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2. . Presentation Outline. BackgroundDevelopment of Preferred Drug List (PDL) ProgramStatus of PDL ProgramMaximum Allowable Cost (MAC) Pricing Program . . . . . 3. Medicaid Coverage of Prescription Drugs. Prescription drug coverage is an optional benefit. In Virginia, this coverage is provided through fee-for-service and managed care programs.Virginia has instituted several provisions to control prescription drug utilization and spending: generic substitution, drug utilization review, manu1144
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1. Status Report: Medicaid Preferred Drug List Program and Maximum Allowable Cost (MAC) Pricing Presentation to:
Senate Finance Committee
Health & Human Resources Subcommittee
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7. 7 What is a PreferredDrug List (PDL) Program? PDL is a prior authorization program that divides Medicaid covered prescription drugs into two categories:
(1) Those that are available with no prior authorization, known as preferred drugs.
(2) Those that are available with prior authorization, known as nonpreferred drugs.
A preferred drug is selected based on safety and clinical efficacy first, then on cost effectiveness.
Many classes of drugs are not subject to the PDL program.
All clinical decisions regarding the PDL and prior authorization process are made by DMAS Pharmacy and Therapeutics (P&T) Committee.
8. 8 2003 Appropriations Act: Preferred Drug List (PDL) Program Item 325(ZZ.1) of the 2003 Appropriations Act directs DMAS to:
Implement PDL program no later than Jan. 1, 2004
Seek input from physicians, pharmacists, pharmaceutical manufacturers, patient advocates, and others
Form a Pharmacy & Therapeutics (P&T) Committee
Ensure drugs on the PDL are safe and clinically effective before considering cost effectiveness
Include several key provisions: 72-hour emergency supply; 24-hour prior authorization process; expedited review of denials; and consumer/provider training and education
Report to General Assembly on main design components
Generate net savings of $9 million GF in FY 2003 and $18 million GF in future fiscal years
9. 9 Role of P&T Committee The P&T Committee shall recommend to the Department:
therapeutic classes of drugs to be subject to the PDL and prior authorization requirements
specific drugs within each class to be included on the PDL
appropriate exclusions for medications, including atypical anti-psychotics, used for the treatment of serious mental illnesses such as bi-polar disorders, schizophrenia, and depression
appropriate exclusions for medications used for the treatment of brain disorders, cancer, and HIV-related conditions
other appropriate exclusions and grandfather clauses
10. 10 Members of P&T Committee Member Background
Randy Axelrod (MD) (Chairman) Anthem Chief Medical Officer
Roy Beveridge (MD) Oncologist
Avtar Dhillon (MD) Psychiatrist (CSB)
James Reinhard (MD) Psychiatrist (DMHMRSAS)
Arthur Garson, Jr (MD) Dean, UVA Med. School
Mariann Johnson (MD) Family Practice
Eleanor (Sue) Cantrell (MD) Local Health District Director
Christine Tully (MD) Geriatrician, VCU/MCV
Mark Szalwinski (Pharmacist) Sentara Health Care
(Vice Chairman)
Gill Abernathy (Pharmacist) INOVA Health System
Mark Oley (Pharmacist) Westwood Pharmacy
Renita Warren (Pharmacist) Edloes Pharmacies
11. 11 PDL Development Process
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13. 13 Critical Steps Taken in Development Process Met with more than 30 interested parties (manufacturers, providers, pharmacists, advocates, state agencies, etc.) to solicit input into design of PDL program
Formed PDL Implementation Advisory Group
Developed a Virginia-specific program
Provided broad access to all PDL information through dedicated website and e-mail (pdlinput@dmas.state.va.us)
ALL decisions regarding preferred and non-preferred drugs were made by the P&T Committee
14. 14 Critical Steps Taken in Development Process Developed extensive education program
Memorandum and reminder postcard sent to all providers
Information (English & Spanish) sent to all recipients
Regional and targeted training programs for pharmacists, health systems, and provider associations
Extensive beta-site testing with community and long-term care pharmacists
Individual, personal contact made with high volume Medicaid prescribers and pharmacists
Implementation of initial drug classes has gone smoothly
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18. 18 Drug Classes To Be Added to PDL Program in April 2004 Therapeutic Class Description
Oral Hypoglycemics
Leukotrine Modifiers
Bisphosphonates
Traditional NSAIDs
Serotonin Receptor Agonists
Oral Anitfungals Used in The Treatment of:
Diabetes
Allergic Conditions/Asthma
Osteoporosis
Inflammatory Conditions
Migraine Headache
Nail Fungal Infections
19. 19 Review Of Additional Drug Classes Ophthalmologic drugs will be added in July
P&T Committee will review antibiotics and long-acting narcotics at its February 9th meeting for possible inclusion in PDL in July, 2004
By April, 2004, the P&T Committee will have reviewed the top 50 therapeutic classes based on overall expenditures except those that have been excluded from the program and the antidepressants
20. 20 Antidepressants (SSRIs) Medicaid spent approximately $29.5 million in total funds (net of rebates) on SSRIs ($15.8), anti-anxiety drugs ($6.9), and new generation antidepressants ($6.8) in FY 2003
The SSRI drug class is the third highest in expenditures
Generic forms of the SSRIs are coming onto the market
Grandfathering patients currently on a SSRI eliminates concern regarding changing a patients drug regimen
Excluding the SSRIs, anti-anxiety drugs and new generation antidepressants from the PDL would cost approximately $5 million (total funds) annually; a grandfather provision would cost roughly half of this amount
21. 21 Evaluation of PDL Program DMAS will be conducting a thorough evaluation of the PDL Program to address the following key issues:
Has the PDL program been implemented in a way to ensure a high rate of compliance without adversely affecting patient access/care?
What impact has the PDL program had on Medicaid pharmaceutical spending?
Has the PDL program impacted patient health outcomes for Medicaid clients?
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23. 23 Maximum Allowable Cost (MAC) Pricing for Generic Drugs Currently, Virginia Medicaid reimburses pharmacies the Average Wholesale Price (AWP) of the drug minus 10.25% for brand and generic drugs
With multiple source generic drugs, pharmacies often can purchase them for far less than this amount (sometimes 40-60% or greater below brand costs)
Under a MAC pricing program, DMAS would reimburse pharmacies a maximum amount based on the cost that the drug can be purchased by pharmacies in the marketplace
Provides an incentive for pharmacies to be prudent purchasers of generics
MAC price would be set at a level that reflects pharmacies acquisition costs plus an appropriate profit
24. 24 MAC Pricing for Generics At least 35 other state Medicaid programs utilize MAC pricing for generics
MAC pricing is used throughout the commercial insurance market
State Medicaid programs and private insurers vary in how aggressive they are in setting their MAC pricing
The DMAS P&T Committee has recommended strongly that Virginia Medicaid implement a MAC Program
The MAC that is set for each drug must be reviewed and updated periodically to ensure appropriate pricing
DMAS estimates the net savings for its proposed MAC program to be $5.15 million (GF) in each year of the 2004-2006 biennium