Commercial

Medical Policy

Notification

Parenterally Administered Terbutaline Sulfate for the Prevention or Treatment of Pre-Term Labor

Notification Issue Date:

The policy has been reviewed and reissued to communicate the Company’s continuing position on parenterally administered terbutaline sulfate for the prevention or treatment of pre-term labor.

Title:

Parenterally Administered Terbutaline Sulfate for the Prevention or Treatment of Pre-Term Labor

Policy #:

07.10.04c

Policy

MEDICALLY NECESSARY

Terbutaline sulfate administered by injection or continuous infusion for prevention or treatment of preterm labor (<37 weeks) in the hospital inpatient or outpatient setting is considered medically necessary and, therefore, covered, when the use of terbutaline sulfate does not exceed 72 hours.

NOT MEDICALLY NECESSARY

In the following situations, terbutaline sulfate administered by injection or continuous infusion for prevention or treatment of preterm labor (<37 weeks) is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use in the treatment of illness or injury:

In the hospital inpatient setting that exceeds 72 hours
In the outpatient setting that exceeds 72 hours
In the home setting

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

BLACK BOX WARNING

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, parenterally administered terbutaline in the inpatient or outpatient hospital setting for prevention or treatment of preterm labor up to 72 hours is eligible for payment under the medical benefits of the Company's products when the medical necessity criteria listed in this medical policy are met.

Subject to the terms and conditions of the applicable benefit contract, parenterally administered terbutaline in the home setting for prevention or treatment of preterm labor is not eligible for payment under the medical benefits of the Company's products because the service is considered not medically necessary and, therefore, not covered.

US FOOD AND DRUG ADMINISTRATION (FDA)

In 1998, the FDA addressed physicians and other health professionals about concerns regarding the subcutaneous administration of terbutaline sulfate via infusion pump for off-label use as a treatment for and prevention of preterm labor. Terbutaline sulfate is approved only for the treatment of asthma, and the approved labeling for terbutaline sulfate injections states that the drug should not be used for the management of preterm labor. Data establishing the safety and efficacy of the use of terbutaline sulfate as a tocolytic agent have not been submitted to the FDA.

On February 17, 2011, an FDA Drug Safety Communication was sent to healthcare professionals indicating that "injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death." In addition, the FDA Drug Safety Communication indicates that "oral terbutaline should not be used for prevention or treatment of preterm labor because it has not been shown to be effective and has similar safety concerns." Boxed Warnings and Contraindications noted in the labeling are now being required by the FDA. These label changes are consistent with statements from the American College of Obstetricians and Gynecologists.

PEDIATRIC USE

The safety and effectiveness of terbutaline sulfate have not been established in individuals below the age of 12 years.

Description

Preterm labor is defined as the presence of contractions that are strong and frequent enough to cause progressive effacement and dilation of the cervix before 37 weeks gestation. Preterm birth accounts for 70 percent of neonatal morbidity and mortality. The effectiveness of nonpharmacologic treatments of preterm labor, such as bed rest and hydration, is unclear. In general, indications for tocolysis with agents such as terbutaline include continuous, regular uterine contractions related to cervical changes in a preterm mother. Tocolytic agents may prolong gestation for two to seven days, providing time to administer steroids in an attempt to produce fetal lung maturity and to transport the individual to a facility that has a neonatal intensive care unit (NICU). Ritodrine was previously approved by the US Food and Drug Administration (FDA) for use as a tocolytic agent, but it was voluntarily withdrawn from the US market in 1998; thus, other agents in use today for tocolysis, such as magnesium sulfate, terbutaline, calcium channel blockers, or indomethacin are used off-label and have not been approved by the FDA for use in preterm labor.

On February 17, 2011, an FDA Drug Safety Communication that was sent to healthcare professionals indicated that "injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment of preterm labor beyond 48-72 hours in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death." Additionally, "oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns."

References

American College of Obstetricians and Gynecologists (ACOG); Practice bulletin 159: Management of preterm labor. Obstet Gynecol. 2016;127(1):e29-e38 (replaced by Practice Bulletin 171).

American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin 171: Management of preterm labor. Obstet Gynecol. 2016;128(4):e155-e164.

American Hospital Formulary Service (AHFS). Terbutaline sulfate injection. AHFS Drug Information 2023. [LexiComp Web site]. 12/12/2023. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed February 28, 2024.

Chawanpaiboon S, Laopaiboon M, Lumbiganon P, et al. Terbutaline pump maintenance therapy after threatened preterm labour for reducing adverse neonatal outcomes. Cochrane Database of Syst Rev. 2014;(3):CD010800.

Elsevier's Clinical Pharmacology Compendium. Terbutaline sulfate injection. [Clinical Key Web site]. 01/16/2024. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed February 28, 2024.

Haas DM, Benjamin T, Sawyer R, Quinney SK. Short-term tocolytics for preterm delivery - current perspectives. Int J Womens Health. 2014;6:343-349.

Haas DM, Imperiale TF, Kirkpatrick PR, et al. Tocolytic therapy: a meta-analysis and decision analysis. Obstet Gynecol. 2009;113(3):585-594.

How HY, Hughes SA, Vogel RL, et al. Oral terbutaline in the outpatient management of preterm labor. Am J Obstet Gynecol. 1995;173(5):1518-1522.

Jones JS, Morrison J, Istwan N, et al. The interval to spontaneous delivery following discontinuation of maintenance tocolysis. J Matern Fetal Neonatal Med. 2006;19(6):331-335.

King JF, Grant A, Keirse MJ, Chalmers I. Beta-mimetics in preterm labour: an overview of the randomized controlled trials. Br J Obstet Gynaecol. 1988;95(3):211-222.

Lewis R, Mercer BM, Salama M, et al. Oral terbutaline after parenteral tocolysis: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol.1996;175(4 Pt 1):834-837.

Lexi-Drugs Compendium. Terbutaline sulfate injection. [LexiComp Web site]. 02/24/2024. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed February 28, 2024.

Mackeen AD, Seibel-Seamon J, Muhammad J, et al. Tocolytics for preterm premature rupture of membranes. Cochrane Database Syst Rev. 2014;(2):CD007062.

Merative Micromedex^® DRUGDEX^® (electronic version). Terbutaline sulfate injection. [Micromedex Web site]. Merative L.P., Ann Arbor, Michigan, USA. 12/26/2023. Available at: https://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed February 28, 2024.

National Institute for Health and Clinical Excellence (NICE). Preterm labour and birth [NG25]. [NICE Web site]. November 20, 2015. (Updated: 08/02/2019, 06/10/2022). Available at: https://www.nice.org.uk/guidance/ng25. Accessed February 28, 2024.

National Institutes of Health, U.S. National Library of Medicine. Label: Terbutaline sulfate tablet. Updated 11/12/2020. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fbf54709-5857-4dbc-9233-ebd7abff88c8#LINK_7adfa280-e102-4fb9-a45d-78635aaf2608. Accessed February 28, 2024.

National Women's Health Network. Why do doctors still use terbutaline to delay preterm labor despite its major health risks? 04/26/2018. Available at: https://www.nwhn.org/doctors-still-use-terbutaline-delay-preterm-labor-despite-major-health-risks/. Accessed on February 28, 2024.

Neilson JP, West HM, Dowswell T. Betamimetics for inhibiting preterm labour. Cochrane Database Syst Rev. 2014;(2):CD004352.

Parilla BV, Dooley SL, Minogue JP, Socol ML. The efficacy of oral terbutaline after intravenous tocolysis. Am J Obstet Gynecol. 1993;169(4):965-969.

Rodier P, Miller RK, Brent RL. Does treatment of premature labor with terbutaline increase the risk of autism spectrum disorders? Am J Obstet Gynecol. 2011;204(2):91-94.

Ross MG. Preterm labor. [Medscape Web site]. 05/04/2021. Available at: https://emedicine.medscape.com/article/260998-overview. Accessed February 28, 2024.

Sanchez-Ramos L, Kaunitz AM, Gaudier FL, Delke I. Efficacy of maintenance therapy after acute tocolysis: a meta-analysis. Am J Obstet Gynecol. 1999;181(2):484-490.

Terbutaline sulfate injection, USP (Prescribing Information). Berkeley Heights, NJ: Hikma Pharmaceuticals USA Inc: 02/2021. Available at: https://www.drugs.com/pro/terbutaline.html. Accessed February 28, 2024.

Terbutaline sulfate injection, USP (Prescribing Information). Lake Zurich, IL: Fresenius Kabi: 04/2022. Available at: http://editor.fresenius-kabi.us/PIs/US-PH-Terbutaline_Sulfate_Inj_FK_451001E_April_2022-PI.pdf. Accessed February 28, 2024.

Theplib A, Phupong V. Success rate of terbutaline in inhibiting preterm labor for 48 h. J Matern Fetal Neonatal Med. 2016;29(5):841-844.

Thornton JG. Maintenance tocolysis. BJOG. 2005;112 Suppl 1:118-121.

US Food and Drug Administration (FDA). FDA Drug Safety Communication: New warnings against use of terbutaline to treat preterm labor. [FDA Web site]. 02/24/2011. Available at: https://web.archive.org/web/20150918082954/http://www.fda.gov/Drugs/DrugSafety/ucm243539.htm. Accessed February 28, 2024.

US Food and Drug Administration (FDA). Drug Safety and Availability. [FDA Web Site]. 08/04/2017. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-new-warnings-against-use-terbutaline-treat-preterm-labor. Accessed February 28, 2024.

Vogel JP, Nardin JM, Dowswell T, et al. Combination of tocolytic agents for inhibiting preterm labour. Cochrane Database Syst Rev. 2014;(7):CD006169.

Yamasmit W, Chaithongwongwatthana S, Tolosa JE, et al. Prophylactic oral betamimetics for reducing preterm birth in women with a twin pregnancy. Cochrane Database Syst Rev. 2015;(12):CD004733.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

O60.00 Preterm labor without delivery, unspecified trimester

O60.02 Preterm labor without delivery, second trimester

O60.03 Preterm labor without delivery, third trimester

HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

THE FOLLOWING CODE IS USED TO REPRESENT PARENTERAL TOCOLYTIC THERAPY WITH TERBUTALINE FOR THE TREATMENT OF PRETERM LABOR IN THE FACILITY SETTING:

J3105 Injection, terbutaline sulfate, up to 1 mg

NOT MEDICALLY NECESSARY

THE FOLLOWING CODE IS USED TO REPRESENT TOCOLYTIC THERAPY FOR THE TREATMENT OF PRETERM LABOR IN THE HOME SETTING:

S9349 Home infusion therapy, tocolytic infusion therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 07.10.04c:

03/20/2024	The policy has been reviewed and reissued to communicate the Company’s continuing position on parenterally administered terbutaline sulfate for the prevention or treatment of pre-term labor.
06/28/2023	The policy has been reviewed and reissued to communicate the Company’s continuing position on parenterally administered terbutaline sulfate for the prevention or treatment of pre-term labor.
06/15/2022	The policy has been reviewed and reissued to communicate the Company’s continuing position on parenterally administered terbutaline sulfate for the prevention or treatment of pre-term labor.
03/24/2021	This policy has been reissued in accordance with the Company’s annual review process.
02/26/2020	The policy has been reviewed and reissued to communicate the Company’s continuing position on parenterally administered terbutaline sulfate for the prevention or treatment of pre-term labor.
02/15/2018	This policy has undergone a routine review, and no revisions have been made.

Version Effective Date:

2/22/2017

Version Issued Date:

2/22/2017

Version Reissued Date:

3/20/2024