Evolution of a Community Pharmacist to a Specialty

PharmacistGary M. Cohen, BS Pharm, RPh

CEO, NASPNick Calla, RPh

Community Specialty Pharmacy Network (CSPN)

Terri Smith Moore, PhD, RPhURAC

Gerry Crocker, NASP

Gary M CohenBSPharm, RPh | Co-Founder, CEO NASP

• Healthcare business executive• More than 30 years of pharmacy & related experience: retail & chain pharmacy management, healthcare

publishing, pharmacy continuing education, certification boards

Previously• Publisher of Specialty Pharma Journal• CEO Synergy Healthcare Communications• Launched Pharmacy Power-Pak• Interim Executive Director, Specialty Pharmacy Certification Board

Arnold & Marie Schwartz College of Pharmacy, Long Island University, 1981

Licensed to practice pharmacy in Florida & New York

Nick Calla

Terri Smith Moore• More than 30 years of healthcare and pharmacy experience, including pharmacy practice, association

management, pharmacy academia, the Federal government, management consulting, managed care pharmacy, quality/performance standards and measurement.

• Currently with URAC in accreditation product development; previously a reviewer• Previously with the National Quality Forum• BS Pharm and MBA (Health Services Administration), Howard University• PhD Pharmacy Administration, University of Texas at Austin

Specialty Pharmacy Market

5

Specialty drug pipeline

exploding

Kroger acquires Axium Specialty Pharmacy… Kinney Drug to build a Specialty Pharmacy..Giant Eagle partnering for Specialty Solution

“Pharmacy

Reimbursement

Under Pressur

e”

“Physician practices

continue to be

acquired by hospital

services”

“…Cancer death rates dropping….becoming a chronic disease

Biosimilars, drug formularies

and utilization management

will be a focus of payors

Agenda

I. Specialty Marketplace – R Channel

II. Stakeholder NeedIII.Headwinds & TailwindsIV.Roadmap to Specialty

Specialty Pharmacy Market

• Fastest growing segment in Pharmacy today and the foreseeable future

• $90B+ market in the U.S. in 2012; $100B+ in 2013• 15-20% trend experienced by payors • 50% of top 100 drugs and 8 of the top 10 will be

specialty pharmaceuticals by 2016• Specialty market is fragmented with extreme variation

in patient care management, service and outcomes• Affordability is a key issue today and in the future

Why is Specialty Pharmacy Different?

• Comparable to a physician “specialist” vs. “primary care” physician – Deeper knowledge/education is required – drugs, therapies and diseases

• Fewer patients encountered (3-5% of population)• Economics/high drug cost (> $2000/30 day supply)

– Benefit coverage – 50% pharmacy & 50% medical benefit

• Drug distribution channels – Limited/Exclusive distribution products– Drug handling/storage (cold chain)

• Data reporting & REMS• More intense clinical programs

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What are Specialty Drugs?

A drug that requires special handling/administration and/or a higher level of patient care management (and high cost)

Retail Specialty Factoids

• Retail market share for specialty drugs is at 18% and steadily declining

• Retail specialty growth rate @ 4% vs. 19% for mail order specialty pharmacies

• Limited distribution specialty drugs on the rise……– Manufacturers don’t believe retail pharmacy can manage

patients, collect data and improve adherence• Limited networks for specialty prescriptions are

increasing……– Payors don’t believe retail pharmacists have specialty

knowledge/expertise, collect data, improve adherence, provide necessary services and be price competitive

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Local Delivery of Specialty Medications

• More self-administered drugs in development• Less special handling• Improved side effect profile• Pressure for wider distribution of products• Specialty @Retail initiatives - chains & independents• Medical benefit to pharmacy benefit transition• Medicaid & Part D member growth

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Top Therapeutic Classes by Channel

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Key Stakeholder Concerns

PHARMA• Cost of

manufacturing• Initiation of therapy• Adherence to

medication therapy• Patient financial

assistance program• Biosimilars

PHARMA• Cost of

manufacturing• Initiation of therapy• Adherence to

medication therapy• Patient financial

assistance program• Biosimilars

PHYSICIAN• Administrative

burden• Facilitate patient P

A’s• Buy & Bill

challenges• Patient data

PHYSICIAN• Administrative

burden• Facilitate patient P

A’s• Buy & Bill

challenges• Patient data

PATIENT• Cost of medication• Quality of life• Side-effect mgmt. • Ease of use• Disease

progression

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•Contract pricing•Enhanced reporting services (Data, Data, Data)•Consistent……clinical services/adherence•Utilization management programs•Enhanced patient services (free supplies)•Performance guarantees and reporting•Access to drug products•Accreditations (ACHC, URAC)

Payor - Specialty Pharmacy Selection Criteria

Anticipated Changes in Specialty Pharmacy Management Based on

Health Care Reform

Source: EMD Serono Digest 2012.

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57%

42%

34%

33%

29%

25%

27%

Specialty Value Proposition – Manufacturer

Services•Drug handling•Inventory management & returns•New to therapy•Clinical management •Adherence •Data collection & reporting

Value•Improvement in patient’s condition•Better quality of life•Lower overall medical costs•Reduced hospitalizations/re-admissions

Rx Abandonment at Retail

•Don’t understand or do not want to take the time to deal with specialty drugs/PAs•Medical benefit billing•Central support area – slow response•Patient requires financial assistance•High cost – inventory/return issues•Cost to fill issue•Pharma HUBs re-direct Rx to preferred Specialty Pharmacies•PBM re-direct Rx to its own Specialty Pharmacy

Headwinds

• Margin pressure – from all payors• Network lockout (PBMs & MCOs)• Limited distribution drugs (Pharma)• Shift in Medicaid programs to managed care• Affordability/cost-sharing – patients & MCOs• New cost basis for Rx’s – acquisition cost + DF• Exchanges/ACOs – low cost products

Tailwinds

• AWP inflation• Biosimilars – higher margins• Aging population• Specialty drug pipeline• Patient life expectancy increasing• Focus on adherence• Health reform – more covered patients• Growth in government programs• Physician buy & bill declining

Road Map to Providing Specialty Pharmacy Services

• Training/education • Access to the drugs • Proper handling/refrigeration• Patient assistance programs• Access to payor networks • Clinical programs• Adherence (MPRs)• Data collection and reporting• Develop physician relationships• Build, buy or partner for services

(or more)

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Specialty Pharmacy Constituents

Patients• Higher member satisfaction• Care Management program support• Education and counseling• Insurance and coverage assistance• Better healthcare

Payors• Proven cost savings• Utilization management• Higher patient and physician

satisfaction• Accountability and better care• Product access and pipeline

control

Specialty Pharmacy

Manufacturers• Reliable, seamless distribution• Appropriate utilization• Patient persistency and

adherence• Access to integrated data• Better outcomes

Physicians• Lower administrative burden• Incentives aligned with patient

care• Assistance in patient education

and follow-up• Convenient solution with better

patient services

SP Stakeholder Value Proposition

Stakeholder Service(s) Value Proposition

Patient Benefits Investigation, Clinical/patient assessments, product fulfillment

Product availability, financial support on OOP expenses, increased compliance and persistency, increase overall quality of life

Physician Coordinated support for patient care, reimbursement support,

Collaborative partner to extend, execute and report on patient care

Payer Implement drug utilization requirements and report on patient and SP performance

Cost savings through appropriate drug utilization, compliance data reporting to validate performance

ManufacturerPatient delivered benefits support, compliance and disease management services, inventory management and data

Provides valuable data that provides insight into patients and business performance, deliver services that increase compliance & persistency and supply chain efficiencies through inventory management and decreased returns

HUB/Patient Support Center

Interfacing with HUB for referrals, coordinate product fulfillment, benefits verification, services and data

Coordinated care/data between SP, HUB and physician

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Medical vs. Pharmacy Benefit Coverage

• Medical • Typically not self administered• Typically billed post service

directly to health plan by provider via CMS1500 or UB04/UB92 claim

• Utilization management less common (but increasing)

• Manufacturer rebates less common (but increasing)

• Typically flat copay/coinsurance.

• Pharmacy• Typically are self administered • Billed to the PBM by the

dispensing pharmacy via a real time NCPDP adjudication

• Subject to PBM rules - Utilization management commonplace.

• Typically a “tiered” copay design• Manufacturer rebates common

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Base Services

•Benefits investigation•Intake processing

– Patient assessment– Clinical Assessment

•Utilization management•Reimbursement assistance

– Alternate funding •Base data capture, transfer & reporting•Patient contact

– Delivery new/refill coordination– Refill reminder– Education

•Dispense & fulfillment

Specialty Pharmacy Service Listing

Enhanced Services

•Patient contact– Compliance calls– Side effect management

•Disease/case management•Adherence programs•Outcomes management•Enhanced data capture, transfer & reporting•Inventory management•Nursing support services•REMS support services/data

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External Resources/Partners

• Technology• Trade relations &

Pharma contracting• Specialty training• Distribution (LDD)• Referral management• Prior authorizations

• Clinical programs • Nursing services• Infusion services • Reimbursement & billing

services• Inventory solutions• Call center (to handle 24

hours patient calls)

Technology Supporting Specialty Pharmacy

• Order management system– Workflow management, track order through entire process

• Exception driven workflow– Let simple therapy items flow through seamlessly– Require additional activities based on complexity of

disease, drug, data collection, etc.• Customizable data collection• Real-time data extraction and analysis

– Custom manufacturer reporting• Integrate with or long side of existing system• Can be configured to support your business needs

SP Informatics – Typical Data Sets

• Manufacturer:– SP location– Physician– Dispense– Compliance – Therapeutic– Payor– REMS– Inventory – Lab values– Program specific

• MCO:– Physician– Dispense– Adherence/Compliance– Clinical programs– Formulary compliance– Performance guarantees– Business performance metrics– Customer service metrics

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Continuous Quality Improvement• Accreditation

– Pharmacies– Demonstrate compliance

with set of well-vetted standards

– Collect/report data on specific measures

• Certification• Pharmacists

Value of Quality Improvement

© 2012 URAC 29

Value to Consumers and EmployersAssures that consumers will receive due process (e.g.,

patient appeals process).

Guarantees that confidential information will be appropriately and securely handled.

Provides employers a measure of comparison to select health care vendors.

Provides access to performance data.

Reduces burden of oversight of health care vendors’ operations.

Value to PolicymakersStandards keep pace with health care advancements

more readily than if undertaken by legislation/regulation.

Affords a cost effective supplement to state oversight of MCO compliance with state regulations.

Ensures that consumer protections are incorporated into managed care operations.

Provides transparency and accountability through nationally recognized and publicly available

standards.

Value to Health InsurersAllows multi-state MCOs to meet different states’

requirements through a single accreditation process.

Differentiates among health insurers, giving accredited companies a marketing advantage.

Encourages operational efficiencies that improve results and reduce costs.

Provides evidence that the insurer is keeping current with quality benchmarks and best practices.

Value to Health Care ProvidersPromotes appropriate clinical oversight of clinical

processes.

Assures same specialty peer-to-peer decision-making for physicians engaged in dispute resolution.

Incorporates provider protections and ensures a timely credentialing process.

Gives providers a voice throughout the health care system.

Value of Accreditation

© 2012 URAC 30

Value of Accreditation to Stakeholders

• Consumers– Ensures confidential information is properly handled, and assures

consumer empowerment• Employers

– Provides performance data and the means of comparison• Health Plans (MCOs)/Insurers

– Ensures participating organizations are meeting operational standards• Policymakers

– Ensures consumer protections are part of operations• Health care providers

– Promotes oversight to clinical process

Specialty Pharmacy Accreditation Standards

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Specialty Pharmacy Measures

Medication Possession Ratios

Complaint Response Timeliness

Dispensing Accuracy

Call Center Performance

Distribution Accuracy

Prescription Turnaround Time

Overall Client Satisfaction

Overall Consumer Satisfaction

19URAC Copyright ©2013

URAC Accreditation/Achievement Process

© 2012 URAC 34

Certified Specialty Pharmacist (CSP)

• The CSP Curriculum:– Specialty 101– Managed care pharmacy– Key disease states by pharmacy practice setting– In-depth clinical and business content– Adherence – Empathy/compassion module – Product distribution/handling – Financial/economic challenges

CSP Value – Specialty Pharmacists

• Validates experience and expertise• Provides recognition and increased credibility for specialty

pharmacists• Provides advantage in competitive job market• Protect patients by improving outcomes and reducing errors• May create job advancement or increased earnings opportunities• Better serves payor requirements• Better positions pharmacists to handle limited or exclusively

distributed drugs• Increases understanding of specialty pharmacy by related

disciplines and stakeholders

Who is Creating the Certification?

• Specialty Pharmacy Certification Board

• Subject Matter Experts from across the industry

• Specialty Pharmacists, Educators, Opinion Leaders

• Consultants specializing in psychometrics & certification best practices

Q & A