Testimony by Joyce Mauk, MD
House Public Health
Feb. 19, 2013
Chairman Raymond and members, thank you for the opportunity to speak to you today. My name is Joyce Mauk, and I am a developmental pediatrician in Fort Worth. I am here today on behalf of the 47,000 members of the Texas Medical Association, Texas Pediatric Society, and Texas Federation of Psychiatric Physicians to oppose House Bill 473 by Representative Turner.
House Bill 473 would prohibit a physician from prescribing antipsychotic or neuroleptic drugs to a Medicaid-enrolled child age 5 or younger unless the physician first obtained prior approval from the state or a Medicaid managed care organization. Further, the bill specifies that one criterion which must be considered when establishing prior approval is whether the drug had received approval from the Food and Drug Administration (FDA) for use in children. Though House Bill 473 may be well intentioned, there are likely to be significant negative consequences to the children we care for if this legislation is enacted.
Antipsychotic and neuroleptic medications often are used to treat schizophrenia, bipolar disorder, delusional disorder, and severe behavioral disorders. However, they also are used “off-label” to manage developmental an neurological disorders, including autism spectrum disorder, attention deficit-hyperactivity disorder (ADHD), seizures, and other conditions in children.
“Off-label” prescribing of drugs, meaning without FDA approval, is common in medicine. The majority of drugs prescribed to children have not been evaluated by the FDA for use in this population. In the results of a study required by the 81st Legislature, HHSC reported that, “off-label prescribing is the norm in all pediatric care. Historically, about 75 to 80 percent of drugs in the U.S. have had no FDA-approved marketing indications for children and adolescents. This is an artifact of the historical FDA drug approval process.” This is true not just for antipsychotic agents but all drug classes, including drugs commonly used for asthma, allergies, diabetes, heart conditions, or cancer.
As a pediatric provider, I rely on the use of “off-label” prescribing on a daily basis to provide the best medical care possible to the children I serve.
In addition to the barriers that restricting off-label use of medication in children would create, the prior authorization process may also pose major challenges.
Antipsychotic medications are an important tool for treating non-behavioral health conditions in children with severe disabilities. Physicians often rely on these agents to treat severe seizure disorders, which are dangerous and potentially life threatening without timely intervention. Requiring prior authorization may not only delay the initiation of treatment with these essential medications, but may also result in opting instead for the use of less effective medications which do not require prior approval – which is not only detrimental for patients in terms of health outcomes, but also will likely result in higher costs to our health care system.
We all have the best interest of our children in mind, which is why in 2011, HHSC put provisions in place that require prior approval for any antipsychotic prescription to a Medicaid child under age 3, and for the third antipsychotic medication prescribed concurrently to any Medicaid recipient under age 18. From the perspective of a medical provider who treats children with special health care needs on a daily basis, House Bill 473 will not improve current system. It will instead create unnecessary barriers to the proper use of these drugs in young children who are in great need – often in crisis – as well as divert utilization to less-desirable second line treatment agents. For these reasons, our organizations oppose this legislation.
Thank you for your time.
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