Direct Medical Costs for Surgical and Medical Treatment of Condylomata Acuminata FREE

THE TREATMENT of condylomata acuminata entails costs for patients and insurers. While many studies have attempted to compare the efficacy of various treatments against placebo and each other, limited data exist regarding the costs of each therapeutic option. In this article, we estimate and compare the direct medical costs of each of several commonly used treatment modalities: podophyllum resin, podofilox, trichloroacetic acid, imiquimod, interferon alfa-2b, cryotherapy, electrodesiccation, cold steel excision, loop electrosurgical excision procedure (LEEP), and laser surgery.

A cost model was constructed for each treatment modality (Table 1) by reviewing the literature for estimates of the typical frequency and duration of treatment courses (Table 2), obtaining a set of physician fee schedules (Table 3), approximating the wholesale costs of medications (Table 4), and considering the relative efficacy of the treatments in clearing condylomata (Table 5).

For simplicity, combinations of treatments that may commonly be used in clinical practice are not studied. Direct medical costs are taken to include the aggregate costs of any physician visits and procedures as well as costs for medications and medical devices not provided at the office visits. Office visit and physician-administered treatment costs are estimated from the November 1999 Medicare fee schedule for participating providers, and the costs of medications and medical devices are average wholesale prices quoted in the 2000 Drug Topics Red Book. While some practitioners may administer similar medications or procedures in different ways, we use commonly accepted guidelines reported in the medical literature to determine the duration and frequency of typical treatment regimens. Whenever newer published empirical data on the duration and frequency of treatment regimens associated with a given treatment modality are available, this information has been used to supersede manufacturer guidelines.

All of the treatment types considered in this study except LEEP are specifically classified by a 1997 report of the American Medical Association on external genital warts as "patient-applied," "health care provider–administered," or "alternative" treatments.²⁴ Estimates of the short-term efficacy of the examined treatments are used to weight the relative costs of different treatment approaches.²⁵ Perfect (100%) efficacy in this context is defined as clearance of all condylomata at the end of therapy. Long-term efficacy, recurrence rates, and figures for sustained clearance of treated warts are not considered in the cost analysis. This simplification is used since extremely limited information is available regarding posttreatment efficacy beyond a few months; the medium-term posttreatment efficacy data are disparate and difficult to interpret. Other patient-related considerations for selecting one treatment type over another are also not endogenous to this cost analysis: these may include patient pain tolerance, preference for self- or physician-administered treatment, desire for rapidity of treatment, concern regarding scarring, and previous treatment failure.

Excluding subsequently mentioned exceptions, all physician visits in this model are treatment visits. Initial and follow-up visits are included for patient-applied treatments, in which the initial visit is the prescription visit and the final visit is required for discontinuation of treatment. A follow-up visit is also included for surgical options requiring only a single treatment visit.

Physician visits were either evaluation and management (E/M) initial or follow-up visits without physician-administered treatments, or treatment visits during which no other service was performed. Initial visits at which physician-administered treatments were not provided were considered initial level 2 (99202) or 3 (99203) outpatient E/M visits. Follow-up visits at which physician-administered treatments were not provided were considered as follow-up level 2 (99212) or 3 (99213) outpatient E/M visits. Treatment visit costs were derived by averaging the costs associated with the appropriate Current Procedural Terminology (CPT) destruction codes for lesions, including condylomata, located on the penis, vulva, or anus, respectively. For instance, the cost of a hypothetical cryotherapy treatment was defined as the mean of the costs of cryosurgery of the penis (54056), cryosurgery of the anus (46916), and simple destruction at the vulva (56501). For treatment of extensive condylomata, level 3 E/M codes and extensive destruction CPT codes were used; more limited treatments were represented by level 2 E/M codes and simple destruction CPT codes.

Brief treatment for simple condylomata (Table 6) can be accomplished with podofilox, cryotherapy, electrodesiccation, surgical excision, LEEP, or laser for costs ranging from approximately $200 to $300. Podophyllum resin is more expensive, at $385 for a similar treatment regimen, and trichloroacetic acid and imiquimod are yet more expensive at $513 and $607, respectively. Interferon alfa-2b would entail much higher cost, $2744, by the predictions of this model.

In the case of extensive condylomata requiring prolonged treatment (Table 6), LEEP would be the most affordable treatment modality ($294), followed by surgical excision ($318), podofilox ($334), and electrodesiccation ($415). Laser ($535) and imiquimod ($649) are slightly more expensive. Cryotherapy and podophyllum resin are several times the cost of the least expensive modalities, at $1449 each. Again, interferon alfa-2b treatment is the most expensive alternative ($5803).

Adjusting the costs of each type of treatment to reflect differences in efficacy results in a slightly different cost distribution (Table 7). Comparing the costs to achieve 100% clearance reveals that surgical excision is the lowest-cost modality ($285), followed by LEEP ($316), electrodesiccation ($347), carbon dioxide laser ($416), podofilox ($424), and pulsed-dye laser ($479). Cryotherapy ($951) and trichloroacetic acid ($986) are about 3 times as expensive as the lowest-cost treatment. Imiquimod ($1255) and podophyllum resin ($1632) are more expensive still. Interferon alfa-2b has an efficacy-adjusted cost of $6665. The mean direct medical costs (medication and physician) per clearance for treating condylomata for each of the modalities are shown in Figure 1.

Our estimates suggest varying costs to patients and insurers depending on the therapeutic options selected by physicians. In our model, after adjusting for efficacy, surgical treatments appear to be lowest cost. Surgical excision, LEEP, and electrodesiccation are the most inexpensive, followed closely by carbon dioxide and pulsed-dye laser. The only medical treatment at this end of the cost distribution is podofilox, which has a cost comparable to that of laser. Physician-administered medical therapies are approximately 2 (trichloroacetic acid), 4 (podophyllum resin), or more than 10 (interferon alfa-2b) times the cost of laser treatment. Cryotherapy is also more than twice as expensive as podofilox or the surgical modalities.

Overall, the low costs associated with surgical treatments derive from the high levels of clearance that may be achieved with few treatments. Imiquimod, by virtue of its higher medication cost and protracted duration of treatment, and podophyllum resin, because of the numerous physician-administered treatments required, are relatively more expensive.

Notably, the model also stratifies aggregate costs by the intensity of the treatment regimen. For treating specific types of disease, treatments that are usually more expensive may be relatively more affordable. Efficacy-adjusted costs for a brief course of cryotherapy to treat simple condylomata ($339) are thus comparable to those for the low-cost modality for the same indication (surgical excision, $228). For a prolonged course to treat extensive condylomata, imiquimod ($1298) is less expensive than cryotherapy ($1834) and approximately the same cost as trichloroacetic acid ($1288).

One important reservation about the aggregate cost estimates derived herein is that the underlying assump tions regarding relative efficacies and the number of treatments usually required with the various treatment modalities are based on physician studies and pharmaceutical company recommendations that may be flawed. Few studies have compared multiple treatment modalities on the same patient population.

Also, this analysis assumes aggressive billing of patients by physicians and rigorous scheduling of follow-up appointments. In actual situations, follow-up visits may be less frequent. Physicians may in some cases receive substantially less reimbursement than that mandated by the Medicare fee schedule used in this analysis.

The present model extends previous work on the cost-effectiveness of treatment strategies for condylomata. Earlier cost studies have examined fewer treatment modalities. In some cases, these studies have incorporated assumptions that may be inaccurate, unsupported by the literature, outdated, or otherwise not applicable to US medicine. For instance, Langley and colleagues^{21 ,23} have collaborated on 2 recent articles that discuss the costs of various types of treatment but ultimately provide complete cost models for only 2 modalities, imiquimod and podofilox. They conclude that imiquimod is slightly more cost-effective than podofilox in "cost per sustained cleared patient."²¹ However, as has been discussed previously, sustained clearances associated with different treatment modalities are inherently difficult to compare given different durations of follow-up and the absence of any true long-term studies that track disease remission for periods of greater than several months. The short-term clearance rate for podofilox that Langley and colleagues include in their analysis is 0.283,²³ which is less than half the other estimates in the literature. Even after entering their low rate into our model, our consensus estimate for podofilox efficacy is 0.63 (Table 5). In addition, the Langley cost analyses are based in part on a dated cost model for genital warts constructed by Strauss and colleagues.²⁶ The earlier article by Strauss et al uses cost data from 1992, and makes unusual cost assumptions, such as costing the second and subsequent treatment visits as follow-up E/M visits rather than as more expensive treatment visits. Strauss et al also explicitly decline to consider relative efficacies of treatment alternatives since their advisory panel "concludes that no therapy is consistently more effective than another."²⁶

In contrast to the analyses of Langley et al, Mohanty's²² cost comparison of treatment of condylomata with podophyllum resin and podofilox finds podofilox to be highly cost-effective. The "overall cure rate"²² with podofilox is found to be 66%, close to the other estimates in the literature. Mohanty's model is limited by its consideration of only 2 treatment modalities. The Mohanty model may also be less relevant to the United States since it examines cost of care in the United Kingdom and computes treatment costs by estimating the cost of physician time in minutes and adding medication costs for physician-administered medications.

In conclusion, the results of this study clarify the direct costs of treatment of condylomata acuminata with different medical and surgical techniques. In particular, surgical modalities, including cold-steel excision, electrodesiccation, LEEP, and laser, appear to be low cost and require few treatments. Of the patient-administered drugs, podofilox is the most affordable. Obviously, there are multiple other factors that we do not examine in this analysis that may contribute to the choice of treatment modality.

A cooperative effort of the Clinical Epidemiology Unit of the Istituto Dermopatico dell'Immacolata–Istituto di Recovero e Cura a Carattere Scientifico (IDI-IRCCS) and the Archives of Dermatology.

Accepted for publication December 28, 2000.

Corresponding author and reprints: Murad Alam, MD, 195 Davis Ave, Brookline, MA 02445 (e-mail: murad@alam.com).