Imagine two versions of a
medication that are essentially identical but one costs 100 times as much as
the other. Using the more expensive variety enriches the drug company that
manufactures it and the doctors that administer it—with patients and the
American people paying the price. Yet that’s exactly what’s happening with two
drugs that are used to treat a form of macular degeneration and diabetic
macular edema, 2 common conditions that cause blindness, principally in older
people. And the reason this is happening is the steadfast refusal of Congress
to allow Medicare to consider cost in making reimbursement decisions.
The story came to light when
Medicare released data in April about how it spends its money. It turns out
that eye doctors are among the physicians who get more than a million dollars a
year from Medicare. The reason: they inject the drug Lucentis (ranibizumab)
into the eyes of their patients, an effective treatment for macular
degeneration or macular edema, and are paid the average price of the drug plus
6% overhead by Medicare. They could, however, inject a far cheaper version of
the drug, using the chemotherapy agent Avastin (bevacizumab) off-label. In
absolute dollars, Lucentis costs $2023 per dose and Avastin costs $55 per dose.
And a typical patient is treated up to 12 times per year, sometimes for years.
It turns out that that
National Institutes of Health (NIH) actually funded a study of over 1000
patients comparing treatments for the more common of the 2 eye conditions for
which the drug is used, neovascular macular degeneration. The study found no
difference in effectiveness between the 2 drug variants, Lucentis and Avastin.
Not enough patients were enrolled to determine if there are statistically
significant differences in safety. That is, it’s possible that one version of
the drug is safer—and since a compounding pharmacy has to convert the
chemotherapy drug Avastin into the drug used by eye doctors, this is a
theoretical possibility—but we don’t know for sure. Subsequent studies have
found minor differences in the safety profiles of Avastin and Lucentis, which
are both made by the same drug company.
Carefully performed modeling of what we can expect over
the next 10 years—making reasonable assumptions about how common the eye
conditions will be, how beneficial treatment is likely to be, the extent of
side effects—shows that if current practice patterns continue, in which 2/3 of
people are treated with the cheaper drug and 1/3 with the costlier drug, then
Medicare will spend $20 billion on these 2 treatments and patients will spend
$5 billion (on co-pays). If, however, everyone started using the cheaper drug,
then Medicare would spend only $2 billion and patients only $420 million. And
if everyone switched to the more expensive drug, Medicare would spend $57
billion and patients would spend $14 billion. So what should we do?
A recent opinion piece in JAMA suggests that Medicare, which
is currently prohibited from negotiating over drug prices, could get around
this problem by using a technical loophole. It can exercise flexibility in how
it figures out how much to pay for a product or service if the current payment
amounts are “inherently unreasonable because they are either grossly excessive
or deficient.” To date, this process has never been invoked in paying for
medications.
The article in Health Affairs
describing the predictive model suggests that Medicare could selectively
increase reimbursement to doctors who use the cheaper drug or that Congress
could modify the regulations for “biosimilars” (as the generic versions of
biologically complex drugs such as Lucentis are called). All these approaches
take as a given that for Medicare to spend 1/6 of its entire Medicare Part B budget
on one drug is absurd. Just how absurd becomes apparent if we look at the
cost-effectiveness of Lucentis: medical costs would go up $2 million/QALY
(quality-adjusted life year) if everyone took Lucentis instead of Avastin,
though most health economists consider $50,000-$100,000/QALY a reasonable
amount to pay.
What all this tells me is
that it’s time we stop pretending that cost-effectiveness analysis is unethical.
Spending $25 billion in 10 years when we could achieve the same end by spending
$2 billion is what’s unethical. Comparative effectiveness research, which is
supported by the Affordable Care Act and which forms the foundation of the new
independent research agency, the Patient Centered Outcomes Research Institute
(PCORI), is legally prohibited from considering cost. But if we don’t start
considering cost explicitly, we will pay dearly in the not so distant future.
No comments:
Post a Comment