Medicare Prescription Drug Benefit Realities

David K. Cundiff

Disclosures
In This Article

The Medicare Debate

Conservatives in Congress maintain that the country cannot afford a $400 billion Medicare prescription benefit at this time of record federal deficits. Liberals feel that the puny proposed drug benefit is a cruel joke on seniors. Both are right. Republicans in Congress and the President feel that Medicare costs are unsustainable without major restructuring. Democrats counter that the popular Medicare program should be improved, not relegated to competing HMOs. Again, both groups speak the truth.

A Commonwealth Fund report found that out-of-pocket costs for Medicare beneficiaries enrolled in health plans have doubled since 1999, to an average of $1964 in 2003. People in poor health pay $5305. These projections do not include cost sharing for mental health services, rehabilitation, and long-term care.[1] The proposed $400 billion added benefit is only 20% of the projected drug bill of more than $2 trillion for seniors from 2006 to 2015.[2,3] It will not begin to slow the rate of increase in Medicare recipients' out-of-pocket costs. This $2 trillion projection may be a gross underestimate, since a recent Rand Corporation study concluded that medical tests and treatments, including drug treatments, are underprescribed by almost 50%.[4]

It's time to take a step back and consider what portion of this projected $2 trillion+ on drugs will help seniors and serve the public health. The principles of evidence-based medicine[5] should be employed to distinguish between essential and nonessential medications for individual patients. For example, any civilized society should have 100% insurance coverage for opioids and other drugs to treat cancer pain. However, off-label or experimental use of cancer chemotherapy should be at the patient's or drug company's expense.

The evidence basis of cancer chemotherapy is much less well established than in other areas of medicine. Clinical end points that matter to patients -- survival and quality of life -- often get less attention than response rates that interest doctors, drug companies, and the US Food and Drug Administration (FDA).

To approve new drug applications for metastatic or locally advanced cancers that have no effective treatments, the FDA does not require evidence that the drug prolongs life or improves the quality of life. Dr. Robert Temple, FDA Director of Medical Policy, describes this guideline, "...our accelerated approval rule allows us to rely on a reasonable surrogate, a surrogate end point reasonably likely to predict clinical benefit. But it quite explicitly doesn't say that clinical benefit, for example, quality of life, has to be demonstrated."[6] Despite such easy access of chemotherapy drugs to FDA approval, about half of cancer chemotherapy administered in the United States is for off-label indications.[7]

A dark joke circulates around the hospital wards about the effectiveness of high-tech efforts to prolong life in the terminally ill. "The patient with advanced cancer asked the oncologist, 'Will this new chemotherapy make me live longer?' The doctor replies, 'No, but it will seem longer.'"

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