Harvard Pilgrim Prior Auth Drug Coverage Update

Drug-specific Coverage Criteria (Selected Excerpts)

Biologic/advanced therapy — rheumatology and SSc-ILD

Covered when ALL of the following are met:

ALL of the following

Diagnosis: The member has a documented diagnosis consistent with the labeled rheumatologic indication (e.g., rheumatoid arthritis [RA], psoriatic arthritis [PsA], ankylosing spondylitis, polyarticular juvenile idiopathic arthritis [PJIA], systemic juvenile idiopathic arthritis [SJIA], giant cell arteritis [GCA]) as specified for the requested biologic/advanced therapy.
Prior therapy: The member has had an adequate trial and failure, contraindication, or intolerance to the required number of conventional or prior biologic therapies where specified by the product-specific criteria (for RA and similar indications this generally means trial and failure, contraindication, or intolerance to ONE or TWO conventional DMARDs such as methotrexate, leflunomide, or sulfasalazine as noted in product sections).
Prescriber: The medication is prescribed by or in consultation with an appropriate specialist (e.g., rheumatologist for RA, PsA, SjIA; dermatologist for psoriasis; gastroenterologist for IBD-related biologics) when specified in the product-specific criteria.
Baseline evaluation: Relevant baseline assessments (e.g., TB screening, hepatitis B/C testing, baseline CBC and liver function tests, pregnancy status when applicable) have been documented when required by the product labeling or clinical guidance.
Dosing and intent: The requested agent, dose, and frequency are consistent with FDA- labeled dosing for the requested indication and the request is for initiation or continuation consistent with established coverage duration (typically up to 1–2 years subject to reauthorization criteria).
Use limitations: The agent will not be used in combination with another biologic agent or targeted immunomodulator unless specifically allowed by the product labeling or other product-specific criteria.

Systemic sclerosis-associated interstitial lung disease (SSc-ILD) - product-specific

Diagnosis: The member has a documented diagnosis of systemic sclerosis-associated interstitial lung disease (SSc-ILD) confirmed by exclusion of other known causes of interstitial lung disease and supportive imaging and/or biopsy consistent with SSc-ILD (for example, HRCT showing fibrotic NSIP, UIP, or centrilobular fibrosis patterns or lung biopsy consistent with SSc-ILD).
Prescriber: The request is prescribed by or in consultation with a pulmonologist or rheumatologist experienced in management of SSc-ILD.
Disease severity / progression: Documentation of physiologic impairment or disease progression attributable to SSc-ILD (for example, decline in forced vital capacity [FVC] or worsening symptoms, radiographic progression, or other objective evidence) or other clinical rationale for therapy initiation per product labeling.
Prior therapy: Documentation of prior supportive or standard therapy trials when appropriate (e.g., immunosuppressive therapy such as mycophenolate mofetil or alternatives) OR documentation that such therapies are contraindicated or not tolerated, when aligned with product-specific labeling or guideline recommendations.

Operational notes

Coverage duration: Approvals are generally granted for up to 1 year for SSc-ILD and up to 1–2 years for other rheumatologic indications; reauthorization requires evidence of continued benefit as described above.
Concomitant therapies: When clinically indicated and allowed by labeling, concomitant use of low-dose corticosteroids or conventional DMARDs may be permitted; concurrent use of two biologic or targeted immunomodulators is not permitted unless specified by product labeling.
Documentation: Prior authorization must include relevant medical records supporting diagnosis, prior therapy trials (dates, doses, responses), baseline testing, and plan for monitoring; incomplete documentation may result in denial or delay.

Voquezna (vonoprazan-containing regimens) — H. pylori / erosive esophagitis / NERD

Covered when ALL of the following are met:

ALL of the following

Helicobacter pylori infection: The member has a documented diagnosis of H. pylori infection confirmed by an appropriate diagnostic test (e.g., urea breath test, stool antigen, or biopsy-based testing).
Regimen selection: The requested vonoprazan-containing regimen (e.g., vonoprazan/amoxicillin/clarithromycin; vonoprazan/amoxicillin/metronidazole; Voquezna Dual/Triple Pak where applicable) is consistent with an FDA-approved regimen or evidence-based guideline for H. pylori eradication.
Prior therapy requirement: The member has had a trial and failure, contraindication, or intolerance to bismuth quadruple therapy (e.g., bismuth + metronidazole + tetracycline + a PPI) OR clinician documents why bismuth quadruple therapy is inappropriate, when Voquezna is being requested as salvage therapy per criteria.
Combination agents: When Voquezna Dual or Triple Pak is requested, the combination components are being used as specified (Dual Pak = vonoprazan + amoxicillin; Triple Pak = vonoprazan + amoxicillin + clarithromycin) and accompanied by appropriate duration of therapy per labeling.

Actions, Documentation, and Denial Risks for Prescribers

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Many specialty and Part D drugs listed below require prior authorization. Submit complete clinical documentation to avoid delays or denials.

Prior authorization is required for the specific products listed in the "Products Affected" entries.
PA duration notes vary by product (examples below).
When applicable, a prerequisite Part D drug or step-therapy trial must be documented.

Prior Authorization

Prior Authorization — detailed clinical documentation expected

Some products require detailed prior authorization clinical criteria to be met (diagnosis, mutation status, prior response to platinum therapy, prior endocrine or chemotherapy trials, prescriber specialty, etc.). Review the individual product entry under "Products Affected" for required diagnostic tests and prior therapy history.

Examples: Rubraca requires documented deleterious BRCA mutation (germline or somatic) and prior response to platinum therapy for maintenance; Lynparza requires oncologist prescriber and may require prior endocrine/chemotherapy history.
Many biologic and advanced therapies require prescriber specialty (e.g., oncologist, rheumatologist, dermatologist) and step-therapy documentation.

Prior Authorization

Prior authorization and duration (example: everolimus)

Prior authorization approvals may be limited in duration and tied to specific prior-therapy windows. For example, everolimus approvals reference required prior therapies (e.g., progression after letrozole/anastrozole for HR+ breast cancer) and a coverage duration (commonly 2 years).

Everolimus: coverage duration = 2 years; required documentation includes failure of listed prior endocrine or targeted therapies as applicable.
Check each product entry for coverage duration and prior-therapy specifics.

Prior Authorization

GLP‑1 / Type 2 diabetes agent PA requirements

GLP‑1 agents and other diabetes agents may require documentation of prior antidiabetic therapy or trials. Document either prescriber confirmation of diagnosis or a trial history with oral antidiabetic agents as specified.

Type 2 diabetes confirmation may be met by prescriber documentation or a record of a 90‑day trial of a metformin-containing agent or other listed classes.
Ensure documentation shows trials of listed drug classes or rationale for intolerance/contraindication.

Prior Authorization

Prior authorization and duration (general)

PA approvals frequently reference a standard coverage duration (often 2 years) and reauthorization requirements (e.g., clinical response). Document response at reauthorizations.

Many products list Coverage Duration = 2 years; some specify 1 year or plan-year for conditions like ATTR-CM.
Reauthorization typically requires evidence of clinical benefit (per product entry).

Prior Authorization

PA required per product — check each product entry

Prior authorization may be required on a per-product basis and frequently includes prescriber specialty, required diagnostic evidence, and prior therapy steps. Review the product-specific "Products Affected" entry for details.

Products listed in the policy each include Required Medical Information, Prescriber Restrictions, Coverage Duration, and whether a prerequisite Part D drug is required.

Prior Authorization

Prescriber restriction example — Lynparza

Some oncology agents (e.g., Lynparza) are restricted to specialists. Ensure the prescriber is an oncologist or that consultation documentation is provided.

Lynparza: Prescribing physician must be an oncologist; required documentation includes mutation and prior chemotherapy/endocrine therapy history.

Step Therapy

Prior authorization and prerequisite / step therapy

Prior authorization often requires documentation of prior therapy trials or step therapy. For immunomodulators and targeted agents, the policy commonly requires failure, contraindication, or intolerance to specified conventional or biologic therapies before approval.

Document trials and outcomes (failure, intolerance, contraindication) for required prior agents (e.g., methotrexate, leflunomide, sulfasalazine; prior TNF inhibitors for some agents).
Examples: Cosentyx, Enbrel, Wyost, and other biologics require specified prior trials or failure of listed agents.

Step Therapy

Rinvoq prior auth — required prior therapy documentation

For some products (e.g., Rinvoq), prior authorization requires documentation of prior failed therapies and specific step-therapy pathways. Provide dates and durations of prior trials and clinical rationale for switching.

Rinvoq: document failed trials of conventional or specified biologic therapies as detailed in the product entry.
Provide duration and reasons for discontinuation (failure, intolerance, contraindication).

Prior Authorization

TIRF (transmucosal fentanyl) prior authorization requirements

Transmucosal Immediate‑Release Fentanyl (TIRF) products are restricted to management of cancer-related breakthrough pain in opioid‑tolerant cancer patients and require prescriber specialty documentation. They are not covered for non-cancer pain.

TIRF will not be covered for any non-cancer pain indication.
Coverage limited to adult cancer patients already tolerant to around‑the‑clock opioid therapy; pediatric approval for fentanyl lozenges may be approvable for patients ≥16 years in some cases.
Prescribing physician must be an oncologist or pain management specialist; document opioid‑tolerant baseline regimen and continuing around‑the‑clock opioids.

Step Therapy

Biologic / advanced therapy PA and step requirements

Biologics and advanced therapies have step-therapy, prerequisite Part D drug requirements, and prescriber‑specialty expectations. Provide documentation of prior biologic or conventional therapy trials and specialty consultation when required.

Examples: Many TNF and interleukin inhibitors require trial/failure of conventional therapies like methotrexate or prior TNF inhibitors.
Prescriber specialty (dermatologist, rheumatologist, gastroenterologist, oncologist, etc.) is commonly required or requested.

Prior Authorization

ATTR‑CM — PA and prescriber restriction

ATTR‑CM therapies require cardiologist prescribing and specific diagnostic confirmation; provide mutation or biopsy/scintigraphy/MRI evidence and NYHA class.

ATTR‑CM initial: provide diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy by either: documented TTR mutation, cardiac or noncardiac tissue biopsy confirming TTR amyloid deposits, or cardiac imaging (MRI or scintigraphy) suggestive of amyloidosis with exclusion of light‑chain amyloidosis.
Document NYHA Functional Class I–III heart failure and note prescriber is a cardiologist.
Coverage and reauth duration notes: often plan‑year or specified in product entry.

Prior Authorization

Wyost — PA and prescriber restriction

Wyost and similar immunomodulators require prescriber specialty and specific prior‑therapy documentation. Provide evidence of TNF inhibitor failure/intolerance and conventional therapy trials as applicable.

Wyost: Prescribed by or in consultation with a gastroenterologist or rheumatologist; document inadequate response or intolerance to one or more TNF inhibitors and required conventional therapy trials.
Include dates and reasons for prior therapy discontinuation.

Note

Products Affected — confirm product is listed

Products Affected: The policy lists numerous specific NDC / product entries (see "Products Affected" blocks). Providers must confirm whether the prescribed product appears on the list and follow the product‑specific requirements.

Examples include Abilify Mycite kits, Arikayce (Cayston listed separately), many branded biologics (Humira/adalimumab variants, Enbrel, Cosentyx), specialty oncology and rare disease agents (Lynparza, Rubraca, Trikafta, Truqap, Lytgobi, Turalio, Vyndamax, etc.).
When a product is on the list, follow the Required Medical Information and Prerequisite Therapy guidance in its entry.

Denial Risk

Missing diagnosis or prescriber specialty — denial risk

Missing diagnosis or prescriber specialty documentation is a common cause of denial. Ensure the submitted chart notes explicitly state the diagnosis, relevant mutation or lab results, prior therapy trials (with dates and outcomes), and the specialty of the prescriber or consultant.

For oncology agents, include mutation testing results (BRCA, EGFR, ALK, FGFR2, PIK3CA/AKT1/PTEN), prior platinum response, and lines of therapy.
For specialty conditions, document subspecialty consultation or that prescriber is within the required specialty (e.g., cardiologist for ATTR‑CM, pulmonologist for pulmonary fibrosis agents, neurologist for certain seizure/disorder drugs).

Documentation Required

ATTR‑CM — required documentation

ATTR‑CM documentation: include genetic testing or biopsy/imaging evidence, NYHA class, and cardiology prescriber information to support coverage. Lack of these items may result in denial.

Provide one of: documented TTR mutation, histologic confirmation of TTR amyloid deposits, or cardiac imaging (MRI/scintigraphy) suggestive of amyloidosis plus exclusion of light‑chain amyloidosis.
Document NYHA Functional Class I–III and that a cardiologist prescribed or co‑managed therapy.

Documentation Required

Submission of use and setting information (Part B vs Part D)

Whether a drug is covered under Medicare Part B or Part D may depend on the drug's use and setting. Submit information describing the drug use (indication, administration route, infusion vs outpatient prescription) and setting to enable correct Part B vs Part D determination.

Include details on administration (e.g., physician office infusion, facility-administered vs pharmacy-dispensed self‑administered), the clinical indication, and any billing codes if available.
Failure to submit use/setting information may delay determination of whether the drug is covered under Part B or Part D.

Documentation Required

Examples — required documentation for select products

Product-specific documentation examples: include device/dev kit information, prior oral therapy documentation, specialty prescriber notes, and infectious disease or pulmonary testing as applicable.

Abilify Mycite: include documentation of diagnosis (bipolar I disorder, major depressive disorder, or schizophrenia), evidence of worsening symptoms on oral aripiprazole, and that the prescriber is a psychiatrist.
Arikayce / Cayston: for MAC lung disease, include diagnosis of MAC lung disease, documentation of use as part of combination regimen, and prior sputum culture results showing failure to achieve at least two negative cultures after ≥6 months of multidrug background therapy; prescriber should be infectious disease specialist or pulmonologist.
Everolimus: include diagnosis specifics (e.g., Advanced HR+ breast cancer with prior aromatase inhibitor failure, ARCC with progression after sorafenib/sunitinib) and prescriber specialty (neurologist/oncologist as applicable).
Icatibant: include documented HAE diagnosis with at least one severe attack in past 6 months and confirmatory labs for Types 1 & 2 (low C4, reduced C1 esterase inhibitor level or function); prescriber should be allergist/hematologist/immunologist.
Jynarque (tolvaptan for ADPKD): include baseline liver tests and monitoring plan (ALT, AST, bilirubin measured pre-initiation, at 2 and 4 weeks, then monthly for first 18 months; if >18 months on therapy, labs at least every 3 months).
Lytgobi: include diagnosis of unresectable/metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions; prescriber = oncologist.
Rubraca: include documented deleterious BRCA mutation and platinum‑sensitive response history for maintenance therapy; prescriber = oncologist.
Stivarga: include diagnosis (GIST, HCC, metastatic colorectal cancer) and documentation of prior failures (imatinib, sunitinib, sorafenib, and relevant chemotherapies); prescriber = oncologist.

Step Therapy

Step therapy / prerequisite Part D drug — provider actions

Step therapy / prerequisite Part D drug notes: when Criteria indicates "Criteria DOES require use of a prerequisite Part D drug", attach pharmacy records or prescriber attestation documenting prior Part D drug trials or provide rationale for why a trial is clinically inadvisable.

Kineret (RA): document trial and failure/intolerance/contraindication to conventional therapies as specified for RA.
Lipid‑lowering (Nexletol/Nexlizet): document maximally tolerated statin therapy or statin intolerance and LDL‑C level and qualifying diagnosis (HeFH, ASCVD, high CVD risk).
Otezla: for certain dermatologic indications, document trial and failure of required topical therapies.
Stelara, Voquezna, select immunomodulators: document required prior generic or branded therapy trials per product entry.

Step Therapy / Required Prior Trials

Drug / Context	Required prior agent(s)
Adalimumab family — Rheumatoid arthritis (RA)
Trial and failure, contraindication, or intolerance to ONE conventional therapy: methotrexate, leflunomide, or sulfasalazine
Adalimumab family — Polyarticular juvenile idiopathic arthritis (PJIA)
Trial and failure, contraindication, or intolerance to ONE conventional therapy: methotrexate, leflunomide, or sulfasalazine
Adalimumab family — Plaque psoriasis
Failed or unable to tolerate at least one topical agent (corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, or coal tar)

Situation	Documented trial(s) required
Plaque psoriasis (biologics like Cosentyx, Skyrizi)
Failure or intolerance to at least one topical class (corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar)
Non-radiographic axial spondyloarthritis / Enthesitis-related arthritis
Minimum one-month trial and failure, contraindication, or intolerance to TWO NSAIDs at maximally indicated doses
Migraine (Ubrelvy) — acute treatment
Inadequate response, intolerance, or contraindication to at least one triptan medication

Product / Area	Prerequisite Part D drug required?
Everolimus (multiple indications) — e.g., Advanced HR+ BC, ARCC, NET
Criteria DOES require use of a prerequisite Part D drug (specified per indication)
Gomekli (neurofibromatosis type 1) — plexiform neurofibromas
Criteria DOES NOT require use of a prerequisite Part D drug
Type 2 Diabetes GLP-1 agents (initial)
Criteria DOES require use of a prerequisite Part D drug (minimum 90-day trial of listed comparator agents or documentation)
Jaypirca (GVHD, myelofibrosis, PV) — hematology indications
Criteria DOES require use of a prerequisite Part D drug

Scenario	Required documentation / alternative
Kineret — Rheumatoid arthritis initial
Trial and failure, contraindication, or intolerance to TWO of the listed agents (etanercept, a formulary adalimumab, abatacept, upadacitinib, tofacitinib) OR attestation that trials are inappropriate OR continuation of prior therapy
Kineret — NOMID initial
Confirmatory NLRP3 mutation OR two characteristic clinical symptoms plus elevated acute phase reactants (attest if mutation testing not available)

Agent / Indication	Required prior chemotherapy regimens (document)
Krazati (adagrasib) — NSCLC
Document prior systemic therapy: patient has received at least one prior systemic therapy (eg, chemotherapy, immunotherapy)
Krazati — Colorectal cancer
Document prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
Fotivda — relapsed/refractory RCC
Document prior two or more systemic therapies for advanced RCC

Therapy area / product	Trial and failure requirement
Nerlynx (extended adjuvant HER2+ breast cancer)
Prior adjuvant Herceptin-based therapy required; for advanced/metastatic use, prior two or more anti-HER2 regimens
Nexletol / Nexlizet (lipid-lowering)
Elevated LDL-C while on maximally tolerated statin therapy OR statin contraindication/intolerance

Drug (example)	Prior therapy failure required
Rinvoq — Rheumatoid arthritis and other indications
Requires trial and inadequate response or intolerance to TNF inhibitors for multiple indications; for RA includes trial/failure of a conventional therapy plus TNF inhibitor failure (documentation required)

Product / Indication	Topical trial required
Otezla — Plaque psoriasis
Failure or intolerance to at least one listed topical therapy (corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar) required before approval

Product	Prior trial(s) required before approval
Skyrizi — Plaque psoriasis
Failed or intolerant to at least one topical class (corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar) or other listed therapies prior to biologic approval
Skyrizi — Crohn's disease
Document diagnosis of moderate-to-severe Crohn's disease with prescriber consultation as specified (prior therapy per indication)

Voquezna use case	Required prior therapies
H. pylori (Voquezna Dual/Triple Pak or Voquezna)
Trial and failure, contraindication, or intolerance to bismuth quadruple therapy required before Voquezna regimens
HRH / MHRH / NERD indications
Inadequate response, intolerance, or contraindication to TWO generic PPIs required for erosive esophagitis healing/maintenance or NERD criteria as specified

Acute migraine treatment	Required prior agent
Ubrelvy — migraine acute treatment
Inadequate response, intolerance, or contraindication to at least one triptan medication required prior to approval

Agent / Example	Required prior therapies before authorization
Xeljanz / other JAK inhibitors — Rheumatoid arthritis
Trial and failure, contraindication, or intolerance to ONE conventional therapy (methotrexate, leflunomide, or sulfasalazine) AND inadequate response or intolerance to one or more TNF inhibitors required before authorization
Stelara / similar biologics
Trial, intolerance, or contraindication to Yesintek or Steqeyma prior to coverage (per indication)

Coverage Exclusions and Coding-related Notes

Denial Risk

Denial risk: missing diagnosis or prescriber specialty

Requests lacking required documentation of diagnosis or prescriber specialty for drugs that list those requirements may be denied; always include the diagnosis and specialty documented in the product entry.

Denial Risk

Denial risk: Dupixent exclusion for acute bronchospasm/status asthmaticus

Dupixent will not be approved for relief of acute bronchospasm or status asthmaticus; do not submit PA requests for those indications.

Denial Risk

Denial risk: Icatibant exclusion for acquired angioedema or ACE inhibitor use

Icatibant will not be approved for members with acquired angioedema or for those concurrently taking an ACE inhibitor.

Denial Risk

Denial risk: Iclusig exclusion for newly diagnosed chronic phase CML

Iclusig will not be approved for members with newly diagnosed chronic phase CML; verify that the indication and disease phase match the product criteria.

Denial Risk

Denial risk: insufficient diagnostic or prior therapy documentation

Requests lacking documentation of required diagnosis or prior therapy (e.g., high fracture risk or prior osteoporosis therapy trials for denosumab entries) may be denied—include the necessary diagnostic and prior therapy evidence.

Denial Risk

Denial risk: Mekinist prior therapy exclusion

Mekinist will not be approved as a single agent for members who have received prior BRAF‑inhibitor therapy; ensure prior therapy history matches the product exclusion.

Denial Risk

Denial risk: explicit coverage exclusion — quinine for leg cramps

Quinine sulfate will not be approved for treatment or prevention of nocturnal leg cramps; do not submit for this indication.

Denial Risk

Denial risk: Rubraca concurrent therapy exclusion

Rubraca will not be approved for concurrent use with other chemotherapy agents; ensure requests document non‑concurrent use when seeking maintenance coverage.

Denial Risk

Denial risk: Rydapt treatment setting exclusion (no single‑agent induction)

Rydapt will not be approved as single‑agent induction therapy for AML; authorization applies when used as first‑line in combination with standard induction and consolidation regimens per the product criteria.

Denial Risk

Denial risk: TIRF exclusion for non‑cancer pain

TIRF products are not covered for any non‑cancer pain indication; PA requests for non‑cancer pain will be denied.

Denial Risk

Denial risk: TIRF non‑cancer indication denied

TIRF coverage is limited to opioid‑tolerant cancer patients; do not submit for non‑cancer pain as these requests will be denied.

Denial Risk

Denial risk: Voquezna prerequisite therapy not met

Voquezna indications require prior trial/failure/intolerance/contraindication to bismuth quadruple therapy for H. pylori and inadequate response to two generic PPIs for HRH/MHRH/NERD—include those prior therapy records to avoid denial.

Denial Risk

Denial risk: missing ATTR‑CM documentation

Missing documentation for ATTR‑CM (confirmatory testing or NYHA class) may trigger denial; include required confirmatory items and NYHA documentation.

Billing Rule

Billing risk: missing use/setting information affects Part B vs Part D determination

Failure to submit the use and setting of the drug can prevent determination of Medicare Part B versus Part D coverage; include setting and intended use information with the PA.

Key Definitions and Terms Used

Prerequisite Part D drug — definition

DefinitionA required prior Part D medication or therapy that must be tried and documented before the requested Part D/specialty product will be approved.

How documentedPer individual product entries: record of trial duration, reason for failure/intolerance, or attestation that a trial is inappropriate.

When requiredSpecified in product criteria where 'Prerequisite Therapy Required' is indicated (varies by drug).

Most actionableIf a product lists a prerequisite Part D drug, submit documentation of prior use (trial/failure/intolerance) or a clinical justification — requests lacking this may be denied.

Coverage Duration — definition (authorization period, common 2 years)

DefinitionThe authorization period assigned when a therapy is approved by prior authorization; commonly specified as 2 years in this policy excerpt (some products or settings specify 1 year or plan-year).

Typical duration2 years for most listed Part D and specialty drugs; some products (e.g., Jynarque initial) list 1 year or plan-year for ATTR-CM reauth.

Reauthorization noteReauthorization may require documentation of continued benefit (clinical response) and updated diagnostic/monitoring data per product-specific criteria.

Non-radiographic axial spondyloarthritis (nr-axSpA) — definition

DefinitionActive non-radiographic axial spondyloarthritis characterized by objective signs of inflammation (e.g., elevated CRP and/or sacroiliitis on MRI) without definitive radiographic structural damage on sacroiliac joints.

Prior therapy requirementMinimum duration of one-month trials and failure, contraindication, or intolerance to two NSAIDs at maximally indicated doses is required before biologic therapy.

DocumentationProvide objective evidence of inflammation (CRP and/or MRI) and records of the two NSAID trials at appropriate doses/durations.

Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer — definition

DefinitionAdvanced hormone receptor–positive (HR+), HER2‑negative breast cancer: postmenopausal HR+ HER2‑ disease meeting criteria for systemic therapy (e.g., requiring exemestane in combination when prior aromatase inhibitor failure).

Example requirementFor everolimus use in Advanced HR+ BC: member is postmenopausal, concurrently taking exemestane, and has documented failure of letrozole or anastrozole.

PrescriberPrescribing physician typically a medical oncologist per product entry.

Subependymal Giant Cell Astrocytoma (SEGA) — definition

DefinitionSubependymal giant cell astrocytoma (SEGA): a TSC‑associated intracranial tumor documented as SEGA where the patient is not a candidate for surgical resection or requires systemic therapy.

ContextListed as an indication for everolimus and other TSC‑related agents; prescriber should be a neurologist or oncologist per entries.

DocumentationProvide clinical diagnosis of SEGA associated with tuberous sclerosis complex and rationale for medical (non‑surgical) management.

Rapidly progressing ADPKD — definition

DefinitionRapidly progressing autosomal dominant polycystic kidney disease (ADPKD): ADPKD with clinical features indicating rapid progression and eligibility for tolvaptan (Jynarque) initiation.

Monitoring requirementBaseline and ongoing hepatic monitoring required: ALT/AST/bilirubin prior to initiation, at 2 and 4 weeks after initiation, then monthly for the first 18 months (if <=18 months total therapy) or at least every 3 months if patient has received Jynarque >18 months.

Liver injury exclusionPatient must not have history of significant liver impairment or injury (excluding uncomplicated polycystic liver disease).

NOMID — definition

DefinitionNOMID (Neonatal‑Onset Multisystem Inflammatory Disease): an autoinflammatory disorder requiring confirmation by NLRP3 (CIAS1) mutation or clinical criteria (≥2 characteristic symptoms) plus elevated acute phase reactants for Kineret authorization.

Diagnostic criteriaEither genetic confirmation (NLRP3 mutation) OR two characteristic clinical features (e.g., urticaria-like rash, sensorineural hearing loss, chronic aseptic meningitis, musculoskeletal symptoms, skeletal abnormalities) plus elevated ESR/CRP/SAA.

PrescriberPrescribed by or in consultation with allergist/immunologist, rheumatologist, or pediatric specialist as specified.

gBRCA-mutated — definition

DefinitiongBRCA‑mutated: deleterious or suspected deleterious germline BRCA mutation (gBRCA) documented for indications such as Lynparza in breast, ovarian, pancreatic, or prostate cancer.

Use caseDocumentation of germline or somatic BRCA mutation is required per product-specific criteria (e.g., Lynparza maintenance/therapeutic settings).

EvidenceSubmit genetic testing results (germline and/or somatic) consistent with the product entry requirement.

FGFR2 fusion/rearrangement — definition

DefinitionFGFR2 fusion/rearrangement: presence of fibroblast growth factor receptor 2 gene fusions or other rearrangements detected in intrahepatic cholangiocarcinoma or related tumors and required for FGFR2‑targeted therapies (e.g., Lytgobi).

TestingProvide tumor genomic testing demonstrating FGFR2 fusion or rearrangement; prescriber typically an oncologist.

Indication contextUsed to establish eligibility for targeted FGFR2 inhibitors in previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma.

MASH (Metabolic dysfunction-associated steatohepatitis) — definition

DefinitionMetabolic dysfunction‑associated steatohepatitis (MASH): formerly known as NASH; diagnosis of MASH without cirrhosis with fibrosis stage F2 or F3 required for certain therapies (e.g., Rezdiffra).

Diagnostic confirmationFibrosis stage F2‑F3 must be confirmed by specified testing: combinations of serum biomarkers (e.g., ELF, FIB‑4) plus imaging biomarkers (e.g., FibroScan, MRI‑PDFF) OR alternative validated biomarker/imaging panels or liver biopsy within 12 months.

Risk factorsAt least one metabolic risk factor (e.g., Type 2 diabetes, hypertension, obesity) must be present for initiation criteria.

PIK3CA-mutated breast cancer — definition

DefinitionPIK3CA‑mutated breast cancer: hormone receptor‑positive (HR+), HER2‑negative advanced or metastatic breast cancer harboring a PIK3CA mutation, for which Piqray (alpelisib) in combination with fulvestrant is indicated after progression on endocrine therapy.

DocumentationSubmit tumor genomic testing confirming PIK3CA mutation and evidence that Piqray will be used with fulvestrant following progression on an endocrine‑based regimen.

PrescriberPrescribing physician should be an oncologist per product criteria.

Opioid tolerant — definition (morphine equivalent thresholds)

DefinitionOpioid‑tolerant: patients taking around‑the‑clock opioid therapy equivalent to morphine 60 mg/day or more (or specified equianalgesic doses) for a week or longer qualify as opioid tolerant for TIRF coverage.

Equianalgesic examplesExamples listed: morphine oral 60 mg/day or more; fentanyl transdermal 25 mcg/hour or more; oxycodone oral 30 mg/day or more; hydromorphone oral 8 mg/day or more; or an equianalgesic dose of another opioid daily for a week or longer.

Policy implicationOpioid tolerance must be documented for TIRF approval; patients must remain on around‑the‑clock opioids while receiving transmucosal fentanyl.

Opioid tolerant (duplicate definition entry)

Definition (duplicate)Opioid‑tolerant: patients taking around‑the‑clock opioids (examples and equianalgesic doses provided) for a week or longer qualify as opioid tolerant for TIRF products.

Common examplesMorphine 60 mg/day, fentanyl transdermal 25 mcg/hr, oxycodone 30 mg/day, hydromorphone 8 mg/day, or equianalgesic opioid dose daily for ≥1 week.

Coverage noteTIRF products are covered only for opioid‑tolerant adult cancer patients with breakthrough pain and are not covered for non‑cancer pain.

NYHA Functional Class — definition

DefinitionNYHA Functional Class: New York Heart Association classification I–III; documentation of NYHA Class I, II, or III heart failure is required for initiation and reauthorization of ATTR‑CM therapies (e.g., Vyndamax).

Use in policyReauthorization requires continued documentation that the patient remains NYHA Class I–III; prescriber must be a cardiologist.

Coverage periodATTR‑CM coverage is managed on a plan‑year basis per the policy entry.

Part B Versus Part D determination — definition and submission note

DefinitionPart B Versus Part D determination: a billing/coverage decision that some drugs may be payable under Medicare Part B or Part D depending on the clinical use and setting; the payer may request submission of information describing the drug's use and setting to make this determination.

What to submitProvide information describing the intended use and care setting (e.g., outpatient infusion, physician‑administered versus self‑administered) to allow determination of Part B vs Part D coverage.

ConsequenceFailure to submit use/setting information may prevent accurate Part B/Part D determination and delay authorization decisions.

OpenPayer

Prior authorization medical necessity guidelines — Part 1 (drug product list excerpt)

Drug-specific Coverage Criteria (Selected Excerpts)

Actions, Documentation, and Denial Risks for Prescribers

Initial Therapy / Conventional Therapy Requirements

Reauthorization and Continuation of Therapy

Step Therapy / Required Prior Trials

Site of Care and Billing Determination Notes

Coverage Exclusions and Coding-related Notes

Key Definitions and Terms Used

Background and Scope