Each new medication or advance in medical technology represents years of very expensive research. After safety and effectiveness have been demonstrated in the lab and in animals, a product or technique must be evaluated in a large group of human subjects before approval by the Food and Drug Administration. Clinical trials often take years to complete and may involve several medical centers and teams of investigators.
The Tufts Center for Drug Development estimated last year that each new prescription medication cost on average $2.6 billion and took more than 10 years to develop and gain approval. Costs had increased almost 150 percent over the preceding decade, the center said.
Even after a new drug or technology is approved, its affordability must be addressed. Health-care dollars are not limitless. Government policymakers and insurance companies must determine if coverage for a medical advance is worth the cost.
Since the late 1960s, effectiveness and affordability of therapy have been expressed in terms of "quality adjusted life years," or QALY, the term used inside the industry. The mathematics behind this computation are complex. Both quality and quantity of life are measured after a medical intervention for a suspected or confirmed diagnosis. A year of perfect health following a procedure is considered one QALY, while a year of bedridden life might be ranked as one-half QALY.
For decades, a cutoff of $50,000 per QALY has been used to assess the affordability of a test or treatment. Drugs or procedures costing more than that were unlikely to be approved for coverage by insurance companies or governmental programs. But this ceiling has been repeatedly challenged in recent years.
Screening of current or former smokers, who are at increased risk of lung cancer, illustrates the issue. Very early diagnosis is crucial if cures are to be achieved in persons with lung cancer.
Low-dose computed tomography employs X-rays to obtain three-dimensional images of the body. The radiation exposure of a low-dose tomography is 80 percent less than a conventional CT scan. When used in a spiral manner, low-dose scans of the chest can detect lung cancers that are missed on routine chest X-ray. They can detect a growth as small as a split pea, while a chest X-ray may only detect a growth the size of a cherry tomato. But low-dose tomography is many times more expensive than an X-ray.
Calculation of the QALY for low-dose screening includes the costs of subsequent diagnostic tests and treatment for any lung cancer or other abnormality that is detected. And, even with early detection, a lung cancer may have already spread. A low-dose tomography may also detect a non-malignant tumor for which additional tests and costs are incurred.
The critical questions for the new technology are:
* Will annual low-dose tomographys for current and former smokers save or lengthen lives?
* Is screening affordable?
Reports offered widely varying answers.
A study in The New England Journal of Medicine in November 2014 analyzed the cost-effectiveness of annual, low-dose spiral tomography, comparing this strategy with annual chest X-ray. The large, multi-center study evaluated more than 52,000 persons. They were randomly assigned to have either annual low-dose screening or a chest X-ray over a three-year period.
Compared to the x-ray group, low-dose scanning led to a 20 percent reduction in death due to lung cancer. For the low-dose group, the cost per year of life gained was $52,000. But The cost per QALY gained was $81,000, above the traditional threshold for affordability.
Based upon the results of this study, the U.S. Preventive Services Task Force gave a "B" recommendation for low-dose tomography screening for lung cancer. This rating means there is moderate certainty that the test leads to a desirable outcome. Private health insurers are required to cover the cost of screening for procedures with an "A" or "B" recommendation.
Contact Clif Cleaveland at cleaveland1000@comcast.net.