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Doxylamine Succinate and Pyridoxine Hydrochloride (Diclegis®, Bonjesta®) Duration Limit

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Doxylamine Succinate and Pyridoxine Hydrochloride (Diclegis®, Bonjesta®) Duration Limit Cigna National Formulary Coverage Policy Drug Quantity Management – Per Days Doxylamine succinate and pyridoxine hydrochloride (Diclegis®, Bonjesta®) Duration Limit Table of Contents Product Identifer(s) National Formulary Medical Necessity ................ 1 60889 Conditions Not Covered....................................... 2 Background .......................................................... 2 References .......................................................... 2 Revision History ................................................... 2 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. National Formulary Medical Necessity Criteria Cigna covers quantities as medically necessary when the following criteria are met: Diclegis (10 mg doxylamine/10 mg Maximum quantity per 365 days = 720 tablets (120 tablets per 30 days) pyridoxine) immediate release tablets, generics A quantity of 720 Diclegis tablets per 365 days (six fills of 120 tablets/30 days) will be covered without prior authorization. This is enough drug for individuals to complete six months of therapy. For coverage of additional quantities (for example, 9 months of therapy), a coverage review is required. The objective of this program is to prevent stockpiling, misuse and/or overuse while providing a sufficient quantity for indications. Page 1 of 3 Cigna National Formulary Coverage Policy: DQM Per Days Doxylamine succinate and pyridoxine hydrochloride 1. Exceptions can be made for individuals with continued nausea and vomiting of pregnancy beyond six months. An additional three fills of 120 tablets/30 days can be approved to allow for a total treatment duration of nine months. Bonjesta (20 mg doxylamine/20 mg Maximum quantity per 365 days = 360 tablets (60 tablets per 30 days) pyridoxine) extended release tablets A quantity of 360 Bonjesta tablets per 365 days (six fills of 60 tablets/30 days) will be covered without prior authorization. This is enough drug for individuals to complete six months of therapy. For coverage of additional quantities (for example, 9 months of therapy), a coverage review is required. The objective of this program is to prevent stockpiling, misuse and/or overuse while providing a sufficient quantity for indications. 1. Exceptions can be made for individuals with continued nausea and vomiting of pregnancy beyond six months. An additional three fills of 60 tablets/30 days can be approved to allow for a total treatment duration of nine months. Conditions Not Covered Any other exception is considered not medically necessary. Background Overview Diclegis and Bonjesta are fixed dose combination drug products of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a Vitamin B6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. The initial recommended dose of Diclegis is two tablets orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking two tablets daily at bedtime. However, if symptoms persist into the afternoon of Day 2, take the usual dose of two tablets at bedtime that night then take three tablets starting on Day 3 (one tablet in the morning and two tablets at bedtime). If these three tablets adequately control symptoms on Day 4, continue taking three tablets daily. Otherwise take four tablets starting on Day 4 (one tablet in the morning, one tablet mid-afternoon and two tablets at bedtime). The maximum recommended dose is four tablets (one in the morning, one in the mid-afternoon and two at bedtime) daily. The initial dose of Bonjesta is one tablet orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking one tablet daily at bedtime only. However, if symptoms persist on Day 2, increase the daily dose to one tablet in the morning and one tablet at bedtime. The maximum recommended dose is two tablets per day, one in the morning and one at bedtime. Diclegis and Bonjesta should be taken on an empty stomach with a glass of water. Swallow tablets whole. Do not crush, chew, or split Diclegis or Bonjesta tablets. References 1. Diclegis® [prescribing information] Bryn Mawr, PA: Duchesnay USA, Inc.; June 2018. 2. Bonjesta® [prescribing information] Bryn Mawr, PA: Duchesnay USA, Inc.; June 2018. Revision History Type of Summary of Changes Approval Date Revision Annual Reviewed by Clinical Specialists. No change to criteria. 03/26/2020 Revision Page 2 of 3 Cigna National Formulary Coverage Policy: DQM Per Days Doxylamine succinate and pyridoxine hydrochloride “Cigna Companies” refers to operating subsidiaries of Cigna Corporation. All products and services are provided exclusively by or through such operating subsidiaries, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Cigna Behavioral Health, Inc., Cigna Health Management, Inc., QualCare, Inc., and HMO or service company subsidiaries of Cigna Health Corporation. The Cigna name, logo, and other Cigna marks are owned by Cigna Intellectual Property, Inc. © 2021 Cigna. Page 3 of 3 Cigna National Formulary Coverage Policy: DQM Per Days Doxylamine succinate and pyridoxine hydrochloride .
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