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Issue #15, April 2000
n ACCOLATE (zafirlukast) (ZEN) and SINGULAIR (montelukast sodium) (MSD)
have been added via Special Authorization (SA) for individuals > 18 years for
The Expert Committee on Drug Evaluation and
the prophylaxis and chronic treatment of asthma as an alternative to in-
creased doses of inhaled glucocorticosteroids. Patients must be unable to use
long-acting b agonists or have demonstrated persistent symptoms despite use
of long-acting b agonists. These criteria are based upon the recently pub-
EXPERT COMMITTEE MEMBERS:
lished Canadian Asthma Consensus Report [CMAJ 1999; 161 (11 Suppl)].
D. Neil Graham, M.D., FRCP (C), FACP (Chair)
There is Level I evidence for use of long-acting b agonists as add-on therapy
William F. Dryden, BSc (Pharm), PhD. ARCST
to moderate or higher doses of inhaled glucocorticosteroids, whereas the use
Erwin G. Friesen, BSc (Pharm), Pharm. D., FCSHP of Leukotriene-Receptor Antagonists (LTRAs) as add-on therapy is supported
only by Level II evidence. As a result, long-acting b agonists should be the
ALBERTA HEALTH AND WELLNESS
n ADVAIR (combination of salmeterol and fluticasone) (GLA), which is indi- LIAISON:
cated only for patients with reversible obstructive airways disease >12 years
of age, was added as an unrestricted benefit. Advair has been shown to be
superior to monotherapy with the single agents. According to the 1999
Canadian Asthma Consensus Report, inhaled long-acting b agonists should be
used as add-on therapy to moderate or higher doses of inhaled gluco- corticosteroids to achieve control of persistent asthma symptoms (Level I). n ALERTEC (modafinil) (DAX) is the only drug approved in Canada, to date,
specifically for the treatment of narcolepsy. This condition is estimated toaffect approximately 1,500 Albertans. Alertec will be available to patients via
SA according to the following: For the treatment of documented narcolepsy
when initially prescribed by a sleep specialist affiliated with a recognized level
1 lab or a general neurologist or a psychiatrist.
n MONUROL (fosfomycin tromethamine) (PFR) is a single dose treatment for
uncomplicated urinary tract infections (UTI). It has been shown to be compa-
rable in efficacy to 7-10 days of fluoroquinolone therapy. Monurol is more
costly than treatment of UTI with older agents or 3-day fluoroquinolone
regimens; however, it is cost-effective when compared with 7-10 days offluoroquinolones. Patient compliance is likely to improve with the single dose
n PLAVIX (clopidogrel bisulfate) (WIN) has been available on the AHWDBL via
SA since January 15, 2000 for the prevention of thrombosis post intravascularstent placement. SA criteria have now been broadened and Plavix will becovered for the prevention of cardiovascular events according to the follow-ing: For those patients who are not able to take ASA either due to a contrain-dication to ASA or have recurrent events while on ASA.
n INHIBACE PLUS (cilazapril and hydrochlorothiazide) (HLR) is deferred pend-
ing further review and discussion by the Expert Committee on the clinical valueand cost-effectiveness of combination antihypertensive products in light of the
recently published International Society of Hypertension Guidelines for the
ARICEPT (donepezil hydrochloride)
n XENICAL (orlistat) (HLR) has been shown to have significant effects on
weight loss, weight regain and improvement in metabolic profile of obese
criteria for ARICEPT were developed
individuals. These outcomes, including an effect on glycemic control, may be
of particular benefit to Type II diabetics; however, this must be explored further.
As a result, Xenical has been deferred for further review to allow consultation
with the manufacturer and Alberta diabetologists regarding these benefits and
impact upon long-term health outcomes. Furthermore, additional information
Examination) score between 10 to 26.
is required regarding guidance on when patients should discontinue Xenical.
As a point of clarification, SA reim-bursement will be considered andcontinuously provided for those
n ALDARA (imiquimod) (MMH), which is indicated for the treatment of exter-
above 26 while on ARICEPT, provid-
nal genital and perianal warts/condyloma acuminata in adults, was not added.
A less expensive alternate therapy, WARTEC (podophyllotoxin) (PMS), is avail-
of starting ARICEPT was <26.
able on the AHWDBL and is also a patient-applied therapy. n RELENZA (zanamivir) (GLA) is indicated for the treatment of uncomplicated acute illness due to influenza virus in patients 12 years and older who have
been symptomatic for no more than 2 days. The primary endpoint in clinicaltrials was the median time to alleviation of major signs and symptoms of
influenza. Results showed a statistically significant reduction of 1 day in this
endpoint; however, no data have been provided which show a significant
impact of Relenza on major complications of influenza or on mortality and
morbidity endpoints. Furthermore, there is insufficient evidence for efficacy in
high risk patients (e.g. elderly or patients with underlying respiratory disease).
n TOBI (tobramycin sulfate) (PGC), a preservative-free formulation of
Globulin (BAYHEP) and Tetanus
tobramycin sulfate for inhalation, was not added to the AHWDBL. Consulta-
Immune Globulin (BAYTET) be
tions with infectious diseases and cystic fibrosis specialists indicated that the
theoretical risk of lung damage due to the preservative has not been seen
clinically. It appears that the compounding of preservative-free tobramycin
solution for inhalation can be done relatively easily and at lower cost. Therefore
there is no incentive for adding this expensive formulation to the AHWDBL
n VIAGRA (sildenafil citrate) (PFI), which is indicated for the treatment of
erectile dysfunction (ED), has not been added. Following consultation with
Alberta experts, there was no strong support for addition of this product to the
Influenza Virus Vaccine (FLUVIRAL)
AHWDBL. Products for the treatment of ED have historically not been covered
on Alberta government-sponsored drug programs.
lent) (PNEUMOVAX 23) have also been removed and will be provided free of charge to individuals at risk. Additional information on availability can be obtained from regional public health.
Dr. Judith Baker joined the Expert Committee in May 1999. She obtained
her BSP (Pharmacy), M.Sc. (Pharmaceutics) and Ph.D. in Biological Psychiatryfrom the University of Saskatchewan. Dr. Baker is a member of numerousprofessional associations including the Alberta Pharmaceutical Association(APhA) of which she was President in 1990, the Canadian Pharmacists Asso-ciation (CPhA), the Canadian College of Clinical Pharmacy, the Capital HealthRegion (CHR) Pharmacists Association and the Canadian College ofNeuropsychopharmacology. Dr. Baker has been a member of and has chairedmany committees including the APhA Regulatory Affairs Committee, theAPhA Drug Schedules Committee, and the CHR Pharmacists Long-term CareCommittee. Dr. Baker has also held teaching appointments at the Universityof Alberta and the University of Aston (UK). In addition to practicing as apart-time community pharmacist, Dr. Baker is currently involved in manyprojects related to pharmacy practice through her consulting roles for theAlberta Wellnet Pharmacy Information Network, APhA, AMA, CPhA, HealthOutcome Pharmacies, and Capital Health Authority. Dr. Baker currently chairsthe APhA Practice Review Committee and is a member of the AMA CognitiveImpairment Clinical Practice working group and a member of the AlbertaWellnet Pharmacy Network Project Team. Dr. Bakers vision of the Albertagovernment-sponsored drug programs is that they should be comprehensivein terms of the range of drug therapies offered but must be administered in afiscally responsible manner. Solutions will have to be found to the questionssuch as Who will benefit most from treatment? and How can we affordto pay for the drug treatment? that are posed by the new and extremelyexpensive biotechnology drugs.
The Canadian Anti-Doping Program – September 2006 Abbreviated Therapeutic Use Exemption Guidelines Abbreviated Therapeutic Use Exemption Guidelines As per the CANADIAN ANTI-DOPING PROGRAM (CADP), Section 1: General Principles, Rule 1.5, “The Canadian Centre for Ethics in Sport may issue detailed guidelines or practices for these Rules and Standards from time to time.” These Abbrevi
Geschäftsfeld Presse Tel: 030/27909-135 I Fax: 030/27909-335 Pressemitteilung Herber Schlag für MS-Patienten – Harter Schlag ge- gen die Grundlage von Innovationen Der Kern des Arzneimittelmarktneuordnungsgesetzes (AMNOG) ist die Ver- handlung von Rabatten auf den Listenpreis eines innovativen Arzneimittels zwischen dessen Hersteller und dem GKV-Spitzenverband. Der Gesetzge- be