“Predilution Sets For Distributing Antigens” in Patent Application Approval Process (USPTO 20190351051)

2019 DEC 05 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- A patent application by the inventors Strader, James (Austin, TX); Pulitzer, Jovan Hutton (Frisco, TX), filed on August 5, 2019, was made available online on November 21, 2019, according to news reporting originating from Washington, D.C., by NewsRx correspondents.

This patent application is assigned to Roca Medical Ltd. (London, United Kingdom).

The following quote was obtained by the news editors from the background information supplied by the inventors: “Immunotherapy (IT) is recognized as one of the most curative treatment for allergies. By exposing the immune system to slowly increasing concentrations of immunomodulators such as an allergen or antigen, it will eventually stabilize and regain control the portion that is hypersensitive to the allergen or antigen. In general, immunotherapy is the ‘treatment of disease by inducing, enhancing, or suppressing an immune response.’ Immunotherapies designed to elicit or amplify an immune response are classified as activation immunotherapies, while immunotherapies that reduce or suppress are classified as suppression immunotherapies. The active agents of immunotherapy are collectively called immunomodulators. They are a diverse array of recombinant, synthetic and natural preparations, often cytokines.

“Immunotherapy involved in the treatment of allergies is a type of suppression immunotherapy, often termed desensitization or hypo-sensitization. This is compared with allergy treatments such as antihistamines or corticosteroids which treat only the symptoms of allergic disease. Immunotherapy is the only available treatment that can modify the natural course of the allergies, by reducing sensitivity to the immunomodulators such as antigens or allergens. An antigen and an allergen can both cause one’s immune system to respond. An allergen is an antigen, but not all antigens are allergens. An antigen is any substance that is capable of causing one’s immune system to produce antibodies. They are typically organic, or living, produced proteins. An allergen is any antigen that causes an allergic reaction. A non-allergen antigen could be a bacteria, virus, parasite, or fungus that causes an infection. This could also be something else that causes antibody immune system response, like toxins, chemicals, tissue cells involved in transplants or blood cells from a blood transfusion. An allergen is an environmentally produced substance that causes an allergic reaction, although the substance may not be harmful. Allergens cause no reactions in some individuals, while possibly causing a hypersensitive reaction in others. Common allergens include such things as pollen, plants, smoke, feathers, perfumes, dust mites, toxic mold, food, drugs, animal dander, and insect bites and stings.

“The exact mechanisms of how IT works are not fully understood, but they involve shifting a patient’s immune response from a predominantly ‘allergic’ T-lymphocyte response to a ‘non-allergic’ T-lymphocyte response.

“Current accepted processes for performing allergy immunotherapy include injecting immunomodulator matter in the form of antigen material into patient subjects. This is referred to as subcutaneous immunotherapy (SCIT), requiring a patient to visit a doctor’s office for weekly injections. It’s is very expensive and time-consuming. A second technique, sublingual immunotherapy (SLIT), involves the application of allergy extracts (antigens), and allergens placed into a pill form and swallowed by the patient or disposed in ‘allergy drops’ which are placed under the tongue for the allergens/antigens to be absorbed into the oral mucosa. Transdermal patches may have been used without much success and mostly were used for patch testing to see if a patient reacts to various chemicals or allergens.

“Of the people who start traditional subcutaneous injected immunotherapy (SCIT), 90% fail to complete their therapy due to needle fatigue and not being able to see a doctor in their office once or more per week for several years. Further, doctors charge for every one of those visits. Further, doctors trained to give injections for allergy are concentrated in high population and upper middle class places. People in rural areas and people who do not live in upper middle class areas cannot get to an allergist for shots. Consider an inner city kid having to ride public transportation and pay a high copay just to get a high risk injection if an alternative therapy were available!

“Allergies are also linked to depression and suicide and are among the top ten reasons for missed work and lost productivity. Lastly, allergies and asthma result in billions of dollars in lost productivity and healthcare costs among the 90% of allergy patients that either never get immunotherapy or fail immunotherapy delivered under its current administration methods.

“Currently, allergens are not readily reimbursed when received from a pharmacist for the simple reason that the National Drug Code (NDC) code is not included in the database to which the pharmacist has access. Without an NDC code in the database, the pharmacist cannot access that information. By not being able to access information, the pharmacist cannot interface with a benefits provider for reimbursements nor can they have access to the Average Wholesale Price (AWP), which is the benchmark that has been used for many years for pricing and reimbursement of prescription drugs for both government and private payers. Initially, this AWP was intended to represent the average price that wholesalers used to sell medications to providers, such as physicians, pharmacies, and other customers. However, the AWP is not a true representation of actual market prices for either generic or brand drug products. 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). The WAC is the manufacturer’s list price of the drug when sold to the wholesaler, while the DIRP is the manufacturer’s list price when sold to non-wholesalers. Typically a 20% mark-up is applied to the manufacturer-supplied WAC or DIRP, which results in the AWP figure.

“The publishers then in turn sell these published AWPs to government, private insurance, and other buyers of prescription drugs, who use these data tables to determine reimbursement and retail prices. Because 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. However, 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.

“Market pricing on brand drugs tend to be about 16.6 percent less than the AWP. However, the relation of AWP to generic pricing is not clear. Older generics tend to have a large spread between the AWP and WAC, which in turn gives a large spread, and higher profit margins for the pharmacy or other provider of the drug. Many payers, such as PBMS or HMOs, will determine a maximum allowable cost (MAC) pricing on generics to avoid being overcharged. Newer generic products, compared to older generics, may not have as favorable of a spread, thus the need for MAC.

“Collusion between AWP publishers and wholesalers to artificially inflate the AWP, and in turn increase the spread, has led to court cases in the U.S. In these cases, it was alleged that increasing the spread benefited the wholesaler because customers (pharmacies and large institutions) were more likely to buy from them than a competing wholesaler where the spread was not as desirable. The publisher of AWPs profited because pharmacies were more likely to buy the pricing lists from the publisher that noted the higher AWPs used in calculating the spread, than to buy them from other publishers with lower AWPs. Due to this pricing fraud, many payers, including government payers, are no longer using AWP for pricing, and are switching to other more transparent pricing benchmarks, such as WAC or AMP (average manufacturers price). However, AWP may still be found in use in the U.S. because it has been the standard for decades.

“However, in order for a pharmacist to access the AWP and to be able to interface with benefits providers, the product associated with an NDC must be in the database. Currently, allergens are on item that does not exist in the database.”

In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors’ summary information for this patent application: “In one embodiment, a method for delivering allergens to a pharmacist in a pre-diluted kit form is provided. The method comprises providing a bulk container of base concentrate antigen containing at least one antigen at a predetermined concentrated level, providing a plurality of sequential bulk containers each containing a fixed amount of a carrier solution for diluting antigens. The method further comprises creating a sequential and more diluted sequence of antigens by the steps of a) dispensing from the bowl container a fixed amount of the base concentrate antigen containing at least one the antigen at the predetermined concentrated level to a first of the sequential bulk containers for being diluted in the carrier contained therein, b) dispensing a fixed amount of the contents of the first of the sequential bulk containers to a next of the sequential bulk containers for being diluted in the carrier contained therein, and c) sequentially repeating step b dispensing a fixed amount of the contents of a previous one of the sequential bulk containers to the next of the sequential bulk containers for being diluted in the carrier contained therein until the last of the sequential bulk containers has contents dispense therein from the previous of the sequential bulk containers. The method further comprises providing a plurality of end-use sealable containers that can receive a finite end amount of diluted antigens, dispensing from each of the sequential bulk containers a finite end amount of diluted antigens into one of the plurality of end-use sealable containers, where in the end-use seal containers filled from each of the sequential bulk containers comprises a group of end-use sealable containers associated with each of the sequential bulk containers, sealing each of the end-use containers after diluted antigens are disposed therein, and disposing a select number of the sealed end-use sealable containers from each of the groups of end-use sealable containers into a container comprising a kit to provide a plurality of kits for dispensing to pharmacists.”

The claims supplied by the inventors are:

“1. A method for delivering allergens to a pharmacist in a pre-diluted kit, the method comprising: providing a bulk container of base concentrate antigen including at least one antigen at a predetermined concentrate level; providing a plurality of sequential bulk containers each including a fixed amount of a carrier solution for diluting antigens; creating a sequential and diluted sequence of antigens by: a) dispensing from the bulk container a fixed amount of the base concentrate antigen including at least one the antigen at the predetermined concentrated level to a first of the sequential bulk containers for being diluted in the carrier solution included therein, b) dispensing a fixed amount of the carrier solution of the first of the sequential bulk containers to a next of the sequential bulk containers for being diluted in the carrier solution included therein, and c) sequentially repeating step b by dispensing a fixed amount of the carrier solution of a previous one of the sequential bulk containers to the next of the sequential bulk containers for being diluted in the carrier solution included therein until a last one of the sequential bulk containers has contents dispensed therein from the previous of the sequential bulk containers; providing a plurality of end-use sealable containers that can receive a finite amount of diluted antigens; dispensing from each of the sequential bulk containers a finite end amount of diluted antigens into one of the plurality of end-use sealable containers; sealing each of the plurality of end-use sealable containers after diluted antigens are disposed therein, wherein each one of the plurality of the sealed end-use containers includes at least one insert that: provides an elongated interior in the sealed end-use container, the elongated interior having a volume corresponding to at least a dose, and fills space within the sealed end-use container to dispose a prediluted antigen at an elevated level in the sealed end-use container for extraction; and disposing each of a plurality of the sealed end-use containers into one of a plurality of receiving pockets of an end container, wherein each of the plurality of receiving pockets is associated with one of a plurality of sequential diluted allergen levels, and wherein the end container includes indicators each disposed in association with one of the plurality of receiving pockets indicating a dilution level of an associated one of the plurality of the sealed end-use containers.

“2. The method of claim 1, wherein the method is carried out in a sterile environment.

“3. The method of claim 1, further comprising indicating on the end container a National Drug Code (NDC) of the base concentrate antigen.

“4. The method of claim 1, wherein each of the plurality of the sealed end-use containers includes more than one diluted antigen.

“5. The method of claim 4, further comprising indicating on the end container a plurality of National Drug Codes (NDC), wherein each of the plurality of NDCs is associated with a base concentrate antigen of each of the more than one diluted antigen.

“6. The method of claim 1, wherein each of the plurality of the sealed end-use containers includes only a single diluted antigen.

“7. The method of claim 1, wherein the carrier solution includes a saline solution.

“8. The method of claim 1, wherein the carrier solution includes a glycerol solution.

“9. The method of claim 1, wherein the finite end amount of diluted antigen dispense from each of the sequential bulk containers is the same.

“10. The method of claim 9, wherein the finite end amount of diluted antigen dispensed from each of the sequential bulk containers includes a single dose as defined by a medical professional.

“11. The method of claim 1, wherein the indicators each include a color code, there being a separate color code associated with each dilution level and wherein each of the plurality of the sealed end-use containers associated with each of the dilution levels has a corresponding color code disposed thereon.”

URL and more information on this patent application, see: Strader, James; Pulitzer, Jovan Hutton. Predilution Sets For Distributing Antigens. Filed August 5, 2019 and posted November 21, 2019. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220190351051%22.PGNR.&OS=DN/20190351051&RS=DN/20190351051

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