Prior authorization medical necessity guidelines — formulary product listings (partial)
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Section of Harvard Pilgrim Health Care's 2026 prior authorization medical necessity guidelines listing pharmacy products and summarizing prior authorization criteria, documentation, step therapy and prescriber restrictions for selected specialty drugs.
No material clinical or coverage changes in this revision.
Coverage Criteria — Product-Specific Requirements
inv-01: Abilify Mycite — Initial Therapy — coverage when criteria met
Covered when ALL of the following are met:
From product PA summary (chunk 5).
inv-02: Abiraterone — Initial Therapy — coverage when criteria met
Covered when ALL of the following are met:
From product PA summary (chunk 10).
inv-03: Humira and Biosimilars - Indication and Prescriber Requirements — high-level summaries (partial)
High-level indication and prescriber summaries (partial):
Prescriber specialty or consultation required by indication (e.g., dermatologist, gastroenterologist, ophthalmologist, rheumatologist); coverage duration typically 2 years; some Humira entries require prerequisite Part D therapy (chunk 29).
inv-04: Aimovig - Migraine — requirements (partial)
Covered when ALL of the following are met:
Initial approval duration: 6 months; subsequent approval: 2 years; no prerequisite Part D drug required (chunk 32).
inv-05: Akeega - Prostate Cancer — requirements (partial)
Covered when ALL of the following are met:
From product PA summary (chunk 35).
inv-06: Alecensa - Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug not required (chunk 38).
inv-07: Alunbrig - Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug not required (chunk 43).
inv-08: Alosetron - Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug not required (chunk 41).
inv-09: Arcalyst - Indications — Covered when ALL of the following are met
Covered when ALL of the following are met:
Coverage duration 2 years; prerequisite Part D drug not required (chunk 45).
inv-10: Arikayce - Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug required (background multidrug regimen) (chunk 48).
inv-11: Armodafinil/Modafinil - Indications — Covered when ALL of the following are met
Covered when ALL of the following are met:
Not approved for generalized fatigue, jet‑lag, or sleep‑deprivation not associated with a covered diagnosis (chunk 52).
inv-12: Augtyro - Indications — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug not required in excerpt (chunk 55).
inv-13: Augtyro Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
From Augtyro product summary (chunk 55).
inv-14: Austedo Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Coverage duration and details per product summary (chunk 60).
inv-15: Avmapki Fakzynja Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug required per product summary (chunk 63).
inv-16: Ayvakit Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
From product summary (chunk 66).
inv-17: Balversa Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug required (chunk 69).
inv-18: Benlysta Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Benlysta will not be approved as monotherapy, for members with severe active lupus nephritis or severe active CNS lupus, for autoantibody‑negative members, or in combination with other biologics or IV cyclophosphamide (chunk 72).
inv-19: Benlysta — Initial Therapy — (duplicate inventory entry)
Covered when ALL of the following are met:
Exclusions: not approved as monotherapy, for severe active lupus nephritis or severe active CNS lupus, for autoantibody‑negative members, or combined with other biologics/IV cyclophosphamide (chunk 72).
inv-20: Berinert — Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
From product summary (chunk 75).
inv-21: Besremi — Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
From product summary (chunk 78).
inv-22: Bexarotene gel — Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
From product summary (chunk 81).
inv-23: Bosulif — Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug required (chunk 85).
inv-24: Braftovi — Indication-Specific Criteria — Covered when ALL of the following are met (by indication)
Covered when ALL of the following are met (by indication):
Not indicated for wild‑type BRAF melanoma or wild‑type BRAF CRC (chunk 88).
inv-25: Brukinsa — Indication-Specific Criteria — Covered when ALL of the following are met
Covered when ALL of the following are met (indication‑specific):
Prerequisite Part D drug required for some indications (chunk 91).
inv-26: Brukinsa - Covered with criteria — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug required for some indications (chunk 91).
inv-27: Cabometyx - Covered with criteria — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug required (chunk 94).
inv-28: Calquence - Covered with criteria — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug required (chunk 97).
inv-29: Caplyta - Covered with criteria — Covered when ALL of the following are met
Covered when ALL of the following are met:
No prerequisite Part D drug required per excerpt (chunk 100).
inv-30: Caprelsa - Covered with criteria — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug not required (chunk 103).
inv-31: Carglumic Acid - Covered with criteria — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug not required (chunk 106).
inv-32: Cayston - Covered with criteria — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug not required per excerpt (chunk 109).
inv-33: Cayston - Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
From Cayston PA summary (chunk 109).
inv-34: Cobenfy Starter Pack - Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
From product summary (chunk 113).
inv-35: Cometriq - Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
From product summary (chunk 116).
inv-36: Copiktra - Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug required (chunk 119).
inv-37: Cosentyx - Indication-specific Criteria — Covered when ALL relevant indication-specific criteria are met
Covered when ALL relevant indication‑specific criteria are met:
From Cosentyx PA summary (chunks 124–125).
From product summary (chunks 124–125).
inv-38: Cotellic — Covered when ALL of the following are met
Covered when ALL of the following are met:
Exclusion: not indicated for wild‑type BRAF melanoma (chunk 128).
inv-39: Cresemba — Covered when ALL of the following are met
Covered when ALL of the following are met:
From product summary (chunk 131).
inv-40: Danziten — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug required; continuation of prior therapy approvable (chunk 134).
inv-41: Dasatinib — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug required (chunk 137).
inv-42: Daurismo — Covered when ALL of the following are met
Covered when ALL of the following are met:
From product summary (chunk 140).
inv-43: Diacomit — Covered when ALL of the following are met
Covered when ALL of the following are met:
From product summary (chunk 143).
inv-44: Dichlorphenamide Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
From product summary (chunk 146).
inv-45: Doptelet Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prerequisite Part D drug required (chunk 149).
inv-46: Droxidopa Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
From product summary (chunk 152).
inv-47: Dupixent Indication-Specific Criteria — Covered when ALL applicable indication-specific criteria are met
Covered when ALL applicable indication‑specific criteria are met:
Prerequisite Part D drug required for listed indications (chunks 155–156).
From product summary (chunks 155–156).
No explicit exclusion criteria for Abilify Mycite are listed in this extract. The product entry indicates Off-Label Uses: N/A and Exclusion Criteria: N/A, and requires documented diagnosis and prior oral aripiprazole worsening for PA. (See product listing for full criteria.)
No explicit exclusion criteria for Abiraterone are listed in this extract. The entry reports Off-Label Uses: N/A and Exclusion Criteria: N/A, and specifies required documentation that abiraterone is used in combination with prednisone for the approved prostate cancer indications.
Off-label uses are not specified in this excerpt for the products shown. Where listed in the extract, Off-Label Uses are recorded as N/A for the product entries included here.
For armodafinil/modafinil, the policy explicitly excludes use for generalized fatigue, jet lag, or sleep-deprivation not associated with a covered diagnosis. Covered indications in the entry are narcolepsy, excessive sleepiness associated with obstructive sleep apnea, and shift-work sleep disorder.
Provider Actions — Prior Authorization, Documentation, and Denial Risks
Abilify Mycite — submit PA with diagnosis and oral aripiprazole failure/worsening
Abilify Mycite requires prior authorization. The provider must document a diagnosis of bipolar I disorder, major depressive disorder, or schizophrenia and show worsening symptoms on oral aripiprazole; the prescribing physician must be a psychiatrist. Coverage duration is 2 years; a prerequisite Part D drug (oral aripiprazole) is required prior to approval.
- Documented diagnosis (bipolar I disorder, major depressive disorder, or schizophrenia)
- Documentation of worsening symptoms with oral aripiprazole
- Prescriber must be a psychiatrist
- Prerequisite Part D drug: oral aripiprazole required
- Coverage duration: 2 years
Abiraterone — submit PA with diagnosis and combination therapy statement
Submit prior authorization for abiraterone with documentation of metastatic castration‑resistant prostate cancer (CRPC) or metastatic high‑risk castration‑sensitive prostate cancer and that abiraterone is being used in combination with prednisone; prescriber must be an oncologist or urologist. Coverage duration is 2 years.
- Documented diagnosis: metastatic CRPC OR metastatic high‑risk castration‑sensitive prostate cancer
- Statement that abiraterone is used in combination with prednisone
- Prescriber must be an oncologist or urologist
- Coverage duration: 2 years
Humira and biosimilars — PA and indication‑specific documentation required
Prior authorization is required for listed Humira products and biosimilars. The provider must supply indication‑specific required medical information and, when specified, prescriber specialty or consultation documentation.
- Documented diagnosis specific to the Humira indication (e.g., ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, RA, PJIA, hidradenitis suppurativa, uveitis)
- For plaque psoriasis and certain indications, documentation of failed/intolerant trials of listed topical/systemic therapies
- Prescriber specialty or consult where specified (dermatologist, gastroenterologist, ophthalmologist, rheumatologist)
- Coverage duration typically 2 years
Aimovig — PA with migraine diagnosis; initial 6 months, then 2 years
Aimovig requires prior authorization. For initial approval submit documented diagnosis of migraine; initial approval is 6 months and subsequent approvals 2 years. For continuation, provide documentation of clinically significant reduction in migraine days per month.
- Documented diagnosis of migraine for initial approval
- Initial approval duration: 6 months; subsequent approval: 2 years
- For continuation: documented clinically significant reduction in migraine days per prescriber assessment
Akeega — PA with oncology diagnosis, BRCA status, and regimen details
Akeega requires prior authorization. The provider must document metastatic prostate cancer with deleterious/suspected deleterious BRCA mutation and that the drug is being used in combination with prednisone per regimen; prescriber must be an oncologist. Coverage duration noted.
- Documented diagnosis: metastatic prostate cancer with deleterious or suspected deleterious BRCA mutation
- Statement that drug is used in combination with prednisone and regimen details as indicated
- Prescriber must be an oncologist
- Coverage duration: 2 years
Alecensa — PA with documented ALK‑positive NSCLC or adjuvant indication
Alecensa prior authorization required. Provide documentation of ALK‑positive metastatic NSCLC or adjuvant use after resection of ALK‑positive tumor; prescriber must be an oncologist. Coverage duration 2 years; no prerequisite Part D drug required.
- Documented diagnosis: ALK‑positive metastatic NSCLC OR adjuvant use post resection of ALK‑positive tumor
- Prescriber must be an oncologist
- Coverage duration: 2 years
Alunbrig — PA with ALK‑positive metastatic NSCLC and oncologist prescriber
Alunbrig requires prior authorization. The provider must document ALK‑positive metastatic NSCLC and the prescriber must be an oncologist. Coverage duration is 2 years.
- Documented diagnosis: ALK‑positive metastatic NSCLC
- Prescriber must be an oncologist
- Coverage duration: 2 years
Alosetron — PA with documented severe diarrhea‑predominant IBS (female)
Alosetron prior authorization required. Submit documentation of severe diarrhea‑predominant irritable bowel syndrome in a female patient. Coverage duration: 2 years.
- Documented diagnosis: severe diarrhea‑predominant IBS in a female
- Coverage duration: 2 years
Arcalyst — PA with indication‑specific diagnostic documentation
Arcalyst requires prior authorization with indication‑specific documentation (e.g., CAPS, IL‑1 receptor antagonist deficiency, recurrent pericarditis). Coverage duration is 2 years.
- Documented diagnosis per indication: CAPS (FCAS/Muckle‑Wells), IL‑1RA deficiency for maintenance in patients ≥10 kg, or recurrent pericarditis with indication‑specific justification
- Coverage duration: 2 years
Arikayce — PA with MAC diagnosis and ≥6 months multidrug regimen failure documentation
Arikayce prior authorization required. The provider must document MAC lung disease, that Arikayce is part of a combination antibacterial regimen, and that the patient did not achieve ≥2 negative sputum cultures after at least 6 consecutive months of a multidrug background regimen; specialist involvement may be required. Coverage duration 2 years.
- Documented diagnosis: Mycobacterium avium complex (MAC) lung disease
- Statement that Arikayce is used as part of a combination antibacterial regimen
- Documentation that patient did not achieve ≥2 negative sputum cultures after ≥6 months of multidrug background regimen
- Prescribed by or in consultation with an infectious disease or appropriate specialist
- Coverage duration: 2 years
Armodafinil/Modafinil — PA with approved sleep disorder diagnosis; exclusions apply
Armodafinil/Modafinil requires prior authorization. Submit documentation of narcolepsy, excessive sleepiness associated with obstructive sleep apnea, or shift‑work sleep disorder. Do not submit for generalized fatigue, jet‑lag, or sleep‑deprivation without a covered diagnosis.
- Documented diagnosis: narcolepsy OR excessive sleepiness associated with OSA OR shift‑work sleep disorder
- Exclusion: generalized fatigue, jet lag, or sleep‑deprivation not associated with a covered diagnosis
- Coverage duration: 2 years
Augtyro — PA with NSCLC or NTRK fusion‑positive tumor diagnostic documentation
Augtyro is subject to prior authorization for indicated uses. Provide documentation that the patient has NSCLC or an NTRK gene fusion–positive solid tumor that is locally advanced/metastatic or not amenable to surgery and has progressed or lacks satisfactory alternatives.
- Documented diagnosis: NSCLC OR NTRK gene fusion–positive solid tumor that is locally advanced/metastatic or where surgery would cause severe morbidity
- Documentation that disease has progressed following treatment or there is no satisfactory alternative therapy
- Coverage duration and prescriber restrictions per full criteria
Augtyro — PA required for all indications; supply listed documentation
Augtyro (all medically‑accepted indications) requires prior authorization with the required documentation as listed in the criteria.
- Submit indication‑specific documentation for all requests per product criteria
Austedo — PA with diagnosis of tardive dyskinesia or Huntington’s chorea
Austedo/Austedo XR require prior authorization. Document the diagnosis (tardive dyskinesia or chorea associated with Huntington’s disease) as specified.
- Documented diagnosis: Tardive dyskinesia OR chorea associated with Huntington’s disease
- Coverage and prescriber details per product criteria
Avmapki Fakzynja — PA with KRAS mutation and prior systemic therapy documentation
Avmapki Fakzynja co‑pack requires prior authorization. Providers must document diagnosis (recurrent low‑grade serous ovarian cancer), presence of a KRAS mutation, and prior systemic therapy.
- Documented diagnosis: recurrent low‑grade serous ovarian cancer (LGSOC)
- Laboratory/proof of KRAS mutation
- Documentation of prior systemic therapy received
- Coverage duration: 2 years
Ayvakit — PA with mutation‑specific diagnosis and specialist prescriber
Ayvakit requires prior authorization. The provider must document the specific indicated diagnosis (e.g., PDGFRA Exon 18 mutation‑positive unresectable/metastatic GIST or systemic mastocytosis) and the prescribing physician must be an allergist, immunologist, or specified specialist.
- Documented diagnosis per indication (PDGFRA Exon 18 mutation‑positive unresectable/metastatic GIST; advanced systemic mastocytosis; indolent systemic mastocytosis)
- Prescriber must be an allergist, immunologist, or specified specialist
- Coverage duration: 2 years
Balversa — PA with FGFR3 alteration and prior therapy documentation
Balversa requires prior authorization. Providers must document locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 alterations and prior systemic therapy; prior PD‑1/PD‑L1 therapy status must be documented.
- Documented diagnosis: locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
- Documentation of progression after at least one line of systemic therapy and prior PD‑1/PD‑L1 inhibitor exposure or ineligibility
- Prescriber specialty per product criteria
- Coverage duration: 2 years
Benlysta — PA: document active autoantibody‑positive SLE and concurrent standard therapy
Benlysta prior authorization requires documented active, autoantibody‑positive systemic lupus erythematosus (or active lupus nephritis) and concurrent standard therapy; prescriber must be a nephrologist or rheumatologist. Benlysta is not approved as monotherapy or for certain severe disease states.
- Documented active, autoantibody‑positive SLE (e.g., ANA, anti‑dsDNA, anti‑Sm) OR active lupus nephritis
- Documentation of concurrent standard therapy (antimalarials, corticosteroids, or immunosuppressives)
- Prescriber must be a nephrologist or rheumatologist
- Exclusions: not approved as monotherapy, for severe active lupus nephritis or severe active CNS lupus, for autoantibody‑negative members, or in combination with other biologics/IV cyclophosphamide
- Coverage duration: 2 years
Benlysta — ensure required medical information and prescriber specialty are documented
Benlysta prior authorization requires the medical documentation above and prescriber specialty (nephrologist or rheumatologist); absence of these may prevent approval.
- See required documentation: active, autoantibody‑positive SLE or active lupus nephritis, concurrent standard therapy
- Prescriber must be a nephrologist or rheumatologist
Berinert — PA: document HAE and allergist/immunologist prescriber
Berinert prior authorization requires documentation of hereditary angioedema and that the prescriber be an allergist or immunologist.
- Documented diagnosis of hereditary angioedema (HAE)
- Prescriber must be an allergist or immunologist
- Coverage duration: 2 years
Bexarotene gel — PA with documented CTCL and specialist prescriber
Bexarotene gel prior authorization requires documentation of cutaneous T‑cell lymphoma and that the prescriber be an oncologist or dermatologist.
- Documented diagnosis of cutaneous T‑cell lymphoma
- Prescriber must be an oncologist or dermatologist
- Coverage duration: 2 years
Bosulif — PA with Ph+ CML documentation and prerequisite Part D therapy
Bosulif prior authorization requires documentation of Philadelphia chromosome‑positive CML per specified scenarios; a prerequisite Part D drug is required and prescriber must be a hematologist or oncologist.
- Documented diagnosis: chronic phase Ph+ CML (newly‑diagnosed or resistant/intolerant to at least one prior therapy) OR accelerated/blast phase Ph+ CML
- Prescriber must be a hematologist or oncologist
- Prerequisite Part D drug required
Braftovi — PA with BRAF mutation, combination therapy details, and oncology prescriber
Braftovi prior authorization requires documentation of BRAF V600E/V600K mutated disease and planned combination therapy per indication; prescriber must be an oncologist. Braftovi is not indicated for wild‑type BRAF disease.
- Documented diagnosis per indication (metastatic CRC with BRAF V600E; unresectable/metastatic melanoma with BRAF V600E/V600K; metastatic NSCLC with BRAF V600E)
- Planned combination therapy details (e.g., cetuximab, binimetinib)
- Prescriber must be an oncologist
- Exclusion: not indicated for wild‑type BRAF melanoma or wild‑type BRAF CRC
- Coverage duration: 2 years
Brukinsa — PA with diagnosis, prior therapy history, and hematology/oncology prescriber
Brukinsa prior authorization requires documented eligible hematologic malignancy with prior therapy history; prescriber must be a hematologist or oncologist and a prerequisite Part D drug is required for some indications.
- Documented diagnosis per indicated hematologic malignancy (e.g., MCL with prior therapy, relapsed/refractory MZL after anti‑CD20 regimen, WM, CLL/SLL, relapsed FL with obinutuzumab)
- Prescriber must be a hematologist or oncologist
- Prerequisite Part D drug required for indicated uses
- Coverage duration: 2 years
Brukinsa — ensure diagnostic and prior‑therapy documentation
Brukinsa prior authorization requires the specific diagnostic and prior‑therapy details and specialist prescriber; missing this documentation may prevent approval.
- Provide documented diagnosis and prior therapies as specified for the requested indication
- Prescriber must be a hematologist or oncologist
Cabometyx — PA with indication‑specific diagnosis and oncology prescriber
Cabometyx prior authorization required. Document the diagnosis corresponding to the requested indication (e.g., advanced RCC, progressed DTC after VEGFR therapy, HCC after sorafenib), and prescriber must be an oncologist; prerequisite Part D drug may be required.
- Documented diagnosis per indication (advanced RCC; DTC progressed after VEGFR therapy and RAI‑refractory/ineligible; HCC with sorafenib failure/contraindication/intolerance; pNET/epNET previously treated)
- Prescriber must be an oncologist
- Prerequisite Part D drug required per indication
- Coverage duration: 2 years
Calquence — PA with hematologic diagnosis, prior therapy details, and specialist prescriber
Calquence prior authorization required. Provide documentation of CLL/SLL or MCL with prior therapy or ineligibility for standard therapy; prescriber must be a hematologist or oncologist; a prerequisite Part D drug may be required.
- Documented diagnosis: CLL/SLL OR MCL with at least one prior therapy or ineligible for standard therapy
- Prescriber must be a hematologist or oncologist
- Prerequisite Part D drug required for some indications
- Coverage duration: 2 years
Caplyta — PA with documented mood disorder diagnosis
Caplyta prior authorization required. Document diagnosis of bipolar depression or major depressive disorder (when used adjunctively); criteria indicate no prerequisite Part D drug is required.
- Documented diagnosis: bipolar depression OR major depressive disorder (if used adjunctively with antidepressant)
- No prerequisite Part D drug required per criteria
Caprelsa — PA with medullary thyroid cancer diagnosis and specialist prescriber
Caprelsa prior authorization required. Document symptomatic or progressive medullary thyroid cancer with unresectable locally advanced disease; prescriber must be an endocrinologist or oncologist.
- Documented diagnosis: symptomatic or progressive medullary thyroid cancer with unresectable locally advanced disease
- Prescriber must be an endocrinologist or oncologist
- No prerequisite Part D drug required
- Coverage duration: 2 years
Carglumic Acid — PA with NAGS deficiency diagnostic documentation
Carglumic Acid prior authorization required. Document chronic or acute hyperammonemia due to N‑acetylglutamate synthase (NAGS) deficiency.
- Documented diagnosis: chronic or acute hyperammonemia due to NAGS deficiency
- No prerequisite Part D drug required
- Coverage duration: 2 years
Cayston — PA: document CF diagnosis and Pseudomonas in lungs
Cayston prior authorization required. Providers must document a diagnosis of cystic fibrosis and evidence of Pseudomonas aeruginosa in the lungs; coverage duration 2 years. Lack of these diagnostics may lead to denial.
- Documented diagnosis: cystic fibrosis
- Evidence of Pseudomonas aeruginosa in the lungs (microbiologic or clinical)
- Coverage duration: 2 years
Cayston — missing diagnostic information may trigger denial
Cayston prior authorization: ensure documentation of CF diagnosis and Pseudomonas aeruginosa evidence when submitting requests; absence may trigger denial.
- Provide CF diagnosis and evidence of Pseudomonas aeruginosa in the lungs
Cobenfy Starter Pack — PA with schizophrenia diagnosis and psychiatrist prescriber
Cobenfy Starter Pack requires prior authorization. Document a diagnosis of schizophrenia and that the prescribing physician is a psychiatrist; continuation of prior therapy may be approvable.
- Documented diagnosis of schizophrenia
- Prescriber must be a psychiatrist
- Coverage duration: 2 years; continuation of prior therapy may be approved
Cometriq — PA with oncology diagnosis and oncologist prescriber
Cometriq requires prior authorization. Document progressive, metastatic medullary thyroid cancer and that the prescriber is an oncologist.
- Documented diagnosis: progressive, metastatic medullary thyroid cancer
- Prescriber must be an oncologist
- Coverage duration: 2 years
Copiktra — PA with relapsed/refractory CLL/SLL and ≥2 prior therapies
Copiktra prior authorization required. Document relapsed or refractory CLL/SLL with at least two prior therapies and that the prescriber is a hematologist or oncologist; absence of this history may lead to denial.
- Documented diagnosis: relapsed or refractory CLL or SLL
- Documentation of at least two prior therapies
- Prescriber must be a hematologist or oncologist
- Coverage duration: 2 years
Cosentyx — PA with indication‑specific prior therapy trials and specialist involvement
Cosentyx prior authorization requires indication‑specific documentation (e.g., failed topical/systemic therapies for plaque psoriasis; two NSAID trials for axial conditions) and that the prescriber be or consult with a dermatologist or rheumatologist; some indications require prerequisite Part D therapy.
- Documented diagnosis per indication and prior therapy trials (e.g., failed topical/systemic agents for plaque psoriasis; minimum one‑month NSAID trials and failure/contraindication/intolerance to two NSAIDs for axial conditions)
- Prescriber must be or consult with dermatologist or rheumatologist
- Prerequisite Part D drug required in some indications
- Coverage duration: 2 years
Provider Actions — Additional Documentation, Step Therapy, and Denial Risks
Step Therapy / Prerequisite Part D Drug Requirements
| Drug | Step therapy requirement |
|---|---|
| Abilify Mycite | Requires prior use of oral aripiprazole (prerequisite Part D drug) with documentation of worsening symptoms on oral aripiprazole prior to approval |
| Scope | Step therapy requirement |
|---|---|
| Selected dermatologic and rheumatologic indications (e.g., plaque psoriasis, RA, PJIA, non-radiographic axial spondyloarthritis, enthesitis-related arthritis) | Trial and failure, contraindication, or intolerance to specified conventional or topical therapies (examples: topical corticosteroids, vitamin D analogs, methotrexate, leflunomide, sulfasalazine) required prior to biologic coverage as specified by indication |
| Drug | Step therapy requirement / Thresholds |
|---|---|
| Arikayce | Prerequisite Part D drug required: member must have received a multidrug background regimen for a minimum of 6 consecutive months and not achieved at least two negative sputum cultures prior to Arikayce approval |
| Drug | Step therapy requirement |
|---|---|
| Avmapki Fakzynja (co-pack) | Prerequisite Part D drug required: criteria specify prior systemic therapy and presence of KRAS mutation; prior therapy must be documented prior to approval |
| Drug | Step therapy requirement |
|---|---|
| Balversa | Prerequisite Part D drug required: member must have progressed during/after at least one line of prior systemic therapy (and prior PD-1/PD-L1 therapy or be ineligible), documented before approval |
| Drugs | Step therapy requirement |
|---|---|
| Bosulif | Prerequisite Part D drug required: criteria require prior therapy (e.g., prior TKI like imatinib) documented before approval |
| Brukinsa | Prerequisite Part D drug required for some indications: documentation of prior therapy (e.g., anti‑CD20 regimen) required prior to approval |
| Drugs | Step therapy requirement |
|---|---|
| Brukinsa | Prerequisite Part D drug required for some indications; prior therapy history must be documented (see product-specific criteria) |
| Cabometyx | Prerequisite Part D drug required: prior VEGFR-targeted therapy or sorafenib failure/contraindication/intolerance must be documented per indication |
| Calquence | Prerequisite Part D drug required: prior therapy or ineligibility for standard therapy must be documented prior to approval |
| Indications | Step therapy requirement |
|---|---|
| Non-radiographic axial spondyloarthritis and enthesitis-related arthritis (Cosentyx) | Minimum one-month trial and failure, contraindication, or intolerance to two NSAIDs at maximally indicated doses required prior to approval |
| Drugs | Step therapy requirement |
|---|---|
| Danziten | Prerequisite Part D drug required: criteria indicate prior therapy (e.g., imatinib) resistance or intolerance must be documented prior to approval |
| Dasatinib | Prerequisite Part D drug required: documentation of resistance or intolerance to prior therapy (including imatinib where specified) required before approval |
| Drug | Step therapy requirement |
|---|---|
| Doptelet | Prerequisite Part D drug required: documentation of prior therapies and indication-specific criteria required prior to approval |
| Drug | Step therapy requirement |
|---|---|
| Dupixent | Prerequisite Part D drug required for listed indications: trial and failure/contraindication/intolerance to specified topical, inhaled, or systemic therapies must be documented per indication |
| Drug | Step therapy requirement |
|---|---|
| Eltrombopag | Prerequisite Part D drug required: indication-specific prior therapies (e.g., corticosteroids, immunoglobulins, splenectomy for ITP) must be documented before approval |
| General statement | Requirement |
|---|---|
| Document trials and outcomes where applicable | Document trial/failure, contraindication, or intolerance to specified prior conventional or listed therapies as required by the product-specific criteria |
| Drug | Step therapy requirement |
|---|---|
| Eucrisa | Initial approval requires trial and failure, contraindication, or intolerance to one prescription-strength topical corticosteroid unless the affected area is sensitive (face, axillae, groin); reauthorization requires documented positive clinical response |
| General statement | Requirement |
|---|---|
| Prerequisite Part D drugs (general) | Some product criteria explicitly require use of a prerequisite Part D drug prior to approval; specific agent(s) may be listed in product-level criteria |
| Drug | Step therapy requirement |
|---|---|
| Trulicity | Initial therapy requires either prescriber documentation of Type 2 Diabetes OR a trial with a minimum 90-day supply of a listed oral antidiabetic agent/class (e.g., metformin-containing agent); reauthorization requires demonstration of positive clinical response |
| Scope | Note |
|---|---|
| Mixed product-level prerequisite Part D therapy indicators | Product entries vary: some (e.g., Hyrnuo, Ibrance, Iclusig) require prerequisite Part D drug use for certain indications, while others do not—refer to product-specific criteria |
| Scope | Note |
|---|---|
| Mixed statements across products | Indicates whether prerequisite Part D drug therapy is required varies by drug and indication; confirm requirement at the product-level criteria |
Continuation Criteria — Reauthorization and Response Requirements
Coding and Key Clinical Thresholds
Definitions and Term Clarifications
Background — Scope and Document Notes
This excerpt is a section of Harvard Pilgrim Health Care's prior authorization medical necessity guidelines summarizing product-specific prior authorization requirements for multiple biologic and specialty drugs. Each product entry includes the required documented diagnosis, any prerequisite therapy or Part D drug requirements, prescriber specialty restrictions where applicable, coverage durations (commonly 2 years), and specific exclusion statements when provided. Providers should consult the full product criteria for detailed documentation and step-therapy requirements before submitting a PA request.
Biosimilar Products and Related PA Notes
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