The USP Drug Classification (USP DC) is an independent drug classification system developed in response to stakeholder input that it would be helpful to have a classification system beyond the Medicare Model Guidelines (MMG), to assist with formulary support outside of Medicare Part D. The Healthcare Quality & Safety Expert Committee goal is to create a comprehensive classification system for use in drug formulary development or review in non-acute or outpatient care settings. This tool has the potential to provide guidance towards the design and comparison of balanced formularies.
The USP DC is intended for use by any stakeholder interested in a classification of drugs for use in formulary development or review. The classification system can have many uses for formulary support including but not limited to:
- Building and mapping formularies
- Reviewing formulary adequacy for a minimum baseline of drugs
- Identifying drugs in a particular pharmacologic grouping. The latter has allowed interested stakeholders to review formularies and compare formulary design and benefits
USP DC is intended to be part of a comprehensive formulary review process and not intended to replace the final review provided by the local pharmacy and therapeutics (P&T) committees. Moreover, USP DC is not intended for review of medical benefit drug coverage since USP DC does not include all drugs administered in a clinical setting.
Origins of Development
USP has a long history of creating classification systems for the purpose of formulary review. USP has developed and updated the USP Medicare Model Guidelines since 2004, under the Medicare Prescription Drug Improvement and Modernization Act (2003), Section 1860D-4(b)(3)(C)(ii). This section included a requirement that Part D plans cover at least 2 two drugs in each USP Category and Class.
The USP DC was initiated by stakeholder feedback to meet evolving public health needs. Over the past ten years, the USP MMG has been adopted in other health policy settings outside of its intended Medicare utilization. Through this extension of use, public comment and stakeholder feedback has identified the need to create a an independent classification system that can provide a more comprehensive inclusion of outpatient drugs, more frequent revisions, and more detailed mapping tools for implementation.
The USP DC is a classification system separate from the MMG and is not endorsed or funded by the Centers for Medicare & Medicaid Services.
A comparison of the USP Drug Classification System (USP DC) to the Medicare Model Guidelines (MMG)
|USP Medicare Model Guidelines (USP MMG)||USP Drug Classification (USP DC)|
|Developed under the Medicare Modernization Act to support Medicare Part D requirements||
Provides Drug Examples
|Developed through USP Expert Volunteers, Stakeholder Engagement, and Public Comment Processes||Part D eligible drugs only||Common US outpatient drugs|
Utilizes USP Guiding Principles for establishing Categories and Classes
|CMS FRF- MMG Alignment File (triennial)||USP DC- RxNorm Alignment File (annual)|
|Implementation Tools: Mapping to RxNorm||√||√|
|Stakeholder Focus in Public Comment||Medicare Stakeholders||All Stakeholders|
|Publication Version||USP MMG v7.0||USP DC 2018|
|Publication Date||February 2017||February 2018|
*Upon request of Centers for Medicare and Medicaid Services (CMS)
The USP DC 2018 is organized into three lists: 1. Single Entity List, 2. Combination List, and 3. Vaccine List. The Single Entity List is a listing of unique active pharmaceutical ingredients (APIs). The Single Entity List also indicates if a given API is available in combination products. The Combination List is a listing of drugs with multiple APIs. The Vaccine list is a listing of vaccines.
Below is a definition of the data elements on the USP Drug Classification.
|Single Entry List|
|USP Category||A USP Category is the broadest classification of the USP Drug Classification system, and provides a high level formulary structure. There are 52 USP categories.|
|USP Class||A USP Class is a more granular classification, occurring within a specific USP Category in the USP Drug Classification system. There are 164 USP classes.|
An attribute of a drug, providing additional informational groupings on drugs based on therapeutic use or pharmacology.
The pharmacotherapeutic groups are currently being developed and therefore not intended to be used for review of formulary adequacy for a minimum baseline of drugs. There are 64 pharmacotherapeutic groups. For the first USP DC, the pharmacotherapeutic groups are included in the following reviewed USP categories: Antivirals, Blood Glucose Regulators, Dermatological Agents, Gastrointestinal Agents, Metabolic Bone Disease Agents, Ophthalmic Agents, and Respiratory Tract/Pulmonary Agents.
|Example Drug||An example drug is an active pharmaceutical ingredient (API) in a drug product. This is in contrast to inactive ingredients such as excipients. An example drug includes the API of a drug product but not its strength or dosage form. There are 1388 example drug placements in the USP DC 2018 single-entity list.|
A flag to indicate if an active pharmaceutical ingredient (API) exists in combination with at least one other API. For review of the combination drugs, users can refer to the Combination List.
(C)= combination available, exists in combination with another API, and is listed on the Combination List.
(U)= unique API, exists only in combination with another API, not as monotherapy, within the context of a USP Category.
|Combination Class by USP Category||Combination drugs are listed within the context of a USP Category.|
|Combination Example Drug||A combination example drug is a drug product with at least two active pharmaceutical ingredients (API).|
|Vaccine Example Drug||Listing of vaccines.|
The USP DC is developed through USP’s independent, science-based, expert-led process that relies on stakeholder input, including formal public comment periods and other in-person events.
USP Drug Classification Expert Panel
The USP Drug Classification Expert Panel was created for the 2015-2020 cycle under the Healthcare Quality & Safety Expert Committee. This Expert Panel of academicians, practitioners, formulary experts, patient advocates, and clinicians began their work on developing the USP DC in March of 2016. The Expert Panel advises the Healthcare Quality & Safety Expert Committee on issues discovered during the annual revision processes that are relevant to developing, implementing, and revising the USP DC.
Drug Identification and Drug Summary Files
Drugs included in the USP DC 2018 are identified through various sources including Drugs@FDA, RxNorm Current Prescribable Content, Purple book: Lists of Licensed Biological Products, stakeholder feedback, and publically available prescription formularies.
The Drug Summary Files were developed specifically for the Expert Panel by USP staff with key drug information that would inform about placement of drugs in USP categories and classes. The Drug Summary Files include FDA regulatory information, approved FDA labeling, and FDA Established Pharmacologic Class. When applicable, primary peer-reviewed scientific articles and treatment guidelines were also included in the Drug Summary Files.
Public Comment Process
The second round of public comment period began upon completion of the draft USP DC 2018 in September 2017. This draft was made available via the USP.org website for public comment from September 25th to October 30th. Stakeholders had the opportunity to provide comments via email, public comment form, stakeholder 1:1 consultations, and open microphone web meetings.
Thirty four stakeholders provided comments and over sixty requests were evaluated for incorporation in the draft. The stakeholders included drug manufacturers, regulators, health plans/PBMs, academia, and patient advocacy groups. The Expert Panel reviewed the public comments in November 2017, and the draft was balloted and approved by the Healthcare Quality & Safety Expert Committee in December 2017.
The Expert Panel used the following guiding principles to inform their development of the USP DC 2018.
Types of Example Drugs Listed
The Expert Panel’s goal was to include a comprehensive list of drugs used in non-acute and outpatient care settings. This includes prescription medications patients receive from community pharmacies, specialty pharmacies, skilled nursing facilities, and infusion centers. At this time, the Expert Panel has excluded hospital-only, over-the-counter, and FDA unapproved medications from the USP DC 2018. Some listed drugs may have over-the-counter products as well as prescription-only dosage forms.
Approach to creating Categories and Classes
The USP Drug Classification retains the guiding principle of the Medicare Model Guidelines (MMG), to strike a balance of assuring patient access to the drugs that patients need with the flexibility that health plans require in offering an affordable and effective benefit.
In creating the categories and classes, there are careful considerations to minimize the creation of categories or classes with less than three drug examples.
In creating the categories and classes, there was consideration in naming the category and class to be broad enough to encompass future mechanism of actions.
Approach to Placement of Example Drugs
The USP DC utilizes pharmacotherapeutic evidence within the context of FDA-approved indications for placing example drugs. A drug in the associated list may appear in more than one USP Category or USP Class if there is a scientifically valid and clinically meaningful patient care issue.
Combination drugs may be included in the associated list if there is a scientifically valid and clinically meaningful patient care issue addressed by the combination product.
Specific dosage forms/formulations/delivery systems are generally not listed but may be included in the associated list if there is a valid and clinically meaningful patient care issue addressed by these more specific factors.
The USP DC will be updated and made available at usp.org annually.
The USP Drug Classification Expert Panel will continue to identify and evaluate FDA approved drugs for placement in 2018. Information on participation in the public comment process for the placement of new drugs will be available on this website. With each yearly update, the Expert Panel will consider stakeholder requests to advance public health interest and evolving public health needs.