Microsoft word - drug_review_volume_v_issue_9_gardasil+revatio.doc
Drug Review Recently Introduced Products Volume V, Issue 9 Potential Plan Drug Name Indication
Treatment of Parkinson’s disease, as monotherapy or as an adjunct
Treatment of HIV-1 infected adult patients, who are treatment experienced and
have failed prior antiretroviral therapy
Treatment of Attention Deficit Hyperactivity Disorder (“ADHD”) in children (6 years $
Little increase estimated in drug plan expenditure
Drug plan expenditure estimated to be somewhat increased
Potential for large increase in drug plan expenditure
Gardasil® – A Preventative Vaccine for Cervical Cancer
Gardasil® is indicated for the prevention of infection caused by the Human Papillomavirus (“HPV”) and genital warts, pre-cancerous
lesions, and cervical, vulvar and vaginal cancers associated with HPV. HPV is one of the most common sexually transmitted
infections in Canada. Approximately 75% of Canadians will have at least one HPV infection in their lifetime. Without Pap testing or
treatment, about 1% of women with HPV infection will eventually go on to develop cervical cancer.
Gardasil® protects against HPV types 6, 11, 16 and 18, which are implicated in 70% of cervical cancers and 90% of genital warts.
Clinical trials were conducted in women aged 16 to 26 years only, hence, its indication is limited to girls and women aged 9 to 26 years.
Gardasil® is administered intramuscularly in 3 separate injections over a six month period, with no booster shots required at present.
The cost for 3 injections is approximately $430.00. Gardasil® will be Excluded for clients who have adopted ClaimSecure’s Managed Formularies because preventative vaccines are excluded under the plan. For plans with open formularies, preventative
vaccines are automatically covered, unless specifically excluded at the individual group level. Should you wish to change coverage
of preventative vaccines, please contact Shellina Sevany in ClaimSecure’s Clinical Services Department at (905) 949-3025 or 1-888-
Recommendation: Exclude ClaimSecure reserves the right to amend in part or in its entirety stated special authorization clinical guidelines Revatio – Another option for Pulmonary Arterial Hypertension
Revatio® is indicated for pulmonary arterial hypertension (“PAH”). PAH causes the arteries of the lungs to constrict leading to right
heart failure. It is a rare disease, with approximately 500 patients diagnosed in Canada. Current treatment includes Flolan®,
Revatio’s® mechanism of action is to cause relaxation of the pulmonary vascular smooth muscle, resulting in decreased blood
pressure. Interestingly, the active ingredient in Revatio® and Viagra® are the same, however, the dosages and the strengths are
different. The recommended dose for Revatio® is 20mg three times a day, whereas Viagra’s® dose is 25mg up to 100mg once
daily. Revatio® costs $33.00 per day, for an annual expenditure of approximately $12,000.
However, Flolan®, an intravenous injection, is covered by most provincial hospital programs. As such, for clients who have adopted
ClaimSecure’s Managed Formularies, it will be placed under Special Authorization to ensure patients with PAH, have tried and
failed conventional therapies, including Flolan®, first. For plans with open formularies, Revatio® will automatically be covered. Should you wish to exclude or cover Revatio® under Special Authorization, please contact Shellina Sevany in ClaimSecure’s Clinical
Services Department at (905) 949-3025 or 1-888-479-7587 Ext. 3025.
Recommendation: Special Authorization ClaimSecure reserves the right to amend in part or in its entirety stated special authorization clinical guidelines
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