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. The PA process requires that certain medications must be approved in order to be reimbursed by West Virginia Department of Health and Human Resources, Bureau for Medical Services (BMS). This approval is based on previously specified criteria.
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 Bureau for Medical Services’ staff, 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 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 PDL inclusion or exclusion of each medication.
Incorporating all of this information, the current 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 the West Virginia Bureau for Medical Services (BMS) for final decisions. The DUR Committee then recommends PA criteria to the State.
4. How does a pharmaceutical manufacturer participate in this process?
The Department of Health and Human Resources, Bureau for Medical Services, will determine which classes of drugs are most commonly utilized or where utilization challenges exist. The Bureau may choose to request to review drug classes alone or in therapeutic groups (cardiovascular drugs, endocrine, etc.). After the order of drug class review is determined, notice will be posted to the BMS website. At that time, the manufacturer will be requested to submit any clinical information and a supplemental rebate offer for the product(s) in review. All materials must be received by Magellan as per notifications provided. The supplemental rebate program is voluntary on the part of the manufacturer. The deadlines for the annual meeting in the fall will be subject to the SSDC timeline.
5. 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. Until that time, the new drug would be nonpreferred and available via the PA process. In addition, the new drug would not be listed on the PDL until officially reviewed. The P & T Chair will also participate in the process to determine whether to exempt the drug from the six month rule based on his/her clinical judgement. If a new chemical entity is considered unique and has been classified as a priority drug by the FDA, the Bureau may indicate that this drug is preferred until the class is once again reviewed.
Recommendations regarding the PDL status of new medications will be made by the State’s current vendor at the time of the next review of the therapeutic class to which that medication belongs. The schedule for these class reviews may be altered if new medications are determined to have a significant clinical and/or financial impact as described above.
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.
6. How does a pharmaceutical manufacturer submit clinical material or other information for consideration by the P&T Committee?
Information may be sent to Magellan by email (preferred) to Dr.Nina Bandali at firstname.lastname@example.org. For reviews of classes or products at upcoming P&T meetings, Magellan Medicaid Administration 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.
7. 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 Sovereign States Drug Consortium (SSDC) is a state-administered Medicaid supplemental rebate program that allows participating states to pool their prescription utilization numbers to obtain 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.
8. 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.
9. 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 the Bureau for Medical Services (BMS). Only documentation from published, peer-reviewed medical journals will be accepted. The BMS, in consultation with the State’s vendor, will propose reevaluation of the entire therapeutic class only if the data submitted supports that factual information was, indeed, in error.
10. 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, the Bureau for Medical Services, or the State’s 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 for mailing no later than 3 weeks prior to the P & T meeting.
11. 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.
12. Who are the points of contact at the Bureau, Magellan, 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 Magellan Medicaid Administration is:
Nina Bandali, PharmD
Magellan Health Services, Inc.
10101 Alliance Rd, Suite 201
Cincinnati, OH 45242
The contact person for Goold Health Systems for SSDC related questions is Shelley Kelley via email at email@example.com.
13. What types of questions go to the Bureau and what types to Magellan and what types to GHS (SSDC)?
Except for information concerning BMS policy, all questions regarding the PDL process and clinical information should be directed to Magellan. Questions regarding how to submit bids, negotiation terms and bid pricing information may be directed to Shelley Kelley via email at firstname.lastname@example.org.
14. Will patients be required to switch their medications if they are stabilized to the preferred drugs when the PDL is revised?
Some medications in certain classes may be grandfathered. This means that patients already stabilized on a medication that is not included on the PDL will not require a PA to continue on that medication. However, there are times when patients stabilized on a certain medication will be required to change to a different medication or different form of a medication. BMS recognizes the clinical and practical impacts of such changes and makes every effort to minimize these occurrences and to provide adequate notice.
15. 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.
16. 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 two weeks 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.
17. Is the pricing information confidential?
By law, pricing information is confidential.
18. How often will therapeutic classes be reviewed and changes made to the PDL?
Will all manufacturers submit pricing information again?
West Virginia is a member of the Sovereign States Drug Consortium (SSDC). The Consortium reviews therapeutic classes annually in the fall of each year.
Please refer to the SSDC website at www.rxssdc.org for a detailed schedule regarding supplemental rebates.
19. Who makes the final decision as to what drugs are included on the PDL?
The Secretary of West Virginia Department of Health and Human Resources has the final authority for PDL decisions.
20. 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.