Less controversial are plans for more FDA-CMS collaboration in the area of post-market surveillance. Once a drug comes to
market, Gottlieb said, the two agencies will be involved in a number of efforts to evaluate safety and appropriate use; one
early initiative is to coordinate policies for establishing patient registries to answer outstanding questions not resolved
in clinical trials.
CMS is also working with its other sister agencies to gain more information on the effectiveness and value of medical treatments.
A collaboration with NCI aims to encourage post-approval cancer studies to provide more information about off-label uses for
A main source of data on the effectiveness of drugs and medical treatments is the Agency for Healthcare Research & Quality
(AHRQ), which is charged by Section 1013 of the MMA to support more comparative effectiveness studies on medicines widely
used by the elderly. In December 2005, AHRQ released its first comparative effectiveness review (CER) on proton pump inhibitors
(PPIs). It found PPIs may be as effective as surgery in treating GERD (gastroesophageal reflux disease), but noted little
difference in effectiveness among brand-name and generic drugs.
Additional CERs will assess how well drugs manage cancer-induced anemia and off-label use of certain antipsychotics, among
other topics related to 10 priority research areas: arthritis, cancer, diabetes, depression, dementia, heart disease, pulmonary
disease, pneumonia, stroke, and stomach ulcers. In January, AHRQ began the process of identifying another set of important
health conditions that warrant comparisons of treatment options. This second group will include conditions prevalent in Medicaid
populations and state children's health programs, as well as Medicare.
Where CER analysis finds knowledge gaps in the existing literature, AHRQ will call on a network of research centers to answer
the questions. Current studies are assessing the effectiveness and safety of drugs in treating arthritis, whether antidepressants
raise the risk of pneumonia in the elderly, and how well new glucose-control drugs manage diabetes.
FDA is working more closely with AHRQ to keep abreast of its growing portfolio of health outcomes research involving marketed
drugs. In January, FDA Office of Drug Safety Deputy Director Anne Trontell moved to AHRQ for a one-year assignment. Trontell
will provide FDA input on AHRQ drug safety and effectiveness research, including comparisons of drugs and other treatments.
Closer collaboration between CMS and FDA is likely to build tension between the contradictory missions of the two agencies:
FDA's task is to promote public access to safe and effective drugs and medical products, while CMS aims to ensure that it
pays appropriately for reasonable and necessary treatments. Just how much blurring arises between the two goals remains to
Managing Medications One way the government aims to control drug spending is by paying special attention to patients who are taking several therapies
concurrently. Medicare requires prescription drug plans (PDPs) to establish Medication Therapy Management Programs (MTMPs)
for seniors with multiple chronic diseases who spend more than $4,000 a year on medicines. The aim is to ensure appropriate
prescribing, boost compliance, and reduce adverse events for these patients.
Retail pharmacists back MTMP as a way to gain reimbursement from PDPs for counseling patients on appropriate medication use.
Pharma companies stand to benefit from improved patient compliance and fewer side effects. However, it's optional for patients
to sign up for MTMP services, and it's not clear how strongly PDPs will work to implement a program that adds to their costs
while offering uncertain benefits: MTMP may boost drug spending as a way to keep patients out of hospitals and doctors' offices,
but stand-alone drug plans have little to gain from this trade-off.
On the other hand, Medicare Advantage plans that cover both medical services and prescription drugs have greater incentives
to establish effective MTMPs and more experience with case management activities to do so. CMS is working on methods for measuring
total costs and savings from MTMPs, and pharma companies may find such efforts helpful in demonstrating the value of medicines
in improving healthcare. So far, CMS has provided little guidance on how drug plans should meet the MTMP requirement, but
has promised to do so in the coming year as drug plans become more established.
Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at email@example.com