Future of Drug Delivery and Formulary
Melissa Grimes Ayles, Director of Partner
Relations & Business Development, Patient
Services, Inc.
Mike Ellis, Corporate VP, Specialty Pharmacy &
Infusion, Walgreens
Surya Singh M.D., Corporate Vice-President,
Head of Medical Benefit Management, CVS
Caremark
Burt Zweigenhaft, Vice Chairman, Onco360
Oncology Pharmacy
Future of Drug Delivery and
Formulary
Melissa Ayles, MBA
Director, Partner Relations and
Business Development
Patient Services, Inc.
Cancer Patient Challenges
• Affordability and Accessibility of Medication
– Specialty Tier Medications
– 24% annual income for drug alone
– ACA = AACA “Almost Affordable Care Act”
• Advanced Diagnostics
– Individualized medicine
• Value-Based Therapy
– Ancillary medications and treatments
PSI the Missing Link
• Copay Assistance
– Affordability of medicinal copay needs
– Deductible, out of pocket costs
– Formulary of therapy treatment meds
• Premium Assistance
– Provision of reimbursement vehicle
• Ancillary Services
– Incidental Expenses (wheelchair, oxygen, transportation)
• Network of Specialty Pharmacies
– Focused on Value-Based Cancer Care
Office of Inspector General
SPECIAL ADVISORY BULLETIN, MAY 21, 2014
HTTPS://OIG.HHS.GOV/FRAUD/DOCS/ALERTSANDBULLETINS/2014/INDEPENDENT-CHARITY-BULLETIN.PDF
Compliance is a High Priority
(New Office of Inspector General Special Advisory Bulletin, May 21, 2014)
1. Disease Funds will…
a. Be legitimately defined in accordance with “widely
recognized clinical standards” (e.g. FDA, CMS???)
b. Be defined “in a manner that covers within each fund a
broad spectrum of products wherever possible including generics”.
c. “Not be defined by reference of specific symptoms, severity of
symptoms, method of administration, stages of particular disease, type
of drug treatment, or any other way of narrowing”
d. Not be defined as “high cost or specialty drug funds” and must consider
other financial variables beyond income (e.g. costs of living, debt)
Compliance is a High Priority
(New Office of Inspector General Special Advisory Bulletin, May 21, 2014)
2. No single-drug funds…
a. Providing copayment for only one drug or only one
manufacturer.
b. Unless fund is legitimately defined, includes combining
two or more related disease funds, covers any drugs
needed by patient, covers all copayments for items and services
needed by patients and is submitted for consideration to OIG on
a case by case basis.
Compliance is a High Priority
(New Office of Inspector General Special Advisory Bulletin, May 21, 2014)
3. Diluting Funds May Be Acceptable…
a. According to legal counsel discussions with OIG,
OIG may consider single drug funds if they are “diluted”.
(1). Dilution means: Premium , Copayment, Travel
Expenses, and Ancillary Expenses (Nursing, labs,
diagnostic test, physician copays, infusion costs, etc.)
4. Reporting must be OIG compliant and not correlate
donation amount with patient usage
Consequences to Patients and Manufacturers
Patients
• No access to rare and orphan drugs
• Barrier to assistance: adverse health; life/death
• Most vulnerable populations (Medicare beneficiaries);
establishes a class medical society
Manufacturers
• Add more drugs to the “fund” including generics –supporting
other drugs
• Add premium assistance if a “copayment” program
• Provide “copayment” assistance for only private patients
• If single donor program; dilute with copay, premium, travel
expense, ancillary services
PSI Solutions
• Created and defends model
– Passion and motivation to help patients afford and gain
access to care they need, not just copay assistance
• Broaden Disease State Funds
– Formulary expansion to include generics, and value based
therapies
– Funds include
• Premium Assistance
• Copay Assistance (Deductibles as well as copays)
• Ancillary Services Assistance
Melissa Ayles
Director, Partner Relations and Business Development
Patient Services, Inc.
972.890.2162
mayles@uneedpsi.org
http://www.patientservicesinc.org/
http://www.cancersupportcommunity.org/General-DocumentsCategory/Elevating-the-Patient-Voice.pdf
Future of Drug Delivery
and Formulary
Mike Ellis, Corporate VP,
Specialty Pharmacy & Infusion,
Walgreens
Future of Drug Delivery
and Formulary
Surya Singh M.D., Corporate
Vice-President, Head of Medical
Benefit Management, CVS
Caremark
Generics and Biosimilars in Oncology
• Increasing availability of generics in oncology creating
opportunities for inclusion in specialty tier(s) and
potential exclusions
• Biosimilars – several questions remain, but they are
coming and development activity is increasing
– Sandoz has largest current global biosimilar sales (mainly in
EU) at $500M with an estimated annual growth rate of 20%
and active pipeline
– Amgen developing portfolio of six biosimilars
– Several other manufacturers (Teva, Hospira) active in
biosimilars globally but have not publicly declared plans in US
1
2
1. “No biotech copycat drug lift off before 2017 - Novartis CEO.” Reuters, August 25, 2014. Accessed September 3, 2014 at
http://www.reuters.com/article/2014/08/25/novartis-biosimilars-idUSL5N0QV25X20140825
2. “Amgen makes room for biosimilars despite cutting manufacturing 23%.” BioPharmareporter.com July 30, 2014. Accessed September 3, 2014 at
http://www.biopharma-reporter.com/Markets-Regulations/Amgen-makes-room-for-biosimilars-despite-cuttingmanufacturing
Trastuzumab claims: Substantial Variation in
Allowed Amounts
Source : 2013 CVSC Book of Business
This slide contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not
affiliated with CVS Caremark.
Role of Home & Ambulatory Care in Oncology
• Current role in administration of selected supportive
care agents
• Potential role in administration of longer term
therapies (not cytoxic chemotherapy)
• Partnerships with provider organizations & cancer
centers
Future of Drug Delivery
and Formulary
Burt Zweigenhaft, Vice
Chairman, Onco360 Oncology
Pharmacy