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This activity is supported by an independent educational grant from Jazz Pharmaceuticals. Live Webcast
Integrating Novel Therapies and Recent Evidence for Obstructive Sleep Apnea into
Plan Algorithms and Management Strategies
Phyllis Zee, MD, PhDBenjamin and Virginia T. Boshes Professor in Neurology
Chief of Sleep MedicineDirector, Center for Circadian and Sleep Medicine
Northwestern University Feinberg School of Medicine
Learning Objectives
• Apply available criteria, risk factors, and clinical indicators for the timely and accurate diagnosis of obstructive sleep apnea (OSA)
• Evaluate the efficacy and safety data associated with available and emerging pharmacotherapies for the management of excessive daytime sleepiness (EDS) in patients with OSA
Epidemiology of Obstructive Sleep Apnea
• ~22 Million Americans have moderate to severe OSA
• Affects ~26% of adults aged 30-70 years
• 13% of men
• 6% of women
• Only 20% with OSA have been diagnosed
OSA Affects 1 in 12 Americans
Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Am J Epidemiol. 2013;177(9):1006-14 Information for clinicians. SleepApnea.org website. https://www.sleepapnea.org/learn/sleep-apnea-information-clinicians/. Accessed October 2019.
Natural History of OSA
Marin-Oto M, Vicente EE, Marin JM,. Multidisc Resp Med. 2019;14(21).
Susceptibility Pre-symptomatic Clinical Disease
Genetics• Craniofacial
abnormalities• Ventilatory control• Obesity
Epigenetics• Environment• Alcohol• Smoking• Sedentary lifestyle
Aging• Menopause• Hypothyroidism• Heart failure
Recovery, Disability, Death
Assessment and Diagnosis
Severe snoring
Male gender
History of apnea
Post-menopausal female High hip-to-waist
ratio
Body habitus• High BMI (≥30)
or
• Neck circumference≥17 in for men; ≥16 in for women
Balk EM, Moorthy D, Obadan NO, et al. Diagnosis and Treatment of Obstructive Sleep Apnea in Adults [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 Jul. (Comparative Effectiveness Reviews, No. 32.) Available from: https://www.ncbi.nlm.nih.gov/books/NBK63560/. Accessed November 2019.
Suspect OSA in individuals with
these clinicalindicators
Other Clinical Symptoms of OSA
Hypertension (often treatment resistant) Atrial fibrillation
Daytime sleepinessAwakening with choking
Apnea or choking reported by sleep partner
Morning headaches
Characteristics Also Suggestive of a Significant Risk of OSA
Institute for Clinical Systems Improvement. Diagnosis and treatment of obstructive sleep apnea. 6th ed. Bloomington, Minn.: Institute for Clinical Systems Improvement; June 2008.
Interventions and OSA Treatment Modalities
Interventions: Lifestyle Modifications
Memon J, Manganaro SN. Obstructive sleep disordered breathing. StatPearls [Internet]: https://www.ncbi.nlm.nih.gov/books/NBK441909/. Updated February 21, 2019. Accessed October 2019.
Avoid caffeine, alcohol, and
sedatives 4 to 6 hour before
bedtime
Maintain regular
sleep hours
Sleep on side vs. back or
stomach
Improve sleep
hygiene
Exercise regularly
Smoking cessation
Interventions: Nonpharmacological Treatments
• Treat nasal obstruction
• Use of oral appliances for mild-to-moderate OSA
• Continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) for moderate-to-severe OSA
• Alternatives for patients who fail other therapies
• Surgery
• Hypoglossal nerve stimulation
Memon J, Manganaro SN. Obstructive sleep disordered breathing. StatPearls [Internet]: https://www.ncbi.nlm.nih.gov/books/NBK441909/. Updated February 21, 2019. Accessed October 2019.Foldvary-Schaefer N. Sleep Apnea. Cleveland Clinic. https://my.clevelandclinic.org/ccf/media/files/Neurological-Institute/sleep-disorders-center/sleep-apnea.pdf. Accessed October 2019.
Interventions:Oral Appliances
• Patients with mild OSA who are resistant to CPAP may benefit from an oral appliance
• Oral appliances are designed to support the jaw in a forward position to help maintain an open upper airway
• Tongue-retaining mouthpieces hold the tongue forward to keep it from collapsing into the airway
Oral appliance therapy. American Academy of Dental Sleep Medicine. https://www.aadsm.org/oral_appliance_therapy.php. Updated August 7, 2015. Accessed October 2019.
Efficacy of Oral Appliances
• Four randomized, controlled studies reported oral appliance use improved apnea-hypopnea index (AHI), arousal index, and oxygen saturation, and reduced snoring
• However, the benefit provided by the appliance differed substantially among trials
• Patients reported high levels of adherence with the appliance
• Common complaints associated with use of an appliance:• Jaw discomfort in the morning• Excessive salivation at night• Dry mouth• Teeth grinding
Blanco J, Zamarrón C, Abeleira pazos MT, Lamela C, Suarez quintanilla D. Sleep Breath. 2005;9(1):20-5.Mehta A, Qian J, Petocz P, Darendeliler MA, Cistulli PA. Am J Respir Crit Care Med. 2001;163(6):1457-61.Gotsopoulos H, Chen C, Qian J, Cistulli PA. Am J Respir Crit Care Med. 2002;166(5):743-8.
Mean decline in AHI
Reduction in hourly arousals
Decreased score on the Epworth sleepiness scale (ESS)
Improvement oxygen saturation
40-60%
30-50%
23-66%
3-4%
Interventions:Hypoglossal Nerve Stimulation
• Surgically implanted device thatunilaterally stimulates the hypoglossal nerve in synchrony with ventilation
• Hypoglossal nerve stimulation activates the genioglossus muscle, resulting in a slight forward displacement of the tongue, improving the patency of the airway
• Recommended for adults with AHI ≥15 who failed CPAP and BMI <33
The emerging option of upper airway stimulation therapy. May Clinic website. https://www.mayoclinic.org/medical-professionals/pulmonary-medicine/news/the-emerging-option-of-upper-airway-stimulation-therapy/mac-20431242. Published February 10, 2018. Accessed October 2019.
Upper Airway Stimulation Improved Measures of OSA at 12 Months
• Multicenter, prospective, single-group, cohort design “STAR” trial
• Implanted an upper airway stimulator in patients (n=126) with OSA resistant to CPAP
• 83% men
• Mean age: 54.5 years
• Mean BMI: 28.4
• Primary endpoints (at Month 12)
• Apnea-hypopnea index (AHI)
• Oxygen desaturation index (ODI)
• Procedure-related AEs was <2%
*p<0.001 vs. baseline
Strollo PJ, Soose RJ, Maurer JT, et al. N Engl J Med. 2014;370(2):139-49.
68% ↓ 70% ↓
32.0
28.9
15.3*13.9*
0
5
10
15
20
25
30
35
Apnea-Hypopnea Index Oxygen Desaturation Index
Me
an S
core
at
12
Mo
nth
s
Primary Endpoints Baseline
Month 12
Improvements in OSA Measures Observed in the STAR Trial Were Maintained for 36 Months
78% reduction in sleep apneaevents per hour
76% reduction in snoring
reported by sleep partner
81% reported nightly usage of
the device
Woodson BT, Soose RJ, Gillespie MB, et al. Otolaryngol Head Neck Surg. 2016;154(1):181-8.Woodson BT, Strohl KP, Soose RJ, et al. Otolaryngol Head Neck Surg. 2018;159(1):194-202.
• 92% (116/126) of patients in the STAR trial completed a 36-month follow-up evaluation
• Improvements in objective respiratory and subjective quality-of-life outcome measures were maintained for 3 years post-enrollment
• Adverse events were uncommon
Interventions:Continuous Positive Airway Pressure (CPAP)
• First-line therapy for moderate to severe apnea
• CPAP involves sending a constant flow of positive pressure into the upper airways
• Pressure is delivered through a mask or other device that fits over the nose and/or mouth
• Constant positive pressure keeps airways open during sleep, eliminating the obstruction that causes obstructive apnea
Redline S. JAMA. 2017;317(4):368-370.
• CPAP is effective, but treatment outcomes of daytime sleepiness, medical co-morbidities, such as hypertension, heart disease and diabetes are inconsistent.
Weaver TE, Maislin G, Dinges DF, et al. Sleep. 2007;30(6):711-9.Antic NA, Catcheside P, Buchan C, et al. Sleep. 2011;34(1):111-9.Weaver TE, Kribbs NB, Pack AI, et al. Sleep. 1997;20(4):278-83.
32% of patients who use CPAP 6+ hours reported functional impairment.
Half of patients do not consistentlyuse CPAP devices at 3months.
Up to one-third of OSA patients report excessive sleepiness despite compliance with CPAP.
Challenges In OSA Treatment
A Meta-Analysis of 11 Trials Suggests the Efficacy of CPAP is Variable
• Meta-analysis of 11 studies of
patients with OSA
• CPAP reduced Epworth
Sleepiness Scale (ESS) score by a
mean of 2.94 points vs placebo
• In 6 studies, which included only
patients with severe OSA and ESS
scores >11, mean ESS reduction was
4.75
• Mean ESS reduction in patients
with mild OSA was 1.1 points (NS)
Reduction in ESS Score with CPAP Use
Patel SR, White DP, Malhotra A, Stanchina ML, Ayas NT. Arch Intern Med. 2003;163(5):565-71.
Faccenda et al, 2001
Monasterio et al, 2001
Engleman et al, 1999
Redline et al, 1998
Ballester et al, 1999
Engleman et al, 1997
Jenkinson et al, 1999
Barbé, 2001
Montserrat et al, 2001
Henke et al, 2001
Engleman et al, 1998
Combined
-2 0 2 4 6
Change in ESS Score
Patients with Residual Excessive Sleepiness Use CPAP Less Than Patients Without RES
Analysis of 1047 patients; n= 912 patients without residual excess sleepiness (RES-) and n=135 patients with residual excess sleepiness (RES+) as assessed by the Epworth Sleepiness Scale score*p<0.001 vs 3–4 and 4–5 h
Gasa M, Tamisier R, Launois SH, et al. J Sleep Res. 2013;22(4):389-97.
18.5%22.3%
15.0%
8.7%*
30.0% 28.6%
22.0%
12.3%*
0
5
10
15
20
25
30
35
3-4 h 4-5 h 5-6 h > 6 h
Pre
vale
nce
of
Re
sid
ual
Ex
cess
Sle
ep
ine
ss (
%)
CPAP Use (hours/night)
Prevalence of RES in entire cohort (n=1047)
Prevalence of RES in the RES+ group (n=135)
Registry Analysis of CPAP Compliance and Residual Excessive Sleepiness (RES)
Excessive Daytime Sleepiness (EDS) in Patients with OSA Can Be Caused by Multiple Factors
In mild-to-moderate sleep apnea, daytime sleepiness may be caused by sleep disorders not impacted by use of CPAP
Periodic limb movement
Chronic sleep deprivation
Undiagnosed narcolepsy
Idiopathic hypersomnolence
Extreme Sleepiness. National Sleep Foundation. https://www.sleepfoundation.org/articles/extreme-sleepiness. Accessed November 2019.
Interventions:Approved Therapies for Treatment of EDS in OSA
Agent Mechanism of Action Approval Date Indication
Modafinil Non-amphetamine stimulant 1998Improve wakefulness in adults with excessive sleepiness associated with OSA
ArmodafinilR-enantiomer of modafinil; inhibits dopamine reuptake
2007Improve wakefulness in adults with excessive sleepiness associated with OSA
SolriamfetolDopamine/norepinephrine reuptake inhibitor
March 2019Improve wakefulness in adults with excessive daytime sleepiness associated with OSA
PROVIGIL [modafinil package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; 2015; NUVIGIL [armodafinil package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; 2017; Sunosi [solriamfetol package insert]. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2019; Wakix [pitolisant package insert]. Plymouth Meeting, PA: Harmony Biosciences, LLC.; 2019.
Modafinil + CPAP Reduced Sleepiness in Patients with EDS More Than CPAP Use Alone
14.413.2
12.4
14.2
10.1* 9.6*
0
2
4
6
8
10
12
14
16
Baseline Week 1 Week 4
Reduction in Mean Epworth Sleepiness Scale Score
CPAP + Placebo CPAP + Modafinil
Pack AI, Black JE, Schwartz JR, Matheson JK. Am J Respir Crit Care Med. 2001;164(9):1675-81.
Epw
ort
h S
lee
pin
ess
Scal
e S
core
Regular users of CPAP received modafinil (n=77) or placebo (n=80) for 4 weeks.*p<0.001 vs. CPAP + placebo
Modafinil/Armodafinil – Adverse Events
Modafinil (%) (n=934)
Placebo (%) (n=567)
Headache 34 23
Nausea 11 3
Nervousness 7 3
Rhinitis 7 6
Back Pain 6 5
Diarrhea 6 5
Anxiety 5 1
Dizziness 5 4
Dyspepsia 5 4
Insomnia 5 1
Armodafinil (%) (n=645)
Placebo (%) (n=445)
Headache 17 9
Nausea 7 3
Dizziness 5 2
Insomnia 5 1
Anxiety 4 1
Diarrhea 4 2
Dry Mouth 4 1
Depression 2 0
Dyspepsia 2 0
Fatigue 2 1
PROVIGIL [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; 2015.NUVIGIL [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; 2017.
Solriamfetol: A Recently Approved Therapy For EDS
• Selective dopamine and norepinephrine reuptake inhibitor
• Distinguished from other wake-promoting agents by its dual reuptake inhibition at dopamine and norepinephrine transporters
• Distinguished from amphetamine stimulants by its lack of release of monoamines
• Together, these differences may account for its wake-promoting effects and lack of rebound hypersomnia
• Low abuse potential
Baladi MG, Forster MJ, Gatch MB, et al. J Pharmacol Exp Ther. 2018;366(2):367-376.Bogan RK, Feldman N, Emsellem HA, et al. Sleep Med. 2015;16(9):1102-8.Ruoff C, Swick TJ, Doekel R, et al. Sleep. 2016;39(7):1379-87.
Differentiation of Solriamfetol from Other Wake-Promoting Agents
• Not direct- or indirect-acting dopamine receptor agonists
• Bind to the dopamine transporter in vitro and inhibit dopamine reuptake
• Activity associated with increased extracellular dopamine levels in some brain regions in vivo
Mo
daf
inil/
Arm
od
afin
il
• Selectively inhibits reuptake of dopamine and norepinephrine
• Reduced release of monoamines relative to amphetamine stimulantsSo
lria
mfe
tol
Baladi MG, Forster MJ, Gatch MB, et al. J Pharmacol Exp Ther. 2018;366(2):367-376.
TONES 2: Effects Observed as Early as Week 1 and Maintained over 12 Weeks
*p<0.05; †p<0.001 vs. placebo300 mg data not shown
Thorpy MJ, Shapiro C, Mayer G, et al. Ann Neurol. 2019;85(3):359-370.
Improvement in the Epworth Sleepiness Scale Score from Week 1 Through Week 12
(n=59)(n=58) (n=55)
Improvement in Objective Wakefulness from Week 1 Through
Week 12
(n=59)(n=58) (n=55)
TONES 3: Maintenance of Wakefulness: Effects Observed Across the Day
*p<0.05
Schweitzer PK, Rosenberg R, Zammit GK, et al. Am J Respir Crit Care Med. 2019;199(11):1421-1431.
Solriamfetol Significantly Increased Sleep Latency
TONES 2 and TONES 3: Adverse Events
Adverse Event Placebo (n=119)Solriamfetol combined
(n = 355)
Any adverse event, n (%) 57 (47.9) 241 (67.9)
Serious adverse event, n (%) 2 (1.7) 3 (0.8)
Adverse event leading to discontinuation, n (%) 4 (3.4) 26 (7.3)
Most common adverse events, n (%)
Headache 10 (8.4) 36 (10.1)
Nausea 7 (5.9) 28 (7.9)
Decreased appetite 1 (0.8) 27 (7.6)
Nasopharyngitis 8 (6.7) 18 (5.1)
Dry mouth 2 (1.7) 16 (4.5)
Anxiety 0 25 (7.0)
Schweitzer PK, Rosenberg R, Zammit GK, et al. Am J Respir Crit Care Med. 2019;199(11):1421-1431.
Summary
• CPAP is the first-line medical therapy for patients with more severe OSA
• Excessive daytime sleepiness remains a problem for many patients despite adequate treatment of OSA
• Modafinil and armodafinil are FDA-approved for OSA patients with EDS
• A novel therapy, solriamfetol, has been recently approved to improve wakefulness in adults with excessive daytime sleepiness associated with OSA
Addressing Barriers to Appropriate OSA Therapy and Interventions for Optimal Member Access to Care
Jeffrey D. Dunn, PharmD, MBA(Formerly)
Vice PresidentClinical Strategy and Programs and Industry Relations
Magellan Rx Management
Learning Objectives
• Describe potential cost offsets garnered through appropriate therapeutic interventions for OSA
• Characterize the available treatment modalities for OSA in terms of outcomes and patient adherence
Why is OSA So Underdiagnosed?
Atypical symptoms,
particularly in women
Lack of disease awareness among
physicians and patients
Signature symptoms
occur during sleep
Sleep Apnea: NHLBI sheds light on an underdiagnosed disorder. U.S. Department of Health and Human Services website. https://www.nhlbi.nih.gov/news/2017/sleep-apnea-nhlbi-sheds-light-underdiagnosed-disorder. Accessed October 2019. Fessenden M. Sleep Apnea in Women and Why It’s Underdiagnosed. Advanced Sleep Medicine Services, Inc. website. https://www.sleepdr.com/the-sleep-blog/sleep-apnea-in-women-and-why-its-underdiagnosed/. Accessed October 2019. Braley TJ, Dunietz GL, Chervin RD, Lisabeth LD, Skolarus LE, Burke JF. J Am Geriatr Soc. 2018;66(7):1296-1302.
Barriers to OSA Treatment
Barriers to treatment for EDS in OSAFrost & Sullivan. Hidden health crisis costing America billions. Underdiagnosing and undertreating obstructive sleep apnea draining healthcare system. Darien, IL: American Academy of Sleep Medicine; 2016. Available at: https://aasm.org/resources/pdf/sleep-apnea-economic-crisis.pdf. Accessed October 2019.
Efficacy & safety
concerns
CostPatient access
Low awareness
Economic and Societal Burden of Undiagnosed OSA
$86.9 Billion
$6.5
$26.2
$30.0
Lost Productivity
Workplace Accidents
Motor Vehicle Accidents
Comorbid Disease
Total$149.6 Billion
Frost & Sullivan. Hidden health crisis costing America billions. Underdiagnosing and undertreating obstructive sleep apnea draining healthcare system. Darien, IL: American Academy of Sleep Medicine; 2016. Available at: https://aasm.org/resources/pdf/sleep-apnea-economic-crisis.pdf. Accessed October 2019.
Cost of Undiagnosed OSA by Member
Diagnosed, $2,105
Undiagnosed, $6,366
$0 $1,000 $2,000 $3,000 $4,000 $5,000 $6,000 $7,000
Cost per Person
Dia
gno
stic
Sta
tus
Per Member Cost of OSA by Diagnostic Status
Undiagnosed DiagnosedPlan members with
undiagnosed OSA have
3xthe medical costs of those
who have received a diagnosis
Frost & Sullivan. Hidden health crisis costing America billions. Underdiagnosing and undertreating obstructive sleep apnea draining healthcare system. Darien, IL: American Academy of Sleep Medicine; 2016. Available at: https://aasm.org/resources/pdf/sleep-apnea-economic-crisis.pdf. Accessed October 2019.
Importance of Diagnosis
• Reduce consequences associated with excessive daytime sleepiness including accidents
• Mitigate long-term complications of OSA and comorbid diseases including
• Depression
• Obesity
• Metabolic syndrome
• Type 2 diabetes
• Cardiovascular disease
Watson NF. J Clin Sleep Med. 2016; 12(8):1075-7.
OSA Treatment Options
CPAP Oral Sleep Appliances CNS Stimulants
Benefits of OSA Treatment
Benefit Notes
Symptoms and daily functioning
• Improvement in sleepiness and daily functioning• Improvement in subjective and objective sleepiness and measures of quality of life,
cognitive function, and depression
Motor vehicle accidents
• Reduction in the risk of automobile accidents• Reduction in accident frequency and concentration faults
Blood pressure, CV disease, pulmonary disease, and stroke
• Reduction in blood pressure• CV risk reduction• Reduced hospitalization with CV and pulmonary disease• Reduced incidence of fatal and non-fatal CV events in patients with severe OSA• Reduced risk of recurrent atrial fibrillation after successful cardioversion
Blood glucose • Decrease in insulin sensitivity
Wickwire EM, Albrecht JS, Towe MM, et al. Chest. 2019;155(5):947-961. Management of obstructive sleep apnea in the primary care setting. Intermountain Health website. c. Accessed October 2019.
Both CPAP and Oral Appliances are Effective OSA Therapies
Phillips CL, Grunstein RR, Darendeliler MA, et al. Am J Respir Crit Care Med. 2013;187(8):879-87.
Ap
nea
-Hyp
op
ne
a In
dex
(ev
ents
/h)
60.0
0.0
20.0
40.0
Baseline Apnea-Hypopnea Index (events/h)
60.00.0 20.0 40.0
CPAP
Oral Appliance
All Metrics of Sleep-Disordered Breathing Improved Regardless of Treatments• Randomized, crossover trial comparing 1
month each of CPAP and oral appliance treatment on cardiovascular and neurobehavioral outcomes
• CPAP was more efficacious than MAD in reducing AHI
• Sleepiness, driving simulator performance, and disease-specific quality of life improved on both treatments by similar amounts
• Quality of life was higher with the oral appliance vs. CPAP
(n=126 patients with moderate-severe OSA)
AHI: Apnea-Hypopnea IndexMAD: Mandibular advancement device
Adherence to OSA Therapy is Key to Improving Clinical and Economic Outcomes
• Lack of adherence is a key factor that compromises the potential benefits of treatment
• Differences in efficacy and adherence between treatments can influence outcomes
• The potentially greater efficacy of CPAP may be offset by inferior adherence
Phillips CL, Grunstein RR, Darendeliler MA, et al. Am J Respir Crit Care Med. 2013;187(8):879-87.
5.2
7.0*
0
2
4
6
8
10
CPAP Oral Appliance
Pat
ien
t A
dh
ere
nce
(h
ou
rs/n
igh
t) p<0.00001 vs. CPAP
Adherence to the Oral Appliance was Significantly Greater vs. CPAP
(n=126 patients with moderate-severe OSA)
Concerns About the Safety of CNS Stimulants May Impact Adherence to These Agents
• The European Medicines Agency determined the benefits of modafinil-containing medicines only outweighed their risks when treating patients with narcolepsy
• For all other indications, including EDS due to OSA, the risk for development of skin or hypersensitivity reactions and neuropsychiatric disorders outweighed the clinical efficacy
• The US Drug Enforcement Agency has rated modafinil and armodafinil as Schedule IV agents due to their ability to produce psychoactive and euphoric effects
• Although these agents are generally safe, concerns about their safety and/or abuse may impact adherence leading physicians to consider newly introduced non-CNS stimulants such as solriamfetol for patients with EDS due to OSA
European Medicines Agency recommends restricting the use of modafinil. July 22, 2010. Avialable at: https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-restricting-use-modafinil_en.pdf. Accessed October 2019.
Treating OSA Saves Patients and the Health System Money
Frost & Sullivan. Hidden health crisis costing America billions. Underdiagnosing and undertreating obstructive sleep apnea draining healthcare system. Darien, IL: American Academy of Sleep Medicine; 2016. Available at: https://aasm.org/resources/pdf/sleep-apnea-economic-crisis.pdf. Accessed October 2019.
Home Workplace
• Decreased direct medical costs and co-pays for comorbid conditions
• Hypertension
• Diabetes
• Reduced use of medication to manage symptoms of OSA
• Alcohol
• Cigarettes
• Sleeping pills
• Reduced cost of auto accidents and higher insurance premiums
• Fewer workplace absences per year
• Increases productivity
• Improves employment stability
• Greater number of promotions and bonuses
• Fewer workplace accidents
Savings Associated With OSA Treatment
• Annual savings for payers and purchasers if every American with OSA was diagnosed and treated
• Treatment costs would be more than offset by:
• Reduced healthcare utilization
• Improved management of comorbidities
• Increased productivity
• Reduced accident-related costs
$100.1 billion
Frost & Sullivan. Hidden health crisis costing America billions. Underdiagnosing and undertreating obstructive sleep apnea draining healthcare system. Darien, IL: American Academy of Sleep Medicine; 2016. Available at: https://aasm.org/resources/pdf/sleep-apnea-economic-crisis.pdf. Accessed October 2019.
The OSA Benefit Design
Benefit Design for OSA
Formulary positioning
Utilization management
Benefit design
• Health plans should recognize the complexity of OSA treatment and its benefit• Benefit design and coverage criteria should reflect recommendations of evidence-
based guidelines• Provide inclusive coverage with reasonable cost-sharing based on formulary tiering to
avoid adversely impacting adherence to the prescribed therapeutic regimen
Sample OSA Pharmacy Benefit Design
Current guidelines advocating
modafinil and armodafinil for
EDS in OSA
Evaluate newly introduced
therapies for EDS based on safety, efficacy
and cost
Benefit design/coverage criteria:
• Inclusive coverage• Promote access to agents with
different MOAs to optimize outcomes• Tiering/cost-sharing• Utilization management
Payer Case Management Services
• Examples of the benefits of case management services
• Coordinate the referral process
• Ensure patients go to the appropriate specialists and receive best treatment
• Enhance adherence
Patient
Sleep Specialist
Mental Health Professionals
Social Worker
Primary Care Provider
Dietician, Exercise
Therapist
Cardiologist,Endocrinologist,
& other specialists
Summary
• A lack of disease awareness among physicians and patients leads to the underdiagnosis of OSA
• Health plan members with undiagnosed OSA are estimated to be three times higher than those who have received a diagnosis
• Prompt and effective treatment can mitigate the long-term complications of OSA and minimize the impact comorbid diseases
• Lack of adherence is a key factor that compromises the potential benefits of treatment
• Concerns about the safety of CNS stimulants may impact adherence to these agents
• Health plans should recognize the complexity of OSA treatment and its benefit
Multidisciplinary Collaborations for Successful Care of Patients with OSA
Edmund Pezalla, MD, MPHChief Executive Officer
Enlightenment Bioconsult, LLC
Overview
• Review the rationale for multidisciplinary collaborations of the successful care of patients with OSA
OSA Treatment Challenges
• Prevalence may be higher than estimated
• OSA has a multifactorial pathophysiology and is associated with increased morbidity and mortality
• The efficacy of the current standard of care—CPAP—is limited by low adherence
• Management is often complicated by the presence of multiple comorbidities
• Access to specialized sleep laboratories and specialists is limited
Morbidity and Mortality Weekly Report. October 30, 2009. 58(42);1175-1179. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5842a2.htm. Accessed October 2019; Bartlett DJ, Marshall NS, Williams A, Grunstein RR. Sleep Med. 2008;9(8):857-64; Stepnowsky C. Med Res Archives. 2019;7(7); Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Am J Epidemiol. 2013;177(9):1006-14.
The Prevalence of Sleep-Related Disorders May Be Higher Than Estimated
Sleep-Related Problems Affect An Estimated 70 Million Americans1
1. Morbidity and Mortality Weekly Report. October 30, 2009. 58(42);1175-1179. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5842a2.htm. Accessed October 2019; 2. Bartlett DJ, Marshall NS, Williams A, Grunstein RR. Sleep Med. 2008;9(8):857-64
Only 50% of Patients Mention Sleep Difficulties During a
Primary Care Visit2
OSA is a Common, Yet Under Appreciated Chronic Sleep Disorder
• OSA has a multifactorial pathophysiology and is associated with increased morbidity and mortality
• Highly prevalent in middle-aged to older adults
• Many patients live with OSA for years before diagnosis
• Health care costs for OSA patients are ~3x higher vs healthy controls
Stepnowsky C. Med Res Archives. 2019;7(7); Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Am J Epidemiol. 2013;177(9):1006-14.
Diagnosed5%
Undiagnosed21%
Unaffected74%
Americans (30-70 y) with OSA
Guidance on the Long-Term Management of OSA is Unclear
• Clinical guidelines exist for initial treatment of OSA with CPAP
• However guidance on long-term care is lacking• Unanswered questions include
• Which specialist should initiate the patient’s diagnostic and therapeutic process?
• Which specialty should be responsible for managing comorbidities?
• How often, and for how long, should a patient be followed after diagnosis?
• When should a new sleep study be performed?
Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. J Clin Sleep Med. 2019;15(2):301-334; Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. J Clin Sleep Med. 2019;15(2):335-343; Kushida CA, Nichols DA, Holmes TH, et al. Sleep. 2015;38(2):315-26; Marin-Oto M, Vicente EE, Marin JM,. Multidisc Resp Med. 2019;14(21).
OSA Should Be Approached as a Chronic Disease Requiring Long-Term, Multidisciplinary Care
• Rationale for multidisciplinary OSA care:
• A heterogeneous disorder with varying risk factors, clinical presentation, pathophysiology and comorbidity
• Diagnosis and management can benefit from a team of providers across a spectrum of specialties
• Need to manage comorbid conditions
• Increasing number of therapeutic options
• Delivery of patient-centered care
Stepnowsky C. Med Res Archives. 2019;7(7)
Features of a Multidisciplinary Sleep Center
• A multidisciplinary sleep center provides care that is…
• Collaborative
• Coordinated
• Team-based
• Protocol-driven
• Technology-enabled
• Efficient
Traditional vs. Multidisciplinary OSA Care
Sutherland K, Kairaitis K, Yee BJ, Cistulli PA. Multidisc Respir Med. 2018;13:44.
Presentation• Daytime
sleepiness• Snoring• Apnea• Obesity
Diagnosis• PSG • Obtain AHI
Recognition & Diagnosis
Traditional Care Multidisciplinary Care
Risk factors
SymptomsComorbidConditions
Multi-specialty
evaluation
Recognition & Diagnosis
TreatmentCPAP
Treatment Patientpreference
Predictors of
response
Adjunctive care
Treatment of
comorbid conditions
Treatment
PSG: PolysomnographyAHI: Apnea-Hypopnea Index
Monitor CPAP adherence and efficacy
Reinforce CPAP
Try alternative therapy
Restart CPAP
Follow Up
Patient-centered outcomes
Treatment optimization
Follow Up
In Multidisciplinary Management, Responsibility for Care is Shared by PCPs and Specialists
Conventional Care Multidisciplinary Care
Sleep Center PCP Office PCP Office Sleep Center
Intake/Screening
Evaluation
Diagnosis
Management
Kushida CA, Nichols DA, Holmes TH, et al. Sleep. 2015;38(2):315-26
→
→
Development, implementation, and follow up of a management plan by
PCP and Sleep Physician
↙
←Patient with sleep complaint referred to Sleep Center
Patient completes sleep questionnaires
↓Patient evaluated by a Sleep Physician and diagnostic testing ordered
↓
Diagnostic testing interpreted by a Sleep Physician
↓Patient diagnosed by a Sleep Physician
↓
Treatment and follow up by a Sleep Physician
Patient with sleep complaint referred to Sleep Center
↓
Patient screened by a PCP and nurse and referred to Sleep Center
OR
Diagnostic testing by a Sleep Technologist
Patient evaluated by a Sleep Physician and diagnostic testing ordered as necessary
↓Testing interpreted by a Sleep Physician
↓
Patient diagnosed by a Sleep Physician
Medical Specialties Participating in a Multidisciplinary Sleep Center
Clinical Challenge(s) Potential Specialty Involvement
Refractory to CPAP
• Dentistry• Oral and maxillofacial surgery• Otolaryngology• Sleep medicine
OSA and Insomnia• Behavioral sleep medicine• Sleep medicine
Insomnia and Post-Traumatic Stress Disorder• Behavioral sleep medicine• Sleep medicine• Psychiatry
OSA and Craniofacial Anomalies
• Neurology• Orthodontics• Otolaryngology• Plastic surgery• Pulmonology• Sleep medicine
OSA and Neuromuscular Disease• Neurology• Pulmonology• Sleep medicine
Shelgikar AV, Durmer JS, Joynt KE, Olson EJ, Riney H, Valentine P. J Clin Sleep Med. 2014;10(6):693-7.
Patients Given More Therapeutic Options in a Multidisciplinary Care Setting
71%
29%No Treatment
CPAP
Before Multidisciplinary Evaluation After Multidisciplinary Evaluation
OSA patients (n=70) by evaluated for treatment by a multidisciplinary team that included a pulmonologist, otolaryngologist, maxillofacial surgeon and an internal medicine specialist. There was a significant reduction (p<0.001) in the number of patients given no treatment in the multidisciplinary setting vs. usual care.
Carioli D, Romano M, Colobo A, Marra M, Mantero M. Eur Respir J. 2017:3:P41.
31%
18%12%
10%
10%
7%
4%3% 3% Mandibular advancement device
Maxillomandibular surgery
Otolaryngology surgery
CPAP
Other
Positional treatment
Bariatric surgery
Weight loss
No treatment
Multidisciplinary Settings Allow for a More Personalized Approach to Care for Each Patient
Multidisciplinary Care Setting
One or More Specific
Diagnoses
Specific Trea
tmen
tR
ecom
men
da
tion
s
Implementation of a Multidisciplinary Approach to Sleep Care
Interpretation of test results and diagnosis
Discuss results with PCP to determine treatment options
PCP and specialists meet with patient and
caregivers to discuss treatment
Evaluation by subspecialists
PCP reviews physical, clinical signs and symptoms
and refers to Sleep Clinic
Regular monitoring and
follow up by PCP
Care Team Members• Primary care physician• Otolaryngologist• Oral surgeon• Sleep medicine physician• Orthodontist
Care Team Members (cont’d)• Dental sleep medicine specialist• Speech pathologist• Nutritionist• Bariatric surgeon
Camacho M, Ryhn MJ, Fukui CS, Bager JM. Cranio. 2017;35(2):129; Pauna HF, Serrano TLI, Moreira APSM, et al. J Otol Rhinol. 2017;6(4).
Integrating Therapy into the Multidisciplinary Care of OSA
Pauna HF, Serrano TLI, Moreira APSM, et al. J Otol Rhinol. 2017;6(4).
Assessment and routine monitoring
Primary Care
• History and physical exam• Assessment of general health• Management of comorbidities• Referral to specialists• Routine monitoring of
efficacy/safety and adherence to sleep therapy
Specialist Intervention
Sleep medicine specialistCPAP;
pharmacologic therapy
Dental specialistOral appliances;
oral surgery
NutritionistWeight loss;
healthy eating
Physical TherapistExercise;
positional therapy
Case Management Services Within the Health Plan May Assist with Appropriate Referrals
• Role of case management services
• Coordinate the referral process
• Ensures patients receive care from the appropriate specialist(s)
Patient
Sleep Specialist
Mental Health Professionals
Social Worker
Primary Care Provider
Nutritionist, Physical
Therapist
Otolaryngologist, dental
professionals,other specialists
Summary
• OSA is underdiagnosed
• Management is complicated by the presence of multiple comorbidities
• Patients may benefit when their care is managed by a team of providers across a spectrum of sleep medicine-related specialties
• Patients treated in a multidisciplinary setting are given access to a greater number of therapeutic options
• Case management services can assist in the referral process to ensure patients receive care from the appropriate specialists
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This activity is supported by an independent educational grant from Jazz Pharmaceuticals. Live Webcast
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