Ocrelizumab is pricey
but experts credit Genentech with showing restraint
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by Alexandria Bachert
Staff Writer, MedPage TodayMarch 31, 2017
The drug's price tag
is a costly $65,000 per year, but experts agree that it's comparable with other
MS therapies, especially as the price of MS drugs has continued to increase
over the years.
What's your opinion of the magnitude of benefit for this drug?
Given the differences between clinical trial populations and real-world
patients, would you expect to see this kind of risk reduction in routine
practice?
Caleb Alexander, MD, Johns
Hopkins Bloomberg School of Public Health: Ocrelizumab represents an important new treatment choice for
those with MS, especially the minority of patients that have primary
progressive disease. With that said, the clinical benefits are modest and as is
typically the case with new approvals, long-term safety and efficacy are
unclear.
Fred D. Lublin, MD, FAAN, FANA,
Icahn School of Medicine at Mount Sinai: Ocrelizumab showed excellent effects on reducing disease
activity and disability in relapsing MS; the effect in primary progressive MS
was more modest, but this is the first agent to successfully alter the course
of primary progressive MS. In relapsing MS, the experience in practice was
similar to that seen in the clinical trials. For primary progressive MS, we
will need to learn from experience.
Jonathan E. Howard, MD,
NYU Langone Medical Center:
I think that the real-world benefits of this drug will be large, especially for
patients with relapsing-remitting MS. It is similar to Rituxan [rituximab],
which we have been using off-label for years. For patients with progressive MS
the benefits will be more modest. It slows progression, but won't get patients
out of wheelchairs.
David A. Hafler, MD, Yale
School of Medicine: The drug is highly
efficacious in patients with relapsing remitting MS and expect to see the same
risk reduction in routine practice for selected patients with new onset,
inflammatory disease. The efficacy of the drug is significantly more modest in
primary progressive disease. While I agree with its approval, we need to better
understand the mechanism of the neurodegenerative aspect of primary progressive
MS which appears not to be mediated by the peripheral adoptive immune system.
Anthony Reder, MD, University
of Chicago Medicine: This drug is in the
same league as the best available drugs for RRMS; the FDA believes there is an
effect on progressive MS; known side effects are minimal; and the price is not
excessive (in relative terms). This is a quadfecta! And it should be effective
for many types of "real world" MS because the trials spanned RR and
PPMS.
Eric Williamson, MD,
Perelman School of Medicine at the University of Pennsylvania: It's tremendous and we expect to see these
significant anti-inflammatory effects in practice.
Is $65,000 per year a fair price for the stated benefit?
Alexander:
Depends who you ask. One thing is certain – this price is going to be closely
scrutinized, and rightly so. We need to be talking about what constitutes a
"fair price" more often, instead of ducking from this question.
John R. Corboy, MD,
University of Colorado School of Medicine: Fair is a challenging concept in the world of MS therapies.
While the wholesale cost as quoted will certainly be competitive with all
presently-approved medications, the other MS disease modifying therapies are
subject to substantial and nontransparent cost reductions which shield the
actual costs. That said, ocrelizumab will rank well in cost-benefit analyses,
compared to other approved therapies.
Robert J. Fox, MD, FAAN,
Cleveland Clinic: With MS therapies,
we haven't figured out a good way to compare price and benefit. Nonetheless,
the price of ocrelizumab appears to be approximately on-par with other approved
MS therapies.
Hafler: As the interferons
and Copaxone were originally priced at ~$15,000, it is hard to say what a fair
price would be. However, I applaud Roche/Genentech in bringing the price below
market hopefully allowing us to partner with insurers to use ocrelizumab as a
first-line drug.
Aaron Miller, MD, Icahn
School of Medicine at Mount Sinai: I regret the extraordinarily high price for all marketed
disease-modifying therapies. Nonetheless, Genentech is to be commended for at
least reversing what has seemed to be a never-ending and unwarranted escalation
of prices for MS DMTs [disease-modifying therapy]. Ocrevus has been priced
lower than virtually every other drug.
Jody Corey-Bloom, MD, UC
San Diego School of Medicine: Genentech should be commended for reducing the annual cost
compared to other disease modifying therapies.
Robert T. Naismith, MD,
Washington University School of Medicine in St. Louis: While $65,000/year is high, ocrelizumab is
one of the least expensive MS therapies. Roche clearly listened to many
neurologists who were concerned about rising drug prices.
Reder: This is uniquely low
for a first-in-class, highly effective MS drug. Some other new drugs attempted
to use "unique mechanism, highly effective" as leverage to price
their drug above prevailing rates. Of course, the ideal would be a drug as
inexpensive as sunlight, but there are significant development costs for
biologic drugs.
Prices for MS drugs in general have risen considerably over the
years -- how much of a problem is that and what can be done about it?
Fox: Given the high cost
of MS drugs, research should focus on identifying the patients who are most
likely to benefit from therapy. If we can direct the right therapies to the
right patients, then I think we can better manage the growing overall cost of
MS therapies.
Corey-Bloom:
I believe that Genentech's lower pricing of ocrelizumab will actually encourage
other pharmaceutical companies to go the same route, especially if they want to
maintain their market share. And I hope that clinicians caring for patients
with MS will take every opportunity to encourage pharmaceutical companies to do
so.
Alexander:
There is a growing consensus that current levels and increases in drug prices
are unsustainable, and MS products are an important part of this mix. Our
current system doesn't price products based on value. While it's risky to make
predictions, there is a lot of policymaker interest in many different potential
solutions, ranging from Medicare price negotiations to price-gouging bills.
Jeffrey Cohen, MD,
Cleveland Clinic: The high price of MS
medications is a significant contributor to the high overall cost of MS care. I
anticipate that ultimately legislative action will be necessary to lower
medication costs in the U.S.
Miller: Ultimately the
inappropriate escalation of drug prices in the U.S. will have to be addressed
through legislative action. Continued pressure from patients on their
government representatives will be necessary, supported and orchestrated by
not-for-profit organizations, such as the National MS Society, and by
professional organizations, such as the American Academy of Neurology.
Corboy: The cost escalations
for MS therapies over the last 15-years defy all logic and are a substantial
problem. They result from a combination of pharmaceutical companies taking
advantage of our free market system and the complete abdication of political
leaders. Until the legislators and president of the U.S. try to actually
improve healthcare, nothing will change.
Lana Zhovtis Ryerson, MD, NYU Langone
Medical Center: MS is now labeled as one of the most expensive
conditions to treat and can become a significant issue with possible changes in
healthcare laws. Using effective medications early on in the disease can help
reduce the burden of disability of patients in the long run, which will
ultimately be cost saving for society. Furthermore, the introduction of generic
medications is required to bring down the price of disease modifying therapies.
