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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 

10/1/2023              

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

* Generic equivalent available

2

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 contraindications:(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 2022.

2

Diclegis prescribing information. Duchesnay, Inc. October 2022.

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

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:

  1. 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
  2. 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
  3. 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

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

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. 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
  3. 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 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 Prior Authorization with Quantity Limit _ProgSum_ 10/1/2023