ASCO--Researchers at Virginia Commonwealth University's Massey
Cancer Center have launched what is believed to be the first willingness-to-pay
study done in a real-life setting. Thomas J. Smith, MD, reported
on potential problems created by the innovative study design at
a scientific session of the ASCO annual meeting in Philadelphia.
All patients in the study, designed by Dr. Smith and attorney
Karen Swisher, must be insured by the co-sponsor Trigon Blue Cross/Blue
Shield and must have a terminal cancer with "absolutely no
option of curative therapy," Dr. Smith said.
Patients will be randomized to either stay with their fee-for-service
insurance or to cash in their insurance policy for a lump sum
"indemnity" payment of approximately $18,000.
Patients randomized to the lump sum payment can do whatever they
want with the money, "save it, buy a boat, give it to their
grandchildren," Dr. Smith said, but if they want palliative
chemotherapy or radiotherapy, then it must be paid for from the
lump sum. This is analogous to the proposed "medical IRAs"
in which patients would purchase care out of their own funds,
As an ethical protection, all patients will receive hospice care.
Furthermore, if the lump sum is spent on treatment that is producing
positive results, the patient may continue on standard insurance
to avoid the risk of depleting the indemnity fund. Patients can
also convert back to standard insurance by repaying the indemnity,
"but they would have to sell the boat or otherwise raise
the money," Dr. Smith said.
An additional randomization is to standard or advanced patient
education, to see if such information better informs their decision
making. The primary endpoints are quality of life, patient satisfaction,
and cost of care.
The researchers plan to enroll 120 patients over the next 3 years,
and the study team is now working with primary care physicians
and pulmonary physicians to enhance accrual.