 |
 |
|
|
The Medicare drug benefit may be helping more older Americans with heart failure get the medications recommended for controlling the disease, a new study finds.
The study, of nearly 7,000 older heart failure patients in one large insurance plan, found that the number of filled prescriptions for standard heart failure medications increased after the Medicare drug benefit kicked in in 2006.
The biggest increase was seen among seniors who had previously lacked any form of drug coverage.
Since January 2006, Medicare beneficiaries have been able to purchase the “Part D” prescription-drug benefit subsidized by the program and available through private plans. Drugmakers strongly backed the 2003 law creating the drug program, and one of the criticisms of the landmark policy shift was that the pharmaceutical industry would be the biggest winner.
A 2007 report by IMS Health, a firm that provides sales data to the drug industry, found that the Medicare drug benefit boosted sales of pricey brand-name cholesterol-lowering statins and ulcer drugs by 5 percent to 7 percent, for example.
However, there has also been evidence that the goal of the program — helping seniors, especially those with low incomes, afford needed medications — is being met.
For example, a 2009 study by the research organization RAND found that by 2008, Medicare drug coverage had trimmed seniors’ annual out-of-pocket drug costs by 16 percent, on average, while increasing the number of prescriptions by 7 percent.
The new findings, reported in the American Heart Journal, are the first to show that the program may be helping more beneficiaries with heart failure get the medications that are routinely recommended to help lower their risk of hospitalization and extend their lives.
Heart failure is a chronic condition in which the heart can no longer pump efficiently enough to meet the body’s needs, leading to symptoms like fatigue, breathlessness on exertion and fluid buildup. Guidelines state that people with heart failure should take drugs called beta-blockers in combination with either an ACE inhibitor or similar medications known as angiotensin II receptor blockers (ARBs).
For the current study, researchers led by Dr. Julie M. Donohue of the University of Pittsburgh looked at records for 6,950 heart failure patients age 65 and older who were enrolled in a Pennsylvania Medicare managed care program between 2003 and 2007.
In the year before the Medicare drug benefit kicked in, 534 plan members had no drug coverage, while just over 4,600 had coverage with quarterly caps of $150 or $350. The remaining 1,800 had drug coverage through an employer or union, with no cap on benefits.
After January 2006, the study found, the number of filled prescriptions for heart failure drugs increased among beneficiaries who had previously lacked drug coverage or had limited coverage.
Among those who had lacked coverage, the average number of filled prescriptions per year rose from 13 to roughly 19, according to Donohue’s team.
In line with that, the percentage who filled at least one prescription for a beta-blocker increased from 45 percent in the two years prior to Medicare Part D, to 59 percent in 2006 and 2007. For a beta-blocker plus an ACE inhibitor or ARB, the corresponding figure rose from 21 percent to 32 percent.
Plan members who had previously had drug coverage with quarterly caps showed smaller increases. The percentage filling a prescription for a beta-blocker, for instance, rose from between 55 and 58 percent to about 63 percent.
“These findings,” Donohue and her colleagues write, “are consistent with a major goal of the (Medicare Part D) policy, which was to reduce financial barriers to medication access among the elderly.”
However, Medicare drug coverage did not erase the gaps in prescription drug use seen between seniors who had previously lacked coverage and those who’d had generous benefits through an employer or union.
Before and after Medicare Part D kicked in, about 45 percent of the latter group had filled prescriptions for both a beta-blocker and an ACE inhibitor or ARB. And while that rate rose among seniors who had previously lacked coverage, it stood at 32 percent after Medicare drug coverage came into effect.
Still, Donohue’s team writes, that increase in prescription use could potentially translate into fewer heart-failure hospitalizations — and lower costs — as well as longer lives.
Future research, they say, should investigate whether that is the case.
SOURCE: http://link.reuters.com/pam58m American Heart Journal, July 2010.
Mail this post
The fate of a GlaxoSmithKline Plc diabetes drug may become clearer on Wednesday when U.S. advisers vote on whether the widely used pill carries too much heart risk to stay on the market.
The high-stakes decision by a panel of outside experts is designed to help the Food and Drug Administration settle a three-year safety dispute over Avandia.
Views on Avandia’s risks are mixed within the FDA. Opinions also could be split within the 33-member panel of scientific experts after hearing hours of sharply conflicting data on Tuesday on whether Avandia causes heart attacks.
Avandia’s U.S. sales were just 1.5 percent of Glaxo’s 2009 revenues, but investors fear the company could face more lawsuits if the drug is pulled from the market.
On Tuesday, Glaxo agreed to pay $460 million to settle thousands of lawsuits over Avandia, Bloomberg reported, citing people familiar with the settlements.
Glaxo will settle about 10,000 suits for an average of $46,000 each, Bloomberg said. A Glaxo spokeswoman declined to comment. Plaintiffs’ lawyers reached by Reuters also could not confirm a settlement.
The advisory panel is due to vote Wednesday afternoon on recommendations ranging from keeping the drug on the market with no warnings, to urging a withdrawal. Restrictions on use or beefing up warnings are among other choices.
Because the FDA asked panelists to select only one of the five options, there may be no clear majority.
The agency will make the final call in the coming months but usually follows the advice of its panels.
The debate on Avandia’s safety has raged since warnings were placed on the drug in 2007 saying some research linked the drug to a higher heart attack risk but the data is “inconclusive.”
DIVIDED FDA
FDA staff are deeply divided over the safety of Avandia, also known as rosiglitazone, and the agency has thrown the issue to the expert panel to untangle.
Dr. David Graham, an FDA reviewer who has pushed for Avandia’s withdrawal for years, said the agency applies different standards when deciding whether to approve a drug versus determining risk after a medicine is on the market.
Graham told the panel on Tuesday the Record study relied on by Glaxo to show no increased heart attack risk from Avandia compared to older diabetes drugs would not pass muster for an approval. “You wouldn’t even hear about it because it’s garbage,” he said.
Dr. Ellis Unger, a deputy director of drug evaluation, said he found Record’s results “pretty reassuring” on heart safety.
But he added it was up to the expert panel to decide if Record was legitimate.
“Can we trust the sponsor (Glaxo) with the results of Record? I think that is something the committee is going to need to think about,” Unger said.
Panelists asked some questions of Tuesday’s presenters but gave little hint on how they were leaning.
On Wednesday morning, ahead of the voting, the panel will hear from a statistical expert and an opinion on TIDE, a trial comparing Avandia to Takeda Pharmaceutical Co’s rival diabetes pill, Actos, which some FDA staff see as safer.
GLAXO DEFENDS
Glaxo officials defended Avandia before the advisers on Tuesday saying diabetes was a serious disease that needed multiple treatment options to control blood sugar and prevent devastating complications including amputations and blindness.
“When used appropriately, (Avandia) has a positive benefit/risk profile and should remain a treatment for type 2 diabetes,” said Dr. Murray Stewart, a Glaxo vice president for drug research and development.
For the FDA, the Avandia case is seen as a test of how the agency will handle major controversies under Democratic President Barack Obama. Officials are facing heavy pressure from consumer groups and some lawmakers who say the FDA fumbled decisions in past administrations and failed to protect the public.
(Reporting by Lisa Richwine; Editing by Tim Dobbyn)
Mail this post