AHRQ Comparative Effectiveness Reviews Will Expand Beyond Medicare

The Agency for Healthcare Research & Quality is preparing to expand the scope of its comparative effectiveness reviews beyond the Medicare population.

AHRQ plans to review comparative effectiveness of treatments for conditions found in younger people, such as Medicaid and State Children's Health Insurance Program (SCHIP) beneficiaries.

The agency received suggestions on proposed topics relevant to the broader populations during a Jan. 11 open forum on the program, mandated by Section 1013 of the Medicare Modernization Act.

AHRQ Director Carolyn Clancy said, "for those folks who have spoken up quite passionately and articulately about Medicaid and SCHIP, I just wanted to clarify one point - you're quite right that the first round of priorities was focused on the Medicare population. This was the decision of then-Secretary of Health & Human Services Tommy Thompson. We are quite explicitly looking to broaden that mandate here, so your comments will be heard."

Participants recommended a number of priority areas for comparative effectiveness reviews, many of them mental health-related, that are relevant to the younger Medicaid/SCHIP population: depression, bipolar disorder, schizophrenia, attention deficit hyperactivity disorder, autism, asthma, obesity, methamphetamine dependency and AIDS. One proposed to examine infertility treatment in light of the many children it spawns who have special healthcare needs.

Judith Kramer, the principal investigator with Duke University's AHRQ-funded Center for Education & Research on Therapeutics (CERT), said the seven CERT PIs agree AHRQ should examine: the safety and efficacy of off-label use of drugs and devices; methodological issues with comparative studies that involve observational data sets or randomized trials with non-inferiority hypotheses; priorities for head-to-head comparisons; and group randomized trials.

In addition, they should study drug-drug interactions, especially with the heavily medicated Medicare population, and with older generics and alternative medications; how to prevent over- and under-prescribing; and how to improve the utility of laboratory monitoring of drug therapy.

Stakeholders recommended other studies as well. Lawrence Brown, assistant professor at the University of Tennessee's Health Science Center in Memphis, called for studies comparing models of medication therapy management.

Pharmaceutical Research & Manufacturers of America Senior Director for Policy Randy Burkholder urged AHRQ to focus on "organization, delivery and management of healthcare items and services" rather than just "research on specific medical products."

Many commenters wanted more cost-effectiveness information, CMS Acting Chief Medical Officer Barry Straube noted. "We have started talking about [this] internally at CMS."

"Clearly there were a whole bunch of specific areas, disease-specific mostly, ADHD, behavioral health issues, very important I think on behavioral health the emphasis we heard today, asthma, certainly obesity was the one that was very highly commented upon, AIDS, diabetes, and many, many other conditions, including...dental health," Straube said.

AHRQ is soliciting proposals for a topic or priority condition for research at ¹ effectivehealthcare.ahrq.gov. The deadline is March 15.

Comments are due Jan. 31 for five comparative effectiveness studies AHRQ proposed: drug therapies for inflammatory arthritis; drugs for Alzheimer's disease; combinations of lipid-lowering agents; coronary artery stents vs. coronary artery bypass graft surgery; and long-term benefits and harms of angiotensin-converting enzyme inhibitors vs. angiotensin II receptor antagonists for hypertension.

The topics stem from the 10 "priority conditions" common in the Medicare population AHRQ identified in 2004 (² (Also see "AHRQ Drug Effectiveness Comparisons Will Focus On 10 “Priority Conditions”" - Pink Sheet, 20 Dec, 2004.), p. 11).

In its first study, released in December 2005, AHRQ found little difference in performance of various brand and generic proton pump inhibitors and surgery for managing gastroesophageal reflux disease (³ (Also see "PPIs Get AHRQ Stamp Of Approval Vs. Surgery; Generics Could Be Big Winners" - Pink Sheet, 19 Dec, 2005.), p. 17).

More study reports are expected soon. "In the coming months, we're going to be releasing a series of reports on comparative effectiveness reviews on high-priority topics," Clancy said. Two are expected shortly: "Effectiveness of Epoeitin and Darbepoetin for Managing Anemia For Patients Undergoing Cancer Treatment" and "Evidence for Off-Label Use of Atypical Anti-Psychotic Medications."

Commenters complained the agency didn't vet the initial set of 10 topics publicly and that it did not allow enough time for comment on the first draft study.

"AHRQ should through an open public process develop clear objective criteria for selecting research priority topics and when it proposes research topics, it can then provide rationale based on those criteria," PhRMA's Burkholder said. He called for "a consistent approach to soliciting comment on draft reports when they are released," with all such reports "released as draft with opportunity for public comment."

"We will," Clancy said. "Every step of this process will be transparent, from establishing priorities to the opportunity to comment on questions to the opportunity to comment on draft reviews."

National Alliance on Mental Illness Legislative Affairs Director Andrew Sperling cautioned against letting payers turn effectiveness research into treatment guidelines that restrict physicians' discretion.

"Unfortunately, we're increasingly seeing comparative effectiveness research being labeled as 'evidence-based practice,' and then being used at payers, specifically state Medicaid programs as justification for restrictive policies such as prior authorization, step therapy and in many cases outright removal of therapeutic options from preferred drug lists," Sperling said.

One example of study misuse cited by Sperling is the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE), published in September (⁴ (Also see "CATIE Suggests Zyprexa Useful As Initial Schizophrenia Treatment – NEJM" - Pink Sheet, 26 Sep, 2005.), p. 4). "We see payers already using just the first stage of this, we believe, in an inappropriate way to restrict access to the newer more effective medications that treat schizophrenia."

"We strongly support what AHRQ is doing and we support Section 1013," Sperling said, "but we just want to make sure that comparative effectiveness trials are not essentially unjustifiably used as the basis for restrictive policies both in Medicare and in SCHIP and Medicaid."