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Part D Bill Would Protect Access to Psychotropics

Proposed legislation to amend Medicare Part D prescription drug coverage would remedy some of the obstacles to obtaining psychiatric medications identified by APA-supported research.

A bill introduced in the House last month and supported by APA would give Medicare beneficiaries enrolled in the Part D prescription drug program improved access to critical psychiatric medications.

The Medicare Part D Drug Class Protection Act (HR 3061), which also is endorsed by patient advocacy groups and mental health organizations, would protect access to six critical classes of medications within Part D, including three classes—antipsychotics, antidepressants, and anticonvulsants—commonly used to treat psychiatric disorders.

"By requiring near-universal coverage for important classes of psychiatric medications and other medications linked with higher-than-average patient costs, the Medicare Part D Drug Class Protection Act will promote patient balance and fairness within prescription drug plans and the overall viability of the Medicare Part D program," said APA President Carolyn Robinowitz, M.D.

The bill, introduced by Rep. Lloyd Doggett (D-Texas), would require Medicare prescription drug plan (PDP) formularies to offer "all or substantially all" drugs in six classes of medications used to treat HIV/AIDS, mental illness, cancer, epilepsy, autoimmune diseases such as Crohn's, and transplantation.

In addition, the bill would limit insurers' ability to restrict the availability of these medications.

The bill comes on the heels of findings announced by the American Psychiatric Institute for Research and Education (APIRE) that patients with psychiatric illness dually eligible for the Medicaid and Psychiatry (JAACAP) analyzing different aspects of the 36-month follow-up data.

At the time of the follow-up, the children were aged 10 to 13.

Another one of the four studies found an increase in delinquency and experimentation with drugs, tobacco, and alcohol among children with ADHD, compared with a normative comparison group. And another study found some slowing of developmental gains in height and weight among children treated with stimulants.

The latter issue has been a concern to some parents and physicians. Investigators in that study, "Effects of Stimulant Medication on Growth Rates Across 3 Years in the MTA Follow-Up," wrote that the finding "may provide enough evidence to consider revision of clinical practice parameters to acknowledge the possibility of stimulant-related slowing in the usual developmental gains in height as well as weight during the course of treatment prepubertal children with ADHD."

Disadvantage Disappeared

Children who received medication management had fewer symptoms than other groups at 14 and 24 months after randomization. However, the take-home message from the follow-up, which received prominent coverage in the lay press, was that the disadvantage disappeared at 36 months. All of the groups showed symptom improvement over baseline.

The original MTA studies included 579 children randomized to receive medication management, behavior therapy, a combination of medication management and behavior therapy, or usual care in the community. The study treatments lasted 14 months.

At three years, 485 of the original 579 subjects participated in the follow-up, then aged 10 to 13. In contrast to the significant advantage of the treatment over behavior therapy and community care for ADHD symptoms at 14 and 24 months, treatment groups did not differ significantly on any measure at 36 months.

The percentage of children taking medication less than 50 percent of the time changed between 14 and 36 months across the initial treatment groups: it significantly increased in the behavior therapy group (15 percent to 45 percent), significantly decreased in the combined treatment group (91 percent to 71 percent), and remained constant in the community care group (60 percent to 62 percent). Regardless of their treatment-use changes, all of the groups showed symptom improvement over baseline.

The investigators concluded that the disappearance of the medication advantage may be due to age-related decline in ADHD symptoms, changes in medication management intensity, starting or stopping medications altogether, or other factors not yet evaluated.

"This is a very interesting and useful collection of articles," said APA Trustee and child psychiatrist David Fassler, M.D. "The researchers provide the kind of longer-term follow-up in real-world settings that's often missing from standard clinical trials.

"The results are also consistent with general clinical experience," he said. "Ongoing treatment with medication can be extremely helpful for some children and adolescents with ADHD. However, treatment should be evaluated on a regular basis, and when medication is no longer needed, it should be discontinued.

"It's also not surprising that children in all treatment groups showed improvement over time with respect to the core symptoms of ADHD," Fassler said. "This would be consistent with the natural history of the disorder for many young people."

But Fassler also noted that a significant limitation was that the original MTA study did not include an untreated control group.

"Although the findings are interesting, they should be interpreted with caution in view of significant methodological issues and shortcomings," he said. "The initial design didn't include an untreated control group, which would be important to more fully assess the overall efficacy of treatment."

Substance Use, Delinquency Linked

The follow-up report in JAACAP titled "Delinquent Behavior and Emerging Substance Use in the MTA at 36 Months: Prevalence, Course, and Treatment Effects" compared the delinquency and substance use rates in 487 children from the MTA study and 272 children in a local normative comparison group.

The MTA children had significantly higher rates of delinquency (27.1 percent) than the normative control group (7.4 percent) at 36 months. They also had significantly higher rates of substance use (17.4 percent versus 7.8 percent), including drugs, tobacco, and alcohol. These findings appear to contradict previous studies indicating that treatment with stimulants is protective against substance abuse.

In an interview with Psychiatric News, lead author Brooke Molina, Ph.D., cautioned against overinterpreting the findings. She is an associate professor of psychiatry and psychology at the University of Pittsburgh School of Medicine.

For example, the children in the follow-up study were 10 to 13 years old, too young to have developed anything like a true addictive disorder. "We are talking about experimentation with alcohol, tobacco, and marijuana, not abuse, dependence, or addiction," Molina said.

She also emphasized that the controlled treatments in the MTA study lasted only 14 months.

"There have been findings in the literature that stimulant treatment protects kids, and we didn't find that," Molina said. "The relative advantage of stimulant medication didn't hold up two and three years after treatment with regard to substance abuse."

But Molina cautioned that the children's functioning could have been worse had they not received any treatment at all. "Because the study did not include a large group of untreated children with ADHD, we really don't know what their delinquency and substance use levels would have been if they'd received no treatment," she said.

One treatment modality, however, appeared to outperform the others with regard to substance use. The researchers found that at 24 months, the children who received behavior therapy had significantly less substance use than the other MTA children. (At 36 months, it was also less but fell short of statistical significance.)

"That's a nice finding because it means that there were probably some ingredients in our behavior therapy that were protective," Molina told Psychiatric News. Those ingredients include parent training and academic support, she said.

In general, Molina said the findings indicate that clinicians need to follow children with ADHD over time, and especially as they enter adolescence, regardless of the status of their treatment for the core symptoms of ADHD.

"Clinicians should support parents to stay involved through adolescence," she said. "Clinicians need to stick with the family and help them understand that ongoing parental involvement and monitoring are important."

Fassler emphasized also that study treatments lasted only 14 months.

"I would agree with the authors' conclusion that relatively brief treatment does not necessarily prevent serious problems from emerging as a child grows up," he said. "Clearly, this is an issue that warrants further research. As physicians, we ultimately need to try and identify the kids who may be at particular risk and develop appropriate and effective strategies designed to reduce the incidence of such serious, long-term consequences."

The JAACAP reports can be accessed at <www.jaacap.com> under the August issue.

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