WWW.ICER-REVIEW.ORG 1© 2020 INSTITUTE FOR CLINICAL AND ECONOMIC REVIEW A LOOK AT ACUTE THERAPIES FOR MIGRAINE FEBRUARY 2020 Summary WHAT IS MIGRAINE? Migraine is a common cause of headache and is...

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WWW.ICER-REVIEW.ORG 1© 2020 INSTITUTE FOR CLINICAL AND ECONOMIC REVIEW
A LOOK AT ACUTE THERAPIES FOR MIGRAINE FEBRUARY 2020
Summary
WHAT IS MIGRAINE?
Migraine is a common cause of headache and is
characterized by episodic, recu
ent attacks that are
classically pulsatile or thro
ing, frequently involve
one side of the head, and are associated with nausea
and sensitivity to external stimuli such as light, sound,
and smells. Migraine attacks vary in their frequency
and intensity, but when severe can be a disabling,
chronic condition that can impact all aspects of
life including personal relationships and ability to
work. An estimated 40 million adults or 12-15% of
adults in the United States (US) report migraine or
severe headaches.
TREATMENT OPTIONS
Standard management of migraine focuses on two
strategies: preventive therapy to reduce the number
of migraine attacks and acute therapy to relieve
migraine symptoms after an attack begins. This
eview examines acute treatments for migraine. For
individuals with mild symptoms, migraine can be
treated with over the counter pain medications (e.g.,
ibuprofen, acetaminophen). For those with moderate
or severe symptoms, the use of specific migraine
medications is recommended. The most commonly
used migraine specific medication class for acute
treatment are “triptans”. Though effective and safe
for many patients with migraine, triptans may not be
sufficiently helpful, can have intolerable side effects,
or may have contraindications (e.g., patients with
cardiovascular disease). For these reasons, new
treatment options are needed.
Calcitonin gene-related peptide (CGRP) antagonists
are an emerging class of drugs for acute treatment
of migraine. On December 23, 2019, the first CGRP
antagonist for the treatment of acute migraine,
u
ogepant (U
elvy™, Allergan) was approved by
the US Food and Drug Administration (FDA). Another
CGRP antagonist, rimegepant, is cu
ently under
eview by the FDA.
Lasmiditan (Reyvow™, Lilly), a selective 5-HT 1f agonist
(triptans are 5-HT 1
1d agonists), is another new
acute treatment for migraine. It was approved on
October 11, 2019 by the FDA.
KEY REPORT FINDINGS
• For those people with migraine who are not able
to take triptans, results from clinical trials show
that lasmiditan, rimegepant, and u
ogepant
all decrease symptoms of migraine attacks and
improve function compared with placebo. The
evidence provides moderate certainty that all three
treatments offer a small or substantial net health
enefit, with high certainty of at least a small net
health benefit.
• The evidence also suggests that rimegepant
and u
ogepant provide comparable net health
enefits to each other. Lasmiditan probably has
similar efficacy to the other two medications but
it also has significantly higher rates of dizziness
and discontinuation.
• For patients with migraine who can take triptans,
indirect comparisons suggest that triptans
are similar or more effective than lasmiditan,
imegepant and u
ogepant.
POLICY RECOMMENDATIONS
• Given that the evidence does not demonstrate
superiority of the newer agents to existing less-
expensive treatment options, it is reasonable
for insurers and other payers to develop prio
authorization criteria for lasmiditan, rimegepant
and u
ogepant to ensure prudent use of these
new therapies.
• Prior authorization criteria should be based on
clinical evidence, specialty society guidelines, and
input from clinical experts and patient groups. The
process for authorization should be clear and
efficient for providers.
• Manufacturers and researchers should develop
long term comparative trials of acute treatments
for migraine that assess outcomes over the entire
course of a migraine attack. Manufacturers should
also conduct real-world comparative studies of
acute treatments for migraine.
A LOOK AT ACUTE THERAPIES FOR MIGRAINE
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Clinical Analyses
How strong is the evidence that lasmiditan, rimegepant, and u
ogepant improve
outcomes in patients with acute migraine?
ICER EVIDENCE RATINGS
Evidence ratings weighed uncertainties about potential harms of the treatments against the benefits.
For all adults with acute migraine, the evidence provides high certainty of a comparable net health
enefit between rimegepant and u
ogepant. For lasmiditan, there was moderate certainty that it offers
a comparable or inferior net health benefit compared to rimegepant and u
ogepant.
Lasmiditan Rimegepant U
ogepant
For adults with moderate-severe
migraine attacks that have not
esponded to non-prescription
medicines and for whom triptans
have not been effective, are not
tolerated, or are contraindicated
Moderate certainty
of a small or
substantial health
enefit compared
to no treatment
Moderate certainty
of a small or
substantial health
enefit compared
to no treatment
Moderate certainty
of a small or
substantial health
enefit compared
to no treatment
For adults with acute migraine
who can tolerate triptans
Comparable or
inferior net health
enefit to triptans
Comparable or
inferior net health
enefit to triptans
Comparable or
inferior net health
enefit to triptans
KEY CLINICAL BENEFITS STUDIED IN CLINICAL TRIALS
How effective are these therapies?
Results from placebo controlled clinical trials suggest that lasmiditan, rimegepant and u
ogepant
decrease symptoms of migraine attacks (pain, phonophobia, photophobia, or nausea) and improve
function compared to placebo at two hours.
Patients with “no
pain” at 2 hours
(pain freedom)
Patients free of most bothersome
symptom (phonophobia,
photophobia, or nausea) at 2 hours
Patients achieving
full function at 2
hours
Lasmiditan vs. placebo   
Rimegepant vs. placebo   
U
ogepant vs. placebo   
A LOOK AT ACUTE THERAPIES FOR MIGRAINE
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Clinical Analyses (continued)
Additional analyses conducted by ICER suggest no difference between lasmiditan, rimegepant and
u
ogepant in decreasing symptoms of migraine attacks (pain, phonophobia, photophobia, or nausea)
and improving function at two hours. However, compared to triptans (sumatriptan and eletriptan),
ICER’s analyses suggest that lasmiditan and CGRP antagonists were less effective in decreasing
symptoms of migraine attacks at two hours.
HARMS
Overall, the adverse events (AEs) observed in clinical trials were mild or moderate in intensity. Nausea
was the most commonly reported AE in the rimegepant and u
ogepant trials.
In the lasmiditan trials, central nervous system-related AEs like dizziness, excess sleepiness, and a
tingling sensation were the most frequently reported. Higher rates of discontinuation was observed
in the long-term trials of lasmiditan compared to rimegepant and u
ogepant. Due to concerns about
excessive sleepiness with lasmiditan, the FDA label advises that patients should not drive or operate
machinery within eight hours of taking a lasmiditan dose.
SOURCES OF UNCERTAINTY
Lack of head-to-head studies: We used indirect analyses to compare lasmiditan, rimegepant and
u
ogepant to each other, and to triptans due to lack of head-to-head studies.
Patient important outcomes: The primary outcomes reported included efficacy and side effects of
a single dose of each drug compared to placebo at two hours after initial study medication. Though
patients highlighted the importance of outcomes after two hours, protocols for use of rescue
medications differed among trials, which made it difficult to assess the benefits of these drugs after
two hours.
Durability of effect: Most data for these drugs came from trials treating a single migraine attack;
outcomes when used over time for repeated attacks are uncertain.
Minimal long-term safety data for new therapies: Triptans are considered to have safety concerns
elated to vasoconstrictive effects and, when used with certain other medications such as SSRIs, ca
y
a risk of serotonin syndrome, although decades of use have suggested that these complications
may be extremely infrequent in clinical practice. In contrast, the newer agents which appear to be
potentially safer have much less clinical information to demonstrate long-term safety at this time.
A LOOK AT ACUTE THERAPIES FOR MIGRAINE
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Economic Analyses
LONG-TERM COST-EFFECTIVENESS
Do these treatments meet established thresholds for long-term cost-effectiveness?
For adults with moderate-severe migraine attacks patients for whom triptans are not effective, not
tolerated, or are contraindicated:
• Lasmiditan exceeds commonly accepted thresholds for cost-effectiveness of $50,000-$150,000 pe
quality-adjusted life year (QALY) at the estimated net price when compared to placebo
• Both u
ogepant and rimegepant* fall below commonly cited thresholds for cost-effectiveness at the
estimated net price when compared to placebo
Lasmiditan
vs. placebo
Rimegepant*
vs. placebo
U
ogepant
vs. placebo
Cost per QALY gained $151,800 $39,800 $40,000
* The price for rimegepant was assumed to be the same as u
ogepant.
For adults with acute migraine who can tolerate triptans, sumatriptan and eletriptan are both more
effective and less expensive than these newer agents.
Because none of these treatments has been shown to extend patients’ lives, ICER did not calculate
what prices would be needed to reach alternative cost-effectiveness thresholds based on equal value of
Life Years Gained (evLYG).
A LOOK AT ACUTE THERAPIES FOR MIGRAINE
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Economic Analyses (continued)
VALUE-BASED PRICE BENCHMARKS
What is a fair price for these therapies based on its value to patients and the health
care system?
Lasmiditan Rimegepant U
ogepant
Annual Price to Achieve
$100,000 - $150,000/QALY
Threshold
$2,900-$3,348 $4,160-$4,640 $4,150-$4,630
Lasmiditan’s annual list price of $4,610 is higher than ICER’s value-based price benchmark range of
$2,900-$3,348. Rimegepant’s assumed annual list price of $4,896 is higher than ICER’s value-based
price benchmark range of $4,160-$4,640. Finally, u
ogepant’s annual list price of $4,896 is higher than
ICER’s value-based price benchmark range of $4,150-$4,630.
POTENTIAL SHORT-TERM BUDGET IMPACT
How many patients can be treated before crossing ICER’s $819 million budget
impact threshold?
Lasmiditan: At its cu
ent list price, approximately 12% of eligible patients could be treated in a given
year without crossing the ICER budget impact threshold of $819 million per year.
Rimegepant: At its cu
ent placeholder list price, approximately 16% of eligible patients could be treated
in a given year without crossing the ICER budget impact threshold of $819 million per year.
U
ogepant: At its cu
ent list price, approximately 16% of eligible patients could be treated in a given
year without crossing the ICER budget impact threshold of $819 million per year.
A LOOK AT ACUTE THERAPIES FOR MIGRAINE
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Voting Results
The Midwest CEPAC deliberated on key questions raised by ICER’s report at a public meeting on
January 23, 2020. The results of the votes are presented below. More detail on the voting results is
provided in the full report.
CLINICAL EVIDENCE
• All panelists found adequate evidence to
demonstrate a net health benefit for treatment
with lasmiditan, rimegepant, or u
ogepant
compared with no treatment.
• All panelists found that the evidence was
insufficient to distinguish the net health benefit
etween rimegepant and u
ogepant.
• A majority of panelists found the evidence
insufficient to distinguish
Answered Same DayApr 08, 2022

Solution

Dr. Saloni answered on Apr 09 2022
12 Votes
Running Head: ICER Assessment 1
Question and Answe
Contents
Answer 1    3
Answer 2    3
Answer 3    3
Answer 4    4
References    7
Answer 1
The drugs evaluated by ICER are rimegepant, u
ogepant, and lasmiditan. U
ogepant and rimegepant are CGRP (calcitonin gene-related peptide) antagonists, whilst Lasmiditan is the 5-HT1F receptor agonist. With the introduction of these novel medications, individuals suffering from migraines will have accessibility to treatments in instances when triptans are inefficient or are not recommended due to cardiovascular risk. The ICER assessment highlights the value of these novel medicines, and derived from the results, u
ogepant and rimegepant are more cost-effective than lasmiditan in cases whereby triptans are ineffective (ICER, 2020).
Answer 2
The cost per QALY for lasmiditan is $151,800. The cost per QALY for u
ogepant is $39,800. The cost per QALY for rimegepant is $40,000. Moreover, the QALYs were estimated by multiplying the difference in utility value caused by the intervention by the period of the intervention effect. When compared to standard treatment for triptan-ineligible individuals, lasmiditan had the greatest incremental cost-effectiveness proportion, while rimegepant and u
ogepant had lower and almost identical ratios (ICER, 2021).
Answer 3
The policy recommendations for payers state that given the similar underlying mechanisms of rimegepant and u
ogepant, and accessible evidence indicating no substantial variation in efficacy or safety, it is not i
ational for payers to confer lower costs by offering a selective formulary position on the drug, such as the probability of isolation of one among other drugs. If just a single drug is supported, patients and doctors should be able to acquire coverage for the alternative CGRP drug unless a trial of the prefe
ed therapy fails to show satisfactory results (Agboola et al., 2020).
Furthermore, the policy recommendations for providers state that with the introduction of these advanced therapeutic approaches, migraine professionals should discover new ways to inform primary healthcare clinicians on the thorough utilisation of triptans and certain other acute potential treatments to enhance the adequate care of the larger sample of...
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