Frequently Asked Questions regarding the West Virginia Medicaid Preferred Drug List (PDL)
1. Is a Preferred Drug List (PDL) the same as a formulary? How is it different?
A formulary is a list of drugs that are available and approved for use by an insurance company, managed care organization, or hospital. Drugs must be prescribed from the formulary and no exceptions are available.
A Preferred Drug List (PDL), on the other hand, is a component of the Prior Authorization (PA) process. All medications are covered; however, certain medications may require a PA before the prescription can be filled. In general, preferred medications do not require a PA and non-preferred medications do require one. The PA process requires that non-preferred drugs meet specified criteria in order to be reimbursed by the Bureau for Medical Services (BMS). Medications which have been deemed to be clinically and/or economically advantageous to other similar drugs will be preferred or have preferential status on the PDL. Most medications on the PDL can be prescribed and dispensed without prior authorization.
2. Who develops PA criteria?
West Virginia Medicaid PA criteria are developed by the BMS staff, with the assistance of the West Virginia University School of Pharmacy and are reviewed by the State’s Medicaid Drug Utilization Review (DUR) Board.
3. What is the general process for the PDL?
Each drug is reviewed on its clinical merits relative to other medications in the same therapeutic class. Published, peer-reviewed clinical trials are the primary source of information used by the State’s PDL vendor for this review. Data regarding efficacy, effectiveness, adverse effects, and tolerability is analyzed and compared to other drugs within the therapeutic class. From this analysis, the clinical staff determines an agent’s superiority, equivalency, or inferiority relative to the comparator drugs.
After the clinical review, a financial analysis is performed. This analysis incorporates utilization data from the State as well as net drug costs from the manufacturers. With this data, the financial staff determines the fiscal impact of the PDL status (preferred or non-preferred) of each medication.
Incorporating all of this information, the PDL Vendor makes suggestions to the State’s Medicaid Pharmaceutical and Therapeutics (P&T) Committee regarding the PDL status of each medication. After reviewing and discussing these suggestions, the P&T Committee makes recommendations to BMS for final decisions. The DUR Board then recommends PA criteria to the State.
4. How often will therapeutic classes be reviewed and changes made to the PDL?
Therapeutic classes are reviewed annually, at a minimum. Classes may be reviewed more often if new drugs are introduced to the class.
5. Who makes the final decision as to what drugs are included on the PDL?
The Secretary of the West Virginia Department of Health and Human Resources has the final authority for PDL decisions.
6. Are new drugs included on the PDL?
If a therapeutic class has been reviewed by the P & T Committee and the Secretary of DHHR has approved the recommended drugs in that category, new chemical entities must be listed in FDB for 6 months prior to the next scheduled P & T Committee meeting to be eligible for review. Until that time, the new drug will be non-preferred and available via the PA process. In addition, the new drug will not be listed on the PDL until officially reviewed. If a new drug is considered unique and has been classified a priority drug by the FDA, the Bureau and the P&T Chair may, based on clinical judgement, exempt the drug from the six month rule.
This process does not always apply to line item extensions, such as new strengths or dosage forms of previously available medications or combination drugs whose primary ingredients have already been reviewed by the Committee, or generics of currently available medications.
7. Can PDL decisions be appealed?
PDL decisions may not be appealed. If a pharmaceutical manufacturer believes that factual information was misrepresented at the P&T Meeting, that manufacturer may submit documentation supporting their viewpoint to BMS. Only documentation from published, peer-reviewed medical journals will be accepted. BMS, in consultation with the State’s PDL vendor, will propose reevaluation of the entire therapeutic class only if the data submitted supports that factual information was, indeed, in error.
8. Are P&T Committee meetings open to the public?
In accordance with the West Virginia Sunshine Law, P&T Committee meetings are open to the public. This law requires that a public announcement of the meetings be made at least 10 days prior to the scheduled meeting date. Except for specific pricing information, proprietary information or confidential information, the records of the P&T Committee are available to the public as well.
9. How many people are on the P & T committee? Who do they represent? How were they chosen?
The P&T Committee is comprised of a minimum of seven (7) and a maximum of fifteen (15) members, each of whom is appointed by the Secretary of DHHR. Physicians from various specialties, nurse practitioners, physician assistants, and registered pharmacists are all included on the committee.
10. How does a pharmaceutical manufacturer submit clinical material or other information for consideration by the P&T Committee?
Information may be sent to Goold Health Services (GHS) by email (preferred) to Dr. Chad Bissell at firstname.lastname@example.org. For reviews of classes or products at upcoming P&T meetings, GHS will send a solicitation to their contacts at affected manufacturers approximately six to eight weeks prior to the P&T meeting date. This solicitation will contain a list of products scheduled for review and instructions for submission including a deadline.
11. How does a pharmaceutical manufacturer submit pricing information for consideration by the P & T Committee?
WV Medicaid is a member of the Sovereign States Drug Consortium (SSDC). The SSDC is a state-administered Medicaid supplemental rebate program that allows participating states to negotiate together to maximize Supplemental Rebates from pharmaceutical manufacturers. By participating in this Medicaid pharmaceutical purchasing pool, state Medicaid programs save money without reducing quality of care. Manufacturers submit bids to the SSDC electronically. See the SSDC website, www.rxssdc.org for more details.
12. Is the pricing information confidential?
By law, pricing information is confidential.
13. Can manufacturers review drug monographs prior to the P & T meetings?
This information is distributed only to the Medicaid P & T Committee for their use. These documents are considered proprietary by the State’s PDL Vendor.
14. How can a pharmaceutical manufacturer or a member of the public present comments to the P&T Committee?
There will be a public comment period at the beginning of each P&T Committee meeting. During this time, speakers will be given up to 3 minutes per drug topic to make a presentation to the Committee of that medication. The representative will not be permitted to ask questions of the Committee, BMS, or the State’s PDL Vendor during this time. Slide presentations are not permitted. Handout materials are limited to 2 pages and may be given to the Bureau’s secretary at the beginning of the meeting for distribution during the Executive Session or provided to the Bureau via mail no later than 3 weeks prior to the P & T meeting.
15. How are decisions of the Bureau communicated to companies and public?
The PDL will be published on the West Virginia BMS website at www.dhhr.wv.gov/bms.
16. Will patients be required to switch their medications if the status of the drug changes when the PDL is revised?
In most cases, patients will be required to change their medication to a preferred medication. However, certain medications may be grandfathered. This means that patients already stabilized on a medication will not require a PA to continue on that medication. BMS recognizes the clinical and practical impacts of such changes and makes every effort to minimize these occurrences and to provide adequate notice.
17. Who are the points of contact at the BMS and GHS?
At the West Virginia Bureau for Medical Services, the contact person is:
Vicki Cunningham, R.Ph.
Bureau for Medical Services
350 Capitol Street, Room 251
Charleston, WV 25301
Phone: (304) 558-1700
FAX: (304) 558-1542
The contact person for GHS is:
Chad Bissell, PharmD
Goold Health Services
PO Box 1090
Augusta, ME 04332-1090
SSDC related questions may be sent to the SSDC System Administrator via email at email@example.com
18. What types of questions go to BSM and what types to GHS and what types to the SSDC?
Except for information concerning BMS policy, all questions regarding the PDL process and clinical information should be directed to GHS. Questions regarding how to submit bids, negotiation terms and bid pricing information should be directed to the SSDC.
19. What is the Bureau’s policy regarding advertising of the preferred products (stickers, sales aids, shelf talkers)?
The Bureau for Medical Services requests that these types of advertising be reviewed by the BMS staff. These should be sent to the attention of:
Vicki Cunningham, R.Ph.
Bureau for Medical Services
350 Capitol Street, Room 251
Charleston, WV 25301-3707.
These types of materials should not indicate that Medicaid is the producer of the advertisement or responsible for the content of the advertisement.