Prior authorization: Tryvio (aprocitentan) — documentation and attestations

Prior authorization is required for Tryvio (aprocitentan). The request must document that the patient has persistent BP >140/90 mmHg and has failed optimal dosing of at least three antihypertensive medications concurrently from different classes (one must be a diuretic) for a minimum of 4 weeks; it must be prescribed by or in consultation with a cardiologist or disease‑state specialist; prescriber must attest that other causes of uncontrolled hypertension have been ruled out; and prescriber must attest that serum aminotransferase levels and total bilirubin were measured prior to initiation and will be repeated periodically during treatment.

• Persistent blood pressure >140/90 mmHg required
• Failed ≥3 antihypertensive classes concurrently (one a diuretic) for ≥4 weeks
• Specialist prescriber (or documented consultation) required
• Attestation that other causes (e.g., non‑compliance, white coat) were ruled out
• Baseline and periodic serum aminotransferase and total bilirubin measurements required

Prescriber attestations required (labs, specialist, diuretic trial)

Prior authorization submissions must include prescriber attestation that baseline and periodic liver monitoring (serum aminotransferases and total bilirubin) will be performed, that the medication is prescribed by or in consultation with a specialist, and that prior trials included a diuretic among failed agents.

• Attest baseline and planned periodic LFTs (aminotransferases and total bilirubin)
• Confirm specialist prescribing or consultation
• Confirm one failed medication was a diuretic

Attestations: rule‑out causes, liver monitoring, concomitant therapy

Prior authorization requires prescriber attestations that alternative causes of uncontrolled hypertension were ruled out, baseline and periodic liver testing will occur, and documentation of concomitant use with other antihypertensives.

• Attest other causes ruled out (e.g., non‑compliance, white coat)
• Document baseline LFTs and plan for periodic repeats
• Document use with at least three other antihypertensive agents

Baseline and ongoing liver testing; exclude alternative causes

Prior authorization must confirm baseline and ongoing liver function testing and that other causes of uncontrolled hypertension have been excluded before initiation.

• Baseline serum aminotransferases and total bilirubin measured prior to start
• Plan to repeat these tests periodically during treatment
• Prescriber attests other causes of uncontrolled BP have been ruled out

Comprehensive prior authorization requirements (attestations, monitoring, concomitant therapy)

Prior authorization submissions must document ruling out other causes of uncontrolled hypertension, baseline and planned periodic liver tests, and concomitant use with ≥3 other antihypertensive drugs at maximally tolerated doses, plus specialist involvement and age per label.

• Rule out other causes (attestation)
• Baseline and periodic LFTs (aminotransferases and total bilirubin)
• Concomitant use with ≥3 other antihypertensive drugs at maximally tolerated doses
• Prescribed by or in consultation with cardiologist/disease specialist
• Patient meets package‑insert minimum age

Attestation of liver tests and ≥3 concomitant antihypertensives

Prior authorization must include prescriber attestation of baseline and periodic liver tests and confirmation that the patient will be on at least three other antihypertensive agents at maximally tolerated doses.

• Baseline and periodic serum aminotransferase and total bilirubin testing
• Confirmation of concomitant therapy with ≥3 antihypertensive drugs at maximally tolerated doses
• Patient meets package‑insert age requirement

Renewal requirements: clinical benefit, monitoring, and combination therapy

Renewal requires prescriber attestation of clinically significant improvement or stabilization, documentation of required laboratory monitoring (baseline and periodic LFTs), and confirmation that therapy remains in combination with at least three other antihypertensive drugs at maximally tolerated doses.

• Prescriber attestation of clinical benefit or stabilization for renewal
• Documentation of baseline and periodic serum aminotransferase and total bilirubin measurements
• Confirm continued use with ≥3 antihypertensive agents at maximally tolerated doses
• Patient continues to meet package‑insert minimum age

Require combination therapy with ≥3 antihypertensives at maximal doses

Prior authorization requires the agent be used in combination with at least three other antihypertensive drugs at maximally tolerated doses; documentation of medication list and dosing should be provided.

• Document medication list showing at least three concomitant antihypertensive agents
• Confirm each is at maximally tolerated dose per prescriber

Prior authorization and renewal requirements — Iqirvo® (elafibranor)

Iqirvo® requires prior authorization with a documented diagnosis of primary biliary cholangitis, specialist prescriber or consultation, ALP > 200 IU/L, and either a 12‑month trial and failure of ursodiol (with Iqirvo added) or documented contraindication/intolerance to ursodiol; renewal requires documentation of ALP improvement or stabilization and continued meeting of ursodiol trial/intolerance conditions.

• Diagnosis of primary biliary cholangitis (PBC) documented
• Prescribed by or in consultation with gastroenterologist/hepatologist/disease specialist
• ALP > 200 IU/L required for initial approval
• 12‑month trial and failure of ursodiol prior to Iqirvo (or contraindication/intolerance)
• Renewal: documentation of improvement or stabilization in ALP

Prior authorization: Xolremdi (mavorixafor) — diagnostic confirmation and specialist prescriber

Prior authorization for Xolremdi (mavorixafor) requires documentation of a WHIM syndrome diagnosis confirmed by genetic testing (CXCR4 mutation) and that the drug is prescribed by or in consultation with an appropriate specialist.

• Diagnosis of WHIM confirmed by genetic testing identifying CXCR4 mutation
• Prescribed by or in consultation with hematology/immunology/infectious disease or other specialist
• Patient meets package‑insert minimum age

Prior authorization: Vafseo (vadadustat) — CKD and lab prerequisites

Prior authorization for Vafseo (vadadustat) requires documentation of chronic kidney disease (N18.9), pretreatment hemoglobin ≤ 11 g/dL, at least 3 months of dialysis, absence of uncontrolled hypertension, and that the patient is not receiving other erythropoiesis‑stimulating agents.

• Diagnosis of CKD (ICD‑10 N18.9) documented
• Pretreatment hemoglobin ≤ 11 g/dL
• Receiving dialysis for ≥3 months
• No uncontrolled hypertension
• Not currently on other ESAs
• Patient meets package‑insert minimum age

Renewal prior authorization — Iqirvo: ALP response and ursodiol history

Renewal of Iqirvo requires documentation (progress notes, labs) demonstrating improvement or stabilization in alkaline phosphatase (ALP) and continued fulfillment of the ursodiol trial or intolerance condition specified for initiation.

• Progress notes or laboratory reports showing ALP improvement or stabilization
• Confirmation of prior 12‑month ursodiol trial and failure (if applicable) or documented intolerance/contraindication to ursodiol

Prior therapy requirement: failed trials of ≥3 concurrent antihypertensive classes

Prior therapy requirement (step therapy): patient must have failed optimal dosing of at least three antihypertensive medications concurrently from different classes (one must be a diuretic) for a minimum of 4 weeks before approval of advanced therapy.

• Failed optimal dosing of ≥3 antihypertensive classes concurrently
• One failed agent must be a diuretic
• Minimum trial duration: 4 weeks

Step therapy prerequisite: failed ≥3 classes including a diuretic

Step therapy prerequisite: the patient must have failed multiple (at least three) concurrent antihypertensive classes including a diuretic before advanced/add‑on therapy is considered.

• At least three concurrent antihypertensive classes failed
• At least one failed medication must be a diuretic

Step therapy implied: document multiple failed antihypertensives (one a diuretic)

The policy implies step therapy: prescriber must document that the patient tried and failed multiple antihypertensive medications (including a diuretic) prior to approval.

• Document trials and failures of multiple antihypertensives
• Include diuretic trial among failed medications

Contingent therapy: used with ≥3 other antihypertensives after failure/intolerance

Therapy is contingent on failure or intolerance of other antihypertensive agents such that the new agent will be used in combination with at least three other antihypertensive drugs at maximally tolerated doses.

• Evidence of failure or intolerance to other agents required
• Document plan to use the drug with ≥3 antihypertensives at maximally tolerated doses

No explicit sequencing beyond combination‑therapy requirement

The policy does not specify additional sequencing beyond the requirement that the drug be used in combination with at least three other antihypertensive agents at maximally tolerated doses.

• No explicit step‑therapy sequencing detailed
• Requirement remains: combined use with ≥3 agents at maximally tolerated doses

Renewal: document continued combination with ≥3 antihypertensives at maximal doses

Renewal requires documentation showing continued use with at least three other antihypertensive agents at maximally tolerated doses (documented medication list and dosing), which implies prior trials for initial approval.

• Provide current medication list showing ≥3 concomitant antihypertensive agents at maximally tolerated doses
• This requirement implies prior optimization/trials of other agents

Step therapy expectations: prior optimization of ≥3 agents at maximally tolerated doses

Policy expects prior optimization of at least three other antihypertensive agents at maximally tolerated doses before adding the adjunct therapy; prescribers should document optimization and dosing.

• Document that each concomitant antihypertensive was optimized to maximally tolerated dose
• Provide evidence of trials and dosing adjustments prior to initiation

Step therapy (Iqirvo®): ursodiol 12‑month trial and failure (or documented intolerance)

For Iqirvo®, step therapy requires a 12‑month trial and failure of ursodiol before Iqirvo is added, unless there is a documented contraindication or intolerance to ursodiol.

• 12‑month ursodiol trial and documented failure required prior to Iqirvo initiation when applicable
• If ursodiol contraindicated or intolerant, document this to allow Iqirvo monotherapy

Ensifentrine initial approval: document ≥2‑week trial and failure of standard COPD therapy

Initial approval for ensifentrine (Ohtuvayre™) requires documentation of trial and failure of at least a 2‑week course of standard COPD therapy (either triple therapy ICS+LABA+LAMA or dual LABA+LAMA) prior to approval.

• Document trial and failure of ≥2 weeks of triple therapy (ICS + LABA + LAMA) OR dual LABA + LAMA
• Provide evidence in the medical record prior to initial approval

Document diagnosis, failed trials, specialist involvement, and rule‑out of other causes

Prescriber must document diagnosis of treatment‑resistant hypertension (persistent BP >140/90) and provide records showing failure of optimal dosing of at least three antihypertensive medications concurrently from different classes (one must be a diuretic) for a minimum of 4 weeks, plus evidence of specialist involvement and attestation that other causes were excluded.

• Diagnosis: treatment‑resistant hypertension (persistent BP >140/90)
• Failed optimal dosing of ≥3 antihypertensives concurrently from different classes for ≥4 weeks
• One failed medication must be a diuretic
• Evidence of specialist prescribing or consultation
• Attestation that other causes of uncontrolled BP were ruled out

Required clinical documentation for initial authorization

Required clinical documentation includes records that the patient failed optimal dosing of at least three antihypertensive medications concurrently from different classes for a minimum of 4 weeks, that one failed medication was a diuretic, that alternative causes were ruled out, and that baseline and periodic serum aminotransferase and total bilirubin testing were/will be performed.

• Document failed trials: ≥3 antihypertensive classes, concurrent, ≥4 weeks
• Include diuretic among failed medications
• Attest alternative causes were excluded
• Baseline LFTs and plan for periodic monitoring (aminotransferases and total bilirubin)

Prescriber attestation: baseline and periodic liver tests

Prescriber must attest that serum aminotransferase levels and total bilirubin were measured prior to initiation and will be repeated periodically during treatment.

• Baseline aminotransferases and total bilirubin documented
• Planned periodic repeats documented in the medical record

Document planned combination therapy with ≥3 antihypertensives

Documentation must show that the medication will be used in combination with at least three other antihypertensive drugs at maximally tolerated doses.

• Provide current medication list with dosing showing ≥3 concomitant antihypertensives
• Confirm maximally tolerated dosing for each concomitant agent

Document diuretic trial and specialist prescribing/consultation

Documentation must confirm that one of the tried‑and‑failed medications is a diuretic and that the therapy is prescribed by or in consultation with a cardiologist or other disease‑state specialist.

• Identify the diuretic among prior failed medications
• Include specialist prescriber name or consult note

Complete documentation checklist for initial authorization

Documentation must include prescriber attestations that other causes of uncontrolled hypertension have been ruled out, baseline and planned periodic liver tests (aminotransferases and total bilirubin), confirmation of use with ≥3 antihypertensives at maximally tolerated doses, and that the patient meets the package‑insert minimum age.

• Attestation other causes ruled out
• Baseline and periodic LFTs documented
• Confirmation of ≥3 concomitant antihypertensives at maximal doses
• Patient meets package‑insert minimum age

Documentation requirements: rule‑out, liver tests, concomitant therapy, age

Prescriber attestation that other causes of uncontrolled hypertension were ruled out, documentation of baseline aminotransferase and total bilirubin measurements and plan for repeats, documentation of combination therapy with ≥3 antihypertensive drugs at maximally tolerated doses, and confirmation patient meets package‑insert minimum age are required.

• Attest other causes excluded
• Baseline and periodic liver tests documented
• Medication list with ≥3 antihypertensives at maximal doses
• Age per package insert confirmed

Required documentation for initial authorization

For initial authorization, prescriber must attest other causes of uncontrolled hypertension are ruled out; document baseline serum aminotransferase and total bilirubin and plan for periodic repeats; document combination therapy with ≥3 antihypertensive drugs at maximally tolerated doses; and confirm patient meets package‑insert minimum age.

• Attestation other causes ruled out
• Baseline LFTs and monitoring plan
• Concomitant use with ≥3 antihypertensive drugs at maximal doses
• Patient meets package‑insert age requirement

Required documentation and attestations for renewal

Prescriber must attest to clinically significant improvement or stabilization for renewal, confirm baseline and periodic liver testing, confirm continued concomitant use with ≥3 antihypertensive drugs at maximally tolerated doses, and verify patient meets package‑insert age.

• Attestation of clinical improvement or stabilization
• Baseline and periodic aminotransferase and total bilirubin documented
• Continued combination therapy with ≥3 agents at maximal doses
• Confirm package‑insert age criteria met

Attestation and monitoring documentation required at renewal

Prescriber must attest to clinically significant improvement or stabilization and provide documentation of baseline and periodic serum aminotransferase and total bilirubin measurements; renewal must also document continued use in combination with ≥3 antihypertensive agents at maximally tolerated doses and age per label.

• Attestation of improvement/stabilization
• Baseline and periodic liver monitoring records
• Evidence of continued combination therapy with ≥3 agents
• Age verification per package insert

Required documentation: baseline/periodic measurements, med list, age, renewal attestation

Documentation must include baseline measurements prior to initiation and records showing periodic repeat measurements during treatment; a medication list demonstrating use of at least three other antihypertensive drugs at maximally tolerated doses; evidence the patient meets package‑insert minimum age; and prescriber attestation of clinical improvement or stabilization for renewals.

• Baseline and periodic monitoring records
• Medication list with ≥3 antihypertensives at maximal doses
• Patient age per package insert
• Prescriber attestation for renewal

Renewal documentation (Iqirvo®): ALP response required

Renewal for Iqirvo requires documentation (progress notes, labs) of improvement or stabilization in ALP.

• Progress notes or lab reports demonstrating ALP improvement or stabilization

Progress notes and labs required for renewal (drug‑specific examples)

Progress notes and laboratory reports documenting clinical improvement or stabilization (for example, ALP for Iqirvo or response to therapy for vadadustat) are required for renewals.

• Provide progress notes and labs documenting clinical response
• Specify which biomarker is used (e.g., ALP for Iqirvo)

Denial risk: missing documentation of BP threshold or failed trials

Requests lacking documentation of persistent BP >140/90 mmHg or failure of optimal dosing of ≥3 antihypertensive medications concurrently (including a diuretic) for a minimum of 4 weeks, or without attestation that other causes were ruled out, are at risk of denial.

• Document persistent BP >140/90 mmHg
• Document failed trials of ≥3 antihypertensives concurrently for ≥4 weeks (include a diuretic)
• Provide attestation that other causes of uncontrolled BP were excluded

Denial risk: insufficient medication trial documentation

Failure to document trials of at least three antihypertensive medications from different classes for a minimum of 4 weeks, including a diuretic, and lack of prescriber attestation that other reasons for uncontrolled hypertension were ruled out may trigger denial.

• Document each prior agent, class, dose, and duration (≥4 weeks)
• Include at least one diuretic among failed agents
• Attach prescriber attestation ruling out alternative causes

Denial risk: missing attestation that reversible causes are excluded

Failure to attest that other reasons for uncontrolled hypertension (e.g., non‑compliance, white coat syndrome) have been ruled out may trigger denial of the request.

• Include explicit prescriber attestation that reversible causes were excluded

Denial risk: missing combination therapy, attestations, liver tests, or specialist involvement

Failure to document use in combination with at least three other antihypertensive drugs at maximally tolerated doses, lack of prescriber attestations, absence of baseline and periodic LFTs, or not prescribed by/in consultation with a cardiologist or disease‑state specialist may trigger denial.

• Provide medication list with dosing showing ≥3 concomitant agents at maximally tolerated doses
• Attach prescriber attestations and baseline/periodic LFT results
• Include specialist prescriber or consult note

Denial risk: missing required attestations and age verification

Failure to document prescriber attestations (that other reasons for uncontrolled hypertension have been ruled out, that baseline and periodic liver tests will be performed, that the drug will be used with ≥3 other antihypertensives at maximally tolerated doses, and that patient meets package‑insert minimum age) may trigger denial.

• Ensure all required attestations are present
• Confirm age per package‑insert is documented

Denial risk: missing rule‑out attestation or combination therapy documentation

Failure to document prescriber attestation that other reasons for uncontrolled hypertension were ruled out, or lack of documentation that the medication is being used in combination with at least three other antihypertensive drugs at maximally tolerated doses, may trigger denial.

• Include attestation ruling out alternative causes
• Provide medication list showing ≥3 concomitant agents at maximal doses

Denial risk: missing liver monitoring attestation or concomitant therapy documentation

Failure to provide prescriber attestation of required baseline and periodic liver tests, or failure to document concomitant use with at least three other antihypertensive drugs at maximally tolerated doses, may make the request ineligible.

• Submit baseline LFTs and plan for periodic monitoring
• Document concomitant antihypertensive regimen with dosing

Denial risk at renewal: missing response attestation, monitoring, or combination therapy

Failure to provide prescriber attestation of clinically significant improvement or stabilization at renewal, failure to document baseline and periodic serum aminotransferase and total bilirubin measurements, or not using the drug in combination with ≥3 other antihypertensive drugs at maximally tolerated doses may trigger renewal denial.

• Provide attestation of clinical benefit/stabilization
• Include baseline and follow‑up liver monitoring records
• Confirm ongoing combination therapy with ≥3 agents at maximally tolerated doses

Triggers for denial: missing combination therapy, monitoring, age, or renewal attestation

Lack of documentation showing the agent is used in combination with at least three other antihypertensive drugs at maximally tolerated doses, absence of baseline and periodic measurements, failure to meet minimum age per package insert, or missing prescriber attestation on renewal are triggers for denial.

• Medication list with ≥3 concomitant agents at maximally tolerated doses required
• Baseline and periodic monitoring records required
• Age per package insert must be documented
• Renewal requires prescriber attestation of improvement/stabilization

Triggers for denial (Iqirvo®): ALP, specialist, ursodiol history, cirrhosis

For Iqirvo®, absence of documented ALP >200 IU/L, lack of specialist prescribing/consultation, lack of documented prior 12‑month ursodiol trial (or documented contraindication/intolerance), or presence of decompensated cirrhosis may trigger denial.

• ALP > 200 IU/L required for initial approval
• Specialist prescriber or consult required
• Document 12‑month ursodiol trial and failure (or contraindication/intolerance)
• Decompensated cirrhosis excludes therapy

Iqirvo® renewal denial trigger: missing ALP improvement/stabilization documentation

Lack of documentation of improvement or stabilization in alkaline phosphatase (ALP) at renewal may trigger denial of Iqirvo® renewal.

• Provide labs/progress notes demonstrating ALP improvement or stabilization at renewal

Denial risk: missing diagnostic confirmation or specialist involvement (drug‑specific)

For initial approvals, absence of required diagnostic confirmation (for example, genetic testing identifying a CXCR4 mutation for WHIM or documentation of CKD diagnosis and dialysis status for vadadustat) or missing specialist involvement may result in denial.

• Provide genetic testing confirmation for WHIM (CXCR4 mutation) when applicable
• Document CKD diagnosis and dialysis duration for vadadustat
• Include specialist prescriber or consult notes

Tryvio (aprocitentan) placement and approval durations

New product placement: Tryvio (aprocitentan) is recommended Non‑PDL with initial approval duration 6 months and renewal 1 year.

• Tryvio (aprocitentan) Non‑PDL placement
• Initial approval duration: 6 months
• Renewal duration: 1 year