Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/ Case Summary:  The enrollee is requesting reimbursement and authorization and coverage for the daily use of Cialis (Tadalafil). The enrollee has prostate pain, initially seen with complaints of bladder pressure, constipation, fatigue, nocturia, sexual dysfunction, urinary frequency and urinary urgency. Cialis was prescribed. A follow up visit indicated symptoms had improved with Kegel exercises. The enrollee did not want to take Finasteride or similar medications due to risk of impotence on the side effects list. He was experiencing sexual dysfunction, urinary dribbling and urinary frequency. Review of the enrollees active medications in the record shows the provider prescribed Finasteride tablet. The providers assessment/plan on a follow up visit indicates the enrollee requested Cialis.  There is insufficient evidence in the record of the providers recommendation for Cialis over Finasteride for the treatment of this enrollees medical condition. A comprehensive review and meta-analysis study indicates the medical treatment with alpha-blockers, including Tamsulosin, (Flomax) and 5-alpha reductase inhibitors (Finasteride) is associated with sexual dysfunction, such as retrograde ejaculation and erectile dysfunction, respectively. A study showed that Tamsulosin showed better efficacy than Tadalafil (Cialis) in treating lower urinary tract symptoms (LUTS), Cialis also showed significant improvement in erectile dysfunction (ED), which was not seen with Tamsulosin. This study recommended that once daily Tadalafil was well-tolerated and effective for the treatment of LUTS secondary to BPH when associated with ED. However, in another study, although the Tadalafil (Cialis) study group showed a greater improvement in their erectile function compared to the Tamsulosin (Flomax) study group, the Tamsulosin study group also showed significant improvement in erectile function. This strengthens the theory of a possible pathophysiological association between BPH-LUTS and ED, in which the treatment of BPH alone can potentially treat the associated ED. Tadalafil (Cialis) is a phosphodiesterase type-5 (PDE5-1) inhibitor that is FDA approved for the treatment of LUTS secondary to BPH, with or without erectile dysfunction. While there are studies to support the efficacy of Tadalafil for erectile dysfunction secondary to BPH, it is not clear from the record the enrollees symptom report of sexual dysfunction is severe enough to be considered a clinical diagnosis of erectile dysfunction secondary to BPH or if it is simply part of the clinical syndrome associated with his currently untreated BPH. There is insufficient evidence in the record that erectile dysfunction is one of enrollees active diagnoses. Despite the enrollees concern for impotence associated with finasteride, the record does not indicate that Finasteride is not recommended due to the enrollees erectile dysfunction. On the contrary, the record shows the provider has prescribed both Cialis and Finasteride. While the provider indicates the enrollee refused Finasteride and requested Cialis, there is no medical recommendation nor clinical documentation to support the enrollee has erectile dysfunction and that Finasteride is contraindicated. As a result, there is insufficient data to support Cialis is more effective than Finasteride or Tamsulosin (standard therapy for BPH) in treating this enrollees medical condition. Final Result: The reviewer determined that the requested services were not medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified in urology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or similar medical condition.