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Only Generic Prozac and Paxil Will Be Approved Med

Posted by Phillipa on May 1, 2009, at 20:53:39

For those who are medicaire or medicaid. I don't think this article will make you happy me included. Phillipa


From Medscape Medical News
Prior-Authorization Policy Causes Few Problems for Depressed Patients
Janis Kelly





May 1, 2009 In contrast to antipsychotics, prior authorization (PA) for "nonpreferred" antidepressants does not appear to have a negative impact on the health of permanently disabled individuals, new research suggests.

A study conducted by investigators at Harvard Medical School, in Boston, Massachusetts, evaluated the impact of a controversial prior-authorization policy by Michigan Medicaid on antidepressant use and health outcomes among dual Medicaid and Medicare enrollees with a designation of permanent disability.

The study is published April 27 in Archives of Internal Medicine.

Led by Alyce S. Adams, PhD, the investigators found the Michigan policy decreased the proportion of patients starting treatment with "nonpreferred" antidepressants from 53% to 20% and caused a small but significant decrease in therapy initiation overall (9 per 10,000 population).

In addition, the study showed the policy increased switching among established users but did not cause increased disruptions in treatment or adverse events such as hospitalization or emergency-department use.

The "nonpreferred" drugs include the selective serotonin-reuptake inhibitors (SSRIs) citalopram hydrobromide (Celexa, Forest Pharmaceuticals), fluvoxamine maleate (Luvox, Solvay Pharmaceuticals), branded fluoxetine hydrochloride (Prozac and Sarafem, Eli Lilly), and sertraline hydrochloride (Zoloft, Pfizer) and the serotonin-norepinephrine-reuptake inhibitor (SNRI) venlafaxine hydrochloride (Effexor XR, Wyeth). "Preferred" drugs included generic fluoxetine and paroxetine hydrochloride (Paxil and Paxil CR, Wyeth).

"Changes in drug benefits or coverage are often confusing for all stakeholders when they are first implemented. Therefore, clinicians can anticipate that patients may need additional assistance in filling prescriptions during the implementation period of a new policy," Dr. Adams told Medscape Psychiatry.

It is also important to note that clinicians, including nurses, physicians, pharmacists, and patient advocates, also have key anecdotal evidence of the impact of such policies. By sharing these stories with policy makers, they can help inform the adaptation and adjustment of policies as needed in the short term, as appears to have happened in the state of Michigan, where the requirement for prior authorization for antidepressants was subsequently dropped, she added.

Dr. Adams pointed out that the results in this study of antidepressant use were quite different from those she found in a similar prior study examining the effect of prior authorization for atypical antipsychotic drugs. "For those populations, we did observe statistically significant increases in disruptions in therapy (primarily gaps in refills) associated with the policy change," she said.

"We did anticipate that we might see some disruptions in therapy for new patients due to idiosyncratic differences in patient response to SSRI and SNRI therapy. However, the fact that we did not see any impact does not necessarily mean that all SSRI and SNRI therapies are equivalent. All we can say is that we did not find any adverse consequences for patients newly treated on antidepressants," Dr. Adams said.

Not the Last Word

Two other experts in pharmaceutical outcomes and policy found the Adams study well-designed, convincing, and generally reassuring but warned that the data do identify a subgroup that may be at increased risk those prescribed antidepressants who did not begin treatment.

"The results basically show that a PA policy does not lead to a significant disruption of treatment for patients on [antidepressant] therapy when the PA policy was put into place, but does significantly impact the initial drug choice for newly treated patients. Shifting to preferred drugs in new patients did not appear to adversely affect the patient outcomes achieved," Jeffrey S. McCombs, PhD, from the University of Southern California's School of Pharmacy, in Los Angeles, who has also studied the effects of prior-authorization restrictions on the use of antidepressants, told Medscape Psychiatry.

However, Dr. McCombs pointed to a potential risk that some new patients prescribed a nonpreferred antidepressant will be denied and never fill a prescription for an alternative.

"Clinicians should be concerned about their patients not receiving some form of antidepressant drug therapy. This can be mitigated by using a preferred drug or working with the patient and pharmacy when a nonpreferred drug is thought to be best for the patients for a legitimate clinical reason. Most PA systems allow these prescriptions to be filled once the required documentation is received," said Dr. McCombs.

Joel Farley, PhD, from the University of North Carolina's Eshelman School of Pharmacy, in Chapel Hill, who recently analyzed the effect of Medicaid step-therapy prior-authorization policy for atypical antipsychotic medications, said that 1 potential criticism of the study pertains to the logic used to define a switch.

"The authors point out that switching was defined as the initiation of a second antidepressant within 6 months of the first. However, this could relate to both a switch from 1 drug to another and the addition of another drug to the first.

"These 2 distinct behaviors do not necessarily constitute the same risk to a patient from a PA process. A switch may be considered a potential unintended consequence from a PA, but augmentation would more closely resemble an appropriate modification to therapy by a physician in the face of a nonresponsive patient," said Dr. Farley.

 

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