The Impact of Healthcare Policy Based on Drug Plan Perspective Versus The Ministry of Health Perspective: A Case Study of The Odprn Recommendations of Restricting Reimbursement of Testosterone Replacement Therapy For Hypogonadism In Ontario, Canada.

 The results of this analysis suggest that the reimbursement restriction proposed by the ODPRN would generate additional costs to other areas of the healthcare system.  The burden of the policy change could completely offset savings and generate costs of up to $1 million to the healthcare budget.  No chart review or formal assessment was conducted to demonstrate or quantify inappropriate use of TRT, therefore the conclusion of cost savings forecasted by the ODPRN must be interpreted with caution.  Healthcare policy recommendations based on drug costs alone underestimate the true cost of the Ministry of Health. CONCLUSIONS METHODS  A hybrid epidemiological and claims-based approach was used to forecast the proportion of patients with testosterone deficiency (TD) in Ontario. (Table 1)  The BIA included costs of TRTs and the key cost drivers of physician visits, administering injectable TRTs, testosterone level testing and EAP evaluation and processing. TRT drug costs consisted of average yearly expenditures claimed (IMS Health data).  JSS Medical Research evaluated the ODPRN scenarios with and without inappropriate TRT use over a 3-year period. Option A assumed the statusquo where no change was applied to the current coverage criteria while option B restricted all forms of TRT to the EAP, option C restricted oral and topical forms of TRT only, and option D restricted topical forms of TRT only.  Due to unsubstantiated evidence of inappropriate use, the base case analysis relied on expert opinion, and assumed all users of TRT would qualify. The sensitivity analyses replicated the ODPRN assumptions of inappropriate use, terminating coverage of 46%, 15% and 7% of patients in options B, C and D, respectively.  Historical claims made by Ontario beneficiaries during 2008-2014 were utilized to forecast market growth. (Figure 1)  The ODPRN conducted a BIA from the narrow perspective of prescription drug costs only, driven by the presumption that all formulations of TRT are of equal therapeutic value.  JSS Medical Research replicated the BIA from the perspective of the Ministry of Health including the cost of administering injectable TRTs, laboratory testing, physician visits and EAP evaluation and processing.  Important differences between the ODPRN and JSS Medical Research estimates with respect to budgetary forecasts (up to 6.2M) were observed.  The ODPRN assumed that a high proportion of TRT use was inappropriate, however this was not based on patient chart review or formal assessment. The presence of a claim for testosterone level testing and/or utilization rates from other provinces were used as a proxy for ‘’appropriate’’ use. This method was limited as patients who used testosterone tests not publicly reimbursed, who claimed the tests on a private insurance or paid out-ofpocket would therefore be assumed to inappropriately use TRT.  Another important difference can be attributed to the ODPRN assumption of exponential (or power) growth, which was not supported by more recent public drug plans claims. (Figure 1)  Although less costly from a drug acquisition standpoint, injectable TRT is associated with high physician burden due to arduous administration. Selfadministration, consisting of deep intra-muscular injections of a highly viscous solution and requiring physical force, does not offer a clinically relevant alternative to physician administration. Table 6. Forecasted Number of Users and Expenditures for TRT in 2016, Net Budget Impact per Option. OBJECTIVES: The Ontario Drug Policy Research Network (ODPRN) published recommendations to restrict reimbursement and coverage criteria of testosterone replacement therapy (TRT) in Ontario to the Exceptional Access Program (EAP). The ODPRN’s budget impact analysis (BIA) evaluated the following 4 reimbursement scenarios: no reimbursement change (option A), restricting coverage of all forms of TRT to the EAP (option B), restricting oral and topical forms only (option C), or restricting topical forms only (option D). The analysis assumed exponential growth of TRT expenditures and inappropriate use in 7%-46% of patients and took into consideration drug prescription costs alone, resulting in forecasted savings ranging from $7-$16 million over a 3-year period. JSS Medical Research performed the BIA from the ministry of health perspective. METHODS: Our hybrid epidemiological and claims-based BIA considered both the costs of TRT and key cost drivers associated with reimbursement policy change: physician visits, injectable TRT administration fees, testosterone level testing, and EAP evaluation and processing. Ontario prescription drug expenditures based on claims data, as well as published literature and expert opinion were utilized. We evaluated the impact of the ODPRN scenarios with and without inappropriate TRT use over a 3-year period. RESULTS: Based on the JSS assumption that all patients currently qualify for TRT, and taking into consideration key cost drivers, option B would cost $1.01 million; option C $766,000, and option D $252,000. A sensitivity analysis was undertaken using ODPRN assumptions of inappropriate use, in which JSS Medical Research forecasted savings of $373,000-$13.4 million as opposed to savings of $7-$16 million forecasted by the ODPRN. CONCLUSIONS: ODPRN savings exclude key cost drivers and assume a greater magnitude of inappropriate use. The burden of the policy change could completely offset savings and generate costs of up to $1 million to the healthcare budget. Healthcare policy recommendations based on drug costs alone underestimate the true cost to the Ministry of Health, shifting, and in this case creating additional costs to other areas of the healthcare system.