AAFP Objects to United States Pharmacopeia's Classification of Certain Antidepressants

November 06, 2013 02:11 pm News Staff

The AAFP is asking the United States Pharmacopeia(www.usp.org) (USP) to rethink its proposed classification of certain antidepressants as part of the upcoming Medicare Model Guidelines Version 6(www.usp.org) (MMG v6).

According to the Medicare Prescription Drug Improvement and Modernization Act, the USP is charged with developing a list of medication categories and classes for use by prescription drug plans and revising such classification as needed "to reflect changes in therapeutic uses of covered Part D drugs and the additions of new covered Part D drugs."

In an Oct. 24 letter to USP Therapeutic Information and Formulary Support Expert Committee Chair N. Jo Braden, M.D., AAFP Board Chair Jeff Cain, M.D., of Denver, expressed specific concern regarding the USP's proposal that certain antidepressants be relegated to an "other" category, which, he said, could have unintended consequences.

The 'Other' Antidepressants

The following medications are examples of the antidepressants the United States Pharmacopeia's Therapeutic Information and Formulary Support Expert Committee is proposing be classified as belonging to an "other" category:

  • bupropion (Aplenzin, Wellbutrin);
  • maprotiline (Ludiomil);
  • mirtazapine (Remeron);
  • nefazodone (Serzone);
  • trazodone (Desyrel, Oleptro, Trialodine);
  • aripiprazole (Abilify) and
  • quetiapine (Seroquel).

"For example, health plans may then cover these 'other' antidepressants under cost-sharing arrangements that are less favorable than those currently applied to products in the more specific antidepressant categories," said Cain. "The AAFP advocates for a broad availability of antidepressant drugs for all patients who need them and, therefore, we encourage the United States Pharmacopeia to reconsider this proposal."

Cain asked committee members to be "mindful of the physician-patient relationship," and he called on them to protect patient access to "affordable and efficacious" medications and ensure physicians' ability to prescribe "is not unduly hindered by restrictive formularies."

"Patients are not homogenous and often respond differently to pharmaceuticals based on the mechanism of action and delivery intervals," Cain said in the letter. "This unique and complex response becomes more common in those patients who are prescribed multiple pharmaceuticals for their health conditions, which is a situation frequently seen in primary care practices.

"These patients and their physicians need the flexibility to align treatment plans with those pharmaceuticals that produce the most favorable outcomes for the specific patient and their health condition(s)."

Cain also noted that primary care physicians are responsible for a majority of depression diagnoses and prescribe more than half of all antidepressants in the United States, making the issue one of particular concern to the Academy and its members. Moreover, he pointed out that primary care patients being treated for chronic conditions are at an increased risk for depression.

"For this reason, we believe that physicians and patients must have broad options to find those antidepressant pharmaceutical treatments that are most effective on an individual basis," Cain said.

According to the USP timeline, the guidelines will undergo approval in mid-December before being presented to CMS in early January. The final USP MMG v6 will be posted on or around Feb. 1.


please wait Processing