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Specialty Pharmacy’s Role in Patient Persistence & Compliance. Dick Rylander President BioPharmaceutical Strategies LLC Former VP Commercial Operations & IT Actelion Pharmaceuticals, US. Speaking Qualifications. 26 years with Parke-Davis

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Specialty Pharmacy’s Role in Patient Persistence & Compliance

Dick Rylander


BioPharmaceutical Strategies LLC

Former VP Commercial Operations & IT

Actelion Pharmaceuticals, US

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Speaking Qualifications Compliance

  • 26 years with Parke-Davis

    • 16 product launches including Lopid; Lipitor; Rezulin; Procan SR; ERYC; Loestrin and others

    • Sales; management; marketing; managed care; incentive planning and special projects

  • 5 ½ years with Actelion Pharmaceuticals as VP Commercial Operations & IT

    • Developed the specialty distribution systems for Tracleer and Zavesca

      • Accredo; Caremark; PharmaCare; Gentiva and Curascript

    • Responsible for managed care; contracting; reimbursement services; IT; data/analytics; forecasting; inventory management, pricing, market research, training, sales force alignment, CRM…

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Specialty vs. Retail Compliance

  • In the presentation we’ll:

    • Define the audiences

    • Outline some of their needs

    • Consider their different perspectives

    • Look at what impacts compliance

    • Share some examples of specialty efforts

    • Frame the strengths/weaknesses of various channels

    • Define when to use specialty

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Specialty Phcy Compliance





Retail Phcy

Who are the audiences?

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Manufacturer Compliance

Who is expecting what?

  • They spend a LOT of money finding patients and getting an Rx written

  • 30-40% of Rx’s written never get filled

  • Dropout rates over the first 6-12 months are HIGH

  • Every patient retained as long as possible is one that contributes to sales and outcomes

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Patient Compliance

Who is expecting what?

  • They don’t now if they can afford the medication's)

  • They worry about side effects

  • They may not understand their disease

  • They may be afraid to ask questions

  • They may believe they need to make sacrifices to get and take their medications

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Retail Phcy Compliance

Who is expecting what?

  • Handle high volumes of patients

  • Are pressed to carve out time to counsel and advise patients

  • Work on small margins and are stretched thin

  • Have broad general knowledge of many diseases but may not have depth

  • Insurance is more focused on mass market high volume drugs where patients don’t need special support

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Specialty Phcy Compliance

Who is expecting what?

  • Mail Order rather than retail based (most)

  • Centralized personnel and services

  • Tend to deal heavily in smaller disease states

  • Tend to deal with more expensive medications

  • Deal with insurance plans for approval, appeals, etc., on a daily basis

  • May have more depth of knowledge in specialty diseases

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Payers Compliance

Who is expecting what?

  • They want to know that the medication is effective and will treat the condition…the first time

  • They need to believe that the treatment is cost effective

  • They need to know that this will reduce hospitalization, ER visits and other costly services

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Employer Compliance

Who is expecting what?

  • Needs to know their money is being well spent

  • That their long term cost exposure is limited

  • That the medication and treatment choices are right

  • That the therapeutic choices will reduce recurring costs

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Specialty Phcy Compliance





Retail Phcy

What are the common needs?

  • Once an Rx gets to the pharmacy:

    • Get it filled quickly

    • At the lowest cost to the patient

    • Get refills fast

    • Answer questions

    • Minimize any concern that will stop the patient from taking the medication

    • Deal with any AE’s or SAE’s

    • If there are problems getting insurance approval or if the co-pay is too high get it resolved

    • Keep the patient on therapy for the duration of treatment

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Compliance, Adherence Complianceand Persistency

  • What are the barriers to patients getting and taking medications and continuing to get refills and what can Specialty Pharmacy do better than retail or manufacturers themselves?

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Patient Barriers Compliance

  • Fear of medications

  • Fear of cost

  • Not understanding the disease

  • Worry about side effects

  • Insurance issues (poor or none)

  • Co-pay’s unaffordable

  • Misinformation

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Access Barriers Compliance

  • Formulary restrictions

  • Prior-Authorization process

  • Timing delays

  • Co-pay’s

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Who are some of the major SPP’s? Compliance

  • Accredo (Medco)

  • Caremark

  • CuraScript/Priority (Express Scripts)

  • Aetna Specialty (Aetna)

  • PharmaCare (CVS)

  • RxCrossRoads (OmniCare)

  • Walgreens Specialty (Walgreens)

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Statistics and Data Compliance

  • 75% of health plans use SPP’s

  • By 2008 biotech drugs may account for 25% of drug spend

  • There are over 600 biotech drugs in development which may require SPP’s

  • More and more drugs will be specialty and require special handling, education, training and assistance

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Stats & Data Compliance

  • Clinical outcome programs administered by SPP’s:

    • MS: 95%+ compliance vs. 80% in retail

    • PAH: Flolan’s central line infection rate was .044 vs. a national average of .45 (a 10 fold difference)

    • Hemophilia: Option Care program after 3 years (in one case example) had a 96% compliance rate vs. <50% prior

    • RA: Caremark data shows 97% compliance vs. 78% at retail and adherence rates of 89% vs. 80%

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Examples of programs at SPP’s Compliance


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Examples of programs at SPP’s Compliance

Accredo offered this example:

  • Unspecified Drug (confidentiality)

    • Known compliance issues (52-55%)

    • Built categories based on Pt. answers

    • Created risk identifiers

    • Model combined objective + subjective responses

  • Result: Compliance climbed to 90%

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ONCOLogic™ - ComplianceValue Proposition

CuraScript has demonstrated superior Oncology patient management through compliance assistance programs:

  • Over 1,000 active patients on service for oral oncology agents

  • Xeloda Average Refill Rate 5.6 cycles/ Average Days 117.6

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Compliance Calculation Report Compliance

  • CuraScripts approach to determining compliance results uses a formula:

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US Bioservices Compliance

  • Harold G. Hilley, Vice President US Bioservices with 12 years in specialty suggests:

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Actelion - Tracleer Compliance

When we planned for the launch we believed we would need certain services:

  • Each patient needed to be touched to understand their financial challenges, co-pay, etc.

  • Special effort made to get prior-auth approval

  • Someone to handle appeals of denials

  • Regular follow up with patients to make sure they got their questions answered

  • Access to payers, state Medicaid's, etc.

  • Monitoring and report of AE’s/SAE’s

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Tracleer Compliance(cont’d)

  • We chose four (4) SPP’s based on their ability to meet our anticipated needs

  • We designed:

    • A closed data system with daily reporting

    • An incentive system to:

      • assure getting patients on therapy within defined periods of time

      • maintain patients on therapy

    • Reporting to tell us how they performed

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Tracleer Results Compliance

  • We built an enrollment system that coordinated with the SPP’s to find those “in plan” with payers

  • We tracked the speed and identified reasons which cases were delayed and why

  • We worked with the SPP’s to understand why patients discontinued and built compliance efforts

  • We steadily improved the percentage of patients getting on and staying on therapy

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How does ComplianceSpecialty compare to Retail?

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When does it make sense Complianceto consider SPP’s?


  • Prescription volume is limited

  • It is a niche disease or smaller population

  • Patients are likely to have co-pay issues

  • Ongoing patient education & training is needed

  • Prior-Auth’s are likely

  • Side effects need to be managed

  • Appeals will be necessary

  • Quality data is needed

  • Quick response is important

  • You need better compliance, adherence and persistence

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SPP’s & Manufacturers Compliance

  • It’s a partnership

    • Sharing information

    • Consulting on outcome data and desired results

    • Developing marketing plans together

    • Planning for future success as a TEAM

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References Compliance

  • “The Rise and Role of Specialty Pharmacy” Biotechnology Healthcare October 2005. David Suchanek http://www.biotechnologyhealthcare.com/journal/fulltext/2/5/BH0205031.pdf

  • “A Practical Approach to Addressing a Longer-Term Benefits Strategy” Employee Benefit Plan review November 2005. David Carver and F. Randy Vogenberg http://www.aon.com/about/publications/pdf/issues/vogenberg_carver_practicalapproach_nov05.pdf

  • “Specialty Pharmacies Seek Ways to Deliver Financial and Clinical Outcomes to Payers” Specialty Pharmacy News July 2005. http://www.aishealth.com/DrugCosts/specialty/SPN_SPs_Seek_Ways_to_Deliver_Outcomes.html

  • “Overview of a Specialty Pharmacy” CuraScript Specialty Pharmacy Management Guide and Trend Report. 2004. http://www.express-scripts.com/ourcompany/news/industryreports/specialtytrendreport/2004/overview.pdf

  • DrugTrend Report: Managing Generation Rx. Vol 7, May 2005, Medco

  • Special case examples from Accredo; Caremark, CuraScript and US Bioservices