Managed Care - December 2008 - (Page 41)

Nausea and Vomiting of Pregnancy Cost Effective Pharmacologic Treatments James P. Reichmann, MBA;1 Michael S. Kirkbride, BSc, Pharm D2 1,2 American HomePatient, Brentwood, Tenn. Nausea is the single most common medical condition in pregnancy, affecting 50% to 90% of women (Gadsby 1993). It is a common gastrointestinal complaint that is accompanied by vomiting in only 25% to 55% of all pregnancies (Broussard 1998). The most extreme form of nausea and vomiting of pregnancy (NVP) is present in approximately 0.3% of pregnancies and is commonly referred to as hyperemesis gravidarum (HG) (Berkovitch 2002). Hyperemesis gravidarum has a clear clinical definition that includes persistent vomiting leading to loss of more than 5% of original body weight and to associated electrolyte imbalance and ketonuria (Goodwin 1998). Although the terms are often used interchangeably, morning sickness and NVP should be differentiated by clinical examination. Classic morning sickness involves symptoms of nausea that may or may not be accompanied ABSTRACT Nausea and vomiting of pregnancy (NVP) can range from morning sickness to moderate NVP to hyperemesis gravidarum (HG). If it is left unmanaged, health plans may pay for expensive unproven outpatient therapies that are not necessary for treatment of simple morning sickness or moderate NVP. Meanwhile, patients with serious hyperemesis gravidarum whose treatment is delayed may suffer needlessly, ending up with multiple hospitalizations or emergency room (ER) visits. Two expensive, heavily marketed outpatient therapies with scant supportive evidence in the treatment of NVP have recently emerged and some health plans are providing coverage without a thorough review of the medical evidence or cost implications. Health plans may have an opportunity to save a significant amount and to improve member satisfaction by utilizing evidencebased knowledge of pharmacologic interventions that are driven, in order, by known safety, proven efficacy, and cost effectiveness. Disclosures The authors were both previously employed by Matria Healthcare Inc. They have not written this article on behalf of their present employer, American HomePatient. They report no conflicts. Author correspondence James Reichmann 1322 Garrick Way Marietta, GA 30068 E-mail: jim.reichmann@ahom.com by vomiting and, as the name implies, it occurs in the morning and improves during the day. NVP occurs throughout the day and frequently affects activities of daily living (O’Brien 1992). Both forms commonly present in the first trimester, becoming profound between 10 and 15 weeks and then subside at around 20 weeks. A rare disorder, hyperemesis gravidarum is characterized by severe and persistent nausea and vomiting that may necessitate hospitalization. This condition causes women to experience dehydration, vitamin and mineral deficiencies, and the loss of greater than 5% of pre-pregnancy weight (Goodwin 1998). Other possible causes of nausea and vomiting (peptic ulcers, hepatitis, pyelonephritis, pancreatitis, cholecystitis, appendicitis, gastroenteritis, and hyperthyroidism) should always be considered before administering any therapeutic agents. Affected women usually pro- gress from morning sickness to mild or moderate nausea and vomiting to HG, making it important for clinicians to move patients to treatments appropriate to their clinical presentation. As with mild to moderate NVP, symptoms of HG often resolve before 20 weeks gestation. However, cases have been reported where symptoms extend beyond that time period. Morning sickness, NVP, and hyperemesis gravidarum are all generally self-limiting problems, disappearing by the fourth month of pregnancy. Pharmacological therapies No drug has been approved by the Food and Drug Administration (FDA) for the treatment of morning sickness, NVP, or hyperemesis gravidarum since 1983, when Bendectin, the combination of doxylamine and pyridoxine, was removed from the market amid litigation alleging that women treated with the drug deliv- DECEMBER 2008 / MANAGED CARE 41

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Managed Care - December 2008 Editor's Memo Contents Legislation & Regulation News and Commentary Medication Management Compensation Monitor ICD-10 Offers Huge Opportunity, Challenge Part D at a Crossroads Plans Can Weather the Financial Crisis DM vs. Medical Home? Tackle Prediabetes Reasonable Approach to Morning Sickness Formulary Files Tomorrow's Medicine Outlook

Managed Care - December 2008

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