CurrentBlue Cross Complete of MichiganPolicy H9572_27PASTPPOInd_C

Medicare Part D Prior Authorization and Step Therapy Criteria

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This document governs prior authorization and step therapy requirements for medications under the 2027 Medicare Plus Blue PPO and Meijer Core Comprehensive Formulary programs. Coverage may require clinical or administrative criteria, and some drugs may require prior treatment with formulary alternatives.

Policy Summary

PayerBlue Cross Complete of Michigan

PolicyMedicare Part D Prior Authorization and Step Therapy Criteria

Policy CodePolicy H9572_27PASTPPOInd_C

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with the applicable clinical documentation and evidence of required prerequisite therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2027Plan year

354Document pages

PA and STAuthorization types

5Products pending CMS review

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CurrentBlue Cross Complete of MichiganPolicy H9572_27PASTPPOInd_C

Medicare Part D Prior Authorization and Step Therapy Criteria

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Policy Summary

PayerBlue Cross Complete of Michigan

PolicyMedicare Part D Prior Authorization and Step Therapy Criteria

Policy CodePolicy H9572_27PASTPPOInd_C

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with the applicable clinical documentation and evidence of required prerequisite therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2027Plan year

354Document pages

PA and STAuthorization types

5Products pending CMS review

Explicit coverage exclusions

Medication Coverage Criteria

All medically accepted indications

Coverage is listed for all medically accepted indications.

The medication is requested for a medically accepted indication.

Prior authorization applies.

Afinitor breast cancer criteria

Covered when the breast cancer indication and both treatment requirements are met.

ALL of the following

Advanced hormone receptor-positive, HER2-negative breast cancer.
Use in combination with exemestane.
Trial of letrozole or anastrozole.

Afinitor RCC criteria

Covered for renal cell carcinoma when the prerequisite therapy requirement is met.

ALL of the following

Renal cell carcinoma.
Trial of sunitinib or sorafenib.

Akeega prostate cancer criteria

Covered when either applicable prostate cancer pathway is met.

ONE of

Deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, with combination use with prednisone.
Deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer.

Alpha-1-proteinase inhibitor criteria

Covered when all clinical eligibility requirements are met.

ALL of the following

ONE of
- Necrotizing panniculitis.
- Alpha-1 antitrypsin deficiency with FEV1 less than 80% predicted.FEV1 <80% predicted
Age 18 years or older.>=18 years
Congenital alpha-1 antitrypsin deficiency consistent with PIZZ, PIZ (null), or PI (null, null) phenotype.

Alunbrig criteria

Covered when all requirements are met.

ALL of the following

ALK-positive metastatic disease.
Prior crizotinib therapy.

Ambrisentan criteria

Covered when all requirements are met, unless the treatment-naive exception applies.

ALL of the following

WHO Group 1 pulmonary arterial hypertension.
Right-heart catheterization is documented.
Prescribed by or in consultation with a cardiologist or pulmonologist.
ONE of
- Trial of sildenafil or tadalafil.
- Patient is treatment-naive.

Arcalyst criteria

Covered when all requirements are met.

ALL of the following

Specified recurrent inflammatory condition.
Prior anti-inflammatory therapy in combination with colchicine.

Pending CMS criteria

Final criteria are pending CMS review.

Final coverage criteria for Adbry and Adempas are pending CMS review.

No finalized clinical criteria are provided.

Medically accepted indications

Covered when used for a medically accepted indication, subject to any product-specific requirements.

The requested medication is used for a medically accepted indication.

Product-specific criteria may also apply.

Auvelity

Covered when both requirements are met.

ALL of the following

Major depressive disorder.
Prior use of another generic formulary antidepressant.

Balversa

Covered when both requirements are met.

ALL of the following

Locally advanced or metastatic urothelial carcinoma.
Trial of at least one prior systemic therapy.>=1 prior systemic therapy

Banzel

Covered when the required prerequisite therapy has been tried.

Trial of divalproex or the additional prerequisite therapy identified in the policy.

The remainder of the prerequisite statement is truncated in the source.

Beqalzi

Covered when both requirements are met.

ALL of the following

Relapsed or refractory mantle cell lymphoma.
Trial of a BTK inhibitor.

Bexarotene

Covered for medically accepted indications; the following applies to cutaneous T-cell lymphoma.

Prior systemic therapy for cutaneous T-cell lymphoma.

Bexarotene topical

Covered for medically accepted indications; the following applies to cutaneous T-cell lymphoma.

Use after, or documented intolerance of, other therapies.

Bosentan

Covered when all clinical and treatment requirements are met.

ALL of the following

WHO Group 1 pulmonary arterial hypertension.
Right-heart catheterization is documented.
Prescribed by or in consultation with a cardiologist or pulmonologist.
Trial of sildenafil or tadalafil unless the treatment-naive exception applies.

Bosulif

Covered for medically accepted indications; the displayed oncology pathway requires prerequisite therapy.

For the accelerated-phase or other specified oncology indication, meet the stated prerequisite therapy requirement.

The indication and prerequisite wording are truncated in the source.

Briviact

Covered when prior antiseizure therapy is documented.

ALL of the following

Trial of levetiracetam.
Trial of one additional therapy.
The additional therapy is not identified in the source excerpt.

Brukinsa

Covered when the requirement for the requested diagnosis is met.

ONE of

Mantle cell lymphoma: Trial of Calquence.
Relapsed or refractory marginal zone lymphoma: Trial of at least one anti-CD20-based regimen.>=1 regimen
Relapsed or refractory follicular lymphoma: Combination use with obinutuzumab and trial of at least two lines of systemic therapy.>=2 lines
CLL or SLL:

Budesonide ER

Covered for medically accepted indications except the following use.

Maintenance of remission in ulcerative colitis is excluded.

Bysanti

Covered when the applicable indication-specific prerequisite is met.

ONE of

Adult schizophrenia: Trial of lurasidone and paliperidone.
All other indications: Trial of at least two agents from the specified prerequisite list.>=2 agents
The list is truncated in the source.

Cabometyx

Covered when the requirement for the requested indication is met.

ONE of

First-line advanced renal cell carcinoma: combination use with nivolumab.
Hepatocellular carcinoma: trial of sorafenib.
Locally advanced or metastatic differentiated thyroid cancer that is radioactive iodine-refractory or ineligible: trial of VEGFR-targeted therapy.

Calcipotriene

Covered after prerequisite topical therapy.

Trial of at least one generic topical therapy.>=1 generic topical

Calquence

Covered for medically accepted indications; additional MCL requirements apply.

For mantle cell lymphoma, at least one prior MCL therapy has been received.>=1 prior MCL therapy

A separate criterion for previously untreated MCL is incomplete in the source.

Cavhanza

Covered when formulation and disease-specific requirements are met.

ALL of the following

Unable to swallow the capsule formulation.
For specified chronic-phase or accelerated-phase Philadelphia chromosome-positive CML, prior therapy included imatinib.

Tadalafil

Covered when the exclusion does not apply.

The patient is not receiving nitrate therapy.

Cobenfy

Covered for schizophrenia after prerequisite antipsychotic therapy.

ALL of the following

Treatment of schizophrenia.
Prior use of antipsychotics.

Copiktra initial therapy

Covered when both requirements are met.

ALL of the following

Relapsed or refractory CLL.
At least two prior therapies.>=2 prior therapies

Cotellic initial therapy

Covered when both requirements are met.

ALL of the following

Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.
Prerequisite use of vemurafenib.

Daurismo

Covered when both requirements are met.

ALL of the following

Treatment of newly diagnosed disease.
Use of a prerequisite Part D drug.

Diacomit

Covered when both requirements are met.

ALL of the following

Trial of two generic anticonvulsants.2 anticonvulsants
Combination use with clobazam.

Dihydroergotamine nasal spray

Covered after both formulary triptan trials.

ALL of the following

Trial of one oral formulary triptan.
Trial of one non-oral formulary triptan.

Drizalma Sprinkle

Coverage requires the stated member confirmation.

Confirmation that the member meets the criterion.

The criterion is incomplete in the source excerpt.

Dulera initial therapy and reauthorization

Initial therapy requires one listed inhaled-therapy trial; reauthorization requires response.

Initial therapy: Trial of Breo Ellipta or Advair HFA.

Reauthorization: Response to therapy.

Emsam

Covered after the required trials.

Trial with two of the listed alternatives.2 trials

The alternatives are not provided in the source excerpt.

Criteria pending CMS review

Final criteria are pending CMS review.

Indications, exclusions, prerequisite therapy, and other criteria are pending CMS review for Dupixent, Ebglyss, Enbrel, and Endari.

Entyvio Pen Crohn's disease and ulcerative colitis

Covered when all Crohn's disease requirements are met.

ALL of the following

Moderately to severely active Crohn's disease.
Trial of two of adalimumab-aaty or adalimumab-fkjp, Steqeyma or Yesintek.2 therapies
Currently receiving or previously received intravenous Entyvio induction dosing.

Epidiolex diagnosis-specific criteria

Covered when the diagnosis-specific prerequisite is met.

ONE of

Lennox-Gastaut syndrome: Trial of two generic seizure-treatment alternatives.2 alternatives
Dravet syndrome: Trial of two of valproic acid, clobazam, or topiramate.2 therapies
Tuberous sclerosis complex seizures: Trial of two generic seizure-treatment alternatives.2 alternatives

Eprontia migraine prevention

Covered for migraine prevention when either pathway applies.

ONE of

Trial of at least two generic migraine-prevention alternatives.2 alternatives
Unable to swallow tablets or capsules.

Eucrisa

Covered for atopic dermatitis after the required topical-steroid trial.

Trial of a generic topical steroid.1 generic topical steroid

Eulexin

Covered after the required antiandrogen trial.

Trial of generic bicalutamide.

Fanapt

Covered when the applicable indication-specific prerequisite is met.

ONE of

Adult schizophrenia: Trials of lurasidone and paliperidone.
Other indications: Trials of at least two listed alternatives.>=2 alternatives
The alternatives are not shown in the source excerpt.

Fasenra

Final criteria are pending CMS review.

Indications, exclusions, prerequisite therapy, and other criteria are pending CMS review.

Fetzima

Covered for major depressive disorder after the stated prerequisite therapy.

Trial of the required antidepressant therapy, including desvenlafaxine and duloxetine as identified in the source.

The source wording is truncated.

Filspari

Final criteria are pending CMS review.

Indications, exclusions, prerequisite therapy, and other criteria are pending CMS review.

Fintepla

Covered after the required prerequisite trials.

Trials of two prerequisite therapies.2 therapies

The specific therapies are not shown in the source excerpt.

Fotivda

Covered for advanced renal cell carcinoma after prior systemic therapy.

Trial of two or more prior systemic therapies.>=2 therapies

Fruzaqla

Covered for metastatic colorectal cancer after all applicable prior therapies.

ALL of the following

Trial of fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
Trial of an anti-VEGF therapy.
Trial of an anti-EGFR therapy.

Fulphila

Covered for all medically accepted indications.

Use for a medically accepted indication.

No prerequisite Part D therapy is required.

Perampanel

Covered after the required generic trials.

Trial of two generic drugs.2 generic trials

Gavreto

Covered when the specified thyroid cancer setting is documented.

ALL of the following

Advanced or metastatic RET fusion-positive thyroid cancer requiring systemic therapy.
Radioactive iodine is appropriate.

Fingolimod hydrochloride

Covered for all medically accepted indications.

Use for a medically accepted indication.

Gilotrif

Covered as first-line therapy when all biomarker and disease requirements are met.

ALL of the following

Metastatic non-small cell lung cancer.
Non-resistant EGFR mutation detected by an FDA-approved test.
First-line treatment.
Use of a prerequisite Part D drug.

Gomekli

Covered for all medically accepted indications.

Use for a medically accepted indication.

Growth hormone

Covered for all medically accepted indications.

Use for a medically accepted indication.

Plan-year coverage applies to Genotropin and Genotropin Miniquick.

Haegarda

Final criteria are pending CMS review.

Indications, exclusions, prerequisite therapy, and other criteria are pending CMS review.

Hernexeos

Covered for all medically accepted indications.

Use for a medically accepted indication.

Tasimelteon

Covered for all medically accepted indications.

Use for a medically accepted indication.

Humira indication-specific coverage

Covered when the applicable indication-specific requirements are met.

ONE of

Rheumatoid arthritis: Moderately to severely active disease and trial of one DMARD.
Polyarticular juvenile idiopathic arthritis: Active disease and trial of leflunomide or methotrexate.
Psoriatic arthritis: Active psoriatic arthritis.
Plaque psoriasis: Moderate to severe chronic plaque psoriasis.

Ibrance breast cancer coverage

Covered when the applicable breast cancer regimen is documented.

ONE of

HR-positive/HER2-negative advanced or metastatic breast cancer with an aromatase inhibitor as initial endocrine-based therapy or fulvestrant after progression on endocrine therapy.
Endocrine-resistant, PIK3CA-mutated, HR-positive/HER2-negative locally advanced or metastatic breast cancer with inavolisib and fulvestrant following recurrence on or after adjuvant endocrine therapy.

Iclusig leukemia coverage

Covered when the applicable leukemia pathway is met.

ONE of

Newly diagnosed Ph-positive ALL with chemotherapy.
T315I-positive Ph-positive ALL as monotherapy when no other kinase inhibitor is indicated.
T315I-positive CML in chronic, accelerated, or blast phase.
Accelerated- or blast-phase CML when no other kinase inhibitor is indicated.
Other chronic-phase CML indications after trials of at least two prior kinase inhibitors.>=2 prior kinase inhibitors

Imbruvica graft-versus-host disease coverage

Covered for chronic graft-versus-host disease when prior systemic therapy is documented.

ALL of the following

Chronic graft-versus-host disease.
Prior systemic therapy.

General medically accepted indications

Covered when used for a medically accepted indication, subject to product-specific criteria.

The requested medication is used for a medically accepted indication.

Imkeldi formulation requirement

Covered when at least one formulation limitation applies.

ONE of

Unable to swallow the tablet formulation.
Unable to achieve the prescribed dose with the tablet formulation.

Inlyta advanced renal cell carcinoma

For first-line advanced renal cell carcinoma, both requirements apply.

ALL of the following

Combination treatment is required.
Trial of one prior systemic therapy.1 prior systemic therapy

Inqovi myelodysplastic syndrome

Covered for myelodysplastic syndrome after the required trial.

Trial with intravenous azacitidine.

General indication-based coverage

Coverage is subject to the applicable medically accepted or FDA-approved indication.

The product is prescribed for an applicable medically accepted indication, or an FDA-approved indication where specified.

Isotretinoin initial coverage

Covered when both the indication and prerequisite requirement are met.

ALL of the following

Use for a medically accepted indication.
Trial of an oral prerequisite therapy.
The source does not identify the complete therapy name.

Itovebi coverage

Covered when both requirements are met.

ALL of the following

Endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative disease.
Use with fulvestrant.

Iwilfin coverage

Covered when both requirements are met.

ALL of the following

High-risk neuroblastoma in the qualifying patient population.
The response criterion is truncated in the source.
Prior immunotherapy.

Jadenu/deferasirox coverage

Covered for medically accepted indications.

Use for a medically accepted indication.

Plan-year coverage; no prerequisite Part D drug is required.

Jakafi polycythemia vera coverage

Covered for polycythemia vera when both requirements are met.

ALL of the following

Polycythemia vera with the required inadequate response criterion.
The response wording is truncated in the source.
Trial of one or two lines of systemic therapy.1–2 lines

Jaypirca lymphoma coverage

Covered when the applicable lymphoma pathway is met.

ONE of

Mantle cell lymphoma: Two lines of systemic therapy, including a BTK inhibitor.2 lines
Relapsed or other specified disease: Treatment with a covalent BTK inhibitor.
The disease wording is truncated in the source.

Jideytro pending criteria

Final criteria are pending CMS review.

Indications, exclusions, prerequisite therapy, and other criteria are pending CMS review.

Jylamvo coverage

Covered after the required methotrexate trial.

ALL of the following

Use for a medically accepted indication.
Trial of methotrexate tablets.

General medically accepted indications

Coverage is listed for all medically accepted indications.

Use for a medically accepted indication.

No additional clinical criterion is displayed.

Kerendia indication-specific criteria

Covered when either applicable indication pathway is met.

ONE of

Chronic kidney disease associated with type 2 diabetes.
ALL of the following
- Heart failure with LVEF >=40%.LVEF >=40%
- Trial of an SGLT2 inhibitor unless contraindicated or intolerant.

Kineret rheumatoid arthritis criteria

Covered for rheumatoid arthritis when all requirements are met.

ALL of the following

Moderately to severely active rheumatoid arthritis.
TWO of
- Enbrel.
- Adalimumab-aaty or adalimumab-fkjp.
- Xeljanz or Xeljanz XR.
Positive clinical response to therapy.

Kisqali breast cancer criteria

Covered when the applicable endocrine combination is used.

ONE of

HR-positive/HER2-negative advanced or metastatic breast cancer with an aromatase inhibitor as initial endocrine-based therapy, or fulvestrant as initial therapy or after progression on endocrine therapy.
HR-positive/HER2-negative stage II or III early breast cancer at high risk of recurrence with an aromatase inhibitor.

Krazati

Covered for the specified lung cancer indication after prior systemic therapy.

ALL of the following

KRAS G12C-mutated locally advanced or metastatic NSCLC.
Prior systemic therapy.

Lazcluze

Covered for the specified locally advanced disease with combination therapy.

ALL of the following

Locally advanced disease.
Combination use with amivantamab.

Lenvima

Covered when the applicable combination regimen and prior-treatment requirements are met.

ONE of

First-line renal cell carcinoma with pembrolizumab.
Renal cell carcinoma after one prior anti-angiogenic therapy with everolimus.
Advanced endometrial carcinoma with progression after prior systemic therapy and pembrolizumab.

Levetiracetam tablet for oral suspension

Covered when the stated trial requirement is met.

A trial is required before coverage.

The complete trial requirement is not present in the source excerpt.

Lifyorli

Covered when all listed oncology requirements are met.

ALL of the following

Platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Combination use with nab-paclitaxel.
One to three prior therapies.1–3 prior therapies
Bevacizumab is included as prerequisite therapy.

Liraglutide

Covered when either diabetes documentation pathway is met.

ONE of

Chart notes confirm ongoing treatment for type 2 diabetes mellitus.
Chart notes document type 2 diabetes supported by A1c >=6.5%, fasting plasma glucose >=126 mg/dL, or 2-hour plasma glucose >=200 mg/dL during OGTT.A1c >=6.5% OR FPG >=126 mg/dL OR 2-hour PG >=200 mg/dL

Livtencity

Covered for post-transplant CMV infection or disease after one prerequisite antiviral trial.

ALL of the following

Post-transplant CMV infection or disease.
ONE of
- Trial of valganciclovir.
- Trial of cidofovir.
- Trial of foscarnet.

Lonsurf

Covered when the indication-specific oncology pathway is met.

ONE of

Metastatic colorectal cancer: combination use with bevacizumab; prior fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy and anti-VEGF therapy.
RAS wild-type metastatic colorectal cancer: the preceding requirements plus anti-EGFR therapy.
Metastatic gastric or gastroesophageal junction adenocarcinoma: at least two prior chemotherapy lines including applicable fluoropyrimidine, platinum, taxane, irinotecan, or HER2/neu-targeted therapy.>=2 prior lines

Lumakras

Covered when the applicable mutation-specific pathway is met.

ONE of

KRAS G12C-mutated locally advanced or metastatic NSCLC with at least one prior systemic therapy.>=1 prior systemic therapy
KRAS G12C-mutated metastatic colorectal cancer after prior fluoropyrimidine-based therapy.
The remaining colorectal cancer criterion is truncated.

Lybalvi

Covered when the applicable indication-specific prerequisite is met.

ONE of

Adult schizophrenia: Trials of lurasidone and paliperidone.
Other indications: Trials of at least two listed alternatives.>=2 alternatives
The complete list is not shown.

Lynparza

Covered when the applicable malignancy-, mutation-, and treatment-specific requirement is met.

ONE of

Specified BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer after platinum-based chemotherapy; combination with bevacizumab applies where specified.
gBRCAm, HER2-negative metastatic breast cancer after prior chemotherapy; HR-positive disease requires prior endocrine therapy or endocrine therapy considered inappropriate.
gBRCAm metastatic pancreatic adenocarcinoma after at least 16 weeks of first-line platinum chemotherapy without progression.>=16 weeks without progression
HRR gene-mutated mCRPC after enzalutamide or abiraterone.

Products without additional displayed criteria

Coverage is based on a medically accepted indication; no additional clinical criterion is displayed.

Use for a medically accepted indication.

No additional criterion is displayed in this excerpt.

Budesonide ER is not covered when used for maintenance of remission in ulcerative colitis.

Tadalafil is not covered when the patient is receiving nitrate therapy.

Entyvio Pen cannot be used in combination with a potent immunosuppressant, such as azathioprine or cyclosporine, or with another biologic or targeted DMARD indicated for the same condition.

Adalimumab products cannot be used in combination with another biologic or targeted DMARD indicated for the same condition.

Kineret cannot be used in combination with another biologic or targeted DMARD indicated for the same condition.

Liraglutide is not covered when used for treatment of weight loss only.

Initial Therapy Requirements

Product-specific initial therapy criteria for Auvelity through Lynparza

Product-specific initial therapy requirements are summarized below; each product follows the indicated nested logic.

Auvelity: major depressive disorder and prior generic formulary antidepressant.

Balversa: locally advanced or metastatic urothelial carcinoma and at least one prior systemic therapy.

Banzel: trial of divalproex or the additional prerequisite identified in the policy.

Beqalzi: relapsed or refractory mantle cell lymphoma and BTK inhibitor trial.

Bexarotene: prior systemic therapy for cutaneous T-cell lymphoma; topical Bexarotene: after or intolerance of other therapies.

Reauthorization and Continuation

Dulera reauthorization

Reauthorization requires continued benefit.

Response to therapy.

Entyvio Pen continuation

Reauthorization requires continued benefit.

Documentation of positive clinical response to therapy.

Humira reauthorization requiring positive clinical response

Reauthorization requires continued benefit.

Documentation of positive clinical response to therapy for the applicable indication.

Kineret positive clinical response

Prerequisite and Step-Therapy Requirements

Product	Required prior therapy	Indication	Source criteria
Afinitor	Letrozole or anastrozole; exemestane combination required	Advanced HR-positive, HER2-negative breast cancer	Use with exemestane after a trial of letrozole or anastrozole.
Afinitor	Sunitinib or sorafenib	Renal cell carcinoma	Prior sunitinib or sorafenib therapy is required.
Alunbrig	Crizotinib	ALK-positive metastatic disease	Use crizotinib before Alunbrig.
Ambrisentan	Sildenafil or tadalafil; exception for treatment-naive patients	WHO Group 1 pulmonary arterial hypertension	Use sildenafil or tadalafil before ambrisentan unless the patient is treatment-naive.
Auvelity	Another generic formulary antidepressant	Major depressive disorder	Use another generic formulary antidepressant as prerequisite therapy.
Balversa	At least one prior systemic therapy	Locally advanced or metastatic urothelial carcinoma	Trial of at least one prior systemic therapy.
Banzel	Divalproex or additional prerequisite therapy	All medically accepted indications	Trial of divalproex or an additional prerequisite therapy; remainder of criterion is truncated.
Beqalzi	A tyrosine kinase (BTK) inhibitor	Relapsed or refractory mantle cell lymphoma	Trial of a BTK inhibitor.
Bexarotene	Prior systemic therapy	Cutaneous T-cell lymphoma	Prior systemic therapy is required.
Bexarotene gel	Other therapies; intolerance is acceptable	Cutaneous T-cell lymphoma	Use after, or document intolerance of, other therapies.
Bosentan	Sildenafil or tadalafil; exception for treatment-naive patients	WHO Group 1 pulmonary arterial hypertension	Trial of sildenafil or tadalafil unless the patient is treatment-naive; source text is truncated.
Briviact	Levetiracetam and one additional therapy	All medically accepted indications	Trial of levetiracetam and one additional therapy; remaining criterion is truncated.
Brukinsa	Calquence	Mantle cell lymphoma	Trial of Calquence.
Brukinsa	At least one anti-CD20-based regimen	Relapsed or refractory marginal zone lymphoma	Trial of at least one anti-CD20-based regimen.
Brukinsa	Obinutuzumab combination and at least two systemic therapy lines	Relapsed or refractory follicular lymphoma	Use with obinutuzumab and trial two or more lines of systemic therapy.
Brukinsa	Calquence or Imbruvica	Chronic lymphocytic leukemia or small lymphocytic lymphoma	Trial of Calquence or Imbruvica.
Bysanti	Lurasidone and paliperidone	Adult schizophrenia	Trial lurasidone and paliperidone.
Bysanti	At least two specified prerequisite agents	All other indications	Trial at least two agents from the specified list; list is truncated.
Bysanti	Lurasidone and paliperidone	Adult schizophrenia	For adult schizophrenia, trial lurasidone and paliperidone.
Bysanti	At least two specified prerequisite therapies	All other indications	For other indications, trial at least two listed prerequisite therapies.
Cabometyx	Nivolumab combination	First-line advanced renal cell carcinoma	Use nivolumab in combination with Cabometyx.
Cabometyx	Sorafenib	Hepatocellular carcinoma	Trial of sorafenib.
Cabometyx	VEGFR-targeted therapy	Locally advanced or metastatic differentiated thyroid cancer that is radioactive iodine-refractory or ineligible	Trial of VEGFR-targeted therapy.
Calcipotriene	At least one generic topical therapy	All medically accepted indications	Trial of at least one generic topical therapy.
Calquence	At least one prior therapy for mantle cell lymphoma	Mantle cell lymphoma	Receive at least one prior therapy for MCL.
Cavhanza	Prior therapy including imatinib	Specified chronic-phase or accelerated-phase CML	Prior therapy for specified CML indications must include imatinib.
Cobenfy	Antipsychotics	Schizophrenia	Use antipsychotics before Cobenfy.
Copiktra	At least two prior therapies	Relapsed or refractory CLL	Use at least two prior therapies.
Cotellic	Vemurafenib	Unresectable or metastatic melanoma with BRAF V600E or V600K mutation	Prerequisite use of vemurafenib.
Daurismo	A prerequisite Part D drug	Newly diagnosed disease	Use a prerequisite Part D drug; disease indication is incomplete in the source.
Diacomit	Two generic anticonvulsants; clobazam combination required	Treatment indication for Diacomit	Trial of two generic anticonvulsants and combination use with clobazam.
Diacomit	Two generic anticonvulsants; clobazam combination required	Treatment indication for Diacomit	Trial of two generic anticonvulsants before coverage; combination use with clobazam is also required.
Dihydroergotamine nasal spray	One oral and one non-oral formulary triptan	All medically accepted indications	Trial of two formulary triptans: one oral and one non-oral.
Dulera	Breo Ellipta or Advair HFA	All medically accepted indications	Trial of Breo Ellipta or Advair HFA.
Emsam	Two listed alternative therapies	All medically accepted indications	Trial with two listed alternatives; alternatives are not included in the excerpt.
Entyvio Pen	Two of adalimumab-aaty or adalimumab-fkjp, Steqeyma or Yesintek	Moderately to severely active Crohn's disease	Trial two of the specified therapies.
Entyvio Pen	Two of adalimumab-aaty or adalimumab-fkjp, Steqeyma or Yesintek, or tofacitinib	Moderately to severely active ulcerative colitis	Trial two of the specified therapies.
Epidiolex	Two generic seizure-treatment alternatives	Lennox-Gastaut syndrome	Trial two generic alternatives for seizure treatment.
Epidiolex	Two of valproic acid, clobazam, or topiramate	Dravet syndrome	Trial two of valproic acid, clobazam, or topiramate.
Epidiolex	Two generic seizure-treatment alternatives	Seizures associated with tuberous sclerosis complex	Trial two generic alternatives for seizure treatment.
Eprontia	At least two generic migraine-prevention alternatives, unless unable to swallow tablets or capsules	Migraine prevention	Trial at least two generic alternatives or document inability to swallow tablets or capsules.
Eucrisa	One generic topical steroid	Atopic dermatitis	Trial of one generic topical steroid.
Eucrisa	One generic topical steroid	Atopic dermatitis	Use a generic topical steroid before Eucrisa.
Eulexin	Generic bicalutamide	All medically accepted indications	Trial of generic bicalutamide.
Fanapt	Lurasidone and paliperidone for adult schizophrenia; at least two alternatives for other indications	All medically accepted indications	Prior therapy is required; alternatives for non-schizophrenia indications are not shown.
Fintepla	Two prerequisite therapies	All medically accepted indications	Trial of two prerequisite therapies; specific therapies are not shown.
Fotivda	Two or more prior systemic therapies	Advanced renal cell carcinoma	Trial of two or more prior systemic therapies.
Fruzaqla	Fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; anti-VEGF and anti-EGFR therapy	Metastatic colorectal cancer	Trial required for specified chemotherapy, anti-VEGF, and anti-EGFR therapies.
Perampanel	Two generic drugs	All medically accepted indications	Trial of two generic drugs.
Gilotrif	A prerequisite Part D drug; specific drug not identified	First-line metastatic NSCLC with non-resistant EGFR mutations detected by an FDA-approved test	Use of a prerequisite Part D drug is required.
Humira	One DMARD; leflunomide or methotrexate for polyarticular JIA; one NSAID for ankylosing spondylitis	Indication-specific rheumatoid arthritis, polyarticular JIA, or ankylosing spondylitis	Required therapy depends on indication.
Ibrance	Aromatase inhibitor or fulvestrant; inavolisib plus fulvestrant for PIK3CA-mutated disease	HR-positive/HER2-negative advanced or metastatic breast cancer; endocrine-resistant PIK3CA-mutated disease	Use the applicable endocrine-based combination regimen.
Ibrance	Inavolisib plus fulvestrant	Endocrine-resistant PIK3CA-mutated HR-positive/HER2-negative locally advanced or metastatic breast cancer	Use after recurrence on or after completing adjuvant endocrine therapy.
Iclusig	Chemotherapy; or no indicated alternative kinase inhibitor; or at least two prior kinase inhibitors	Ph-positive ALL or CML, indication-specific	Requirements vary by disease status and include chemotherapy or prior kinase inhibitor trials.
Imbruvica	Prior systemic therapy	Chronic graft-versus-host disease	Prior systemic therapy is required.
Imbruvica	Systemic therapy	Chronic graft-versus-host disease	Use a prerequisite Part D drug identified as systemic therapy.
Imkeldi	A prerequisite Part D drug	All medically accepted indications	Use a prerequisite Part D drug.
Inlyta	One prior systemic therapy	First-line advanced renal cell carcinoma	Trial of one prior systemic therapy.
Inqovi	Intravenous azacitidine	Myelodysplastic syndrome	Trial with intravenous azacitidine.
Isotretinoin	An oral prerequisite therapy; specific therapy not shown	All medically accepted indications	Trial of either an oral prerequisite therapy; source text is truncated.
Itovebi	Fulvestrant	Endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative disease	Use with fulvestrant; indication text is truncated.
Iwilfin	Prior immunotherapy	High-risk neuroblastoma	Prior immunotherapy is required.
Jakafi	One or two lines of systemic therapy	Polycythemia vera	Trial of one or two lines of systemic therapy.
Jaypirca	Two lines of systemic therapy including a BTK inhibitor	Mantle cell lymphoma	Two lines of systemic therapy, including a BTK inhibitor.
Jaypirca	A covalent BTK inhibitor	Relapsed or refractory disease	Treatment with a covalent BTK inhibitor; source text is truncated.
Jylamvo	Methotrexate tablets	All medically accepted indications	Trial of methotrexate tablets.
Kerendia	An SGLT2 inhibitor such as Jardiance or Farxiga, unless contraindicated or intolerant	Heart failure with LVEF ≥40%	Trial of an SGLT2 inhibitor is required.
Kineret	Two of Enbrel, adalimumab-aaty or adalimumab-fkjp, or Xeljanz/XR	Moderately to severely active rheumatoid arthritis	Trial of two specified therapies; positive clinical response also required.
Kisqali	Aromatase inhibitor or fulvestrant, as applicable	HR-positive/HER2-negative advanced, metastatic, or high-risk early breast cancer	Use the specified endocrine-therapy combination.
Krazati	Prior systemic therapy	KRAS G12C-mutated locally advanced or metastatic NSCLC	Prior systemic therapy is required.
Krazati	Systemic therapy	KRAS G12C-mutated locally advanced or metastatic NSCLC	Systemic therapy is required as prerequisite therapy.
Lazcluze	Amivantamab combination	Locally advanced disease	Combination use with amivantamab is required.
Lenvima	Pembrolizumab or everolimus, as applicable	Renal cell carcinoma or advanced endometrial carcinoma	Use pembrolizumab or everolimus in the specified combination regimen.
Levetiracetam tablet for oral suspension	A trial; complete requirement not shown	All medically accepted indications	A trial is required; source text does not identify the complete requirement.
Lifyorli	Nab-paclitaxel combination; one to three prior therapies; bevacizumab included	Platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer	Use with nab-paclitaxel and satisfy the specified prior-treatment history.
Livtencity	Valganciclovir, cidofovir, or foscarnet	Post-transplant CMV infection or disease	Trial one of valganciclovir, cidofovir, or foscarnet.
Lonsurf	Indication-specific chemotherapy and targeted therapies	Metastatic colorectal, gastric, or gastroesophageal junction adenocarcinoma	Complete applicable chemotherapy, anti-VEGF, anti-EGFR, bevacizumab, or HER2/neu-targeted therapy.
Lumakras	At least one prior systemic therapy	KRAS G12C-mutated locally advanced or metastatic NSCLC	Trial of at least one prior systemic therapy.
Lybalvi	Lurasidone and paliperidone for adult schizophrenia; at least two alternatives for other indications	All medically accepted indications	Trial lurasidone and paliperidone for adult schizophrenia; other alternatives are not fully shown.
Lynparza	Platinum chemotherapy, as applicable	Specified ovarian, fallopian tube, or primary peritoneal cancers	Prior platinum-based chemotherapy is required for applicable indications.
Lynparza	Bevacizumab plus platinum-based chemotherapy	Advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer	Combination use with bevacizumab and prior platinum-based chemotherapy.
Lynparza	Prior chemotherapy	gBRCAm, HER2-negative metastatic breast cancer	Prior chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
Lynparza	Prior endocrine therapy or endocrine therapy considered inappropriate	HR-positive breast cancer	Previous endocrine therapy or endocrine therapy considered inappropriate.
Lynparza	At least 16 weeks of first-line platinum-based chemotherapy without progression	gBRCAm metastatic pancreatic adenocarcinoma	Disease must not have progressed on at least 16 weeks of first-line platinum-based chemotherapy.
Lynparza	Enzalutamide or abiraterone	HRR gene-mutated metastatic castration-resistant prostate cancer	Trial of enzalutamide or abiraterone.
Lynparza	Abiraterone plus prednisone or prednisolone	Metastatic castration-resistant prostate cancer	Combination use with abiraterone and prednisone or prednisolone.

Prior Authorization and Documentation Actions

Prior Authorization

Prior Authorization Required

Submit prior authorization (PA) before dispensing the affected product. Coverage is subject to the product-specific indication, prerequisite, exclusion, duration, and documentation rules below; verify the current formulary and submit clinical records when criteria are pending CMS review.

Acitretin; Actimmune; Adbry; Adempas; Afinitor; Afinitor Disperz; Aimovig; Akeega; Alecensa; Alosetron; Alpha-1-proteinase inhibitor; Alunbrig; Ambrisentan; Arcalyst; Arikayce.
Armodafinil; Aubagio; Augtyro; Auvelity; Avmapki Fakzynja; Ayvakit; Balversa; Banzel; Benlysta; Beqalzi; Betaseron; Bexarotene (oral and topical); Bosentan; Bosulif; Braftovi; Briviact; Brukinsa; Budesonide ER; Bysanti.
Cabometyx; Calcipotriene; Calquence; Caprelsa; Cavhanza; Cayston; Tadalafil; Clomiphene; Cobenfy; Cometriq; glatiramer acetate/Glatopa; Copiktra; Cosentyx; Cotellic; Cresemba; Cystaran; Dalfampridine; Daurismo; Diacomit; dihydroergotamine; Drizalma Sprinkle; Dulera.
Ensacove; Entyvio Pen; Epidiolex; Procrit; Eprontia; Erivedge; Erleada; pirfenidone; Eucrisa; Eulexin; Fanapt; Fasenra; Fetzima; Filspari; Fintepla; Fotivda; Fruzaqla; Fulphila; perampanel; Gavreto; fingolimod; Gilotrif; Gomekli.
Haegarda; Hernexeos; tasimelteon; adalimumab; Humulin R U-500; Hyrnuo; Ibrance; Ibtrozi; icatibant; Iclusig; Idhifa; Imbruvica; Imkeldi; IVIG; Increlex; Inluriyo; Inlyta; Inqovi; Inrebic; gefitinib; isotretinoin; Itovebi; ivermectin; Iwilfin.
Jadenu/deferasirox; Jakafi; Jaypirca; Jideytro; Jylamvo; Jynarque/tolvaptan; Leukine; leuprolide; lidocaine/prilocaine topical; lidocaine topical; Lifyorli; liraglutide; Livtencity; Lonsurf; Lumakras; Lybalvi; Lynparza. PA also applies to the listed products when supplied under their generic or alternate formulation names.

Clinical Thresholds and Supporting Values

FEV1

FEV1 thresholdLess than 80% predicted

Applicable diagnosisAlpha-1 antitrypsin deficiency or necrotizing panniculitis

Related pulmonary conditionSymptomatic emphysema

Patient age

Minimum age18 years of age or older

Applicable deficiencyCongenital alpha-1 antitrypsin deficiency

Qualifying phenotypesPIZZ, PIZ (null), or PI (null, null) of AAT

Policy Terms and Clinical Abbreviations

Definitions

Prior authorizationClinical and/or administrative criteria must be met before coverage is provided.

Step therapyPrevious treatment with one or more formulary drugs may be required before coverage is provided.

Disease statesMCL means mantle cell lymphoma; MZL means marginal zone lymphoma; FL means follicular lymphoma; CLL/SLL means chronic lymphocytic leukemia or small lymphocytic lymphoma.

Product statusProducts identified with prior authorization criteria are subject to the formulary program’s authorization requirements; some criteria are pending CMS review.

Biomarker-defined diseaseKRAS G12C-mutated NSCLC means locally advanced or metastatic non-small cell lung cancer characterized by a KRAS G12C mutation; EGFR mutations must be detected by an FDA-approved test for the defined Gilotrif indication.

Clinical terminology

Program Background

The program monitors selected medications to support appropriate and cost-effective drug therapy. Prior authorization may require clinical or administrative criteria before coverage is provided, while step therapy may require use of formulary alternatives before the requested medication is covered. Criteria are based on current medical information and recommendations of the Blues' Pharmacy and Therapeutics Committee.

Policy Summary

PayerBlue Cross Complete of Michigan

PolicyMedicare Part D Prior Authorization and Step Therapy Criteria

Policy CodePolicy H9572_27PASTPPOInd_C

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with the applicable clinical documentation and evidence of required prerequisite therapy.

SourceLink

On This Page

Symptomatic emphysema.

Trial of Calquence or Imbruvica.

Ankylosing spondylitis:

Active disease and trial of one NSAID.

Crohn's disease: Moderately to severely active Crohn's disease.

Ulcerative colitis: Moderately to severely active ulcerative colitis.

Hidradenitis suppurativa: Moderate to severe hidradenitis suppurativa.

Uveitis: Non-infectious intermediate, posterior, or panuveitis.

mCRPC with combination abiraterone and prednisone or prednisolone.

Bosentan: Group 1 PAH, right-heart catheterization, specialist oversight, and sildenafil/tadalafil trial unless treatment-naive.

Briviact: levetiracetam and one additional therapy.

Brukinsa disease pathways

MCL: Calquence trial.
Relapsed/refractory MZL: anti-CD20-based regimen.
Relapsed/refractory FL: obinutuzumab combination and at least two systemic therapy lines.
CLL/SLL: Calquence or Imbruvica trial.

Bysanti pathways

Adult schizophrenia: lurasidone and paliperidone trials.
Other indications: at least two specified prerequisite therapies.

Cabometyx pathways

First-line advanced RCC: nivolumab combination.
HCC: sorafenib trial.
Specified differentiated thyroid cancer: VEGFR-targeted therapy trial.

Calcipotriene: at least one generic topical trial.

Calquence for MCL: at least one prior MCL therapy.

Cavhanza: unable to swallow capsules; specified CML pathways require prior imatinib.

Cobenfy: schizophrenia and prior antipsychotic use.

Copiktra: relapsed/refractory CLL and at least two prior therapies.

Cotellic: BRAF V600E/V600K unresectable or metastatic melanoma and vemurafenib.

Daurismo: newly diagnosed disease and prerequisite Part D drug.

Diacomit: two generic anticonvulsant trials and clobazam combination.

Dihydroergotamine nasal spray: one oral and one non-oral formulary triptan trial.

Drizalma Sprinkle: required member confirmation; criterion incomplete in source.

Dulera

Trial of Breo Ellipta.
Trial of Advair HFA.

Emsam: two listed alternative trials; alternatives not shown.

Entyvio Pen: qualifying Crohn's disease or ulcerative colitis, two applicable prerequisite therapies, and IV Entyvio induction.

Epidiolex diagnosis pathways

Lennox-Gastaut syndrome: two generic seizure-treatment alternatives.
Dravet syndrome: two of valproic acid, clobazam, or topiramate.
Tuberous sclerosis complex seizures: two generic seizure-treatment alternatives.

Eprontia migraine prevention

Two generic migraine-prevention alternatives.
Unable to swallow tablets or capsules.

Eucrisa: generic topical steroid trial for atopic dermatitis.

Eulexin: generic bicalutamide trial.

Fanapt pathways

Adult schizophrenia: lurasidone and paliperidone.
Other indications: at least two listed alternatives.

Fetzima: required antidepressant therapy, including desvenlafaxine and duloxetine as stated.

Fintepla: two prerequisite therapy trials.

Fotivda: at least two prior systemic therapies for advanced RCC.

Fruzaqla: fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy, anti-VEGF, and anti-EGFR therapy for metastatic colorectal cancer.

Perampanel: two generic drug trials.

Gavreto: advanced/metastatic RET fusion-positive thyroid cancer requiring systemic therapy when radioactive iodine is appropriate.

Gilotrif: first-line metastatic NSCLC with non-resistant EGFR mutation detected by an FDA-approved test and prerequisite therapy.

Humira: indication-specific disease activity/severity and prerequisite therapy; no duplicate biologic or targeted DMARD.

Ibrance pathways

HR-positive/HER2-negative advanced/metastatic breast cancer with aromatase inhibitor or fulvestrant sequencing.
Endocrine-resistant PIK3CA-mutated disease with inavolisib and fulvestrant after adjuvant endocrine therapy recurrence.

Iclusig pathways

Newly diagnosed Ph-positive ALL with chemotherapy.
Specified T315I-positive ALL/CML or accelerated/blast-phase CML when no other kinase inhibitor is indicated.
Other chronic-phase CML: at least two prior kinase inhibitors.

Imbruvica: chronic graft-versus-host disease and prior systemic therapy.

Inlyta first-line advanced RCC: combination therapy and one prior systemic therapy.

Inqovi MDS: intravenous azacitidine trial.

Isotretinoin: oral prerequisite therapy trial.

Itovebi: endocrine-resistant PIK3CA-mutated HR-positive/HER2-negative disease with fulvestrant.

Iwilfin: high-risk neuroblastoma after prior immunotherapy.

Jakafi polycythemia vera: required inadequate response criterion and one or two systemic therapy lines.

Jaypirca: MCL requires two systemic therapy lines including a BTK inhibitor; another pathway requires a covalent BTK inhibitor.

Jylamvo: methotrexate tablet trial.

Kerendia heart failure with LVEF >=40%: SGLT2 inhibitor trial unless contraindicated or intolerant.

Kineret rheumatoid arthritis: moderately to severely active disease, two specified prior therapies, and positive clinical response.

Kisqali pathways

Advanced/metastatic HR-positive/HER2-negative breast cancer with specified aromatase inhibitor or fulvestrant combination.
Stage II/III early HR-positive/HER2-negative breast cancer at high recurrence risk with aromatase inhibitor.

Krazati: KRAS G12C-mutated locally advanced/metastatic NSCLC after systemic therapy.

Lazcluze: locally advanced disease with amivantamab combination.

Lenvima pathways

First-line RCC with pembrolizumab.
RCC after one prior anti-angiogenic therapy with everolimus.
Advanced endometrial carcinoma after prior systemic therapy with pembrolizumab.

Levetiracetam tablet for oral suspension: a trial is required; details are incomplete.

Lifyorli: platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer; nab-paclitaxel combination, one to three prior therapies, and bevacizumab prerequisite.

Liraglutide diabetes evidence

Chart notes confirm ongoing type 2 diabetes treatment.
Qualifying A1c, fasting glucose, or 2-hour OGTT glucose documentation.

Livtencity prerequisite

Valganciclovir trial.
Cidofovir trial.
Foscarnet trial.

Lonsurf pathways

Metastatic colorectal cancer pathway with bevacizumab and applicable chemotherapy/anti-VEGF trials.
RAS wild-type colorectal cancer also requiring anti-EGFR therapy.
Metastatic gastric/GEJ adenocarcinoma with at least two prior chemotherapy lines or appropriate HER2/neu-targeted therapy.

Lumakras pathways

KRAS G12C-mutated locally advanced/metastatic NSCLC with at least one prior systemic therapy.
KRAS G12C-mutated metastatic colorectal cancer after prior fluoropyrimidine-based therapy.

Lybalvi pathways

Adult schizophrenia: lurasidone and paliperidone trials.
Other indications: at least two listed alternatives.

Lynparza pathways

Specified ovarian, fallopian tube, or primary peritoneal cancer after platinum therapy, with bevacizumab where required.
gBRCAm HER2-negative metastatic breast cancer after prior chemotherapy; HR-positive disease requires endocrine therapy or inappropriateness.
gBRCAm metastatic pancreatic adenocarcinoma after at least 16 weeks of first-line platinum therapy without progression.
HRR-mutated mCRPC after enzalutamide or abiraterone, or mCRPC with abiraterone plus prednisone/prednisolone as specified.

Continuation requires clinical response and compliance with combination restrictions.

ALL of the following

Positive clinical response to therapy.
Do not use with another biologic or targeted DMARD indicated for the same condition.

Denial Risk

Product-Specific Criteria and Denial Risks

Before requesting authorization, match the drug to the covered indication and document required combination therapy, prior treatment, step therapy, exclusions, or intolerance. Failure to establish these product-specific conditions may result in denial.

Afinitor: disease-specific prerequisites; advanced HR-positive/HER2-negative breast cancer requires exemestane plus a letrozole or anastrozole trial; RCC requires sunitinib or sorafenib. Akeega: qualifying BRCA-mutated prostate cancer indication and required prednisone combination.
Alunbrig: ALK-positive metastatic disease and prior crizotinib. Ambrisentan/bosentan/tadalafil: PAH diagnosis, specialist oversight, right-heart catheterization where specified, and sildenafil or tadalafil prerequisite; tadalafil is excluded with nitrate therapy. Arcalyst: inflammatory disease therapy with colchicine. Alpha-1-proteinase inhibitor: alpha-1 antitrypsin deficiency documentation, qualifying phenotype, symptomatic emphysema, and FEV1 less than 80% predicted.
Auvelity: major depressive disorder and another generic formulary antidepressant prerequisite. Balversa: locally advanced/metastatic urothelial carcinoma and at least one prior systemic therapy. Banzel: divalproex or other required prerequisite therapy. Beqalzi: relapsed/refractory mantle cell lymphoma and prior BTK inhibitor. Bexarotene: prior systemic therapy for oral product; other therapy or intolerance for topical product. Brukinsa: indication-specific prior Calquence, anti-CD20 regimen, systemic-line, or combination obinutuzumab requirements.
Bysanti, Fanapt, Lybalvi, and Cobenfy: schizophrenia requires the specified antipsychotic trials; other indications require trials of at least two alternatives, with Cobenfy requiring an antipsychotic prerequisite. Calcipotriene and Eucrisa: generic topical or topical-steroid trial. Calquence: prior therapy for MCL. Cavhanza: prior imatinib and inability to swallow capsules. Copiktra: relapsed/refractory disease and at least two prior therapies. Cotellic: BRAF V600E/V600K melanoma and vemurafenib.
Daurismo: qualifying newly diagnosed disease and prerequisite Part D therapy. Diacomit: two generic anticonvulsant trials plus clobazam; avoid prohibited combinations. Dihydroergotamine: two formulary triptan trials, one oral and one non-oral. Dulera: Breo Ellipta or Advair HFA trial; reauthorization requires response. Emsam: two required antidepressant trials. Entyvio Pen: moderately-to-severely active Crohn's disease or ulcerative colitis, indication-specific trials of alternatives, prior/current IV induction, no duplicate biologic/targeted DMARD or potent immunosuppressant, and response for reauthorization.
Epidiolex: indication-specific step therapy—two generic seizure alternatives for Lennox-Gastaut syndrome or tuberous sclerosis complex, or two of valproic acid, clobazam, or topiramate for Dravet syndrome. Eprontia: indication-specific criteria; Eucrisa: required topical-steroid trial; Eulexin: generic bicalutamide trial; Fetzima: desvenlafaxine and duloxetine; Fintepla, perampanel, and similar seizure products: required generic alternatives. Fotivda: at least two prior systemic therapies. Fruzaqla: metastatic colorectal cancer requires fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy, anti-VEGF, and anti-EGFR therapy when applicable.
Gavreto: RET fusion-positive thyroid cancer and restriction based on whether radioactive iodine/systemic therapy is appropriate. Gilotrif: first-line metastatic NSCLC, non-resistant EGFR mutation, FDA-approved biomarker test, and required prerequisite therapy. Haegarda: criteria pending CMS review. Ibrance: HR-positive/HER2-negative disease, aromatase inhibitor or fulvestrant sequencing, or inavolisib/fulvestrant combination as applicable. Iclusig: chemotherapy for newly diagnosed Ph+ ALL, T315I or no-other-kinase-inhibitor situations, or at least two prior kinase inhibitors for other CP-CML. Imbruvica: systemic therapy prerequisite. Imkeldi: tablet formulation limitation and prerequisite therapy. Inlyta: required combination regimen and prior systemic therapy. Inqovi: IV azacitidine trial for MDS.
Isotretinoin: required oral prerequisite therapy. Itovebi: endocrine-resistant PIK3CA-mutated HR-positive/HER2-negative disease with fulvestrant. Iwilfin: high-risk neuroblastoma after immunotherapy. Jakafi: systemic therapy requirement for polycythemia vera. Jaypirca: lymphoma treatment requirements, including two systemic lines and covalent BTK inhibitor where applicable. Jylamvo: methotrexate tablet trial. Jynarque/tolvaptan: product-specific PA. Kerendia: CKD with T2DM; heart failure with LVEF at least 40% requires an SGLT2-inhibitor trial unless contraindicated or intolerant. Kineret: RA diagnosis and two required alternatives; avoid duplicate biologic/targeted DMARD therapy. Kisqali: endocrine combination and disease-specific sequencing.
Krazati: KRAS G12C-mutated NSCLC and prior systemic therapy. Lazcluze: amivantamab combination. Lenvima: pembrolizumab or everolimus combination and prior anti-angiogenic/systemic therapy as indicated. Lifyorli: platinum-resistant ovarian/fallopian tube/primary peritoneal cancer, nab-paclitaxel combination, and one to three prior therapies including bevacizumab. Livtencity: prior valganciclovir, cidofovir, or foscarnet. Lonsurf: bevacizumab combination and required colorectal or gastric cancer prior therapies. Lumakras: KRAS G12C mutation and required prior systemic or colorectal regimens. Lynparza: mutation- and indication-specific platinum, endocrine, chemotherapy, enzalutamide/abiraterone, or abiraterone/prednisone prerequisites.
Other therapy requirements include: maintenance therapy is excluded for budesonide ER; prohibited combination therapy must be avoided for Entyvio, adalimumab, and Kineret; required trials of two alternatives apply where specified to Emsam, Fanapt, Bysanti, Lybalvi, and seizure therapies; document intolerance when a prerequisite cannot be used.

Documentation Required

Documentation and Reauthorization

Include complete clinical records with each PA. Document diagnosis, severity, biomarker or mutation results, prior and current regimens, combination partners, specialist involvement, and treatment response for reauthorization. Products marked pending CMS review require confirmation of the applicable CMS criteria before submission.

Pending CMS-review status: Adbry, Adempas, Austedo, Besremi, Cosentyx, Dalfampridine, Fasenra, Filspari, Haegarda, Icatibant, Jideytro, and other products whose source criteria are listed as pending CMS review. Do not infer unlisted criteria; verify the current plan criteria.
Alpha-1-proteinase inhibitor: document congenital alpha-1 antitrypsin deficiency with qualifying PIZZ, PIZ(null), or PI(null,null) phenotype, symptomatic emphysema, and FEV1 less than 80% predicted; patient must be at least 18 years old. Ambrisentan and bosentan: document right-heart catheterization, WHO Group 1 PAH, prerequisite sildenafil/tadalafil trial, and cardiologist or pulmonologist oversight.
Gavreto: provide RET fusion and thyroid-cancer documentation and whether systemic radioactive iodine is appropriate. Gilotrif: provide FDA-approved EGFR biomarker-test results and first-line metastatic NSCLC documentation. Akeega, Ibrance, Itovebi, Kisqali, Lenvima, Lifyorli, Lonsurf, Lumakras, and Lynparza: document the disease subtype, mutation status where required, regimen partner, prior lines, and treatment sequence.
Adalimumab: document moderately-to-severely active disease and indication-specific prerequisites for RA, JIA, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, hidradenitis suppurativa, or noninfectious uveitis; do not combine with another biologic or targeted DMARD. Reauthorization requires positive clinical response. Entyvio Pen likewise requires documentation of IV induction and positive response at reauthorization.
Liraglutide: submit chart notes confirming type 2 diabetes or qualifying laboratory evidence (A1C at least 6.5%, fasting plasma glucose at least 126 mg/dL, or 2-hour OGTT glucose at least 200 mg/dL); weight loss alone is excluded. Drizalma Sprinkle requires member confirmation. Dulera reauthorization requires response to therapy. Document IVIG medical necessity and applicable Part B criteria.
For all prerequisite therapies, provide drug names, dates or duration, response, failure, intolerance, contraindication, and reason the formulary alternative is unsuitable. For combination regimens, document that all required agents will be used together and that prohibited duplicate biologic, DMARD, immunosuppressant, or targeted therapy is absent.
Where coverage duration is specified as plan year, submit renewal before expiration and include current response. Products with plan-year or other duration limitations include armodafinil, Aubagio, Benlysta, Brukinsa, Cystaran, fingolimod, Fulphila, Genotropin, Humulin R U-500, Inluriyo, leuprolide, Liraglutide, Lonsurf, and other products identified in the current criteria.

Step Therapy

Step-Therapy and Formulary Alternatives

Apply step therapy before submitting or dispensing when a prerequisite Part D drug or formulary alternative is required. Record successful trials, inadequate response, intolerance, contraindication, or inability to use the required formulation; otherwise the PA may be denied.

Required prerequisite or step therapy includes: Afinitor—sunitinib or sorafenib for RCC and letrozole/anastrozole plus exemestane for specified breast cancer; Akeega—prednisone; Alunbrig—crizotinib; Arcalyst—anti-inflammatory therapy with colchicine; Auvelity—generic antidepressant; Balversa—prior systemic therapy; Banzel—divalproex; Beqalzi—BTK inhibitor; Bexarotene—prior systemic or other therapy; Briviact—levetiracetam and another anticonvulsant; Brukinsa—indication-specific Calquence, anti-CD20, or systemic therapy.
Bysanti, Cobenfy, Fanapt, and Lybalvi—required antipsychotic trials; Cabometyx—nivolumab combination for first-line RCC, sorafenib for HCC, or prior VEGFR-targeted therapy for DTC; Calcipotriene—generic topical; Calquence—prior therapy; Cavhanza—imatinib and inability to swallow capsules; Copiktra—two prior therapies; Cotellic—vemurafenib; Daurismo—required Part D therapy; Diacomit—two generic anticonvulsants plus clobazam; Dihydroergotamine—oral and non-oral triptan trials; Dulera—Breo Ellipta or Advair HFA.
Entyvio Pen—two required alternatives for Crohn's disease or ulcerative colitis plus IV induction; Epidiolex—indication-specific alternatives; Eprontia—indication-specific migraine criteria; Eucrisa—topical steroid; Eulexin—generic bicalutamide; Emsam and Fetzima—required antidepressant trials; Fintepla and perampanel—two generic alternatives; Fotivda—two prior systemic therapies; Fruzaqla—specified metastatic colorectal cancer regimens; Gilotrif—required prior therapy where applicable; Ibrance—endocrine therapy sequencing; Iclusig—prior kinase inhibitors where applicable; Imbruvica—systemic therapy; Imkeldi—tablet formulation limitation; Inlyta—prior systemic therapy; Inqovi—IV azacitidine.
Isotretinoin—required oral therapy; Itovebi—fulvestrant; Iwilfin—prior immunotherapy; Jakafi—one or two lines of systemic therapy; Jaypirca—BTK inhibitor and systemic lines; Jylamvo—methotrexate tablet; Kerendia—SGLT2 inhibitor for qualifying heart failure unless contraindicated or intolerant; Kineret—two alternatives for RA; Kisqali—endocrine therapy; Krazati—prior systemic therapy; Lazcluze—amivantamab; Lenvima—required combination and prior therapy; Lifyorli—nab-paclitaxel and prior therapies; Livtencity—valganciclovir, cidofovir, or foscarnet; Lonsurf—required colorectal/gastric cancer therapies; Lumakras—prior systemic therapy; Lynparza—indication-specific prior chemotherapy, endocrine, or androgen-directed therapy.
Avoid prohibited combinations, including Entyvio with potent immunosuppressants or another biologic/targeted DMARD for the same condition, and adalimumab or Kineret with another biologic or targeted DMARD for the same condition. Budesonide ER is not covered for maintenance of remission in ulcerative colitis; tadalafil is not covered with nitrate therapy; liraglutide is not covered for weight loss alone.
PA-only products without a stated prerequisite still require authorization and appropriate indication documentation: Actimmune, Aimovig, Alecensa, Alosetron, Arikayce, Armodafinil, Augtyro, Avmapki Fakzynja, Ayvakit, Benlysta, Betaseron, Braftovi, Caprelsa, Cayston, Clomiphene, Cometriq, Cresemba, Cystaran, Ensacove, Erivedge, Erleada, pirfenidone, Fulphila, Gomekli, Hernexeos, tasimelteon, Humulin R U-500, Hyrnuo, Ibtrozi, Idhifa, Increlex, Inluriyo, Inrebic, gefitinib, ivermectin, Jadenu/deferasirox, Leukine, leuprolide, lidocaine/prilocaine, lidocaine, and related products.
When criteria are pending CMS review—Adbry, Adempas, Austedo, Besremi, Cosentyx, Dalfampridine, Fasenra, Filspari, Haegarda, Icatibant, and Jideytro—confirm the current CMS-reviewed requirements before applying step therapy or approving coverage.

Kerendia heart failure

Heart-failure LVEF thresholdGreater than or equal to 40%

Required prior therapyTrial of an SGLT2 inhibitor, such as Jardiance (empagliflozin) or Farxiga (dapagliflozin)

ExceptionThe SGLT2 inhibitor trial is not required when contraindication or intolerance is documented

Type 2 diabetes diagnostic thresholds

Hemoglobin A1c>= 6.5%

Fasting plasma glucose>= 126 mg/dL

2-hour oral glucose tolerance test plasma glucose>= 200 mg/dL

Pancreatic adenocarcinoma platinum-chemotherapy response

Cancer typeGermline BRCA-mutated metastatic pancreatic adenocarcinoma

TreatmentFirst-line platinum-based chemotherapy

Required interval without progressionAt least 16 weeks without disease progression

WHO Group 1 PAH means pulmonary arterial hypertension classified as World Health Organization Group 1; SGLT2 inhibitor therapy includes Jardiance (empagliflozin) and Farxiga (dapagliflozin).

Oncology abbreviationsmCRPC means metastatic castration-resistant prostate cancer; gBRCAm means germline BRCA-mutated disease; HRR means homologous recombination repair; HR-positive means hormone receptor-positive disease.