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Palsonify (paltusotine) — coverage criteria for acromegaly

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Defines initial authorization criteria and approval duration for Palsonify (paltusotine) for adults with acromegaly who had an inadequate response to surgery or for whom surgery is not an option; intended for prescribers and pharmacy prior authorization reviewers.

Policy Summary

Payermedimpact

PolicyPalsonify (paltusotine) — coverage criteria for acromegaly

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization showing diagnosis, specialist involvement, ≥30-day trial and failure/intolerance/contraindication to an injectable SSA, and IGF-1 above ULN.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial approval duration

12 monthsrenewal approval duration

≥30 daysrequired SSA trial

IGF-1 above ULNIGF-1 requirement

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DraftmedimpactPolicy N/A

Palsonify (paltusotine) — coverage criteria for acromegaly

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Policy Summary

Payermedimpact

PolicyPalsonify (paltusotine) — coverage criteria for acromegaly

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization showing diagnosis, specialist involvement, ≥30-day trial and failure/intolerance/contraindication to an injectable SSA, and IGF-1 above ULN.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial approval duration

12 monthsrenewal approval duration

≥30 daysrequired SSA trial

IGF-1 above ULNIGF-1 requirement

prescriber specialty

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met

Initial Approval Criteria: (1) Documented diagnosis of acromegaly requiring medical therapy; (2) Prescribed by, or in consultation with, an endocrinologist, neurosurgeon, or specialist experienced in acromegaly management; (3) Inadequate response to pituitary surgery and/or surgery is not an option; (4) Documentation of inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue (SSA) following a trial of at least one month (>= 30 days) (e.g., octreotide, lanreotide, Sandostatin, Somatuline); (5) Historical or current IGF-1 above the upper limit of normal for age/sex.see node text

Approval duration stated as 12 months initial, 12 months renewal.

Initial Approval

Covered when ALL of the following are met for adults with acromegaly:

Initial Approval Criteria: 1) Documented diagnosis of acromegaly requiring medical therapy; 2) Prescribed by, or in consultation with, an endocrinologist, neurosurgeon, or specialist experienced in acromegaly management; 3) Inadequate response to pituitary surgery and/or surgery is not an option; 4) Documentation of inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue following a trial of at least one month (>= 30 days) (e.g., octreotide, lanreotide, Sandostatin, Somatuline); 5) Historical or current IGF-1 above the upper limit of normal for age/sex, or documentation of prior elevation with ongoing requirement for somatostatin-based medical therapy.

Initial Therapy

Covered when ALL of the following are met:

Initial Approval: 1) Documented diagnosis of acromegaly requiring medical therapy; 2) Prescribed by or in consultation with an endocrinologist, neurosurgeon, or specialist experienced in acromegaly management; 3) Inadequate response to pituitary surgery and/or surgery is not an option; 4) Documentation of inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue following a trial of at least one month (>= 30 days) (e.g., octreotide, lanreotide, Sandostatin, Somatuline); 5) Historical or current IGF-1 above the upper limit of normal for age/sex, or documentation of prior elevation with ongoing requirement for somatostatin-based medical therapy; 6) Provider attestation that patient has been counseled and is able to comply with administration instructions where applicable.

All elements required for initial approval as written in source document.

Initial Approval

Covered when ALL of the following are met for adults with acromegaly:

Initial Approval Criteria: 1) Documented diagnosis of acromegaly requiring medical therapy; 2) Prescribed by, or in consultation with, an endocrinologist or neurosurgeon, or specialist experienced in acromegaly management; 3) Inadequate response to pituitary surgery and/or surgery is not an option; 4) Documentation of inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue (SSA) following a trial of at least one month (≥ 30 days) (e.g., octreotide, lanreotide, Sandostatin, Somatuline); 5) Historical or current IGF-1 above the upper limit of normal for age/sex, or documentation of prior elevation with ongoing requirement for somatostatin-based medical therapy; 6) Provider attestation that patient has been counseled on and is able to comply with empty-stomach administration instructions.

Initial Approval Criteria

Covered when ALL of the following are met for adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option:

Initial approval requirements: 1) Documented diagnosis of acromegaly requiring medical therapy; 2) Prescribed by, or in consultation with, an endocrinologist or neurosurgeon, or specialist experienced in acromegaly management; 3) Inadequate response to pituitary surgery and/or surgery is not an option; 4) Documentation of inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue (SSA) following a trial of at least one month (>= 30 days) (e.g., octreotide, lanreotide, Sandostatin, Somatuline); 5) Historical or current IGF-1 above the upper limit of normal for age/sex, or documentation of prior elevation with ongoing requirement for somatostatin-based medical therapy; 6) Provider attestation that patient has been counseled on and is able to comply with empty-stomach administration instructions.

Each numbered element is required (AND logic).

Initial Approval

Covered when ALL of the following are met

Initial Approval Criteria: Documented diagnosis of acromegaly requiring medical therapy; prescribed by or in consultation with an endocrinologist, neurosurgeon, or specialist experienced in acromegaly management; inadequate response to pituitary surgery and/or surgery is not an option; documentation of inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue after a trial of >= 30 days (e.g., octreotide, lanreotide, Sandostatin, Somatuline); historical or current IGF-1 above the upper limit of normal for age/sex or documentation of prior elevation with ongoing requirement for somatostatin-based medical therapy; provider attestation that patient has been counseled on and is able to comply with empty-stomach administration instructions.

Initial Therapy

Covered when ALL of the following are met

Initial Approval Criteria: (1) Documented diagnosis of acromegaly requiring medical therapy; (2) Prescribed by, or in consultation with, an endocrinologist or neurosurgeon, or specialist experienced in acromegaly management; (3) Inadequate response to pituitary surgery and/or surgery is not an option; (4) Documentation of inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue (SSA) following a trial of at least one month (>= 30 days) (e.g., octreotide, lanreotide); (5) Historical or current IGF-1 above the upper limit of normal for age/sex, or documentation of prior elevation with ongoing requirement for somatostatin-based medical therapy; (6) Provider attestation that patient has been counseled on and is able to comply with empty-stomach administration instructions when applicable.

Capture AND logic exactly as stated in source.

Initial Approval

Covered when ALL of the following are met

Initial Approval Criteria: Documented diagnosis of acromegaly requiring medical therapy; prescribed by or in consultation with an endocrinologist, neurosurgeon, or specialist experienced in acromegaly management; inadequate response to pituitary surgery and/or surgery is not an option; documentation of inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue following a trial of at least one month (≥ 30 days) (e.g., octreotide, lanreotide, Sandostatin, Somatuline); and historical or current IGF-1 above the upper limit of normal for age/sex, or documentation of prior elevation with ongoing requirement for somatostatin-based medical therapy; plus provider attestation that patient has been counseled on and is able to comply with empty-stomach administration instructions.

All elements required for approval

Acromegaly - Initial Therapy

Initial Approval Criteria for acromegaly-related agents (where surgery is not an option or response to surgery is inadequate): Covered when ALL of the following are met

Acromegaly initial approval: 1) Documented diagnosis of acromegaly requiring medical therapy; 2) Prescribed by, or in consultation with, an endocrinologist, neurosurgeon, or specialist experienced in acromegaly management; 3) Inadequate response to pituitary surgery and/or surgery is not an option; 4) Documentation of inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue following a trial of at least one month (>= 30 days) (e.g., octreotide, lanreotide, Sandostatin, Somatuline); 5) Historical or current IGF-1 above the upper limit of normal for age/sex, or documentation of prior elevation with ongoing requirement for somatostatin-based medical therapy; 6) Provider attestation that patient has been counseled on and is able to comply with empty-stomach administration instructions.

Voyxact (sibeprenlimab-szsi) - Initial Therapy

Initial Approval Criteria for Voyxact (sibeprenlimab-szsi) in primary IgA nephropathy:

Voyxact initial approval: 1) Diagnosis of primary immunoglobulin A nephropathy (IgAN); 2) Diagnosis confirmed by kidney biopsy consistent with IgAN; 3) Prescriber is a nephrologist or in consultation with a nephrologist; 4) Patient meets definition of high risk of disease progression defined as proteinuria >= 0.5 g/day OR urine protein-to-creatinine ratio (UPCR) >= 0.8 g/g; 5) Patient is stable on a maximally tolerated dose of ACE inhibitor (ACEI) or ARB unless contraindicated.

Quantity limit 1 syringe per 4 weeks; age >= 18 years

Voyxact - Renewal

Renewal Criteria for Voyxact:

Voyxact renewal: 1) Patient remains on maximally tolerated ACEI or ARB unless contraindicated; 2) Prescribed by, or in consultation with, a nephrologist; 3) Prescriber submits clinical documentation that the patient has experienced clinical benefit compared to baseline (e.g., reduction in proteinuria or UPCR or stabilization/improvement in eGFR).

Approval duration 12 months

Attruby (acoramidis) - Initial Therapy

Initial Approval Criteria for Attruby (acoramidis):

Attruby initial approval: Documented diagnosis of transthyretin-mediated cardiomyopathy (ATTR-CM), either wild-type or variant (hereditary), confirmed by appropriate diagnostic evaluation (e.g., Tc 99m PYP scan, cardiac MRI, biopsy, and/or genetic testing).

Initial Approval

Covered when ALL of the following are met:

Initial Approval: 1) Documented diagnosis of transthyretin-mediated cardiomyopathy (wild-type or variant) confirmed by appropriate diagnostic evaluation (e.g., Tc-99m PYP scan, cardiac MRI, biopsy, and/or genetic testing). 2) Prescribed by, or in consultation with, a cardiologist, geneticist, or specialist experienced in management of transthyretin amyloidosis. 3) Documentation of clinical features consistent with symptomatic cardiomyopathy (e.g., dyspnea, fatigue, lower extremity edema, reduced exercise tolerance). 4) Documentation that patient is receiving optimized guideline-directed medical therapy (GDMT) for heart failure as clinically appropriate (e.g., beta-blocker, ACEi/ARB/ARNI, MRA, SGLT2i, diuretics), or documented medical reasons why GDMT is not fully optimized.

Renewal

Covered at renewal when ALL of the following are met:

Renewal: Documentation (e.g., progress note) that at least ONE of the following has occurred since treatment initiation: stabilization or improvement in functional status (e.g., New York Heart Association functional class) or other clinical benefit; AND continued documentation that patient is receiving optimized guideline-directed medical therapy for heart failure as clinically appropriate, or documented medical reasons why not fully optimized.

Document evidence of clinical benefit or stabilization since initiation.

Renewal Criteria

Renewal is allowed when ALL of the following are documented:

Renewal requirements: 1) Documentation (e.g., progress note) that at least ONE of the following has occurred since treatment initiation: stabilization or improvement in functional status (e.g., NYHA class, 6-minute walk distance) OR reduction in cardiovascular-related hospitalization frequency; AND 2) Documentation that patient is receiving optimized guideline-directed medical therapy (GDMT) for heart failure as clinically appropriate (e.g., beta-blocker, ACEi/ARB/ARNI, MRA, SGLT2i, diuretics), or documented medical reason(s) why GDMT is not fully optimized.at least ONE outcome; GDMT documented or justified

Provider must supply progress notes showing outcomes and GDMT status.

Renewal Criteria

Covered at renewal when ALL of the following are met

Renewal requirements: 1) Documentation (e.g., progress note) that at least ONE of the following has occurred since treatment initiation: stabilization or improvement in functional status (e.g., NYHA class, 6-minute walk distance) OR reduction in cardiovascular-related hospitalization frequency versus baseline; 2) Documentation that patient is receiving optimized guideline-directed medical therapy (GDMT) for heart failure (e.g., beta-blocker, ACEi/ARB/ARNI, MRA, SGLT2i, diuretics) OR documented medical reason(s) why GDMT is not fully optimized.at least one clinical outcome

Both elements required for renewal

Renewal Criteria

Renewal covered when ALL of the following are met

Renewal requirements: 1) Documentation that at least ONE of the following has occurred since treatment initiation: stabilization or improvement in functional status (e.g., NYHA class, 6-minute walk distance) OR reduction in cardiovascular-related hospitalization frequency versus baseline; 2) Documentation that patient is receiving optimized guideline-directed medical therapy (GDMT) for heart failure as clinically appropriate (e.g., beta-blocker, ACEi/ARB/ARNI, MRA, SGLT2i, diuretics), and/or documented medical reasons why GDMT is not fully optimized.at least ONE clinical outcome

Both clinical outcome (at least one) and GDMT documentation are required for renewal.

Renewal Criteria

Renewal covered when ALL of the following are met:

Renewal requirements: 1) Documentation (e.g., progress note) that at least ONE of the following has occurred since treatment initiation: stabilization or improvement in functional status (e.g., NYHA class, 6-minute walk distance) OR reduction in cardiovascular-related hospitalization frequency versus baseline; 2) Documentation that the patient is receiving optimized guideline-directed medical therapy (GDMT) for heart failure (examples: beta-blocker, ACEi/ARB/ARNI, MRA, SGLT2i, diuretics) and/or documented medical reason(s) why GDMT is not fully optimized.at least one outcome

Must document either clinical improvement in function or reduced hospitalizations plus GDMT optimization or documented reason for not optimizing GDMT

Initial Approval

Initial approval requirements (as stated):

Initial approval: Documentation that patient is receiving optimized guideline-directed medical therapy (GDMT) for heart failure as clinically appropriate (examples provided), and/or documented medical reason(s) why not fully optimized. Baseline status should be recorded (functional status, hospitalization frequency).baseline documented

Initial approval emphasizes GDMT optimization and baseline clinical status

Renewal (Continuation) Therapy

Renewal covered when ALL of the following are met:

Renewal requirements: 1) Documentation (e.g., progress note) that at least ONE of the following has occurred since treatment initiation: stabilization or improvement in functional status (e.g., NYHA class, 6-minute walk distance) OR reduction in cardiovascular-related hospitalization frequency versus baseline; AND 2) Documentation that the patient is receiving optimized guideline-directed medical therapy (GDMT) for heart failure (e.g., beta-blocker, ACEi/ARB/ARNI, MRA, SGLT2i, diuretics), and/or a documented medical reason why GDMT is not fully optimized.at least ONE outcome

Do not require both outcomes; one is sufficient; GDMT should be optimized unless a medical reason is documented.

No explicit exclusions are stated in the cited coverage criteria excerpts. The approval logic focuses on meeting the listed eligibility elements (diagnosis of acromegaly, specialist involvement, inadequate response to surgery or surgery not an option, prior trial and inadequate response/intolerance/contraindication to an injectable somatostatin analogue for ≥ 30 days, and historical or current IGF‑1 above the age/sex upper limit of normal) rather than on enumerating separate exclusion conditions.

The provided chunks do not list explicit exclusions. Coverage language in these excerpts instead specifies required documentation and conditions for approval (including prior SSA trial, IGF‑1 evidence, specialist prescribing/consultation, and provider attestation regarding empty‑stomach administration) without calling out separate exclusion criteria.

Within these excerpts there are no stated exclusions. The text details the conditions that must be met for initial approval (diagnosis, specialist involvement, prior ≥ 30‑day injectable SSA trial with inadequate response/intolerance/contraindication, and IGF‑1 above ULN) but does not explicitly list exclusionary conditions.

No additional exclusions are specified in this excerpt. The content reiterates the approval requirements (including prior SSA trial and IGF‑1 criteria) and a provider attestation but does not present explicit exclusion statements.

These chunks do not state explicit exclusions beyond the implicit requirement that patients who fail to meet the listed eligibility/diagnostic elements (for example, no prior SSA trial or absent IGF‑1 evidence) would not satisfy coverage criteria. The policy text centers on required conditions for approval rather than enumerating exclusions.

No explicit exclusion conditions are provided in this section. The renewal language emphasizes required documentation of clinical benefit (stabilization/improvement in functional status or reduced cardiovascular hospitalizations) and evidence of optimized guideline‑directed medical therapy (GDMT) or documented reasons why GDMT is not optimized, without listing separate exclusion criteria.

These excerpts do not list explicit exclusions. Renewal and continuation criteria focus on documentation of at least one clinical benefit since initiation and confirmation of optimized GDMT (or reasons why GDMT is not fully optimized) rather than specifying exclusionary conditions.

No explicit exclusions are presented in the cited text. The policy fragments concentrate on required elements for initial approval (diagnosis, specialist involvement, prior ≥ 30‑day SSA trial, and IGF‑1 elevation) and related documentation rather than on listing exclusions.

There are no explicit 'not medically necessary' statements in these chunks. Instead, the policy defines conditions that must be met for approval (including prior SSA trial ≥ 30 days, IGF‑1 above ULN, specialist prescribing/consultation, and provider attestation) and implies that failure to meet those conditions would prevent coverage.

The cited excerpts do not specify explicit 'not medically necessary' language. Coverage is defined by meeting all required criteria; absence of required documentation or unmet eligibility criteria is the mechanism by which a request would not be approved.

Not specified in these chunks are any standalone 'not medically necessary' statements. The text consistently frames decisions around whether the documented clinical elements satisfy the listed approval criteria.

Use would be considered not medically necessary when the coverage criteria are not met. For example, the policy requires documentation of a trial of at least one injectable somatostatin analogue for ≥ 30 days with inadequate response, intolerance, or contraindication; acromegaly patients lacking that documented prior SSA trial (or lacking historical/current IGF‑1 above the age/sex ULN) would not meet approval criteria and therefore would be ineligible for coverage under these criteria.

Initial Therapy Criteria

Covered when ALL of the following are met

Initial therapy nodes: See coverage.criteria_sets[0] - requires diagnosis, specialist prescribing/consultation, inadequate response to surgery or surgery not an option, and documentation of inadequate response/intolerance/contraindication to >=1 injectable SSA after a trial of >=30 days.>=30 days SSA trial

Initial therapy

Initial therapy approval requirements

Initial therapy nodes: Documented diagnosis of acromegaly; prescriber is or consulted with endocrinologist/neurosurgeon/specialist experienced in acromegaly; inadequate response to pituitary surgery or surgery not an option; prior trial (>=30 days) of at least one injectable SSA with documented inadequate response/intolerance/contraindication; historical or current IGF-1 above ULN or prior elevation with ongoing need for somatostatin-based therapy.

Continuation / Renewal Criteria

Voyxact - Continuation Therapy

Renewal criteria for Voyxact require evidence of clinical benefit and continued background therapy.

Voyxact continuation: Patient stable on maximally tolerated ACEI/ARB unless contraindicated; prescriber documents clinical benefit (e.g., reduced proteinuria/UPCR or stable/improved eGFR); prescriber is a nephrologist or in consultation with one.

Continuation Therapy

Renewal/continuation requirements

Continuation: Progress note documenting at least one of: stabilization or improvement in functional status (e.g., NYHA class) or other clinical benefit since treatment initiation; AND continued use under specialist care with GDMT optimization or documented reasons for not optimizing.

Continuation Therapy

Renewal/continuation requires documented clinical benefit and GDMT status.

Step Therapy / Prior Trial Requirements

Step	Requirement
1
Trial and documented inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue (SSA) prior to approval of paltusotine

Step	Requirement
1
Prior trial of at least one injectable somatostatin analogue (e.g., octreotide, lanreotide, Sandostatin, Somatuline)

Step	Requirement
1
{"text":"Trial of at least one injectable SSA (e.g., octreotide, lanreotide) for 6 30 days prior to approval","status":""}

Step	Requirement
1
Trial and documented failure, intolerance, or contraindication to at least one injectable somatostatin analogue before approval of the oral agent

Step	Requirement
1
Trial of at least one injectable somatostatin analogue (e.g., octreotide, lanreotide, Sandostatin, Somatuline) before approval

Step	Requirement
1
Prior trial of at least one injectable somatostatin analogue (e.g., octreotide, lanreotide, Sandostatin, Somatuline) with documentation of inadequate response, intolerance, or contraindication

Step	Requirement
1
{"text":"Trial of at least one injectable SSA prior to approval (documented trial 6 30 days with outcome)","status":""}

Step	Requirement
1
Trial of at least one injectable SSA (e.g., octreotide, lanreotide) before approval of alternative somatostatin-based therapy

Step	Requirement
1
Trial of at least one injectable somatostatin analogue (e.g., octreotide, lanreotide, Sandostatin, Somatuline) with documented inadequate response, intolerance, or contraindication

Step	Requirement
1
Ensure patients are receiving optimized guideline-directed medical therapy (GDMT) (examples: beta-blocker, ACEi/ARB/ARNI, MRA, SGLT2i, diuretics) or document medical reasons why GDMT is not fully optimized before or at renewal

Step	Requirement
1
Expectation that patients are on optimized GDMT prior to or during treatment; documented medical reasons acceptable if GDMT is not optimized

Step	Requirement
0
No additional explicit step therapy steps specified in these sections beyond the requirement to document GDMT optimization where applicable

Step	Requirement
1
Patient should be receiving optimized guideline-directed medical therapy (GDMT) for heart failure as clinically appropriate; if not, provide documented medical reason(s)

Provider Actions / Authorization & Documentation

Prior Authorization

Prior authorization required for Palsonify (paltusotine)

Prior authorization is required for Palsonify (paltusotine). Include documentation of the diagnosis of acromegaly, that the prescriber is (or consulted with) an endocrinologist, neurosurgeon, or specialist experienced in acromegaly management, and evidence of trial and inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue (SSA) following a trial of at least one month (≥ 30 days).

Document diagnosis of acromegaly requiring medical therapy
Prescriber is or consulted with endocrinologist/neurosurgeon/specialist
Trial and failure/intolerance/contraindication to ≥ 30 days of an injectable SSA

Prior Authorization

Initial approval—required documentation and specialist involvement

Initial approval requires documentation of acromegaly diagnosis, specialist prescribing or consultation (endocrinologist, neurosurgeon, or specialist experienced in acromegaly), inadequate response to pituitary surgery or that surgery is not an option, documentation of inadequate response/intolerance/contraindication to at least one injectable SSA after a trial of ≥ 30 days, and historical or current IGF-1 above the upper limit of normal for age/sex (or prior elevation with ongoing need).

Key Numerical & Biomarker Requirements

inv-35: Injectable SSA trial duration — >= 30 days

Injectable SSA trial duration>= 30 days

inv-36: Somatostatin analogue trial duration — >= 30 days

Somatostatin analogue trial duration>= 30 days

inv-37: Minimum SSA trial duration — >= 30 days

Minimum SSA trial duration>= 30 days

inv-38: IGF-1 — above upper limit of normal for age/sex

IGF-1 requirement

Quantity Limits & Age Requirements

inv-179: Voyxact (sibeprenlimab-szsi) — quantity limit 1 syringe

Voyxact quantity limit1 syringe per 4 weeks (quantity limit 1 syringe)

Definitions

inv-120: Injectable somatostatin analogue (SSA) — Examples provided include octreotide, lanreotide, Sandostatin, Somatuline; a required prior trial is described as at least one month (≥ 3...

Injectable SSA examplesExamples include octreotide, lanreotide (brand names: Sandostatin, Somatuline)

Required prior trialAt least one month (≥ 30 days) of an injectable SSA prior to approval

inv-121: injectable somatostatin analogue (SSA) — Examples provided include octreotide, lanreotide, Sandostatin, Somatuline; required prior trial duration ≥30 days.

Injectable SSA examplesOctreotide, lanreotide (Sandostatin, Somatuline) listed as examples

Required prior trial duration≥ 30 days

Background

Palsonify (paltusotine) is described as an oral somatostatin receptor agonist intended for adults with acromegaly who had an inadequate response to surgery or for whom surgery is not an option. The policy places emphasis on prior treatment with injectable somatostatin analogues and on specialist involvement in prescribing and documentation for prior SSA trial and biochemical evidence (historical or current IGF‑1 above the upper limit of normal).

Policy Summary

Payermedimpact

PolicyPalsonify (paltusotine) — coverage criteria for acromegaly

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization showing diagnosis, specialist involvement, ≥30-day trial and failure/intolerance/contraindication to an injectable SSA, and IGF-1 above ULN.

SourceLink

On This Page

Initial approval requires specialist involvement, prior surgery inadequacy or inoperability, prior SSA trial, and IGF-1 evidence.

Initial Therapy Nodes: See coverage.criteria_sets[0] — all criteria (diagnosis, specialist, surgery inadequate/not option, >=30-day SSA trial with inadequate response/intolerance/contraindication, IGF-1 above ULN or prior elevation).

Initial Therapy

Initial therapy covered when criteria met:

Initial Therapy Requirements: See coverage.criteria_sets[0] for full list: diagnosis of acromegaly, specialist prescriber/consult, prior trial of ≥30 days of at least one injectable SSA with inadequate response/intolerance/contraindication, IGF-1 above ULN or prior elevation with ongoing need, and provider attestation on empty-stomach administration compliance.

Initial Therapy Requirements

Initial authorization requires prior SSA trial and corroborating evidence:

Initial therapy: Documented diagnosis of acromegaly; specialist prescribing/consult; inadequate response to surgery or surgery not an option; trial >=30 days of at least one injectable SSA with inadequate response/intolerance/contraindication; historical/current IGF-1 above age/sex ULN or documentation of prior elevation with ongoing requirement; provider attestation of counseling on and ability to comply with empty-stomach administration.>= 30 days

AND logic across all items.

Initial Therapy

Initial therapy coverage requires all of the following:

Initial therapy nodes: Documented diagnosis of acromegaly; specialist prescriber or consultation; inadequate response to pituitary surgery or surgery not an option; prior >=30-day trial and inadequate response/intolerance/contraindication to at least one injectable SSA; IGF-1 above age/sex ULN or prior elevation documented; provider attestation patient can comply with empty-stomach instructions.

Initial Therapy Requirements

Initial approval requires prior SSA trial and specialist involvement.

Initial therapy nodes: See coverage.criteria_sets for full AND logic: documented acromegaly, specialist prescription/consultation, inadequate response to surgery or surgery not an option, trial/failure/intolerance/contraindication to ≥30-day injectable SSA, IGF-1 above ULN, provider attestation regarding empty-stomach administration.

Initial Therapy Requirement

Initial medical therapy coverage conditions

Initial Therapy: Trial of at least one injectable SSA for ≥30 days with documentation of inadequate response, intolerance, or contraindication is required prior to coverage of subsequent somatostatin-based single-agent therapy.>= 30 days

Examples of SSAs: octreotide, lanreotide (Sandostatin, Somatuline).

Voyxact - Initial Therapy

Voyxact initial approval requirements

Voyxact initial: See Voyxact initial approval criteria: biopsy-confirmed IgAN, high-risk proteinuria thresholds, nephrologist prescriber, stable on ACEI/ARB unless contraindicated.

Age >= 18; quantity limit 1 syringe per 4 weeks

Initial Therapy

Initial therapy requirements

Initial: Diagnosis confirmed by appropriate diagnostic testing; prescribed by or in consultation with an experienced specialist; symptomatic cardiomyopathy present; patient on optimized GDMT or has documented reasons for not being optimized.

Initial Approval Context

Initial approval language references optimized GDMT prior to or during therapy.

Initial approval context: Documentation that patient is receiving optimized guideline-directed medical therapy (GDMT) for heart failure as clinically appropriate and/or documented medical reasons why GDMT is not fully optimized.GDMT documented or justified

Initial Approval Criteria

Initial approval references expectation of GDMT optimization.

Initial approval: Patient should be receiving optimized guideline-directed medical therapy as clinically appropriate (examples listed) and/or there must be documented medical reasons why GDMT is not fully optimized.

Initial criteria text fragmented but repeatedly requires GDMT optimization or documented reason.

Initial Therapy

Initial therapy expectations

Initial therapy: Document that patient is receiving optimized guideline-directed medical therapy (GDMT) for heart failure as clinically appropriate (examples: beta-blocker, ACEi/ARB/ARNI, MRA, SGLT2i, diuretics), and/or provide documented medical reasons why GDMT is not fully optimized; baseline functional status and hospitalization frequency should be documented.

Continuation: Document at least ONE clinical benefit since initiation (stabilization/improvement in functional status OR reduced cardiovascular hospitalizations) AND document that the patient is receiving optimized GDMT or provide medical reasons for not optimizing GDMT.at least ONE clinical benefit

Renewal / Continuation therapy

Continuation (renewal) criteria for single-agent heart failure therapies

Continuation: At renewal provide documentation of at least one clinical benefit since initiation (stabilization/improvement in functional status or fewer CV hospitalizations) AND documentation of optimized GDMT or reason for not optimizing.at least one

Renewal / Continuation

Continuation/renewal requires evidence of benefit and GDMT documentation.

Continuation therapy: Documentation of at least ONE clinical benefit since initiation (stabilization/improvement in functional status OR reduction in cardiovascular-related hospitalizations) AND documentation of optimized GDMT or medical reason why not optimized.

Same GDMT examples repeated across document.

Renewal / Continuation

Renewal/continuation requirements

Continuation therapy: At renewal, provide documentation that at least one of: stabilization/improvement in functional status (e.g., NYHA class, 6-minute walk distance) OR reduction in cardiovascular-related hospitalization frequency versus baseline; and documentation of optimized GDMT or documented reason GDMT is not fully optimized.

Continuation Therapy

Continuation (renewal) requires demonstration of clinical benefit and GDMT optimization.

Continuation criteria: Documentation that at least ONE clinical benefit (stabilization/improvement in functional status such as NYHA class or 6-minute walk distance, OR reduction in cardiovascular-related hospitalizations) has occurred since treatment initiation; plus documentation of optimized GDMT or documented medical reason why not optimized.

Diagnosis of acromegaly requiring medical therapy
Specialist prescriber or documented consultation
Inadequate response to surgery or surgery not an option
Prior ≥ 30-day SSA trial with inadequate response/intolerance/contraindication
Historical or current IGF‑1 above age/sex ULN (or prior elevation documented)

Prior Authorization

Initial prior authorization—specialist, surgery status, SSA trial, IGF‑1

For initial prior authorization, the prescriber must be or consult with an endocrinologist, neurosurgeon, or specialist experienced in acromegaly; provide documentation that surgery was inadequate or not an option; document a prior SSA trial of ≥ 30 days with inadequate response, intolerance, or contraindication; and supply IGF‑1 data showing historical or current elevation above the age/sex upper limit of normal.

Specialist prescribing or documented consultation
Record that pituitary surgery was inadequate or not an option
Prior SSA trial (≥ 30 days) with documented inadequate response/intolerance/contraindication
Historical or current IGF‑1 > ULN for age/sex (or prior elevation documented)

Prior Authorization

Initial approval criteria—adult acromegaly and required evidence

Initial approval requires that the patient is an adult with acromegaly needing medical therapy, that the prescriber is or consulted with an endocrinologist/neurosurgeon/specialist experienced in acromegaly, that there is inadequate response to pituitary surgery or surgery is not an option, and documentation of failed or intolerant response to at least one injectable SSA after a ≥ 30‑day trial plus historical or current IGF‑1 above the ULN.

Adult diagnosis of acromegaly requiring medical therapy
Prescribed by or in consultation with appropriate specialist
Inadequate response to pituitary surgery or surgery not an option
Failed/intolerant to ≥ 30‑day injectable SSA trial
Historical or current IGF‑1 above ULN

Documentation Required

Initial authorization—complete documentation required

Prior authorization must document acromegaly diagnosis, specialist prescribing or consultation, inadequate response to surgery or that surgery is not an option, prior ≥ 30‑day SSA trial with inadequate response/intolerance/contraindication, historical or current IGF‑1 above ULN (or prior elevation), and provider attestation regarding empty‑stomach administration when applicable.

Document diagnosis and specialist involvement
Document prior ≥ 30‑day SSA trial and outcome
Provide IGF‑1 results (historical or current > ULN) or prior elevation
Provider attestation patient counseled and able to comply with empty‑stomach instructions

Prior Authorization

Initial prior authorization requirements—diagnosis, specialist, SSA trial, IGF‑1

Initial prior authorization requires documentation of diagnosis, specialist prescribing/consultation, inadequate response to surgery or that surgery is not an option, prior ≥ 30‑day SSA trial with inadequate response/intolerance/contraindication, and IGF‑1 above the age/sex ULN (or prior elevation).

Diagnosis of acromegaly requiring medical therapy
Specialist prescriber or documented consultation
Prior ≥ 30‑day SSA trial with inadequate response/intolerance/contraindication
IGF‑1 above age/sex ULN or prior elevation documented

Prior Authorization

Initial approval prior authorization—required items

Prior authorization for initial approval must include documented diagnosis of acromegaly, specialist prescription or documented consultation, inadequate response to pituitary surgery or statement that surgery is not an option, and trial/failure/intolerance/contraindication to at least one injectable SSA for ≥ 30 days with supporting IGF‑1 data.

Documented acromegaly diagnosis
Specialist prescriber or documented consultation
Surgery inadequate or not an option (documented)
SSA trial ≥ 30 days with documented inadequate response/intolerance/contraindication
Historical or current IGF‑1 above ULN

Prior Authorization

Prior authorization requirements—specialist, SSA trial, IGF‑1, attestation

Prior authorization requires documentation of diagnosis of acromegaly, specialist involvement (prescribed by or in consultation with an endocrinologist, neurosurgeon, or acromegaly‑experienced specialist), prior trial and inadequate response/intolerance/contraindication to at least one injectable SSA (≥ 30 days), elevated IGF‑1 (historical or current), and provider attestation about empty‑stomach administration ability.

Specialist prescriber or consultation documented
Prior ≥ 30‑day SSA trial with inadequate response/intolerance/contraindication
Historical or current IGF‑1 above ULN (or prior elevation documented)
Provider attestation regarding empty‑stomach administration

Prior Authorization

Voyxact prior authorization, duration, and quantity limit

Voyxact (sibeprenlimab‑szsi) is non‑PDL and requires prior authorization. Initial and renewal approvals are for 12 months each, and quantity is limited to 1 syringe per 4 weeks.

Non‑PDL status
Initial approval duration: 12 months
Renewal approval duration: 12 months
Quantity limit: 1 syringe per 4 weeks

Prior Authorization

Prior authorization requirements for Attruby (acoramidis)

Prior authorization for acoramidis (Attruby) requires a documented diagnosis of transthyretin‑mediated cardiomyopathy (wild‑type or variant) confirmed by appropriate diagnostic evaluation (e.g., Tc‑99m PYP scan, cardiac MRI, biopsy, and/or genetic testing), and that the drug is prescribed by or in consultation with an appropriate specialist with documentation of symptomatic cardiomyopathy and GDMT status.

Documented ATTR‑CM confirmed by appropriate testing (Tc‑99m PYP, MRI, biopsy, or genetic testing)
Prescribed by or in consultation with cardiologist/geneticist/specialist experienced in transthyretin amyloidosis
Documentation of symptomatic cardiomyopathy and GDMT status (optimized or documented reasons why not)

Note

Renewal requires documented clinical benefit and GDMT status

Renewal requires documentation of clinical benefit since treatment initiation (see documentation section) and confirmation that the patient is receiving optimized guideline‑directed medical therapy (GDMT) for heart failure or a documented medical reason why GDMT is not fully optimized.

Progress note showing at least ONE of: stabilization/improvement in functional status (e.g., NYHA class, 6‑minute walk) OR reduction in cardiovascular‑related hospitalizations
Documentation patient is on optimized GDMT or documented medical reason why not

Note

Renewal prior authorization—document clinical benefit and GDMT

At renewal, prior authorization requires a progress note or equivalent demonstrating at least ONE clinical benefit since treatment initiation (stabilization or improvement in functional status or reduction in cardiovascular‑related hospitalizations) and confirmation that the patient is receiving optimized GDMT (examples: beta‑blocker, ACEi/ARB/ARNI, MRA, SGLT2i, diuretics) or documented reasons why GDMT is not fully optimized.

Provide progress notes documenting clinical benefit (≥1 outcome)
Confirm optimized GDMT or document medical reasons why not optimized

Prior Authorization

GDMT required for prior authorization and renewal (with evidence of benefit at renewal)

Prior authorization and renewals require documentation that the patient is receiving optimized guideline‑directed medical therapy (GDMT) for heart failure as clinically appropriate, or a documented medical reason why GDMT is not fully optimized; renewals additionally require evidence of clinical benefit since treatment initiation.

Document GDMT optimization (or provide medical justification if not optimized)
At renewal, document at least one clinical benefit since initiation

Documentation Required

Initial and renewal documentation—GDMT, baseline, and clinical benefit

Initial approval requires documentation of GDMT optimization (or medical reasons why not optimized) and baseline clinical status; renewal requires documentation of at least one clinical improvement or stabilization since treatment initiation plus ongoing GDMT documentation or justification.

Record baseline functional status and hospitalization frequency at initiation
Document GDMT optimization or medical reason why not at initial and renewal
At renewal, show ≥ 1 clinical benefit vs baseline

Note

Renewal prior authorization—document benefit and GDMT

Renewal prior authorization requires documentation demonstrating clinical benefit since treatment initiation (e.g., stabilization or improvement in functional status or reduction in cardiovascular‑related hospitalization frequency) and evidence that the patient is receiving optimized GDMT or a documented medical reason why GDMT is not fully optimized.

Progress note showing at least one clinical benefit since initiation
Confirm optimized GDMT or document reasons why not optimized

Step Therapy

Step therapy—injectable SSA trial (≥ 30 days) required

Step therapy requires a prior trial of at least one injectable somatostatin analogue (e.g., octreotide, lanreotide, Sandostatin, Somatuline) for ≥ 30 days with documentation of inadequate response, intolerance, or contraindication before approving oral paltusotine.

Trial of ≥ 30 days of at least one injectable SSA
Document inadequate response, intolerance, or contraindication to the SSA used in the trial

Step Therapy

Required SSA trial details for step therapy

Providers must document a trial of at least one injectable somatostatin analogue (examples: octreotide, lanreotide, Sandostatin, Somatuline) for ≥ 30 days and provide documentation of inadequate response, intolerance, or contraindication to support progression to oral therapy.

Specify SSA agent used, duration (≥ 30 days), and reason for failure/intolerance/contraindication
Include supporting clinical or laboratory data where available

Step Therapy

SSA trial requirement—≥ 30 days with documented outcome

Must have had a trial of at least one injectable somatostatin analogue (e.g., octreotide, lanreotide, Sandostatin, Somatuline) for ≥ 30 days with documentation of inadequate response, intolerance, or contraindication prior to coverage.

Trial duration: ≥ 30 days
Documented outcome: inadequate response, intolerance, or contraindication

Step Therapy

Injectable SSA prior trial must be documented (≥ 30 days)

Requires prior trial of at least one injectable somatostatin analogue (e.g., octreotide, lanreotide) for ≥ 30 days with documentation of inadequate response, intolerance, or contraindication before approving the oral agent.

Document SSA agent, start/end dates, and reason for discontinuation or failure
Attach relevant clinical notes or laboratory results supporting inadequate response

Step Therapy

Step therapy—prior injectable SSA trial and documented failure/intolerance

Step requirement: a trial of at least one injectable somatostatin analogue (e.g., octreotide, lanreotide, Sandostatin, Somatuline) for ≥ 30 days demonstrating inadequate response, intolerance, or contraindication prior to approval of alternative somatostatin‑based therapy.

Provide documentation of SSA trial length (≥ 30 days) and clinical outcome
State why injectable therapy is inadequate or not tolerated if applicable

Step Therapy

Acromegaly step—prior SSA trial (≥ 30 days) required

Before approval for acromegaly agents, the patient must have had an inadequate response, intolerance, or contraindication to at least one injectable somatostatin analogue after a trial of at least one month (≥ 30 days).

SSA examples: octreotide, lanreotide, Sandostatin, Somatuline
Minimum trial: ≥ 30 days

Note

GDMT expectation—document optimized heart failure therapy or justify

Policy expects patients (when applicable) to be receiving optimized guideline‑directed medical therapy (GDMT) as clinically appropriate (examples: beta‑blocker, ACEi/ARB/ARNI, MRA, SGLT2i, diuretics); if GDMT is not optimized, provide documented medical reasons.

Document current GDMT medications or justify why GDMT is not fully optimized
Provide relevant progress notes or medication lists

Documentation Required

Optimize GDMT prior to or at renewal and document clinical benefit

At renewal, providers should ensure patients are receiving optimized GDMT (examples listed: beta‑blocker, ACEi/ARB/ARNI, MRA, SGLT2i, diuretics) or document medical reasons why GDMT is not fully optimized; include progress notes demonstrating clinical benefit.

Confirm GDMT regimen and any contraindications or tolerability issues
Include progress notes showing at least one clinical benefit since initiation

Note

Expectation to document GDMT optimization or provide medical justification

Providers should expect to document GDMT optimization as clinically appropriate; if GDMT is not optimized, provide a documented medical reason. This expectation applies prior to and during therapy where indicated.

List GDMT agents used and dosages or explain why not tolerated/contraindicated
Attach supporting clinical rationale when GDMT is not fully optimized

Documentation Required

Initial approval documentation—diagnosis and SSA trial

Documented diagnosis of acromegaly requiring medical therapy; documentation of inadequate response, intolerance, or contraindication to at least one injectable SSA after a trial of at least one month (≥ 30 days) is required for initial approval.

Provide SSA trial details (agent, duration ≥ 30 days, outcome)
Include IGF‑1 results if available

Documentation Required

Prescriber specialty and surgery status must be documented

Prescriber must be or consult with an endocrinologist, neurosurgeon, or specialist experienced in acromegaly management; document inadequate response to pituitary surgery or that surgery is not an option for the patient.

Include documentation of specialist consultation or that prescriber is a specialist
State surgery outcome or why surgery is not an option

Documentation Required

Required documentation for initial approval—full list

Required documentation for initial approval includes: diagnosis of acromegaly requiring medical therapy; documentation that pituitary surgery was inadequate or not an option; documentation of prior ≥ 30‑day SSA trial with inadequate response/intolerance/contraindication; and historical or current IGF‑1 above ULN or prior elevation with ongoing need for somatostatin therapy.

Diagnosis and specialist involvement
Surgery status (inadequate or not an option)
SSA trial details and outcome (≥ 30 days)
IGF‑1 data showing elevation or prior elevation

Documentation Required

Required documentation for prior authorization (acromegaly agents)

For prior authorization, include: documented diagnosis of acromegaly requiring medical therapy; documentation of inadequate response to pituitary surgery or that surgery is not an option; documentation of inadequate response/intolerance/contraindication to at least one injectable SSA after a ≥ 30‑day trial; historical or current IGF‑1 above ULN or prior elevation with ongoing need; and provider attestation that the patient has been counseled on and can comply with empty‑stomach administration instructions.

Diagnosis and specialist prescriber/consultation
SSA trial (≥ 30 days) with documented outcome
IGF‑1 results or prior elevation documentation
Provider attestation about empty‑stomach administration where applicable

Documentation Required

Documentation checklist—SSA trial, IGF‑1, surgery status, attestation

Document diagnosis of acromegaly; document inadequate response to pituitary surgery and/or state that surgery is not an option; provide record of a trial (≥ 30 days) of at least one injectable SSA with documentation of inadequate response, intolerance, or contraindication; include historical or current IGF‑1 above the age/sex ULN (or prior elevation) and provider attestation regarding empty‑stomach administration.

Attach SSA trial records (dates, agent, dosing, reason for discontinuation)
Attach IGF‑1 lab results or prior elevated records
Include provider attestation of counseling on empty‑stomach administration

Documentation Required

Required documentation—surgery, SSA trial, IGF‑1, attestation

Document diagnosis of acromegaly requiring medical therapy; document inadequate response to pituitary surgery and/or reason surgery is not an option; document prior ≥ 30‑day SSA trial with inadequate response/intolerance/contraindication; provide IGF‑1 above age/sex ULN or prior elevation; and include provider attestation that patient has been counseled on and can comply with empty‑stomach administration instructions.

Provide dates and outcomes of pituitary surgery if performed
Provide SSA trial documentation and IGF‑1 lab results
Provide provider attestation re: empty‑stomach instructions

Documentation Required

Document specialist involvement, SSA trial, and IGF‑1 data

Document diagnosis of acromegaly, specialist involvement (prescribed by or in consultation with an endocrinologist, neurosurgeon, or experienced specialist), prior SSA trial details (≥ 30 days) including inadequate response/intolerance/contraindication, and historical or current IGF‑1 above the upper limit of normal for age/sex (or prior elevation with ongoing need).

Specialist prescriber/consultation documentation
SSA trial agent, duration (≥ 30 days), and documented outcome
IGF‑1 results or documentation of prior elevation

Documentation Required

Provider attestation—empty‑stomach administration counseling

Provider attestation is required that the patient has been counseled on and is able to comply with empty‑stomach administration instructions when applicable; include this attestation in the prior authorization documentation.

Attestation statement included in authorization request
Note applicability when empty‑stomach administration is required

Denial Risk

Denial risk: missing SSA trial documentation (≥ 30 days)

Failure to document a trial of at least one injectable somatostatin analogue (SSA) for ≥ 30 days (e.g., octreotide, lanreotide, Sandostatin, Somatuline) may trigger denial of the request.

SSA trial duration must be shown (≥ 30 days)
Record must show inadequate response, intolerance, or contraindication

Denial Risk

Denial risk: insufficient disease or IGF‑1 documentation

Lack of documentation of inadequate response to pituitary surgery (when applicable) or absence of historical/current IGF‑1 above the upper limit of normal may lead to denial.

Provide surgery outcome or reason surgery not an option
Include IGF‑1 lab results showing elevation or prior elevated records

Denial Risk

Denial risk: missing prior SSA trial outcome documentation

Lack of documentation of inadequate response, intolerance, or contraindication to at least one injectable SSA following a trial of at least one month (≥ 30 days) may trigger denial of initial authorization.

SSA trial and outcome must be documented clearly
Specify reasons for intolerance or contraindication if applicable

Denial Risk

Renewal denial risk—missing documentation of clinical benefit or GDMT

Failure to provide documentation showing at least one required outcome at renewal (stabilization or improvement in functional status or reduction in cardiovascular‑related hospitalizations) or failure to document optimized GDMT (or valid medical reasons why not) may trigger denial of renewal.

Progress note demonstrating ≥ 1 clinical benefit vs baseline
Documentation of GDMT regimen or justification for non‑optimization

Historical or current IGF-1 above the upper limit of normal for age/sex

inv-39: injectable SSA trial duration — ≥ 30 days

Injectable SSA trial duration≥ 30 days

inv-40: prior SSA trial duration — >= 30 days

Prior SSA trial duration>= 30 days

inv-41: prior SSA trial duration — >= 30 days

Prior SSA trial duration>= 30 days

inv-42: Injectable SSA trial duration — >= 30 days

Injectable SSA trial duration>= 30 days

inv-43: IGF-1 — Historical or current IGF-1 above the upper limit of normal for age/sex

IGF-1 evidenceHistorical or current IGF-1 above the upper limit of normal for age/sex, or documentation of prior elevation with ongoing requirement

inv-44: Injectable SSA trial duration — ≥ 30 days

Injectable SSA trial duration≥ 30 days

inv-45: Injectable somatostatin analogue trial duration — >= 30 days

Injectable somatostatin analogue trial duration>= 30 days

inv-46: Proteinuria — >= 0.5 g/day or UPCR >= 0.8 g/g

Proteinuria threshold>= 0.5 g/day or UPCR >= 0.8 g/g

inv-47: 6-Minute Walk Test — referenced as an acceptable measure of functional status (exact numeric threshold not specified)

6-Minute Walk TestReferenced as an acceptable measure of functional status (no numeric threshold specified)

inv-48: NYHA class — referenced as an acceptable measure of functional status (exact class thresholds not specified)

NYHA classReferenced as an acceptable measure of functional status (exact class thresholds not specified)

inv-49: Clinical measures — NYHA class, 6-minute walk distance (exact numeric thresholds not specified)

Clinical measuresNYHA class; 6-minute walk distance (exact numeric thresholds not specified)

inv-50: Clinical outcome requirement — At least ONE of: stabilization/improvement in functional status (NYHA class, 6-minute walk distance) OR reduction in cardiovascular-relat...

Clinical outcome requirementAt least ONE of: stabilization or improvement in functional status (e.g., NYHA class, 6-minute walk distance) OR reduction in cardiovascular-related hospitalization frequency versus baseline

inv-51: Clinical response requirement at renewal — At least one of: stabilization/improvement in functional status (e.g., NYHA class, 6-minute walk distance) OR reduction in cardiovascular...

Renewal clinical response requirementAt least one of: stabilization/improvement in functional status (e.g., NYHA class, 6-minute walk distance) OR reduction in cardiovascular-related hospitalization frequency versus baseline

inv-52: Functional status measures — NYHA class; 6-minute walk distance

Functional status measuresNYHA class; 6-minute walk distance

inv-53: Palsonify prior authorization callout referenced in coding — prior authorization required with documentation of diagnosis, specialist involvement, trial and failure/intolerance/contraindication to a...

Prior authorization requirementPrior authorization required with documentation of diagnosis; specialist involvement; and trial and failure/intolerance/contraindication to at least one injectable SSA after a >=30-day trial

inv-122: IGF-1 above the upper limit of normal (ULN) — Historical or current insulin-like growth factor-1 (IGF-1) level above the age/sex-specific ULN, or documentation of prior elevation with...

IGF-1 thresholdHistorical or current IGF-1 above the age/sex-specific upper limit of normal (ULN)

Alternative documentationOr documentation of prior elevation with ongoing requirement for somatostatin-based therapy

inv-123: Injectable somatostatin analogue (SSA) — Examples listed include octreotide, lanreotide, Sandostatin, Somatuline (as per document).

Injectable SSA examplesOctreotide, lanreotide (brand examples: Sandostatin, Somatuline)

Role in pathwayAgents to be trialed prior to single-agent approval

inv-124: IGF-1 requirement — Historical or current insulin-like growth factor 1 (IGF-1) above the upper limit of normal for age/sex, or documentation of prior elevati...

IGF-1 requirementHistorical or current IGF-1 above the upper limit of normal for age/sex, or documentation of prior elevation with ongoing requirement

inv-125: injectable somatostatin analogue (SSA) — Examples include octreotide, lanreotide, Sandostatin, Somatuline as referenced in the document.

SSA examplesOctreotide, lanreotide, Sandostatin, Somatuline cited in document

Prior trial duration≥ 30 days

inv-126: IGF-1 above the upper limit of normal (ULN) — Historical or current insulin-like growth factor-1 level exceeding the age/sex-specific ULN, or prior documented elevation with ongoing n...

IGF-1 above ULNHistorical or current IGF-1 above the age/sex-specific ULN, or prior documented elevation with ongoing need

inv-127: injectable somatostatin analogue (SSA) — Examples listed include octreotide, lanreotide, Sandostatin, Somatuline; used as prior trial agents of at least 30 days.

Injectable SSA examplesOctreotide, lanreotide, Sandostatin, Somatuline—as prior trial agents

Required trial lengthAt least 30 days prior to approval

inv-128: IGF-1 requirement — Historical or current IGF‑1 above the upper limit of normal for age/sex, or documentation of prior elevation with ongoing requirement for...

IGF-1 requirementHistorical or current IGF-1 above the ULN for age/sex, or documentation of prior elevation with ongoing requirement

inv-129: injectable somatostatin analogue (SSA) — Examples provided include octreotide, lanreotide, Sandostatin, Somatuline.

Injectable SSA examplesOctreotide and lanreotide (Sandostatin, Somatuline) cited repeatedly

inv-130: IGF-1 above ULN — Historical or current insulin-like growth factor 1 value above the upper limit of normal for age and sex, or documentation of prior eleva...

IGF-1 above ULNHistorical or current IGF-1 value above the age/sex-specific ULN, or documentation of prior elevation with ongoing requirement

inv-131: injectable somatostatin analogue (SSA) — Examples provided include octreotide and lanreotide (brand examples: Sandostatin, Somatuline) as agents that should be trialed prior to s...

Injectable SSA examples (brands)Octreotide (Sandostatin), lanreotide (Somatuline)

Clinical roleFirst-line injectable agents to trial before oral single-agent therapy

inv-132: injectable somatostatin analogue (SSA) — Examples include octreotide and lanreotide (brand names cited: Sandostatin, Somatuline) used as first-line medical therapy for acromegaly...

Injectable SSA examplesOctreotide and lanreotide (Sandostatin, Somatuline)

Required trial duration≥ 30 days

inv-133: IGF‑1 requirement — Historical or current insulin-like growth factor 1 (IGF‑1) above the upper limit of normal for age/sex, or documentation of prior elevati...

IGF-1 requirementHistorical or current IGF-1 above the age/sex-specific ULN, or prior elevation documented with ongoing need

inv-134: Voyxact (sibeprenlimab-szsi) — A humanized IgG2 monoclonal antibody that inhibits APRIL to reduce proteinuria in adults with primary IgA nephropathy.

Voyxact descriptionHumanized IgG2 monoclonal antibody that inhibits APRIL to reduce proteinuria in adults with primary IgA nephropathy

inv-135: Attruby (acoramidis) — An oral transthyretin stabilizer indicated for adults with cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATT...

Attruby (acoramidis)Oral transthyretin stabilizer indicated for ATTR-CM (wild-type or variant)

inv-136: ATTR-CM — Transthyretin-mediated cardiomyopathy (wild-type or variant/hereditary), diagnosed by appropriate evaluation such as Tc-99m PYP scan, car...

ATTR-CM diagnosisTransthyretin-mediated cardiomyopathy (wild-type or variant), confirmed by appropriate evaluation such as Tc-99m PYP scan, cardiac MRI, biopsy, and/or genetic testing

inv-137: Optimized guideline-directed medical therapy (GDMT) — Therapies considered appropriate for heart failure management as clinically appropriate, including beta-blocker, ACEi/ARB/ARNI, MRA, SGLT...

Optimized GDMT examplesBeta-blocker, ACEi/ARB/ARNI, MRA, SGLT2i, diuretics (examples of guideline-directed medical therapy)

inv-138: Clinical benefit for renewal — At least one of stabilization or improvement in functional status (e.g., NYHA class, 6-minute walk distance) or reduction in cardiovascul...

Clinical benefit for renewalAt least one of stabilization or improvement in functional status (e.g., NYHA class, 6-minute walk distance) or reduction in cardiovascular-related hospitalization frequency

inv-139: Stabilization or improvement in functional status — Clinical improvement or stabilization demonstrated by measures such as New York Heart Association (NYHA) class or 6-minute walk distance.

Functional status examplesNYHA class; 6-minute walk distance