When trying new cancer treatments, Italy’s state-run health service
is demanding a money-back guarantee. The experiment is being monitored
in the U.S. and across Europe, making a country better known for its
fashion and fettuccine a leader in innovative strategies to rein in drug
spending.
The Italian Medicines Agency has devised deals with
pharma companies that set payment based on how well a patient responds
to treatment, and in some cases where the medication fails to help, the
drugmaker gives a full refund. Italy is signing more such contracts as
growing numbers of medications receive regulatory approval after
mid-stage trials of fewer than 100 patients rather than awaiting
final-stage assessments involving thousands.
A single cancer drug can also be assigned multiple contracts that
differ by tumor type, especially when the risk of failure is higher for a
certain type of cancer. So a company might have to agree to a
money-back guarantee if the drug treats ovarian cancer, while it may
simply offer a discount in the case of breast cancer.
As a result,
Italy secured about 200 million euros ($220 million) in refunded
payments for ineffective treatments in 2015, Russo said, or about 1
percent of total pharmaceutical spending.
Italy
has become a model for other countries and manufacturers negotiating
drug prices based on how well they work. In the U.S., Express Scripts
Holding Co., the largest prescription drug benefits manager, has been
studying the Italian experiment and will roll out a program next year
that sets varying prices for drugs used to treat multiple types of
cancer. And Roche Holding AG is trying to determine whether the Italian
model could work in France.
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