the managed care review board™ - impact edu...•pasi score >10 is moderate-to-severe •fda...

The Managed Care Review Board™

• The first curriculum of its kind, The Managed Care Review Board™ is specifically designed and developed for managed care professionals

• It uses a multidisciplinary, evidence-based process for decision-making that contributes to the optimization of patient outcomes to enhance managed care stakeholders' ability to compare the effects of various treatment options on clinical outcomes, perceived value, and economic implications for the entire health care system

• www.ManagedCareReviewBoard.com is a website devoted to delivering these CE activities

Agenda

6:35 AM – 7:15 AM Evolving Treatment Options and Clinical Benefits Update in Psoriasis and Psoriatic ArthritisPhilip Mease, MDPaul Yamauchi, MD, PhD

7:15 AM – 7:35 AM Current Practice Guidelines Review and Application of CER Analyses to Improve Treatment DecisionsKenneth Schaecher, MD, FACP, CPC

7:35 AM – 7:40 AM Faculty Idea Exchange

7:40 AM – 7:55 AM Analyzing the Available Data to Assess the Value of Psoriasis and Psoriatic Arthritis Treatment OptionsDiana Brixner, RPh, PhD, FAMCP

7:55 AM – 8:15 AM Plan Benefit Designs and Specialty Pharmacy Considerations in a New Era of Health Care ReformJames Kenney, RPh, MBA

8:15 AM – 8:30 AM Moderated Faculty Idea Exchange and Audience Question & Answer Session

Educational Objectives

At the conclusion of this activity, participants should be able to demonstrate improved ability to:

• Analyze the available evidence-base for the treatment of psoriasis and psoriatic arthritis (PsA) in a true CER framework

• Assess current and emerging therapies for the treatment of psoriasis and PSA and cite their clinical trial data

• Address nonadherence factors associated with various therapies for psoriasis and PsA

• Integrate interventions to coordinate health plan and affiliated providers efforts in the health care reform era that will lead to better outcomes for patients with psoriasis and PsA

• Provide accurate and appropriate counsel as part of the managed care treatment team

Evolving Treatment Options and Clinical Benefits Update in

PsoriasisPaul Yamauchi, MD, PhD

Clinical Assistant Professor of DermatologyDavid Geffen School of Medicine at UCLA

Adjunct Associate ProfessorJohn Wayne Cancer Institute

Dermatology Institute & Skin Care Center, Inc.Clinical Science Institute

Presentation Agenda

• Assess current and emerging therapies for the treatment of psoriasis and cite their clinical trial data

Psoriasis Epidemiology and Burden

• Affects 2% to 3% of the US population (~7.5 million Americans)1

• 2 million people present with moderate to severe psoriasis

• 150,000 newly diagnosed cases per year

• Affects males and females equally

• All races and socioeconomic groups

• Total direct and indirect health care costs in the US: $135 billion2

1. National Psoriasis Foundation. https://www.psoriasis.org/sites/default/files/publications/PsoriasisFactSheet.pdf. Accessed March 2016.2. Brezinski EA, et al. JAMA Dermatol. 2015;15:651-658.

Psoriasis is a Systemic Disease

• Chronic relapsing immune-mediated inflammatory disease• Psoriatic plaques

• Erythema (redness)

• Induration (thickness)

• Desquamation (scaling)

• Affected areas of the body• Symmetric

• Extensors (elbows, knees)

• Scalp

• Trunk

• No permanent cure

National Psoriasis Foundation. https://www.psoriasis.org/sites/default/files/publications/PsoriasisFactSheet.pdf. Accessed March 2016.

Comorbidities Associated with Moderate-to-Severe Psoriasis

Odds RatioMetabolic syndrome 5.29

Heavy alcohol consumption 3.61

Regular alcohol consumption 3.33

Hypertension 3.27

Smoking 2.96

Type 2 diabetes 2.48

Hyperlipidemia 2.09

Coronary heart disease 1.95

Sommer DM, et al. Arch Dermatol. Res. 2006;298:321-328.

n=581 adult patients hospitalized for plaque type psoriasis vs; n=1044 hospital-based controls

Screening for Joint Involvement and Comorbidities

Joint Involvement1-3

• Up to 30% of psoriasis patients also develop psoriatic arthritis

• ~85% of patients with psoriatic arthritis are first diagnosed with psoriasis

• Psoriatic arthritis often remains undiagnosed in psoriasis patients

• Patients with severe psoriatic disease require care from both dermatologists and rheumatologists, to adequately manage both skin and joint psoriatic involvement

Comorbidities4

• Patient should be screened for:• Cardiovascular disease

• Obesity

• Depression

• Psoriatic arthritis

• Other immune-mediated diseases

1. Gottlieb AB, et al. J Am Acad Dermatol. 2008;58:851-864.2. National Psoriasis Foundation. https://www.psoriasis.org/about-psoriatic-arthritis. Accessed March 2016.3. Haroon M, et al. Ann Rheum Dis. 2013;72:736–740.4. Kimball AB, et al. J Am Acad Dermatol. 2008;58:1031-1042.

Treatment of Psoriasis: Establishing Clinical Goals

• Goal of treatment1

• Clear the skin• Minimize adverse events• Enhance patient quality of life• Address comorbidities

• Treatment strategies2

• Agree upon treatment goals with the patient before initiating therapy• Regularly evaluate treatment response• Modify therapy when the results are insufficient

• Involve patients in the decision-making process and consider patient preferences when establishing the treatment plan1,2

1. Schaarschmidt ML, et al. Arch Dermatol. 2011;147:1285-1294.2. Brezinski E, Armstrong AW. Semin Cutan Med Surg. 2014;33:91-97.

Importance of Patient Preference When Selecting a Psoriasis Therapy

• High rate of non-adherence to prescribed psoriasis therapy2

• Lack of fit of recommended treatment into a patient’s lifestyle may contribute to poor adherence1

• Medications with a convenient means of administration may favorably impact adherence3

1. Schaarschmidt ML, et al. Arch Dermatol. 2011;147:1285-1294.2. Brezinski E, Armstrong AW. Semin Cutan Med Surg. 2014;33:91-97.3. Jin J, et al. Ther Clin Risk Manag. 2008;4:269-286.

24

19 19 18

0

5

10

15

20

25

30

Means ofadministration

Frequency ofadministration

Duration oftreatment

Cost

Re

lati

ve im

po

rtan

ce

Survey of patients with moderate to severe psoriasis (n=163)1

Assessing Psoriasis Severity

• Severity is primarily determined by the proportion of the body surface area (BSA) affected by psoriasis

• Mild: 1% to 3%

• Moderate: 3% to 10%

• Severe: >10%

• Location also determines severity

• Scalp

• Hands and feet

• Groin and skinfolds The surface area of the hand equals ~1% of the skin

National Psoriasis Foundation. https://www.psoriasis.org/about-psoriasis#severity. Accessed March 2016.

Psoriasis Area and Severity Index (PASI) Score

• Scaling score ranging from 0 to 72

• Three elements characterizing psoriatic plaques• Erythema• Induration• Scaling

• Surface area in each body region• Head• Trunk• Upper/lower extremities

• PASI score >10 is moderate-to-severe

• FDA requires a 75% improvement in the PASI score for a clinical success

Feldman SR, Krueger GG. Ann Rheum Dis. 2005;64:ii65-ii68.

Data from the National Psoriasis Foundation Suggests Psoriasis is Undertreated

49.2%

23.6%

9.4%

0

10

20

30

40

50

60

Mild Moderate Severe

Armstrong AW, et al. JAMA Dermatol. 2013;149:1180-1185.

41.9%

29.5%

21.5%

0

10

20

30

40

50

60

Mild Moderate Severe

Proportions of Patients ReceivingNo Treatment

Proportions of Patients Using Topical Medications Alone

Re

spo

nd

ents

(%

)

Re

spo

nd

ents

(%

)

Psoriasis Severity Psoriasis Severity

Reasons Patients Discontinue Their Psoriasis Therapy

Self-reported Reasons for Utilizing Topical Medications

19%

15%

6% 5%

0

5

10

15

20

25

30

Feweradverseevents

Doctor willnot prescribe

any othertherapy

Convenience Lessexpensive

Top Reasons for Discontinuation of a Biologic Medication

Re

spo

nd

ents

(%

)

Armstrong AW, et al. JAMA Dermatol. 2013;149:1180-1185.

8%

16%

28%

12%

0

5

10

15

20

25

30

Did notwork

Stoppedworking

Adverseevent

Insurancewould notcover orcannotafford

Re

spo

nd

en

ts (

%)

Treatment of Psoriasis

• Topical therapies• Steroid creams

• Vitamin D analogues

• Vitamin A retinoids

• Ultraviolet light/lasers• UVB

• PUVA

• Systemic therapies

• Traditional/biologic DMARDs

Mild

Moderate

Severe

National Psoriasis Foundation. https://www.psoriasis.org/about-psoriasis/treatments. Accessed March 2016.

DMARD = disease-modifying antirheumatic drugs

Systemic Therapies Indicated for the Treatment of Moderate-to-Severe Psoriasis

Treatment Target Approval for Psoriasis

Traditional Systemic Therapies

Acitretin Retinoic acid receptor 1996

Cyclosporine T cells 1997

Methotrexate Folate metabolism 1972

Biologics/Small Molecule Drugs

Adalimumab Tumor Necrosis Factor –a 2008

Apremilast Phosphodiesterase-4 2014

Etanercept TNF–a 2004

Infliximab TNF–a 2006

Infliximab-dyyb TNF-a (biosimilar) 2016

Ixekizumab IL17A 2016

Secukinumab IL17A 2015

Ustekinumab IL12/23 p40 subunit 2009

PASI Rates for Systemic Psoriasis Therapies

36

59

71

8276

82

33

89.7

14

30

45

5851

59

70.7

7

20 1826

40.5

0

20

40

60

80

100

Methotrexate Etanercept Adalimumab Infliximab Ustekinumab Secukinumab Apremilast Ixekizumab

Pe

rce

nt

of

pat

ien

ts a

chie

vin

g PA

SI 7

5/9

0/1

00

PASI 75 PASI 90 PASI 100

1. Saurat JH, et al. Br J Dermatol. 2008158:558-566; 2. Leonardi CL, et al. N Engl J Med. 2003;349:2014-2022; 3. Menter A, et al. J Am Acad Dermatol. 2008;58:106-115; 4. Reich K, et al. Lancet.2005;366:1367-1374; 5. Papp K, et al. Lancet. 2008;371:1675-1684; 6. Langley RG, et al. N Engl J Med. 2014;371:326-338; 7. Otezla (apremilast) prescribing information. Celgene Corp. 2015; 8. UNCOVER-2 trial. Presented at the American Academy of Dermatology annual meeting. 2016.

1 2 3 4 5 6 7 8

(Week 16) (Week 24) (Week 16) (Week 24) (Week 12) (Week 12) (Week 16) (Week 12)

Agents in Late Phase Development for Moderate-to-Severe Psoriasis

DrugMechanism of

ActionDosing and

AdministrationStatus

BrodalumabValeant

Anti-IL-17 SC injection every 2 weeks Phase 3

TildrakizumabMerck & Sun Pharmaceuticals


GuselkumabJohnson & Johnson


BI655066Boehringer Ingelheim & Abbvie

Anti-IL-23 SC injection 12 weeks Phase 3

Teng MW, et al. Nat Med. 2015;21:719-729.

PASI Rates for Systemic Psoriasis Therapies in Development

83% 81%74%

87%

70%

57% 58%

42%

16%

0

10

20

30

40

50

60

70

80

90

100

Brodalumab Guselkumab Tidrakizumab BI655066

Pe

rce

nt

of

pat

ien

ts a

chie

vin

g PA

SI

75

/90

/10

0

PASI 75 PASI 90 PASI 100

1. Papp K, et al. AAD 2015. Abstract; 2. Gordon KB, et al. N Engl J Med. 2015;373:136-144; 3. Papp K, et al. Br J Dermatol. 2015; 4. Krueger JG, et al. J Allergy Clin Immunol. 2015;136:116-124.

1 2 3 4

(Week 12) (Week 16; 200 mg) (Week 16; 200 mg) (Week 12; Phase 1)

Biosimilars and Psoriasis

Perspective• Successor to a biologic medicine that

has lost exclusivity• Not a simple generic, but highly

similar to the reference product • No clinically meaningful differences

between the biosimilar and reference product in terms of the safety, purity, and potency

• The biosimilar infliximab-dyyb was approved by the FDA for the treatment of psoriasis on April 5, 2016

Pending Biosimilar Products

Product US Patent Expiration

Etanercept October 23, 2012

Infliximab December 29, 2014

Adalimumab December 31, 2016

US Food and Drug Administration. Biosimilars: Guidance for Industry. April 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed March 2016.

Summary

• Psoriasis is a common chronic inflammatory skin condition associated with significant morbidity

• Comorbidities must be recognized and appropriately managed

• Dermatologists should screen for joint involvement in their psoriasis patients and collaborate with rheumatologists to adequately manage both skin and joint involvement over the long term

• The primary goals of treatment include clearing the skin, minimizing adverse events, addressing comorbidities, and enhancing patient quality of life

• Patient preference should be considered when selecting therapy

• Multiple treatment options are now available, including a recently approved biosimilar

Evolving Treatment Options and Clinical Benefits Update in

Psoriatic Arthritis

Philip Mease, MDClinical Professor

University of Washington School of MedicineDirector, Rheumatology Clinical Research Division

Swedish Medical Center

Presentation Agenda

• Assess current and emerging therapies for the treatment of psoriatic arthritis and cite their clinical trial data

Psoriatic Arthritis: Overview

• Affects ~0.6% to 1.0% of the population1

• 6% to 42% of patients with psoriasis will develop psoriatic arthritis1-3

• Joint symptoms usually appear within 5 to 10 years of cutaneous disease onset4

• 10% to 15% of patients present with concomitant skin and joint symptoms5

1. Mease PJ, et al. J Am Acad Dermatol. 2013;69:729-735. 2. Gottlieb A, et al. J Am Acad Dermatol. 2008;58:851-864.3. Mody E, et al. Br J Dermatol. 2007;157:1050-1051.4. Mease PJ, Armstrong A. Drugs. 2014;74:423-444.5. Ciocoon DH, et al. Br J Dermatol. 2007;157:850-860.

Psoriatic Arthritis: A Chronic, Systemic Inflammatory Disease

1. Paramarta JE, et al. Rheumatology (Oxford). 2013;52: 1873-1878.; 2. Kane D, et al. Rheumatology (Oxford). 2003;42:1460-1468.; 3. Sandre MK, et al. J Cutan Med Surg. 2015;19:367-376.; 4. Sakkas LI, et al. Semin Arthritis Rheum. 2013;43:325-334.; 5. Brockbank JE, et al. Ann Rheum Dis. 2005;64:188-190.

Enthesopathy (75%)4

Dactylitis (48%)5

DIP involvement (39%)2

Axial involvement (40-50%)1

Nail involvement (85%)3

Skin In

volvem

en

t

DIP=distal interphalangeal predominant

Burden of Psoriatic Arthritis

• Historically considered a benign arthropathy1, however, as many as 66% of patients develop bone erosions and joint deformities2

• Joint damage contributes to3

• Reduced articular function

• Higher mortality

• Increased risk of comorbid disease

• Impaired ability to work and form/maintain social relationships

• Poor quality of life

• Average annual direct and indirect per patient cost associated with psoriatic arthritis is ~$8,367 to $18,1104

1. Shbeeb M, et al. J Rheumatol. 2000;27:1247–1250.2. Kane D, Pathare S. Rheum Dis Clin North Am. 2005;31:641–657.3. Messe PJ, Armstrong AW. Drugs. 2014;74:423–441.4. Lee S, et al. P&T. 2010;35:680-689.

Psoriatic Disease: A Complex, Polygenic Autoimmune Disease with Diverse Clinical Features

Slide courtesy of Oliver FitzGerald.

CASPAR Classification Criteria

Taylor W, et al. Arthritis Rheum. 2006;54:2665-2673.

CASPAR=ClASsification of Psoriatic ARthritis

Criteria CommentSTEM Criteria Clinician considers patient to have an inflammatory arthritis, enthesitis, or spondylitis

1. Evidence of psoriasisa. Currentb. Historyc. Family history

a. Psoriatic skin or scalp disease present todayb. History of psoriasisc. History of psoriasis in a first- or second-degree relative (according to patient report)

2. Psoriatic nail involvement Typical psoriatic nail dystrophy, including onycholysis, pitting, and hyperkeratosis, observed on current physical examination

3. RF negative Preferably by enzyme-linked immunosorbent assay or nephelometry

4. Dactylitisa. Currentb. History

a. Swelling of an entire fingerb. History of dactylitis recorded by a rheumatologist

5. Radiologic evidence of juxta-articular new bone formation

Ill-defined ossification near joint margins (but excludingosteophyte formation) on plain radiographs of a hand or foot

*The specificity/sensitivity is 99%/93% respectively.

A Diagnosis of Psoriatic Arthritis in Patients with Skin Involvement Can be Challenging

41

15

27

2 1 1

13

0

5

10

15

20

25

30

35

40

45

50

Psoriaticarthritis

Psoriasis + OA OA Gout Psoriatic arthritis + gout

OA + gout Indeterminate

Pe

rce

nt

of

pso

rias

is p

atie

nts

Mody E, et al. Br J Dermatol. 2007;157:1050-1051.

OA = osteoarthritis

Screening for Psoriatic Arthritis

Symptom Recognition

• General symptoms• Fatigue

• Morning stiffness >30 min

• Joint symptoms• Reduced range of motion

• Stiffness, pain, throbbing, swelling and tenderness in one or more joints

• Swollen fingers and toes

Screening Tools• Psoriasis Epidemiology Screening

Tool (PEST)1

• Toronto Psoriasis Arthritis Screen (ToPAS)2

• Psoriatic Arthritis Screening Evaluation tool (PASE)2

• Psoriatic Arthritis Screening Questionnaire (PASQ)3

• Early Arthritis for Psoriatic Patients (EARP)4

1. Ibrahim GH, et al. Clin Exp Rheumatol. 2009;27:469-474.2. Gladman DD, et al. Ann Rheum Dis. 2009;68:497-501.3. Dominguez PL, et al. Arch Dermatol Res. 2009;301:573-579.4. Khraishi M, et al. Psoriasis Forum. 2010;16:9-16.5. Tinnazi I, et al. Rheumatology (Oxford). 2012;51:2058-2063.

Psoriatic Arthritis Treatment Principles: Early Intervention and Tight Control

• Early intervention with protocol-driven therapies combined with a treat-to-target approach can control inflammation and minimize disease activity

• Treatment should be aimed at reaching the target of remission or minimal/low disease activity

• Availability of drugs that can slow down or prevent joint damage reinforces the importance of early diagnosis and treatment

• Regular monitoring is required to appropriately adjust therapy to maintain tight control and improve outcomes

Coates LC, et al. Lancet. 2015;386:2489-2498.Gossec L, et al. Ann Rheum Dis. 2016;75:499-510.

GRAPPA Treatment Recommendations (2016)

Standard therapeutic route Expedited therapeutic route

Ass

ess

acti

vity

, im

pac

t an

d p

rogn

ost

ic

fact

ors

DMARDs (MTX, SSZ, LFN), TNFi or

PDE4i

Biologics (TNFi, IL12/23i IL17i) or

PDE4i

Peripheral arthritis

Switch biologic (TNFi, IL12/23i or

IL17i)NSA

IDs

and

IAI c

ort

ico

ster

oid

s as

in

dic

ated

NSAIDs only

TNFi, IL17i or IL12/23i

Axial disease

Switch biologic (TNFi, IL17i or

IL12/23i)

Ph

ysio

ther

apy

and

NSA

IDs

No direct evidence for therapies in axial PsArecommendations based on axial SpA literature

NSAIDs

Biologics (TNFiIL12/23i, IL17i) or

PDE4i

Enthesitis

Switch biologic (TNFi, IL12/23i, IL17i) or PDE4i

Ph

ysio

ther

apy

CS injections: consider on an individual basis due to potential for serious side effects; no clear evidence for efficacy

NSAIDs

DMARDs (MTX, LEF, SSZ) or PDE4i

Dactylitis

Biologics (TNFi, IL12/23i)

Co

rtic

ost

ero

id in

ject

ion

s as

ind

icat

ed


Topicals(keratolytics,

steroids, vit. D analogues, emollients,

calcineurin i)

Phototx or DMARDs (MTX, CSA, acitretin, fumaric acid

esters) or PDE4i

Skin

Biologics (TNFi, IL12/23i, IL17i) or

PDE4i

Top

ical

sas

ind

icat

ed

Switch biologics (TNFi, IL12/23i, IL17i) or PDE4i

Biologics (TNFi, IL12/23i, IL17i) or

PDE4i

Topical or procedural or

DMARDs (CSA, LEF, MTX, acitretin)

Nails


Which domains are involved?

Coates LC, et al. Arthritis Rheumatol. 2016 Jan 8. doi: 10.1002/art.39573. [Epub ahead of print]GRAPPA = Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

EULAR Recommendations for the Management of Psoriatic Arthritis

Peripheral arthritis

• NSAIDs for relief of musculoskeletal symptoms

• Conventional DMARDs in early stage disease

• Methotrexate preferred with skin involvement

• IA/systemic steroids as adjunctive therapy

• Biologics

• Anti-TNF for inadequate response to conventional DMARD

• Anti-IL 12/13 or IL17 for inadequate response to conventional DMARD and ineligible for anti-TNF

• PDE-4 inhibitor for inadequate response to conventional DMARD and ineligible for anti-TNF

• Biologics (anti-TNF) if insufficient response to NSAIDs

Axial disease

• Biologics (anti-TNF) if insufficient response to NSAIDs

Enthesitis and/or Dactylitis

Gossec L, et al. Ann Rheum Dis. 2016;75:499-510.

DMARD = disease-modifying antirheumatic drugs; EULAR=European League Against Rheumatism; IA = intra-articular; NSAID = nonsteroidal anti-inflammatory drugs

Psoriatic Arthritis: Currently Used Therapies

Coates LC, et al. Arthritis Rheumatol. 2016 Jan 8. doi: 10.1002/art.39573. [Epub ahead of print]

Drug name/Manufacturer CommentsDMARDS • Weak recommendation

• Usually required as first line therapy by payers before more expensive treatment options are tried

Methotrexate

Sulphasalazine

Leflunomide

TNF inhibitors • Strongly recommended• TNF-inhibitor drugs are the first-line biologic agents for treating psoriatic arthritisAdalimumab

Certolizumab pegol

Etanercept

Golimumab

Infliximab

Infliximab-dyyb (biosimilar)

IL-17 inhibitor • Strongly recommended• FDA-approved for first-line use in psoriatic arthritis• Does not have to be used after an TNF-inhibitorSecukinumab

IL 12/13 inhibitor • Strongly recommended for peripheral arthritis and enthesitis

Ustekinumab

Phosphodiesterase inhibitor • Good recommendation

Apremilast

Therapies Approved for Psoriatic Arthritis: ACR20 at Week 24

5450

5752

64

4438

51

0

10

20

30

40

50

60

70

80

90

100

Infliximab Etanercept Adalimumab Golimumab Certolizumab Ustekinumab Apremilast30 mg bid

Secukinumab

Pe

rce

nt

of

pat

ien

t ac

hie

vin

gA

CR

20

at

We

ek

24

1. Kavanaugh A, et al. Ann Rheum Dis. 65:1038–1043; 2. Mease P, et al. Arthritis Rheum. 2004;50:2264-2272; 3. Mease P, et al. Ann Rheum Dis. 2009;68:702-709; 4. Kavanaugh A, et al. Ann Rheum Dis. 2013;72:1777-1785; 5. Mease P, et al. Ann Rheum Dis. 2014;73:48-55; 6. McInnes I, et al. Lancet. 2013;382:780-789; 7. Kavanaugh A, et al. Ann Rheum Dis. 2014;73:1020-1026; 8. Cosentyx (secukinamab) prescribing information. Novartis Pharmaceuticals Corporation. January 2016.

1 2 3 4 5 6 7 8

ACR20=American College of Rheumatology 20% improvement criteria

Emerging Therapies in Late-phase Development for Psoriatic Arthritis

Drug Mechanism of Action Dosing & Administration Status

IxekizumabLilly

IL-17A antagonist SC injection every two or four weeks Phase 3

BrodalumabValeant

IL-17 receptor antagonist SC injection every two weeks Phase 3

AbataceptBMS

T cell (T lymphocyte) activation inhibitor

SC injection once weekly Phase 3

TofacitinibPfizer

Janus kinase (JAK) inhibitorOral administrationBID dosing

Phase 3

TildrakizumabMerck & Sun Pharmaceuticals

IL-23 inhibitor Dosed every 12 weeks Phase 3

GuselkumabJohnson & Johnson


RisankizumabBoehringer Ingelheim


Multidisciplinary Management of Psoriatic Arthritis

• Management of psoriatic joint disease often requires the expertise of a rheumatologist in conjunction with dermatology1

• Multidisciplinary care may facilitate the diagnosis of joint disease and offers a more comprehensive treatment approach for patients with both psoriasis and psoriatic arthritis2

1. Velez NF, et al. Arch Dermatol Res. 2012;304:7-13.2. Luelmo J, et al. Rheumatol Clin. 2014;10:141–146.

From Dermatology From Rheumatology

• Peripheral arthritis

•Dactyilitis

•DIP synovitis

• Enthesitis

• Inflammatory low back pain

•Unspecified joint pain

•Asymmetrical oligoarthritis

• Patients with suspected arthritis and psoriasis

• Patients with poor skin and psoriatic arthritis treatment results

• Patients with psoriatic arthritis and severe skin psoriasis

• Suspected skin complications associated with treatment

Sample Referral Criteria for Patients with Psoriatic Disease1

DIP=distal interphalangeal predominant

Summary

• Psoriatic arthritis is a chronic, progressive, debilitating disease affecting 0.3% to 1.0% of the US population

• Up to 40% of patients with psoriasis develop psoriatic arthritis; two-thirds of whom will develop bone erosions and joint deformities

• Early diagnosis and treatment can lead to better outcomes

• Screening tools are available but must be routinely implemented in clinical practice to be effective

• With several novel therapeutic options now available and more in development, treatment decisions in clinical practice remain challenging

• Given the heterogeneous presentation of psoriatic arthritis, multidisciplinary approach is needed for its diagnosis and management

Current Practice Guidelines Review and Application of CER Analyses to

Improve Treatment DecisionsKenneth Schaecher, MD, FACP, CPC

Medical DirectorSelectHealth

Presentation Agenda

• Familiarize participants with current published practice guidelines for the treatment of psoriasis and psoriatic arthritis

• Analyze the available evidence-base for the treatment of psoriasis and psoriatic arthritis in a true comparative effectiveness research framework

Treatment Guidelines: Psoriasis and Psoriatic Arthritis

• Providers and managed care professionals rely on guidelines to inform clinical and benefit design decisions

Menter A, et al. J Am Acad Dermatol. 2011;65:137-174; Coates LC, et al. Arthritis Rheumatol. 2016 Jan 8. doi: 10.1002/art.39573. [Epub ahead of print]; Gossec L, et al. Ann Rheum Dis. 2016;75:499-510.

Limitations of Current Psoriatic Disease Treatment Guidelines

• Health care decision-making, whether at the bedside or in the executive suite, is significantly influenced by guidelines

• While guidelines are critical for the delivery of quality care, they are inherently limited by: • The relative small proportion of medical practices actually studied in well-

designed clinical trials• Lack of head-to-head comparator trials• Inability to keep up with the rapid pace of change in medical therapies

• For example, the psoriasis treatment guidelines have not been updated since 2011 despite the approval of at least 4 novel agents for its treatment

• Reliance on expert opinion and clinical experience• Lack of patient perspective

Menter A, et al. J Am Acad Dermatol. 2011;65:137-174.Coates LC, et al. Arthritis Rheumatol. 2016 Jan 8. doi: 10.1002/art.39573. [Epub ahead of print].Gossec L, et al. Ann Rheum Dis. 2016;75:499-510..

Comparative Effectiveness Research

• Comparative effectiveness research (CER) synthesizes reliable data to compare available therapies in the absence of comprehensive and current treatment guidelines

• CER…• Generates evidence from multiple sources to

compare benefits and harms of methods to treat a clinical condition

• Seeks evidence that is relevant to providers, patients, and payers

• Informs decision making about real-world practices and outcomes

Agency for Healthcare Research and Quality. http://effectivehealthcare.ahrq.gov/index.cfm/what-is-comparative-effectiveness-research1/. Accessed March 2016.

Why CER?

• Health care decision-making must often rely on incomplete data • Lack of head-to-head data can lead to a “trial and error” approach to decision

making• Effectively designed and conducted CER fills data gaps

• Comparison of drug therapies in the absence of head-to-head data• Applicable to a variety of practice settings and patients• Supports decisions about formulary inclusion and positioning

• CER can• Differentiate efficacy of a therapy in a clinical trial vs effectiveness in the real world• Determine threshold of positive effect to alter current behavior

• Patients• Providers• Payers

Brixner DI, et al. J Manag Care Pharm. 2012;18(Suppl. 4-a):S3-S4.Sullivan P, Goldmann D. JAMA. 2011;305:400-401.

Application of CER to Psoriatic Disease

AHRQ CER Report: Psoriatic Arthritis

• Low- to moderate-strength evidence indicates that biologic TNF-α DMARDs improve psoriatic arthritis

• Oral conventional DMARDs may also be beneficial

• AEs associated with DMARDs is insufficient to inform decision making• TNF-α inhibitors are associated with an increased

risk of infection

• Sparse evidence from head-to-head comparisons exists limiting conclusions about which class of DMARDs are superior for minimizing joint damage and optimizing quality of life

Donahue KE, et al. Comparative Effectiveness Review No. 54. Rockville, MD: AHRQ; April 2012.

AHRQ CER Report: Effects of Traditional Systemic Agents on Psoriatic Arthritis Outcomes

Oral DMARDs Strength of Evidence

Sulfasalazine• Greater improvement vs placebo• Minimal clinically important difference not known

Moderate

Methotrexate• Greater improvement vs placebo• Minimal clinically important difference not known

Low

Leflunomide• Improved disease activity vs placebo• No clinically significant improvement in functional capacity• No clinically significant improvement in physical components of health-

related QoL

Low


*Percent of patients achieving ACR20†Health Assessment Questionnaire Minimum Clinically Important Difference (MCID) ≥0.22‡Medical Outcomes Study Short Form 36 PCS = physical component score MCID = 2.2 to 4.7

AHRQ CER Report: Biologic Agents on Psoriatic Arthritis Outcomes

ComparisonStrength of Evidence

Efficacy and Effectiveness Harms

Biologic DMARD + Oral DMARD vs Biologic DMARD or Oral DMARD

• Low• Current evidence limited

• Insufficient• No head-to-head evidence met inclusion

criteria; unable to draw conclusions

Biologic DMARDs • Insufficient; low to moderate• No head-to-head trials met inclusion

criteria; unable to draw conclusions

• Low; insufficient• Evidence limited to placebo-controlled

trials where adverse events were not the primary outcome

• Overall AE profiles appeared to be similar for biologic DMARDs and placebo


Effect of Biologic Agents on Indices of Psoriatic Arthritis Disease Activity


Biologic DMARDs

Improvement in Disease Activity*

Improvement in FunctionalCapacity†

Improvement in Quality of Life‡

Adalimumab 39 to 57% 0.2 to 0.3 2.9 to 7.9

Etanercept 59 to 65% 0.5 to 1.1 8.6

Golimumab 45 to 51% 0.34 to 0.4 5.9 to 7.2

Infliximab 58 to 62% 0.4 to 0.6 6.4 to 8.0

*Percent of patients achieving ACR20†Health Assessment Questionnaire Minimum Clinically Important Difference (MCID) ≥0.22‡Medical Outcomes Study Short Form 36 PCS = physical component score MCID = 2.2 to 4.7

Veterans Affairs Comparison of Biologics for Psoriasis

Veterans Affairs Pharmacy Benefit Management Services. Biologics for Psoriasis and Psoriatic Arthritis. June 2013. http://www.pbm.va.gov/PBM/clinicalguidance/drugmonographs/BiologicsinPsoriasisandPsoriaticArthritisMonographandLiteratureReview.pdf. Accessed March 2016.

Psoriasis

• Ustekinumab is moderately more efficacious than etanercept

• No definite clinically relevant differences in short-term efficacy or effectiveness between Infliximab, adalimumab and etanercept

• Biologic agents are more efficacious and effective than nonbiologic systemic agents

• In real-world practice, incremental gain in effectiveness of biologic agents over methotrexate is small and may not be clinically meaningful

• Limited comparative short-term safety data suggests adalimumab may be better tolerated and less hepatotoxic than methotrexate

• Long-term comparative safety data and cost-effectiveness studies are needed

• Insufficient evidence to support a recommendation to use antipsoriatic biologics as first-line therapy

• Insufficient clinical evidence to support mandating the use of nonbiologic systemic agents before biologics

Veterans Affairs Comparison of Biologics for Psoriatic Arthritis

Veterans Affairs Pharmacy Benefit Management Services. Biologics for Psoriasis and Psoriatic Arthritis. June 2013. http://www.pbm.va.gov/PBM/clinicalguidance/drugmonographs/BiologicsinPsoriasisandPsoriaticArthritisMonographandLiteratureReview.pdf. Accessed March 2016.

Psoriatic Arthritis

• Unclear whether one biologic is better vs others in psoriatic arthritis

• Biologics are disease-modifying vs nonbiologic systemic agents

• Biologics (as a class) may be better tolerated than systemic nonbiologics

• Adalimumab, etanercept, golimumab, and infliximab have evidence to support their first-line use

• Biologics are first-line treatment for patients both plaque psoriasis and psoriatic arthritis

• Adalimumab, etanercept, and infliximab have longer safety records and may be preferable over golimumab or ustekinumab

“Real-world” CER of Biologics for the Treatment of Psoriasis

• Analysis of therapeutic responses to etanercept, adalimumab, infliximab vs ustekinumab during the Psoriasis Longitudinal Assessment and Registry (PSOLAR)

• Primary finding:• In a real-world setting, ustekinumab,

an example of a newer IL12/23 inhibitor biologics, demonstrated greater effectiveness vs TNF inhibitors for the majority of comparisons at 6 and 12 months

Strober B, et al. J Am Acad Dermatol. 2016 Feb 4. pii: S0190-9622(15)02568-2. doi: 10.1016/j.jaad.2015.12.017. [Epub ahead of print]

11

57

10

59

6

36

6

42

17

50

18

56

19

11

19

58

0

10

20

30

40

50

60

70

Baseline 6 months Baseline 12 months

% p

atie

nts

ach

ievi

ng

PG

A s

core

of

0/1

Ustekinumab Infliximab Adalimumab Etanercept

n=2076 patients initiated on a biologic agent

(n=1041) (n=116) (n=662) (n=257)

CER of Systemic Psoriasis Treatments in the Clinical Practice Setting

• Cross-sectional comparison of effectiveness of biologics, non-biologic systemic therapies, and phototherapy for psoriasis across 10 outpatient practice settings (n=713)

• Primary outcome: • Clear or almost clear on the Physician Global

Assessment

• Secondary outcomes• Psoriasis Area and Severity Index• Affected body surface area• Dermatology Life Quality Index

Gelfand JM, et al. Arch Dermatol. 2012;148:487-494.

Real-world Data Suggests Absolute Differences Between Therapies Studied are Small*

23.8%

47.7%

34.2% 36.1%

27.6%

0

10

20

30

40

50

60

70

80

90

100

Methotrexate Adalimumab Etanercept Ustekinumab NB-UVB

% o

f p

atie

nts

77.6% 78.0%75.4%

71.2%68.3%

0

10

20

30

40

50

60

70

80

90

100

Methotrexate Adalimumab Etanercept Ustekinumab NB-UVB

% o

f p

atie

nts

Clear or Minimal Skin Disease Dermatology Life Quality Index

Gelfand JM, et al. Arch Dermatol. 2012;148:487-494.

*Analysis includes biologics approved for the treatment of psoriasis and psoriatic arthritis as of June 2011.

Summary

• Comparison of clinical trial results is difficult due to confounding variables such as variations in study design, patient demographics, and study inclusion criteria• CER allows comparison of treatment methodologies in the absence of head-to-head clinical trial

data

• Data used in to conduct a CER analysis is drawn from multiple sources

• Several CER analyses have been conducted analyzing drug therapies used to treat psoriatic disease• For psoriatic arthritis, few head-to-head comparisons exist, thus limiting conclusions about which

agents may be superior for minimizing joint damage and optimizing quality of life• However, evidence suggest biologics are first-line treatment for patients both psoriasis and psoriatic arthritis

• For psoriasis, clinical trial evidence suggests biologics are more efficacious and effective than nonbiologic systemic agents• Real-world data argues any incremental gain in effectiveness of biologic agents vs methotrexate is small and

may not be clinically meaningful

• CER data is currently lacking for novel agents recently approved for the treatment of psoriatic disease including the phosphodiesterase-4 and IL-17 inhibitors

Analyzing the Available Data to Assess the Value of Psoriasis and Psoriatic Arthritis

Treatment OptionsDiana Brixner, RPh, PhD, FAMCP

Professor, Department of Pharmacotherapy

University of Utah College of Pharmacy

Executive Director, Outcomes Research Center

Director of Outcomes, Program in Personalized Health Care

University of Utah Health Sciences Center

Presentation Agenda

• Assess the value of psoriatic treatment options

Annual Expenditures on the Treatment of Psoriasis in the US is Substantial

Brezinski EA, et al. JAMA Dermatol. 2015;151:651-658.

Source of costAnnual Cost per

Psoriasis Patient ($)*Annual Cost for Psoriasis

Population (Billion $)Estimate of direct health care costs

• Low 6985 51.7

• High 8536 63.2

Estimate of indirect health care costs

• Low 3225 23.9

• High 4787 35.4

Medical comorbidity direct health care costs 4920 36.4

Intangible health care costs 11,498 lifetime cost† 85.1 lifetime cost†

Total Annual Costs $22,863 to $25,796‡ $112 to $135‡

*Adjusted to 2013 dollars using the Consumer Price Index for All Urban Consumers.†On-time cost.‡Does not include intangible health care costs.

Psoriatic Disease Also Places a Large Financial Burden on Patients

• Psoriatic disease (PD) imposes a considerable economic burden1,2

• PD also associated with a higher prevalence of comorbidities and greater health care resource utilization including medication use1,2

• Many patients with psoriatic disease require chronic treatment with higher cost specialty (biologic) agents1,2

• However, a primary reason for patients to not seek treatment is the prohibitive cost of therapy2

• A survey of PD patients indicated that respondents spent >$2500 per year out-of-pocket on their psoriasis care2

• Highest costs were due to health insurance premiums, prescription medications, psoriasis-related physician visits, and over-the-counter therapies2

1. Feldman SR, et al. Arthritis Care Res. 2015;67:708-717.2. Bhutani T, et al. JAMA Dermatol. 2013;149:717-721.

All-cause Health Care Costs for Patients with Psoriatic Disease

$28,265

$18,905

$2389$270

$5883

$436

$5105

$1208 $1540$141

$2309$210

0

5,000

10,000

15,000

20,000

25,000

30,000

Total costs Pharmacy Inpatient Emergencydepartment

Outpatient Other

All-

cau

se h

eal

thca

re c

ost

s ($

)

Moderate to Severe Psoriasis + Psoriatic Arthritis Controls

Feldman SR, et al. Arthritis Care Res. 2015;67:708-717.

Nearly Two-thirds of Patients with Psoriatic Disease are Treated with a Biologic Agent

67.7%

32.3%

0

10

20

30

40

50

60

70

80

90

100

Biologic Alone Biologic +Conventional

DMARD

Pe

rce

nt

of

pat

ien

ts1. Kimball AK, et al. Am J Pharm Benefits. 2015;7:e44-e52.2. Zhu B, et al. Clin Ther. 2013;35:1376-1385.

Psoriatic Arthritis2

(n=3164)

59%

79%

15%

0

10

20

30

40

50

60

70

80

90

100

Biologic Alone OralNon-biologic

Phototherapy

Pe

rce

nt

of

pat

ien

ts

Psoriasis1

(n=6702)

Payers Also Report That Pharmacy Spending on Specialty Biologics Continues to Grow

PwC Health Research Institute. http://www.pwc.com/us/en/health-industries/behind-the-numbers/high-cost-drug.html. Accessed March 2016.

$87.1

$192.2

$401.7

2012 2016* 2020*

109% increase

from 2016

121% increase

from 2012

*projected

Mean Annual Cost of Biologics for Treatment of Psoriatic Disease is >$50,000 per Patient

Wu N, et al. Clin Ther. 2014;36:1231-1241.

Analysis of a PBM Claims Database for 8,306 Privately Insured Patients Conducted January 2008 and August 2011

$24,765

$26,033

$23,443

$24,993

$26,342

$23,450

Rheumatoid arthritis and psoriatic arthritis

Psoriasis and psoriatic arthritis

Ankylosing spondylitis

Psoriatic arthritis

Psoriasis

Rheumatoid arthritis

Mean Cost of Anti-TNF Biologic Agents

Mean Annual Cost Per Psoriatic Disease Patients Treated With Biologics

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

45,000

50,000

Psoriasis Only Psoriatic Arthritsonly

Psoriasis +Psoriatic Arthritis

Psoriatic Arthritis+ Rheumatoid

Arthritis

Mea

n a

nn

ual

co

st (

$)

New Patients(n=1308)

Adalimumab Etanercept Infliximab

Golimumab Ustekinumab

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

Psoriasis Only Psoriatic Arthritsonly

Psoriasis +Psoriatic Arthritis

Psoriatic Arthritis+ Rheumatoid

ArthritisM

ean

an

nu

al c

ost

($

)

Continuing Patients(n=1413)

Adalimumab Etanercept Infliximab

Golimumab Ustekinumab

Howe A, et al. J Manag Care Pharm. 2014;20:1236-1244.

Analysis of the Annual Cost of Biologic Therapies (approved prior to September 2012) for the Treatment Psoriasis and Psoriatic Arthritis

Using a Commercial Claims Database

Adalimumab had the lowest mean

annual cost

Etanercept had the lowest mean

annual cost

Determining the Value of Psoriatic Disease Treatment

Options

Cost Efficacy of Psoriatic Disease Treatments: Caveats

• Biologic agents are more efficacious than conventional DMARDs, but generally carry a higher cost

• The relatively high cost and expanding use of biologics make them an important target for economic evaluation

• Most cost-effectiveness analyses of psoriasis treatments are limited by • Short time horizons• Failure to use quality-adjusted life-years as the effectiveness measure• Failure to cost all relevant resource use

• Cost related to treatment, hospitalization for nonresponders, efficacy, and impact on quality of life are the drivers of cost effectiveness of treatments for psoriatic disease

• Cost efficacy analyses from a US payer perspective for novel agents (eg, apremilast, secukinumab, and ixekizumab) used to treat psoriatic disease are currently limited

D’Souza L, Payette MJ. J Am Acad Dermatol. 2015;72:589-598.Zhang W, et al. Pharmacoeconomics. 2015;33:327-340.

Cost of All Approved Psoriasis Therapies (as of 2013)

Adjusted Monthly Cost per 75% Reduction in PASI

D’Souza L, Payette MJ. J Am Acad Dermatol. 2015;72:589-598.

• Methotrexate and cyclosporine the least costly therapy to achieve PASI 75

• Infliximab the most costly therapy due primarily to cost of infusion

$2,000.00 $4,000.00 $6,000.00 $8,000.00 $10,000.00 $12,000.00 $14,000.00 $16,000.00$-

Ustekinumab 90mg SQ injection

Infliximab 100mg vial

Etanercept 50mg SQ injection

Etanercept 25mg SQ injectionPUVA

Ustekinumab 45mg SQ injectionAcitretin 10 & 25mg tablet

Adalimumab 40mg SQ injection

NBUVB

Cyclosporine 25 & 100mg tablets

Methotrexate 2.5mg tablet

Determining the Value of Treatments for Psoriatic Disease

• Economic evaluation tools include • Cost-effectiveness analysis (CEA): Compares the cost and effectiveness of two or

more treatments

• Cost-utility analysis (CUA): A subtype of CEA, applying quality adjusted life years (QALY) as a measure of effectiveness• Primary outcome measure in CUA is the incremental cost-effectiveness ratio (ICER)

• ICER describes difference in cost between two treatments per QALY gained

• A threshold of $50,000/QALY is often used as a socially acceptable standard against which to compare treatments

Joensuu JT, et al. PLoS One. 2015;10(3):e0119683.

ICER Analysis: Cost-efficacy for Treatment of Psoriasis

• Meta-analysis conducted to determine efficacy (PASI 75) of etanercept, adalimumab, infliximab, and ustekinumab (13 trials; n=5309 patient records)

• Cost-efficacy analysis performed by calculating the ICER per subject achieving PASI 75

6-Month CostIncremental Efficacy of

PASI Response

ICER (cost per additional PASI 75 responder)

Etanercept $17,954 55% Dominated

Adalimumab $13,429 63% $21,3151

Ustekinumab 45mg $16,787 67% $83,9502

Infliximab $19,725 71% $68,1753

Ustekinumab 90 mg $33,574 72% $1,384,9004

1. vs placebo; 2. vs adalimumab; 3. vs ustekinumab 45 mg; 4. vs infliximab

Chi C-C, Wang S-H. Biomed Res Int. 2014;2014:862851.

• Infliximab and ustekinumab 90 mg had the highest efficacy

• Adalimumab had the more favorable cost-efficacy

Sequencing a Non-biologic Agent Early in Treatment is Potentially Cost-saving

Base-case Results Apremilast ComparatorIncremental Difference

Overall costs per patient $234,293 $243,365 -$9072

Life-years per patient 9.82 9.82 0.0

QALYs per patient 6.86 6.72 +0.14

Average time spent on biologic agents, years 4.26 4.82 -0.56

Average time spent with PASI 75 response, years 5.0 4.26 +0.74

Average time spent in best supportive care* 3.96 5.00 -1.04

Incremental cost per QALY gained Dominant

Tencer T, et al. Presented at the 73rd Annual Meeting of the American Academy of Dermatology. March 2015. Abstract 1142.

• Cost-effectiveness assessment from a US payer perspective of placing apremilast before biologics for patients with moderate to severe plaque psoriasis

• 10-year Markov state transition cohort model developed to compare two treatment sequences in the base case: 1) apremilast followed by adalimumab followed by etanercept, and 2) adalimumab followed by etanercept

*Patients who failed etanercept assumed to receive best supportive care (BSC) as last line of treatmentBSC = total healthcare costs following failure of conventional and biologic treatment

Cost Effectiveness of Biologics for Plaque Psoriasis

• Treatment selection in psoriatic disease is influenced by efficacy and tolerability

• Similarly, cost efficacy of an agent is highly influenced by its efficacy and safety• Adverse events often require the consumption of additional health care resources

to manage and/or have a negative effect on patient quality of life (QoL)

• To assess the cost effectiveness of biologic agents with regard to achievement of PASI 75 and a minimally important difference in QoL, 27 studies of biologic agent approved as of January 2012 for the treatment of moderate to severe plaque psoriasis were analyzed

Ahn CS, et al. Am J Clin Dermatol. 2013;14:315-326.

Cost of Achieving a Meaningful Improvement in QoL and Skin Clearance

$9742

$11689

$13299 $13548

0

2000

4000

6000

8000

10000

12000

14000

16000

Infliximab3 mg/kg

Adalimumab40 mg eow*

Adalimumab40 mg eow

Infliximab5 mg/kg

Co

st (

$)

ove

r 1

2 w

ee

ks

Cost per Patient of Achieving PASI 75

$3938

$4565

$5405 $5589 $5710

0

1000

2000

3000

4000

5000

6000

Infliximab3 mg/kg

Etanercept25 mg eow

Infliximab5 mg/kg

Etanercept50 mg eow

Adalimumab50 mg eow*

Co

st (

$)

ove

r 1

2 w

ee

ks

Cost per Patient of Achieving DLQI MID

Ahn CS, et al. Am J Clin Dermatol. 2013;14:315-326.

*after an 80-mg loading doseeow=every other weekPASI=Psoriasis Area Severity IndexDLQI MID=Dermatology Life Quality Index Minimally Important Difference

Summary

• Psoriatic disease imposes a considerable economic burden

• Many patients with psoriatic disease require chronic treatment with higher cost specialty (biologic) agents• Mean annual cost of biologics for treatment of psoriatic disease is >$25,000 per patient

• Relatively high cost and expanding use of biologics make them an important target for economic evaluation

• Several tools are available to assess the cost efficacy of psoriatic disease treatments

• Current data suggests the TNF-a inhibitor biologics are cost-effective, however conclusions are limited by the lack of cost-efficacy analyses conducted from a US payer perspective on newly approved and emerging agents with novel mechanisms of action

Plan Benefit Designs and Specialty Pharmacy Considerations in a New Era of

Health Care ReformJames Kenney, RPh, MBA

Manager, Specialty and Pharmacy Contracts

Harvard Pilgrim Health Care

Presentation Agenda

• Integrate interventions to coordinate health plan and affiliated providers efforts in the health care reform era that will lead to better outcomes for patients with psoriasis and psoriatic arthritis

Healthcare is Transforming

Data driven

Individualized care planning

Multidisciplinary team-based

Managing a population down to the individual

New Model of Chronic Care:Placing the Patient in the Center of Care

Open, two-way communication

Shared decision making

Multidisciplinary team care

Understanding the patient’s perspective

Care coordination

Easy access to care

Clinical information systems & registries

Easy to access & use information

Physician-Patient Communication

• Primary goals of doctor-patient communication include:• Creating a good interpersonal relationship

• Facilitating exchange of information

• Including patients in decision making

• Patients provided information on their diagnosis and prognosis achieve better symptom relief and functional outcomes

• Engaging the patient in the management of their disease

HA JF, et al. Oeschner J. 2010;10:38-43.

Patient-centered Care: Shared Decision Making

• Definition: Health-related decision-making process is made jointly by the patient and health care provider(s)

• Incorporates principles of patient-centered care and evidence-based medicine

• Provider shares information with the patient on the benefits and risks of available options

• Takes into account the provider’s expertise and experience and the patient’s values and preferences

Agency for Healthcare Research and Quality. http://www.ahrq.gov/professionals/education/curriculum-tools/shareddecisionmaking/index.html. Accessed March 2016.

Step 1

Seek patient participation

Step 2

Help patient explore and compare treatments

Step 3

Assess patient’s values and preferences

Step 4

Reach a decisionwith the patient Step 5

Evaluate the decision

Essential Steps of Shared Decision Making

Invite the patient to

participate in treatment decision making

Discuss benefits and

harms

Take into account

what matters to the patient

Decide together on

the best treatment

option

Revisit decision and its

implementation

Agency for Healthcare Research and Quality. http://www.ahrq.gov/professionals/education/curriculum-tools/shareddecisionmaking/index.html. Accessed March 2016.

Redesigning Health Care Benefits:Different Strategies for Different Patients

0

10

20

30

40

50

60

70

80

90

100

0 10 20 30 40 50 60 70 80 90 100

% T

ota

l he

alth

car

e

spe

nd

% of members

Patients who are well or think they are well

Patients with chronic illness

Patients with severe, acute illness,

or injuries

Chronic Inflammatory Conditions are the Most Expensive Specialty Therapy Class

Therapy ClassSpecialty Medical

PMPMSpecialty Pharmacy

PMPM

Total Specialty PMPM

Inflammatory conditions $3.95 $12.30 $16.25

Oncology $7.56 $4.66 $12.23

Multiple sclerosis $0.97 $5.91 $6.88

Immune deficiency $1.87 $3.92 $5.79

Hepatitis agents $0.00 $4.50 $4.50

Growth deficiency $0.00 $1.26 $1.26

Cystic fibrosis $0.00 $1.15 $1.15

Hemophilia $0.33 $0.79 $1.12

All others $6.41 $2.89 $9.30

Milliman Research Report. Commercial specialty medication research: 2016 benchmark projections. December 2015. http://us.milliman.com/uploadedFiles/insight/2016/commercial-specialty-medication-research.pdf . Accessed March 2016.

PMPM = per member per month

Specialty Drug Spending Trend for Inflammatory Conditions

• Represents 27% of all specialty costs and is driven by:• High prevalence of inflammatory conditions such as psoriasis and

psoriatic arthritis

• Expansion in approved indications for the most commonly used drugs in the class

• Recent product launches

• Growth in pharmacy spending for specialty anti-inflammatory products due to plan sponsors shifting management from the medical to the pharmacy benefit as a means of controlling costs• Approximately 76% of costs now paid through the pharmacy benefit

Milliman Research Report. Commercial specialty medication research: 2016 benchmark projections. December 2015. http://us.milliman.com/uploadedFiles/insight/2016/commercial-specialty-medication-research.pdf . Accessed March 2016.

Managing the Spending Trend for Inflammatory Conditions is Challenging

• Benefit design changes implemented to address multiple cost-related issues include• Migrating select medical specialty drugs for management under the

pharmacy benefit

• Standardizing site of care

• Cost sharing

• Specialty tiers

• Introduction of oral biologics

• Biosimilars

EMD Serono Specialty Digest, 11th Edition. 2015.

Designing a Benefit Strategy that Optimizes Patient Care and Controls Costs

• To ensure optimal clinical outcomes and manage costs, the benefit strategy must…• Provide clinical services designed to optimize patient

outcomes and minimize negative consequences• Ensure appropriate use by employing clinical guidelines,

prior authorization, and formulary programs• Equalize benefits between pharmacy and medical to avoid

members selecting a site of administration based on their coverage

Pharmaceutical Strategies Group. Understanding specialty pharmacy management and cost control. http://www.psgconsults.com/Understanding_Specialty_Pharmacy_Management_and_Cost_Control_FINAL.pdf. Accessed March 2016.

Elements of a Benefit Plan Designed To Optimize Patient Care and Controls Costs

Right Drug

Right Site of Care

• Efficacy/safety• Proper duration of

therapy• Correct quantity

(minimize waste)• Preferred products

Right Cost

• Utilization management• Cost-sharing• Deductibles• Copays

• Contracts/ rebates• Outcomes-based

contracts

• Hospital (in/out patient)• Provider office• Retail

pharmacy/clinic• Home nursing care• Home self-care

Specialty Anti-inflammatories: Clinical and Utilization Management

21

30

41

89

93

0 20 40 60 80 100

Remove PA from preferred durgs

Exclude coverage of specific non-preferred products

Strengthen PA for non-preferred drugs

Require PA (SC)

Require PA (IV)

Percent of plans


13

35

70

0 20 40 60 80 100

Allow 90-day supply for stable patients

Include site of service program for IV

Create coverage guidelines across Rx and medical benefit

Percent of plans

(n=70)

(n=70)

IV = intravenous; PA = prior authorization; SC = subcutaneous

drugs

drugs

Specialty Anti-inflammatories: Formulary Management

17%

24%

24%

47%

71%

0% 20% 40% 60% 80% 100%

Select at least 1 preferred product from each routeof administration

Prefer self-administered over provider-administered drugs

Select at least 1 preferred product from eachmechanism of action

Select preferred products regardless of route ofadministration

Select preferred products regardless of mechanismof action

Percent of plans


(n=70)

Specialty Anti-inflammatories: Site of Service Management

17%

29%

29%

56%

50%

56%

0 50 100

Incentivize with lower cost share

Recommend alternate site after firstinfusion

Prior authorization

Percent of plans

Currently implemented Plan to implement within 12 months


n=52 plans that have or plan to have site-of-service programs

Influence of the Site of Care on Treatment Costs and Patient Convenience

Hospital inpatient

Hospital outpatient

Provider office Home

nursing care

Home self-care

Retail clinic

Patient Convenience

Co

st

Specialty Anti-inflammatories: Formulary Tiers

Specialty TiersPercent of

plansMean cost

share

Traditional Benefit Design-Plans with Specialty Tiers

Single tier specialty cost share 71% --

Dollar copay 43% $102

Coinsurance with maximum OOP 57% 22%

Coinsurance max OOP/Rx amount -- $217

High Deductible Plans with Specialty Tiers

Single tier specialty cost share 74% --

Dollar copay 32% $100

Coinsurance with maximum OOP 69% 23%

Coinsurance max OOP/Rx amount -- $326


Summary

• Health care delivery is undergoing a rapid transformation with a new emphasis on patient-centered care

• Health care benefits are evolving in step with changes in care delivery with the goal of optimizing patient outcomes and controlling costs

• Inflammatory conditions such as psoriasis and psoriatic arthritis have the highest per patient per month (PMPM) within the specialty drug therapy class

• Payers implement several utilization and cost management strategies to mitigate the financial impact of treatment

the managed care review board™ - impact edu...•pasi score >10 is moderate-to-severe •fda...

Documents