Research Shows COVID's Impact on Health Care Has Lessened but Not Disappeared - MMIT
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Spotlight on Market Access
Actionable understandings from AIS Health’s in-depth coverage
May 17, 2021 Research Shows COVID’s Impact on Health
Care Has Lessened but Not Disappeared
2 Chart: Anticipated Prescribing
Actions for Tivozanib Assuming
When the COVID-19 pandemic struck and the U.S. essentially shut down,
FDA Approval many people put off medical procedures as facilities didn’t have the capaci-
ty to see them and patients didn’t want to potentially expose themselves to
9 Reality Check: Hereditary
Angioedema COVID. A report from the IQVIA Institute for Human Data Science released
in May 2020 examined the pandemic’s impact on the U.S. health care sys-
tem, including huge drops in diagnostic screenings for cancer (SMA 6/1/20,
p. 1). Now, more than a year later, data from the institute are showing that
while numbers have improved, they have not returned to normal.
“Disruptions from the pandemic that we’ve been experiencing, both
the initial shock disruptions last spring and the sustained impact over the
entire year, affecting both logistical visits, procedures, diagnostics, but also
engagement with preventive screenings and the concern just generally about
engagement in health care with potential long-term risks,” still continue,
according to Michael Kleinrock, senior director of research development at
the IQVIA Institute for Human Data Science.
continued on p. 4
Fotivda Approval Provides New Option for
Certain People With Renal Cell Carcinoma
The renal cell carcinoma (RCC) therapeutic class boasts multiple agents,
but a recent entrant is offering a new tool for certain patients. A Zitter In-
sights survey shows that the majority of oncologist respondents are likely to
prescribe Aveo Oncology’s Fotivda (tivozanib) for advanced RCC.
On March 10, the FDA approved Fotivda for the treatment of adults with
relapsed or refractory advanced RCC who have received at least two prior
systemic therapies. It is the first FDA-approved therapy for this use.
The recommended dose of the oral, next-generation vascular endothe-
lial growth factor (VEGF) tyrosine kinase inhibitor (TKI) is 1.34 mg once
daily for 21 days every 28 days on treatment, followed by seven days off.
The capsule’s monthly list price is $24,150. According to an Aveo slide deck,
that price compares to those of other relapsing or refractory RCC options:
Pfizer Inc.’s Inlyta (axitinib) is $16,628 per treatment cycle, Bayer’s Nexavar
(sorafenib) is $20,760, Exelixis, Inc.’s Cabometyx (cabozantinib) is $21,663,
© Managed Markets Insight & Technology, LLC | 1
MMIT’s Spotlight on Market Access May 17, 2021
and the combination of Eisai Inc.’s Lenvima (lenva- in advanced RCC and do not anticipate incentivizing
tinib) plus Novartis Pharmaceuticals Corp.’s Afinitor oncologists to prescribe Fotivda over Nexavar.
(everolimus) is $37,505.
Zitter Insights also surveyed 100 oncologists during
For the Managed Care Oncology Index: Q4 2020, the same time frame. Almost 70% said they were likely
from Dec. 2, 2020, to Jan. 5, 2021, Zitter Insights to prescribe Fotivda for advanced RCC, as well as
polled 40 commercial payers with 132.0 million prescribe it over Nexavar (see chart below). Respon-
covered lives. Payers with 84% of lives expected they dents were fairly evenly divided on whether they would
would manage the drug to label, while those with 10% refrain from prescribing Nexavar.
of lives anticipated covering it more restrictively than
“With advances in RCC treatment, patients are
its label. Respondents with 6% of lives expected that
living longer, increasing the need for proven, well-tol-
they would not require prior authorization for Fotivda.
erated treatment options in the relapsed or refractory
None of the payers anticipated not covering the drug.
setting,” said Brian Rini, M.D., chief of clinical trials
Zitter Insights and AIS Health are both MMIT com- at Vanderbilt Ingram Cancer Center and principal in-
panies. vestigator of the TIVO-3 trial, in an Aveo press release.
The drug’s approval was based on a handful of clin- “The TIVO-3 study is the first positive Phase 3 study in
ical trials, including TIVO-3, a Phase III study pitting it RCC patients who received two or more prior system-
against Nexavar. Payers covering 40% of lives said they ic therapies, and also the first Phase 3 RCC study to
are likely to use Fotivda to negotiate greater discounts include a predefined population of patients who have
for Nexavar, but those with 42% of lives said they received prior immunotherapy, the current standard
are unlikely to take that action. Those covering 78% of care in earlier-line treatment. With this approval, I
of lives do not expect to prefer Fotivda over Nexavar believe Fotivda represents an attractive intervention,
SOURCE: Zitter Insights, Managed Care Oncology Index: Q4 2020.
© Managed Markets Insight & Technology, LLC. Contact support@mmitnetwork.com. |2MMIT’s Spotlight on Market Access May 17, 2021
and expect it to play a meaningful role in the evolving Asked if payers are likely to cover Fotivda, Wong
RCC treatment landscape.” notes that the agent “is a potent, selective inhibitor of
When it comes to the RCC class in general, any VEGFRs [i.e., VEGF receptors] 1, 2 and 3 with a long
management of it “will be limited to approved indica- half-life designed to improve efficacy and tolerabili-
tions for the medications being utilized or consistency ty. It would be my expectation that payers will cover
with the accepted treatment guidelines,” such as those Fotivda as a third-line treatment option for advanced
from the National Comprehensive Cancer Network RCC since it is consistent with the approved FDA indi-
(NCCN) or the American Society of Clinical Oncology cation, and there is nothing really indicated for this far
(ASCO), says Winston Wong, Pharm.D., president of an advanced disease. Further strength for coverage
of W-Squared Group. “It was not that long ago that will occur if/when the third-line treatment option is
RCC was one of the most difficult cancers to treat. The included in the NCCN and ASCO guidelines.” (NCCN
effectiveness of immunotherapy as a treatment option added Fotivda to its guidelines on March 29, after this
has changed the landscape significantly. True man- interview took place.)
agement of this cancer type would only be present in
plans with pathway programs in place, and, even then,
management would most likely be found for early and
“It was not that long ago that RCC was
first- or second-line advanced disease. Fotivda is the one of the most difficult cancers to treat.
first option for third-line or later RCC disease, based The effectiveness of immunotherapy
upon the TIVO-3 trial.” as a treatment option has changed the
In that trial, points out Mesfin Tegenu, CEO of landscape significantly.”
RxParadigm, “Fotivda was able to show improved
progression-free survival compared to sorafenib. “Sutent (sunitinib malate) has been the long-
However, Fotivda fell short in showing overall survival standing standard of care for renal cell carcinoma
relative to sorafenib. The key takeaway for Fotivda will treatment,” says Tegenu. “Despite NCCN recently rec-
be its safety profile relative to current therapies for ognizing Fotivda by making updates to the guidelines
RCC. Therefore, Fotivda may be an option for a subset following the recent FDA approval, plans will continue
of patients who have failed previous therapies and to monitor its place in therapy similar to the PD-1 [i.e.,
require a more tolerable and safe option.” programmed cell death-1] inhibitors drug class. For ex-
ample, while PD-1 inhibitors have recently been mak-
ing moves to being first-line therapy treatments, there
“The key takeaway for Fotivda will be
continue to be inconsistencies in commercial payer
its safety profile relative to current
coverage for this class of drugs compared to the TKI,
therapies for RCC.” VEGF and mTOR [i.e., mechanistic target of rapamy-
cin] inhibitor classes.”
In addition, Wong points out that “patients who
“The choice of treatment for an advanced RCC
received prior therapy with a checkpoint inhibitor in
patient is mostly determined by their prognostic risk
combination with a VEGF inhibitor or two prior VEGF
stratification,” Wong explains. “The risk stratification
inhibitors saw the greatest reduction in the risk of
is based upon the International Metastatic Renal Cell
progression. Thus, there is now an option for third-line
Carcinoma Database Consortium (IMDC) prognostic
treatment, which would otherwise be a referral to a
model, based upon Karnofsky performance status, time
clinical trial. Response rates were also higher with Fo-
from first diagnosis to treatment, hemoglobin level,
tivda compared to sorafenib. The real question at this
serum calcium, neutrophil count and platelet count.”
point, however, is whether to proceed with a third-line
treatment or move on to a clinical trial. Luckily, this RCC has comorbidities that may complicate man-
would be a determination by the treating oncologist aging the condition, including obesity, diabetes and
and their patient and not a payer.” cardiovascular-related conditions, points out Tegenu.
© Managed Markets Insight & Technology, LLC. Contact support@mmitnetwork.com. |3MMIT’s Spotlight on Market Access May 17, 2021
“Taking into account an individual’s overall health COVID Impact Wanes but Persists
status and other variables (e.g., age and gender) are
continued from p. 1
standard in predicting their outcome; however, there
is still work to be done as it relates to individually “There were about 1 billion fewer diagnosis visits in
managing these patients to improve overall survival. the country in 2020 compared to what we would have
With this said, currently there are no standard meth- expected without COVID,” as well as a drop of around
ods in capturing comorbidities in cancer registries to 21% in expected diagnosis visits in 2020, he explained
aid in tracking and monitoring the patients following during a recent webinar. “It does vary quite a bit by
treatment.” therapy area and specialty as well, and you would
consider perhaps that the missed visits might be more
asymptomatic as opposed to a symptomatic patient,
“Cancer has a way of complicating who might be more engaged or more motivated, more
any comorbidity, and management of actually visiting either an emergency or primary care
comorbidities will depend largely on physician or someone else.”
the clinical presentation and treatment The top impacted specialty-by-diagnosis-visits gap
response.” has been oncology, followed by gastroenterology, der-
matology, ophthalmology and anesthesiology. “In this
Observes Wong, “Cancer has a way of complicating context of diagnosis visits, if you imagine you visit your
any comorbidity, and management of comorbidities doctor, and they diagnose you with three things, that’s
will depend largely on the clinical presentation and three diagnosis visits,” explained Kleinrock.
treatment response.”
It’s been a long road for Fotivda, which the FDA “There were about 1 billion fewer
rejected in 2013 for use in first-line RCC. Aveo has
diagnosis visits in the country in 2020
explored it in other indications, including breast and
compared to what we would have
colorectal cancer, but without success.
expected without COVID.”
Drug’s Patents Expire Soon
“We also have done a little bit of a projection for-
The company holds two patents on tivozanib, one ward through this year, though the mid-year, summer,
of which expires in April 2022 and the second of which and it’s down less in some sense, partly because we
expires in November 2023. In mid-March, though, the don’t have the crater in the spring in the dynamics,”
company said it intends to file applications for patent he said. “We have, as a country, begun to better adapt
term extensions that could push one of those dates to what’s going on with COVID. But this widening gap
back potentially five years. between the expected and the actual is something con-
But if that doesn’t occur, “wide use of this medi- cerning.” Total diagnosis visits are down 12% in 2021
cation may purely be dependent on its clinical value compared with baseline, and the total projected num-
instead of ever-increasing TV ads,” says Tegenu. ber for this year is 288.3 million. “That’s something
that we’re watching very carefully as we go forward. It
Contact Tegenu at Mesfin.Tegenu@rxparadigm.
does seem like there’s a sustained sort of disengage-
com and Wong at w2sqgroup@gmail.com. For more
ment that’s worrying.
information on the Zitter data, contact Jill Brown Ket-
tler at jbrown@aishealth.com. G “What’s interesting,” he continued, “and we
measure this a lot, is whether those missed diagnosis
by Angela Maas
visits translate into less action at the other end of the
This story was reprinted from AIS Health’s monthly treatment journey, which sometimes ends up in pre-
publication RADAR on Specialty Pharmacy. Visit scription medicines.” Researchers found that the total
https://aishealth.com/product/specialty-pharmacy. projected loss of prescriptions through June 2021 is
© Managed Markets Insight & Technology, LLC. Contact support@mmitnetwork.com. |4MMIT’s Spotlight on Market Access May 17, 2021
111 million. The percent of projected prescriptions lost replaced about 10% or 11% of it with telehealth for a
through June 2021 is 3.8%. Cardiology is expected to variety of things,” said Kleinrock. “Prior to this pan-
be most affected, as well as primary care, dermatology, demic, telehealth was much hyped, much vaunted, but
oncology and pediatrics. not actually something people used a whole lot, but
“In this case, we are seeing an impact on prescrip- now it’s become a very solid piece of the system, and
tion medicines, but only down much lower, 3.8%,” that’s very helpful. What it has done, though, is you’ve
he stated. “And if you consider that there are certain seen that the office visits are down a bit from where
acute, episodic events which might result in a prescrip- they were, and that collective total is still below that
tion that definitively haven’t happened during this 100% basis that we’re seeing, so that’s one of the things
COVID period, you would think there’s lots of extra we’ve been watching.”
things, but in reality, we’ve hardly had a…flu season
in the fall 2020 into 2021. Back in the spring of 2020, “Prior to this pandemic, telehealth
there was a significantly lower amount of acute usage
was much hyped, much vaunted, but
of various things — antibiotics and pain medications —
not actually something people used a
potentially linked to elected procedures. So definitely
whole lot, but now it’s become a very
less impact from those [missed] diagnosis visits but
solid piece of the system, and that’s very
still an impact.”
helpful.”
“The continuing patients have actually The institute also found that “essentially the early-
been remarkably resilient” and “are peak COVID states [such as] New York, Louisiana and
staying engaged, being adherent, but Michigan are now using telehealth much less. They
those new ones are missing, and some of used it in the peak to get around some of our logistical
that is worrying.” hurdles; it’s declined quite a lot since. The sustained
use of this engagement tool will be an interesting ques-
As far as how this translates into prescription tion for the new normal going forward.”
usage, Kleinrock explained that the company examines With institutional and office medical claims, “the
new-to-brand and continuing prescriptions. New-to- things that I notice and am sort of heartened by is
brand prescriptions are when a patient is new on that we’re still tracking a little bit below the baseline of the
medicine and hasn’t been on it for the last year. They calibrated view,…but the gap is getting narrower,” stat-
can switch from another product but cannot refill. Con- ed Kleinrock. Institutional medical claims were down
tinuing prescriptions are when patients are refilling a 49% at one point in 2020 and down 25% in February
script. The company uses “calibrated” data “where we 2021, while office medical claims were down as much
create a virtual clean version of 2020 to help us with as 68% in 2020 and down 14% in February 2021. “So
the analysis without the shark bite taken out” in spring there is a little bit of comeback, [but] there may be
2020, he said. “The new patients are the ones who some system capacity issues, as well as patient engage-
have had the problem in terms of this gap vs. what was ment issues that are hampering our recovery here.”
expected,” down almost 40% at a few points during the Elective procedures were down as much as 86%
pandemic, he observed. “The continuing patients have in 2020 and down 2% in late February. “On the one
actually been remarkably resilient” and “are staying hand, obviously the patients who had that procedure
engaged, being adherent, but those new ones are miss- planned had it scheduled differently, maybe just a time
ing, and some of that is worrying.” displacement of two or three months,” he noted. “Some
Not surprisingly, telehealth use has risen during of them may have just been canceled, and that’s a con-
the pandemic. The IQVIA Institute found that “there cern. So when we’re tracking cumulatively below about
was a big drop in these diagnosis visits, and they 20% — and that’s a quarter of the year, maybe less
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— that’s not bad. We’ve gotten some of the way back. “There’s definitely been this sort of scheduling gap”
But there is definitely a concern, and within elective for administration of IV therapies, which have had
procedures, we have a whole bunch of things that are negative cumulative growth, “and this suggests to me
elective — and ‘elective’ is sort of a loaded term, mean- that the immediate drop last spring was the key issue.
ing that they can be scheduled at any time, but you still That recovery has been stable, but obviously we’re not
need them — so when we don’t have them, it could be catching up yet. We want to cross over the zero axis,
a problem. It also becomes a problem for the econom- and it’s not happened yet.”
ics of running our whole health system. For provider
“As we look at the cancer backlog and what we’ve
systems, it also ends up being a question about what
been seeing with claims data and what we’ve been
the next step is for that patient: If they needed that
seeing across the experience, I want to point two things
surgery, if they needed a biopsy, and they couldn’t get
out,” said Jon Morris, M.D., vice president and general
it, [over] time, what does that mean? Is it delayed, or is
manager of US Healthcare Solutions at IQVIA, during
it canceled? And those are things that we keep looking
the webinar. “If you go back to the diagnosis visit, the
at very closely.”
1 billion diagnosis visits that did not occur in 2020,
In hematology/oncology, total claims were down the leading specialty in terms of the decreased diag-
21% at one point in 2020, rose in November and have nosis visits per provider is oncology. Smaller numbers
stayed above the zero baseline since, most recently up certainly with primary care practitioners, pediatricians
7% in late March. Cumulative growth, however, is at and others, but the leading specialty by diagnosis visit
zero. In hematology/oncology, newly diagnosed claims gap per specialty is oncology. And that’s even more
were down almost 25% for weeks 14 through 23 in than anesthesia and others where we saw significant
2020 and up 14% in late March of this year. But cumu- disruption in the procedure volumes,…so I think that’s
latively, they are down 2% now. a really important thing as we think about the lens here
coming into the oncology community, the oncology
backlog.”
“The newly diagnosed patients are really
my worry, and if we think about delayed Second, as far as the prescription impact, “the
diagnosis and delayed treatment, we are oncology prescribing impact is still not back to 100%
of baseline, so at 70% of what we would be expecting at
seeing that gap.”
this point in time, we have a cumulative diagnosis visit
gap from 2020, and we’re seeing fewer prescriptions,
“If we look at the total claims, there’s definitely a
fewer new prescriptions in the patient population. We
recovery back to essentially normal,” he pointed out.
have to look at what that means and how we think
“The newly diagnosed patients are really my worry,
about this across the community.”
and if we think about delayed diagnosis and delayed
treatment, we are seeing that gap, and it’s still a couple Researchers found that providers’:
of percentage points. The worry is the longer that you ◊ Average number of cancer patients before
have that gap, the worse the potential escalation of the COVID-19 outbreak was 94.
that tumor could be and the worse the outcomes, so
◊ Average number of cancer patients per
definitely an interesting thing to watch here.”
week during April 2020 (Wave 1) was 46.
Oncologic sales year-over-year growth of oral drugs
◊ Average number of cancer patients per
was 21% at the end of March 2020 and at 1% in late
week during June 2020 (Wave 2) was 62.
March 2021. Sales of intravenous (IV) cancer drugs
were down as much as 6% in April 2020, down 9% in ◊ Average number of cancer patients per
early 2021, up 4% in March and then back down 2% week during October 2020 (Wave 3) was
and 3%. 72.
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◊ Average number of cancer patients per care, so we are seeing utilization of…remote engage-
week during February 2021 (Wave 4) was ment continuing for this population.”
70. When oncologists were asked what kind of care
So, notes Morris, face-to-face oncologist visits are they are willing to deliver remotely to their cancer
still down 70% to 75% since the start of the pandemic. patients, findings revealed:
“So we’re not back, and if you think about the diagnosis ◊ Discussion of report/test/examinations
visit gap, this is what we’re seeing on the survey when done: 84%.
we engage with the providers themselves, as well as
◊ Follow-up consultation: 83%.
this slow return, and we’re still not back to 100%.”
◊ Easy consultation for patients with stable
During waves 3 and 4, oncologists spent similar
medical conditions: 67%.
amounts of time discussing COVID-19 during patient
consultations: 16% during Wave 3 and 18% during ◊ Control/monitoring of adverse events/
Wave 4. The time spent discussing cancer treatment toxicity/side effects: 67%.
didn’t change, and neither did demand for patient ◊ Discuss the changes in treatment plan/as-
support services. “We’ve seen continuously about 15% sistance on prescription of any drug: 51%.
to 20% of time being spent with patients being spent
◊ Patients taking simpler chemotherapeu-
on the oncology-focused impacts of and talking about
tic options can be consulted remotely:
COVID, the impact of COVID as it relates to that in-
40%.
dividual patient,” he explained. “Coming into October
of last year and into February of this year, [there has The institute has seen telehealth claims “dropping
been] an awful lot of patient-support activity.” off significantly during the past six weeks,” said Morris.
“This precipitous drop in telehealth may be a harbinger
Oncologist surveys found the following information
of things to come as we get back into our face-to-face
about remote consultations:
and our engagement models.”
◊ Average patient proportion prior to the
Delays in surgeries have remained consistently
outbreak was 5%.
above 70% through all four waves of the pandemic.
◊ Average patient proportion during lock- Fewer diagnoses being conducted have dropped from
down was 46%. 55% in Wave 1 to 44% in Wave 4. Delayed chemother-
apy visits have remained slightly below 50% through
◊ Average patient proportion post-lock-
all four waves, and changes in treatment protocol to
down in June 2020 was 31%.
introduce oral cancer medications whenever possible
◊ Average patient proportion in October have risen from 33% in Wave 2 to 43% in Wave 4.
2020 was 29%. “We are seeing over 70% of the oncologists that
◊ Average patient proportion in February we’ve surveyed said that they are still seeing delays,
2021 was 26%. still experiencing delays, and whether that’s a facili-
ty logistic challenge, whether it’s patient-specific or”
◊ Average patient proportion when whether it’s due to labs not being able to be done as
COVID-19 won’t exist is 20%. quickly as they had been before the pandemic, “we’re
“Most of the oncologists are saying now that as we seeing significant barriers still in access to the proce-
get into Wave 4, we’re still at 20% to 25% in remote dures themselves,” he noted.
consultations,” said Morris. “These are established Fewer diagnoses are being conducted when com-
patients, and these are patients that didn’t necessarily pared to the time before the pandemic: 57% down in
miss that diagnosis gap visit. These are the ones who Wave 3 and 55% down in Wave 4. Screening for early
are in the system, the ones who are actively engaged in disease was down more than 80% in both waves, and
© Managed Markets Insight & Technology, LLC. Contact support@mmitnetwork.com. |7MMIT’s Spotlight on Market Access May 17, 2021
postponing of biopsies was down more than 70%. “We can talk about supply and access and availabil-
Delays in imaging were down 71% in Wave 3 and 64% ity of clinic visits to practitioners, we can talk about
in Wave 4. telehealth, [but] there is an element of patient reti-
cence to engage right now,” asserted Morris. “We’ve
The top three cancer types have been breast,
seen it — we’ve seen it across health systems, locations,
colorectal and lung cancer. “Think about how we get
geographies. In the setting of COVID and the pandem-
there: From mammographies, colonoscopies, CT scans,
ic, the challenge of getting patients to engage I think is
the overall decrease in the procedure volume, the de-
a real one for us to be thinking about.”
crease in diagnosis-related visits upstream are trans-
lating into risk here,” Morris pointed out. “The second thing is just the reality of reduced
system capacity,” he continued. “Staffing adjustments,
Screenings Are Still Down having to change the workflow, adjusting the schedul-
ing frequency, cleaning the rooms and wiping rooms
Screenings remain down compared with baseline.
down after patients, all of that has rolled together both
Mammograms were down 87% on April 10, 2020,
on risk mitigation, as well as some of the standard so-
down 50% through quarter-two (Q2) and down 20%
cial distancing measures that have been implemented
through Q4 2020. Pap smears had declined 83% as
from a public health standpoint.”
of April 10, 2020, 43% through Q2 2020 and 14%
through Q4 2020. Colonoscopies had dropped 90%
as of April 10, 2020, 55% through Q2 2020 and 23% “Diagnostics used to screen and monitor
through Q4 2020. CT scan decreased by 53% as of cancer dropped dramatically and
April 10, 2020, then 27% though Q2 2020 and 11% recovered, though an 11% to 23% deficit
through Q4 2020. Prostate-specific antigen (PSA) tests remains.”
were down 60% as of April 10, 2020, 32% through Q2
2020 and 11% through Q4 2020.
The third factor is “health service disruptions, pro-
From early March 2020 to early January 2021, “di- cedure-related disruptions. When all of our anesthesi-
agnostics used to screen and monitor cancer dropped ologists and our nurse anesthetists and our intensivists
dramatically and recovered, though an 11% to 23% were focusing on all of the patients in the ICU, that
deficit remains,” Morris observed. Researchers saw redeployment of resources, that reprioritization of ser-
“blips” around the Fourth of July and Labor Day “but vices has had an effect on the ability of cancer patients
saw things tailing off” as 2020 came to a close. to get in to have these initial diagnosis visits and to be
Based on positive cancer diagnosis per test and the able to go through the appropriate screening.”
modeled impact of reduced screening tests through IQVIA has found that a variety of stakeholders —
2020, “nearly 22 million screening tests for five not only hospitals and providers but entities such as
common tumors may be disrupted, risking delayed or patient-advocacy groups and pharmacists — are taking
missed diagnoses for almost 90,000 patients,” he said. actions to address the cancer diagnosis backlog, includ-
That number breaks down as follows: ing reprioritizing health services activities, developing
new protocols, restructuring workflows, using pharma-
◊ 41,500 breast cancer patients,
cists more effectively and developing patient communi-
◊ 2,097 cervical cancer patients, cation and awareness programs.
◊ 24,000 colorectal cancer patients, and “Getting patients back in the flow is a critical thing
for us,” maintained Morris. “We’ve got a structural
◊ 678 lung cancer patients.
systemic problem that we need to be thinking about.”
There are three significant concerns affecting can-
Visit www.iqvia.com/insights/the-iqvia-institute. G
cer patient engagement, leading to reduced screening
and testing, diagnoses and treatment. by Angela Maas
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Reality Check: Hereditary Angioedema
Our Point of View
Hereditary angioedema (HAE) is a rare but potentially fatal condition that causes swelling in various
parts of the body, including the hands, feet, intestinal tract, face, larynx and trachea. The FDA has
approved eight drugs to treat HAE. Berinert (C1 esterase inhibitor [human]) from CSL Behring, Firazyr
(icatibant injection) from Takeda Pharmaceutical Company Ltd., Kalbitor (ecallantide) from Takeda
and Ruconest (C1 esterase inhibitor [recombinant]) from Pharming Healthcare, Inc. are indicated for
acute attacks. And the approved therapies for prophylaxis to prevent attacks are Takeda’s Cinryze (C1
esterase inhibitor [human]) and Takhzyro (lanadelumab-flyo), CSL Behring’s Haegarda (C1 esterase
inhibitor [human]) and BioCryst Pharmaceuticals, Inc.’s Orladeyo (berotralstat).
Coverage
Commercial Health Exchange Medicare
Pharmacy Benefit
Under the pharmacy benefit, about
58% of the lives under commercial
formularies are covered with utilization
management restrictions. About 32%
of the lives under Medicare Part D
formularies are not covered for at least
one of the drugs.
Unrestricted Restricted Not Covered Not Listed
Commercial Health Exchange Medicare
Medical Benefit
Under the medical benefit, about 63%
of the lives under commercial policies
are covered with utilization
management restrictions. Almost 69%
of the lives under Medicare Part B
policies have access to at least one of
the drugs without utilization
management restrictions. Covered Restricted Not Covered Unknown
DATA CUR R ENT AS O F Q1 2021
© Managed Markets Insight & Technology, LLC. Contact support@mmitnetwork.com. |9MMIT’s Spotlight on Market Access May 17, 2021
Reality Check: Hereditary Angioedema
AIS Health’s View
With the December 2020 FDA approval of Orladeyo, it became the first oral HAE treatment. “As an
oral, once-daily option, Orladeyo provides significant attack reduction without the burden associated
with injectables — the hallmark of treatment options,” wrote Evercore ISI analyst Liisa Bayko in a
Dec. 4, 2020, research note. “Our market research showed that patients and physicians were eagerly
awaiting an oral option, with anticipated use of Orladeyo reaching 34% of prophylaxis HAE market by
[year-end] 2021 — driven by switching and growth of the market with use of prophylaxis rising from
60% to 80% over time.”
Trends From AIS Health
FDA Approves Orladeyo on
Specialty Pharmacy
Strategies and Analysis for Managing High-Cost Specialty Products
Administration Unveils Blueprint Aimed at High Drug Prices
May 2018
In December 2020, the FDA approved BioCryst Pharmaceuticals, Inc.’s Orladeyo (berotralstat)
After more than a year of promising action to counter the high costs of pre-
VOLUME 15 | NUMBER 5
scription drugs, the Trump administration on May 11 unveiled its American Patients
First blueprint aimed at lowering medication prices and reducing costs for con-
sumers. It remains to be seen how effective — or even how implementable — the
4 Studies Examine
Adherence, Cost From
various strategies are, which focus on four areas: better competition, tougher nego-
tiation, incentives for lower list prices and decreased out-of-pocket costs. During
Use of Certain Drugs
a press conference unveiling the blueprint, President Trump called out various
for prophylaxis to prevent hereditary angioedema attacks in people at least 12 years old. It is the
stakeholders within the pharmaceutical channel, but it’s unclear at this point how
5 Prime Says Managing
Soliris Per Its Clinical Trial concerned they should be.
MG Population Will Help According to Trump, these strategies will “start to take effect very soon.”
With Appropriate Use The blueprint, says Steve Wojcik, vice president, public policy, National Busi-
ness Group on Health, “generally followed what was in the Administration’s pro-
7 Digest: Plans’ Focus
Remains on Cancer,
posed budget, by and large.”
Evercore ISI analysts Ross Muken and Michael Newshel agree: “The specific
first oral treatment approved for this use. Dosing for the plasma kallikrein inhibitor is one 150
Site-of-Care Programs
‘immediate actions’ included in the blueprint are largely a rehash of prior proposals
from February’s White House budget that are relatively benign for the industry and
7 Chart: Management
Policies in Place or Being not majorly disruptive, driving some relief in the stocks today,” they wrote in a May
Considered for Biosimilars 11 research note.
continued on p. 10
8 New FDA Specialty
Approvals
mg capsule once daily. The drug’s annual price is $485,000.
Deemed Guidance 2020 Deadline Has Impact Beyond Pharma
12 News Briefs When the Biologics Price Competition and Innovation Act of 2009 (BPCIA)
was enacted as part of the Affordable Care Act, Congress left much of the details
Subscribers to Radar on Specialty up to the FDA to determine. In addition to creating the 351(k) biosimilar approval
Pharmacy (formerly Specialty pathway, Congress via the BPCIA wanted to bring all biologics together under the
Pharmacy News) can access same law, which it planned to do through the “deemed to be a license” provision.
searchable archives, back issues,
postings from the editor and
The FDA issued draft guidance in 2016 on how it interprets that section of the
more at AISHealth.com. If you law, which is slated to take effect in less than two years. However, as the countdown
need help logging in, email continues, many questions remain on how the agency will implement this guidance.
support@aishealth.com. Manufacturers should be keeping payers abreast of the status of any impacted drugs,
as they could affect the way those drugs are managed, among other things.
Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online
While most biologics are licensed under the Public Health Service (PHS) Act
Managing Editor and approved through a biologics license application (BLA), some protein products
Angela Maas
amaas@aishealth.com
have gained FDA approval under the Federal Food, Drug, and Cosmetic (FD&C)
Executive Editor Act through a new drug application (NDA). The BPCIA did two things to impact
Jill Brown this: First, it modified the definition of a “biological product” to include a “protein
Director, Data Solutions (except any chemically synthesized polypeptide).” Second, it said that biologics
Susan Namovicz-Peat
approved under the FD&C Act on or before March 23, 2020 — 10 years after the
BPCIA was enacted — would transition over to the PHS Act. Thus, an approved
Published by AIS Health, Washington, DC. An independent publication not affiliated with insurers, vendors, manufacturers or associations.
Payers Likely Would Manage Orladeyo at Parity on
Specialty Pharmacy
Strategies and Analysis for Managing High-Cost Specialty Products
Administration Unveils Blueprint Aimed at High Drug Prices
May 2018 After more than a year of promising action to counter the high costs of pre-
When the FDA approved BioCryst Pharmaceuticals, Inc.’s Orladeyo (berotralstat) in 2020, the
VOLUME 15 | NUMBER 5
scription drugs, the Trump administration on May 11 unveiled its American Patients
First blueprint aimed at lowering medication prices and reducing costs for con-
sumers. It remains to be seen how effective — or even how implementable — the
4 Studies Examine
Adherence, Cost From
various strategies are, which focus on four areas: better competition, tougher nego-
tiation, incentives for lower list prices and decreased out-of-pocket costs. During
Use of Certain Drugs
a press conference unveiling the blueprint, President Trump called out various
stakeholders within the pharmaceutical channel, but it’s unclear at this point how
5 Prime Says Managing
drug became the first oral treatment for prophylaxis to prevent hereditary angioedema attacks.
Soliris Per Its Clinical Trial concerned they should be.
MG Population Will Help According to Trump, these strategies will “start to take effect very soon.”
With Appropriate Use The blueprint, says Steve Wojcik, vice president, public policy, National Busi-
ness Group on Health, “generally followed what was in the Administration’s pro-
7 Digest: Plans’ Focus
Remains on Cancer,
posed budget, by and large.”
Site-of-Care Programs Evercore ISI analysts Ross Muken and Michael Newshel agree: “The specific
‘immediate actions’ included in the blueprint are largely a rehash of prior proposals
According to Zitter Insights, payers with nearly three-quarters of covered lives plan to manage it
from February’s White House budget that are relatively benign for the industry and
7 Chart: Management
Policies in Place or Being not majorly disruptive, driving some relief in the stocks today,” they wrote in a May
Considered for Biosimilars 11 research note.
continued on p. 10
8 New FDA Specialty
Approvals
Deemed Guidance 2020 Deadline Has Impact Beyond Pharma
at parity to other prophylactic treatments. Payers covering 93% of lives said they likely would
12 News Briefs When the Biologics Price Competition and Innovation Act of 2009 (BPCIA)
was enacted as part of the Affordable Care Act, Congress left much of the details
Subscribers to Radar on Specialty up to the FDA to determine. In addition to creating the 351(k) biosimilar approval
Pharmacy (formerly Specialty pathway, Congress via the BPCIA wanted to bring all biologics together under the
Pharmacy News) can access same law, which it planned to do through the “deemed to be a license” provision.
searchable archives, back issues,
postings from the editor and
The FDA issued draft guidance in 2016 on how it interprets that section of the
manage it to label and not allow off-label use.
more at AISHealth.com. If you law, which is slated to take effect in less than two years. However, as the countdown
need help logging in, email continues, many questions remain on how the agency will implement this guidance.
support@aishealth.com. Manufacturers should be keeping payers abreast of the status of any impacted drugs,
as they could affect the way those drugs are managed, among other things.
While most biologics are licensed under the Public Health Service (PHS) Act
Managing Editor and approved through a biologics license application (BLA), some protein products
Angela Maas
amaas@aishealth.com
have gained FDA approval under the Federal Food, Drug, and Cosmetic (FD&C)
Executive Editor Act through a new drug application (NDA). The BPCIA did two things to impact
Jill Brown this: First, it modified the definition of a “biological product” to include a “protein
Director, Data Solutions (except any chemically synthesized polypeptide).” Second, it said that biologics
Susan Namovicz-Peat
approved under the FD&C Act on or before March 23, 2020 — 10 years after the
Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online
BPCIA was enacted — would transition over to the PHS Act. Thus, an approved
Published by AIS Health, Washington, DC. An independent publication not affiliated with insurers, vendors, manufacturers or associations.
HAE Needs Patient-Specific Care Specialty Pharmacy
on Strategies and Analysis for Managing High-Cost Specialty Products
Hereditary angioedema is a rare but potentially fatal condition that can cost hundreds of
Administration Unveils Blueprint Aimed at High Drug Prices
May 2018 After more than a year of promising action to counter the high costs of pre-
VOLUME 15 | NUMBER 5
scription drugs, the Trump administration on May 11 unveiled its American Patients
First blueprint aimed at lowering medication prices and reducing costs for con-
sumers. It remains to be seen how effective — or even how implementable — the
4 Studies Examine
Adherence, Cost From
various strategies are, which focus on four areas: better competition, tougher nego-
tiation, incentives for lower list prices and decreased out-of-pocket costs. During
thousands of dollars annually per person. In addition, management of this condition cannot
Use of Certain Drugs
a press conference unveiling the blueprint, President Trump called out various
stakeholders within the pharmaceutical channel, but it’s unclear at this point how
5 Prime Says Managing
Soliris Per Its Clinical Trial concerned they should be.
MG Population Will Help According to Trump, these strategies will “start to take effect very soon.”
With Appropriate Use The blueprint, says Steve Wojcik, vice president, public policy, National Busi-
ness Group on Health, “generally followed what was in the Administration’s pro-
7 Digest: Plans’ Focus
simply be a one-size-fits-all approach. HAE is “variable and patient specific,” says Kendra
posed budget, by and large.”
Remains on Cancer,
Site-of-Care Programs Evercore ISI analysts Ross Muken and Michael Newshel agree: “The specific
‘immediate actions’ included in the blueprint are largely a rehash of prior proposals
from February’s White House budget that are relatively benign for the industry and
7 Chart: Management
Policies in Place or Being not majorly disruptive, driving some relief in the stocks today,” they wrote in a May
Considered for Biosimilars 11 research note.
continued on p. 10
Howard, Pharm.D., vice president of product development at Option Care Enterprises, Inc., and
8 New FDA Specialty
Approvals
Deemed Guidance 2020 Deadline Has Impact Beyond Pharma
12 News Briefs When the Biologics Price Competition and Innovation Act of 2009 (BPCIA)
was enacted as part of the Affordable Care Act, Congress left much of the details
Subscribers to Radar on Specialty up to the FDA to determine. In addition to creating the 351(k) biosimilar approval
Pharmacy (formerly Specialty pathway, Congress via the BPCIA wanted to bring all biologics together under the
“you want to manage at the patient level, patient by patient.”
Pharmacy News) can access same law, which it planned to do through the “deemed to be a license” provision.
searchable archives, back issues,
postings from the editor and
The FDA issued draft guidance in 2016 on how it interprets that section of the
more at AISHealth.com. If you law, which is slated to take effect in less than two years. However, as the countdown
need help logging in, email continues, many questions remain on how the agency will implement this guidance.
support@aishealth.com. Manufacturers should be keeping payers abreast of the status of any impacted drugs,
as they could affect the way those drugs are managed, among other things.
While most biologics are licensed under the Public Health Service (PHS) Act
Managing Editor and approved through a biologics license application (BLA), some protein products
Angela Maas
amaas@aishealth.com
have gained FDA approval under the Federal Food, Drug, and Cosmetic (FD&C)
Executive Editor Act through a new drug application (NDA). The BPCIA did two things to impact
Jill Brown this: First, it modified the definition of a “biological product” to include a “protein
Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online
Director, Data Solutions (except any chemically synthesized polypeptide).” Second, it said that biologics
Susan Namovicz-Peat
approved under the FD&C Act on or before March 23, 2020 — 10 years after the
BPCIA was enacted — would transition over to the PHS Act. Thus, an approved
Published by AIS Health, Washington, DC. An independent publication not affiliated with insurers, vendors, manufacturers or associations.
© Managed Markets Insight & Technology, LLC. Contact support@mmitnetwork.com. | 10MMIT’s Spotlight on Market Access May 17, 2021
Reality Check: Hereditary Angioedema
Key Findings
Characteristics
Market Events Drive Changes Indication
There are currently eight products approved by the FDA for preventing
and treating hereditary angioedema (HAE) attacks. In December 2020, Hereditary
the FDA approved BioCryst Pharmaceuticals, Inc.’s Orladeyo Angioedema
(berotralstat) for prophylaxis to prevent HAE attacks in people at least
12 years old. It is the first oral treatment approved for this use. In August
2018, the FDA approved Shire plc’s (now a Takeda subsidiary) Takhzyro
(lanadelumab-flyo) to prevent HAE attacks in people at least 12 years
old, while in June of that same year, the agency expanded the label of Step-Therapy (ST) Policies
Takeda’s Cinryze (C1 esterase inhibitor [human]) to include the
A review of ST policies for payer-
prevention of HAE attacks in children at least six years old.
controlled formularies:
Pharmacy and Medical Benefit Implications
No ST
Coverage is under both the pharmacy and medical benefits. Self- (89%)
administered products are usually covered under the pharmacy benefit.
ST
Drugs for this indication are generally covered with prior authorization
(11%)
(PA). When PA is defined, diagnosis of HAE is confirmed by C4 and
C1-INH levels below normal as defined by the laboratory performing the Single Step
test. A history of HAE attacks is required. There is minimal step (97%)
restriction with the exception of Cinryze, which most policies will require a
Multistep
step through a generic alternative prophylaxis. (3%)
AIS Health’s View Prior-Authorization (PA)
At the close of 2020, Evercore estimated that Policies
Takhzyro was the market leader among prophylax-
A review of PA policies for payer-
is therapies, with 31% of the market, followed by
Haegarda at 28% and Cinryze at 21%. In 2021, after
controlled formularies:
Orladeyo is available, the firm anticipates Orladeyo
capturing 34% of the market, followed by Takhzy-
No PA
(21%)
ro at 22%, Haegarda at 19% and Cinryze at 14%,
according to a survey Evercore conducted of 25 aller-
PA
(79%)
gists/immunologists with at least 10 HAE patients.
More than half (56%) of them saw Orladeyo as a
Appropriate
first-line treatment, with 48% saying second line and (82%)
4% saying third line. “The market is anticipating the
Restrictive
arrival of this drug,” Bayko wrote. “HAE patients are
(18%)
an educated bunch and our survey shows physician
awareness for Orladeyo is high.”
DATA C U RRE N T AS O F Q1 2021
© Managed Markets Insight & Technology, LLC. Contact support@mmitnetwork.com. | 11About AIS Health The mission of AIS Health — a publishing and information company that has served the health care industry for more than 30 years — is to provide readers with an actionable understanding of the business of health care and pharmaceuticals. AIS Health’s in-depth writing covers the companies, people, catalysts and trends that create the richly textured contours of the health care and drug industry. AIS Health, which maintains journalistic independence from its parent company, MMIT, is committed to integrity in reporting and bringing transparency to health industry data. Learn more at https://AISHealth.com and https://AISHealthData.com. About MMIT MMIT is a product, solutions and advisory company that brings transparency to pharmacy and medical benefit information. MMIT partners with PBMs, payers and pharmaceutical manufacturers from P&T to point of care. We analyze market access trends and market readiness issues, while providing brand and market access solutions to navigate today’s rapidly changing healthcare market. MMIT has been 100% focused on market access for decades. We combine deep domain expertise around drug coverage with innovative technology and trusted data to answer key business questions related to access. MMIT data is trusted by U.S. physicians and sourced through a combination of direct partnerships with payers and PBMs and a technology infrastructure that is powered by smart business logic, artificial intelligence and human validation. Learn more at https://www.mmitnetwork.com. © Managed Markets Insight & Technology, LLC. Contact support@mmitnetwork.com.
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