CurrentMass General Brigham Health PlanPolicy N/A

Somavert (pegvisomant) and Signifor LAR (pasireotide) prior authorization

Defines prior authorization, coverage criteria, quantity limits, and continuation requirements for Somavert (pegvisomant) and Signifor LAR (pasireotide) for members of Mass General Brigham Health Plan (MassHealth UPPL and commercial/exchange). Affects prescribers and pharmacies seeking medical or pharmacy benefit coverage.

Policy Summary

PayerMass General Brigham Health Plan

PolicySomavert (pegvisomant) and Signifor LAR (pasireotide) prior authorization

Policy CodePolicy N/A

Change TypeClarification and operational update

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document prescriber specialty (endocrinologist) or provide endocrinology consult notes; demonstrate required prior surgery failure or ineligibility and prior medication trials per criteria.

SourceLink

POLICY UPDATE CHANGES

Updated header to differentiate medical benefit drugs versus pharmacy drugs in this class; pharmacy criteria removed and referenced to MassHealth Drug List.

Verbiage update regarding member 'not a candidate for surgery' and prescriber specialty.

12 monthsApproval duration

<1/30dSignifor LAR limit

<1/daySomavert limit

Endocrinologist

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Prescriber requirement

Coverage Criteria for Somavert and Signifor LAR

Signifor LAR (pasireotide) — Cushing's disease and acromegaly

Authorization may be granted when ALL of the following are met:

Signifor LAR criteria: 1) Diagnosis of Cushing's disease; 2) ONE of the following: a) Member has failed surgical intervention (recurrence after surgery or failed tumor removal) OR b) Member is not a candidate for surgery; 3) Inadequate response, adverse reaction to ONE, or contraindication to ALL of the following: cabergoline; ketoconazole; Lysodren (mitotane); metopirone (metyrapone); 4) Quantity requested is < 1 kit or vial per 30 days.

Items 2 and 3 represent internal OR and AND groupings as presented in source.

Acromegaly — general criteria (applies to Signifor LAR and Somavert pathways)

Covered when ALL of the following are met:

Acromegaly criteria: 1) Diagnosis of acromegaly; 2) Prescriber is an endocrinologist or consult notes from an endocrinologist are provided; 3) ONE of the following: a) Member has persistent or recurring disease following surgery and/or radiation OR b) Member is not a candidate for surgery; 4) ONE of the following: a) Inadequate response or adverse reaction to one somatostatin analog that does not require prior authorization OR b) Contraindication to the use of somatostatin analogs; 5) ONE of the following: a) Member has moderate-to-severe disease symptoms OR b) Member has mild disease and ONE of: i) Adverse reaction to one somatostatin analog that does not require prior authorization OR ii) Inadequate response or adverse reaction to one dopamine analog (e.g., cabergoline, bromocriptine) in combination with a somatostatin analog with an overlap of 3 months within a 6-month period OR iii) Contraindication to the use of dopamine analogs; 6) Quantity requested is < 1 kit or vial per 30 days (Signifor LAR) or < 1 vial per day (Somavert).

Nested logic preserved per policy text.

Somavert (pegvisomant) — acromegaly-specific criteria

Covered when ALL of the following are met:

Somavert criteria: 1) Diagnosis of acromegaly; 2) Prescriber is an endocrinologist or consult notes from an endocrinologist are provided; 3) ONE of the following: a) Member has persistent or recurring disease following surgery and/or radiation OR b) Member is not a candidate for surgery; 4) ONE of the following: a) Inadequate response or adverse reaction to one somatostatin analog that does not require prior authorization OR b) Contraindication to the use of somatostatin analogs; 5) ONE of the following: a) Member has moderate-to-severe disease symptoms OR b) Member has mild disease and ONE of: i) Adverse reaction to one somatostatin analog that does not require prior authorization OR ii) Inadequate response or adverse reaction to one dopamine analog (e.g., cabergoline, bromocriptine) in combination with a somatostatin analog for overlap of 3 months within a 6-month period OR iii) Contraindication to the use of dopamine analogs; 6) Quantity requested is < 1 vial per day.

Requests for prior authorization will not be eligible for case-by-case review when the member obtained the medication as samples or through a manufacturer's patient assistance program. Such products are explicitly excluded from consideration under the plan's case-by-case authorization process.

Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Signifor LAR and Somavert. Requests may be reviewed case-by-case for members new to the plan who are currently receiving treatment with the requested medication. Authorizations will not be granted when the product is obtained as samples or via manufacturer's patient assistance programs.

Signifor LAR (pasireotide): Diagnosis of Cushing's disease and documentation of surgery failure or ineligibility, and inadequate response/adverse reaction/contraindication to required prior medications (e.g., cabergoline, ketoconazole, mitotane, metyrapone). Quantity limits apply (typically < 1 kit or vial/30 days).
Somavert (pegvisomant): Diagnosis of acromegaly with prescriber who is an endocrinologist or provision of endocrinology consult notes; documentation of persistent/recurring disease after surgery/radiation or surgical ineligibility; evidence of inadequate response/adverse reaction/contraindication to somatostatin and/or dopamine analogs as specified. Quantity limits apply (typically < 1 vial/day).
Requests may be denied if required clinical criteria are not met, if prescriber specialty documentation (endocrinologist or consult notes) is not provided, or if the product was obtained as samples or through patient assistance programs.

Step Therapy

Indications and Background

Acromegaly / Cushing's disease indications

Somavert (pegvisomant) — indicationTreatment of acromegaly in patients with inadequate response to surgery or radiation, or for whom these therapies are not appropriate.

Signifor LAR (pasireotide) — acromegaly indicationTreatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

Somavert (pegvisomant) is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom surgery or radiation is not appropriate. The agent is used when prior interventions have failed or are not suitable and when the prescriber has documented the need for a medical therapy alternative.

Signifor LAR (pasireotide) is indicated for Cushing's disease in patients for whom pituitary surgery is not an option or has not been curative, and it may also be used for acromegaly when surgery is not curative or is not an option. Use is intended for patients who require pharmacologic management after surgical approaches have failed or are contraindicated.

Policy Summary

PayerMass General Brigham Health Plan

PolicySomavert (pegvisomant) and Signifor LAR (pasireotide) prior authorization

Policy CodePolicy N/A

Change TypeClarification and operational update

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Step Therapy and Prior Medication Trials

Step therapy or prior medication trial requirements apply when indicated: members must have failed surgery (recurrence or unsuccessful tumor removal) or be ineligible for surgery, and must have inadequate response, adverse reaction to, or contraindication to specified prior agents before authorization is granted.

For Cushing's disease (Signifor LAR): documentation of failure of surgical intervention or evidence patient is not a surgical candidate, plus trial and inadequate response/adverse reaction/contraindication to agents such as cabergoline, ketoconazole, mitotane (Lysodren), or metyrapone as applicable.
For acromegaly (Signifor LAR when used off-label or Somavert): trial and inadequate response/adverse reaction/contraindication to somatostatin analog(s) and, when applicable, dopamine analog(s) (e.g., cabergoline, bromocriptine) per policy-defined sequencing and overlap requirements.

Documentation Required

Prescriber Specialty Documentation Required

Prescriber specialty documentation is required. The request must be submitted by an endocrinologist or include consult notes from an endocrinologist to support the diagnosis and prior-therapy history.

Endocrinologist prescriber or endocrinology consult notes must be provided for acromegaly and Somavert requests.
Specialty documentation supports surgical history, prior medication trials, intolerance, contraindications, and rationale for the requested therapy.

Denial Risk

Denial Risk / Operational Note

Denial risk: Requests may be denied if the clinical criteria (diagnosis, surgery failure/ineligibility, required prior medication trials, prescriber specialty documentation) are not met, or if the product was obtained as samples or through manufacturer's patient assistance programs.

Authorization may be reviewed but denied for members new to the plan who obtained the product as samples or via patient assistance.
Ensure all required documentation (diagnosis, surgical history, prior medication trials, endocrinology consult or prescriber specialty) is submitted to avoid denial.