#esoutcomes19 1 … · competition how do we continue to ensure you and your members pay the lowest...


YEAR AFTER YEAR, ONE THING REMAINS CERTAIN — HIGH-COST THERAPIES ARE ENTERING THE MARKET

Andy Behm PharmD, BCGP

Vice President, Office of Clinical Evaluation and Policy

Jason Dohm PharmD

Vice President, Formulary Strategy

WHAT WE DO KNOW:

NEW DRUGS ARE COMING


What we will cover today

FDA approvals, upcoming patent expirations

What’s coming in the top 4 therapy classes?

What’s next? - NASH, gene therapy and more

5© 2019 Express Scripts. All Rights Reserved. #ESOutcomes19

FDA drug approvals

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2010 2011 2012 2013 2014 2015 2016 2017 2018 2019

TRADITIONAL SPECIALTY


Patent expiration landscape

$0

$5

$10

$15

$20

$25

$30

$35

$284B

2019–2023 :

$70B


Market dynamics call for innovative solutions

Generic drug costs are on the rise

• Brand manufacturers’

willingness to compete

• Longer generic

exclusivity periods

• Decreasing manufacturer

competition

How do we continue to ensure you and your members pay the lowest possible cost for the most clinically effective medication?


Brand-for-generic substitution $62Min estimated 2018

client savings

of members

are impacted

of claims convert to

preferred branded

medications

<1%

96%+

Preference of select branded medications and

exclusion of higher net-cost clinically equivalent

generic alternatives

• Decreases net drug costs

• Ensures a seamless

member experience

• Does not impact the member’s

generic copay amount


Biosimilar future opportunity

$4.5

$14.8

$4.0 $3.4$1.3

$20

EXPIRED* 2019 2020 2021 2022 2023

Amevive®

Lemtrada®

Rituxan®

Avastin®

Enbrel®

Herceptin®

Xiaflex®

Aldurazyme®

Lucentis®

Simulect®

Tysabri®

Vectibix®

Dysport®

Entyvio®

Orencia®

Soliris®

Actemra®

Natpara®

Nplate®

Provenge®

Humira®

Lumizyme®

Kadcyla®

Stelara®

Ove

rall U

.S. O

pp

ort

un

ity

(in

$ B

illio

ns)

$55B OPPORTUNITY 71 PATENT EXPIRATIONS THROUGH 2023


Focusing on the classes driving your spend

= 40%

THERAPY CLASS PMPY SPEND PMPY TOTAL

1. Inflammatory conditions $174.45

2. Diabetes $114.85

3. Oncology $80.24

4. Multiple sclerosis $55.81

OF ALL 2018

COMMERCIAL DRUG SPEND

Traditional Generic

Traditional Brand

SpecialtyGeneric

SpecialtyBrand

$0 $20 $40 $60 %80 $100 $120 $140 $160


Inflammatory conditions

Includes a variety of chronic, autoimmune diseases:

•Rheumatoid arthritis, psoriasis, psoriatic arthritis,

juvenile idiopathic arthritis, ankylosing spondylitis,

Crohn’s disease, ulcerative colitis, lupus, etc.

Treatment options: #1 THERAPY CLASS BASED ON PMPY SPEND

17% OF ALL SPEND

TNF

inhibitors

Other

biologics

Targeted

synthetic

DMARDS


Inflammatory conditions pipelineDRUG MANUFACTURER INDICATION* ROUTE APPROVAL

risankizumabAbbVie/Boehringer

IngelheimPsoriasis SC Approved

upadacitinib AbbVie Rheumatoid Arthritis Oral Aug. 20, 2019

ustekinumab Janssen Ulcerative Colitis† IV/SC Oct. 21, 2019

bimekizumab UCB Psoriasis SC 2020

filgotinib Gilead/Galapagos RA, UC, Crohn’s Oral 2020

*RA = rheumatoid arthritis, UC = ulcerative colitis

† expanded indication


BIOSIMILAR (MANUFACTURER)INNOVATOR

(BRAND NAME)APPROVAL LAUNCH

infliximab-dyyb (Inflectra - Pfizer/Celltrion) Remicade April 5, 2016 Nov 28, 2016

infliximab-abda (Renflexis - Merck/Samsung Bioepis) Remicade April 21, 2017 July 24, 2017

etanercept-szzs (Erelzi - Sandoz) Enbrel Aug 30, 2016 2019 or 2029

etanercept-ykro (Eticovo - Samsung Bioepis) Enbrel April 26, 2019 TBD

adalimumab-atto (Amjevita™ - Amgen) Humira Sept 23, 2016 Jan 31, 2023*

adalimumab-abdm (Cyltezo™ - Boehringer) Humira Aug 25, 2017 Ongoing Litigation

adalimumab-adaz (Hyrimoz – Sandoz) Humira Oct 31, 2018 Sept 30, 2023*

adalimumab (Samsung Bioepis) Humira No June 30, 2023*

adalimumab (Mylan) Humira No July 31, 2023*

adalimumab (Fresenius Kabi) Humira No Sept 30, 2023*

adalimumab (Momenta) Humira No Nov 20, 2023*

adalimumab (Pfizer) Humira No Nov 20, 2023*

adalimumab (Coherus) Humira No Dec 15, 2023*

* = Settlement Agreement

Inflammatory conditions biosimilars


The #1 class is our #1 priority

Inflammatory Conditions All other classes

17%OF ALL

DRUG SPEND

Over 100 pages of PA policy

Indication-level management through

SafeGuardRx

Helped clients enrolled in ICCV

avoid spending an additional $87M


Diabetes

#1 TRADITIONAL THERAPY CLASS BASED ON PMPY SPEND

11% OF ALL SPEND

30.3MAmericans have diabetes

7.2 million undiagnosed

84MAmericans have prediabetes

Limited novel pipeline development

More competition with existing classes


* Expanded indication

Diabetes pipeline

DRUG MANUFACTURER INDICATION* ROUTE APPROVAL

insulin lispro Lilly Diabetes SC Approved

glucagon,

intranasalLilly/Locemia Hypoglycemia Intranasal May 26, 2019

glucagon,

rescue penXeris Hypoglycemia SC Jun. 10, 2019

semaglutide Novo Nordisk Diabetes, Type 2Oral

Sep. 20, 2019

Farxiga*

(dapagliflozin)AstraZeneca Diabetes, Type 1 Oral 4Q 2019

19

© 2019 Express Scripts. All Rights Reserved.

A UNIQUE OPPORTUNITY TO LOWER PRESCRIPT ION -DRUG PR ICES

Introducing the National Preferred Flex Formulary

Brand manufacturer launches anauthorized alternative

Members have accessto the lower-pricedauthorized alternative

We evaluate the authorized alternative therapy class for inclusion on the National Preferred Flex Formulary

We are having constructive discussions with brand manufacturers and we anticipate the Flex Formulary will manage even more authorized alternatives in the future.


Cancer

#3 THERAPY CLASS BASED ON PMPY SPEND

8% OF ALL SPEND

100+ types of cancer; most common:

Chemotherapy Targeted therapy Immunotherapy

More than 15.5M Americans

with history of cancer

Women:

breast (30%), lung (13%),

colon (7%), uterine (7%)

Men:

prostate (20%), lung (13%),

colon (9%), bladder (7%)

Treatment options:


Cancer pipeline – pending approvalDRUG MANUFACTURER INDICATION* ROUTE APPROVAL

selinexor Karyopharm Multiple Myeloma Oral July 6, 2019

pexidartinib Daiichi SankyoTenosynovial

Giant Cell TumorOral Aug. 3, 2019

entrectinib GenentechNTRK-fusion

+ Solid TumorsOral Aug. 18, 2019

polatuzumab GenentechDiffuse Large

B-Cell LymphomaIV Aug. 19, 2019

quizartinib Daiichi SankyoAcute Myeloid

LeukemiaOral Aug. 25, 2019

darolutamide Bayer Prostate Cancer Oral Oct. 26, 2019

fedratinib Celgene Myelofibrosis Oral Sept. 3, 2019


Cancer pipeline – biosimilars


(BRAND NAME)INDICATION

ANTICIPATED

APPROVAL

ANTICIPATED

LAUNCH

trastuzumab-dkst

(Ogivri - Mylan/Biocon)Herceptin Breast Cancer Approved Mid-2019

trastuzumab-pkrb

(Herzuma - Celltrion/Teva)Herceptin Breast Cancer Approved Mid-2019

trastuzumab-dttb

(Ontruzant - Merck/Samsung Bioepis)Herceptin Breast Cancer Approved Mid-2019

trastuzumab biosimilar

(Trazimera - Pfizer)Herceptin Breast Cancer Approved Mid-2019

rituximab-abbs (Truxima - Celltrion/Teva) Rituxan Several Cancers Approved 2019

rituximab biosimilar (Pfizer) Rituxan Several Cancers Jul. 2019 2019

bevacizumab-awwb

(Mvasi - Amgen/Allergan)Avastin Several Cancers Approved 2019/2020

bevacizumab biosimilar (Pfizer) Avastin Several Cancers Jun. 2019 2019/2020





ANTICIPATED

APPROVAL

ANTICIPATED

LAUNCH

trastuzumab-dkst


trastuzumab-pkrb


trastuzumab-dttb






bevacizumab-awwb




Ensuring access and value in delicate classes

2016Indication level

management in

Oncology Care Value

7/1/2019First Oncology

drug exclusion

2012PA becomes standard

for approved drugs

EVOLUTION OF ONCOLOGY STRATEGIES

2XX 2016

?


Multiple Sclerosis

Immune system attacks myelin and nerve fibers

Fatigue, walking difficulties, numbness or tingling,

spasticity, weakness, vision problems, cognitive

and emotional changes

#4 THERAPY CLASS BASED ON PMPY SPEND

5% OF ALL SPEND

Immunomodulators Biologics Oral therapies

Affects up to 1M Americans

Treatment options:


Multiple Sclerosis pipeline

*RMS = Relapsing Multiple Sclerosis; SPMS = Secondary Progressive Multiple Sclerosis


cladribine EMD Serono RMS & SPMS Oral Approved

siponimod Novartis RMS & SPMS Oral Approved

diroximel fumarate Biogen RMS Oral Dec. 17, 2019

ozanimod Celgene RMS Oral Mar. 25, 2020

dimethyl fumarateBanner Life

SciencesRMS Oral June 20, 2020

dimethyl fumarate

(generics to Tecfidera)Multiple RMS Oral Sept. 27, 2020











dimethyl fumarate


31© 2019 Express Scripts. All Rights Reserved. #ESOutcomes19All numbers are based on

gross costs net of rebates.

$2.4Bin savings for enrolled clients in 2018

from rebates, utilization management

and financial guarantee payments

19% of patients enrolled

in Diabetes Care ValueSM

started statin therapy

avoiding potential heart

attacks1

-5.2% specialty trend

for plans enrolled

in SafeGuardRx

$5M in early

discontinuation paid

to clients in Multiple

sclerosis Care ValueSM

$94k in savings

for a 10,000 live plan

enrolled in Inflammatory

Conditions Care ValueSM

4.3% lower spending

on diabetes medications

by plans enrolled in

Diabetes Care ValueSM

$46M in cost

avoidance for clients

enrolled in Oncology

Care ValueSM

SafeGuardRx — proven health and savings without tradeoffs

1. 2019 DTR Report


Nonalcoholic Steatohepatitis(NASH)

Fat in liver + liver inflammation

+ liver damage

Cause unknown; associated with:

• high cholesterol

• type 2 diabetes

• insulin resistance

• obesity

Limited treatment options

POTENTIAL POPULATION:

6-16M


NASH pipelineDRUG MANUFACTURER ROUTE PHASE APPROVAL

cenicriviroc Allergan Oral 3 2020+

elafibranor Genfit Oral 3 2020+

obeticholic acid Intercept Pharmaceuticals Oral 3 2020+

aramchol Galmed Pharmaceuticals Oral 2 2021+

firsocostat Gilead Oral 2 2021+

lanifibranor Inventiva Pharma Oral 2 2021+

MGL-3196 Madrigal Pharmaceuticals Oral 2 2021+

pegbelfermin Bristol-Myers Squibb SC 2 2021+

semaglutide Novo Nordisk SC 2 2021+

tipelukast MediciNova Oral 2 2021+


Exclude-at-Launch program

Excluding select new-to-market medications until final formulary status is determined

Proactive clinical and financial reviews • Increased client savings

Even stronger pharma negotiations • Seamless member experience

FORMULARY REVIEW PROCESS

All new-to-market products excluded from coverage

Final formulary status decision


Replacing, modifying, or turning

off genes that cause problems

Can modify cells either inside or outside of the body

When inside, a virus vector containing the good gene

may be injected directly into the part of the body with

the defective cells (LuxturnaTM)

When outside, cells are taken from the patients,

genetically modified, multiplied in the lab, and injected

back into the patient (Kymriah®, Yescarta®)

Gene therapy

A NEW TECHNIQUE THAT USES GENES TO EITHER TREAT OR PREVENT A DISEASE


FDA Approved Cellular and Gene Therapies

DRUG MFG USE TYPE

Imlygic

(talimogene laherparepvec)BioVex Melanoma Cell Therapy

Kymriah (tisagenlecleucel) NovartisAcute Lymphoblastic

LeukemiaCell Therapy

LuxturnaSpark

Therapeutics

Biallelic RPE65 Mutation-

Associated Retinal DystrophyGene Therapy

Provenge (sipuleucel-T) Dendrion Prostate Cancer Cell Therapy

Yescarta

(axicabtagene ciloleucel)Kite Pharma Large B-Cell Lymphoma Cell Therapy


Gene therapy: Near-Term Pipeline

DRUG MANUFACTURER PROJECTED APPROVAL INDICATION

Zolgensma(onasemnogene abeparvovec)

Novartis/AveXis 2019 Spinal muscular atrophy (SMA)

Strimvelis GSK/Orchard 2019adenosine deaminase severe combined

immune deficiency (ADA-SCID)

AMT-061 uniQure 2020 Severe hemophilia B

valoctocogene roxaparvovec BioMarin 2020 Severe hemophilia A

LentiGlobin® Bluebird Bio 2020Transfusion dependent patients

with beta-thalassemia and sickle

cell disease

fidanacogene elaparvovec Pfizer / Spark 2021 Severe hemophilia B

Generx(alferminogene tadenovec)

Angionetics 2021Severe angina/chronic myocardial

insufficiency not receptive to other

surgical or medication therapy

ProstAtak(aglatimagene besadenovec)

Advantagene 2021 Prostate cancer

vocimagene amiretrorepvec Tocagen 2022 High grade glioma (brain cancer)


Other Specialty Drugs Pending Approval

DRUG MANUFACTURER INDICATION ROUTE APPROVAL

romosozumab Amgen/UCB Postmenopausal Osteoporosis SC Approved

onasemnogene Novartis Spinal Muscular Atrophy IV May 2019

bremelanotide AMAG Hypoactive Sexual Desire Disorder SC June 23, 2019

celiprolol Acer Vascular Ehlers-Danlos Syndrome Oral June 25, 2019




romosozumab Amgen/UCB Postmenopausal Osteoporosis SC Approved

onasemnogene Novartis Spinal Muscular Atrophy IV May 2019

bremelanotide AMAG Hypoactive Sexual Desire Disorder SC June 23, 2019

celiprolol Acer Vascular Ehlers-Danlos Syndrome Oral June 25, 2019BREMELANOTIDE (VYLEESI – AMAG PHARMACEUTICALS)

Indication: Premenopausal women with hypoactive sexual desire disorder

Route: SC injection (on demand)

Mechanism: Melanocortin receptor agonist




tafamidis Pfizer Transthyretin Cardiomyopathy Oral Approved

afamelanotide Clinuvel Erythropoietic Protoporphyria SC July 8, 2019

golodirsen Sarepta Duchenne Muscular Dystrophy IV Aug. 19, 2019




tafamidis Pfizer Transthyretin Cardiomyopathy Oral Approved

afamelanotide Clinuvel Erythropoietic Protoporphyria SC July 8, 2019

golodirsen Sarepta Duchenne Muscular Dystrophy IV Aug. 19, 2019

TAFAMIDIS (VYNDAQEL – PFIZER)

Indication: Cardiomyopathy caused by transthyretin-mediated amyloidosis

Route: Oral (once daily)

Mechanism: Transthyretin stabilizer


Key takeaways

Innovation continuing

in the top four therapy

classes, which account

for more than 40% of

your drug spend

Keeping a close eye on

NASH and new gene

therapies

Biosimilars are here,

but drastic market

shifts are not

#esoutcomes19 1 … · competition how do we continue to ensure you and your members pay the lowest...

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