HAP Medicare Part B Prior Authorization and Step Therapy Criteria
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Defines prior authorization and step therapy requirements, documentation expectations, and coverage determination approach for outpatient drugs and biologics billed under HAP Medicare Part B for providers submitting Part B drug requests.
No material clinical or coverage changes in this revision.
Coverage Criteria
General Part B drug coverage criteria
Covered when requirements below are met and consistent with applicable Medicare coverage guidance:
Applies generally; specific drugs have additional criteria such as prescriber specialty, genetic testing, prior biologic trials, step therapy, or exclusions.
hATTR FAP coverage criteria (initial)
Covered when ALL of the following are met for transthyretin-related familial amyloid polyneuropathy (hATTR FAP):
From Required Medical Information group for Amvuttra/vutrisiran entries (effective 1/1/2026).
Transthyretin amyloid cardiomyopathy coverage criteria (initial)
Covered when ALL of the following are met for transthyretin amyloid cardiomyopathy (wild-type or hereditary):
Specific diagnostic tests not listed in these chunks; documentation required.
Transthyretin-related familial amyloid polyneuropathy (hATTR)
Covered when ALL of the following are met:
Applies to hereditary transthyretin-related familial amyloid polyneuropathy.
Transthyretin amyloid cardiomyopathy (wild-type or hereditary)
Covered when ALL of the following are met:
Age requirement stated for cardiomyopathy indication.
General coverage criteria (partial)
Covered when the following are met (as referenced in document chunks):
Stated repeatedly for relevant indications (e.g., cardiomyopathy).
Document references confirmation but does not list specific tests in these chunks
Explicitly stated as N/A in multiple chunks
Epysqli (eculizumab-aagh) — NMOSD
Selected detailed criteria for Epysqli (eculizumab-aagh) from this section
Prescriber: neurologist or in consultation with neurologist recommended in related chunks.
Epysqli (eculizumab-aagh) — MG, aHUS, PNH
Epysqli criteria for other indications
Initial and reauthorization requirements.
aHUS reauthorization guidance.
PNH initial and reauthorization criteria.
Evenity (romosozumab-aqqg)
Romosozumab (Evenity) criteria
Specialist prescriber required; reauthorization constrained by lifetime duration.
Trastuzumab (Herceptin and biosimilars) - Initial coverage
Covered when ALL of the following are met
Hympavzi (marstacimab) - Initial coverage
Covered when ALL of the following are met
iDose TR (travoprost intracameral implant) - Initial coverage
Covered when ALL of the following are met
Initial Therapy
Covered when ALL of the following are met
See pathway options below.
'Failed' defined as inadequate response, intolerance, or documented compliance issues.
Initial therapy / Prior authorization criteria
Covered when ALL of the following are met
Documentation of prior trials required.
'Failed' defined as inadequate response, intolerance, or compliance issues.
Initial Therapy
Covered when ALL of the following are met
Prior medication trials (two alternative paths)
- Path A: Tried and failed one generic prostaglandin eye drop (latanoprost, bimatoprost, or travoprost) AND Durysta.
Failed defined as inadequate response, intolerance, or compliance issues.
- Path B: Unable to use Durysta AND tried and failed two generic topical prostaglandin eye drops.
Failed defined as inadequate response, intolerance, or compliance issues.
Initial authorization criteria
Covered when ALL of the following are met
'Failed' = inadequate response, intolerance, or demonstrated compliance issues with glaucoma eye drops.
Initial coverage criteria
Covered when ALL of the following are met
'Failed' defined as inadequate response, intolerance, or compliance issues.
Initial therapy / Coverage criteria
Covered when ALL of the following are met
Coverage is limited to one‑time administration per FDA labeling or accepted standards of practice.
Initial coverage criteria
Covered when ALL of the following are met:
'Failed' means inadequate response, intolerance, or demonstrated compliance issues. Coverage generally limited to one‑time administration.
Initial coverage criteria
Covered when ALL of the following are met
'Failed' = inadequate response, intolerance, or demonstrated compliance issues.
Quantity limit applied to iDose TR in multiple chunks.
Initial coverage criteria
Covered when ALL of the following are met:
Failed defined as inadequate response, intolerance, or demonstrated compliance issues with glaucoma eye drops.
Some drugs in this policy include explicit exclusions that prohibit combination use with other specified agents or require absence of certain clinical states. For example, trasthyretin-related familial amyloid polyneuropathy entries note that the agent must not be used in combination with TTR stabilizers (e.g., tafamidis) or TTR-lowering agents (e.g., Onpattro), and patients must not have had a liver transplant when these exclusions apply. Providers should confirm per‑drug exclusion statements when submitting prior authorization requests.
No explicit exclusions are stated in the cited sections for the referenced agents. Clinical reviewers should rely on the detailed, per‑drug criteria elsewhere in the document and on applicable Medicare NCDs/LCDs/LCAs for any exclusionary guidance.
The provided excerpts do not list explicit exclusion conditions. Where exclusions apply they are documented in the specific drug entries; absent such language, standard coverage criteria and documentation requirements apply.
Certain products carry specific noncoverage exclusions. Evenity (romosozumab) has a lifetime cumulative use limit: cumulative use beyond 12 months is not covered. Additionally, Evkeeza (evinacumab) entries state it must not be used in combination with a PCSK9 inhibitor (e.g., Repatha), Nexletol, or Nexlizet. These combination exclusions and lifetime limits should be confirmed on the drug‑specific criteria when requesting authorization.
For hemophilia prophylaxis, Hympavzi (marstacimab) must not be used in combination with other drugs indicated for prophylaxis for hemophilia A or B. Prior authorization requires documentation of diagnosis without inhibitors and prior prophylaxis trials; combination use with other prophylactic agents is an exclusion that will risk denial if not adhered to.
No age restrictions are specified in these excerpts except where explicitly noted for particular indications. Where age limits are required by an indication (for example, transthyretin amyloid cardiomyopathy entries require the patient to be at least 18 years of age), that requirement is indicated in the relevant drug criteria.
This excerpt does not list any explicit exclusions. Absent an exclusion statement in the drug‑specific section, reviewers should apply the stated coverage criteria and documentation rules.
No age or prescriber restrictions are specified in this segment; the excerpts list Age Restrictions: N/A and Prescriber: N/A. Confirm per‑drug requirements elsewhere in the policy when prescriber specialty is necessary.
The cited sections indicate Age Restrictions: N/A and Prescriber Restrictions: N/A for the items shown. If a prescriber requirement exists (e.g., some products require a hematologist or endocrinologist), it will be stated in the specific drug entry and must be met for approval.
These excerpts do not include explicit age or prescriber restrictions and list both fields as N/A. Where coverage requires a specialist prescriber or age limit that requirement appears in the individual drug criteria (for example, Evenity requires an endocrinologist).
No specific clinical exclusions are listed here beyond the effect of not meeting required prior trial or diagnostic criteria. For example, denial risks are tied to failure to meet documented prior‑therapy requirements or to missing diagnostic evidence (such as TTR mutation, baseline PND/FAP staging) rather than additional explicit exclusions in these excerpts.
No age or prescriber restrictions are specified in this excerpt; the policy sections cite Age Restrictions: N/A and Prescriber Restrictions: N/A. Confirm individual product pages for any specialty prescriber requirements.
This section does not state explicit exclusions. Coverage is dictated by meeting the documented clinical criteria (diagnosis, prior medication trials, and required supporting medical records); absence of those will lead to noncoverage.
Requests that lack the required documentation, are inconsistent with applicable Medicare NCDs/LCDs/LCAs, or are not supported by medically accepted compendia or peer‑reviewed evidence may be determined not reasonable and necessary and therefore not covered. Providers should include medical records, prior therapy trials, and supporting rationale when requesting exceptions.
No explicit 'not medically necessary' determinations are stated in these chunks. However, failure to meet the specified coverage criteria or to provide required documentation would imply the request is not reasonable and necessary and could be denied.
The cited excerpts do not list explicit 'not medically necessary' conditions. Reviewers should apply the stated clinical criteria and documentation requirements; absence of required elements may lead to a determination of non‑medical necessity.
The policy explicitly states that cumulative use of Evenity beyond 12 months is not covered; such use is considered not medically necessary. That lifetime limit is a clear basis for denial if exceeded.
For intracameral travoprost (iDose TR), the requested eye must not have received prior treatment with IDOSE TR as an exclusion in multiple entries. In addition, failure to provide the required prior topical trial documentation or other required records may render the request not medically necessary and result in denial.
This segment does not list additional specific 'not medically necessary' conditions beyond those tied to failure to meet the clinical criteria or missing documentation. Absent required documentation or prior‑therapy trials, coverage would generally not be approved under the stated criteria.
Coding and Clinical Thresholds
| trastuzumab products | Herceptin, Herceptin Hylecta (trastuzumab/hyaluronidase-oysk), Hercessi (trastuzumab-strf), Herzuma (trastuzumab-pkrb), Trazimera, Kanjinti |
| Hympavzi | marstacimab hncq injection |
| iDose TR | travoprost intracameral implant |
| Durysta | bimatoprost intracameral implant or intracameral sustained-release (named Durysta in text) |
| topical prostaglandin drops | latanoprost, bimatoprost, travoprost |
Provider Actions and Documentation Requirements
Prior authorization required for certain Part B drugs
Certain Medicare Part B drugs listed in this document require prior authorization (PA). PA must be obtained before HAP may approve coverage and to determine whether the drug is covered under the medical (Part B) or pharmacy (Part D) benefit.
PA submission details and required fields
Submit prior authorization requests via the HAP Provider Portal and include required medical information: indication, prior therapy trials (when applicable), prescriber specialty when required, and supporting medical records; requests will be reviewed per FDA labeling or accepted standards of medical practice.
- Use the HAP Provider Portal on www.hap.org to submit PA requests.
- Include indication, documented prior trials, prescriber specialty if specified, and supporting records.
Medical records and diagnostic documentation required for PA
PA requests must include specified supporting medical records and diagnostic documentation as described in the documentation requirements for each agent (e.g., genetic test results, baseline scores, prior therapy records).
- Provide medical records that document prior therapies and responses to treatment.
- Include diagnostic documentation specified for the indication (see per‑drug documentation requirements).
PA documentation for transthyretin-related indications
PA determinations require submission of supporting medical records and, for inherited transthyretin neuropathy, documentation such as a pathogenic TTR mutation (e.g., V30M), baseline PND score ≤ IIIb and/or baseline FAP Stage 1 or 2, and clinical signs/symptoms.
- TTR mutation documentation (example: V30M).
- Baseline PND score ≤ IIIb and/or baseline FAP Stage 1 or 2.
- Clinical signs/symptoms (motor disability, peripheral/autonomic neuropathy).
PA applies to Amvuttra (vutrisiran) with diagnostic and age requirements
Amvuttra (vutrisiran) injection requires prior authorization; for transthyretin amyloid cardiomyopathy confirm diagnosis with appropriate testing and for all indications ensure age and diagnostic requirements are met as specified.
- Amvuttra effective 1/1/2026 — documentation required per indication.
- For cardiomyopathy, provide confirmation of diagnosis with appropriate testing; age ≥18 where noted.
PA and typical coverage duration
Prior authorization is required for many specialty drugs in this document; coverage duration is generally up to 1 year and dosing will be approved according to FDA labeling or accepted standards of medical practice.
- Typical coverage duration referenced: up to 1 year.
- Dose approvals follow FDA‑approved labeling or accepted standards of medical practice.
Trastuzumab PA plus biosimilar-first step
Trastuzumab products (including Herceptin, Herceptin Hylecta, Hercessi, Herzuma, etc.) require prior authorization and step therapy: patient must first try the biosimilars Trazimera AND Kanjinti before other trastuzumab formulations will be approved.
- Coverage duration generally up to 1 year; dose per FDA labeling.
- Must trial Trazimera AND Kanjinti prior to other trastuzumab products.
Hympavzi PA: diagnosis, prescriber, prior trials, dosing
Hympavzi (marstacimab) requires prior authorization with documentation of hemophilia A or B without inhibitors, prescription by a hematologist, documentation of prior prophylaxis trials (for hemophilia A: two drugs including Hemlibra; for B: two prophylaxis drugs such as Alprolix, BeneFIX, or Idelvion), and adherence to the specified loading and maintenance dosing.
- Prescription must be written by a hematologist.
- Document absence of factor VIII or IX inhibitors.
- Document prior prophylaxis trials (Hemlibra required among trials for hemophilia A).
- Initial loading and maintenance dosing per criteria (300 mg loading; 150 mg weekly maintenance).
iDose TR PA: diagnosis plus step‑therapy documentation
iDose TR (travoprost intracameral implant) requires prior authorization with medical records showing a diagnosis of open‑angle glaucoma or ocular hypertension and meeting step‑therapy trial requirements (either one generic prostaglandin trial plus Durysta, or inability to use Durysta plus two failed generic prostaglandin trials).
- Provide medical records documenting diagnosis of open‑angle glaucoma or ocular hypertension.
- Pathway A: failed one generic prostaglandin (e.g., latanoprost, bimatoprost, travoprost) AND Durysta.
- Pathway B: unable to use Durysta AND tried and failed two generic topical prostaglandin drops.
- 'Failed' = inadequate response, intolerance, or documented compliance issues.
PA documentation required for iDose TR
Prior authorization for iDose TR must include medical records demonstrating diagnosis of open‑angle glaucoma or ocular hypertension and documentation of required prior therapy trials per the two alternative pathways; failure must be documented as inadequate response, intolerance, or compliance issues.
- Medical records showing which agents were tried and the clinical response or intolerance.
- If Durysta was used, document Durysta trial and failure; if not usable, document reason unable to use Durysta and two failed generic prostaglandin trials.
PA requirement and step‑therapy precondition for iDose TR
Prior authorization is required for iDose TR; patient must have open‑angle glaucoma or ocular hypertension and meet step‑therapy trial requirements (one generic prostaglandin + Durysta OR inability to use Durysta plus two generics) before approval.
- Age and prescriber restrictions: Age N/A; Prescriber N/A unless specified elsewhere.
- Ensure documentation of failed trials per definition before PA approval.
PA contingent on meeting iDose TR clinical and documentation criteria
Prior authorization is required and approval for iDose TR is contingent on meeting the specified prior therapy requirements and providing medical records that document diagnosis and prior medication trials.
- Document diagnosis of open‑angle glaucoma or ocular hypertension.
- Provide records that demonstrate prior topical prostaglandin and Durysta trials (or inability to use Durysta).
PA required; one‑time administration and criteria for iDose TR
Prior authorization is required for iDose TR when all criteria are met; the implant is a one‑time administration and PA should document diagnosis and prior therapy trials per the policy pathways.
- One‑time administration only; coverage limited to a single administration as indicated per FDA labeling.
- PA must show which pathway (A or B) the patient meets and supporting records.
PA required — iDose TR indication and prior trial requirement
Prior authorization is required when using iDose TR; the patient must have open‑angle glaucoma or ocular hypertension and must meet required prior trial pathways (see coverage criteria for Path A or B).
- 'Failed' trials must be clearly documented (inadequate response, intolerance, or compliance issues).
PA/Step therapy required for iDose TR — approval contingent on trials
PA and step therapy are required for iDose TR; approval is contingent on documentation that the patient has open‑angle glaucoma or ocular hypertension and met the topical prostaglandin/Durysta trial requirements.
- Provide evidence of prior topical prostaglandin failures and Durysta trial or documented inability to use Durysta.
PA required — documentation of prior topical trials and one‑time administration
Prior authorization is required and coverage is contingent on meeting clinical criteria including diagnosis plus required prior topical prostaglandin trial(s) and Durysta trial where specified.
- Document specific agents tried and outcomes (response, intolerance, compliance).
- Coverage duration and administration limits (one‑time) apply per FDA labeling.
PA required — iDose TR one‑time administration limit
Prior authorization is required for one‑time administration of the iDose TR intracameral implant; coverage is limited to a single administration as indicated per FDA labeling or accepted standards of medical practice.
- PA must document diagnosis and prior therapy pathway met.
- Limit: one‑time administration per course.
PA/Step therapy pathways required for iDose TR
Prior authorization/step therapy for iDose TR must demonstrate: (1) diagnosis of open‑angle glaucoma or ocular hypertension; AND (2) either failed one generic topical prostaglandin plus Durysta, or inability to use Durysta with failure of two generic topical prostaglandin drops.
- Path A: one generic topical prostaglandin (latanoprost, bimatoprost, travoprost) + Durysta — both tried and failed.
- Path B: unable to use Durysta and tried and failed two generic topical prostaglandin drops.
- Failure = inadequate response, intolerance, or demonstrated compliance issues.
General step therapy requirement and failure definition
Step therapy requires documented trial and failure of preferred or more cost‑effective drugs before progressing to non‑preferred Part B agents; failure must be shown as inadequate response or intolerance in the medical record.
- Failure must be indicated by the provider or documented in medical records.
- Applies to MAPD members not currently receiving the Part B drug.
No other step therapy sequencing specified
No additional sequencing beyond the specified per‑drug step requirements is defined in other sections of the document.
Step therapy: biosimilar and alternative trial requirements
Step therapy rules vary by drug; where specified, HAP requires trials of preferred biosimilars or alternatives (examples include biosimilar‑first requirements for trastuzumab and trials of Avastin or specific biosimilars for ophthalmic/chemotherapy agents).
- Examples: must try Mvasi AND Zirabev prior to some bevacizumab product approvals; Trazimera AND Kanjinti required before other trastuzumab formulations.
Trastuzumab biosimilar‑first step requirement
For trastuzumab products the policy requires trial of the biosimilars Trazimera AND Kanjinti before other trastuzumab formulations will be approved.
- Document prior trials of Trazimera and Kanjinti in the medical record before submitting PA for other trastuzumab products.
Hympavzi step therapy: prior prophylaxis trials required
For Hympavzi, step therapy requires documented prior trials of two prophylactic agents (for hemophilia A one trial must include Hemlibra; for hemophilia B examples include Alprolix, BeneFIX, or Idelvion) prior to approval.
- Document prior prophylaxis agents tried and outcomes.
- Ensure prescription is by a hematologist and show absence of inhibitors.
iDose TR step therapy pathways and failure definition
iDose TR step therapy requires either: (a) trial and failure of one generic topical prostaglandin eye drop (e.g., latanoprost, bimatoprost, travoprost) plus Durysta, or (b) inability to use Durysta and failure of two generic topical prostaglandin eye drops; 'failed' is defined as inadequate response, intolerance, or compliance issues.
- Specify agents tried and clinical response in submitted records.
- If patient cannot use Durysta, provide reason and document two failed generic prostaglandin trials.
Required supporting documentation for PA/step requests
Medical records supporting PA and step‑therapy requests must be provided, including documentation of prior therapies and responses to treatment; for off‑label or exception requests include peer‑reviewed literature as supporting evidence.
- Include medical records showing prior therapies, dates, and clinical outcomes.
- Attach literature or rationale when requesting exceptions for dosing, route, or off‑label use.
Required supporting documentation for transthyretin indications
Submit medical records supporting transthyretin‑related requests that include documentation of a pathogenic TTR mutation (example V30M), baseline PND score ≤ IIIb and/or FAP Stage 1 or 2, and clinical signs/symptoms; for cardiomyopathy provide confirmation testing.
- TTR mutation documentation (e.g., V30M).
- Baseline PND ≤ IIIb and/or baseline FAP Stage 1 or 2.
- Clinical signs/symptoms (motor disability, peripheral/autonomic neuropathy).
- Confirmation testing for transthyretin amyloid cardiomyopathy.
Hemophilia prophylaxis documentation and exclusion
Medical records supporting requests must be provided for hemophilia prophylaxis products and must document diagnosis of hemophilia A or B without inhibitors; combination use with other prophylaxis drugs is not permitted.
- Document absence of factor VIII or IX inhibitors.
- Do not submit requests showing concurrent use with other prophylactic hemophilia agents.
Required documentation for ophthalmic implant (iDose TR) requests
Medical records supporting ophthalmic implant requests must document diagnosis of open‑angle glaucoma or ocular hypertension and prior topical prostaglandin and Durysta trials (or inability to use Durysta) including which agents were tried and the reason they failed.
- List agents tried (e.g., latanoprost, bimatoprost, travoprost) and dates.
- Document failure reason: inadequate response, intolerance, or compliance issues.
- If Durysta not used, document rationale for inability to use Durysta.
Denial risk: missing required documentation
Failure to provide required documentation (e.g., TTR mutation, baseline PND/FAP stage, confirmation testing for cardiomyopathy, prior topical/Durysta trials, or medical records demonstrating prior therapies and responses) may result in denial of the prior authorization.
- Missing genetic or baseline severity documentation for transthyretin indications risks denial.
- Missing prior topical/Durysta trial records for iDose TR risks denial.
Denial risk: requests not meeting PA or Medicare criteria
Requests that do not meet prior authorization criteria or that conflict with applicable Medicare NCDs/LCDs/LCAs or HAP coverage criteria may be denied.
- Providers are responsible for checking applicable Medicare coverage guidance; Medicare guidance supersedes if conflict exists.
Denial triggers: missing diagnostic or baseline data
Lack of provided medical records supporting a request or missing required diagnostic documentation (e.g., TTR mutation, baseline PND ≤ IIIb or FAP Stage 1–2) may trigger denial.
Coverage duration must align with standards of practice
Coverage duration for some transthyretin cardiomyopathy indications must be within accepted standards of medical practice; deviations from standard coverage duration may result in non‑coverage.
- Typical coverage duration referenced for many agents: up to 1 year.
- Coverage duration must align with accepted standards of medical practice.
Denial risk: inadequate prior therapy records
Failure to provide supporting medical records of prior therapies and responses may result in denial; ensure records clearly show trials, dates, and outcomes.
- Include documentation of prior therapies, dates, and clinical responses or intolerances.
Denial risk: hemophilia prophylaxis documentation and exclusion
For hemophilia prophylaxis, missing documentation that the patient has hemophilia A or B without inhibitors or evidence of required prior prophylaxis trials will risk denial; the policy also prohibits use in combination with other prophylaxis drugs.
Denial risk: iDose TR missing step‑therapy documentation
iDose TR requests that lack documentation of required prior topical prostaglandin trials and/or Durysta trial (or inability to use Durysta) may be denied.
- Document which topical prostaglandin agents were tried and the clinical outcome.
- If claiming inability to use Durysta, include the clinical rationale.
Denial risk for missing supporting medical records
Failure to provide supporting medical records with the request may lead to denial for any listed PA/ST drug.
Denial risk: absent documentation of required topical trials
Lack of supporting medical records or failure to document required prior topical prostaglandin trials will trigger denial for iDose TR requests.
Denial risk: missing topical/Durysta trial evidence for implants
Absence of required prior topical prostaglandin/Durysta trials or clinical documentation as specified may result in denial of requests for ophthalmic implant coverage.
Denial risk: documentation absent or incomplete
Lack of supporting medical records for a PA request may lead to denial; always attach relevant clinical notes, test results, and prior medication records.
Basis for denial: unmet iDose TR clinical criteria
Coverage of iDose TR requires documentation that the patient has open‑angle glaucoma or ocular hypertension and has met required prior trials; absence of these will form the basis for denial.
Denial risk: prior topical therapy not demonstrated
Requests lacking documentation that prior topical prostaglandin therapy was tried and failed (or Durysta when required) may be denied.
Denial risk: missing diagnosis or failed prior trials
Requests that do not document open‑angle glaucoma or ocular hypertension and failure of required prior topical prostaglandin trials (and Durysta where specified) may be denied.
Denial risk: missing clinical criteria or medication trials
Requests lacking documentation that the patient meets the clinical criteria for open‑angle glaucoma or ocular hypertension or has failed required topical prostaglandin trials (including Durysta when required) may be denied.
Initial Therapy Criteria
Initial therapy / step requirements (examples)
Examples of initial therapy/step requirements referenced in the drug list:
Examples are illustrative; follow drug‑specific nodes for exact requirements.
Initial therapy
Initial therapy prior authorization requirements
Amvuttra/vutrisiran entries effective 1/1/2026.
Initial therapy requirements
Initial authorization requires:
Required medical information group described in Amvuttra entries.
Initial therapy (partial)
Partial document excerpt.
Initial step requirements
Initial coverage often requires prior trials of specified alternatives
Applies to trastuzumab product entries.
Step therapy examples for bortezomib/J‑codes.
Hympavzi dosing
Hympavzi initial dosing
Initial authorization
Failed defined as inadequate response, intolerance, or compliance issues.
Initial therapy / authorization
'Failed' defined as inadequate response, intolerance, or compliance issues.
Initial therapy requirements
Initial coverage requires diagnosis, documentation, and specified prior topical therapy trials.
Documentation of which agents tried and the nature of failure is required.
Failure = inadequate response, intolerance, or demonstrated compliance issues.
Prior medication requirements
Failure defined as inadequate response, intolerance, or compliance issues.
Initial therapy criteria
Age and prescriber restrictions: N/A unless specified elsewhere.
Initial authorization
One‑time administration per FDA labeling; coverage duration typically one course.
Initial therapy
Initial coverage requires:
One‑time administration per FDA labeling; documentation must specify nature of failure (inadequate response, intolerance, or compliance issues).
Initial therapy requirements
'Failed' = inadequate response, intolerance, or demonstrated compliance issues.
Initial coverage requirements
Coverage is for a one‑time administration as indicated per FDA labeling or accepted standards.
Reauthorization / Continuation Criteria
Reauthorization clinical response requirements
Reauthorization clinical response requirements
Clinical outcome documentation required for reauthorization.
Step Therapy Rules
| Requirement | Details |
|---|---|
| Preferred/more cost-effective drug(s) must be tried and failed before advancing to a non-preferred Part B drug (step therapy). | |
| Applies to MAPD members who are not currently receiving the Part B drug; 'failed' is defined as inadequate response or intolerance documented by the provider or medical records. |
| Requirement | Details |
|---|---|
| Step therapy sequencing | |
| No specific step therapy steps or sequencing requirements are documented in the referenced chunks. |
| Requirement | Details |
|---|---|
| Step therapy requirement | |
| No step therapy requirement is specified in the provided chunks for this entry. |
| Example | Step therapy instruction |
|---|---|
| Bevacizumab/ophthalmic agents | |
| Must try Avastin (bevacizumab) or specified biosimilars (examples: Mvasi and Zirabev) before certain ophthalmic agents as listed. |
| Requirement | Details |
|---|---|
| Trastuzumab biosimilar-first step | |
| Trial of the biosimilars Trazimera AND Kanjinti is required before coverage of other trastuzumab formulations (e.g., Herceptin and listed trastuzumab products). |
| Indication | Step therapy requirement |
|---|---|
| Hympavzi — Hemophilia A | |
| For hemophilia A prophylaxis: trial of two prophylactic agents is required and one must be Hemlibra; prescription must be written by a hematologist and medical records must document absence of inhibitors. |
| Device/Drug | Prior trial requirement |
|---|---|
| iDose TR (travoprost intracameral implant) | |
| Requires prior topical prostaglandin therapy and Durysta per specified pathways: either one generic prostaglandin eye drop plus Durysta, or inability to use Durysta plus two failed generic topical prostaglandin drops; 'failed' defined as inadequate response, intolerance, or documented compliance issues. |
| Requirement | Details |
|---|---|
| Topical prostaglandin and/or Durysta trial | |
| Patient must meet one of two pathways: (a) tried and failed one generic prostaglandin topical drop (latanoprost, bimatoprost, travoprost) AND Durysta; OR (b) unable to use Durysta and tried and failed two generic topical prostaglandin drops. Failure = inadequate response, intolerance, or compliance issues. |
| Requirement | Details |
|---|---|
| Topical prostaglandin trial options | |
| Either: one generic prostaglandin drop plus Durysta; or if patient cannot use Durysta, failure of two generic topical prostaglandin drops (latanoprost, bimatoprost, travoprost). 'Failed' defined as inadequate response, intolerance, or compliance issues. |
| Requirement | Notes |
|---|---|
| Prior authorization and prior trials required | |
| Trial(s) of generic topical prostaglandin(s) and/or Durysta per the two alternative pathways must be documented; prior authorization is required and medical records must support the failures or inability to use Durysta. |
| Requirement | Details |
|---|---|
| Topical prostaglandin and Durysta pathways | |
| Patient must have tried and failed either: (a) one generic prostaglandin eye drop (latanoprost, bimatoprost, travoprost) plus Durysta; OR (b) if unable to use Durysta, two generic topical prostaglandin drops. Failure = inadequate response, intolerance, or compliance issues. |
| Requirement | Evidence needed |
|---|---|
| Documented failed trials per pathways | |
| Medical records must document the diagnosis (open-angle glaucoma or ocular hypertension) and the required prior medication trials per pathway A (one generic prostaglandin + Durysta) or pathway B (unable to use Durysta + two generic prostaglandins); 'failed' defined as inadequate response, intolerance, or compliance issues. |
| Requirement | Details |
|---|---|
| Prior topical prostaglandin drops and/or Durysta required | |
| Step therapy requires trial and failure of topical generic prostaglandin(s) and Durysta per the two alternative pathways described before iDose TR placement. |
| Requirement | Details |
|---|---|
| Pathway A or B for iDose TR | |
| Either: tried and failed one generic prostaglandin eye drop plus Durysta; OR unable to use Durysta and tried and failed two generic topical prostaglandin drops. 'Failed' = inadequate response, intolerance, or documented compliance issues. |
| Requirement | Coverage implication |
|---|---|
| Prior trials required before coverage | |
| Member must have documented failure of the required topical prostaglandin and Durysta pathway (or two generic prostaglandin failures if Durysta cannot be used); documentation is required to support one-time administration approval. |
| Requirement | Details |
|---|---|
| Required topical prostaglandin trials (specific agents) | |
| Trial of generic prostaglandin eye drops (latanoprost, bimatoprost, or travoprost). If Durysta was tried and failed, one generic prostaglandin trial plus Durysta is sufficient; if Durysta cannot be used, two generic topical prostaglandin trials are required. 'Failed' defined as inadequate response, intolerance, or compliance issues. |
Quantity Limits and Administration
Site of Care
Biosimilar and Alternative Preference
Definitions
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