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ph-1030

Bonjesta, Diclegis Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1030

This prior authorization applies Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace formularies

POLICY REVIEW CYCLE

Effective Date	Date of Origin
10/1/2022

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Bonjesta^® (doxylamine/pyridoxine ER) Tablet	Treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitation of use: Bonjesta has not been studied in women with hyperemesis gravidarum		1
Diclegis^® (doxylamine/pyridoxine delayed release)^a Tablet	Treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitation of use: Diclegis has not been studied in women with hyperemesis gravidarum	ª- Generic equivalent available	2

Agent(s)

FDA Indication(s)

Notes

Ref#

Bonjesta^®

(doxylamine/pyridoxine ER)

Tablet

Treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

Limitation of use: Bonjesta has not been studied in women with hyperemesis gravidarum

Diclegis^®

(doxylamine/pyridoxine delayed release)^a

Tablet

Treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

Limitation of use: Diclegis has not been studied in women with hyperemesis gravidarum

ª- Generic equivalent available

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Guidelines

Pyridoxine (Vitamin B₆) is recommended as a first line pharmacologic treatment for pregnant women who have nausea and vomiting, either taken alone or with the antihistamine doxylamine. As a single agents, pyridoxine for pregnancy related nausea and vomiting is usually dosed as 10-25 mg orally 3 or 4 times a day, while doxylamine is doses as 12.5 mg also 3 or 4 times a day.An additional antihistamine (dimenhydrinate, diphenhydramine, prochlorperazine, or promethazine) may be added to the pyridoxine and doxylamine combination if symptoms are persistent.

Both pyridoxine and doxylamine are available over the counter.(3)

Safety

Bonjesta has the following contraindications:(1)

Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation
Monoamine oxidase (MAO) inhibitors

Diclegis has the following contrainidcations:(2)

Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation
Monoamine oxidase (MAO) inhibitors

REFERENCES

Number	Reference
1	Bonjesta prescribing information. Duchesnay, Inc. June 2018.
2	Diclegis prescribing information. Duchesnay, Inc. June 2018.
3	ACOG Practice Bulletin: Nausea and Vomiting of Pregnancy. Obstetrics and Gynecology, 131:1, January 2018. https://www.ncbi.nlm.nih.gov/pubmed/29266076.

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Agent Names	Strength	Targeted MSC	Available MSC	Effective Date

BONJESTA*doxylamine-pyridoxine tab er	20 MG	M ; N ; O ; Y	N
DICLEGISdoxylamine-pyridoxine tab delayed release ; DOXYLAMINEdoxylamine-pyridoxine tab delayed release	10 MG	M ; N ; O ; Y	O ; Y

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Agent GPI	Agent Names	Strength	QL Amount	Dose Form	Days Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist	Effective Date

50309902100430	BONJESTA*Doxylamine-Pyridoxine Tab ER 20-20 MG	20 MG	60.0	TABS	30	Days
50309902100620	DICLEGIS*Doxylamine-Pyridoxine Tab Delayed Release 10-10 MG	10 MG	120.0	TABS	30	Days

CLIENT SUMMARY – PRIOR AUTHORIZATION

Agent Names	Strength	Client Formulary
BONJESTA*doxylamine-pyridoxine tab er	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
DICLEGISdoxylamine-pyridoxine tab delayed release ; DOXYLAMINEdoxylamine-pyridoxine tab delayed release	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Agent Names	Strength	Client Formulary
BONJESTA*Doxylamine-Pyridoxine Tab ER 20-20 MG	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
DICLEGIS*Doxylamine-Pyridoxine Tab Delayed Release 10-10 MG	10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	Target Agent(s) will be approved when ALL of the following are met: ONE of the following: The requested agent is being used to treat pregnancy related nausea or vomiting (not including hyperemesis gravidarum) OR The patient has another FDA approved indication for the requested agent AND The prescriber has provided information that the use of the individual ingredients within the target combination agent as separate dosage forms is not clinically appropriate for the patient AND The patient does NOT have any FDA labeled contraindications to the requested agent AND Length of Approval: Up to due date of pregnancy NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Module

Clinical Criteria for Approval

Target Agent(s) will be approved when ALL of the following are met:

ONE of the following:
1. The requested agent is being used to treat pregnancy related nausea or vomiting (not including hyperemesis gravidarum) OR
2. The patient has another FDA approved indication for the requested agent AND
The prescriber has provided information that the use of the individual ingredients within the target combination agent as separate dosage forms is not clinically appropriate for the patient AND
The patient does NOT have any FDA labeled contraindications to the requested agent AND

Length of Approval: Up to due date of pregnancy

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
QL with PA	Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met: The requested quantity (dose) does NOT exceed the program quantity limit OR ALL of the following: The requested quantity (dose) is greater than the program quantity limit AND The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR ALL of the following: The requested quantity (dose) is greater than the program quantity limit AND The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND The prescriber has provided information in support of therapy with a higher dose for the requested indication Length of Approval: Up to due date of pregnancy

Module

Clinical Criteria for Approval

QL with PA

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

The requested quantity (dose) does NOT exceed the program quantity limit OR
ALL of the following:
1. The requested quantity (dose) is greater than the program quantity limit AND
2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
ALL of the following:
1. The requested quantity (dose) is greater than the program quantity limit AND
2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: Up to due date of pregnancy

This program applies to Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace formularies.

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

BCBSAL _ PS _ Bonjesta, Diclegis Prior Authorization with Quantity Limit _ProgSum_ 10/1/2022 _

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