WO2017025812A1 - Procédé de réorientation de codes ndc dans une base de données pharmaceutiques d'allergènes dérivés de venins et utilisés en immunothérapie aux venins - Google Patents

Procédé de réorientation de codes ndc dans une base de données pharmaceutiques d'allergènes dérivés de venins et utilisés en immunothérapie aux venins Download PDF

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Publication number
WO2017025812A1
WO2017025812A1 PCT/IB2016/001332 IB2016001332W WO2017025812A1 WO 2017025812 A1 WO2017025812 A1 WO 2017025812A1 IB 2016001332 W IB2016001332 W IB 2016001332W WO 2017025812 A1 WO2017025812 A1 WO 2017025812A1
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Prior art keywords
ndc
level
venom derived
database
venom
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PCT/IB2016/001332
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English (en)
Inventor
James Strader
Jovan Hutton PULITZER
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ROCA Medical Ltd.
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Priority claimed from US15/171,920 external-priority patent/US20170024526A1/en
Application filed by ROCA Medical Ltd. filed Critical ROCA Medical Ltd.
Publication of WO2017025812A1 publication Critical patent/WO2017025812A1/fr

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    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/10—Office automation; Time management

Definitions

  • the following disclosure relates to repurposing an existing database related to the pharmaceutical industry and reimbursement for such things as allergens involved in venom immunotherapy that are not currently supported in the database or only a few of which are supported.
  • Immunotherapy basically involves a series of allergy shots given to reduce one's sensitivity to various allergens that may cause an allergic reaction.
  • This immunotherapy can either be venom based or environmentally based.
  • VIT venom based immunotherapy
  • treatments are available for allergies to stings such as honeybees, Yellowjackets, Hornets, paper wasps, fire ants and snakebites.
  • insect stings very small amount of the insect venom is injected under the skin in a dilute saline solution. This type of therapy is recommended for all patients who have experienced systemic reaction to insect sting and have specific IgE to venom allergens shown either my skin or blood test.
  • VIT as compared to Environmental Immunotherapy is different than pollins and the such that one might be exposed to in the environment in that VIT is basically associated with allergens that are flown around inside a special injection device that, when counter, may threaten the lives of those who are sent to to it ... Insect venom allergy or snake venom.
  • the primary offenders associated with VIT are prone primarily insects that sting rather than those that might or, as noted hereinabove, snakes.
  • the insects that sting are typically members of the order of Hymenoptera of the class insect.
  • the process is to immunize the individual with small and graded doses of the venom.
  • an anti-venom which is manufactured via a purified process in another animal such as a sheet.
  • the approved anti-venom for the pit viper (rattlesnake, copperhead and water moccasin) is based on a purified product made in sheet known as CroFab.
  • CroFab a purified product made in sheet known as CroFab.
  • antigen is any structural substance that serves as a target for the receptors of an adaptive immune response or, alternatively, and more simply stated, and antigen is any substance that causes an immune system to produce antibodies against it.
  • An allergen is a type of antigen that produces an abnormally vigorous immune response in which the immune system fights off a perceived threat that would otherwise be harmless to the body. These reactions are termed allergies.
  • venom as the allergen
  • the immune system can initially accommodate this and, as a doses increase, the immune system will continue to adapt and build up antibodies to this allergen, i.e., the venom of the particular insect or snake or other such.
  • allergens associated with the venom immunotherapy are specifically associated with allergens that originate from the internal organs of animals, insects or reptiles.
  • APN Average Wholesale Price
  • AWP has often been compared to the "list price” or "sticker price", meaning it is an elevated drug price that is rarely what is actually paid.
  • AWP is not a government-regulated figure, does not include buyer volume discounts or rebates often involved in prescription drug sales, and is subject to fraudulent manipulation by manufacturers or even wholesalers. As such, the AWP, while used throughout the industry, is a controversial pricing benchmark.
  • the AWP may be determined by several different methods.
  • the drug manufacturer may report the AWP to the individual publisher of drug pricing data, such as Medi-Span.
  • the AWP may also be calculated by the publisher based upon a mark-up specified by the manufacturer that is applied to the wholesale acquisition cost (WAC) or direct price (DIRP).
  • WAC wholesale acquisition cost
  • DIRP direct price
  • the WAC is the manufacturer's list price of the drug when sold to the wholesaler
  • DIRP is the manufacturer's list price when sold to non-wholesalers.
  • a 20% mark-up is applied to the manufacturer-supplied WAC or DIRP, which results in the AWP figure.
  • AWP is a component of the formulas used to determine reimbursement
  • elevated AWP numbers can drastically increase the dollar amount that government, private insurance programs, and consumers with coinsurance must pay.
  • Pharmacies typically buy drugs from a wholesaler and then sell them to the public. Many patients have coinsurance or copayments, where they only pay for a portion of their prescription cost. The insurance company then pays the rest of the cost (the reimbursement) to the pharmacy. Insurance companies include prescription benefit manager (PBM), health maintenance organization (HMO) or government programs, such as Medicaid or Medicare Part B or D. In addition, the pharmacy receives a dispensing fee for filling the prescription. Fees are, for example, set between $3 to $5 per prescription, but may vary by state.
  • Reimbursements are based on AWPs.
  • pharmacies purchase drugs based on the WAC.
  • the difference between the WAC (what the pharmacy actually paid for the drug) and the reimbursement from insurance (based on AWP) is known as the spread, and equates to the profit that the pharmacy receives.
  • a method for adjudicating reimbursement for venom derived allergens between a pharmacist and a reimbursing entity comprises obtaining at a central control center National Drug Codes (NDC's) for a plurality of venom derived allergens at a defined concentration level, each NDC uniquely identifying that particular allergen as to its manufacture, the particular allergen, the packaging and the defined concentration level, and further obtaining information as to a description of the particular venom derived allergen, concentration level and manufacturer determining by the central control center an Average Wholesale Price (AWP) for each of the venom derived allergens associated with each of the NDC's, storing in a central control database the obtained NDC's in association with an associated AWP and associated information for the venom derived allergen, which associated information includes translation information to allow practitioners to determine from a desired diluted level and number of doses of a desired NDC carrying venom derived antigen and a known dil
  • NDC's National Drug Codes
  • FIG. 1 illustrates a general diagrammatic view of the overall interface of basic databases
  • Fig. 1 A illustrates an DA code
  • FIG. 2 illustrates a diagrammatic view of a database that is populated by a central control system
  • Fig. 3 illustrates a flow chart for the operation at the central control system for receiving DCs from the manufacturer
  • Fig. 4 illustrates a flow chart for the operation of populating third-party database by the central control system
  • Fig. 5 illustrates a flow chart for the operation at the pharmaceutical location
  • Fig 6 illustrates a flow chart for the overall generation of the AWP and the interface with the benefit providers
  • Figure 7 illustrates a diagrammatic view of flow beginning at the prick test and following through to filling the prescription at the pharmacist location;
  • Figure 8 illustrates a flowchart for interfacing with database for accessing benefits by the pharmacist
  • Figure 9 illustrates a flowchart for the parsing operation at the database for parsing non- DC allergens to an NDC-bearing base concentrated allergen
  • Fig. 10 illustrates a diagrammatic view of a dilution sequence of diluting a concentrated antigen extract
  • Fig. 11 illustrates a process flow for diluting an antigen extract
  • Fig. 12 illustrates a process flow for the overall distribution chain
  • Fig. 13 illustrates a process flow for multiple extracts
  • FIG. 14 illustrates an alternate embodiment of Fig. 13
  • FIG. 15 illustrates a flowchart for one example of processing a physician script
  • Fig. 16 illustrates a diagrammatic view of a table in a relational database relating distributed doses back to DC-bearing dose
  • FIG. 17 illustrates a second example of that illustrated in Figure 15;
  • Fig. 18 illustrates a diagrammatic view of processing of a script received from a physician at a pharmacist to compound a patient-specific dosage
  • FIG. 19 illustrates an alternate embodiment of that illustrated in Figure 18;
  • FIG. 20A illustrates a diagrammatic view of a process of filling a script received from a position and Figure 20B illustrates a table associated with such process;
  • Fig. 21 illustrates an overall process flow illustrating the prick test, the script flowing through to the final patient does
  • Fig. 22A illustrates a flowchart for parsing an antigen having a base dose with more than the prescribed antigens and Figure 22B illustrates a table associated with the parsing operation.
  • Fig. 1 there is illustrated a diagrammatic view of the overall system for transferring DC's between systems.
  • the NDC or National Drug Code, is a unique 10-digit, 3-segment number. It is a universal product identifier for human drugs in the United States. The code is present on all nonprescription (OTC) and prescription medication packages and inserts in the U.S.
  • OTC nonprescription
  • the 3 segments of the NDC identify the labeler, the product, and the commercial package size.
  • the first set of numbers in the NDC identifies the labeler (manufacturer, repackager, or distributer).
  • the second set of numbers is the product code, which identifies the specific strength, dosage form (i.e, capsule, tablet, liquid) and formulation of a drug for a specific manufacturer.
  • the third set is the package code, which identifies package sizes and types.
  • the labeler code is assigned by the FDA, while the product and package code are assigned by the labeler.
  • the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02.
  • the first segment of numbers identifies the labeler.
  • the labeler code "0777” is for Dista Products Company, the labeler of Prozac.
  • the second segment, the product code identifies the specific strength, dosage form (i.e, capsule, tablet, liquid) and formulation of a drug for a specific manufacturer.
  • "3105" identifies that this dosage form is a capsule.
  • the third segment is the package code, and it identifies package sizes and types. Our example shows that the package code "02" for this bottle of Prozac identifies that 100 capsules are in the bottle.
  • the FDA maintains a searchable database of all NDC codes on their website. This is illustrated in Fig. 1A.
  • the NDC codes are unique codes that are applied for and assigned to specific individuals to be associated with specific products.
  • Each manufacturer of allergens for example, has a unique NDC associated with the product that they provide, which is assigned to that manufacture for that product based upon their applying for such. The manufacturer, therefore, has full ownership of that NDC.
  • the approval of that manufacture is required.
  • a manufacturer of a well-known drug will provide information to the database and populate that database and the record associated with that NDC with the information regarding that product associated with that NDC but they will also define what the AWP is for that product.
  • a manufacturer 102 has associated there with its own proprietary database 1044 to store their NDCs.
  • This can be provided to a central control center 106.
  • the central control center 106 desires to have access to these NDCs of the manufacturer 102. This is the primary reason that these NDCs do not exist in any other database.
  • the central control center 106 would have some type of contractual relationship with the manufacturer 102 for the purpose of maintaining some type of exclusivity with respect to the manufacturer's NDC.
  • these NDCs are stored in a central control database 108.
  • the central control 106 can modify the information. Primarily, the main aspect that they had is the AWP. This allows the central control 102 to control this AWP.
  • the AWP is the benchmark price. This is not necessarily the price that the pharmacist, for example, will charge to the customer but, rather, it is the benchmark price. Further, this is not even the price that will be reimbursed to the pharmacist even if the pharmacist billed the customer for such. Thus, of course, this would not result in any type of price-fixing; rather, all that is controlled by the central control 106 is the inclusion of AWP within the database. This AWP can be utilized by the reimbursing entities and the such for centering on a final reimbursement price.
  • the data associated in with these venom derived allergens is then downloaded into a third party database 110 associated with a third-party information provider.
  • This information provider is one of many information providers that provide access through a network 112 to a pharmacy 1 14. It is noted, however, that the central control 106 first confirms that none of the NDCs associated with any of the venom derived allergens is actually currently in the third party database 110. Once these NDCs and their associated information and associated AWP's are stored in the third party database 110, the central database 108 has some control over both the information and the AWP associated with each of the NDCs.
  • a pharmacist when a pharmacist receives a request from a physician to fill a prescription for a venom derived allergen for delivery to the physician, the pharmacist can access the third party database 110 and determine that this is, in fact, in the database and is a reimbursable prescription.
  • Fig. 2 there is illustrated a diagrammatic view of the third party database. This includes, in one column, DC's, and a second column AWP's and in a third column information regarding the product associated with the NDC.
  • FIG. 3 there is illustrated a flowchart depicting the initial operation of populating the database 108.
  • the central control 106 initiates the process at a block 202 and proceeds to block 304 in order to receive the NDC from the manufacturer with the associated information regarding the associated product.
  • This is one associated with product in the database of the control center 106 and also with products controlled by the control center 106.
  • the control center 106 is typically associated with some type of distribution center such that, in the information that they associate with the NDC in the database 108, the control center 106 and the entity associated therewith are the distribution arm for that product, i.e., this is where the product is ordered from by the pharmacist.
  • the program then proceeds to a block 308 wherein the AWP for that particular product and associated with that NDC is defined.
  • This is a number that is set at whatever level is determined to be correct and appropriate by the control center 106.
  • This wholesale price is not necessarily associated with the record that is stored in the database 110. However, it is this information that is utilized in determining what the AWP will be for that NDC and associated product. A number of factors, of course, enter into that calculation, including practical knowledge of how the insurance industry reimburses for venom based allergens.
  • the information is stored in the central control database 108.
  • Fig. 4 there is illustrated a flowchart depicting the transfer of data, which is initiated at a block 404 and then proceeds to a block 406 to access the third- party database through the network 112.
  • the program then flows to a function block 410 to confirm that no NDCs in the control database 108 exists within that third-party database 110.
  • the program then flows to a function block 412 to populate the third-party database 110 with information from the control database 108, which, as described above, includes the information from the manufacture, information regarding the central control center 106 as being a source of the product and the AWP for that product, all associated with the NDC for that product.
  • Fig. 5 there is illustrated a flowchart for the operation at the pharmacy. This is initiated at a block 502 and then proceeds to a block 504 wherein the pharmacist receives a request from a physician for a venom derived allergen. This might actually be presented to the pharmacist by a patient which desires to receive the venom derived allergen for dilution and processing by the pharmacist or it may in fact be an already diluted venom derived allergen that could be actually self-administered by the patient. The program then flows to a decision block 506 to determine if the product is in stock.
  • the program flows to a function block 512 to check the database for reimbursement and, if not, the program flows to a block 510 to process a stock item by whatever procedure the pharmacist utilizes.
  • the pharmacist enters the NDC of the product, as indicated in a block 514.
  • the program then flows to a decision block to determine if the NDC is found, this being block 516. If not found, the program exits and, if found, the program flows the function block 518 wherein the pharmacist can view the AWP for that product. This gives the pharmacist some idea as to what might be reimbursable, but also, the insurer itself will illustrate some type of potential co-pay. This just indicates the amount that the patient will pay at the counter.
  • the pharmacist then can enter an amount that the pharmacist will claim that they want to be paid for this particular product. It may be less than the AWP but not more than AWP. This, of course, is a function of what the pharmacist desires. This is indicated by block 520.
  • a third-party database 110 having information contained therein, which is controlled by the central control center 106 with respect to the venom derived allergens. Part of this is the AWP and part of it is the source for that venom derived allergen.
  • the insurer has access to this information and can utilize it to adjudicate a claim. Information from the insurer can be linked to this database indicating a co-pay, for example.
  • the process for adjudicating any claim requires that some entity or party has worked with the insurance company or the reimbursing entity to negotiate the particular reimbursement or any benefits that are provided. If the pharmacist is apprised of an AWP in the database for a particular venom derived allergen, they at least have a price that they can charge for the product. For example, if the pharmacist has a product on the shelf with an NDC any position writes a prescription for that venom derived allergen, the pharmacist just needs to know how much to charge the patient. By accessing the third-party database 110, the AWP can be determined. However, that alone doesn't allow the pharmacist to determine whether benefits are associated with that particular venom derived allergen.
  • an adjudicating party or entity there has to be some link between an adjudicating party or entity.
  • the pharmacist can select the NDC and a field (not shown) that directs the pharmacist to an adjudicating party or entity to provide information as to benefits that are available. If such indicates that benefits are available, then the pharmacist knows that they can make a claim to this adjudicating party.
  • the central control center 106 maintains the adjudicating database.
  • the central control center 106 is responsible for interfacing with insurers and the such to provide these benefits. For example, if there are five major insurance companies that reimburse the pharmacist or even Medicare, the central control center 106 will make the arrangements for reimbursement and allow the pharmacist to determine whether the patient, who may be associated with any of these reimbursement entities, can receive benefits. If, for example, the patient had insurance with Insurer A, and central control center 106 had negotiated with Insurer A for certain benefits, this would be made available to the pharmacist.
  • the benefits might provide for some type of co-pay which the pharmacist could charge to the patient and then the pharmacist could make a claim for the remaining value of the venom derived allergen to the adjudicating party, i.e., in this case the central control center 106.
  • the central control center 106 would then process the claim and forward a check to the pharmacist. Since the central control center 106 populated the third-party database 110 with all of the NDCs, the central control center 106 has exclusive rights to adjudicate these NDCs and the associated venom derived allergens. Thus, this unique link from the third-party database 110 to the central control center 106 allows all claims to be adjudicated therethrough because the central control center 106 has exclusive control over these NDC for these venom derived allergens.
  • All of the NDCs, as noted hereinabove, or for venom derived and allergens that are to be dispensed to a patient are a single dose venom derived allergen.
  • each of the NDCs that would be obtained by the manufacturer would be for single dose venom derived allergens rather than bulk venom derived allergens that are currently provided.
  • Fig. 6 illustrates a flow chart depicting the operation wherein the control center is able to determine the AWP by interfacing with the benefit providers. This is initiated at a block 602 and then proceeds to block 604 wherein the control center assembles the various cost information regarding the manufacturers cost to the control center, the expenses of storing the venom derived allergen at the control center, i.e., where the control center is the distributor and provider of the venom derived allergen, and what kind of markup or profit margin the control center expects to receive on a venom derived allergen. The program then flows a function block 606 to determine the AWP.
  • This AWP is based on the information retrieved in block 604 and then a ceiling for the AWP is determined.
  • This ceiling is a number that is arrived at by the control center based upon their knowledge of how the benefit providers reimburse pharmacists and the such. Since the AWP is a ceiling and the pharmacist cannot charge more than that, they provide a number that is a benchmark for the industry. By determining this benchmark, the insurance industry will typically center in on a lower reimbursable price, depending upon how valuable they think a particular venom derived allergen or the such is to the industry. For example, if they sold the product for $350 to the pharmacist, this being the wholesale price, they might set the AWP at $500. Over time, pharmacist may actually make a claim for only $450 which, at first, the insurance copies may reimburse. After a time, the insurance industry may come to the conclusion that this venom derived allergen is only reimbursable at a rate of $400.
  • the program then flows to a function block 612 wherein a control center can interface with benefit providers to determine what the reimbursement levels are and, if necessary, adjust the AWP. However, they can also determine such things as rebate programs and incentives and the such that they can provide to the pharmacist, as indicated by a function block 614. Since they control the database, they can also write information from the interface with that particular part of the database.
  • the program then flows to a function block 616 to adjust the AWP if necessary and then into a function block 618 to adjust the information in the database if necessary.
  • each script is very patient-specific; that is, in a system that is unique to testing for venom derived allergens, it is necessary to determine which of multiple antigens must be combined in a desensitization program. It may be that, for example, a prick test initially indicates that the patient is highly allergic to cat fur, dog care, various types of pollen, certain venoms, and the such.
  • the physician can then determine which antigens need to be combined in some type of prescribed dosage regimen. Since there are so many venom derived allergens that can exist and since each patient is an individual, this combination can be somewhat daunting if the desire of the industry were to provide only that particular combination as a "drug" that has an NDC associated there with. This is practically impossible, of course.
  • This is initiated at a block 702 wherein the physician subjects the patient to what is known as a "prick" test.
  • This prick test is a test whereby the physician introduces a small amount of venom derived allergens into a small area on the skin of an individual. There can be multiple spots that are arranged in a grid on, for example, a portion of the back of the patient. These allergen locations are recorded and then they are observed over a certain period of time.
  • hypoallergenic antigen there is also typically some type of base allergen that is provided such as a hypoallergenic antigen and a hyper allergenic antigen such that there is an area that will result in no response and as an area that will result in a guaranteed response.
  • areas that elicit a positive response indicate that the patient is sensitive to that particular allergen. It may be that the patient is very sensitive to certain of the allergens and just mildly sensitive to others.
  • the physician determines which of the allergens need to be included in a desensitization program. For example, if an individual in Texas showed a positive response to some allergen that rarely occurred in Texas, the physician might not include that in a desensitization regimen.
  • a script is then written by the physician, as indicated by block 704.
  • This can be a script for a single venom derived antigen if that was all that was required for a desensitization program or it could be for a cocktail of multiple venom derived antigens.
  • the physician will define the venom derived antigen or antigens that are to be included in the regimen, the dosage level and the carrier. For example, for the first desensitization level, the most diluted level of antigen will be utilized.
  • the physician will require that the single venom derived antigen or cocktail of antigens be provided in a carrier such as saline or glycerol in a vial that will allow for a certain number of injections. It may be that the physician wants to prescribe for this first desensitization level a dosage that will allow for three injections per week for three weeks.
  • This script is then written and provided to the patient or it can be directly delivered to the pharmacist, as indicated by a path 706 to a block 708 indicating the pharmacist.
  • the pharmacist then creates a patient-specific venom derived antigen cocktail, as indicated by block 710.
  • the pharmacist then lists the antigens that are contained within the cocktail, noting that there could be a single antigen. This is indicated at a block 712 and then the pharmacist accesses the database for price and benefits.
  • This is basically the Pharmacy Benefits Manager (PBM) database, which contains all of the drugs, etc., that are available for reimbursement. If the pharmacist, for example, looks up a particular antigen that was prescribed in the script and does not find it, this indicates that it is not something that can be reimbursed.
  • PBM Pharmacy Benefits Manager
  • this antigen indicates both the AWP for that antigen and benefits associated there with. All of this is pre-populated within the database. However, with respect specifically to any antigen, the NDC for that antigen will only be associated with the base concentrate level. The script, however, is for a particular diluted dosage of that particular antigen and even a combination of multiple antigens at that particular dosage.
  • This database is accessed at a block 714 and then, after access is complete, as indicated by a decision block 716, the prescription is filled at a block 718.
  • each of the scripts set forth by the physician will always have a list of each of the one or more allergens to which the patient exhibited a level of sensitivity thereto and the antigens associated there with. Further, the physician will determine the dosage level also. This is indicated by block 720.
  • Fig. 8 there is illustrated a flowchart depicting the operation of accessing the database, which is initiated at a block 802 and then proceeds to a decision block 804.
  • the decision block 804 determines whether a request for access has been received and, if so, the flowchart proceeds to a block 806 to determine if the particular request of the PBM database is associated with that for an antigen. If not, the program will follow the "N" path to a block 802 to proceed along the normal benefit determining process. This is not described herein.
  • the program flows to a block 810 in order to receive the NDC for the base antigen or antigens and then to a block 812 to receive the dose level for all of the antigens, as well as the carrier and the dilution procedure that is utilized.
  • the program will then flow to a block 814 in order to cross reference the particular dose level that was actually distributed to the patient to the dose of the highest concentrated level of the base concentrate material. This will be on a parsed operational level.
  • This parsed operational level means that, for example, if 10 antigens were distributed in a cocktail, it would be necessary to cross reference the distribution of this particular dosage level to the actual material utilized from the NDC- carrying base concentrated level. If, for example, for a single base concentrated material that yielded an antigen in the cocktail mixed, required 1 mL out of a 50 mL bottle, the benefits for that one milliliter could be determined, as this is a "dosage" of the base concentrated level that is associated with an NDC. As indicated by a block 816, the benefits can be determined for "each" allergen at a base or lowest concentrated level that is associated with an NDC. It is noted that an NDC might be provided for an already diluted level of a particular antigen.
  • Fig. 9 there is illustrated a flowchart for the parsing operation, which is initiated at a block 902.
  • the program then proceeds to a block 904 in order to receive the prescribed script levels.
  • the program then proceeds to a block 906 in order to parse antigens in the cocktail to individual antigens (noting that a single antigen could be provided for).
  • the program then flows to a block 908 in order to cross correlate each of the parsed antigens and the script dose level back to the base concentrated amount, noting that this requires the carrier to be known, the procedure to be known for dilution. Since the script merely states that the most diluted level must be provided for, the pharmacist then to provide that particular antigen.
  • the particular base concentrated antigen could be at different concentrated levels which would require a pharmacist to utilize one of multiple dilution procedures to obtain the final diluted level desensitization regimen.
  • physician prescribes a particular antigen in the cocktail that can be found in an antigen at a base concentrated level that contains multiple antigens. This is very common in the industry. For example, some companies deliver already mixed cocktails for various types of pollen. If the physician only prescribed one out of these types of pollen, then this procedure must be noted so that particular amount of base concentrated material, that can be reimbursed based upon its NDC, could be allocated.
  • Fig. 10 there is illustrated a depiction of a technique for diluting immunomodulators such as antigens, as one example.
  • Preparation of a diluted antigen is performed first by receiving a bottle of extract concentrates at a base concentrate level from an approved vendor. These are formulated in a given weight/volume (w/v) format with a given antigen associated therewith. For typical antigens such as those associated with the cat antigen, these are relatively well controlled.
  • a vendor will provide an extract for a single antigen or allergen.
  • Allergens such as pollen and the such are not as well controlled due to the technique for collecting such. In any event, there are typically very few approved vendors for these extracts and an allergist typically receives these vendor provided concentrates in a sufficient quantity to make the necessary diluted solution.
  • Allergen extract is typically comprised of a non-allergenic material, a non- allergenic protein and an allergenic protein.
  • the extraction solutions can be aqueous containing saline and phenol work could be a glycerinated solution.
  • the allergen is added, the units of measure are sometimes referred to as "AU” for " allergy units,” typically used for mites. These are referred to as “AU/mL.”
  • AU for “ allergy units,” typically used for mites.
  • AU/mL For such things as grass and cat, the term “BAU” is used for "bioequivalent units.”
  • the terminology is, for example, 1 :20 w/v, which stands for lg source material per 20 mL of fluid. The relationship between BAU and 1 :20 w/v depends upon the extract. In any event, there is a defined amount of extract contained within the concentrate.
  • concentrated extracts When concentrated extracts are formulated by an authorized vendor, they are typically provided in standardized versions and non-standardized versions. In standardized versions, they typically are provided in a 50% glycerin dilutant. They can either be a single allergen extract or they can be a mix. For example, one can obtain a "9 Southern Grass Mix (concentrate)" which contains equal parts of: 2 Bermuda at 10,000 BAU/mL, P27 7 Grass at 100,000 BAU/mL, 15 Johnson at 1 :20 w/v. For non-standardized extracts, these are typically provided in either a glycerin dilutant or an aqueous dilutant such as saline. They can be a single extract or a mix.
  • a concentrated extract refers to a formulation that is provided by an authorized vendor that can be diluted in accordance with the processes described hereinbelow. These are typically provided in the 50 mL bottles with a needle compatible.
  • the extract concentrate is disposed in a bottle 1002.
  • This is a sterile concentrate that has an injection stoppered top 1004.
  • Each of these bottles has disposed therein a defined amount of dilutant, depending upon what the final required to be.
  • the amount of dilutant is 4.5 mL.
  • the procedure is to, first, extract a defined amount of the concentrated extract from the bottle 102 and dispose it in the bottle 1006. This is facilitated by the sterile hypodermic that is inserted through the stopper at the top of the bottle 1002 to extract concentrate and then the hypodermic is inserted to the stopper in the bottle 1006 to inject extract from bottle 1002 into bottle 1006.
  • the concentration in the concentrated extract bottle 1002 is 1 :20 w/v. This will result in a dilution of 1 : 10 in bottle 1006. If the amount injected is 0.45 mL.
  • an allergist will then extract from the desired dilution an amount of the diluted antigen for injection percutaneously.
  • desensitization is achieved by using the most diluted antigen level initially and sequentially moving up to a higher concentration level over time 1.
  • Fig. 10 Illustrated in Fig. 10 are three hypodermic needles, one selecting a "dose" from bottle 1014, and labeled hypodermic 1016, a second hypodermic needle 1018 for retrieving a dose from bottle 1012, a third hypodermic needle 1020 for extracting a dose from bottle 1010.
  • Each of the hypodermic needles 1016, 1018 and 1020 will contain a different diluted dose. These would typically be separate needles in the event that the allergist or medical professional is injecting a patient. For other purposes, they could be the same needle, depending upon the dose or concentration required.
  • a "dose” is defined as the amount of all the diluted product that would be required for the desired immunotherapy. This is defined by the medical professional.
  • bottle 1012 If, for example, bottle 1012 were utilized, it may be that 1 mL of diluted solution constituted a "dose.” It could be that less than 1 mL constituted a "dose.”
  • This entire procedure is provided as a "data" procedure which can be designed for particular carriers and the such.
  • the carrier could be a transdermal cream which could be mixed by the pharmacist. Any carrier that is able to contain one or more diluted antigens at any prescribed dilution level can be utilized.
  • Fig. 11 there is illustrated a process flow for the embodiment of Fig. 10. This is initiated at a process block 1102 and then proceeds to block 1104 wherein a certain amount of concentrated extract is received from a vendor, this being a qualified or authorized vendor for the extract. This is typically at a predetermined concentrate level of, for example, 1 :20 m/v. The process then flows to a block 1108 wherein a defined quantity of, for example, 0.45 mL is transferred to a 5 mL bottle which already has a quantity of 4.5 mL buffered saline solution disposed therein.
  • the process then flows to a block 1110 to determine if this was the last dilution step needed, as described hereinabove, depending upon what level of dilution is necessary. If, for example, by steps of dilution are required for a particular patient, and all five steps would be processed. However, it is not necessary to do all five steps if an intermediate dilution is required. This essentially customizes the overall operation for a particular patient. Further, the industry is so regulated such that only 5 mL bottles can be utilized for this dilution process. Thus, it will only be a maximum of 5 mL of diluted material available at any step prior to proceeding to the next step. Thus, if all 5 mL are required, then the next step is not desired or useful.
  • the process flows to a block 11 12 to extract 0.45 mL of diluted antigen from the current 5 mL bottle and then flows back to the input of the process block 1108 after incrementing the bottle count at a block 1114. This continues until the last dilution, at which time the process flows from the block 1110 to a terminate block 1116.
  • any type of carrier could be utilized and bottles larger than 5 mL could in fact be utilized. This all depends upon the number of "doses" at a particular diluted level that are required by the physician right the initial script or prescription.
  • Fig. 12 there is illustrated in overall flow of the operation of moving concentrated antigen from a vendor to an end user via a pharmacist.
  • the liquid antigen in a concentrated extract at the base concentrate level that has associated there with an DC was first received from a vendor that assigned that DC, which is basically a combination of a single antigen or antigens suspended in a sterile agent. This is indicated by a block 1202.
  • the antigen is then diluted by the pharmacist from this extract to a desired diluted level, as indicated by a process block 1204.
  • a sterile carrier and containment material i.e., sterile saline solution or, even a transdermal cream, for distribution to a patient.
  • a sterile carrier and containment material i.e., sterile saline solution or, even a transdermal cream.
  • This will typically be a defined number of doses of a single diluted antigen or multiple diluted antigens, wherein a dose is again defined as being a typical dose that a medical professional would administer to a patient in an office visit necessary to achieve a therapeutic result for which a patient could administer to themselves.
  • This is either transferred as a combined antigen (diluted)/encapsulation product for storage on a shelf, as indicated by a block 1212, or it would be transferred to a medical professional for a patient for management and disposition.
  • Fig. 13 there is illustrated a diagrammatic view of three different extracts of antigens/allergens 1302, 1304 and 1306. Each of these is for a particular antigen or allergen. The first two are for antigens respectively associated with a cat and a dog. The third is for an allergen associated with pollen. They are each diluted in accordance with the process described hereinabove with respect to Fig. 10. As illustrated, the antigen extract in bottle 1302 is transferred as a diluted level to either an encapsulation material in a container 1310 or 1312, each at a different diluted level.
  • any extract will be 100% pure with respect to the particular extract.
  • These concentrated extracts are not typically mixed, which is typically a function that the medical professional or compounding pharmacist will perform. This, of course, is a customized mixture for a particular patient, i.e., this is a patient-specific combination as defined by the medical professional in the script provided to the pharmacist.
  • the operation of Fig. 13 will be facilitated in order to ensure that the containers 1310 - 1320 contained only a single antigen.
  • this would be stored on the shelf as a single allergen combination of the base concentrate level.
  • each of the immunomodulators or antigens at the concentrated levels in the bottles 1302 - 1306 are diluted in accordance with the process noted hereinabove wherein they are sequentially diluted in the associated 5 mL bottles. However, note that only a maximum of 5 mL can be extracted from a given bottle at the last dilution level.
  • a viscous transdermal cream can be utilized that is initiated at an original fixed value in grants such that each dose will be associated with a single gram of that transdermal cream material, and then the amount of diluted antigen must be adjusted such that single dose is contained within 0.3 mL of the material. Thereafter, if 3 mL of antigen is extracted from a given bottle, this constitutes 10 doses such that a single dose will be associated with a single dose of the final encapsulation material.
  • the carrier material in the container 1402 now acts as a consolidator of all of the antigens for a cocktail.
  • Fig. 15 there is illustrated a flowchart depicting one example of the generation of a script for a single antigen and filling of that fiction based on that script and getting reimbursed therefor.
  • This is initiated at a block 1502 and then proceeds to a block 1504 in order to prepare the physician script for a single antigen.
  • the program then flows to a block 1506 in order to define the requirements of the maximum dilution for the initial desensitization.
  • the physician defined at which level the script is written for. For example, the physician sets forth a regimen. This regimen defines six levels of dilution of a defined DC base concentrate antigen, each level of dilution are required for a predetermined amount of time.
  • the most diluted level might be required to be administered in three doses per week for three weeks for total of nine doses.
  • the first script would require the pharmacist to deliver to the patient a vial containing nine doses at that diluted level of the at least a single antigen.
  • the physician could then require the second higher level to be provided over the course of one week at three doses per week.
  • This might require a second script to be filled by the pharmacist or, alternatively, the pharmacist could fill that script that same time and maintained that particular vial on the shelf for distribution to the patient at a later time, all of this depending upon the script provided by the physician.
  • the physician could require the patient to come into the office for observation and then write another script. This would be a separate and distinct operation and prescription which would be independently associated with a different set of benefits possibly.
  • the program flows to a function block 1508 wherein the pharmacist selects concentrate antigen and then goes to the dilution process required in order to achieve the desired diluted level.
  • the program then proceeds to a function block 1510 wherein the pharmacist enters the NDC code for the base concentrate level and the script level. Basically, what the pharmacist does is enter the antigen name and the dosage level provided by script.
  • the program then proceeds to a function block 1512 in order to perform a lookup in the PBM database for the particular antigen that is associated with the script.
  • a table for a single antigen and the overall crosscorrelation information This is a relational database.
  • this table can be seen that there is provided a column for the NDC code which is populated for a particular antigen. This indicates the name of the antigen and also information associated there with.
  • the base level is indicated by a dilutant level Dl or a base concentrate level there than provide five additional dilutant levels D2 through D6.
  • Each one of these dilutant level columns has associated there with a particular range of dilutant levels. As indicated by example, there are levels 1 through 3 for each of diluted levels, with more possible. Therefore, if the most diluted level, D6 were selected and that the procedure required that the dilutant level Z6 for the dilutant level column D6 were selected as the end dilutant level that was required by the physician in the script provided to the pharmacist, this would be what was put into the PBM system. However, there is no NDC associated with this particular antigen at this particular dilutant level.
  • each column for the dilutant level D6 has three procedures such that there are provided three different amounts of the base extract that would be required, Zl, ⁇ and Zl". For example, it might be that this requires corresponding levels of 0.8 mL, 1.0 mL or 1.1 mL for those three different levels in order to accommodate the three different dilution procedures SI, S2 and S3. Thus, it is not just a mere crosscorrelation operation but, rather, and overall knowledge of the process that is required in order to determine how much actual product was utilized of the original base NDC-carrying antigen. Only when the amount of the base concentrate NDC-carrying antigen that is utilized is known can the actual dosage be determined.
  • Fig. 17 there is illustrated a flowchart for a second example for preparing a script for a cocktail, which is similar to the flowchart of Fig. 15. This is initiated at a block 1702 and then proceeds to a block 1704 to generate a script for a cocktail which is a patient-specific cocktail based upon a prick test performed. This is unique to that patient for that particular time. The program then proceeds to a function block 1706 in order to provide in that script a list of the antigens to be placed into the cocktail by the pharmacist, the final dilutant level of each, the dosage and the particular carrier.
  • the program then flows to a function block 1708 in order to select the procedure that the pharmacist will utilize to provide this final diluted product with the prescribed number of dosages. This might be prescribed by the physician or it might be selected by the pharmacist.
  • the program then flows to a function block 1710 wherein the pharmacist performs the dilution operation and then combines various antigens into the cocktail, at a block 1712.
  • the program then proceeds to a function block 1714 wherein the NDC for each antigen is entered into the database, the dose level and the procedure.
  • the program then proceeds to a function block 1716 to parse the particular antigens at the database, this parsing required in order to process each antigen in the database separately, as there must be a crosscorrelation back to each individual antigen, since only each individual antigen has an NDC associated there with.
  • the program then proceeds to a function block 1718 in order to correlate the antigen back to the lowest concentrate DC- carrying level, as described hereinabove with respect to the embodiment of Fig. s 15 and 16 and then to a function block 1720 in order to define the benefits and then to a function block 1722 in order to end the program, after the cocktail has been distributed to the end user such as the patient or the medical professional.
  • Fig. 18 there is illustrated a process, which is similar to that described hereinabove, for creating a cocktail from three different base concentrate antigens 1302, 1304 and 1306, referring hereinabove to the description with respect to Fig. 13. These are diluted down in five separate steps to a final dilution level D6.
  • a final vial 1802 that receives the final dosage from each of the processes for diluting the initial base concentrate levels. It may be that each of the final vials D6 each have 5 mL contained therein.
  • 3 mL of each of the extracts can be placed therein resulting in a vial with 9 mL therein.
  • a vial 1804 which is the result of a different selection of cocktails from the D4 level. This, again, would have the three antigens in the concentrate level D4/D4/D4. This would again be provided to the PDM database which would then, based upon the dilutant level for each of the antigens and the procedure utilized to achieve that dilutant level to relate this back to the antigens utilized at the lowest DC- carrying concentrate level. If, for example, this vial 1804 resulted in 9 mL of material but the physician only required three doses of 1 mL each for two weeks, this would only require 6.0 mL. The pharmacist might only dispense 6 mL out of the 9 mL to the patient or professional.
  • a vial 1806 provided that has been provided where in it receives diluted antigens from slightly different vials.
  • the three antigens are D5/D6/D6 and this is provided back to the PDM database.
  • all three vials 1802, 1804 and 1806 will each be input to the PDM system with their procedure and the result will be that, for this example specifically, that the reimbursement be the same, as the starting dilutant will be identical. This is procedure specific and script specific, with the cocktail noted as being patient-specific.
  • each of the base antigens 1302, 1304 and 1306 are subjected to a different procedure wherein each of the original starting amounts are input to a first diluting vial 1902 and are subsequently diluted through vials 1904, 1906, 1908 and 1910 to a final vial 1912. This is then distributed to the patient.
  • This final vial represents the dilution at the vial 1910, which is D6/D6/D6.
  • Fig. 20A there is illustrated a diagrammatic view of an overall process where in the DC is associated with an intermediate level of dilutant.
  • the dilutant level D4 is illustrated as having an NDC associated there with, as well as the base concentrate level of.
  • NDC the base concentrate level of.
  • the reimbursement and be defined back to this intermediate concentrate level is indicated in a table in Fig. 20B, wherein the table can have associated with original diluted levels D4, D5 and D6 crosscorrelation relationships with respect to the base concentrate level but, in this table, there are only three diluted levels required, the dilutant level for vial D4, the vial D5 and the vial D6.
  • FIG. 21 there is illustrated a process for mapping prick test to the script.
  • a diagram of the prick test indicated by a reference numeral 2102.
  • This diagram 2102 indicates the locations of the particular allergens that were administered to locales on the person of the patient.
  • This diagram illustrates the results with a "P” indicating a positive reaction and that an "X” indicating a negative reaction.
  • the "P” indicates a sensitivity that must be considered in the script.
  • the particular manufacturers of antigens might have a cocktail already existing in the base concentrate. This is illustrated with the bottom three test associated with antigens A(n-2), A(n-l) and AN. These are the last three antigens in the list.
  • the script will have to include only the last two for the patient-specific script but the pharmacist only has the cocktail of all three available to them.
  • the script will have a AO, Al, A3, A4 A(n-l) and AN as the antigens that are required for the desensitization regimen. This will be provided to the pharmacist which will then select NDC-carrying antigen bottles AO, Al, A3, A4 And finally a bottle 2102 containing A(n-2), A(n-l) and AN , wherein only A(n-l) and AN are required in script to fill the prescription. This is then processed to provide the final patient dosage in the cocktail in the vial 2104.
  • Fig. 22A there is illustrated a flowchart depicting the overall parsing operation before the operation of Fig. 21 A.
  • a decision block 2202 will determine such and flow to a block 2204.
  • the program will then flow to a function block 2206 in order to determine the base dosage for the script as required by and set forth by the physician of the antigens with the particular NDC, even though that NDC is associated with more than the antigens required by the script.
  • the program then flows to a function block 2208 in order to determine the benefits. This is illustrated best with respect to the table of Fig. 22B.

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Abstract

Selon l'invention, un procédé permettant de statuer sur un remboursement pour des allergènes dérivés de venins entre un pharmacien et une entité de remboursement consiste à obtenir les codes nationaux des médicaments (National Drug Codes - NDC) pour une pluralité d'allergènes dérivés de venins; à stocker dans une base de données centrale de contrôle les codes NDC obtenus accompagnés d'un AWP associé et d'informations associées pour les allergènes dérivés de venins, lesquelles informations associées comprenant des informations de traduction permettant aux praticiens de déterminer, à partir d'un niveau de dilution et d'un certain nombre de doses désirés d'un antigène désiré dérivé de venins et portant codes NDC et d'une procédure de dilution connue, la manière de revenir par traduction au taux de concentration de base de l'antigène dérivé de venins et portant codes NDC utilisé pour créer le niveau de dilution et le nombre de doses désirés; et à déterminer si des codes NDC quelconques figurant dans la base de données centrale de contrôle sont présents dans la base de données tierce et, si ce n'est pas le cas, à transférer dans la base de données tierce les codes NDC associés qui n'y figurent pas.
PCT/IB2016/001332 2015-08-11 2016-08-11 Procédé de réorientation de codes ndc dans une base de données pharmaceutiques d'allergènes dérivés de venins et utilisés en immunothérapie aux venins WO2017025812A1 (fr)

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US15/171,920 US20170024526A1 (en) 2015-06-02 2016-06-02 Method for managing reimbursements for previously non database allergens
US201662349626P 2016-06-13 2016-06-13
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US20060020514A1 (en) * 2004-07-23 2006-01-26 Paul Yered Method and system for aggregating multiple prescription claims
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