Rx benefit rich source of data

BOSTON, Dec. 29 (UPI) -- Next week Medicare's prescription-drug benefit -- with an estimated 21 million enrollees so far -- goes into effect amid controversy and confusion, but health-policy experts say the new benefit will not only save seniors thousands of healthcare dollars, it is also likely to become a major source of information on how well drugs are working in patients.

"An unintended effect of the Medicare Part D benefit could be the creation of the world's most valuable resource for understanding how drugs are used, especially by the elderly and the chronically ill, and their risks and benefits," said Richard Platt, professor and chair of the department of ambulatory care and preventive medicine at Harvard Medical School and Harvard Pilgrim Health Care in Boston.

Platt and other experts weighed in on Part D's possible benefits, pitfalls and potential in a series of articles in this week's New England Journal of Medicine.

Platt told United Press International that the database that could be created from the new Medicare program would allow "an open and transparent way to determine safety issues with very little loss of privacy."

He said the resource would be created by linking information on drug dispensing to patients' other health information.

"Medicare data are available for more than 40 million people," Platt said. "These data can transform our ability to assess drugs under real-life conditions, particularly in this vulnerable population, which is often underrepresented in clinical trials.

"However, in order to realize this benefit, we must make it a priority, justify it to the public, and provide adequate funding.

"To understand the opportunity before us, it helps to understand how little we know now. The Food and Drug Administration often approves a drug for long-term use on the basis of minimal long-term safety data: as few as 100 people may have been followed for adverse effects in studies lasting at least one year."

The FDA cannot usually compel post-marketing studies of drugs, and reliance on adverse reports can be spotty, Platt pointed out.

"Medicare data will offer a great opportunity to improve our ability to understand the balance of benefits and risks of drug treatment. If we take advantage of this opportunity, we will know much more about whether drugs are used as intended, whether they have their intended effects, and how risky they are," he said.

The experts also offered input on the drug benefit's more widely publicized windfall: the enormous potential for saving money.

"It is important for doctors to advise patients that there is the potential for major savings with these plans," said Arnold Epstein, chair of the Department of Health Policy and Management at the Harvard School of Public Health in Boston.

"The more drugs they take, the more savings are possible. They could save an enormous amount of money," Epstein, an associate editor of NEJM, pointed out.

However, the path to those savings could be difficult. Even Mark McClellan, head of the Centers for Medicare and Medicaid Services, admitted that the detail in the plan will take some scrutiny by doctors and patients.

"Taking advantage of the new prescription drug benefit will require some effort," he wrote in the Journal article, "but the effort will pay off for Medicare beneficiaries and their physicians.

"Improved access to prescription drugs will support physicians' efforts to work with patients to prevent disease and its complications, and patients with limited means will no longer have to choose between their medications and other basic necessities."

Nevertheless, Richard Kravitz, professor of internal medicine at the University of California, Davis, noted that polls taken as late as October 2005 found that the majority of older Americans did not understand the plan nor planned to sign up for the benefits.

Epstein said that would probably be a mistake, even for people who at age 65 are relatively healthy and aren't taking any drugs. He said those same people who are healthy at 65 or 68 may need considerable medication at age 73 or 75, and there are penalties for not signing up when first eligible.

"However, there is no reason for a rush to judgment," he said. "They can take their time to evaluate opportunities for choosing the best plan."

"There is no time to waste," Kravitz said in his article in the Journal, "but plenty of time to gather information and review options." People eligible on Jan. 1, 2006, have until May 15, 2006, to join a plan without penalty.

Patients who may lose out from the new program are those who are dually eligible under Medicare and Medicaid programs, said Rachel Elliott, clinical senior lecturer at the University of Manchester, United Kingdom.

These patients are often poorer and sicker than others and have a higher rate of mental illness -- nearly one-third of that group. If they don't sign up on their own, they will be assigned automatically to a plan.

That, argued Epstein, could cause problems because it might include changes in medication and the possibility that patients won't take new medications or will suffer side effects that will lead to non-compliance with their medical regimen. That, in turn, could lead to exacerbation of their illnesses, he said.

CMS's McClellan said that doctors and patients can find information on the Internet to help them made decision on the prescription-drug benefit at these sites:

Materials for the doctors' offices: www.medicare.gov, www.eldercare.gov

Financial help for patients: www.ssa.gov/prescriptionhelp

Making a plan decision: www.benefitscheckup.org