Drug Therapy Guidelines: Phosphodiesterase-5 Inhibitors Viagra® (sildenafil) Cialis® NF (tadalafil),Levitra® NF(vardenafil) Effective Date: 11/15/05 Committee Review Dates: 7/15/98, 9/7/00, 11/28/00, 11/27/01, 11/19/02, 11/11/03, 11/2/04, 11/15/05 Policy Statements: Non-Formulary/ 3rd tier or Prior Authorization drugs may require an appropriate trial of a Formulary agent(s) based on benefit coverage or criteria. A therapeutic trial of samples of a Non-Formulary or Prior Authorization agent will not be accepted as rationale for medical necessity to continue that agent. Please be sure to list all therapies that have been previously tried on the request form so that your request can be processed in a timely manner. • A drug will be approved based on coverage criteria for FDA approved indications. Requests for newly approved indications will be reviewed by the Medical Director as per FDA labeling and an internal policy will be developed to assure consistency of review until an updated guideline is approved and published. • Off-label/investigational uses will be reviewed for medical appropriateness on a case by case basis. Literary evidence will be sought for well designed and well conducted investigations published in peer-reviewed articles that demonstrate safety, efficacy, improvement in health outcomes and comparison data supporting effectiveness equal to or superior to established conventional therapies. For medical injectables administered by the healthcare provider, guidelines are designed to give providers a concise overview of medical criteria utilized in determining coverage of services rendered. Guidelines provide clinically significant information about medical treatment that if not adhered to, may affect the payment you receive. Please remember that when a service is denied because it does not meet the medical necessity criteria contained within the guideline, the member is held harmless and cannot be billed. For both self-medication obtained at the retail pharmacy and medical injectables administered by the provider, please note that payment for covered services is subject to the limitations noted in the member’s contract and the member's eligibility at the time the services are rendered. Indication: For the treatment of erectile dysfunction. Recommended Guidelines:
Coverage for the medications in this class is limited to:
1. Men, 19 years of age and older 2. In the absence of a claim for a nitrate product within the last 30 days 3. At a quantity of #6 tablets per 30 days.
Viagra® (sildenafil), Cialis® (tadalafil), Levitra® (vardenafil)
There will be no exception for quantity limits for the treatment of erectile dysfunction. Exceptions to this quantity limit will be considered for certain conditions other than erectile dysfunction on a case by case basis. Literary evidence establishing clinical efficacy should be included as part of the prior authorization request.
Prescription Writing Tips:
¾ As the drug is not effective for all patients, please consider writing the first prescription
for each patient without refills. This will allow you the opportunity to discuss the efficacy of the drug with the patient, determine the most appropriate dose for subsequent prescriptions, and prevent drug waste secondary to lack of effect.
¾ Viagra® 50 mg taken as needed, approximately 1 hour before sexual activity. However,
sildenafil may be taken anywhere from 30 minutes to 4 hours before sexual activity. Based on effectiveness and tolerance, the dose may be increased to a maximum recommended dose of 100mg or decreased to 25 mg. The maximum recommended dosing frequency is once daily. For patients > 65 yo or those with renal or hepatic dysfunction, the starting dose should not exceed 25mg.
¾ Cialis® 10 mg prior to anticipated sexual activity (dosing range: 5-20 mg); to be given as
one single dose and not given more than once daily. Note: Erectile function may be improved for up to 36 hours following a single dose; adjust dose
¾ Levitra® 10 mg 60 minutes prior to sexual activity; dosing range: 5-20 mg; to be given as
one single dose and not given more than once daily Elderly ≥65 years: Initial: 5 mg 60 minutes prior to sexual activity; to be given as one single dose and not given more than once daily. Dosing considerations are made for interacting drugs (i.e. alpha blocker, erythromycin, indinavir, itraconazole, ketoconazole, ritonavir)
Clinical Update Phosphodiesterase-5 Inhibitors Possibly Associated With Vision Loss July 11, 2005 The Food and Drug Administration (FDA) announced new labeling for sildenafil (Viagra®), tadalafil (Cialis®), and vardenafil (Levitra®). The updated package inserts note rare cases of sudden vision loss attributed to nonarteritic ischemic optic neuropathy (NAION) reported from postmarketing surveillance. NAION is a condition where blood flow is blocked to the optic nerve. NAION is more common in persons with heart disease, diabetes, hypertension, those who smoke, are >50 years of age, or who have certain eye problems. Vision loss in one eye has been reported in some men after taking these products. It is not known if sildenafil, tadalafil, or vardenafil are directly the cause of this condition or if other related factors are responsible. Patients taking a PDE5 inhibitor and who may experience vision loss should stop taking the product and notify a healthcare provider immediately. Additional information can be found on the following FDA website: http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#ED References:
1. Jackson G, Gillies H, Osterloh I.Past, present, and future: a 7-year update of Viagra (sildenafil citrate). Int J
2. Lexi-Comp Inc, Sildenafil Monograph, http://www.crlonline.com (accessed October 5, 2005).
Viagra® (sildenafil), Cialis® (tadalafil), Levitra® (vardenafil)
3. Lexi-Comp Inc, Tadalafil Monograph, http://www.crlonline.com (accessed October 5, 2005). 4. Lexi-Comp Inc, Vardenafil Monograph, http://www.crlonline.com (accessed October 5, 2005). 5. Michal, R et al. Sex in America – A definitive survey. 6. Montorsi, F. Briganti, A. et al. The use of phosphodiesterase type 5 inhibitors for erectile dysfunction.
Current Opinion in Urology. 14(6):357-359, November 2004
7. US Food and Drug Administration, http://www.fda.gov/medwatch (accessed Ocober 4, 2005).
Viagra® (sildenafil), Cialis® (tadalafil), Levitra® (vardenafil)
Kenneth R. Pugha,b,*, W. Einar Mencla,b, Annette R. Jennera,b,Leonard Katzb,c, Stephen J. Frostb,c, Jun Ren Leea,b,Sally E. Shaywitza, Bennett A. Shaywitza,daDepartment of Pediatrics, Yale University School of Medicine, PO Box 3333, New Haven,bHaskins Laboratories, New Haven, CT 06511, USAcDepartment of Psychology, University of Connecticut, Storrs, CT, USAdDepartment of Neurology, Yale
COMPETENCIES FOR NURSING CARE OF PATIENTS WITH SUBSTANCE RELATED DISORDERS Madeline A. Naegle1, Nurses and midwives, the largest group of providers, deliver basic and specialty healthcare worldwide. They are uniquely positioned to deliver interventions for drug use, abuse and dependence. Few provide such care however, because their basic educations lacked information and clinica
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