Apr 16, 2019
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Welcome to this ASCO in Action podcast. This is ASCO's podcast
series where we explore policy and practice issues that have impact
on oncologists, the entire cancer care delivery team, and most
importantly the individuals who care for people with cancer.
My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the
host of the ASCO in Action podcast series. For today's podcast, I
am delighted to have as my guest Dr. Jeffrey Ward. He's the chair
of ASCO's Government Relations Committee, and a longtime active
member in that area. In addition to his important contributions to
ASCO over the years, Dr. Ward is a medical oncologist and a
hematologist at the Swedish Cancer Institute in Edmonds,
Washington.
Our conversation today will focus on utilization management in
cancer care, or the policies that public and private insurers use
to control the use of anticancer drug therapies, such as prior
authorization requirements, restrictive formularies, step therapy,
or fail first requirements, and specialty specific tiers. These are
all new and complex topics for some listeners. For others, there's
great familiarity. And we're going to explore all of them in the
coming discussion.
In September of 2017, ASCO published in the Journal of Oncology
Practice a policy statement on the impact of utilization management
practices specifically directed at cancer drug therapies. In that
statement, ASCO outlined its opposition to payer imposed
utilization management policies that restrict patient access to
high quality, high value cancer care. The statement also points to
high quality clinical pathways as the best first option for
ensuring the appropriate utilization of anticancer drugs and the
delivery of the highest quality cancer care.
So with that as introduction, Dr. Ward, I'm delighted to welcome
you to the podcast, and really looking forward to hearing your
thoughts on utilization management. Thank you for being here.
It's a pleasure. Thanks for inviting me.
So to get the conversation started, can you just define first
exactly what we mean by the phrase utilization management?
Utilization management is classically when insurers or payers put
controls over what care a patient may receive. And in our case,
that usually means control of the drug therapies that they're going
to get. I think that utilization management more strictly could
also include when providers themselves use practices that try to
strive for the highest quality care at the best price.
So that already raises the possibility that there are a number of
utilization management policies that payers could employ focusing,
for example, on the use of specific prescription medications or
other interventions. What are some of the more common utilization
management practices that are being used specifically in cancer
care?
Well, I think the one that we run into every day is specialty care
pricing. I was talking to the MedPack folks at Congress just a
couple of months ago and began telling them the contortions we go
through in a practice, where in my practice, we have seven docs. We
have two full-time people who their whole job is to get
authorization for drugs, and then to figure out how the people are
going to pay for their co-pays that can sometimes be several
thousand dollars a month. It's a restriction that I suspect the
drug companies actually utilize to try and market their drug by
providing co-pay support.
At the same time, I think payers build it into the pricing of their
insurance. So it's become a big part of what happens. And it's
almost a dance between practices and payers. But it takes a
tremendous amount of time and effort. And I'm not sure that it
accomplishes a whole lot.
Wow. I mean, I think there's a lot that we could unpack there. And
I think for some of our listeners, it would help to frame this in
even more realistic terms. We shouldn't use specific drugs or drug
names. But I'm curious if you could provide a more concrete example
of what exactly would happen to Mr. Smith in your office when you
make a recommendation for a treatment, and what then ensues in
terms of this specialty tier pricing.
Sure. So Mr. Smith has prostate cancer. And he is appropriately
treated with a very expensive oral medication along with his
castrate therapy. And in doing so, I write a prescription. I send
that prescription to a specialty pharmacy.
They then begin doing a preauthorization process, or that
preauthorization process may be done from the doctor's own office.
They get preauthorization for the drug, but they find out that the
patient has a 20% co-pay. This drug may cost $12,000 a year, and so
the patient is now responsible for the other 20% of that cost.
If it is a commercial payer, then the patient will-- then the
specialty pharmacy will go to the drug company, and the drug
company will provide co-pay support. That requires often the
patient to give them a copy of their last tax return, and there
will be some other requirements to show that they don't have the
ability to easily pay for that co-pay.
If that kind of process wasn't in place, the patient would probably
in many circumstances deny the treatment and not get the best care
that they deserve.
If it's a Medicare patient, then the drug company directly
providing co-pay support is called fraud. And so in that
circumstance, the pharmacy will then-- or the practice will turn to
foundations that help provide co-pay support, and try and get the
patient foundation support. You're better apt to do that in January
or this time of year in March than you are in November, December,
because foundations tend to run out of money.
So you run around scrounging up foundation support for your patient
until you're able to do it. That puts delays that can sometimes
last weeks before you can initiate a treatment.
And not to put too fine a point on it, but in this example, you
recommended a specific therapy, and ultimately the patient getting
it, the delay is really in scrounging up or managing the co-pay
through these various channels. Is that a fair assessment of what
you've described? Or did I miss something?
That's exactly right. And so the patient will almost always get the
drug, but there can be considerable delays.
OK. And so that answers, in a sense, the next question, that the
concern about the overall impact of this kind of approach on
individual patients is a delay in terms of needed therapies. And
sometimes that might be a critically important one, but other times
it might be honestly less critical.
But it's also a lot of work. And there's a lot of expense on the
side of the practice in navigating this. Is that also a fair
assessment?
Yes. And none of that is, of course, reimbursed. It's become an
expected part of practice, but it is a burden on practices.
OK. And just out of curiosity, what do you think the alternative
would be? Since all of this seems to boil down to the fact that
there is co-pay, and there are multiple ways of mitigating the
impact of co-pay on the actual individual patient. What would the
alternative to this actually be?
Well, I think in a perfect world, the alternative would be that the
patient would not have the co-pay, and the drug companies would
admit that they're actually lowering their price significantly when
they provide co-pay support. And patients would pay less. And we
wouldn't have to go through the dance now. That seems, at this
point in time, unrealistic. But I think that right now, the payers
really have this locked into their cost of their insurance. So it
is a dance that's expected. If there was a way to get rid of that,
that would be great. One suggestion that has been made is that part
D drugs that are cancer drugs actually get moved to part B, and
that they get paid for that way for Medicare patients. And then the
co-pay issue with part D drugs goes away for the Medicare patients.
And then maybe some policy might follow on the commercial side.
Maybe not, right?
Yeah. That may follow. But the commercial side is a little bit
easier, because the commercial side, you can get direct support
from the pharmaceutical company for their co-pay. And you can't do
that for Medicare patients.
OK. So let's-- forgive the pun-- take the next step and talk about
step therapy. As I understand it right now, the White House and
Congress, along with ASCO and other stakeholders, we are all
working-- and I think it's true at this point in a fairly
collaborative way to try to talk about and start to address the
high cost of prescription drugs here in the US.
One part of these efforts from CMS has been to propose expanded use
of step therapy. Can you describe what step therapy would look like
for a patient with cancer?
Sure. I think that some of us prefer the word fail first to step
therapy, because that's more descriptive of what it is. Step
therapy is the idea that before you can get drug B, you have to use
and fail drug A. Most step therapy is based on price of the drug.
And we don't think that that applies very well to cancer
patients.
Most of our patients, there is a best drug for them. And to have to
use inferior drugs to get to the best drug is problematic, not just
in time and delays, but we know that our disease evolves over time.
And if you use an inferior drug first, the superior drug may not
work nearly so well as a second line therapy.
So in an ideal situation, hypothetically, were there two drugs that
on average offered the same response rate, progression free
survival, overall survival, and similar toxicities where one costs
less than the other, this approach might make sense, assuming there
weren't mitigating factors at the individual patient level. And
it's fair to point out, I think, that in other domains outside of
oncology, classically blood pressure management, step therapy has
been accepted and is reasonably successful.
If I'm hearing you right though, the problem we see in oncology is
that kind of ideal equivalence is rare. And most of the time there
really are reasons, good reasons, defensible evidence-based
reasons, that oncologists select one treatment or another. Is that
a fair summary?
Yes, I think it is. An example where someone I think might
inappropriately use step therapy would be in renal cell cancer,
where we have a number of TKIs that are available. Someone may say
that they all have similar response rates. Of course, none of them
have been compared head to head. And so that makes it very
difficult to say whether they're really the same or not.
But they do have different toxicities. And so even if you would say
on average their toxicities are similar, for a given patient, one
drug may be better tolerated or more appropriate than another. To
use those drugs in a step therapy fashion would be inappropriate,
and I think would harm patients.
There are circumstances where I think step therapy is easy to apply
in oncology, but they are few and far between. One example where
step therapy I think will be applied-- and I wouldn't have problems
with it-- is in the biosimilar products.
And my understanding then is that the Medicare Advantage, at least,
some of the plans began allowing step therapy just at the beginning
of this year, 2019. Have you begun to see or hear about any impact
on patients yet as a result of that or is it still too early?
I have seen payers doing some step therapy in, for example, the
biosimilar realm, or even requiring you to use a filgrastim instead
of pegfilgrastim. But I have not yet seen the part D payers using
step therapy. I don't know whether ASCO and its state affiliate
counsel has begun gathering examples across the country
otherwise.
The filgrastim-pegfilgrastim issue that you just mentioned, I
think, is a good one for highlighting some of the subtle challenges
here. It's probably fair to say that the impact on hard measures,
like infection or admission to the hospital, will be
indistinguishable.
But in one case there are multiple either office visits or health
care professional interactions or a burden on the part of the
family members or patient for regular administration, whereas with
the other choice, of course, there's one dose per cycle. So the
price, if you will, of that convenience, I think, is another issue
that will eventually bubble to the surface. Right?
Yes. And the ironic thing about that step therapy is that if a
patient decides that they want to self-administer the drug at home,
they have to pay co-pays for the privilege of giving themselves a
shot.
Right. Well, we could probably fill the whole podcast with perverse
incentives and bizarre quirks of the system, I'm sure, in terms of
drug administration, right?
I think that that's one of our problems.
So look, we've identified these challenges. Of course, our job here
is both to highlight them so that our members and listeners are
aware, but even more importantly is to do something about that. So
can you start to describe how ASCO is working with Congress and the
administration to address some of these issues to encourage
policies that would be better for people with cancer?
Well, I think one of the first things that we've done is we've
collaborated with our state affiliate societies in individual
states where there has been legislation regarding some of these
utilization management activities that don't make a lot of sense.
There are a number of bills last year in just step therapy itself.
In a number of states, I think there were a total of about 90-some
odd bills that addressed some kind of utilization management in
different states across the country last year.
We have a similar bill that's in the legislature here in Washington
state right now that is looking at step therapies, and to put some
curbs on it, and more particularly, to make the processes
transparent so that when you do have a step therapy in place, you
know it. You understand it. And you know what literature has been
used so that you have an ability to appeal it if it's appropriate
for your patient. So those kind of processes ASCO is
facilitating.
The big picture, I think, is that we need to somehow develop a
reimbursement system that actually incentivizes oncologists and
payers to work together instead of being at odds over this. And
that would involve developing pathways that are value based, but in
our mind, very distinct from step therapy.
Well, I mean, that's a natural segue to the next topic, which is,
in fact, ASCO's 2017 policy statement, which addressed utilization
management, and pointed to high quality clinical pathways as payers
best first option for ensuring appropriate utilization of
anticancer drugs. Can you talk a little bit about why we at ASCO
have turned to focus on that as the tool to drive the delivery of
high quality care?
Well, I think there are several reasons. One, we've staked out a
position that we believe that as oncologists we should be
responsible for the way we use drugs, and the management of our
patients' care, and that part of that responsibility should be to
be cognizant of the cost and the value of the drugs we give.
But we don't believe that we should be responsible for the prices
that those drugs carry. A system that we have right now in buy and
bill makes us responsible for that. And many of the reimbursement
reforms that have been done, the oncology care model being one of
them, for example, actually makes oncologists responsible for the
cost of the drugs in the reimbursement scheme. We think that that
is a mistake, and that there are better ways to try and leverage
the cost of drugs than making us responsible for them.
Right. I mean, one of the things we say is that we don't set the
launch price, and we're not responsible for it. But in these
models, it can be the case that expensive new drugs that drive up
the cost of care even when they do deliver better outcomes and are
the right therapy can become a financial liability for the
prescriber, right? And that's a real challenge, I think, for
us.
Correct. I mean, I was a lead author on a paper that we published a
year or so ago in the Journal of Oncology Practice that used a
model to demonstrate what the risks of taking on responsibility for
the cost of drugs in a model like OCM would be. And in doing so
determined that if you were a small practice of less than 10
doctors, there was a 10% risk that you could have a 30% deficit in
your drug costs just on the basis of who happened to walk in your
door.
The end result would be that if you were in that kind of
arrangement and taking on risk for the cost of your drugs, whether
you were successful or not would depend less on the skill and the
choices you made, but on who walked in your front door.
Yeah. And that's a real problem, because we certainly don't want a
system where there's an incentive and disincentive to select or
select against certain sick patients, obviously.
So I guess the one question that some people may ask as they think
about this is whether there are any situations where the
utilization management policies we're seeing now do provide a
benefit. That is, are there patients or outcomes that are improved
because of the current utilization management tools? Are there
places where costs are controlled or there's more effective
management of resources in general? Meaning, are there any silver
linings in this right now?
I think that for individual payers, particularly large payers,
there may be a silver lining that we don't see. So I'm guessing as
to whether this exists or not. Many of them, I believe, get
rebates, often volume rebates, based on step therapy. Whether that
actually computes into lower premiums for patients or not or simply
higher profits for the insurer, that would be well out of my realm
of knowledge.
But I think that there is some leverage. I think there'd be a
better way to develop leverage. And that would be if we were using
routinely value-based pathways and partnering with insurers to be
able to put downward price on drug-- downward pressure on drug
prices.
Right. So alignment of incentives is what you're describing at the
end there. And I think that's ultimately the best solution for many
of the problems that plague us in the health care system.
With that, I want to thank you, Dr. Ward, once again for joining me
on this ASCO in Action podcast. It was a real delight to hear your
thoughts, and to gain a little bit of deeper knowledge. Thanks for
doing that.
You're great. It was fun to be here.
For listeners who want more information on utilization management
policies and the latest cancer policy news and updates, visit ASCO
in Action, which is literally ascoaction.asco.org on the web. And
otherwise, until next time, thank you for listening to this ASCO in
Action podcast.