FOLIC ACID SUPPLEMENTATION (Counseling and Preventive Medication)
Evidence Statement
References 
|
Updated 9/30/11
Evidence StatementClinical Preventive Service RecommendationsU.S. Preventive Services Task Force RecommendationThe U.S. Preventive Services Task Force (USPSTF) recommends that all women planning or capable of pregnancy take a daily supplement containing 0.4 to 0.8 mg (400 to 800 µg) of folic acid.1Evidence Rating: A (Strongly Recommended/Good Evidence) The USPTF found convincing evidence that folic acid supplementation in the periconceptional period reduces the risk for neural tube defects and that supplementation at usual doses is not associated with serious harms.1 Evidence-Based Recommendation:American Academy of Family Physicians (AAFP)The American Academy of Family Physicians (AAFP) recommends that clinicians prescribe 0.4-0.8 mg/day of folic acid supplementation from at least 1 month prior to conception through the first trimester of the pregnancy to women who have not had a previous pregnancy affected by a neural tube defect.2 Evidence Rating: SR (Strongly Recommends) Good quality evidence exists which demonstrates the substantial net benefit of folic acid supplementation over harm; the intervention is perceived to be cost-effective and acceptable to nearly all patients.2 American Academy of Family Physicians (AAFP) The American Academy of Family Physicians (AAFP) recommends that clinicians prescribe 0.4 mg folic acid supplementation to women not planning a pregnancy but of childbearing potential who have not had a previous pregnancy affected by a neural tube defect.2 Evidence Rating: R (Recommended) Although evidence exists which demonstrates the net benefit of folic acid supplementation, either the benefit is only moderate in magnitude or the evidence supporting a substantial benefit is only fair. The intervention is perceived to be cost-effective and acceptable to most patients.2 American Academy of Family Physicians (AAFP) The American Academy of Family Physicians (AAFP) recommends that clinicians prescribe 4 mg/day of folic acid supplementation from 1 to 3 months prior to conception through the first trimester of pregnancy to women who are planning a pregnancy and have had a previous pregnancy affected by a neural tube defect.2 Evidence Rating: SR (Strongly Recommended) Good quality evidence exists which demonstrates the substantial net benefit of folic acid supplementation over harm; the intervention is perceived to be cost-effective and acceptable to nearly all patients.2 Condition / Disease Specific InformationEpidemiology of Condition/DiseaseSpina bifida and anencephaly are severe, potentially fatal birth defects. Both are neural tube defects (NTD) resulting in failure of the neural tube to fuse correctly. Approximately 3,000 pregnancies are affected by NTDs, and approximately 2,200 infants are born with neural tube defects each year.5 Many NTD-affected pregnancies do not result in a live birth because they are electively or spontaneously aborted (commonly referred to as a miscarriage) or result in fetal death or stillbirth.5Anencephaly is always fatal and affected infants die shortly after birth.3 The majority of infants born with spina bifida grow into adulthood, but have severe medical complications such as paralysis and varying degrees of bowel and bladder incontinence.4 Folic acid, a B vitamin, prevents NTDs. Evidence (from populations not consuming foods fortified with folic acid) shows that consuming the recommended daily amount of synthetic folic acid (0.4 mg) through folic acid supplements can reduce a woman's chance of having a NTD-affected pregnancy by 40% to 80%.6 Synthetic folic acid can be consumed via folic acid supplements, folic acid-containing multivitamins, cereals that have been fortified with folic acid, and fortified grains. The natural form of this vitamin, folate, can be found in foods such as green leafy vegetables, orange juice, and beans. Synthetic folic acid vitamin supplementation is recommended because it is easier for the body to absorb than folate found in food and because up to 50% of naturally occurring folate is lost during cooking.7 Condition/Disease Risk FactorsDespite the known benefit of folic acid, only 33% of women of childbearing age report taking vitamins that contain folic acid and certain subpopulations have even lower rates of vitamin supplementation.8NTD rates are highest among the Hispanic population. Efforts to ensure supplementation among this population are important for eliminating health disparities.9 The Value of PreventionEconomic Burden of Condition/DiseaseThe economic burden of NTDs is substantial. The total lifetime cost for a child born with spina bifida is estimated to be $636,000 (in year 2002 dollars).10 Applying the prevalence rate for spina bifida from the National Birth Defect Prevention Network data11 to the 4 million live births each year, that amounts to $814 million in lifetime costs for each one-year cohort of births (all children born in one year).10 Costs associated with NTDs are shared by parents, employers, and communities.Workplace Burden of Condition/DiseaseApart from the excess medical costs for affected children, employers face productivity loss costs associated with employees' absences to care for children with spina bifida. A 2009 study reported that caregivers of children with spina bifida worked, on average, 9.2 hours less per week, resulting in an average lifetime productivity cost of $158,771 (in 2005 dollars).12Economic Benefit of Preventive InterventionThe economic benefit of folic acid supplementation is based on the cost savings that result from averted direct and indirect costs of each NTD that is prevented with supplementation.Estimated Cost of Preventive InterventionIn 2004, the private-sector cost of counseling to promote folic acid supplementation averaged $23 per session; approximately 95% of all paid claims fell within the range of $0 to $81 per session.14The cost of supplementation is highly variable, depending on the type of vitamin supplement that is taken and for how long. The cost of over-the-counter vitamins is relatively cheap and is an out-of-pocket cost for beneficiaries. Prescription strength folic acid (recommended for women who have had a previous pregnancy affected by a NTD) costs approximately $100 per year.15 Estimated Cost of TreatmentNot ProvidedCost-Effectiveness and/or Cost-Benefit Analysis of Preventive InterventionAt present there is no evidence on the incremental cost-effectiveness of folic acid supplementation. A study undertaken before the implementation of the folic acid fortification program, examined a public and provider education program as a possible strategy to increase folic acid consumption through consumption of vitamin supplements and estimated that, compared to no program, the cost-effectiveness of supplementation was approximately $5,000 per quality-adjusted life year (QALY).13Preventive Intervention InformationPreventive Intervention: Purpose of Counseling and Preventive MedicationEncouraging a woman to increase her folic acid intake prior to pregnancy via support, counseling, and/or prescription vitamins can lead to improved nutrition, thereby improving her chance of a healthy pregnancy and reducing her risk of an NTD-affected pregnancy.Benefits and Risks of InterventionA double-blind, placebo-controlled, randomized trial showed that folic acid supplementation before and during pregnancy decreased the risk of a first occurrence of a neural tube defect.16,17 The efficacy of such folic acid supplementation has since been confirmed by many other studies.The South Carolina NTD prevention program has reported great success in preventing the recurrence of isolated NTDs by providing counseling and vitamins to women who have had a previous NTD-affected pregnancy.18 Initiation, Cessation, and Interval of Counseling and Preventive MedicationFolic acid supplementation is believed to have minimal risks. Folic acid is considered nontoxic even at very high doses and is rapidly excreted in the urine.Folic acid supplementation information should be provided during routine healthcare visits and throughout the first trimester of pregnancy. Folic acid supplements should be prescribed/recommended, as medically indicated. Intervention Process, Counseling, and Preventive MedicationClinicians should 1) advise all women of child-bearing age who are capable of becoming pregnant about the importance of folic acid supplementation and 2) provide them with guidance on folic acid supplementation and, if needed, a prescription for folic acid supplements.Treatment InformationNot ApplicableStrength of EvidenceThe level of evidence supporting the recommendations contained in this section is described below.Evidence-Based Research: Summary Plan Description Language: Folic Acid (Counseling, Preventive Medication)Covered CounselingCounseling to promote the use of folic acid supplements (for the prevention of neural tube defects) is a covered benefit.Initiation, Cessation, and IntervalCounseling on folic acid supplementation is a covered benefit for all women considering pregnancy and all pregnant women through the first trimester of pregnancy.Summary Plan Description Language: Folic Acid Supplementation (Preventive Medication)Covered Preventive Medication
Initiation, Cessation, and IntervalFolic acid medications of any type are covered, when used to reduce the risk of having a pregnancy affected by a neural tube defect.CPT Codes
Other Information and ResourcesBusiness Group Resource(s)CDC ResourceAuthor(s)Campbell KP, Grosse S, Chattopadhyay S. Folic acid supplementation evidence-statement: counseling and preventive medication. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser's Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006. Updated 2011.References
| ||||||||||||||