Xyrem Prescription and Distribution Process
`Video Script 2/2/01)
`
`1
`
`Audio
`1. [Fade in music]
`
`[Up music.]
`
`Video
`Graphic texture of oranges and
`yellows
`
`logo of Xyrem emerges
`
`[Fade out music.]
`
`Titles
`
`Fade in first
`title/logo graphic.
`
`Xyrem® (Sodium
`Oxybate) Oral
`Solution
`
`Fade out first
`title/logo graphic.
`Fade in video title.
`
`Prescription and
`Distribution
`Process
`
`2. Narcolepsy, it is a serious
`debilitating condition that
`diminishes the quality of life for
`approximately 125,000
`Americans.
`
`Fade to head-to chest shot of
`narrator.
`
`3. Xyrem is a promising new
`medication that, for some patients
`with narcolepsy, can significantly
`reduce the incidence of cataplexy,
`as well as improve symptoms of
`daytime sleepiness.
`
`4. But, because Xyrem is a
`controlled substance, Orphan
`Medical wants to make certain
`that “only” patients for whom it is
`prescribed have ongoing access to
`this important treatment.
`
`Fade to table-top shot of
`Xyrem box and a display of its
`contents.
`
`Fade back to shot of narrator
`sitting on desk.
`
`AMN1006
`IPR of U.S. Patent No. 7,765,106
`
`
`Video Script 2/2/01)
`
`1
`
`Audio
`1. [Fade in music]
`
`[Up music.]
`
`Video
`Graphic texture of oranges and
`yellows
`
`logo of Xyrem emerges
`
`[Fade out music.]
`
`Titles
`
`Fade in first
`title/logo graphic.
`
`Xyrem® (Sodium
`Oxybate) Oral
`Solution
`
`Fade out first
`title/logo graphic.
`Fade in video title.
`
`Prescription and
`Distribution
`Process
`
`2. Narcolepsy, it is a serious
`debilitating condition that
`diminishes the quality of life for
`approximately 125,000
`Americans.
`
`Fade to head-to chest shot of
`narrator.
`
`3. Xyrem is a promising new
`medication that, for some patients
`with narcolepsy, can significantly
`reduce the incidence of cataplexy,
`as well as improve symptoms of
`daytime sleepiness.
`
`4. But, because Xyrem is a
`controlled substance, Orphan
`Medical wants to make certain
`that “only” patients for whom it is
`prescribed have ongoing access to
`this important treatment.
`
`Fade to table-top shot of
`Xyrem box and a display of its
`contents.
`
`Fade back to shot of narrator
`sitting on desk.
`
`AMN1006
`IPR of U.S. Patent No. 7,765,106
`
`
`
`2
`
`Fade in titles as
`mentioned.
`
`•
`
`law
`enforcement
`• prosecutors
`•
`field law
`enforcement
`personnel
`• pharmaceutical
`distribution
`experts
`•
`forensic experts
`• DEA
`consultants
`• drug diversion
`experts
`
`5. Orphan Medical is committed to a
`distribution plan that is both safe
`and effective for patients and also
`protects the general public by
`minimizing opportunities for the
`diversion of Xyrem to
`unauthorized individuals.
`
`Fade to shot of Orphan
`representative making a
`presentation about success
`plans—perhaps pointing to a
`bullet point on an overhead
`screen.
`
`6. To achieve that goal, Orphan
`Medical--after extensive
`consultation with law
`enforcement, prosecutors, field
`law enforcement personnel,
`pharmaceutical distribution
`experts, forensic experts, DEA
`consultants, and drug diversion
`experts-- has developed a
`comprehensive, restrictive
`distribution program.
`
`7. In addition to thorough patient
`and physician education about
`Xyrem,
`
`8. As well as multiple security
`checks before, during and after
`prescription fulfillment.
`
`Fade to build graphic that
`begins with shot of Xyrem box
`in center of screen.
`
`Fade to shot of narrator
`holding up a variety of
`patient/physician education
`material and, then, setting it
`down on the desk.
`
`Cut to split-screen shot
`showing
`a) pharmacist assistant
`verifying doctor's license
`b) pharmacist unlocking
`cabinet,
`c) patient signing for delivery
`by Federal Express.
`
`AMN1006
`IPR of U.S. Patent No. 7,765,106
`
`
`
`9. The purpose of this video is to
`outline, step-by-step, all of the
`security measures that will occur
`whenever a prescription of Xyrem
`is written and filled.
`
`10.
`
` When Xyrem first becomes
`available, a select group of
`physicians with a documented
`history of prescribing medications
`for patients with narcolepsy will
`receive an educational module, in
`the mail, called the Physician
`Success Program.
`
`11.This program will introduce these
`selected physicians to Xyrem and
`includes a videotape, Physician
`Success Program contact
`information, a patient education
`presentation, templates for
`medical records and patient
`contracts, and information about
`third-party payor reimbursement.
`
` This mailing will be documented
`and no medication samples will
`ever be provided.
`
`3
`
`Cut back to narrator.
`
`Fade to freeze-frame shot of a
`physician consulting with a
`patient.
`
`Begin action
`
`Fade in title with
`freeze frame.
`
`Notify A Select
`Group of
`Physicians about
`Xyrem®
`
`Fade out title
`
`Fade to table-top display of
`Physician Success Program
`materials.
`
`Fade in titles when
`mentioned in
`narration.
`• Documented
`mailing
`• No physician
`samples
`
`AMN1006
`IPR of U.S. Patent No. 7,765,106
`
`
`
`4
`
`Fade to shot of rep and
`physician meeting and
`discussing Physician Success
`Program materials.
`
`Fade in title
`
`Specialty
`Pharmacy
`
`Fade out title.
`
`Fade in narrator
`
`Fade to shot of pharmasist
`
`12.Complementing this effort, a
`representative from Orphan
`Medical will visit each targeted
`physician and reinforce the
`information provided in the
`Physician Success Program.
`
` The representative will ask the
`physician to sign a receipt if any
`additional Physician Success
`Program materials are left for the
`physician’s office.
`
`13.
`
` A crucial component of the secure
`distribution of Xyrem is the use of
`a specialty pharmacy. The
`specialty pharmacy is a single,
`centrally-located facility that will
`have a variety of distribution,
`documentation, and security
`responsibilities.
`
`14.A staff of dedicated pharmacists,
`reimbursement specialists, and
`customer service representatives
`will provide a closed-loop
`distribution system that will not
`only serve patients and
`prescribers, but will also be able
`to generate data, recording
`prescribers, patients and dosing
`that could provide information for
`any possible investigations and
`prosecutions for state and federal
`authorities.
`
`AMN1006
`IPR of U.S. Patent No. 7,765,106
`
`
`
`5
`
`Fade in benefit title.
`
`Secure inventory
`storage
`
`15.This distribution system begins
`with a secure holding warehouse
`area where an inventory of Xyrem
`is kept, according to scheduling
`requirements by federal and state
`laws and checked several times a
`day.
`
`16.On a regular basis, a small supply
`of Xyrem is moved from the gated
`and locked warehouse to a gated
`and locked area within the same
`pharmacy. Only qualified
`pharmacists and pharmacy
`technicians, dedicated to the
`Xyrem Program will be allowed
`access or will handle Xyrem.
`
`17.Both Orphan and the pharmacy
`acknowledge and document every
`time any inventory is moved.
`
`18.Now, let’s take a step-by-step look
`at how the specialty pharmacy
`provides verification and
`documentation of both the
`prescription and the prescribing
`physician before preceding to fill
`any requests for Xyrem.
`
`19.When a physician determines that
`Xyrem is an appropriate
`medication for a patient,
`
`20.The prescription is faxed or
`mailed, depending on each states
`pharmacy board regulations,
`directly to the specialty
`pharmacy.
`
`Fade to shot of pharmacy
`employee unlocking holding
`warehouse to reveal Xyrem
`supply.
`
`Cut to shot of pharmacy
`employees transferring
`inventory.
`
`Slow fades shot of
`a) pharmacy personnel signing
`some transaction
`documentation b) Orphan
`personnel at computer screen
`documenting the same.
`
`Fade to shot of narrator.
`
`Fade to shot of physician in
`the office using Orphan
`Medical’s materials to educate
`a patient about Xyrem.
`
`Fade to shot of physician
`faxing prescription.
`
`AMN1006
`IPR of U.S. Patent No. 7,765,106
`
`
`
`Cut to shot of pharmacy
`employee picking up
`prescription fax and sitting
`down at a computer to verify
`physician’s eligibility.
`
`Freeze frame.
`
`21.Upon receipt of the prescription,
`the specialty pharmacy first
`verifies if the prescribing
`physician is on Orphan Medical’s
`list of targeted physicians and has
`active DEA and State License.
`Additionally, the pharmacy
`checks data from the physician’s
`home State Board of Health to
`determine if there are any
`pending or previous actions
`against the physician.
`
`22.Next, the pharmacy calls the
`physician’s office to verify the
`origin of the prescription.
`
`Fade to split-screen shot of
`pharmacist and physician on
`the phone.
`
`Freeze frames.
`
`6
`
`Fade in title with
`freeze frame.
`
`Physician
`verification
`
`Fade in title with
`freeze frames.
`
`Prescription
`verification
`
`23.If it is the physician’s first time
`prescribing Xyrem, the specialty
`pharmacy will ship a Xyrem
`Physician Success Program to the
`Physician's office to ensure that
`the physician is given every
`opportunity to become thoroughly
`familiar with a prescriber’s
`responsibilities regarding Xyrem.
`
`24.Another important benefit of
`using a single, specialty pharmacy
`for the distribution of Xyrem is
`that it’s possible to keep all the
`data about inventory, physicians,
`reimbursement, patients, and
`delivery in one efficient and
`quickly-accessible location.
`
`Fade to table-top display of the
`Physician Success Program
`components.
`
`Fade to shot of narrator.
`
`Fade in benefit title.
`
`All data in one
`location
`
`AMN1006
`IPR of U.S. Patent No. 7,765,106
`
`
`
`25.Some of the data available include
`prescriptions by physician
`specialty, prescriptions by patient
`name, prescriptions by volume or
`frequency, and prescriptions by
`dose.
`
`7
`
`Fade to build title graphic.
`
`Fade in title.
`
`Data Available
`
`Fade in bullet points
`when mentioned.
`• Prescriptions
`by physician
`specialty
`• Prescriptions
`by patient name
`• Prescriptions
`by volume
`(frequency)
`• Prescriptions
`by dose
`
`26.The specialty pharmacy will also
`be responsible for contacting the
`patient’s third-party payor to
`research benefits, file claims,
`appeal denials, and collect
`reimbursement.
`
`27.The specialty pharmacy will also
`follow specific procedures for
`communicating with the patient
`both before and after the Xyrem is
`shipped.
`
`28.First, the specialty pharmacy will
`contact the patient directly to
`make specific arrangements for
`the patient or the patient’s
`authorized designee to personally
`receive the package containing
`the Xyrem and to discuss or verify
`third-party payor reimbursement.
`
`Cut to shot of pharmacy
`employee on phone with
`insurance company.
`
`Fade to shot of narrator.
`
`Slow fades of patient and
`pharmacist discussing
`arrangements over the phone.
`
`Fade in title.
`
`Patient
`communication
`
`AMN1006
`IPR of U.S. Patent No. 7,765,106
`
`
`
`8
`
`Pharmacy finds a doctors that
`does not verify.
`
`Fade to shot of pharmacy
`employee putting Xyrem in
`Fed Ex packaging.
`
`Fade in title.
`
`Overnight delivery
`
`Cut to close-up shot of
`pharmacy employee adding the
`Patient Success Program to
`the Fed Ex packaging.
`
`Fade to table-top display of
`Patient Success Program
`materials.
`
`Fade to shot of Fed Ex
`employee with package
`knocking on a patient’s door.
`Patient—answers the door and
`they have a brief conversation.
`The Fed Ex employee shakes
`his head and gets signature.
`At the same time, the person
`closes the front door.
`
`29.Throughout this entire process of
`verification and documentation, if
`any of the data or behavior
`suggests the possibility that
`Xyrem may be used
`inappropriately, the specialty
`pharmacy is empowered to contact
`the appropriate authorities.
`
`30.The patient’s medication will be
`shipped overnight by Federal
`Express utilizing a tracking
`system designed specifically for
`the specialty pharmacy.
`
`31.And, if it is the patient’s first time
`receiving Xyrem, the specialty
`pharmacy will also include the
`Patient Success Program in the
`package.
`
`32.This program will introduce the
`patient to their responsibilities
`pertaining to Xyrem and includes
`a videotape, Patient Success
`Program contact information,
`advice for safe in-home storage
`and disposal, advice for traveling
`with Xyrem, and information
`about third-party payor
`reimbursement.
`
`33.Shipments of Xyrem can only be
`left with the patient or the
`patient’s authorized designee.
`Therefore, if the patient or the
`patient’s designee is not available
`to receive or sign for the Xyrem,
`the package will be returned to
`the specialty pharmacy.
`
` Also, if the package is somehow
`lost, the specialty pharmacy will
`initiate an immediate
`investigation.
`
`AMN1006
`IPR of U.S. Patent No. 7,765,106
`
`
`
`9
`
`Fade to shot of specialty
`pharmacy employee working
`at an in-house FedEx
`computer station.
`
`Fade in title.
`
`Real-time tracking
`
`Cut to split-screen shot of
`pharmacy employee and
`patient on the phone. Patient
`has all the Xyrem materials
`spread out on a table.
`
`Cut to close-up shot of patient
`removing contents of the
`Xyrem box.
`
`Cut to slow fades of pharmacy
`employee and patient on the
`phone. Patient is holding and
`reading a patient education
`brochure.
`
`Pharmacy finds a patient that
`does not verify on getting a
`refill
`
`Fade to shot of narrator.
`
`34.Because the specialty pharmacy
`provides next-day, follow up
`through their in-house FedEx
`computer stations, they will
`telephone the patient within 24
`hours after receiving the
`shipment of Xyrem.
`
`35.During this call, the specialty
`pharmacy will confirm receipt of
`the Xyrem prescription and the
`Patient Success program,
`
`36.counsel the patient about Xyrem
`dosing and compliance,
`
`37.and ensure the patient’s
`understanding of the Patient
`Success Program as well as the
`patient’s legal responsibilities and
`liabilities relating to the
`bifercated scheduling of Xyrem.
`
`38.The specialty pharmacy also
`keeps track of expected
`prescription refill dates and will
`contact the patient ahead of time.
`Patients who request a refill
`before their refill date will be
`flagged and their physician
`contacted. The physician
`verification process is repeated
`before every refill is sent.
`
`39.As you can see, the Xyrem
`prescription and distribution
`process is a comprehensive
`program that ensures the
`responsible distribution of this
`important medication.
`
`AMN1006
`IPR of U.S. Patent No. 7,765,106
`
`
`
`10
`
`40.Both physicians and patients will
`receive a thorough education
`about the use and safe handling of
`Xyrem.
`
`Fade to shot of physician and
`patient in the office reviewing
`patient education materials.
`
`41.Strict adherence to security and
`verification protocols will
`minimize diversion of the
`medication to unauthorized
`individuals.
`
`Fade to shot of Fed Ex
`employee at patient’s door.
`Patient is signing the Fed Ex
`receipt and receiving the
`package of Xyrem.
`
`Fade in title.
`
`Thorough
`physician and
`patient education
`
`Fade in title.
`
`Helps prevent
`diversion
`
`42.A staff of dedicated specialists
`provide a closed-loop distribution
`system that will not only serve
`patients and prescribers, but will
`also have information to support
`any possible investigations and
`prosecutions.
`
`43.And, most importantly, the Xyrem
`prescription and distribution
`process will ensure that this life-
`changing medication will be
`available to the thousands of
`patients who so desperately need
`it.
`
`[Fade in music.]
`
`44.[Up music.]
`
`Fade to shot of pharmacy
`employee entering data on a
`PC.
`
`Fade in title.
`
`Prosecution
`assistance
`
`Fade to shot of happy patient
`after talking on phone at home
`with the success program.
`
`Fade to black.
`
`Roll credits,
`disclaimers, contact
`information,
`copyright, etc.
`
`AMN1006
`IPR of U.S. Patent No. 7,765,106
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