Regulatory Focus™ > News Articles > US Consumers Press For Experimental Drug Coverage

US Consumers Press For Experimental Drug Coverage

Posted 24 January 2012 | By Alexander Gaffney, RAC 

A recent study published by the Harvard School of Public Health indicates that US consumers are largely in favor of government and private insurance plans covering treatment regimens determined to be experimental.

62% of study participants indicated that they "oppose decisions by the government or health insurance plans" to deny enrollees reimbursement for experimental or cost-ineffective treatments.

Many government programs and private insurers will not provide reimbursement for a product until it has received marketing approval from the US Food and Drug Administration (FDA). This typically occurs when a product can demonstrate that it is both safe and effective for an indication. FDA does not take cost in to consideration, and instead leaves that determination up to insurers.

In an interview with Reuters, Dr. Nancy Berlinger of the Hastings Center noted the subjectivity of a drug being "worth the cost".

"If an expensive drug can extend a sick person's life for six months, that may not sound like a worthwhile expenditure. But individuals might say, 'This could allow me to see my daughter get married,' or, 'That could get my child to the end of the school year with me here,'" said Berlinger.

The competing question, says Berlinger, is "Ought we to pay for drugs when we don't have [a] preponderance of evidence that they're helpful?"

Further, some drugs might impart a benefit, but at an enormous cost that outweighs the benefits to that patient and other patients in the insurance pool.



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