VIAGRA, Sildenafil Citrate Form

Sildenafil (Viagra®) is a phosphodiesterase-5 (PDE5) inhibitor. FDA Approved Indication(s) Viagra is indicated for the treatment of erectile dysfunction (ED). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Viagra is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Erectile Dysfunction (must meet all):

1. Diagnosis of ED;
   2. Age ≥ 18 years;
   3. If brand Viagra is requested, member must use generic Viagra (sildenafil 25 mg, 50 mg, 100 mg), unless contraindicated or clinically significant adverse effects are experienced;
      *Therapeutic failure does not constitute acceptable medical justification.
2. Sildenafil (Viagra) is NOT prescribed concurrently with nitrates or guanylate cyclase stimulators;
3. Dose does not exceed both of the following (a and b): a. 100 mg per day; b. Health plan approved quantity limit. Approval duration:
   HIM – 12 months
   Commercial – Benefit Renewal Date (quantity limits are plan specific) B. Other diagnoses/indications (must meet 1 or 2):

4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.33 for health insurance marketplace; or Page 1 of 5

   CLINICAL POLICY Sildenafil for ED
   b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.103 for health insurance marketplace; or

5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace.
   II. Continued Therapy A. Erectile Dysfunction (must meet all):
6. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If brand Viagra is requested, member must use generic Viagra (sildenafil 25 mg, 50 mg, 100 mg), unless contraindicated or clinically significant adverse effects are experienced;
      *Therapeutic failure does not constitute acceptable medical justification.
7. If request is for a dose increase, new dose does not exceed both of the following (a and b): a. 100 mg per day; b. Health plan approved quantity limit. Approval duration:
   HIM – 12 months
   Commercial – Benefit Renewal Date (quantity limits are plan specific) B. Other diagnoses/indications (must meet 1 or 2):
8. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and HIM.PA.103 for health insurance marketplace; or

9. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line Page 2 of 5

   CLINICAL POLICY Sildenafil for ED
   of business: CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ED: erectile dysfunction
   FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): patients using nitric oxide donors (e.g., organic nitrates or organic nitrites in any form); administration with guanylate cyclase (GC) stimulators (e.g., Adempas (riociguat)); hypersensitivity • Boxed warning(s): none reported V. Dosage and Administration
   Indication Dosing Regimen ED 50 mg orally 1 hour (0.5 - 4 hours) before sexual activity Co-administration of erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): consider a starting dose of 25 mg Maximum Dose 100 mg/day
   (25 mg/48 hours with co- administration of ritonavir) VI. Product Availability
   Tablets: 25 mg, 50 mg, 100 mg VII.