Vardenafil Patient Assistance Programs and Eligibility Criteria

In addition, the incidence of these

Side Effects

All the parameters in Table 1 were varied individually in one-way sensitivity analyses and simultaneously in probabilistic sensitivity analyses over the ranges specified. The distributions for the parameters were chosen according to the parameter type and level of uncertainty regarding the distribution. Utility weights were conservatively assigned uniform distributions because they were the most uncertain parameters, and triangular distributions were used for the cost of vardenafil and the number of prescriptions filled per patient per year. Finally, normal distributions were used for age and the probability of potency with vardenafil [12]. Table 2 shows the results of the incremental cost-effectiveness analysis for zero, four, six, and eight monthly doses of vardenafil under the base case assumptions.

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Compared with providing no vardenafil, four doses per month cost $576/QALY gained. Providing six doses per month versus the current policy of 4 per month cost about $2600/QALY gained, and the cost per QALY gained doubled to approximately $5200 when eight fildena ct doses per month were compared with six. In a one-way sensitivity analysis of the strategy of providing six doses of vardenafil per month versus four, the results were sensitive to the added utility of providing two more doses per month and the cost of vardenafil. If the added utility of two additional doses decreased to 0.001 from 0.01 in the base case, then the incremental cost-effectiveness ratio (ICER) increased to $23,261/QALY gained (Fig. If the cost per dose of vardenafil increased to $15 (base case $1.69), then the ICER rose to $22,906 (Fig.

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Further increasing the cost to $17.32, the average wholesale price of a vardenafil 20-mg tablet in 2009, resulted in an ICER of $26,449/QALY gained for the six-dose strategy. When the cost per dose was $20, the ICERs for providing six or eight doses were about $30,500/QALY gained or $61,000/QALY gained, respectively. In a probabilistic sensitivity analysis of providing six doses of vardenafil per month versus four, parameter values were randomly selected 5000 times from the distributions. At a willingness-to-pay threshold of $50,000/QALY, the strategy of providing six doses was favored in approximately 84% of the iterations. At a willingness-to-pay threshold of $20,000/QALY, supplying six doses per month was favored in almost 63% of the iterations. events did not differ from placebo [7].

It is therefore unlikely that their

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inclusion would have changed our results.

Non-medical use

The Markov model had four health states (Fig. Men began in a potent state if vardenafil was successful or an ED state if vardenafil was unsuccessful. We assumed that vardenafil was discontinued after two 1-month prescriptions were filled if it was not effective (i.e., transition from vardenafil unsuccessful to not on vardenafil health state, which was also an ED state). Men could also die of natural causes. Although we assumed that men continued to respond to vardenafil in the base case analysis, we did allow for subsequent failures in the sensitivity analysis (i.e., transition from vardenafil successful to not on vardenafil).

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The model had a yearly cycle length and a lifetime time horizon because ED is a chronic condition. Efficacy values for vardenafil were obtained from the published literature (Table 1), except for the increased utility of six and eight doses per month of vardenafil. We were very conservative with these estimates and assumed that most of the benefit from vardenafil occurs when going from a state of ED to that of being potent. Consistent with this assumption, four versus zero doses of vardenafil per month were associated with the utilities of potency (i.e., 0.87 in 60-year-old men) [6] and no potency (i.e., utility of potency minus disutility of ED) [3,4], respectively. We assumed that the increased utility associated with 6 doses of vardenafil per month versus 4 was 0.01, and we used a 50% reduction in the incremental utility gain of 8 doses per month versus 6 (i.e., utility of 0.005).

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These assumptions bias the analyses against providing additional monthly doses. On the basis of available data, we assumed that there was no increased morbidity and mortality related to vardenafil use [7,8] and no loss of treatment effect with time [9–11]. Finally, most vardenafil prescriptions in the VA were for men between the ages of 55 and 64 years, so we assumed the mean age of the cohort to be 60 years. We did not specify risk factors for ED (e.g., diabetes, atherosclerosis, radical prostatectomy, spinal cord injury), because studies have found no obvious change in the effectiveness of PDE5 inhibitors according to the cause of ED [7]. The effect of parameter uncertainty was explored in sensitivity analyses. Finally, we used theoretical cohorts of 60-year-old

men with ED, and vardenafil may be used

Patient Assistance & Copay Programs for Vardenafil

Compared with six doses, providing eight doses was favored in 61% of iterations at a threshold of $50,000/QALY gained and in 35% at a $20,000/QALY gained threshold. We evaluated the cost-effectiveness of providing various monthly doses of vardenafil for veterans with ED. Of the strategies investigated, four doses per month was the most economical approach, as expected, because the monthly cost of vardenafil increases as the number of doses provided increases and the utility of additional doses does not increase proportionally. Nevertheless, the use of six or eight doses per month also compares favorably with other accepted medical strategies [13,14], and the results were stable across a wide range of inputs. The increased utility of providing additional doses of vardenafil had to decrease to 0.001 for the ICER to increase to more than $20,000/QALY gained.

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Although to our knowledge no one has assessed whether providing additional doses of vardenafil or other medications for the treatment of ED is associated with increased utility, we believe that this is a reasonable assumption given the ability to increase the frequency of intercourse if desired. In addition, we used a very conservative estimate and assumed that there was a reduction in the added utility of providing additional doses beyond six per month. The results were also sensitive to the cost per dose of vardenafil. Therefore the cost/QALY gained may be significantly higher in other health care systems, where vardenafil costs more and where tablet splitting is not used. Also, the cost per unit for all strengths of vardenafil was essentially the same in the VA. both in younger men, such as those

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The details of this analysis were limited, however, and costs were expressed in 1999 British pounds. The objective of this study was therefore to compare the incremental cost-effectiveness of four, six, and eight doses per month of vardenafil in a cohort of male veterans with ED. We used a Markov model to estimate the incremental cost-effectiveness of zero, four, six, or eight doses of vardenafil per month in hypothetical cohorts of 60-year-old male veterans with erectile dysfunction. Analyses were conducted from a third-party payer perspective (i.e., VA). We used a 3% discount rate for all costs and benefits, according to the recommendations of the US Panel on Cost-Effectiveness in Health and Medicine [5].

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Effectiveness was reported as QALYs to account for improvement in quality of life as a result of vardenafil. QALYs are the product of the time spent in a health state and the quality of life utility associated with that state summed over time. Utilities are a measure of preference for a health state and range from 0, representing death, to 1, representing perfect health. Vardenafil costs were from VA pharmacy data through March of fiscal year 2009 and are reported in US dollars. The cost per dose of vardenafil was based on the cost per 30-day equivalent prescription for all strengths of vardenafil (i.e., cost per 30-day prescription divided by 4).

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Although a vast majority of these vardenafil prescriptions were for 20-mg strength tablets, the cost per unit for all strengths was essentially the same. The cost per 30-day equivalent prescription was used because it reflects the routine use of tablet splitting for certain strengths of vardenafil. For example, two 20-mg tablets are dispensed for four 10-mg doses. If the 10-mg dose is not effective, the provider will increase the dose to 20 mg. Because vardenafil is not available as a 40-mg tablet, no tablet splitting would occur for the 20-mg dose. with spinal cord injuries, and in older men.

• Cost analysis shows vardenafil is competitively priced among ED medications.
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We varied the age of the cohort from 40 to 80 in

• Some treatment centers offer vardenafil payment plans for affordability.
• The price of vardenafil can be affected by changes in patent status.
• Lower-cost vardenafil options are available in certain markets with subsidies.

the sensitivity analyses, however, and the

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We varied the cost over a wide range in the sensitivity analyses, however, and the cost per dose had to increase to $15 before the ICER rose above $20,000/QALY gained. Second, we assumed a value of 0.01 for the utility of two additional monthly doses of vardenafil. In this case, there had to be almost no benefit from the additional doses to change the conclusions of our analysis. Third, we did not explicitly model adverse events from vardenafil (e.g., cardiovascular events, priapism). Although including them could increase total costs in the vardenafil groups, the incidence of all serious events was less than 2% in a recent systematic review of PDE5 inhibitors for ED [7]. resulting ICERs did not change much.