Comparison of Standard Collagenase Clostridium Histolyticum Protocol and Modified Interferon Alpha 2 Beta Protocol for the Management of Peyronie’s Disease at 2 Large Healthcare Organizations
Healthcare organizations make protocol decisions based on the cost benefit of medical treatments. The only FDA-approved intralesional therapy (ILT) for Peyronie&[prime]s Disease (PD) is Collagenase Clostridium Histolyticum (CCH). ILT CCH costs > $3000 per injection. The usual CCH protocol, based on pivotal clinical trials, includes 2 ILT injections per cycle with CCH and an additional visit for in-clinic modeling. Hellstrom (2006) studied ILT with Interferon Alpha 2 Beta (IFN) in a small, randomized, placebo-controlled trial and found ILT IFN to be a safe and effective for PD. ILT IFN costs $75 per injection. Both ILT CCH and ILT IFN are both part of the ILT treatment algorithm in the American Urological Association&[prime]s guidelines for PD. The goal of this study was to compare outcomes of two ILT protocols at 2 different health care organizations in the same community with consideration for both clinical outcome and organizational cost.
Site 1 used the standard CCH protocol. This consisted of 4 visits per treatment cycle for up to 4 cycles including pharmacologic erection with goniometric measurement (curvature measurement), 2 CCH injections (0.58mg), and a visit for modeling (office modeling and home instructions). Site 2 used a modified IFN protocol of up to 6 cycles, at least 4 weeks apart. Each cycle consisted of a single visit in which there was: pharmacologic erection, goniometric measurement, pharmacologic detumescence (phenylephrine), dorsal nerve block, IFN ILT (0.25 ml, 1.5 million IU/injection) and instructions on home penile modeling in the flaccid state.
26 patients from site 1 with a mean pre-ILT CCH treatment curvature of 38° received treatments for a mean number of 3 cycles, (range 1-4). The ILT CCH treatment resulted in a mean curvature decrease of 19.5° or 52% decrease from baseline. The average cost of the medication was $18,000 per patient; the total cost of the CCH for the 144 injections given was $432,000. 26 patients from site 2 with a mean pre-ILT IFN curvature of 58°, received treatments for a mean number of 3 cycles, range 1-6. The ILT IFN treatment resulted in a mean curvature decrease of 17.5° or 34% from baseline. The average cost of medication was $75 per patient; the total cost of the INF for the 86 injections was $2,150.
These two protocols provide similar efficacy at markedly discrepant costs.