Scrip 100 December 2008

POLICY & REGULATION
charged that tier four pricing “turns the According to the latest Express Scripts Drug The NEI was encouraged to do the trial
ordinary notion of insurance on its head Trend report, speciality drug spend in the by a Medicare advisory panel, since seniors
… instead of spreading the risks and costs US increased by 14% in 2007. The ﬁ gure largely use Lucentis and the cost disparity
across a wide pool of people to protect a is also forecast to grow through 2011 at between Avastin versus Lucentis is substantial.
smaller number of very sick patients from 18-20% per year, three to four times the rate “The NEI-sponsored trial signals a new
ﬁ nancial ruin, insurers are gouging the sickest of non-specialty spending. Express Scripts level of activism in the US by the single
patients to keep premiums down for healthier also says that, of the $286 billion spent on
largest payer body: the Centers for Medicare
people”. The editorial called for Congress pharmaceuticals in the US in 2007, $60 billion
and Medicaid Services,” according to IMS,
to ﬁ nd out “how best to protect people went to speciality drugs. By 2011, it predicts
writing about the harbingers of change in
from medical and ﬁ nancial disaster”. Another that US speciality spend will have grown to
Pharmaceutical Executive earlier in 2008.
editorial, in USA Today, said that the tiered $100 billion. Globally, the situation is just as
The US will no longer categorically accept
system was originally a good idea, but “some alarming. Recently, David Twinberrow, director
drug makers’ pricing of biologics. IMS added
insurers have taken the idea too far”. of oncology at IMS Health, was quoted as
that: “Although the trial may be expensive,
Amid these complaints, Karen Ignagni, saying, “Affordability is a big issue.”
any cost might be miniscule compared to
president and CEO of America’s Health
potential savings from avoiding widescale use
Insurance Plans (AHIP), the industry lobbying
NIH head-to-head trial
of Lucentis. Until now, the problem for payers,
group, had stated that tier four “is a balance There are other indicators that
policymakers and prescribers was that funding
of making sure people have access to the pharmaceutical and biotech companies are
head-to-head trials has been prohibitively
newest developments while … trying to operating in a much more cost-conscious
expensive. However, if real-life data from
encourage cost containment”. Writing in an environment in the US – where billions of
healthcare utilisation databases can be used
opinion piece in USA Today, Ms Ignagni said dollars could be at stake.
to make head-to-head comparisons routine,
that AHIP encourages Congress to create a One involves the decision by the US
Pandora’s box will be opened.”
national institution to compare new drugs National Eye Institute (NEI; part of the NIH)
The CATT trial, however, has not
with the treatment options currently available to put $16 million of its own money into a
been without controversy – as the NIH
and provide patients and doctors with data head-to-head trial of two Genentech VEGF
is effectively funding Avastin’s off-label use.
about which are safest, work best and are inhibitors as treatments for age-related
“Should the trial results support Avastin
most cost effective. This would “transform the macular degeneration (AMD): iv Lucentis
for AMD, there is no clarity on whether
healthcare system to one that is driven by (ranibizumab) versus iv Avastin.
there will be a move to give it a label for
research and rewards best practice”.
this indication – or who would do so,”
Policy watchers cite larger concerns.
IMS warned.
Writing in a perspective article in the New
Given that most people will
Health reformers in the US are also mulling
England Journal of Medicine, Dr Thomas Lee
need an expensive intervention
over a long-sought plan to create a national
of Partners Healthcare System in Boston and
Dr Ezekiel Emanuel of the National Institutes
at some point, shifting these
institute to evaluate the comparative merits
of drugs, devices and procedures, purportedly
of Health (NIH), stated that, given that most
costs of expensive new drugs to
to save Medicare money and improve
people will need an expensive intervention at
some point, shifting these costs of expensive
the sick is an issue of concern to
medical care.
In August, two powerful Democratic
new drugs to the sick is an issue of concern society at large
leaders – Senate Finance Committee Chair
to society at large. “At some point in our
Max Baucus and Senate Budget Committee
lives, we may all join that small pool of users
Chair Kent Conrad – introduced a bill to
of high-cost care … when we are sick and Avastin is approved as a cancer drug but
establish the public-private Health Care
scared, we do not want to be preoccupied by with the help of compounding pharmacists,
Comparative Effectiveness Research Institute.
the cost of treatments,” they wrote. retinal specialists had started using the
This was proposed to function as a non-proﬁ t
One solution would be for society at product off-label before Lucentis received
entity, not a federal agency, governed by a
large to get tougher in “avoiding using … FDA approval in 2006. Many stuck to Avastin
public-private board of governors, according
interventions in situations where they are due to cost: $40-75 a shot if a pharmacist
to Mr Baucus. Among other objectives, the
unlikely to help,” they noted. splits off a small fractional dose into tiny
institute would have a private group to
Additionally, Americans must collectively get ophthalmic syringes. (This compares with
help plan research and disseminate ﬁ ndings
more discriminating about what technologies roughly $2,000 per injection for Lucentis, and
about head-to-head comparisons of medical
will be supported, Dr Lee told Scrip. For the with a typical course of eight to 12 injections,
treatments.
interventions that really do provide value, the cost of Lucentis might amount to about
The bill has not gained much momentum,
everyone should chip in, even if only a small $24,000 compared with $900 for Avastin.)
but industry watchers expect Senator Baucus
number of patients need the technology or IMS Health has identiﬁ ed the NEI’s trial,
to reintroduce it in 2009. Healthcare ﬁ rms
product. “We do this already for heart and called CATT, as one of its top 10 “harbingers
worry that any federally funded comparisons
bone marrow transplants, but we should be of change” highlighted in its yearly analysis
of clinical effectiveness might be a slippery
consistent in our approach,” he said. Dr Lee of strategic issues facing the industry as it
slope to cost-effectiveness analyses, which are
supports some kind of knowledge base which moves forward. IMS stated that the trial
common in Europe.
would provide recommendations for when bears watching because head-to-head
expensive anticancers like Roche’s Avastin trials are normally only conducted by drug
(bevacizumab) should be used. “This would makers – but in this case, Genentech declined
allow consistency among payers,” he said. to participate. (Genentech questions the
Nancy Faigen is Scrip’s
What is driving an increase in such wisdom of spending a large sum in view of a
assistant US editor.
aggressive tiered pricing? US payers are ﬁ nite US R&D budget, and it maintains that
looking at future costs, and they are worried. it developed Lucentis with safety concerns in
They all see the same issue: the level of mind, and that Avastin remains unproven as
potential demand for these new treatments. an eye treatment.)
62
www.scripnews.com/supplements Scrip 100
Page 1 | Page 2 | Page 3 | Page 4 | Page 5 | Page 6 | Page 7 | Page 8 | Page 9 | Page 10 | Page 11 | Page 12 | Page 13 | Page 14 | Page 15 | Page 16 | Page 17 | Page 18 | Page 19 | Page 20 | Page 21 | Page 22 | Page 23 | Page 24 | Page 25 | Page 26 | Page 27 | Page 28 | Page 29 | Page 30 | Page 31 | Page 32 | Page 33 | Page 34 | Page 35 | Page 36 | Page 37 | Page 38 | Page 39 | Page 40 | Page 41 | Page 42 | Page 43 | Page 44 | Page 45 | Page 46 | Page 47 | Page 48 | Page 49 | Page 50 | Page 51 | Page 52 | Page 53 | Page 54 | Page 55 | Page 56 | Page 57 | Page 58 | Page 59 | Page 60 | Page 61 | Page 62 | Page 63 | Page 64 | Page 65 | Page 66 | Page 67 | Page 68 | Page 69 | Page 70 | Page 71 | Page 72 | Page 73 | Page 74 | Page 75 | Page 76 | Page 77 | Page 78 | Page 79 | Page 80 | Page 81 | Page 82 | Page 83 | Page 84 | Page 85 | Page 86 | Page 87 | Page 88 | Page 89 | Page 90 | Page 91 | Page 92 | Page 93 | Page 94 | Page 95 | Page 96 | Page 97 | Page 98 | Page 99 | Page 100 | Page 101 | Page 102 | Page 103 | Page 104 | Page 105 | Page 106 | Page 107 | Page 108 | Page 109 | Page 110 | Page 111 | Page 112 | Page 113 | Page 114 | Page 115 | Page 116 | Page 117 | Page 118 | Page 119 | Page 120 | Page 121 | Page 122 | Page 123 | Page 124 | Page 125 | Page 126 | Page 127 | Page 128