mutated — Lynparza definition

DefinitionA documented germline or somatic BRCA mutation that is considered deleterious or likely deleterious

Context of useRequired for Lynparza coverage in specified breast, ovarian, pancreatic, and prostate cancer indications

DocumentationMutation status must be provided as part of required medical information for authorization

FGFR2 gene fusions or other rearrangements — Lytgobi definition

DefinitionFGFR2 gene fusions or other rearrangements: genetic alterations in FGFR2 identified in tumor tissue (e.g., intrahepatic cholangiocarcinoma)

IndicationRequired for Lytgobi coverage in previously treated unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma

Prescriber requirementPrescribed by or in consultation with an oncologist

PIK3CA-mutated breast cancer — definition

DefinitionHormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer with a documented PIK3CA mutation

Treatment contextMember must have progressed on or after an endocrine-based regimen and Piqray is used in combination with fulvestrant

PrescriberPrescribing physician must be an oncologist

MASH (formerly NASH) — Rezdiffra definition

DefinitionMetabolic dysfunction-associated steatohepatitis (MASH), formerly NASH, without cirrhosis with fibrosis stage F2 or F3 confirmed by specified biomarker/imaging or liver biopsy

Diagnostic confirmation options(1) Both a serum biomarker (e.g., ELF, FIB-4) AND an imaging biomarker (e.g., FibroScan, MRI-PDFF), or (2) one advanced assessment: FAST, MAST, MEFIB, or liver biopsy within 12 months

Additional requirementPresence of >=1 metabolic risk factor (e.g., type 2 diabetes, hypertension, obesity)

TF/C/I — definition

TF/C/I meaningTrial and failure, contraindication, or intolerance (used to specify prior therapy requirements)

Typical applicationUsed throughout policy to indicate required prior therapy trials or acceptable reasons to omit trials

DocumentationProvider must document trials, contraindications, or intolerances when claimed

ALK-positive — definition

DefinitionTumors that test positive for anaplastic lymphoma kinase (ALK) gene rearrangements

Clinical requirementDocumented ALK-positive status is required for coverage of multiple oncology indications (e.g., ALK-positive NSCLC, ALK-positive ALCL, ALK-positive IMT)

PrescriberPrescribing physician must be an oncologist where specified

SSA therapy — definition (somatostatin analog)

DefinitionSomatostatin analog (SSA) therapy refers to treatment with agents such as Sandostatin LAR

Clinical contextSSA therapy is required concomitantly and inadequate response to SSA must be documented for Xermelo use in carcinoid syndrome diarrhea

Prescriber requirementPrescribing physician must be a gastroenterologist, hematologist, or oncologist

Billing Rule

Document site-of-care and use for Medicare Part B vs Part D determination

For drugs that may be covered under Medicare Part B or Part D depending on the setting, include information describing the use and site of care to allow correct benefit determination (e.g., hospital outpatient vs. pharmacy benefit).

Provide clinical context and intended site of administration when submitting the request.
Include documentation that clarifies whether the drug use falls under Part B or Part D coverage rules.