Medicare to Directly Cover Use Of a Genentech Stroke Drug
Wall Street Journal, 8-4-05
When a company creates a useful drug to treat a devastating disease it may have only won half the battle. Take, for instance, the stroke drug tPA (tissue plasminogen activator), which experts agree is widely underutilized.
Stroke is a devastating condition that occurs when a blockage (usually a blood clot) obstructs a blood vessel leading to the brain (called an ischemic stroke) or, alternately, when a blood vessel in the brain bursts (hemorrhagic stroke). Both types of stroke can rapidly lead to death or crippling disability, although the overwhelming majority of strokes (about 80%) are ischemic. tPA, if given within three hours of stroke onset, can dissolve blood clots in ischemic stroke patients and help to save brain function. Unfortunately, tPA is only rarely used—in part because Medicare has not, until recently, reimbursed hospitals to cover the full cost of using the drug.
In what promises to create a major change in the treatment of acute stroke patients in the U.S., the federal Medicare agency will for the first time begin specifically paying hospitals for the use of [tPA]. The fact that Medicare hasn't previously paid specifically for the use of the drug, called tPA from Genentech Inc., has proven to be an impediment to its use, stroke experts say. …
Joseph Broderick, a stroke expert and chief of neurology at the University of Cincinnati, termed the decision "as important as any development since tPA was demonstrated as the first effective treatment for ischemic stroke in 1995." The drug has been available in the U.S. since 1996.
The decision to specifically reimburse for tPA use illustrates one of the continuing struggles in government health care programs. More often than not, bureaucrats issue one-size-fits-all rules that don’t adapt to medical advances, or don’t take account of the overall value of pharmaceuticals. Medicare is certainly making strides in this respect, and should be applauded, but much more needs to be done to ensure better cost-benefit analysis throughout government health care programs.
Drug ad controls pledged / Major firms plan to follow new volunteer rules
The San Francisco Chronicle, 8-3-05
Direct to consumer advertising (DTC)—TV ads that promote drugs directly to consumers—have come under fierce criticism for their role in promoting drugs with rare side effects (like Vioxx) and, supposedly, driving up consumer drug prices. Pharmaceutical companies have responded to these charges by publishing a new set of voluntary “Guiding Principles” for DTC that will take affect in January:
The nation's top drugmakers voluntarily pledged Tuesday to improve and restrict advertising designed directly for consumers, a practice that has drawn heightened scrutiny in the aftermath of recent drug safety controversies, such as the link between the pain - killer Vioxx and heart attacks.
Johnson & Johnson, Bristol Myers Squibb, Merck, Pfizer and 19 other firms agreed to comply with policies designed to eliminate exaggerated drug claims, warn people about risks, give drug regulators a better chance to reject TV spots before they air and ban adult topics like Viagra ads from family viewing hours.
The full list of guidelines can be found here. The guidelines suggest that pharmaceutical companies now recognize that they are the inevitable targets of consumer backlash—and Congressional ire—when rare risks debated in medical journals migrate onto the front-page of the New York Times. The only solution to this problem is to make consumers better educated participants in their own treatment. In short, savvy, fully informed patients are the industry’s best customers.
OUR OPINIONS: Not buying this 'remedy' Not enough that the pharmaceutical industry plans to reduce consumer ads. FDA controls are needed, too
The Atlanta Journal–Constitution, 8-5-05
Our second article on DTC this week comes courtesy of the Atlanta Journal-Constitution
, which takes a dim view of the industry’s new voluntary guidelines because, it says, advertising increases the cost of new medicines and “provide little or no health benefit” to consumers:
Direct-to-consumer ads inflate the price of drugs --- already the fastest rising component of health-care costs --- and they provide little or no health benefit. Drug manufacturers claim the ads educate consumers about diseases and treatment options, but critics contend the ads are primarily used to grow new markets for the drugs among patients who don't necessarily need them. They point to the explosion of consumer interest stimulated by advertising for anti-arthritis drugs such as Vioxx and Celebrex, which were found last year to increase the risk of heart problems in some patients. Many of the patients taking the two drugs would have done just as well with over-the-counter pain relievers, but they were convinced by advertisers that they had to use the prescription remedies instead.
We think that the Journal-Constitution lays far too much blame on companies for America’s staggering health care costs. As a recent article in Forbes noted, prescription-drug spending only represents a fraction of total U.S. health care costs—about 11%. Drug spending is rising, but primarily because more people are being treated for conditions—like asthma—that experts generally consider undertreated. Policymakers who are really concerned about wasteful consumer health care spending should help promote HSAs or other kinds of high-deductible insurance, which put consumers in control of their own spending, and makes them less likely to spend money on treatments they don’t really need—whether those are prescription drugs or MRIs.
Health Monopoly Makes Canada Odd Nation Out
Nadeem Esmail, The Fraser Institute, 8-4-05
Canada’s universal health care system, Medicare, is facing a crisis: too many people wait too long, and sometimes die, before they get the care they need. Still, a recent Canadian Supreme Court decision legalizing the sale of private health insurance in Quebec province has led to a fierce national debate over the supposed inequities of mixing public and private insurance. Esmail, however, points out that many advanced nations that offer universal health coverage rely on market options like private health insurance and privately financed providers to make their systems work more efficiently. For instance,
Germany and Switzerland, two nations who deliver access to care without delays and that have for many years relied on competitive private provision of publicly funded services, are now encouraging patients to choose among competing insurers for their publicly guaranteed care. …
There is no single solution to all of Canada’s woes. However, in the interests of all of Canada’s patients we should look at what others are doing and adopt those policies that work best. This will mean incorporating more competition in the public insurance scheme here in Canada and implementing a cost sharing scheme for publicly funded services. It will also mean allowing patients to seek care on their own terms with their own hard earned resources when they desire to do so, as all of these nations and every other developed nation with a universal access health care program has done.
Medicare: Yesterday and Tomorrow
Joseph R. Antos, Ph.D., American Enterprise Institute, 8-2-05
Antos notes that America’s one-size-fits-all Medicare program ended in 2003 with the Medicare Modernization Act, which, “[for the first time provided] greater assistance with health costs to the less fortunate, rather than uniform subsidies for all regardless of need,” along with “a system of bids to foster cost saving competition among plans and ensure that federal payments reflect actual market conditions.” Still, Antos says,
Greater reforms are necessary if Medicare is to meet the demands of the baby boomers, who are poised to double the program’s enrollment over the next few decades. We can no longer afford to give Medicare beneficiaries the illusion that health care is a virtually free good. Instead, beneficiaries should be offered health plan choices reflecting the realistic costs of providing care. All health plans in Medicare, including the traditional program, should compete on an equal footing for enrollees. Subsidies should be structured to ensure that those with the greatest needs (in terms of both income and health status) get the greatest help.
Pricing should be as transparent and free of government controls as possible. Consumers (and their doctors) can hardly be expected to purchase wisely if they do not know the price. Similarly, if the price structure reflects political calculation rather than the combined judgments of millions of consumers and providers, policy-induced shortages and other market distortions will develop, and health care resources will be wasted.
Medicine for Medicaid
Tom Nerney, Regina E. Herzlinger, Wall Street Journal, 8-2-05
Herzlinger (a Senior Fellow at the Manhattan Institute) and Nerney note that the best proposals for reforming Medicaid are being generated not from the federal government, but at the state level, where governors are embracing a wide range of market-based reforms. Herzlinger and Nerney then pinpoint the underlying principles behind these reforms:
Three characteristics are central to such programs: (1) liberating enrollees to manage their own health care purchases; (2) freeing providers to design innovative care programs, tailored for the unique needs of the recipients; and (3) enabling intelligent choice with new information and support.
For example, South Carolina Gov. Mark Sanford's plan would liberate recipients with a budget sufficient to meet their particular health care needs, a catastrophic health insurance policy, and free preventive care. Enrollees could roll over unexpected annual funds. [Gov. Sanford] would enable intelligent choice by transforming the Medicaid agency from a health care purchaser and micro-manager to an educator and facilitator. [Florida Gov.] Jeb Bush's consumer-driven Medicaid program frees supply by encouraging innovations such as provider-sponsored, community-based health service systems. …
Study confirms treatment switch is beneficial for women with early breast cancer
Medical News Today, 8-5-05
A new study reported in the Lancet
last week found that the drug anastrozole showed a clear advantage over the standard breast cancer treatment tamoxifen when it was used after 2 years of tamoxifen therapy:
For more than 20 years tamoxifen has been the standard treatment after surgery for postmenopausal women with hormone-responsive early breast cancer. However, research has shown that an aromatase inhibitor called anastrozole is effective and tolerable in this group of patients compared with tamoxifen when used as a first-line treatment. Studies have also suggested that taking anastrozole after two years of tamoxifen could be beneficial.
Raimund Jakesz (Vienna Medical Universit, Vienna, Austria) and colleagues from the Austrian Breast and Colorectal Cancer Study Group and the German Adjuvant Breast Cancer Group combined data from two multicentre, randomised trials looking at the effect of taking anastrozole after tamoxifen. In both trials postmenopausal women who had received two years of tamoxifen treatment were randomised to receive anastrozole (1618 women) or tamoxifen (1606 women) for a further three years. The investigators found that after two years of follow-up there was a 40% decrease in the risk of an event for women in the anastrozole group when compared with women on tamoxifen (67 events with anastrozole vs 110 with tamoxifen). The researchers defined an event as a local or distant recurrence, or cancer arising in the other breast. More patients had bone fractures on anastrozole but there were fewer cases of blood clots than in the tamoxifen group.
Professor Jakesz concludes: "Although further investigation is necessary to ascertain the ideal sequence and duration of adjuvant endocrine therapy, this combined analysis confirms that post-menopausal women who receive tamoxifen as adjuvant therapy should be switched to anastrozole after 2 years of treatment."
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