After last week’s foray into patents and
pharmaceutical policy, which is perhaps the most technical and specialized area
of pharmaceutical policy, I will return to the never-ending story of pharmaceutical
prices and the controversy over Sovaldi, Gilead's break-through Hepatitis C
drug. Sovaldi has a "sticker
price" of $84,000 for a 12-week course of treatment, at the end of which
90% or more of patients would be expected to be cured. Since Sovaldi is a pill
that is given once a day, the 12-weeks of treatment means that there are 84
daily doses. The math is easy, even if the price, unlike the pill, is hard to
swallow--$1,000 per pill. The drug has been a huge financial success for
Gilead, which reported
$2.274 billion in sales in just the first quarter of 2014. However, the backlash has been equally
huge. In a rare display of
bipartisanship in Washington, Senator Ron Wyden (D.-Ore), the Chair of the
Senate Finance Committee and Senator Chuck Grassley (R.-Iowa), the Ranking
Member of the Finance Committee, sent a demand
for information concerning the development costs of Sovaldi and Gilead’s
pricing decision. However, even more
than the investigation by two senior senators, the impetus for today’s post
came from the blog RxObserver, which featured a post
entitled Sovaldi: A Poster Child for Predatory Pricing [sic]. Before discussing the epithet “predatory
pricing,” the perspective of RxObserver requires a bit of explanation. RxObserver is a site that primarily provides
the views of pharmaceutical benefit managers (PBMs), or as the blog itself
states its purpose: “the Clearinghouse of the Future for Pharmacy Benefits.” It
is, in general, a very high-quality blog, with an editorial staff composed
primarily of well-recognized academic and government experts in health care
policy. I regularly read it and find it
useful, although I was taken aback by that “predatory” epithet. Download PDF
Why would I take issue with referring to Gilead’s pricing
of Sovaldi as “predatory”? Because
Gilead’s business strategy is not any more worthy of condemnation than any
other pharmaceutical company. As I
previously posted,
pharmaceutical companies are like virtually all sellers in a basically free market—they
set their prices at what the market will bear.
Alexion’s price for Soliris, a drug for the very rare disease paroxysmal
nocturnal hemoglobinuria, was $409,000
per year back in 2010. Shire’s price
for its drug, Elaprase, for the even more rare Hunter syndrome, was $375,000 in
2010. Are the people whose lives depend
on Alexion’s or Shire’s drugs less victimized by predation? After one $84,000 course of Sovaldi (perhaps
a second course for some patients), the patient is cured and the insurance
company is off the hook for further Hepatitis C-related expenses. But patients who take Soliris or Elaprase
will be paying (actually their insurers will be paying) those far higher prices
for life, year after year after year. So
while the much higher prices of those drugs also engendered significant
backlash and controversy there is one significant difference—the patient populations
were much smaller. Why did smaller
patient populations make the controversies over those much higher prices, not
to mention their recurring nature, recede into the background so much more
quickly?
The reason that Sovaldi’s price has generated more
controversy than even much more expensive drugs is because the patient
population is so large that Sovaldi could have a significant impact on the
entire national health care system. RxObserver’s
post relies for its data on an article
in Health Affairs (a very
well-respected health policy publication) that estimates the overall impact of
Sovaldi on Medicare costs under Medicare
Part D. Tricia Neuman, Jack Hoadley and Juliette Cubanski, the authors of the Health Affairs article
estimate that the cost of Sovaldi alone could cause a 3% to 8% or even greater
increase in the overall cost of Medicare Part D depending, of course, on the
number of patients treated. Moreover, while Medicare Part D costs are insured in the private
sector by Medicare
Prescription Drug Plans or Medicare Advantage Plans, Medicare patients
would still shoulder a significant financial burden of $7,000 or more each
because of the copayments and caps of Medicare Part D plans.
So is it “predatory” to
charge more people a high price than to charge fewer people a much higher
price? I don’t think so. Rather, Gilead’s pricing of Sovaldi put a
spotlight on pharmaceutical pricing that is undoubtedly brighter and harsher
than Gilead anticipated and engendered a healthy debate about pharmaceutical
prices. Neuman, Hoadley, and Cubanski
suggest that a result of this controversy might well be to give Medicare the
power to negotiate prices, a power which the VA used to get a deeply discounted
price of $44,000 for Sovaldi. I could
devote an entire post to the question of whether Medicare should have the power
to negotiate prices, but the short answer is it is complicated and it is also unlikely
that it will happen. It is complicated
because even though Medicare cannot negotiate prices, the insurers providing
Part D coverage can. Through their PBMs the insurers actually have significant
market power to wield in those negotiations.
It is unlikely because Congress is unlikely to come to any agreement on
such a proposal in the near term and because the pharmaceutical industry is
still the biggest kid on the block called “K Street.” What is more likely is that Gilead will make
price concessions in confidential negotiations with major insurers; insurers
will limit coverage to those patients clearly in greatest need of treatment,
and the system will muddle through. In pharmaceutical policy terms, billions
spent for breakthrough life-saving drugs is not really a bad thing at all. It is the tens of billions spent on the
marketing and consumption of me-too drugs that is the real problem.
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