Idorsia announces its insomnia medication, QUVIVIQ (daridorexant),
is now covered by CVS
Ad hoc announcement pursuant to Art. 53 LR
- The approximately 20 million US lives covered by CVS will now
have easier and more affordable access to QUVIVIQ
Allschwil, Switzerland &
Radnor, PA, United
States – July
10, 2023Idorsia Ltd (SIX: IDIA) and Idorsia
Pharmaceuticals US Inc. today announced that, effective
immediately, CVS is covering QUVIVIQ® (daridorexant) CIV on the
Performance Drug List (PDL). Approximately 20 million people are
enrolled in this CVS plan, providing increased access to QUVIVIQ
for the millions of adults who can benefit from this latest
prescription insomnia therapy. QUVIVIQ is now covered by two of the
largest insurance plans in the US, Express Scripts and CVS, and
several associated regional plans, as well as TRICARE, the
healthcare program for active and retired US military personnel and
their families.
QUVIVIQ was approved in January 2022 for the treatment of adult
patients with insomnia, characterized by difficulties with sleep
onset and/or sleep maintenance.1 It is a dual orexin receptor
antagonist (DORA), which blocks the binding of the wake-promoting
neuropeptides orexins and is thought to turn down overactive
wakefulness, as opposed to treatments that generally sedate the
brain. Since availability of the product in May 2022, QUVIVIQ has
quickly gained traction with patients and physicians, and more than
180,000 prescriptions have been dispensed to date.
Sleep is overwhelmingly seen as the third pillar of health,
alongside diet and exercise. Poor quality or insufficient sleep can
affect many aspects of the daily lives of people with trouble
sleeping including the ability to concentrate, mood and energy
levels.2
Patty Torr, Idorsia US President and General Manager,
commented:“Millions of Americans with insomnia are not
getting enough nightly sleep. With CVS adding QUVIVIQ to their
national formulary, insomnia patients will now have affordable
access to this latest prescription medication, helping them get the
sleep they need.”
In the long-term, insomnia is associated with numerous serious
health conditions, such as psychiatric disorders, cardiovascular
disease, type 2 diabetes, substance abuse and dementia.3,4,5
For more information about QUVIVIQ, see the Full
Prescribing Information and Medication
Guide
Important Safety
Information
QUVIVIQ is a prescription medicine for adults who have trouble
falling asleep or staying asleep (insomnia).
Do not take QUVIVIQ if you
fall asleep often at unexpected times (narcolepsy).
QUVIVIQ may cause serious side effects,
including:
- Decreased awareness and alertness. The morning
after you take QUVIVIQ, your ability to drive safely and think
clearly may be decreased. You may also have sleepiness during the
day.
- Do not take more QUVIVIQ than prescribed.
- Do not take QUVIVIQ unless you are able to stay in bed for at
least 7 hours before you must be active again.
- Take QUVIVIQ at night within 30 minutes before going to
bed.
QUVIVIQ is a federally controlled substance because it can be
abused or lead to dependence.
Before taking QUVIVIQ, tell your healthcare provider
about all of your medical
conditions, including if you:
- have a history of depression, mental illness, or suicidal
thoughts or actions; drug or alcohol abuse or addiction; a sudden
onset of muscle weakness (cataplexy); daytime sleepiness
- have lung or breathing problems, including sleep apnea
- have liver problems
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed
Tell your healthcare provider about all of the medicines
you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements
- Taking QUVIVIQ with certain medicines can cause serious side
effects. QUVIVIQ may affect the way other medicines work and other
medicines may affect the way QUVIVIQ works.
- Do not take QUVIVIQ with other medicines that can make
you sleepy unless instructed by your healthcare
provider.
What should I avoid while taking QUVIVIQ?
- Do not drink alcohol while taking QUVIVIQ. It can increase the
effects of alcohol, which can be dangerous.
- Do not drive, operate heavy machinery, do anything dangerous,
or do other activities that require clear thinking if you do not
feel fully awake, or you have taken QUVIVIQ and have less than a
full night of sleep (at least 7 hours), or if you have taken more
QUVIVIQ than prescribed.
QUVIVIQ may cause other serious side effects,
including:
- Worsening depression and suicidal thoughts.
Call your healthcare provider right away if you have any worsening
depression or thoughts of suicide or dying.
- Temporary inability to move or talk (sleep paralysis)
for up to several minutes, or hallucinations while you are going to
sleep or waking up.
- Complex sleep behaviors such as sleep-walking,
sleep-driving, preparing and eating food, making phone calls,
having sex or doing other activities while not fully awake that you
may not remember the next morning. Stop taking QUVIVIQ and call
your healthcare provider right away if you experience a complex
sleep behavior.
The most common side effects of QUVIVIQ are
headache and sleepiness.
These are not the only side effects of QUVIVIQ. Call your doctor
for advice about side effects.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-108
Notes to the editor
About InsomniaAccording to the Diagnostic and
Statistical Manual of Mental Disorders, 5th edition (DSM-5®),
insomnia is defined as a combination of difficulty obtaining
sufficient sleep and dissatisfaction with sleep combined with a
significant negative impact on daytime functioning. Chronic
insomnia is defined as difficulty initiating and/or maintaining
sleep on at least three nights per week for at least three months,
despite adequate opportunity to sleep.
Insomnia is a condition of overactive brain activity during
sleep, and studies have shown that areas of the brain associated
with wakefulness remain more active during sleep in patients with
insomnia.
Insomnia is the most common sleep disorder, affecting more than
25 million adults in the US.6 Poor quality or insufficient sleep
can affect many aspects of the daily lives of people with trouble
sleeping including the ability to concentrate, mood and energy
levels.2 In the long-term, insomnia is associated with numerous
serious health conditions, such as psychiatric disorders,
cardiovascular disease, type 2 diabetes, substance abuse and
dementia.3,4,5
References
- QUVIVIQ Prescribing Information. Idorsia Pharmaceuticals US
Inc. Jan/2022.
- Ustinov Y, Lichstein KL, Wal GS, Taylor DJ, Riedel BW, Bush AJ.
Association between report of insomnia and daytime functioning.
Sleep Med. 2010 Jan;11(1):65-8. doi: 10.1016/j.sleep.2009.07.009.
Epub 2009 Sep 23.
- Olfson M, Wall M, Liu SM, Morin CM, Blanco C. Insomnia and
Impaired Quality of Life in the United States. J Clin Psychiatry.
2018 Sep 11;79(5):17m12020. doi: 10.4088/JCP.17m12020.
- Doghramji K. The epidemiology and diagnosis of insomnia. Am J
Manag Care. 2006 May;12(8 Suppl): S214-20. PMID: 16686591.
- de Almondes KM, Costa MV, Malloy-Diniz LF, Diniz BS. Insomnia
and risk of dementia in older adults: Systematic review and
meta-analysis. J Psychiatr Res. 2016 Jun;77:109-15. doi:
10.1016/j.jpsychires.2016.02.021. Epub 2016 Mar 8. PMID:
27017287.
- Bhaskar S, Hemavathy D, Prasad S. Prevalence of chronic
insomnia in adult patients and its correlation with medical
comorbidities. J Family Med Prim Care. 2016;5(4):780-784.
doi:10.4103/2249-4863.201153.
About Idorsia USIdorsia US, an affiliate of
Idorsia, is reaching out for more – we have more ideas, we see more
opportunities, and we want to help more patients. To achieve this,
we will help develop Idorsia into a leading biopharmaceutical
company, with a strong scientific core. With commercial operations
based outside of Philadelphia, PA, one of densest communities of
life sciences talent in the world, we are helping to realize the
company’s ambition of bringing innovative medicines from bench to
bedside. Our goal is to build a commercial footprint that will
deliver Idorsia’s deep pipeline of products from its R&D engine
to the US market – with the potential to change the lives of many
patients.
About IdorsiaIdorsia Ltd is reaching out for
more – We have more ideas, we see more opportunities and we want to
help more patients. In order to achieve this, we will develop
Idorsia into a leading biopharmaceutical company, with a strong
scientific core.
Headquartered near Basel, Switzerland – a European biotech-hub –
Idorsia is specialized in the discovery, development and
commercialization of small molecules to transform the horizon of
therapeutic options. Idorsia has a 20-year heritage of drug
discovery, a broad portfolio of innovative drugs in the pipeline,
an experienced team of professionals covering all disciplines from
bench to bedside, and commercial operations in Europe, Japan, and
the US – the ideal constellation for bringing innovative medicines
to patients.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol:
IDIA) in June 2017 and has over 1,300 highly qualified specialists
dedicated to realizing our ambitious targets.
For further information, please
contact
US MediaChristopher ClarkSenior Director, US
Head of CommunicationsIdorsia Pharmaceuticals US, 100 Matsonford
Road, Radnor, PA 19087 +1 (215) 421
4887christopher.clark@idorsia.comwww.idorsia.us
Global Investors &
MediaAndrew C. WeissSenior Vice President, Head of
Investor Relations & Corporate CommunicationsIdorsia
Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58
844 10 10investor.relations@idorsia.commedia.relations@idorsia.com
www.idorsia.com
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of new products expected to be introduced by the company and
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such forward-looking statements. Should one or more of these risks
or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those
described herein as anticipated, believed, estimated or
expected.
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