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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
10-01-2024

FDA LABELED 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)* Tablet	Treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.	* generic 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)*

Tablet

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

* generic 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 and Diclegis have the following contraindications:(1,2)

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 USA, Inc. October 2022.
2	Diclegis prescribing information. Duchesnay USA, Inc. June 2023.
3	ACOG Practice Bulletin No. 189: Nausea and Vomiting of Pregnancy. Obstetrics & Gynecology. 2018;131(1):e15-e30. doi:10.1097/aog.0000000000002456

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)	Target Generic Agent(s)	Strength	Targeted MSC	Available MSC	Final Age Limit	Preferred Status

Diclegis	doxylamine-pyridoxine tab delayed release	10-10 MG	M ; N ; O ; Y	O ; Y
Bonjesta	doxylamine-pyridoxine tab er	20-20 MG	M ; N ; O ; Y	N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist

Bonjesta	Doxylamine-Pyridoxine Tab ER 20-20 MG	20-20 MG	60	Tablets	30	DAYS
Diclegis	Doxylamine-Pyridoxine Tab Delayed Release 10-10 MG	10-10 MG	120	Tablets	30	DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Bonjesta	doxylamine-pyridoxine tab er	20-20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Diclegis	doxylamine-pyridoxine tab delayed release	10-10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Bonjesta	Doxylamine-Pyridoxine Tab ER 20-20 MG	20-20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Diclegis	Doxylamine-Pyridoxine Tab Delayed Release 10-10 MG	10-10 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 labeled indication for the requested agent and route of administration AND There is support 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 labeled indication for the requested agent and route of administration AND
There is support 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 The requested quantity (dose) exceeds the program quantity limit AND ONE of the following: BOTH of the following: The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication OR BOTH of the following: The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR BOTH of the following: The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND There is support for 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
The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
1. BOTH of the following:
  1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication OR
2. BOTH of the following:
  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
  2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
3. BOTH of the following:
  1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication

Length of Approval: Up to due date of pregnancy

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.

Commercial _ PS _ Bonjesta_Diclegis_PAQL _ProgSum_ 10-01-2024