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Pharming het aandeel van 2017

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  1. forum rang 4 Vriendelijke 10 oktober 2017 08:54

    • Vriendelijke

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    Exact wat ik votige week al vertelde,dat de vries geen haast had met het indienen.
    Hij maakt gebruik van de tekorten dus artsen gaan zelf ruconest voorschrijven voor profilactisch gebruik.
    Ooooo wat een slimme man zeg ik had hem door.
  2. [verwijderd] 10 oktober 2017 08:54

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    quote:

    steel engineer schreef op 10 oktober 2017 08:40:

    Betekent onderstaande dat Ruconest slechts uitzonderlijk wordt toegediend?
    "5. Must have documentation of therapeutic failure or severe adverse reaction to Berinert or Firazyr"

    Goede opmerking.

    Berinert mag maar beperkt worden toegediend, enkel specifieke delen van het lichaam toch?

    @jandekkerrs
    Heb je ook de criteria van Berinert? En Cinryze?
  3. [verwijderd] 10 oktober 2017 08:54

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    quote:

    moneymaker_BX schreef op 10 oktober 2017 08:50:

    Kan iemand mij ff bijpraten?
    Wat was HET GROTE nieuws de laatste 18 uur waardoor iedereen zo positief klinkt hedenochtend
    Onno van galapagos was jarig
  5. forum rang 4 Vriendelijke 10 oktober 2017 09:00

    • Vriendelijke

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    Fda zal deze patiënten goed volgen en als de werking goed is kassa voor pharming, en natuurlijk alle pharming beleggers.

    Ook deze patienten gaan niet weer overstappen als het product goed werkt.
  8. TradeMaarRaak 10 oktober 2017 09:03

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    quote:

    weveka schreef op 10 oktober 2017 08:53:

    Ben benieuwd of de move van gisterenmiddag een schijnbeweging was of niet !
    Er is geen echt nieuws, dus.... dobbelstenen erbij pakken maar.
  16. [verwijderd] 10 oktober 2017 09:10

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    Pharming nadert de weerstand 0,81.
    De trend van Pharming blijft ondanks de huidige consolidatiefase nog steeds opwaarts gericht. De hogere bodems wijzen nog steeds op aanhoudende vraag. De steun ligt rond 0,44 (bodem van 6 september). Slaagt Pharming erin om boven de laatste top te breken, dan kan de stijgende trend weer worden hervat en komt er ruimte vrij voor verdere koersstijging. Weerstand hanteren we op 0,81 (top van 26 maart 2012).
    Na een uitbraak boven weerstand 0,81 wordt 0,85 het volgende opwaartse koersdoel.
  18. jandekkers 10 oktober 2017 09:11

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    quote:

    lower schreef op 10 oktober 2017 08:54:

    [...]

    Goede opmerking.

    Berinert mag maar beperkt worden toegediend, enkel specifieke delen van het lichaam toch?

    @jandekkerrs
    Heb je ook de criteria van Berinert? En Cinryze?
    Pharmacy Management Drug Policy
    SUBJECT: Hereditary Angioedema (HAE) For Berinert, Cinryze, Firazyr, Haegarda,
    Kalbitor, Ruconest
    POLICY NUMBER: Pharmacy-19
    EFFECTIVE DATE: 8/11
    LAST REVIEW DATE: 9/29/2017
    If the member’s subscriber contract excludes coverage for a specific service or prescription drug, it is not covered
    under that contract. In such cases, medical or drug policy criteria are not applied. Medical or drug policies apply to
    commercial and Health Care Reform products only when a contract benefit for the specific service exists.
    Proprietary of the Insurance Plan Page 1 of 7
    DESCRIPTION: Hereditary angioedema (HAE) is an autosomal dominant disease that is caused by
    a deficiency in functional C1 esterase inhibitor, which leads to increases in bradykinin levels. The
    increase in bradykinin produces an increase in vascular permeability which leads to episodes of
    nonpruritic, nonpitting, subcutaneous or submucosal edema. Symptoms involve the arms, legs,
    hands, feet, bowels, genitalia, trunk, face, tongue, or larynx and typically begin in early childhood (2-3
    years of age). Attacks can be precipitated by minor trauma and stress, but may occur without an
    apparent trigger.
    The following are measured to help confirm a diagnosis of HAE.
    • Serum complement factor 4 (C4)
    • C1 inhibitor (C1-INH) antigenic protein
    • C1 inhibitor (C1-INH) functional level
    HAE is classified into two main subtypes, Individuals with Subtype I have documented low levels of
    C4, C1-INH protein and C1-INH functional activity. Individuals with Subtype II have normal levels of
    C1-INH protein but low levels of C4 and C1-INH function. Treatment guidelines also acknowledge
    HAE with normal C1-INH (Subtype III) in which the C4, C1-INH protein and C1-INH functional activity
    are all normal.
    HAE can be treated by Berinert (Human C1 Esterase Inhibitor), Cinryze (Human C1 Esterase
    Inhibitor), Haegarda (Human C1 Esterase Inhibitor), Kalbitor (Ecallantide), Firazyr (Icatibant) or
    Ruconest (Recombinant C1 Esterase Inhibitor) each of which is FDA approved to reduce edema
    symptoms. Berinert, Cinryze, Haegarda, and Ruconest treat HAE by replacing Human C1 Esterase
    Inhibitor deficiencies. Kalbitor treats HAE attacks by inhibiting plasma kallkrein which cleaves high
    molecular weight kininogen and results in bradykinin release. Firazyr inhibits bradykinin from binding
    the B2 receptor.
    POLICY:
    Based upon our assessment and review of the peer-reviewed literature Berinert, Cinryze, Firazyr,
    Haegarda, Kalbitor, and Ruconest have been medically proven to be effective and therefore,
    medically necessary for the prophylactic and acute attack treatment of Hereditary Angioedema
    (HAE) following diagnoses if specific criteria are met:
    A. To be considered for drug treatment, individuals must have a confirmed diagnosis of HAE
    based on the following:
    1. Type 1 HAE
    a. Two separate measurements indicating decreased quantities of C4 and C1-INH
    and a history of angioedema OR

    Pharmacy Management Drug Policy
    Hereditary Angioedema (HAE)
    Proprietary of the Insurance Plan Page 2 of 7
    2. Type II HAE
    b. If low C4 quantity but C1-INH protein normal then determine C1-INH function and
    repeat C4 and C1-INH. Decreased levels of C4 and C1-INH function confirms a
    diagnosis of Type II HAE OR
    3. HAE with normal C1-INH (Type III HAE)
    a. Individuals with normal levels of C4 and C1-INH both during an attack and at
    baseline are classified as Type III HAE. Patient must have a family history of
    angioedema along with documented evidence that shows:
    1. Treatment with high doses of the antihistamine cetirizine at 40 milligrams
    a day (or equivalent) for 1 month was not effective OR
    2. Demonstration of a Factor XII mutation that is associated with the disease
    AND
    4. Medications known to cause angioedema (i.e. ACE-Inhibitors, estrogens, angiotensin II
    receptor blockers) have been evaluated and discontinued when appropriate, regardless
    of HAE type AND
    5. Medication must be prescribed by an allergist, immunologist, hematologist or
    dermatologist
    B. Berinert specific criteria
    1. Must have a diagnosis of acute abdominal or facial attacks associated with hereditary
    angioedema (progress notes required)
    2. Must be used for acute attacks--Safety and efficacy as prophylactic therapy has not
    been established and therefore will not be covered
    3. Berinert has been proven to be both safe and effective in adult and pediatric patients
    4. Berinert will be reviewed under the medical benefit when administered by a health care
    professional. If the member transitions to self-administration then Berinert can be
    authorized under the pharmacy benefit.
    5. Dose is 20 units per kg by IV infusion.
    a. Maximum quantity limit of 10 vials per 30 days on Rx benefit
    b. Authorization on the medical benefit will be for 1 month initially then every 6
    months
    c. Authorization on the pharmacy benefit will be for 6 months at a time
    d. Recertification will require documentation of decrease in severity or duration of
    attacks. Documentation including frequency of administration will also be
    required at time of recertification to monitor for appropriate use.
    C. Kalbitor specific criteria
    1. Must have a diagnosis of acute abdominal or facial attacks associated with hereditary
    angioedema (progress notes required)
    2. Must be used for acute attacks--Safety and efficacy as prophylactic therapy has not
    been established and therefore will not be covered
    3. Safety and efficacy has not been established in children under the age of 12 and
    therefore will not be covered
    4. Anaphylaxis has been reported after administration of Kalbitor. Because of the risk of
    anaphylaxis, it should only be administered by a healthcare professional with
    appropriate medical support to manage anaphylaxis and HAE and is therefore covered
    under the medical benefit.
  21. jandekkers 10 oktober 2017 09:12

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    quote:

    lower schreef op 10 oktober 2017 08:54:

    [...]

    Goede opmerking.

    Berinert mag maar beperkt worden toegediend, enkel specifieke delen van het lichaam toch?

    @jandekkerrs
    Heb je ook de criteria van Berinert? En Cinryze?
    Pharmacy Management Drug Policy
    Hereditary Angioedema (HAE)
    Proprietary of the Insurance Plan Page 3 of 7
    5. Must have documentation of therapeutic failure or severe adverse reaction to Berinert or
    Firazyr
    6. The recommended dose of KALBITOR is 30 mg (3 mL), administered subcutaneously in
    three 10 mg (1mL) injections. If the attack persists, an additional dose of 30 mg may be
    administered within a 24 hour period.
    7. Authorization will be for 1 month initially then every 6 months
    a. Recertification will require documentation of decrease in severity or duration of
    attacks. Documentation including frequency of administration will also be
    required at time of recertification to monitor for appropriate use
    D. Cinryze specific criteria
    1. Must have a diagnosis of hereditary angioedema (progress notes required)
    2. Must be used as a prophylaxis – not for acute treatment
    3. For long term prophylaxis, the patient must meet the following:
    a. History of at least two severe HAE attacks (i.e. airway swelling, debilitating
    cutaneous or gastrointestinal episodes) per month that resulted in loss of
    work/school productivity or ER/unscheduled doctor visits OR disability for > 5
    days per month due to HAE AND
    b. Patient has a documented contraindication, severe intolerance, or therapeutic
    failure to 17 alpha-alkylated androgens (e.g. danazol) for HAE prophylaxis AND
    c. Treatment with acute therapy (i.e. Kalbitor, Firazyr, Berinert or Ruconest) did not
    result in meaningful outcomes such as decreased severity of attacks, avoidance
    of hospitalization, etc
    4. Requests for new start of Cinryze will require documentation of therapeutic failure,
    severe intolerance or a contraindication to Haegarda.
    5. Cinryze will be allowed for short-term prophylaxis if being requested prior to medical,
    surgical or dental procedure. Approval will be for one month only.
    6. Cinryze will be reviewed under the medical benefit when administered by a health care
    professional. If the member transitions to self-administration, then Cinryze can be
    authorized under the pharmacy benefit.
    7. Standard dosage is 1000 unit IV infusion over 10 minutes every 3-4 days.
    8. There is a quantity limit of 20 vials per 30 days.
    a. Requests for quantities in excess of the establish quantity limit, will be
    considered based on Cinryze package labeling that states:
    For patients who have not responded adequately to 1000 unit every 3 or 4 days,
    doses up to 2500 unit (not exceeding 100 U/kg) every 3 or 4 days may be
    considered based on individual patient response.
    b. Requests will require documentation of a previous trial with the standard dosage
    (1000 unit) and outcome of the trial, to document the need for the increased
    dose.
    c. No more than 50 vials per 30 days will be authorized.
    9. Authorization on either the medical benefit or the pharmacy benefit will be for 6 months.
    i. Recertification will require documentation of decrease in the severity,
    duration, and/or frequency of attacks. Documentation including frequency
    of administration will also be required at time of recertification to monitor
    for appropriate use
    10.Safety and efficacy in children under the age of 13 has not been established and
    therefore will not be covered
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