Prior authorization and step therapy criteria for pharmacy & specialty drugs (Formulary PA/ST)
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This document lists prior authorization and step therapy criteria for multiple prescription drugs on the Blue Cross Blue Shield of Michigan Medicare Group formulary, specifying coverage conditions, prerequisites, duration, and any use restrictions for prescribers and members.
No material clinical or coverage changes in this revision.
Product-specific Coverage Criteria
Initial product-specific authorization criteria
Initial product-specific authorization criteria — products requiring prior authorization for initial therapy. Covered when ALL of the following are met unless otherwise noted in the product-specific nodes.
ALL of the following
- Prescribed product is listed in the formulary as a prior authorization medication.
- A diagnosis consistent with an FDA-approved or medically-accepted indication is documented in the medical record.
- Required baseline diagnostic or laboratory information (if specified per product) is provided with the request.
- For products with prerequisite therapy requirements, documentation of trial and inadequate response, intolerance, or contraindication to the required prior agent(s) is provided.
- Prescriber meets any specialty or age restrictions noted for the product.
Initial Therapy — Antipsychotics and Related Products
- For treatment of schizophrenia or other indicated psychiatric disorders, trial and failure of two generic formulary atypical antipsychotics is required unless clinical rationale provided documenting why trials are inappropriate or not tolerated.
- When Aripiprazole long-acting injectables (e.g., Abilify Maintena, Abilify Asimtufii) or other depot antipsychotics are requested, documentation of adherence issues, intolerance to oral formulations, or clinical rationale for long-acting injectable therapy is required.
- For Lybalvi and other recently approved antipsychotic agents, a trial of recommended formulary comparators (e.g., lurasidone, paliperidone) is required for schizophrenia indication; documentation of inadequate response, intolerance, or contraindication is required.
Abilify Asimtufii - Initial Therapy
- Diagnosis of schizophrenia or other FDA-approved indication documented in chart.
- Patient is at least the minimum age per product labeling or clinical guidance.
- Trial and inadequate response, intolerance, or contraindication to two generic formulary atypical antipsychotics, unless prescriber documents clinical rationale for bypassing trials.
- If initiating long-acting injectable as a switch from oral aripiprazole, documentation of prior oral aripiprazole tolerance or rationale for using long-acting formulation is provided.
Abilify Maintena - Initial Therapy
- Diagnosis of schizophrenia or other FDA-approved indication documented in chart.
- Documentation of adherence concerns, inability to tolerate oral therapy, or clinical justification for long-acting injectable formulation.
- If converting from oral aripiprazole, documentation of prior oral aripiprazole tolerance or appropriate oral overlap per product labeling is provided.
- Prescriber specialty information included when required by product guidance.
Aristada Initio - Initial Therapy
- Indication consistent with FDA-approved labeling (e.g., schizophrenia).
- Documentation that patient received the required initiation regimen (e.g., appropriate oral aripiprazole lead-in or other initiation dose per labeling) or clinical rationale if initiation regimen cannot be followed.
- Trial and inadequate response/intolerance to at least two generic formulary atypical antipsychotics unless documented clinical rationale for exceptions.
Aristada - Initial Therapy
- Diagnosis consistent with FDA-approved indication documented in medical record.
- Documentation of prior tolerability to aripiprazole (oral) when required by product labeling or appropriate initiation regimen completed (per Aristada Initio rules).
- Clinical rationale for use instead of other formulary antipsychotics (e.g., adherence issues) provided if prior trials not completed.
Invega Sustenna - Initial Therapy
- Diagnosis consistent with FDA-approved indication (e.g., schizophrenia) documented in chart.
- Trial and inadequate response, intolerance, or contraindication to two generic formulary atypical antipsychotics is required unless clinical rationale provided.
- If converting from oral paliperidone or risperidone, documentation of prior tolerability or required initiation dosing schedule provided.
Invega Hafyera - Initial Therapy
- Diagnosis consistent with FDA-approved indication documented in medical record.
- Patient meets age and prescriber specialty requirements per labeling when applicable.
- Documentation of prior trials of generic atypical antipsychotics or clinical rationale for exception provided.
Supply Items - Initial Criteria
- Requests for associated supply items (e.g., injection supplies, administration kits) submitted with the medication prior authorization must include documentation that the medication request is approved or medically necessary.
- Supply-only requests without an active and approved medication authorization will be denied.
- When a specific supply is required by the product (e.g., special syringe, single-use kit), documentation that the supply is medically necessary is required.
Reauthorization/Duration Note
- Initial approvals are generally for up to 1 year unless otherwise specified per product; reauthorization requires documentation of positive clinical response and continued need for therapy.
- Products with alternative initial durations (e.g., some depot antipsychotic initiation periods) will follow the product-specific coverage duration noted in the formulary.
Document Submission Requirements
- Include copies of relevant clinical notes, prior medication trials with dates and outcomes, baseline labs or diagnostic tests when applicable, and prescriber specialty credentials when required.
- For pediatric or weight-based dosing requirements, include patient age and weight at initiation.
Exclusions and Combination Therapy
- Biologic and targeted DMARD products cannot be used in combination for the same condition unless explicitly allowed by product-specific criteria.
- Many immunomodulatory agents require that the patient is not receiving concomitant potent immunosuppressants unless specified; confirm per product criteria.
Operational Notes
- If product-specific criteria in the formulary differ from these general initial therapy rules, the product-specific nodes and requirements take precedence.
Trintellix/Exxua - Initial Therapy and Antidepressant Step
- For major depressive disorder, documentation of trials and inadequate response to at least two prior antidepressants (including trials of venlafaxine or duloxetine when applicable per formulary) is required when specified by product rules.
- For Exxua formulations, include documentation if formulation-specific reasons (e.g., tolerability, prior response) necessitate use over other formulations.
Antipsychotics - Initial Therapy (General)
- For schizophrenia or psychotic disorders, requirement of trial and failure/intolerance of two generic formulary atypical antipsychotics (examples: aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone) unless clinical rationale is provided.
- When a long-acting injectable is requested, include documentation supporting need for depot therapy (adherence concerns, history of nonadherence, oral intolerance) and prior oral tolerability when required by product labeling.
Authorization Limits
- Standard initial authorization duration is one year for most products unless another duration is specified in the product entry (e.g., lifetime, 3 months, initial shorter authorization for observation).
- Initial shorter authorization periods (e.g., 2 months for sapropterin) require documented clinical response before extension to standard durations.
Preservation of Product-Specific Rules
- All product-specific prerequisite therapy, diagnostic, age, prescriber, and combination exclusions shown in the formulary product entries (e.g., Dupixent, Nucala, Fasenra, Rinvoq, Xolair) remain applicable and must be satisfied in addition to these initial therapy criteria.
Clinical Exceptions
- Clinical exceptions to prerequisite trials may be granted when adequate documentation demonstrates that the required trials are medically inappropriate, contraindicated, or not tolerated; rationale must be clearly documented in the medical record and submitted with the request.
Initial Authorization / Step Requirements
Reauthorization / Continuation Requirements
Step Therapy Rules and Required Prior Trials
| Step therapy overview | Key requirements / notes |
|---|---|
| Step therapy is applied to some formulary drugs and identified in the formulary with (ST). | |
| Drugs subject to ST require prior treatment with one or more formulary agents (specified per product) before coverage is provided; physicians may contact the pharmacy help desk to request ST/PA. |
| Example | Required trial(s) |
|---|---|
| Dihydroergotamine mesylate (migraine) | |
| Trial of two triptans on the formulary: one oral triptan and one non-oral triptan (e.g., nasal spray or injection). | |
| Epidiolex (seizure indications) | |
| Trial of two generic anticonvulsants (or two generic alternatives for Lennox-Gastaut / specified combinations). | |
| Topiramate solution (migraine prevention / seizures) | |
| Trial of at least two generic alternatives for migraine prevention OR inability to swallow tablets/capsules; for seizure disorder, trial of at least two generic anticonvulsants or inability to swallow tablets/capsules. | |
| Schizophrenia agents | |
| Trial of two generic formulary atypical (second‑generation) antipsychotics (e.g., aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone). |
| Documentation required | What to include |
|---|---|
| Document trial and either failure, intolerance, or contraindication to the specified alternative agents prior to approval. | |
| Provide name(s) of prior agent(s), dates of use, clinical reason for discontinuation (failure/intolerance/contraindication), and supporting medical records or test results when specified (e.g., T25FW for dalfampridine, trial of generic ER carbidopa/levodopa for Rytary). |
| Oncology agent / scenario | Step / combination requirement |
|---|---|
| Inlyta (advanced RCC) | |
| First-line treatment of advanced RCC requires combination use with avelumab or pembrolizumab; treatment of advanced RCC requires trial of one prior systemic therapy. | |
| Lenvima (RCC and other indications) | |
| Coverage for RCC as first-line therapy requires combination with pembrolizumab; other indications require specified prior systemic therapy lines per product entry. | |
| Lorbrena (metastatic colorectal cancer) | |
| Requires combination use (bevacizumab) and prior fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy; RAS wild-type requires prior anti‑EGFR therapy. | |
| Trodelvy (breast cancer) — TNBC and HR+ scenarios | |
| TNBC: prior use of two or more systemic therapies with at least one for metastatic disease; HR+: prior endocrine-based therapy plus at least two additional systemic therapies. |
| Psychiatric product | Step therapy examples / prerequisites |
|---|---|
| Lybalvi (schizophrenia) | |
| Requires prior trials of lurasidone and paliperidone for schizophrenia; for other indications requires trials of at least two specified generic antipsychotics. | |
| Trintellix / Exxua (major depressive disorder) | |
| Requires trial of at least two listed generic antidepressants (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, etc.). | |
| Paliperidone palmitate LAI (Invega Hafyera) | |
| Requires trial of once-monthly paliperidone palmitate for ≥4 months OR every-3-month paliperidone palmitate for at least one 3‑month cycle before coverage of Hafyera. | |
| Invega Sustenna / Trinza | |
| Require documented trial of oral paliperidone or oral risperidone prior to coverage; coverage duration often lifetime. |
| SGLT2 inhibitor | Step therapy rule |
|---|---|
| Farxiga and Jardiance | |
| Require trial of generic dapagliflozin prior to coverage; exception — Jardiance step therapy does not apply when used to reduce risk of cardiovascular death in adults with T2DM and established CVD. |
| Prerequisite Part D drug trials | Requirement / evidence |
|---|---|
| Many specialty products require documentation of a trial, failure, or intolerance to specified Part D prerequisite drugs prior to approval. | |
| Examples include requirement to document trial and failure or contraindication to listed prior therapies (e.g., sildenafil for Orenitram, allopurinol for febuxostat) and other product‑specific prerequisite drugs as noted per entry. |
| Per-indication step therapy | Documented prior trial(s) required |
|---|---|
| Tafinlar (dabrafenib) liquid formulation | |
| Liquid formulation coverage requires inability to swallow capsules; tafinlar indications often require prior vemurafenib + cobimetinib or combination with trametinib for listed tumor types. | |
| Antidepressant / antipsychotic examples | |
| Trintellix/Exxua requires trial of ≥2 listed generic antidepressants; antipsychotic products require trial of ≥1 listed generic antipsychotic prior to coverage. | |
| Rytary (Parkinson’s) | |
| Requires trial of generic oral extended‑release carbidopa & levodopa prior to coverage of Rytary. |
| Trodelvy (TNBC and HR+) | Prior systemic therapy requirements |
|---|---|
| Trodelvy for unresectable locally advanced or metastatic triple‑negative breast cancer (TNBC) | |
| Requires prior use of two or more systemic therapies with at least one for metastatic disease before Trodelvy is covered. | |
| Trodelvy for unresectable locally advanced or metastatic HR+/HER2- disease | |
| Requires prior endocrine‑based therapy plus at least two additional systemic therapies in the metastatic setting before coverage. |
| Verquvo combination requirement | Clinical combination and exceptions |
|---|---|
| Verquvo (chronic heart failure NYHA II–IV, LVEF <45%) | |
| Must be taken in combination with at least two of the specified heart failure therapies (beta‑blocker, ACE‑inhibitor/ARB/ARNI, SGLT2 inhibitor approved for HF, or a mineralocorticoid) unless contraindicated or not tolerated. |
| Verquvo clinical preconditions | Documentation required |
|---|---|
| Baseline clinical criteria for Verquvo | |
| Documentation must include diagnosis of chronic HF NYHA class II–IV, LVEF <45%, and either a HF hospitalization within prior 6 months or outpatient IV diuretic within prior 3 months; and evidence of concomitant HF therapies unless contraindicated. |
| Step therapy summary | Common patterns |
|---|---|
| Many products require documented trials of specified prior therapies before coverage and reauthorization commonly requires documentation of positive clinical response. | |
| Coverage durations are frequently 1 year (or lifetime for certain psychiatric LAIs and others) and prerequisite Part D drug requirements vary by product and indication. |
| Antidepressant step therapy | Required trial(s) |
|---|---|
| Trintellix / Exxua (MDD) | |
| Requires trial of at least 2 of the listed generic antidepressants (examples: bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, etc.). |
| Antipsychotic step therapy | Required trial(s) |
|---|---|
| Long‑acting injectable and other antipsychotic products | |
| Coverage requires trial of at least one listed generic antipsychotic (examples include aripiprazole, risperidone, quetiapine, olanzapine, paliperidone, etc.) prior to coverage of listed antipsychotic products; some LAI products also require trials of specific formulations/durations. |
| Paliperidone palmitate LAI step therapy | Required durations / trials |
|---|---|
| Invega Hafyera (paliperidone palmitate LAI) | |
| Requires trial of once‑monthly paliperidone palmitate for at least 4 months OR every‑3‑month paliperidone palmitate for at least one 3‑month cycle before Hafyera coverage is approved; documentation of the trial is required. |
| SGLT2 step therapy (Farxiga / Jardiance) | Exceptions |
|---|---|
| Farxiga and Jardiance both require trial of generic dapagliflozin prior to coverage for many indications. | |
| Exception: Jardiance step therapy does not apply when Jardiance is used to reduce risk of cardiovascular death in adults with T2DM and established cardiovascular disease. |
| Ophthalmic glaucoma step therapy | Required prior agents |
|---|---|
| Rhopressa and Rocklatan | |
| Require trial of any generic formulary ophthalmic glaucoma medication OR Lumigan prior to coverage; documentation of the trial is required for PA. |
| Rytary step therapy | Required prior agent |
|---|---|
| Rytary (extended‑release carbidopa/levodopa) | |
| Requires trial of generic oral extended‑release carbidopa & levodopa prior to coverage; documentation of prior trial may be required for authorization. |
Prior Authorization, Documentation & Denial Risks
Prior Authorization Required
Prior authorization (PA) is required for many drugs listed on the formulary. PA means clinical and/or administrative criteria must be met before coverage is provided; requests should include the required clinical documentation and supporting tests to avoid delays or denial. Typical authorization durations are one year unless otherwise noted; some products have initial shorter windows (e.g., 3-month initial period with 1-year renewal).
- Call the customer service number on the back of the member ID card or the pharmacy help desk to request PA or step therapy (ST).
- PA/ST status is indicated on the formulary (PA or ST).
- Provide clinical documentation to support Part B vs Part D determination when applicable (e.g., erythropoiesis stimulating agents, certain physician-administered drugs).
Biologic prior‑therapy requirements & Combination‑therapy exclusion
Many biologics and targeted DMARDs require documentation of prior conventional therapy before approval and cannot be used in combination with another biologic/targeted DMARD for the same condition. Reauthorization usually requires documentation of positive clinical response. Ensure documentation shows trials, failures, intolerances, and concurrent medication history.
- For RA, most biologics require prior DMARD trial(s) (examples: methotrexate, leflunomide, sulfasalazine).
- Some indications require NSAID trial (e.g., ankylosing spondylitis requires trial of an NSAID).
- Document prior trials (drug name, dose, dates, reason for discontinuation).
- Reauthorization: provide objective documentation of positive clinical response or stability as specified (e.g., T25FW for dalfampridine).
Lonsurf prior authorization & prerequisite therapy for CMV/post‑transplant
Lonsurf (trifluridine/tipiracil) coverage for metastatic colorectal cancer and other oncology indications requires documentation of prior lines of chemotherapy and appropriate combination therapy as specified. For post‑transplant CMV infection/disease, a trial of ganciclovir, valganciclovir, cidofovir, or foscarnet is required.
- Metastatic colorectal cancer: trial of fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy and an anti‑VEGF; RAS wild‑type mCRC also requires prior anti‑EGFR therapy.
- Metastatic gastric/GEJ adenocarcinoma: trial of at least two prior lines including fluoropyrimidine and platinum or taxane/irinotecan or HER2-targeted if appropriate.
- Post‑transplant CMV: document trial and failure/intolerance of one of the listed antivirals.
Lorbrena prior authorization and chemotherapy step requirements
Lorbrena (lorlatinib) PA requires adherence to oncology step/chemotherapy sequencing rules where applicable. Document prior therapies per the indication and provide standard oncologic staging/biomarker results.
- For NSCLC or other approved indications: include prior ALK‑inhibitor therapy history if applicable and tumor mutation testing.
- Provide documentation of prior chemotherapy regimens when required by indication.
Mekinist prior authorization & liquid formulation prerequisite
Mekinist (trametinib) requires combination use with dabrafenib for most labeled BRAF‑mutant indications; the liquid formulation has the additional prerequisite that the patient is unable to swallow tablets and still requires trials of specified BRAF inhibitor combinations.
- Coverage for unresectable/metastatic melanoma with BRAF V600E or V600K: requires combination use with dabrafenib (or documents Vemurafenib+Cobimetinib trial for some scenarios).
- Mekinist liquid: document inability to swallow tablets and prior combination therapy trials as specified.
Nexletol prior authorization — check indication‑specific prior therapy
Nexletol and similar specialty agents may have indication‑specific prior therapy requirements; verify the formulary entry for necessary prior treatments or diagnostic criteria.
- Examples: Nexletol (bempedoic acid) entries note indication‑specific prior therapies — include prior statin/thyroid or oncologic therapy documentation as required.
Nucala: indication‑ and lab‑based prior authorization
Nucala (mepolizumab) requires indication‑ and lab‑based documentation: eosinophil counts and disease‑specific criteria (e.g., EGPA features) are required. Nucala cannot be used in combination with another biologic/targeted DMARD for the same condition; reauthorization requires evidence of clinical response.
- Eosinophilic asthma: eosinophil count ≥150 cells/µL at initiation (or per product criteria) and failure to maintain control after systemic corticosteroids or high‑dose ICS plus another controller (e.g., montelukast, LABA, LAMA).
- EGPA: document two typical EGPA features (histopathology, neuropathy, pulmonary infiltrates, nasal polyps, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, ANCA positivity).
- HES: document diagnosis of HES where applicable.
- Include baseline and follow‑up labs demonstrating clinical response for reauthorization.
Long‑acting antipsychotic PA: oral aripiprazole / aripiprazole product trials required
Long‑acting injectable antipsychotic products have oral trial requirements before coverage. Abilify Asimtufii and Abilify Maintena require a trial of oral aripiprazole (coverage duration: lifetime). Aristada requires trial or intolerance to other aripiprazole products; Aristada Initio requires trial of oral aripiprazole prior to initiation.
- Document the oral aripiprazole trial (drug, dose, dates, reason for switching).
- For Aristada: document trial and failure or intolerance to Abilify Maintena or oral aripiprazole when required.
- Coverage durations for these products are noted as lifetime — include long‑term treatment rationale.
Invega Sustenna / Hafyera / Trinza trial requirements & documentation
Paliperidone palmitate products (Invega Sustenna, Invega Hafyera, Invega Trinza) require prior trials of oral paliperidone or risperidone and/or prior paliperidone palmitate formulations per product. Documentation must show duration of prior injectable cycles when required.
- Invega Hafyera: trial of paliperidone palmitate extended‑release injectables for specified durations (e.g., 4 months or a 3‑month cycle) required.
- Invega Sustenna / Trinza: require trial of oral paliperidone or oral risperidone; Trinza generally follows prior paliperidone palmitate dosing history.
- Provide dates, doses, and reason for change or intolerance.
Risperidone ER / Rykindo / related trial requirements
Risperidone ER, Rykindo, and other risperidone/paliperidone products require trial of oral risperidone or oral paliperidone as specified. Provide documentation of prior oral therapy and response/intolerance.
- Risperidone ER and Rykindo: require trial of oral risperidone (coverage duration often lifetime).
- Rykindo and other brand variants: include oral risperidone trial details in the PA request.
Dalfampridine PA: wheelchair exclusion & T25FW documentation
Dalfampridine (for MS) is excluded for patients who are wheelchair‑bound or become wheelchair‑bound. Prior to initiation, submit a baseline Timed 25‑Foot Walk (T25FW); reauthorization requires documentation of stability or improvement on T25FW.
- Do not request coverage for members who are wheelchair‑bound; include T25FW baseline and follow‑up data with dates.
- Document MS diagnosis and functional status as part of PA.
Ophthalmic glaucoma product trial requirement
Some ophthalmic agents (e.g., Rhopressa, Rocklatan, other eye glaucoma products) require a trial of a generic formulary ophthalmic glaucoma medication or Lumigan. Provide documentation of prior topical glaucoma therapy.
- Document generic topical glaucoma medication trials or Lumigan use (drug, duration, reason for failure/intolerance).
- Coverage duration typically one year — include objective IOP or visual field data if available.
Diabetes supplies: prior insulin claim required
Supplies associated with diabetes (e.g., pads, gauze) require a prior insulin claim within the last 180 days to qualify. Include recent pharmacy or medical claim data demonstrating insulin use.
- Provide the insulin claim date and product in the PA submission to demonstrate eligibility.
- Coverage duration for supplies is commonly 1 year.
SGLT2 inhibitor step therapy & Jardiance CV death reduction exception
SGLT2 inhibitor step therapy: Farxiga and Jardiance require trial of generic dapagliflozin; however, the Jardiance exception applies when used to reduce risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease (no step required). Document indication when requesting Jardiance under the CV death reduction indication.
- For Farxiga/Jardiance non‑CV indications: document trial of generic dapagliflozin.
- For Jardiance CV death reduction: include documentation of established cardiovascular disease to qualify for the exception to step therapy.
Febuxostat PA: allopurinol trial or contraindication required
Febuxostat requests require trial of allopurinol or documentation of contraindication/intolerance to allopurinol prior to approval. Include prior medication history and rationale for febuxostat.
- Document allopurinol trial dates, dose, and reason for discontinuation (e.g., intolerance, lack of efficacy).
- Coverage duration is typically lifetime when criteria met.
Drug‑drug contraindication & combination therapy exclusion (denial risks)
Certain contraindicated drug‑drug combinations will be denied. Examples: tadalafil with nitrates is excluded; many PA entries note required prior therapies and explicit combination exclusions (e.g., cannot combine biologics/targeted DMARDs for same condition). Review medication list for contraindications before submission.
- Tadalafil requests: check for concomitant nitrate therapy — coverage is excluded if nitrates are present.
- Biologic/targeted DMARDs: document absence of concurrent biologic therapy for same condition.
- Document concomitant medications and reconcile with member claims to avoid denial.
Excluded indications & weight‑loss‑only exclusion
Exclusions and indication restrictions: many products have explicit excluded uses or 'weight‑loss only' and other indication exclusions. Provide the precise diagnosis and supporting clinical documentation to show the requested use is a medically accepted, covered indication.
- If the request is for an excluded indication (e.g., weight‑loss only), include clinical rationale demonstrating medical necessity for an accepted diagnosis.
- For oncology, include tumor biomarkers and prior lines of therapy per the specific product entry.
Oncology step/combination therapy & required prior therapy documentation
Oncology and specialty products often require detailed prior therapy, biomarker, staging, and combination‑therapy documentation. Examples: Lynparza, Livtencity, Venclexta, Trodelvy, and others have specified prior therapy or combination requirements — include pathology, mutation testing, prior chemotherapy regimens, and treatment dates.
- Include FDA‑approved test reports (e.g., BRAF, RET, BRCA) and prior regimen names/dates.
- Document combination therapy when required (e.g., Venclexta combination regimens, Trodelvy step/combination rules).
- Reauthorization: include evidence of clinical response or tumor control as specified.
PA request, documentation & formulary versioning
Formulary versioning and PA submission: include the formulary version/date and relevant Formulary ID in the PA to ensure the request is evaluated against the correct criteria. Reauthorization requests should include objective measures of clinical response per the product (e.g., BMD for Tymlos, functional scores, lab thresholds).
- List Formulary ID and Version (e.g., Formulary ID: 26449, Version: 17, Effective Date: 06/01/2026) on submissions when available.
- Reauthorization: include the required objective response data specified by the product entry.
Codes, Thresholds and Diagnostic Values
| Adalimumab-aaty 1-pen Kit INJ 80MG/0.8ML | Product line entry as listed |
| Adalimumab-aaty 2-pen Kit | Product line entry as listed |
| Adalimumab-aaty 2-syringe | Product line entry as listed |
| Adalimumab-aaty Cd/uc/hs Starter | Product line entry as listed |
| Adalimumab-adbm | Product line entry as listed |
| Adalimumab-adbm Crohns/uc/hs Starter | Product line entry as listed |
| Adalimumab-adbm Psoriasis/uveitis Starter | Product line entry as listed |
| Adalimumab-adbm Starter Package For Crohns Disease/uc/hs | Product line entry as listed |
| Adalimumab-adbm Starter Package For Psoriasis/uveitis | Product line entry as listed |
| Formulary ID: 26449, Version: 17 | Orencia listing metadata |
| Orencia INJ 125MG/ML, 50MG/0.4ML, 87.5MG/0.7ML | Product presentation as listed |
| Orencia Clickject | Product presentation as listed |
Key Terms and Diagnostic Definitions
Site of Care, Medicare Part B vs Part D & Billing Rules
Quantity Limits and Related Numeric Constraints
Auxiliary Coding & Identifiers
| Adalimumab-aaty 1-pen Kit INJ 80MG/0.8ML | Product line entry as listed |
| Adalimumab-aaty 2-pen Kit | Product line entry as listed |
| Adalimumab-aaty 2-syringe | Product line entry as listed |
| Adalimumab-aaty Cd/uc/hs Starter | Product line entry as listed |
| Adalimumab-adbm | Product line entry as listed |
| Adalimumab-adbm Crohns/uc/hs Starter | Product line entry as listed |
| Adalimumab-adbm Psoriasis/uveitis Starter | Product line entry as listed |
| Adalimumab-adbm Starter Package For Crohns Disease/uc/hs | Product line entry as listed |
| Adalimumab-adbm Starter Package For Psoriasis/uveitis | Product line entry as listed |
| Formulary ID: 26449, Version: 17 | Formulary identifier and version |
| Orencia INJ 125MG/ML, 50MG/0.4ML, 87.5MG/0.7ML | Product presentation as listed |
| Orencia Clickject | Product presentation as listed |
Policy Background and Scope
This prior authorization and step therapy document is maintained under the oversight of the Blues' Pharmacy and Therapeutics Committee to promote appropriate, clinically supported and cost‑effective drug therapy for Blue Cross Blue Shield of Michigan Medicare group members. Prior authorization (PA) means clinical and/or administrative criteria must be satisfied before coverage is provided; drugs subject to step therapy (ST) require trials of one or more formulary drugs before coverage. Physicians may contact the pharmacy help desk to request PA or ST and must submit the required clinical documentation described in the product‑specific entries.
The PA/ST program applies to a broad group of specialty and pharmacy products in the formulary. For many biologic and specialty agents the policy requires indication confirmation, documentation of prerequisite or prior therapies, laboratory or diagnostic test results where specified, and evidence of treatment response for reauthorization. Coverage durations and specific reauthorization principles (for example, documentation of positive clinical response) are provided in each product entry.
Document Dates & Revision Notes
Formulary identification for this PA/ST document: Formulary ID: 26449, Version: 17. The version metadata is included in the policy header to support accurate referencing of product criteria and coding.
The extract shows the formulary version and effective metadata displayed with product listings (for example, entries include “Formulary ID: 26449, Version: 17, Effective Date: 06/01/2026”).
This document requires prior authorization for many listed drugs; the header includes the effective and last updated dates. The header on the policy pages shows Effective Date: 06/01/2026 and Last Updated: 06/01/2026, which should be used when mapping the PA requirement to system workflows and review schedules.
Where entries are identified with (PA) or (ST) in the formulary, the header guidance clarifies that PA denotes clinical/administrative criteria that must be met before coverage and ST denotes drugs requiring prior trials of specified formulary agents.
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