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Pharming het aandeel van 2017
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Pharmacy Management Drug Policy Hereditary Angioedema (HAE) Proprietary of the Insurance Plan Page 4 of 7 E. Firazyr specific criteria 1. Must have a diagnosis of hereditary angioedema (progress notes required) 2. Must be used for acute episodic attacks--Safety and efficacy as prophylactic therapy has not been established and therefore will not be covered 3. Firazyr has potential to attenuate antihypertensive effects of ACE inhibitors and should not be administered to patients taking ACE inhibitors since there are no clinical trials in this population 4. Standard dosing is 30mg subcutaneously injected into abdominal area; if response is inadequate or symptoms recur additional injections of 30mg may be administered at intervals of at least 6 hours with no more than 3 doses per 24 hour period 5. Quantity limit of #3 (3ml each) pre-filled syringes – 9ml/30 days. 6. Authorization will be for 6 months at a time 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. 7. Safety and Efficacy in anyone under 18 years old is not established and therefore will not be covered. 8. Firazyr can be self-administered upon recognition of an HAE attack after training under the guidance of a healthcare professional and therefore will be covered under the pharmacy benefit. F. Ruconest specific criteria 1. Must have a diagnosis of acute attacks associated with hereditary angioedema (progress notes required) 2. Ruconest will not be covered for laryngeal attacks as efficacy has not been established in patients with laryngeal HAE attacks 3. Safety and efficacy in children under the age of 13 has not been established and therefore will not be covered 4. Ruconest will be reviewed under the medical benefit when administered by a health care professional. If the member transitions to self-administration, then Ruconest can be authorized under the pharmacy benefit. 5. Must have documentation of therapeutic failure or severe adverse reaction to Berinert or Firazyr 6. Dose is 50 IU per kg by IV injection a. Maximum dose is 4200 IU with no more than 2 doses within a 24 hour time period b. Quantity limit of 100 ml per 30 days c. Authorization on the medical benefit will be for 1 month initially then every 6 months d. Authorization on the pharmacy benefit will be for 6 months at a time e. 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 7. Based on national shortages of other medications that are FDA approved for HAE prophylaxis and emerging clinical data, requests for Ruconest for hereditary angioedema prophylaxis will be allowed with the following dosing: Pharmacy Management Drug Policy Hereditary Angioedema (HAE) Proprietary of the Insurance Plan Page 5 of 7 50 IU per kg for patients less than 84 kg or 4200 IU for patients greater than or equal to 84 kg twice weekly a. Quantity limit of 16 vials per 28 days b. Approvals will be short term (2 months) until supply of other medications that are FDA approved for HAE prophylaxis is adequate. G. Haegarda 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. Haegarda will be allowed for short-term prophylaxis if being requested prior to medical, surgical or dental procedure. Approval will be for one month only. 5. Haegarda can be self-administered after training under the guidance of a healthcare professional and therefore will be covered under the pharmacy benefit. 6. Standard dosage is 60 International Units (IU) per kg body weight by subcutaneous injection twice weekly. a. Quantity limit of 16 vials per 28 days (defined as the combined total amount of 2000 unit vials AND 3000 unit vials) b. Requests will require documentation of patient’s weight to verify requested dosing is in accordance to the FDA approved dosing. c. Requests for dosing every three days will require documentation of a previous trial of twice weekly dosing that did not lead to a decrease in the severity, duration and/or frequency of attacks. 7. Authorization will be for 6 months at a time. a. 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. 8. Safety and efficacy in children under the age of 13 has not been established and therefore will not be covered POLICY GUIDELINES: 1. Prior-authorization is contract dependent. 2. A normal C4 particularly during an edema attack should make one question the diagnosis of HAE 3. Some medications may trigger or worsen angioedema events in patients with HAE and should be avoided including estrogen contraceptives, hormone replacement therapy, and ACE-Inhibitors.
jandekkers schreef op 10 oktober 2017 07:39 :
[...]
ik kan het je e-mailen
Dank je Jan, maar dat hoeft niet. Ik bedoel, als er geen officieel persbericht van komt zal het imo weinig met de koers doen. Dus als Sijmen slim is, brengt hij het even naar buiten.
@jandekkers, dank voor het delen van!
C200 schreef op 10 oktober 2017 08:08 :
[...]
Dank je Jan, maar dat hoeft niet.
Ik bedoel, als er geen officieel persbericht van komt zal het imo weinig met de koers doen. Dus als Sijmen slim is, brengt hij het even naar buiten.
Pharming dacht ik gelezen te hebben mag in deze fase geen promotie maken voor profylactisch gebruik van Ruconest
De promotie is niet meer nodig voor Pharming. De verzekeraars en patienten hebben het stokje overgenomen
Wat denk jij KarenT? eruit voor 79.5 en eind van de week weer terug voor 76?
this mooi gokken met elkaar nu net even voor tijd, denk dat de barriere van 0.80 geen probleem wordt zo gaan we zo door heen LET MAAR OP.
oorloop schreef op 10 oktober 2017 08:24 :
Wat denk jij KarenT?
eruit voor 79.5 en eind van de week weer terug voor 76?
Iedereen op dit forum is natuurlijk reuze benieuwd naar de ziens- en handelwijze van Karen T.
En zoals jullie weten moet je er eerst in zitten om er uit te kunnen
WOW! goedemorgen weer alleen maar super nieuws weer vandaag er komt iedere dag steeds meer en steeds beter nieuws ,fijn is da daghandelen ik denk dat je ze duur kan terug kopen succes allemaal HOLD!!
jakhals schreef op 10 oktober 2017 08:05 :
Als er 1 verzekeraar over de brug is, dan volgt de rest ook. En 1 maal in een mustang gereden, dan wil je niet meer terug naar je daewoo matiz
Als ik het goed begrijp kan ik dan eindelijk mijn fiets aflossen?
Betekent onderstaande dat Ruconest slechts uitzonderlijk wordt toegediend? "5. Must have documentation of therapeutic failure or severe adverse reaction to Berinert or Firazyr"
F. Ruconest specific criteria 1. Must have a diagnosis of acute attacks associated with hereditary angioedema (progress notes required) 2. Ruconest will not be covered for laryngeal attacks as efficacy has not been established in patients with laryngeal HAE attacks 3. Safety and efficacy in children under the age of 13 has not been established and therefore will not be covered 4. Ruconest will be reviewed under the medical benefit when administered by a health care professional. If the member transitions to self-administration, then Ruconest can be authorized under the pharmacy benefit. 5. Must have documentation of therapeutic failure or severe adverse reaction to Berinert or Firazyr 6. Dose is 50 IU per kg by IV injection a. Maximum dose is 4200 IU with no more than 2 doses within a 24 hour time period b. Quantity limit of 100 ml per 30 days c. Authorization on the medical benefit will be for 1 month initially then every 6 months d. Authorization on the pharmacy benefit will be for 6 months at a time e. 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 7. Based on national shortages of other medications that are FDA approved for HAE prophylaxis and emerging clinical data, requests for Ruconest for hereditary angioedema prophylaxis will be allowed with the following dosing: Pharmacy Management Drug Policy Hereditary Angioedema (HAE) Proprietary of the Insurance Plan Page 5 of 7 50 IU per kg for patients less than 84 kg or 4200 IU for patients greater than or equal to 84 kg twice weekly a. Quantity limit of 16 vials per 28 days b. Approvals will be short term (2 months) until supply of other medications that are FDA approved for HAE prophylaxis is adequate Thanks jandekkers AB
Kan iemand mij ff bijpraten? Wat was HET GROTE nieuws de laatste 18 uur waardoor iedereen zo positief klinkt hedenochtend
Altijd hetzelfde met Moneymaker_BX te beroert om zelf te lezen
Goedemorgen Pharmers, € 0,81 is de volgende weerstand. Hier in het westen schijnt de zon! Mooi nieuws ook zo net nog voor de cijfers. Let the party go on.
Ben benieuwd of de move van gisterenmiddag een schijnbeweging was of niet !
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