Identification of specialty drugs

• US 8,160,898 B2
• Filed: 08/25/2011
• Issued: 04/17/2012
• Est. Priority Date: 01/28/2008
• Status: Active Grant

• Current Assignee: Express Scripts Strategic Development, Inc. (The Cigna Group)
• Original Assignee: Express Scripts Incorporated (The Cigna Group)
• Inventors: Weisbart, Edmond, Behm, Andrew, Tharaldson, Aimee, Miller, Steven
• Primary Examiner(s): Koppikar, Vivek
• Assistant Examiner(s): WINSTON III, EDWARD B
• Application Number:
  US13/217,471
• Publication Number:
  US 20110307271A1
• Time in Patent Office: 236 Days
• Field of Search: 705/2, 705/3
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/087 Inventory or stock management, e.g. order filling, procurement or balancing against orders
• CPC Class Codes: G06Q 30/0278 Product appraisal
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

Abstract

Methods for determining whether a drug is a specialty drug, methods for creating tools to be used in making the determination, and the tools themselves are disclosed. The overall value of a drug depends on the drug'"'"'s attribute values with respect to each of a set of drug attributes (concerning, e.g., the drug'"'"'s route of administration, targeted disease, possible adverse reactions, risk of toxicity, cost, need for patient compliance with the treatment regime, and handling, preparation, and/or storage requirements. If the overall value or its partial overall values meet certain criteria, the drug is deemed to be a specialty drug.

Claims

1. A method comprising:

recording, on a computer processor, a drug attribute A score to a drug based on a characteristic level of specialized clinical services associated with patient understanding of a condition that the drug is used to treat, self management of the condition that the drug is used to treat, or both the patient understanding and the self management of the condition that the drug is used to treat;

recording, on the computer processor, a drug attribute B score to the drug based on a characteristic level of specialized requirements for intensive patient training specific to the administration of the drug or specialized requirements for administration of the drug;

recording, on the computer processor, a drug attribute C score to the drug based on a characteristic level of specialized requirements for clinical monitoring required because of toxicity of the drug and to monitor for therapeutic effect;

recording, on the computer processor, a drug attribute D score to the drug based on a characteristic level of an extent of specialized requirements for compliance assistance by a patient associated with the drug to facilitate therapeutic goals;

recording, on the computer processor, a drug attribute E score to the drug based on a characteristic level of an extent of specialized requirements for handling, preparation, and storage of the drug;

recording, on the computer processor, a drug attribute F score to the drug based on a characteristic level of a distribution channel of the drug;

determining, on the computer processor, total value score for the drug based on the drug attribute A score, drug attribute B score, drug attribute C score, drug attribute D score, drug attribute E score, and drug attribute F score;

determining, on the computer processor, a cost attribute for the drug based on location of a cost of the drug within a cost range of a plurality of cost ranges;

identifying, on the computer processor, a numerical threshold value score based on the cost attribute of the drug; and

comparing, on the computer processor, the total value score of the drug against the numerical threshold value score to identify the drug as a specialty drug.

2. The method of claim 1, wherein recording the drug attribute A score comprises:

recording the drug attribute A score to the drug at a first characteristic level when highly specialized clinical expertise is required to support patient understanding, management, or both patient understand and management of the complex and rare condition of the patient;

recording the drug attribute A score to the drug at a second characteristic level when specialized clinical expertise is required to support patient understanding, management, or both patient understand and management of the complex or rare condition of the patient; and

recording the drug attribute A score to the drug at a third characteristic level when general clinical expertise is required to support patient understanding, management, or both patient understanding and management of the condition of the patient.

3. The method of claim 1, wherein recording the drug attribute B score comprises:

recording the drug attribute B score to the drug at a first characteristic level when very intensive patient training is required specific to medication administration of the drug or when highly specialized requirements for drug administration by a healthcare professional is required;

recording the drug attribute B score to the drug at a second characteristic level when moderately intensive patient training is required specific to medication administration of the drug or when moderately specialized requirements for drug administration by the patient is required; and

recording the drug attribute B score to the drug at a third characteristic level when average level of patient training is required specific to medication administration of the drug or when no specialized requirements for drug administration by the patient is required.

4. The method of claim 1, wherein recording the drug attribute C score comprises:

recording the drug attribute C score to the drug at a first characteristic level when very intensive clinical monitoring is required, including during drug administration, due to highly toxic, commonly occurring, or both highly toxic and commonly occurring adverse drug reactions associated with the drug;

recording the drug attribute C score to the drug at a second characteristic level when moderately intensive clinical monitoring is required, including during drug administration, due to moderately toxic, less commonly occurring, or both moderately toxic and less commonly occurring adverse drug reactions associated with the drug; and

recording the drug attribute C score to the drug at a third characteristic level when average level of clinical monitoring is required to decrease potential for drug toxicity.

5. The method of claim 1, wherein recording the drug attribute D score comprises:

recording the drug attribute D score to the drug at a first characteristic level when compliance assistance is necessary in order to facilitate therapeutic goals;

recording the drug attribute D score to the drug at a second characteristic level when compliance assistance is recommended in order to facilitate therapeutic goals; and

recording the drug attribute D score to the drug at a third characteristic level when compliance assistance is optional in order to facilitate therapeutic goals.

6. The method of claim 1, wherein recording the drug attribute E score comprises:

recording the drug attribute E score to the drug at a first characteristic level when the drug has highly specialized requirements for product handling;

recording the drug attribute E score to the drug at a second characteristic level when the drug has moderately specialized requirements for product handling; and

recording the drug attribute E score to the drug at a third characteristic level when the drug has no specialized requirements for product handling.

7. The method of claim 1, wherein recording the drug attribute F score comprises:

recording the drug attribute F score to the drug at a first characteristic level when the drug is only available through limited distribution channels; and

recording the drug attribute F score to the drug at a second characteristic level when the drug is only available through an open distribution channel.

8. The method of claim 1, wherein recording the drug attribute A score comprises

recording the drug attribute A score to the drug a value of two when highly specialized clinical expertise is required to support patient understanding, management, or both patient understanding and management of the complex and rare condition of the patient, recording the drug attribute A score to the drug a value of one when specialized clinical expertise is required to support patient understanding, management, or both patient understand and management of the complex or rare condition of the patient, and recording the drug attribute A score to the drug a value of zero when general clinical expertise is required to support patient understanding, management, or both patient understand and management of the condition of the patient;

wherein recording the drug attribute B score comprises recording the drug attribute B score to the drug a value of two when very intensive patient training is required specific to medication administration of the drug or when highly specialized requirements for drug administration by a healthcare professional is required, recording the drug attribute B score to the drug a value of one when moderately intensive patient training is required specific to medication administration of the drug or when moderately specialized requirements for drug administration by the patient is required, and recording the drug attribute B score to the drug a value of zero when average level of patient training is required specific to medication administration of the drug or when no specialized requirements for drug administration by the patient is required;

wherein recording the drug attribute C score comprises recording the drug attribute C score to the drug a value of two when very intensive clinical monitoring is required, including during drug administration, due to highly toxic, commonly occurring, or both highly toxic and commonly occurring adverse drug reactions associated with the drug, recording the drug attribute C score to the drug a value of one when moderately intensive clinical monitoring is required, including during drug administration, due to moderately toxic, less commonly occurring, or both moderately toxic and less commonly occurring adverse drug reactions associated with the drug, and recording the drug attribute C score to the drug a value of zero when average level of clinical monitoring is required to decrease potential for drug toxicity;

wherein recording the drug attribute D score comprises recording the drug attribute D score to the drug a value of two when compliance assistance is necessary in order to facilitate therapeutic goals, recording the drug attribute D score to the drug a value of one when compliance assistance is recommended in order to facilitate therapeutic goals, and recording the drug attribute D score to the drug a value of zero when compliance assistance is optional in order to facilitate therapeutic goals;

wherein recording the drug attribute E score comprises recording the drug attribute E score to the drug a value of two when the drug has highly specialized requirements for product handling, recording the drug attribute E score to the drug a value of one when the drug has moderately specialized requirements for product handling, and recording the drug attribute E score to the drug a value of zero when the drug has no specialized requirements for product handling; and

wherein recording the drug attribute F score comprises recording the drug attribute F score to the drug a value of one, two, three, four, five, six, seven eight, nine, or ten when the drug is only available through limited distribution channels, and recording the drug attribute F score to the drug a value of zero when the drug is only available through an open distribution channel.

9. The method of claim 8, wherein the plurality of cost ranges include a first cost range of less than five hundred dollars per 30-day period, a second cost range of from five hundred dollars to one thousand dollars per 30-day period, and a third cost range of greater than on thousand dollars per 30-day period.

10. The method of claim 9, wherein the numerical threshold value is eight when the drug is in the first cost range, the numerical threshold is five when the drug is in the second cost range, and the numerical threshold is zero when the drug is in the third cost range.

11. The method of claim 1, wherein determining the total value for the drug comprises:

adding the drug attribute A score, the drug attribute B score, the drug attribute C score, the drug attribute D score, the drug attribute E score, and the drug attribute F score to obtain the total value for the drug.

12. The method of claim 1, wherein determining the total value for the drug comprises:

respectively weighting the drug attribute A score, the drug attribute B score, the drug attribute C score, the drug attribute D score, the drug attribute E score, and the drug attribute F score; and

adding the weighted drug attribute A score, the weighted drug attribute B score, the weighted drug attribute C score, the weighted drug attribute D score, the weighted drug attribute E score, and the weighted drug attribute F score to obtain the total value for the drug.

13. The method of claim 1, wherein determining the total value for the drug comprises:

multiplying the drug attribute A score, the drug attribute B score, the drug attribute C score, the drug attribute D score, the drug attribute E score, and the drug attribute F score to obtain the total value for the drug.

14. The method of claim 1, wherein the cost of the drug is the average wholesale price (AWP) of the drug.

15. The method of claim 1, wherein the specialty drug is dispensed through a specialty pharmacy.

16. The method of claim 1, further comprising:

receiving drug identification of the drug through a user interface, wherein recordation of the drug attribute A score is in response to receipt of the drug identification.

17. A non-transitory machine-readable medium comprising instructions, which when executed by one or more processors, cause the one or more processors to perform the following operations:

record a drug attribute A score to a drug based on a characteristic level of specialized clinical services associated with patient understanding of a condition that the drug is used to treat, self management of the condition that the drug is used to treat, or both the patient understanding and the self management of the condition that the drug is used to treat;

record a drug attribute B score to the drug based on a characteristic level of specialized requirements for intensive patient training specific to the administration of the drug or specialized requirements for administration of the drug;

record a drug attribute C score to the drug based on a characteristic level of specialized requirements for clinical monitoring required because of toxicity of the drug and to monitor for therapeutic effect;

record a drug attribute D score to the drug based on a characteristic level of an extent of specialized requirements for compliance assistance by a patient associated with the drug to facilitate therapeutic goals;

record a drug attribute E score to the drug based on a characteristic level of an extent of specialized requirements for handling, preparation, and storage of the drug;

record a drug attribute F score to the drug based on a characteristic level of a distribution channel of the drug;

determine total value for the drug based on the drug attribute A score, drug attribute B score, drug attribute C score, drug attribute D score, drug attribute E score, and drug attribute F score;

determine a cost attribute for the drug based on location of a cost of the drug within a cost range of a plurality of cost ranges;

identify a numerical threshold value based on the cost attribute of the drug; and

compare the total value of the drug against the numerical threshold to identify the drug as a specialty drug.