From Diagnosis to Delivery – Disruptive Innovation

in a Specialty PharmacyPartnering with IDNs: BioPharma Strategy Summit

August 17, 2017

JoAnn Stubbings, BSPharm, MHCAAssistant Director, Specialty Pharmacy Services,

Clinical Associate Professor

University of Illinois at Chicago College of Pharmacy

312.996.3098 joanns@uic.edu

OBJECTIVES

• Describe the key characteristics that make an

innovation disruptive and provide examples

• Provide a detailed case study of disruptive

innovation in a specialty pharmacy and tie it

back to the elements of disruption

• Describe opportunities for integration and

strategic partnerships

DISRUPTIVE INNOVATION TRANSFORMS

COMPLICATED, EXPENSIVE PRODUCTS AND

SERVICES INTO SIMPLER, AFFORDABLE ONES

Sources:

Hwang J and Christensen CM. Disruptive innovation in health care delivery: A framework

for business-model innovation. Health Affairs 27(5);2008:1329-1335

• A disruptive business begins with

low quality offerings but eventually

improve quality

• Disruptive businesses in the

initial stages have lower gross

margins, smaller target markets

• Disrupters gain a foothold at the

bottom end of the market that has

been ignored by the incumbent in

favor of more profitable customers

EXAMPLES OF DISRUPTION IN HEALTH CARE

• Minute clinics

• Retail clinics

• Precision medicine/personalized medicine

• Telemedicine/face time

• Changing care of chronic disease: Managing the handoff between diagnosis and adherence

• Passive data collection (wearables and sensors) –change the way healthcare providers interact with patients– Google glass (wearable)

– Digestable sensors

• 3D printers

A MODEL OF DISRUPTION IN SPECIALTY

PHARMACY

• Health system – the original specialty pharmacy

– 1974 – hospital-based investigational drug services documented

– 1978 – first ‘specialty pharmacy’ services for hemophilia patients documented

– 1980s – cyclosporine for kidney transplant, AZT for treatment of AIDS

– 1990s and beyond – hospitals forfeited their ability to become specialty shops to corporate pharmacy organizations

• Specialty pharmacy

management is like navigating

the Chicago ‘el’

• Hub (call center) activity = 1 day

to weeks (insurance

authorization, copayment

assistance)

• Treatment initiation; education

and training; coordination with

clinics; cold chain delivery

• Refill and adherence

management, safety monitoring

and management, clinical

assessments

• Metrics, reporting, outcomes

Normal

56%

At Risk44%

Literacy Risk

CASE STUDY – UNIVERSITY

OF ILLINOIS HOSPITAL AND

HEALTH SCIENCES SYSTEM –

A GRASS ROOTS SPECIALTY

PHARMACY INCUBATOR

• 495 bed academic health center

• DSH; 340B covered entity

• 4,000 employees

• >60 outpatient clinics

• 7 health sciences colleges

• 7 outpatient pharmacies

• 12 Federally Qualified Health

Centers

• 1 million patient encounters

annually

• URAC and ACHC accredited

COMMERCIAL

16% MEDICARE6%

MEDICAID53%

Dual Eligible

24%

SP Payer Mix

SERVICES OFFERED

Specialty Clinics

SPS accepts referrals from clinics via Cerner Specialty Pharmacy Pool. Forward your notes in Cerner to Specialty Pharmacy Services (Pool)

Call CenterInsurance benefit verification

Prior authorization

Medication assistance

SPS program enrollment

Health literacy assessment

Monthly adherence assessments

Escalation to Pharmacist

Documentation in Cerner

Delivery scheduling

Satisfaction surveys

FulfillmentDispensing

Monitor DURs

Multimed management

Safe handling hazardous drugs

Cold chain shipment

Delivery to patient or pickup

Patient Mgt. Program

Specialty Pharmacy Care Plans

Medication and Disease Education

Interventions

Monitoring and Outcomes

Documentation in Cerner

SPECIALTY DISEASE CATEGORIES

Fertility, Growth hormone deficiency, Hepatitis C and Hepatitis B, HIV,

Immune disorders (Crohn’s Disease, IBD, RA, etc.), Lipid disorders,

Multiple sclerosis, Oncology , Orphan disease, Pulmonary arterial

hypertension, Sickle cell disease, Transplant

LOCAL STRATEGY

SERVING THE UI HEALTH

AND UIC COMMUNITY

• ‘Think local and personal’

• The integrated health system

provides seamless delivery of

care ‘from diagnosis to delivery’

• Greater efficiency, improve

outcomes, lower cost

CASE: HCV AND HOMELESS

• 49 year old AA man h/o

schizoaffective disorder,

depression, migraines and GT

1a HCV cirrhosis.

• Tx experienced: relapsed after

12 weeks simepravir+sofosbuvir

• Started treatment with Harvoni

2/26/15 x 24 weeks

• Returned to pharmacy same day

to try to return meds - homeless

TWO TYPES OF DISRUPTION – PROCESS AND OUTCOMES

GREATER

EFFICIENCY

IMPROVE

OUTCOMES

LOWER COST

Embedded Clinical Pharmacists X X X

Clinical Intelligence Systems X X X

Seamless Referrals and PA Submissions X X X

Treatment Integration/Waste Management X X X

Lean Staffing and Layered Learning X X

Custom Delivery Solutions X X

Ability to collect and report Outcomes Data X X X

EXAMPLES OF NEW MODELS

Telehealth X X X

Clinical Performance Contracts X X X

Sources:

Toussaint JS and Mannon M. Hosptals are finally starting to put real-time data to use. Harvard Business Review. November 2014.

Available at: https://hbr.org/2014/11/hospitals-are-finally-starting-to-put-real-time-data-to-use.

Honigman B. The 7 biggest innovations in health care technology in 2014. Available at: https://getreferralmd.com/2013/11/health-care-

technology-innovations-2013-infographic/

STEP 1 – LISTEN TO

OUR PATIENTS

EMBEDDED CLINICAL PHARMACISTS

Transplant

Telehealth

Rheumatology

Medication Therapy

Management

Pharmacy-Based Clinics

Gastroenterology

Women’s Health

Family Medicine

Hepatology

Oncology Cardiology

Pulmonary

PAH

Cardiology/ Heart Center

Internal Medicine/

Managed Care

Infectious Disease

Psychiatry

Dialysis

Diabetes FQHC Neurology Pain

Pediatrics

Free Clinic Sickle Cell Antithrombosis

Pharmacogenetics

CLINICAL INTELLIGENCE SYSTEMS

• Challenge: PCSK9

inhibitors were

approved in 2015

• Anticipated demand

from specialty clinics

and general internal

medicine clinics

• Clinics were not

prepared to manage

challenging PA

process

Sources:

Groo VL, Ardati A, Stubbings JA. Leveraging our strengths: Clinical pharmacist mediated PCSK9 utilization.

American College of Cardiology Annual Scientific Session, Washington DC. March 2017.

Atanda A, Shapiro NL, Stubbings JA, and Groo V. Implementation of a new clinic-based, pharmacist-managed

PCSK9 inhibitor consultation service. To be published in Journal of Managed Care Pharmacy, Best Practices

article, September 2017.

CLINICAL INTELLIGENCE SOLUTION

1. Electronic Health Record

2. Clinic-based Pharmacist

3. Specialty Pharmacy

.

CASE STUDY

• Mr. A is a 52 year old male with history of 3 vessel CABG and AAA

repair at age 50

• Additional history: HTN, sarcoidosis, anxiety, GERD, obesity

• Lipid/statin history:

• PCSK9 ordered – consult generated

TC Trig HDL LDL Drug

Mar 2015 265 70 32 210 Atorvastatin 40mg

Sep 2016 260 39 40 212 Atorvastatin 80mg

PRACTICAL APPLICATIONS OF CLINICAL

INTELLIGENCE SYSTEMS

• The PCSK9 consult service innovation is an example of

an application of a clinical intelligence service and

coordination of care between the provider, a clinic-based

pharmacist, and a specialty pharmacy.

• Benefits of the service:

– Removes the burden from the provider office and

manufacturer/hub

– Increases the success of prior approval

– Improves efficiency, cost effectiveness, and outcomes

• This service could be replicated for other specialty

medications across many clinics

SEAMLESS REFERRALS AND PA SUBMISSIONS

•Range 0-30 days

Benefit Verification to PA Approval* =

3.16 days

Benefit Verification =

<24 hours

Time to Access

Referral from Specialty Clinic via

EHR

Benefit Verfication

Prior Authorization

Start of Therapy

TREATMENT INTEGRATION WITH CLINIC

Treatment Integration with Oncology Clinic

Spec

ialt

y P

har

mac

ySp

ecia

lty

Clin

ic

Diagnosis and Drug Selection

Benefit VerificationPrior Authorization

Approval

Medication Assistance

Start Date

Dispense MedicationWalk to Clinic

Treatment InitiationProgram Enrollment

Monthly Clinical Assessment

Refill MedicationDeliver to Patient at

Homr or in Clinic

Refill AuthorizationLabs and other Diagnositcs

Clinic Appointment

1-2 week Clinical Assessment

• Waste management

• Oral oncology drug will not be

dispensed to patient w/o final approval

from ONC clinic, based on results of

MRI, labs, xrays, and other diagnostic

information.

LEAN STAFFING AND LAYERED LEARNING*

Specialty Pharmacy

Call Center and

Fulfillment

TOTAL FTEs

Assistant Director 1 15

Pharmacists 5

PGY-1 Specialty

Resident

1

Pharmacy Technicians 5

Student Pharmacists 3

Layered Learning

(part-time)

• Independent Study

• APPE, IPPE

• PGY2 residents

10

10

4

* Not included

– Embedded clinical pharmacists in specialty clinics

– Oncology Clinic Pharmacy (Celgene orals and infusions)

– Support staff (IT, finance, contracts, accounts receivable, purchasing, HR)

– Retail fulfillment

• Dispense approximately 1,000

specialty rxs/month

• Staffing covers call center,

clinical program, fulfillment,

and mail order

CUSTOM DELIVERY SOLUTIONS

Contact patient; perform clinical

assessment

Medication ready to be delivered

Determine if patient needs med

(avoid waste)

Schedule delivery and confirm address

Cold pack medication if patient

unable to sign for package

Transfer medication to delivery cooler if it will be handed to

patient

Deliver medication to patient. Document tempature and confirm delivery

ABILITY TO COLLECT PRIMARY DATA AND

REPORT CLINICAL, HUMANISTIC, AND

ECONOMIC OUTCOMES

• For all patients: demographics, medications, line of business, clinical interventions, clinical outcomes

• MPR and Primary Medication Nonadherence and reasons form PMN

• Time to access of medication

• Patient and provider satisfaction

• RA patient demographics and disease activity based on PAS-II score

• Hepatitis C: genotype, medication, and SVR

• Multiple sclerosis: medication, hospitalizations, ER visits, relapses/exacerbations, unmanaged symptoms

• Oral oncology: hospitalizations and ER visits related to cancer

• Medication assistance: including copay cards, foundations, and funds from health system

• Hyperlipidemia: medication, HDL and LDL results

EXAMPLE: PRIMARY MEDICATION

NONADHERENCE

• The overall rate of PMN for all therapies was 18.6%.

• The causes of PMN were related to insurance (33%), coordination (32%), patient (21%), clinical (9%), and cost (5%).

• The highest rate of PMN was for biologic response modifiers (31.8%), followed by MS (20.8%), iron chelation therapy (14.3%), and HCV (13.9%).

Source: Ferri S and Anguiano R. Reasons for primary medication nonadherence in specialty

pharmacy. Academy of Managed Care Pharmacy Annual Meeting, 2016

EXAMPLE: MEDICATION

POSSESSION RATIO

TOTAL

SPS

BRM PAH MS HCV TX HIV ONC

Medicaid 0.91 0.93 0.87 0.92 0.97 0.90 0.84 0.90

Medicare 0.92 0.89 0.89 0.87 0.96 0.92 0.88 0.89

Commercial 0.89 0.89 0.70 0.91 0.93 0.86 0.95 0.90

• Overall MPR is 91%

• No difference by line of business

TOTAL

SPS

BRM PAH MS HCV TX HIV ONC

MPR 0.91 0.91 0.87 0.91 0.96 0.91 0.85 0.90

Min 0.14 0.44 0.47 0.25 0.39 0.14 0.29 0.22

Max 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00

StDev 0.15 0.12 0.15 0.14 0.08 0.17 0.16 0.18

Count 1434 230 23 122 163 655 133 108

% SPS 100.0% 16.0% 1.6% 8.5% 11.4% 45.7% 9.3% 7.5%

OPPORTUNITIES FOR NEW MODELS OF CARE

POINTS OF

COLLABORATION

PARTNERS MODELS

• Prior

authorizations/time to

access

• Clinical services

• Service contracts

• Performance contracts

• Clinical intelligence

systems

• Local access and

personalized care

• Data collection and

reporting

• Manufacturers

• Health plans

• Employers

• Government agencies

• Specialty pharmacies

• Alternative Distribution

Models

• Payment Voucher

• Pay for Performance

• Based on the view that the process for delivery of medical care and services can be continuously improved

• Specific target areas for improvement– Disease state management, preventative care,

patient satisfaction, member outreach

• Incentives– Better clinical care leads to a better clinic

– Monetary

– Favorable public profile

EXAMPLE: CLINICAL PERFORMANCE CONTRACTS

HMO QUALITY IMPROVEMENT (QI) PROGRAM

KEY TAKEAWAYS

• Disrupters gain a foothold at the bottom end of the

market that has been ignored by the incumbent in favor

of more profitable customers

• Health systems can represent grass roots incubators for

specialty pharmacy disruption

• There are opportunities for new models of care and

collaborations