Frequently Asked Questions with Amplity Federal Leadership
The Department of Veterans Affairs (VA) and the Department of Defense’s (DoD) TRICARE Health Plan market comprises over 19 million veterans, active duty and retired military personnel, and their families. However, given the unique complexities of this market, life science and health technology companies may not fully understand the opportunities the federal market offers, nor are they positioned to successfully exploit those opportunities.
With proven experience in both the civilian and federal healthcare management sectors, retired Air Force Colonel David (Dave) W. Bobb, pharmacist, attorney, and former Chief of Pharmacy Operations at the Defense Health Agency, brings valuable insight and expertise into both the TRICARE and Department of Veterans Affairs (VA) market space.
We sat down with Bobb to cover the federal topics we know our clients are most interested in.
Q: How can life science and health technology companies begin to overcome the barriers involved with navigating the complex VA and TRICARE marketplace?
The first step is to understand how these markets work and what makes them unlike working with commercial markets. Issues ranging from contracting, to market access, to optimal formulary placement of medications are managed in different manners with specific requirements. In my opinion, the best way a company can quickly grasp the federal market nuances is to bring along an experienced “guide” who can assist with navigating the federal landscape.
Q: Since DoD/TRICARE operates as both a hospital system and a 3rd party payer, how are medical benefit drugs managed?
Medical benefit drugs are those drugs that are normally not taken or administered at home. For example, drugs that must be given at an infusion center, a prescriber’s office, or other clinical setting are all considered medical benefit drugs. These pharmaceutical products fall under the TRICARE Medical Benefit NOT the TRICARE Pharmacy Benefit. Consequently, these drugs will not go through a formal Department of Defense Pharmacy and Therapeutics Committee review. Any coverage guidance or restrictions will be determined by the TRICARE Medical Benefit office in conjunction with its contractors, Humana Military and Health Net Federal Services. Reimbursement for these drugs is almost always the same, or very close to, the Medicare prevailing rate.
Q: What are some of the pharmaceutical nuances that manufacturers need to keep top of mind in order to ensure smooth access to DoD/TRICARE beneficiaries?
For TRICARE Pharmacy Benefit medications, I believe there are two very important parts a manufacturer needs to keep in mind. First, when your drug is being reviewed by the Department of Defense P& T Committee, it is your responsibility to convince the Committee to grant your drug optimal formulary placement. You don’t want your drug to end up in the Completely Excluded tier or on the Non-Formulary tier behind prior authorizations and different steps. The two main factors the P& T Committee will consider for formulary placement are relative clinical efficacy compared to other drugs in the category currently on formulary, and relative cost compared to current formulary medications in that category. Manufacturers have the ability to dictate that narrative for their products.
Second, once the drug is included on the formulary, manufacturers need to ensure it is easily available for TRICARE beneficiaries at the Military Treatment Facilities (MTFs), an extensive retail pharmacy network, and through the mail order pharmacy operated by Express Scripts. The DoD utilizes Cencora as its primary Prime Vendor and DMS Pharmaceuticals as its secondary wholesaler. This means your drug product needs to be available through Cencora in order for the MTFs and the mail order pharmacy to easily obtain it. For specialty drugs, DMS supplies almost all specialty drugs used or dispensed at a Military Treatment Facility (MTF). For those available through mail order, Accredo is the DoD’s preferred specialty drug distributor. Lastly, keep in mind that Express Scripts serves as TRICARE Pharmacy’s Pharmacy Benefit Manager.
Q: What are the key components of the DoD P& T review process for newly approved drugs and indications?
The process used to evaluate new drugs for inclusion on the TRICARE Pharmacy Benefit formulary follows these steps:
- The Formulary Management Branch (FMB) of the Pharmacy Operations Division at the Defense Health Agency compiles and evaluates clinical information along with pricing information for new drugs that will be reviewed at the DoD P& T Committee meeting. By law, all new drugs must be reviewed within 120 days of market launch.
- The FMB then presents the clinical and pricing information for the new drug, along with the clinical and pricing information for any other drugs in the same class that are currently on formulary, to the DoD P& T Committee. The DoD P& T Committee, comprised of physicians, pharmacists, and other healthcare professionals, evaluates the information presented and makes a recommendation for formulary inclusion or exclusion based on relative clinical efficacy and relative price compared to other drugs in that category. If the drug is to be included on the formulary, the P& T will also recommend which formulary tier the drug should be placed in along with any restrictions, prior authorizations needed, quantity limits, etc.
- Next, the Beneficiary Advisory Committee (BAP) reviews the recommendations the DoD P& T made. The BAP is a chartered Federal Advisory Committee that provides independent advice and recommendations on the development of the TRICARE Uniform Formulary. It includes nongovernmental organizations and associations that represent the views and interests of a large number of eligible covered beneficiaries, contractors responsible for the TRICARE retail pharmacy program, contractors responsible for the national mail-order pharmacy program, and TRICARE network providers. The BAP can agree or disagree with the P& T recommendations, or generate its own recommendations.
- After all of these steps take place, the recommendations are reviewed by the Director of the Defense Health Agency (or designee) who signs the minutes of the meetings. At that point the decisions are final.
The federal healthcare market truly offers a unique opportunity for life science and health technology companies if they understand how it functions. Amplity has extensive experience across delivery channels (e.g., commercial, IDN, government) in a wide range of therapeutic areas. With a unique expertise in Federal access strategy, we can leverage established relationships to ensure our clients and federal decision-makers are making informed choices that optimize patient access to the therapies they need. Our practice offers a rich pool of payer Key Opinion Leaders (KOLs) and many of our consultants, like Dave, have held roles as pharmacy- and medical-benefit decision-makers that drive and control the market. Click here to initiate a discussion with Bobb, and leverage his experience as a former Defense Health Agency’s Chief of Pharmacy Operations for your market access strategy.
About the author
David (Dave) W. Bobb - Principal, Market Access
David W. Bobb is a pharmacist, attorney, and retired United States Air Force Colonel with proven experience in both the civilian and federal healthcare management sectors. Mr. Bobb has consistently provided impeccable results in progressively more challenging and demanding leadership positions. He has successfully managed and executed multi-million dollar budgets, integrated and consolidated diverse healthcare systems, built cohesive high-performing teams, and developed effective medication safety, quality control, and quality assurance programs. In addition, he has analyzed workflow process, patient safety programs, staffing models, and the delivery of professional services such as Medication Therapy Management across the spectrum of pharmacy operations to optimize patient care. Throughout his career, he has provided sound legal advice to federal pharmacists in respect to changing Food and Drug Administration policies, Drug Enforcement Administration laws, and federal and state legislative initiatives. He has worked with Congressional delegations and staffers, and has drafted Congressional testimony for superiors. He has been an integral member of several Boards of Directors, including the American Society for Pharmacy Law, Department of Defense Pharmacy Advisory Board, and the San Antonio Uniformed Services Health Education Consortium. Lastly, Mr. Bobb has provided over 25 CE-accredited pharmacy law presentations and authored over 20 publications for federal pharmacists and technicians.