Core Comprehensive Formulary — Prior Authorization and Step Therapy Criteria (Part D)
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Lists medications on the BCBSM Core Comprehensive Formulary that require prior authorization or step therapy, with product-specific coverage conditions, prerequisite therapies, documentation and duration limits for Part D drug coverage.
No material clinical or coverage changes in this revision.
Product and Indication Coverage Criteria
Xeljanz (tofacitinib) — Initial and Reauthorization Criteria
Covered when ALL of the following initial coverage criteria are met:
ALL of the following
- Xeljanz (tofacitinib): Diagnosis of a medically accepted indication for tofacitinib (e.g., rheumatoid arthritis, psoriatic arthritis, ulcerative colitis) confirmed by medical record documentation.
- For rheumatoid arthritis (RA) and psoriatic arthritis (PsA): trial and inadequate response or intolerance to at least one conventional DMARD (e.g., methotrexate, leflunomide, sulfasalazine) unless contraindicated or clinically inappropriate.
- For ulcerative colitis: trial and inadequate response to or intolerance of conventional therapy (e.g., aminosalicylates, corticosteroids, immunomodulators) and documentation of disease severity warranting tofacitinib.
- No concomitant use with another biologic or targeted DMARD indicated for the same condition (e.g., TNF inhibitors, IL-6 inhibitors) unless documented clinical rationale supports combination therapy.
- Prescriber: prescribed by or in consultation with a specialist appropriate to the indication (e.g., rheumatologist, gastroenterologist, dermatologist).
- Authorization duration: up to 1 year for initial approval; reauthorization requires documentation of positive clinical response and tolerability.
Xolair (omalizumab) — Initial and Reauthorization Criteria
Covered when ALL of the following initial coverage criteria are met:
ALL of the following
- Xolair (omalizumab): Diagnosis of an FDA-labeled or medically accepted indication (e.g., moderate-to-severe persistent allergic asthma with positive IgE and sensitivity to perennial aeroallergen, chronic spontaneous urticaria uncontrolled on antihistamines, or chronic rhinosinusitis with nasal polyps as applicable).
- For allergic asthma: evidence of allergic sensitization (skin test or specific IgE) and baseline total IgE within dosing range; inadequate control despite optimized inhaled controller therapy.
- For chronic spontaneous urticaria (CSU): inadequate response to at least two trials of second-generation, non-sedating H1-antihistamines (up to 4x labeled dose) or documented intolerance/contraindication to antihistamines.
- For nasal polyps or other indications: documentation of disease severity and prior appropriate medical therapy per specialty guidelines.
- No concomitant use with another biologic for the same condition without clinical rationale; reauthorization requires evidence of clinical benefit (symptom improvement, reduced exacerbations, or decreased need for rescue medications).
- Prescriber: specialist appropriate to indication (e.g., allergist/immunologist, pulmonologist, dermatologist, ENT).
- Authorization duration: initial: up to 3 months (or per product labeling) for assessment; reauthorization: up to 1 year with documentation of response.
Prior Trial Examples — Common Step Therapy Expectations
Examples of prior trials or prerequisite therapy frequently required across product-specific criteria (not exhaustive). These examples illustrate common step-therapy expectations that must be documented when applicable:
ANY of the following
- Generic antidepressant trial examples: trial of bupropion and one additional generic formulary antidepressant (e.g., SSRI, SNRI) for major depressive disorder prior to certain branded therapies.
- Migraine prevention examples: trial of at least two generic preventive agents (e.g., propranolol, amitriptyline, topiramate) before specialty migraine agents; for acute migraine agents requiring triptan trial: one oral triptan and one non-oral triptan (e.g., intranasal or injectable).
- Asthma/allergic disease biologic examples: trial and inadequate response to optimized inhaled corticosteroid plus long-acting beta-agonist and at least one additional controller (e.g., LAMA, leukotriene modifier) before select biologics; trial of systemic corticosteroids where specified.
- Oncology prior-therapy examples (see oncology-specific group): require documented prior lines of systemic therapy, prior targeted agents, PD-1/PD-L1 inhibitor exposure, or combination chemotherapy as indicated per product-specific rules (e.g., prior platinum-based chemotherapy, prior anti-HER2 regimens, prior endocrine therapy).
- Antipsychotic examples: trial of two generic formulary atypical antipsychotics (e.g., aripiprazole, olanzapine, quetiapine, risperidone) prior to coverage of certain long-acting injectable or branded antipsychotics for schizophrenia unless contraindicated.
Oncology — Prior-Therapy and Combination Requirements
Oncology products frequently require prior systemic therapy or specific sequencing. Coverage is provided when ALL applicable prior-therapy rules below are met:
ALL of the following
- If the product labeling or product-specific criteria state 'requires prior therapy' or specifies number/types of prior regimens, documentation of those prior therapies (agents, dates, and best response) must be provided.
- Examples: - Agents requiring prior platinum-based chemotherapy: provide evidence of prior platinum exposure and progression or intolerance. - Agents requiring prior PD-1/PD-L1 inhibitor: document prior immune checkpoint inhibitor use if listed. - Agents requiring prior endocrine therapy (breast cancer): document prior aromatase inhibitor or tamoxifen use and setting (adjuvant vs metastatic).
- For combination-required indications, the requested agent must be prescribed in combination with the specified concomitant therapy (e.g., cetuximab with specific BRAF regimens, aromatase inhibitor with CDK4/6 inhibitors) unless clinical rationale for deviation is provided.
- Prescriber: oncology specialist or documentation of oncology consultation for anticancer agents.
- Authorization duration: typically 1 year; initial shorter trial periods (e.g., 3 months) when response assessment is required per product labeling.
Selected Antipsychotics and Related Agents — Initial Coverage Rules
Initial coverage criteria — combination of clinical and administrative requirements for select psychiatric agents:
ALL of the following
- Abilify Asimtufii (aripiprazole) — Initial Coverage: Diagnosis consistent with product labeling (e.g., schizophrenia, bipolar I disorder, adjunct for major depressive disorder). Trial and inadequate response or intolerance to at least one generic oral atypical antipsychotic unless contraindicated. For LAI formulations, documentation of adherence issues or intolerance to oral therapy should be provided. Prescriber: psychiatrist or appropriate mental health specialist. Authorization duration: initial up to 3 months; reauthorization up to 1 year with documented clinical benefit.
- Invega Hafyera (paliperidone palmitate) — Initial Coverage: Diagnosis of schizophrenia or schizoaffective disorder per labeling. Documentation of prior adequate trial and inadequate response, intolerance, or adherence issues with at least two oral atypical antipsychotics OR documented clinical rationale for initiating a long-acting injectable (e.g., poor adherence). Ensure appropriate loading and maintenance dosing is planned. Prescriber: psychiatrist. Authorization duration: initial up to 3 months; reauthorization requires demonstrated clinical benefit.
- Exxua / Trintellix (vortioxetine) — Initial Coverage: Diagnosis of major depressive disorder. Trial and inadequate response to at least two generic formulary antidepressants (examples: an SSRI and an SNRI) unless contraindicated. Prescriber: primary care or mental health provider. Authorization duration: 1 year with reauthorization requiring evidence of benefit.
- Selected antipsychotics — Initial Coverage (general): For antipsychotics used for schizophrenia or related disorders, trial of two generic formulary atypical antipsychotics is expected prior to coverage of certain branded or long-acting injectable formulations, unless contraindicated or clinically inappropriate. Prescriber: psychiatrist preferred. Reauthorization: documentation of symptom improvement or stabilization.
- Aristada / Aristada Initio (aripiprazole lauroxil formulations) — Initial Coverage: Indication consistent with labeling (e.g., schizophrenia). Patient has had a trial and inadequate response or demonstrated intolerance to at least one oral atypical antipsychotic OR exhibits documented adherence challenges. For Aristada Initio, ensure oral tolerability has been established or use per labeled initiation regimen. Prescriber: psychiatrist. Authorization duration: initial up to 3 months; reauthorization up to 1 year with documentation of benefit.
- Invega Sustenna (paliperidone palmitate monthly) — Initial Coverage: Diagnosis aligned with labeling; trial and inadequate response or intolerance to at least one oral atypical antipsychotic or documented adherence concerns supporting LAI use. Prescriber: psychiatrist. Authorization duration: initial up to 3 months; reauthorization requires documented clinical response.
Supplies — Prior Authorization and Billing Considerations
Prior authorization requirement for supplies and administration-related items:
ALL of the following
- Supplies — Prior Authorization: Certain durable medical supplies, injection supplies, and specialty administration kits require prior authorization when billed separately; documentation must indicate medical necessity and that supplies are appropriate for the prescribed product (e.g., syringe type, needle gauge, infusion pump compatibility).
- When the drug is covered under medical benefit (Part B) vs pharmacy benefit (Part D), ensure correct billing pathway and include documentation to support benefit determination (orders, infusion facility notes).
- For home-administered specialty injectables, include documentation of training, patient ability to self-administer (if applicable), and plan for ongoing monitoring. Quantity limits and refill intervals must follow product labeling and payer quantity rules.
- Denial risk: lack of documentation tying supplies to a covered medication or absence of prescriber order will result in claim denial.
Prior Authorization, Step Therapy, and Documentation Requirements
General PA/ST denial risk
Prior authorization (PA) and step therapy (ST) requests are subject to denial if submitted without required clinical or administrative documentation, or when requests do not meet the specific clinical criteria listed for the drug. Provide complete supporting records (diagnosis, prior therapies, relevant labs/tests, and prescribing rationale) to reduce denial risk.
- Include clinic notes, prior medication history, laboratory or diagnostic test results, and documentation of contraindication/intolerance when applicable.
- For reauthorization requests, include objective evidence of positive clinical response or stability as specified in the drug criteria.
Weight-loss exclusion for Liraglutide
Liraglutide (when listed for diabetes indications) and other agents indicated for weight loss are excluded if prescribed for weight-loss only. When coverage is requested for an FDA-approved metabolic or diabetes indication, submit medical records documenting the qualifying diagnosis and supporting lab values (e.g., A1c >= 6.5%, FPG >=126 mg/dL, or 2‑hour OGTT >=200 mg/dL).
- If the indication is T2DM: provide A1c or fasting glucose or OGTT results as noted.
- Requests solely for weight management without a covered diagnosis will be denied.
Explicit exclusions
Certain products are explicitly excluded from coverage in specific clinical situations. Confirm the drug-specific exclusion language before submitting a PA request.
- Examples: Tadalafil excluded when used with nitrate therapy; Dalfampridine excluded for patients who are wheelchair-bound; coverage not provided for hypocalcemia (specific products).
- Sodium oxybate excluded for patients taking sedative hypnotics or with succinic semialdehyde dehydrogenase deficiency.
Use in combination with a potent immunosuppressant
Many JAK inhibitors and related targeted agents cannot be used in combination with potent immunosuppressants or with another biologic/targeted DMARD for the same condition. Verify combination restrictions and provide documentation when a claim involves prior or concurrent immunosuppressive therapies.
- Common potent immunosuppressants referenced: azathioprine, cyclosporine.
- If patient has prior/ongoing immunosuppressant therapy, include rationale and safety justification; concurrent use without justification may be denied.
Combination therapy exclusion (Xeljanz)
Xeljanz (tofacitinib) cannot be used in combination with potent immunosuppressants or with another biologic/targeted DMARD indicated for the same condition. Reauthorization requests should include documentation of clinical benefit and any safety monitoring performed.
- Ensure documentation of trials of required DMARDs per the indication.
- For reauthorization include objective notes of response and any relevant lab monitoring (e.g., CBC, LFTs).
- Combination use with agents listed above will result in denial.
Combination therapy exclusion (Xolair)
Omalizumab (Xolair) coverage requires specific diagnostic and laboratory documentation and cannot be used in combination with another biologic or targeted DMARD for the same condition. Provide IgE values and confirm prior controller trials where required.
- For allergic asthma: document positive skin test or in vitro reactivity plus IgE level (e.g., >30 IU/mL) as specified.
- For CRSwNP and other indications include listed IgE ranges and prior controller therapy failures.
- Combination biologic use for same condition is excluded.
Exclusions (Sodium Oxybate)
Sodium oxybate coverage requires documentation of narcolepsy with cataplexy or excessive daytime sleepiness (EDS) and prior stimulant trials in adults (e.g., armodafinil; SUNOSI when required). Patients on sedative hypnotics or with succinic semialdehyde dehydrogenase deficiency are excluded.
- Provide diagnosis supporting narcolepsy and records of prior stimulant trials and response.
- Do not submit requests for patients on contraindicated therapies (sedative hypnotics).
Abilify Asimtufii trial requirement
Aripiprazole long-acting formulations have specific required prior trials. Abilify Asimtufii requires a trial of oral aripiprazole; documentation of that trial (or intolerance/contraindication) must be included.
- Submit records showing trial of oral aripiprazole and response or documented intolerance.
- Coverage duration for qualifying cases may be lifetime; indicate if request is initial or maintenance.
Abilify Maintena trial requirement
Abilify Maintena prior authorization requires documentation of a trial of oral aripiprazole (or intolerance). Include dates, doses, and clinical response.
- Include documentation of prior oral aripiprazole trial or reason it is inappropriate.
- Specify whether request is for initial therapy or continuation/maintenance.
Exxua / Trintellix step therapy and Antipsychotic trial requirement
Antidepressant and antipsychotic step therapy requirements: medications such as Exxua/Trintellix and select antipsychotics require step trials of specified generic alternatives before coverage. Provide documentation of prior drug trials, dates, and reasons for discontinuation when applicable.
- Exxua/Trintellix requires trials of at least two specified generic antidepressants (list provided in drug criteria).
- Antipsychotics often require trial of generic alternatives (e.g., aripiprazole, risperidone) — include trial details.
Invega Sustenna trial and documentation requirements
For long‑acting injectable antipsychotics (e.g., Invega Sustenna), PA requires documentation of prerequisite trials and administration history. Reauthorization and documentation of prior adequate trials (oral and/or LAI) and clinical response are necessary.
- Invega Sustenna requests commonly require trial of oral paliperidone or risperidone; include duration and outcome.
- Documentation for Invega Trinza and Invega Sustenna should include prior injection dates, product used, and response/tolerability.
- If the policy requires a once-month or three-month LAI trial for escalation, provide proof of adherence and response.
Lipid and diagnostic documentation
Provide lipid panel results, risk stratification, and documentation of trials of high‑intensity statins or other required therapies when requesting lipid-lowering agents that have step or trial requirements.
- For PCSK9s or other specialty lipid agents, include diagnosis (e.g., HeFH), prior statin intolerance documentation, and recent LDL-C values.
- Include documentation of cardiovascular risk or prior event when requested by the drug-specific criteria.
Retevmo coverage requires RET gene fusion/mutation documentation
Retevmo coverage requires documentation of a RET gene fusion or RET mutation as applicable, detected by an FDA‑approved test. For certain thyroid indications, show prior radioactive iodine trial where appropriate.
- Submit results of RET fusion/mutation testing (name of test and result) with date.
- For thyroid cancer indications, include prior radioactive iodine therapy documentation if appropriate.
Voquezna required medical information
Voquezna (vonoprazan triple therapy or related regimens) requests must include required medical information such as H. pylori diagnostic test results and prior therapy history when applicable.
- Include H. pylori test type (urea breath, stool antigen, biopsy) and result.
- Document prior eradication attempts and antibiotics used if this is a salvage or repeat therapy request.
Verquvo required medical information
Verquvo (vericiguat) PA requests must include heart failure diagnosis details and supporting clinical data per drug criteria (e.g., NYHA class, recent hospitalization, concomitant guideline-directed medical therapy).
- Submit evidence of symptomatic chronic heart failure and documentation of background GDMT (e.g., ACEi/ARB/ARNI, beta-blocker, MRA) or reasons they are contraindicated.
- Include recent hospitalization or biomarker data if requested by criteria.
Xatmep required medical information
Xatmep (methotrexate oral solution) and other pediatric oncology supportive agents require specific medical information at submission (diagnosis, weight-based dosing, prior therapies). Ensure full oncology treatment history is included.
- Provide diagnosis, weight, prior chemotherapy lines, and rationale for agent selection.
- Include dosing calculations and planned duration of therapy.
Xeljanz reauthorization documentation
Xeljanz reauthorization requests should include documentation of continued benefit and any safety monitoring performed (e.g., CBC/LFTs). Absence of documented response or safety monitoring may result in denial.
- Include clinic notes demonstrating symptom improvement and labs used for safety monitoring.
- If treatment changed from another agent, include rationale.
Xolair documentation and requirements
Omalizumab (Xolair) PA submissions must include the diagnostic criteria and prior controller therapy failures as specified. Reauthorization requires documentation of clinical benefit.
- Provide IgE levels, allergy testing results, and prior controller medication trials with dates.
- For CSU or CRSwNP include symptom scores or specialist assessments demonstrating benefit.
Demodex blepharitis diagnostic documentation
For Demodex blepharitis treatments, include diagnostic documentation (clinical exam findings consistent with Demodex infestation) and prior conservative therapy trials where requested.
- Document lid margin findings, evidence of Demodex (microscopy if performed), and previous topical/ocular hygiene measures tried.
Administration and product-specific documentation (Rhopressa, Rocklatan, Rytary, Farxiga/Jardiance, Febuxostat)
Specific injectables and ophthalmic products require documentation of prior trials and administration details to support PA: include dates of prior injections/administration, dosing, and response.
- Rhopressa / Rocklatan: include prior topical glaucoma medication trials and intraocular pressure data.
- Rytary: provide trial of generic extended‑release carbidopa/levodopa and response details.
- Farxiga / Jardiance: show trial of generic dapagliflozin when applicable and note exceptions for cardioprotective indications.
- Febuxostat: document trial or contraindication to allopurinol.
Formulary Codes, Formulations, and Key Clinical Thresholds
| 526MG/100ML | formulation listed in products affected |
| 492MG/100ML | formulation listed in products affected |
| 356MG/100ML | formulation listed in products affected |
| 390MG/100ML | formulation listed in products affected |
| 34MG/100ML | formulation listed in products affected |
| 152MG/100ML | formulation listed in products affected |
| Prograf PACK | Product name listed |
| Pulmozyme SOLN 2.5MG/2.5ML | Product name and strength |
| Sirolimus SOLN | Product name |
| Tacrolimus CAPS | Product name |
| Tobramycin NEBU 300MG/5ML | Product name and strength |
| Ventavis | Product name |
| Abilify Asimtufii | Product name |
| Exxua | Product name |
| Exxua Titration Pack | Product name |
| Trintellix | Product name |
| Caplyta | Product name |
| Rexulti | Product name |
| Vraylar CAPS | Product name |
| Zyprexa Relprevv | Product name |
| Aristada | Product name |
| Alcohol Prep Pads PADS 70% | Supply product |
Requirements for Starting Therapy
Reauthorization and Continuing Coverage Requirements
Step Therapy Tables and Required Prior Trials
| Step therapy rule | What provider must document |
|---|---|
| Step therapy applies where 'Prerequisite Therapy Required' is indicated for the product. | |
| Documentation of prior trials/failures of required formulary agents as specified by the product entry (see individual product criteria). |
| Step therapy rule | What provider must document |
|---|---|
| Must have failed or be intolerant to specified generic alternatives before coverage (applies to listed products). | |
| Medical records or chart notes documenting trials of the specified generic alternatives or documentation of intolerance/contraindication. |
| Step therapy rule | What provider must document |
|---|---|
| Prior trials of listed controller medications required for indicated respiratory agents (e.g., inhaled corticosteroid + additional controller). | |
| Documentation of prior controller medication trials (drug names, dates, response) as specified in the product entry. |
| Step therapy rule | What provider must document |
|---|---|
| Step therapy trials required — number and specific agents vary by drug and indication (see product entries for details). | |
| Clinical notes showing trial and inadequate response or intolerance to the named prior therapies per the product-specific criteria. |
| Step therapy rule | What provider must document |
|---|---|
| Must have failed or received prior lines of systemic therapy as detailed (oncology agents such as Lonsurf). | |
| Oncology treatment history documenting prior chemotherapy/biologic regimens and lines of therapy as required by the product entry. |
| Step therapy rule | What provider must document |
|---|---|
| Trial of two specified agents (examples: Enbrel, adalimumab formulations, Rinvoq, Xeljanz/XR, Orencia) required prior to coverage for certain biologics. | |
| Records of trials of the two listed alternative biologic/DMARD agents with dates and reasons for failure/intolerance. |
| Step therapy rule | What provider must document |
|---|---|
| For schizophrenia in adults, coverage of Lybalvi requires trial of lurasidone and paliperidone; other indications require trials of listed agents. | |
| Documentation of trials of lurasidone and paliperidone (or other required agents) including dose, duration, and inadequate response or intolerance. |
| Step therapy rule | What provider must document |
|---|---|
| For metastatic colorectal cancer treated with Lonsurf, requires prior trials of multiple chemotherapy classes and anti-VEGF (and anti-EGFR if RAS wild-type). | |
| Oncology records documenting prior fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapies, anti-VEGF therapy, and anti-EGFR where applicable. |
| Step therapy rule | What provider must document |
|---|---|
| Trial of one high-intensity statin required prior to initiation of Nexletol or Nexlizet unless statin intolerance documented. | |
| Recent lipid panel and documentation of at least one high-intensity statin trial (or documentation of statin intolerance/contraindication). |
| Step therapy rule | What provider must document |
|---|---|
| Trial of sildenafil required prior to coverage of certain pulmonary arterial hypertension agents (e.g., Orenitram). | |
| Documentation of trial and failure or contraindication to sildenafil (dates, dose, reason for failure/contraindication). |
| Step therapy rule | What provider must document |
|---|---|
| Trial of Firmagon (or intolerance) required prior to Orgovyx; for MA-PD plans the Firmagon trial may occur under Part B before Part D step therapy. | |
| Documentation of Firmagon use or intolerance and any applicable Part B administration records if used prior to Part D coverage decision. |
| Step therapy rule | What provider must document |
|---|---|
| Must document prior trials with two alternative azoles before posaconazole DR is authorized for prophylaxis or treatment of IFI. | |
| Records showing trials of two of fluconazole, itraconazole, or voriconazole (medication names, dates, outcomes). |
| Step therapy rule | What provider must document |
|---|---|
| Maximally tolerated statin (or documentation of intolerance) required prior to Praluent initiation per LDL thresholds specified. | |
| LDL values while on a high-intensity statin within the last 120 days and documentation of at least 12 weeks of high-intensity statin or statin intolerance with trials of atorvastatin and rosuvastatin. |
| Step therapy rule | What provider must document |
|---|---|
| Document prior therapies and progression where required for oncology agents (e.g., Polivy, Padcev). | |
| Oncology treatment history including prior lines of systemic therapy, dates, agents, and evidence of progression or intolerance. |
| Step therapy rule | What provider must document |
|---|---|
| Specific prerequisite therapies required for coverage depending on drug and indication (see individual drug entries such as Retevmo, Rinvoq, etc.). | |
| Evidence of required prerequisite therapy (e.g., RET gene testing for Retevmo, prior DMARD/TNF inhibitor trials for Rinvoq) per product-specific criteria. |
| Step therapy rule | What provider must document |
|---|---|
| Prior trial or documented progression required per product-specific criteria (example: Tafinlar requiring prior combination partners or progression). | |
| Clinical documentation verifying prior trial, treatment response, or documented disease progression as required by the product entry. |
| Step therapy rule | What provider must document |
|---|---|
| Trial of at least two generic triptans required prior to coverage of acute migraine agents such as Ubrelvy (unless contraindicated). | |
| Documentation of trials of two generic triptans (agent names, doses, dates) or documentation of contraindication/intolerance to triptans. |
| Step therapy rule | What provider must document |
|---|---|
| Trial of both a generic PDE5 inhibitor (sildenafil or tadalafil) AND a generic endothelin receptor antagonist (bosentan or ambrisentan) required prior to listed PAH products (e.g., Winrevair). | |
| Records documenting trials of the PDE5 inhibitor and the endothelin receptor antagonist, including dates and outcomes. |
| Step therapy rule | What provider must document |
|---|---|
| Trial of a guideline-recommended first-line H. pylori regimen required prior to Voquezna for H. pylori infection. | |
| Documentation of prior first-line H. pylori regimen (clarithromycin triple therapy or bismuth quadruple therapy) and treatment outcome or failure. |
| Step therapy rule | What provider must document |
|---|---|
| Prerequisite Part D drug required for certain products as indicated in the product entry (flagged per product). | |
| Documentation that the prerequisite Part D drug was used as required (medication name, dates, reason for failure/intolerance). |
| Step therapy rule | What provider must document |
|---|---|
| Prerequisite Part D drug required (per product) — many biologics and specialty agents include this requirement in their headers. | |
| Evidence of the required prerequisite Part D therapy, including clinical rationale for use of the requested product if prerequisite not applicable. |
| Step therapy rule | What provider must document |
|---|---|
| Prerequisite Part D drug required per indication when specified in the product entry (e.g., certain oncology and specialty indications). | |
| Medical evidence showing prior Part D drug use per the indication-specific requirement (drug names, dates, response), or rationale if prior therapy not possible. |
| Step therapy rule | What provider must document |
|---|---|
| Must have trials of at least two listed generics prior to coverage for specific antidepressant entries (e.g., Exxua/Trintellix). | |
| Documentation of trials of at least two of the specified generic antidepressants (agent names, dates, and reasons for failure/intolerance). |
| Step therapy rule | What provider must document |
|---|---|
| Must have trial of at least one listed generic antipsychotic prior to coverage of certain antipsychotic products (e.g., Caplyta, Rexulti). | |
| Clinical documentation of trial of specified generic antipsychotic (agent, dose, duration) and inadequate response or intolerance. |
| Step therapy rule | What provider must document |
|---|---|
| Must complete required injectable paliperidone palmitate regimen (per timing/duration) prior to coverage of alternate paliperidone products (Invega Hafyera specifics). | |
| Records confirming completion of required paliperidone palmitate extended-release injectable regimen with dates and dosing schedule per product rule. |
| Step therapy rule | What provider must document |
|---|---|
| Documented trial of oral paliperidone or risperidone required prior to coverage of paliperidone palmitate injectable products (e.g., Invega Sustenna/Trinza). | |
| Documentation of oral paliperidone or risperidone trial (dates, dosing, response) and clinical rationale for the injectable product. |
| Step therapy rule | What provider must document |
|---|---|
| Trial of generic dapagliflozin required prior to Farxiga or Jardiance requests, with exception for Jardiance when used to reduce CV death risk in adults with T2DM and established CVD. | |
| Evidence of trial of generic dapagliflozin (dates, dose) or documentation that the Jardiance request is for the CV death risk reduction indication exempt from step therapy. |
| Step therapy rule | What provider must document |
|---|---|
| Trial of any generic formulary ophthalmic glaucoma medication or Lumigan required prior to coverage of Rhopressa or Rocklatan. | |
| Documentation of prior topical glaucoma medication trial(s) or Lumigan use including agent, duration, and inadequate response or intolerance. |
| Step therapy rule | What provider must document |
|---|---|
| Requires trial of specified oral generic alternatives prior to coverage of multiple listed products (e.g., oral paliperidone or oral risperidone; generic ER carbidopa/levodopa for Rytary; allopurinol for febuxostat). | |
| Clinical documentation confirming trials of the specified oral generic alternatives with dates, dosing, and reasons for failure/intolerance. |
| Site of care consideration | Provider action required |
|---|---|
| Infusion center / Medicare Part B vs Part D: coverage determination may depend on administration setting (Part B vs Part D billing). | |
| Submit information describing the use and setting of the drug (e.g., infusion center administration) to determine Medicare Part B vs Part D coverage pathway. |
Billing Pathway and Setting Considerations
Policy Basis and Formulary Context
This document summarizes the Blue Cross Blue Shield of Michigan Core Comprehensive Formulary prior authorization (PA) and step therapy (ST) clinical criteria for outpatient prescription drugs under Formulary ID 26449, Version 17 (effective 06/01/2026). The criteria reflect the Pharmacy & Therapeutics Committee–endorsed clinical rules used to determine coverage for Part D drugs on the formulary; products requiring PA or ST are identified on the formulary and are subject to the clinical and administrative requirements described herein.
Coverage decisions in this program commonly require documentation of diagnosis, prior trials or contraindications to specified formulary alternatives, and any test or laboratory thresholds noted for an indication (for example, biomarker results for targeted oncology agents, eosinophil counts for eosinophil‑directed biologics, baseline T25FW for dalfampridine, or A1c/FPG/OGTT for diabetes). Many authorizations are issued for 1 year unless another duration is specified; some products have lifetime or other special duration rules.
Providers seeking coverage should follow the PA/ST process: confirm whether the drug is designated (PA) or (ST) on the formulary, supply the required clinical documentation (diagnoses, prior therapy trials, laboratory or genetic test results where required), and contact the pharmacy help desk as noted on the member ID card for authorization requests or questions. Claims may be denied if PA/ST criteria are not met or required documentation is not provided.
Key Terms and Abbreviations
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