Identification of specialty drugs

• US 20090192807A1
• Filed: 01/28/2008
• Published: 07/30/2009
• 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: Miller, Steven, Weisbart, Edmond, Behm, Andrew, Tharaldson, Aimee
• Granted Patent: US 8,050,940 B2
• Time in Patent Office: Days
• US Class Current: 705/306
• 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 for determining whether a drug is a specialty drug, drugs having drug attributes and characteristics within each attribute, the method comprising the steps:

(a) obtaining a tool for use in identifying specialty drugs, the tool comprising the following items;

(i) a set of drug attributes that are relatively more important for determining whether a drug is a specialty drug;

(ii) one or more criteria for determining the attribute value of a drug for each of the relatively more important drug attributes;

(iii) one or more criteria for determining the overall value of a drug based on the attribute values; and

(iv) one or more criteria for determining whether a drug is a specialty drug based on the overall value;

(b) determining for the drug an attribute value for each of the relatively more important drug attributes by applying the criteria of item (ii) of the tool to the characteristics of the drug;

(c) determining for the drug an overall value by applying the criteria of item (iii) of the tool to the attribute values of the drug; and

(d) determining whether the drug is a specialty drug by applying the criteria of item (iv) of the tool to the overall value of the drug.

2. The method of claim 1 wherein determining the drug'"'"'s overall value comprises mathematically combining one or more of the attribute values of the drug.

3. The method of claim 1 wherein step (d) for a drug comprises:

(i) comparing the overall value for the drug with a threshold value and (ii) if the overall value of the drug is equal to or greater than the threshold value, designating the drug as a specialty drug.

4. The method of claim 3 wherein the threshold value to which the overall value is compared is selected from a group of two or more threshold values, each corresponding to a different level of drug cost.

5. The method of claim 1 wherein the tool is a pre-existing tool.

6. The method of claim 1 wherein the tool is obtained from a third party.

7. The method of claim 1 wherein the step of obtaining the tool for use in identifying specialty drugs comprises the steps of:

(a) establishing which of the drug attributes are relatively more important for determining whether a drug is a specialty drug, thereby producing a set of relatively more important drug attributes;

(b) establishing one or more criteria for determining an attribute value of a drug for each of the relatively more important drug attributes;

(c) establishing one or more criteria for determining the overall value of a drug based on the attribute values for that drug; and

(d) establishing one or more criteria for determining whether a drug is a specialty drug based on the overall value of the drug.

8. The method of claim 1 wherein the relatively more important drug attributes include one or more of the following:

(i) physical attributes, (ii) route of administration, (iii) level of patient training required to understand and/or implement the route of administration, (iv) uniqueness of the route of administration, (v) means of preparation of a drug for delivery to the patient, (vi) means of preparing a drug for administration to the patient, (vii) cost, (viii) storage requirements, (ix) handling requirements, (x) delivery requirements, (xi) manufacturer, (xii) availability, (xiii) distribution channels, (xiv) potential toxicity, (xv) level of incidence and/or severity of adverse reactions, (xvi) extent to which compliance with a treatment regime regarding administration will affect treatment outcomes, (xvii) extent to which patient support is necessary to insure compliance with a treatment regime, (xviii) conditions a drug may be used to treat, (xix) level of clinical expertise required to understand conditions a drug may be used to treat, (xx) pervasiveness of conditions a drug may be used to treat, and (xxi) therapy class of conditions the drug may be used to treat.

9. The method of claim 1 wherein the overall value of a drug comprises (a) a partial overall value based on the cost of the drug and (b) a partial overall value based on one or more of the following:

(i) physical attributes, (ii) route of administration, (iii) level of patient training required to understand and/or implement the route of administration, (iv) uniqueness of the route of administration, (v) means of preparation of a drug for delivery to the patient, (vi) means of preparing a drug for administration to the patient, (vii) storage requirements, (viii) handling requirements, (ix) delivery requirements, (x) manufacturer, (xi) availability, (xii) distribution channels, (xiii) potential toxicity, (xiv) level of incidence and/or severity of adverse reactions, (xv) extent to which compliance with a treatment regime regarding administration will affect treatment outcomes, (xvi) extent to which patient support is necessary to insure compliance with a treatment regime, (xvii) conditions a drug may be used to treat, (xviii) level of clinical expertise required to understand conditions a drug may be used to treat, (xix) pervasiveness of conditions a drug may be used to treat, and (xx) therapy class of conditions the drug may be used to treat.

10. The method of claim 1 wherein the overall value of a drug comprises (a) a partial overall value based on the cost of the drug, (b) a partial overall value based on the therapy class of the drug, and (c) a partial overall value based on one or more of the following:

(i) physical attributes, (ii) route of administration, (iii) level of patient training required to understand and/or implement the route of administration, (iv) uniqueness of the route of administration, (v) means of preparation of a drug for delivery to the patient, (vi) means of preparing a drug for administration to the patient, (vii) storage requirements, (viii) handling requirements, (ix) delivery requirements, (x) manufacturer, (xi) availability, (xii) distribution channels, (xiii) potential toxicity, (xiv) level of incidence and/or severity of adverse reactions, (xv) extent to which compliance with a treatment regime regarding administration will affect treatment outcomes, (xvi) extent to which patient support is necessary to insure compliance with a treatment regime, (xvii) conditions a drug may be used to treat, (xviii) level of clinical expertise required to understand conditions a drug may be used to treat, and (xix) pervasiveness of conditions a drug may be used to treat.

11. The method of claim 1 wherein the relatively more important drug attributes include one or more of the following:

(a) the level of specialized clinical services required to support patient understanding and/or self-management of the indicated condition, (b) the level of specialized administration of the drug, (c) the level of specialized clinical monitoring required due to drug toxicity and/or pervasiveness of adverse reactions, (d) the extent to which patient support is necessary to insure compliance with a treatment regime, (e) the product handling, preparation, and storage requirements, and (f) the breadth of distribution channels.

12. The method of claim 1 wherein the relatively more important drug attributes comprise at least three of the following:

(i) route of administration;

(ii) targeted disease or condition;

(iii) possible adverse drug reactions;

(iv) risk of toxicity;

(v) cost;

(vi) extent to which patient support is necessary to insure compliance with a treatment regime;

(vii) handling and/or storage requirements; and

(viii) preparation requirements.

13. The method of claim 1 wherein the overall value of a drug comprises (a) a partial overall value based on the cost of the drug and (b) a partial overall value based on one or more of the relatively more important drug attributes of claim 11.

16. A method for creating the tool of claim 1 for use in identifying which drugs are specialty drugs, drugs having drug attributes, the method comprising the steps:

(a) establishing which of the drug attributes are relatively more important for determining whether a drug is a specialty drug, thereby producing a set of relatively more important drug attributes;

(b) establishing one or more criteria for determining the attribute value of a drug for each of the relatively more important drug attributes;

(c) establishing one or more criteria for determining the overall value of a drug based on the attribute values for that drug; and

(d) establishing one or more criteria for determining whether a drug is a specialty drug based on the overall value of the drug.

17. The method of claim 16 wherein step (b) comprises establishing a scale for one or more of the relatively more important drug attributes so that a value can be assigned to a drug to indicate an attribute value for each such relatively more important drug attribute.

18. The method of claim 17 wherein step (d) comprises establishing at least one threshold value as a criterion against which at least part of the overall value of a drug is compared when determining whether a drug is a specialty drug.

19. The method of claim 18 wherein the threshold value depends on the cost of the drug.

20. The method of claim 19 wherein the cost range for drugs is broken into at least two sub-ranges and a different threshold value is established for each of the sub-ranges.

14. A method for determining whether the drugs in a therapy class of drugs are specialty drugs, drugs having drug attributes and characteristics within each attribute, the method comprising the steps:

(a) obtaining a tool for use in identifying specialty drugs, the tool comprising the following items;

(i) a set of drug attributes that are relatively more important for determining whether a drug is a specialty drug;

(ii) one or more criteria for determining the attribute value of a drug for each of the relatively more important drug attributes;

(iii) one or more criteria for determining the overall value of a drug based on the attribute values; and

(iv) one or more criteria for determining whether the drugs in a therapy class comprising two or more drugs are specialty drugs based on the overall values of two or more drugs;

(b) identifying two or more drugs within that therapy class;

(c) determining for each of the drugs identified in step (b) an attribute value for each of the relatively more important drug attributes by applying the criteria of item (ii) of the tool to the characteristics of the drug;

(d) determining for each of the drugs identified in step (b) an overall value by applying the criteria of item (iii) of the tool to the attribute values of the drug; and

(e) determining whether the drugs in the therapy class are specialty drugs by applying the criteria of item (iv) of the tool to the overall values of the drugs identified in step (b).

15. The method of claim 14 wherein the two or more drugs identified in step (b) are representative of the drugs in the therapy class.

21. A tool for use in identifying specialty drugs, drugs having drug attributes, the tool comprising:

(a) a set of drug attributes relatively more important for determining whether a drug is a specialty drug; and

(b) one or more criteria for determining the attribute value of a drug for each of the relatively more important drug attributes.

22. The tool of claim 21 further comprising:

(c) one or more criteria for determining the overall value for a drug based on the attribute values.

23. The tool of claim 22 further comprising:

(d) one or more criteria for determining whether a drug is a specialty drug based on the overall value.

24. The tool of claim 21 wherein the relatively more important drug attributes include one or more of the following:

(i) physical attributes, (ii) route of administration, (iii) level of patient training required to understand and/or implement the route of administration, (iv) uniqueness of the route of administration, (v) means of preparation of a drug for delivery to the patient, (vi) means of preparing a drug for administration to the patient, (vii) cost, (viii) storage requirements, (ix) handling requirements, (x) delivery requirements, (xi) manufacturer, (xii) availability, (xiii) distribution channels, (xiv) potential toxicity, (xv) level of incidence and/or severity of adverse reactions, (xvi) extent to which compliance with a treatment regime regarding administration will affect treatment outcomes, (xvii) extent to which patient support is necessary to insure compliance with a treatment regime, (xviii) conditions a drug may be used to treat, (xix) level of clinical expertise required to understand conditions a drug may be used to treat, (xx) pervasiveness of conditions a drug may be used to treat, and (xxi) therapy class of conditions the drug may be used to treat.

25. The tool of claim 21 wherein the relatively more important drug attributes include one or more of the following:

(a) the level of specialized clinical services required to support patient understanding and/or self-management of the indicated condition, (b) the level of specialized administration of the drug, (c) the level of specialized clinical monitoring required due to drug toxicity and/or pervasiveness of adverse reactions, (d) the extent to which patient support is necessary to insure compliance with a treatment regime, (e) the product handling, preparation, and storage requirements, and (f) the breadth of distribution channels.

26. The tool of claim 21 wherein the relatively more important drug attributes of the tool comprise at least three of the following:

(i) route of administration;

(ii) targeted disease or condition;

(iii) possible adverse drug reactions;

(iv) risk of toxicity;

(v) cost;

(vi) extent to which patient support is necessary to insure compliance with a treatment regime;

(vii) handling and/or storage requirements; and

(viii) preparation requirements.

27. The tool of claim 21 wherein the criteria of element (b) comprise a scale for one or more of the relatively more important drug attributes so that a value can be assigned to a drug to indicate the attribute value of the drug for that one or more relatively more important drug attribute.

28. The tool of claim 23 wherein the criteria of element (d) comprise at least one threshold value for use as a criterion against which at least part of the overall value of a drug is compared when determining whether a drug is a specialty drug.

29. The tool of claim 28 wherein there are two or more threshold values corresponding to different drug cost sub-ranges within the range of drug costs.