Specialty Pharmacy and REMS Experiences and Challenges in VA. Phillip Streit, Pharm.D. Department of Veterans Affairs Pharmacy Benefits Management
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1 Specialty Pharmacy and REMS Experiences and Challenges in VA Phillip Streit, Pharm.D. Department of Veterans Affairs Pharmacy Benefits Management
2 VA Healthcare System The Veterans Health Administration is home to the United States largest integrated health care system Comprehensive care provided by more than 53,000 independent licensed health care practitioners
3 Statistics at a Glance Number of VA Health Facilities VA Community-Based Outpatient Clinics 817 VA Hospitals 152 *As of 3/31/12
4 Statistics at a Glance Total Enrollees in VA Healthcare System 8.6 million Outpatient Visits 79.8 million Inpatient Admissions 692,000 *Fiscal Year 2011
5 Statistics at a Glance Total Outpatient Prescriptions Dispensed by VA Facilities in FY2011 > 139 million prescriptions 78.5% dispensed by VA Consolidated Mail Outpatient Pharmacies (CMOP)
6 VA Pharmacy Considerations Electronic health records are available to providers and pharmacists Pharmacist disease state specialists actively participate in patient care and collaborate with providers Continuum of care guides and tracks health services All prescriptions are routed through the VA pharmacy, regardless of procurement source
7 VA Pharmacy Considerations Non-formulary prescriptions are reviewed for approval locally VA is the payor for the majority of prescriptions Contract for product purchase is between VA and the manufacturer, not between VA and specialty distributor/pharmacy
8 General Challenges Posed by Specialty Pharmacy Models VA healthcare system often not considered when restricted distribution models for medications are created. Need earlier involvement Those involved in the design of distribution models are at times not familiar with the unique operational, clinical and contractual processes Private sector models cannot always be successfully implemented in the VA Especially problematic when medication has REMS Elements to Assure Safe Use (ETASU)
9 General Challenges Posed by Specialty Pharmacy Models Participation as a specialty pharmacy closed to VA when dispensing and procurement is limited to contracted pharmacies Specialty pharmacy not contracted by manufacturer to service VA and extend upfront applicable Federal Supply Schedule pricing Manufacturer unaware of FSS terms and contractual responsibilities
10 Specialty Pharmacy Challenges Specialty Pharmacy or distributor unaware of FSS pricing and payment by VA Prescription dispensing delayed by SP when Veteran is unnecessarily contacted for payment or insurance information Benefits investigation by outside service does not apply SP doesn t have process in place to accept a credit card for payment and/or buy and bill transaction
11 Specialty Pharmacy Challenges Use of program Hub that first receives the patient s prescription or enrollment form Unnecessary patient contact Marketing Patient assistance programs, benefit or formulary research Privacy concerns Increases delays and possibility of routing to SP not contracted by manufacturer to service VA
12 Specialty Pharmacy Challenges Review of all documents by VA Federal Supply Schedule (FSS) and Pharmacy Benefits Management (PBM) for compliance and acceptability. VA Privacy Office and Ethics Office involvement when necessary Includes program prescription forms, enrollment or registration documents, acknowledgments, release of information, distributor or specialty pharmacy account applications, counseling materials, etc. Creation of VA specific distribution model forms is often necessary
13 Specialty Pharmacy Challenges Specific to SP Dispensing VA pharmacy needs to be made aware of all medication changes, dispensing dates, discontinuation of therapy and adverse events SP must contact VA pharmacy before subsequent refills are dispensed. Therapy or condition may have changed Medication interaction screening Prescriber consultation Payment
14 Specialty Pharmacy Challenges Specific to SP Dispensing VA must have the option to have SP dispensed prescriptions shipped either directly to the patient or to the VA pharmacy for relay to the patient. Document must reflect those options Prescriptions sent directly to a patient SP required to provide a delivery confirmation summary to VA pharmacy) Monthly sales data reporting
15 Transmucosal Immediate-Release Fentanyl (TIRF) Model Program design- Outpatient pharmacy and patient enrollment transmitted to the program via the pharmacy electronic management system to obtain dispensing approval VA pharmacy unable to implement Resulted in a lengthy REMS revision with significant time commitment and cost to the REMS sponsors Earlier VA involvement is critical
16 Goals Continue to drive awareness of VA requirements with all stakeholders and encourage earlier involvement in the distribution model planning phase History of successfully working together with industry to meet all requirements Dedicated to continue making these important medication options available to our Veterans
17 Contact Information Phillip Streit, Pharm.D. Pharmacy Program Specialist Specialty Distribution Department of Veterans Affairs Pharmacy Benefits Management Service
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