System and method for early identification of safety concerns of new drugs

• US 7,856,362 B2
• Filed: 11/20/2006
• Issued: 12/21/2010
• Est. Priority Date: 04/25/2005
• Status: Active Grant

• Current Assignee: Optuminsight, Inc. (UnitedHealth Group Incorporated)
• Original Assignee: Ingenix Incorporated (UnitedHealth Group Incorporated)
• Inventors: Walker, Alexander M.
• Primary Examiner(s): O'Connor; Gerald J.
• Assistant Examiner(s): NGUYEN, HIEP VAN
• Application Number:
  US11/561,579
• Publication Number:
  US 20070174086A1
• Time in Patent Office: 1,492 Days
• Field of Search: 705 2- 3, 707/104
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/00 Administration; Management
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

Abstract

A system and method for identifying safety concerns regarding a drug identify a first group of patients that have received the drug from a database of healthcare claims and extract one or more medical events that the first group of patients have experienced from the database. The system and method also identify a second group of patients that have received a comparator drug in the database and extract one or more medical events that the second group of patients have experienced. The medical events of the first group are compared to the medical events of the second group to determine at least one common occurrence therebetween. The common occurrence(s) is then filtered based upon one or more user defined outcomes, each including at least one diagnosis, procedure or therapeutic classification; non-medical criteria; and/or patient laboratory test data.

Claims

1. A computer-implemented system for administering a drug registry database, comprising:

an electronic database containing a plurality of healthcare claims of a plurality of patients and a plurality of new drug/comparator drug pairs predefined by a system administrator, wherein the predefined new drug/comparator drug pairs each include a new drug for which a threshold number of healthcare claims have been stored and a comparator drug that has substantially similar medical indications as the new drug;

an electronic user interface configured to

display the stored plurality of new drug/comparator drug pairs; and

receive a selection of at least one of the displayed new drug/comparator drug pairs and filter parameters input by a user, wherein the filter parameters comprise a user-selected combination of two or more diagnostic codes, procedure codes, and/or therapeutic drug classes; and

a computer-implemented analysis engine configured to

search the healthcare claims stored in the database in response to the received selection to identify a first and second group of patients satisfying the filter parameters input by the user, wherein the first group includes patients with claim data indicating use of the new drug and the second group includes patients with claim data indicating use of the comparator drug;

identify a comparative occurrence of one or more existing medical conditions or new medical conditions in the first and second groups of patients; and

calculate a probability value indicating a relative likelihood that a patient taking the new drug will have each of the one or more new or existing medical conditions in comparison to a likelihood that a patient taking the comparator drug will have each of the one or more new or existing medical conditions;

wherein the electronic user interface displays each new or existing medical condition and the probability value for the new drug and the comparator drug in accordance with one or more report parameters entered by the user.

2. The system according to claim 1, wherein the display generated by the user interface further includes demographic characteristics, prevalence of diagnosis, prevalence of procedures, prevalence of drug class, or healthcare utilization.

3. A computer-implemented method for administering a drug registry database, comprising a computer performing the following:

storing in an electronic database a plurality of healthcare claims of a plurality of patients and a plurality of new drug/comparator drug pairs predefined by a system administrator, wherein the predefined new drug/comparator drug pairs each include a new drug for which a threshold number of healthcare claims have been stored and a comparator drug that has substantially similar medical indications as the new drug;

displaying the stored plurality of new drug/comparator drug pairs on an electronic user interface;

receiving a selection of at least one of the displayed new drug/comparator drug pairs and filter parameters input by the user via the electronic user interface, wherein the filter parameters comprise a user-selected combination of two or more diagnostic codes, procedure codes, and/or therapeutic drug classes;

searching the healthcare claims stored in the database in response to the received selection using a computer-implemented analysis engine to identify a first and second group of patients satisfying the filter parameters input by the user, wherein the first group includes patients with claim data indicating use of the new drug and the second group includes patients with claim data indicating use of the comparator drug;

using the analysis engine to identify a comparative occurrence of one or more existing medical conditions or new medical conditions in the first and second groups of patients;

using the analysis engine to calculate a probability value indicating a relative likelihood that a patient taking the new drug will have each of the one or more new or existing medical conditions in comparison to a likelihood that a patient taking the comparator drug will have each of the one or more new or existing medical conditions; and

displaying on the electronic user interface each new or existing medical condition and the probability value for the new drug and the comparator drug in accordance with one or more report parameters entered by the user.

4. The method according to claim 3, wherein the display on the user interface further includes demographic characteristics, prevalence of diagnosis, prevalence of procedures, prevalence of drug class, or healthcare utilization.

5. A computer-implemented system for administering a drug registry database, comprising:

an electronic database containing a plurality of healthcare claims of a plurality of patients and a plurality of new drug/comparator drug pairs predefined by a system administrator, wherein the predefined new drug/comparator drug pairs each include a new drug for which a threshold number of healthcare claims have been stored and a comparator drug that has substantially similar medical indications as the new drug;

an electronic user interface configured to

display the stored plurality of new drug/comparator drug pairs; and

receive a selection of at least one of the displayed new drug/comparator drug pairs and filter parameters input by a user, wherein the filter parameters include one or more diagnosis codes, procedure codes, drug categories, demographic characteristics or non-medical consumer data parameters; and

a computer-implemented analysis engine configured to

search the healthcare claims stored in the database in response to the received selection to identify a first and second group of patients satisfying the filter parameters input by the user, wherein the first group includes patients with claim data indicating use of the new drug and the second group includes patients with claim data indicating use of the comparator drug;

identify a comparative occurrence of one or more existing medical conditions or new medical conditions in the first and second groups of patients; and

calculate a probability value indicating a relative likelihood that a patient taking the new drug will have each of the one or more new or existing medical conditions in comparison to a likelihood that a patient taking the comparator drug will have each of the one or more new or existing medical conditions;

wherein the electronic user interface displays each new or existing medical condition and the probability value for the new drug and the comparator drug in accordance with one or more report parameters entered by the user.

6. The system according to claim 5, wherein the display generated by the user interface further includes demographic characteristics, prevalence of diagnosis, prevalence of procedures, prevalence of drug class, or healthcare utilization.

7. The system according to claim 5, wherein the non-medical consumer data parameters available for user selection as filter parameters include household income, home equity status, net worth, and credit rating.

8. A computer-implemented method for administering a drug registry database, comprising a computer performing the following:

storing in an electronic database a plurality of healthcare claims of a plurality of patients and a plurality of new drug/comparator drug pairs predefined by a system administrator, wherein the predefined new drug/comparator drug pairs each include a new drug for which a threshold number of healthcare claims have been stored and a comparator drug that has substantially similar medical indications as the new drug;

displaying the stored plurality of new drug/comparator drug pairs on an electronic user interface;

receiving a selection of at least one of the displayed new drug/comparator drug pairs and filter parameters input by the user via the electronic user interface, wherein the filter parameters include one or more diagnosis codes, procedure codes, drug categories, demographic characteristics or non-medical consumer data parameters;

searching the healthcare claims stored in the database in response to the received selection using a computer-implemented analysis engine to identify a first and second group of patients satisfying the filter parameters input by the user, wherein the first group includes patients with claim data indicating use of the new drug and the second group includes patients with claim data indicating use of the comparator drug;

using the analysis engine to identify a comparative occurrence of one or more existing medical conditions or new medical conditions in the first and second groups of patients;

using the analysis engine to calculate a probability value indicating a relative likelihood that a patient taking the new drug will have each of the one or more new or existing medical conditions in comparison to a likelihood that a patient taking the comparator drug will have each of the one or more new or existing medical conditions; and

displaying on the electronic user interface each new or existing medical condition and the probability value for the new drug and the comparator drug in accordance with one or more report parameters entered by the user.

9. The method according to claim 8, wherein the display on the user interface further includes demographic characteristics, prevalence of diagnosis, prevalence of procedures, prevalence of drug class, or healthcare utilization.

10. The method according to claim 8, wherein the non-medical consumer data parameters available for user selection as filter parameters include household income, home equity status, net worth, and credit rating.

11. A computer-implemented system for administering a drug registry database, comprising:

an electronic database containing a plurality of healthcare claims of a plurality of patients and a plurality of new drug/comparator drug pairs predefined by a system administrator, wherein the predefined new/drug comparator new drug/comparator, drug pairs each include a new drug for which a threshold number of healthcare claims have been stored and a comparator drug that has substantially similar medical indications as the new drug;

an electronic user interface configured to

display the stored plurality of new drug/comparator drug pairs; and

receive a selection of at least one of the displayed new drug/comparator drug pairs and filter parameters input by a user, wherein the filter parameters include one or more diagnosis codes, procedure codes, drug categories, demographic characteristics or patient laboratory test data parameters; and

a computer-implemented analysis engine configured to

search the healthcare claims stored in the database in response to the received selection to identify a first and second group of patients satisfying the filter parameters input by the user, wherein the first group includes patients with claim data indicating use of the new drug and the second group includes patients with claim data indicating use of the comparator drug;

identify a comparative occurrence of one or more existing medical conditions or new medical conditions in the first and second groups of patients; and

calculate a probability value indicating a relative likelihood that a patient taking the new drug will have each of the one or more new or existing medical conditions in comparison to a likelihood that a patient taking the comparator drug will have each of the one or more new or existing medical conditions;

wherein the electronic user interface displays each new or existing medical condition and the probability value for the new drug and the comparator drug in accordance with one or more report parameters entered by the user.

12. The system according to claim 11, wherein the display generated by the user interface further includes demographic characteristics, prevalence of diagnosis, prevalence of procedures, prevalence of drug class, healthcare utilization or individual patient laboratory test data.

13. A computer-implemented method for administering a drug registry database, comprising a computer performing the following:

storing in an electronic database a plurality of healthcare claims of a plurality of patients and a plurality of new drug/comparator drug pairs predefined by a system administrator, wherein the predefined new drug/comparator drug pairs each include a new drug for which a threshold number of healthcare claims have been stored and a comparator drug that has substantially similar medical indications as the new drug;

displaying the stored plurality of new drug/comparator drug pairs on an electronic user interface;

receiving a selection of at least one of the displayed new drug/comparator drug pairs and filter parameters input by the user via the electronic user interface, wherein the filter parameters include one or more diagnosis codes, procedure codes, drug categories, demographic characteristics or patient laboratory test data parameters;

searching the healthcare claims stored in the database in response to the received selection using a computer-implemented analysis engine to identify a first and second group of patients satisfying the filter parameters input by the user, wherein the first group includes patients with claim data indicating use of the new drug and the second group includes patients with claim data indicating use of the comparator drug;

using the analysis engine to identify a comparative occurrence of one or more existing medical conditions or new medical conditions in the first and second groups of patients;

using the analysis engine to calculate a probability value indicating a relative likelihood that a patient taking the new drug will have each of the one or more new or existing medical conditions in comparison to a likelihood that a patient taking the comparator drug will have each of the one or more new or existing medical conditions; and

displaying on the electronic user interface each new or existing medical condition and the probability value for the new drug and the comparator drug in accordance with one or more report parameters entered by the user.

14. The method according to claim 13, wherein the display generated by the user interface further includes demographic characteristics, prevalence of diagnosis, prevalence of procedures, prevalence of drug class, healthcare utilization or individual patient laboratory test data.