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DSHS Formulary Restriction of OxyContin® – A Proposed Policy Analysis. John Pedey-Braswell and Greta Sweney. Washington Medical Assistance Administration’s Formulary Restriction of OxyContin® – A Policy Analysis • As of 11/1/2003, D.S.H.S. will no longer fill OxyContin® prescriptions without prior authorization. Expedited P.A. is available for those patients with chronic cancer pain. • Pharmacies received updated prior authorization lists in mid-October without any accompanying explanation of restriction. • Health care providers sent/delivered list of patients whom they prescribed OxyContin® along with a conversion table for methadone and morphine SR. • Currently, D.S.H.S. is allowing prescriptions to be processed without P.A. due to deluge of phone calls and insufficient staffing – approximate wait time for P.A. was 5 days during first week of November. Why is this restriction necessary? OxyContin® Dose Price/30 days Approximate Morpine SR Dose Price/30 days Approximate Methadone Dose Price/30 days 10mg bid $50.89 15mg bid $25.21 2.5 mg tid to 5mg bid $5.97 or $6.55 20mg bid $93.84 30mg bid $44.11 5mg tid to 10mg bid $7.71 or $7.80 40mg bid $162.00 60mg bid $82.06 5mg qid or 10mg bid $8.88 or $7.80 60mg bid (1x20mg, 1x40mg) $255.84 90mg bid (3x30mg) $123.90 5mg qid or 10mg tid $8.88 or $9.58 80mg bid $294.42 100mg bid or 120mg bid (2x60mg) $119.47 or $159.90 10mg tid to 10mg qid $9.58 or $11.37 160mg bid $457.18 200mg bid (2x100mg) or 240mg (4x60mg) $234.72 or $315.57 10mg qid to 10mg 5 times daily $11.37 or $13.16 Issues Surrounding Opioid Conversion • HMC prescribers long-familiar with using oxycodone 5mg prn. OxyContin® was well-marketed to provide around-the-clock pain relief. • Oxycodone easy to work with: predictable bioavailability and pharmacokinetic profile. No toxic metabolites to worry about in renal failure. • Morphine is more likely to cause excessive-itching due to histamine release, and 6-glucuronide metabolite worrisome in patients with renal disease. • Many prescribers uncomfortable with dosing methadone due to long elimination half-life, and comparatively short duration of analgesic effect. Initial drug accumulation creates opportunities for adverse effects. Potential for drug interactions due to CYP3A4 Ndemethylation. Women may metabolize methadone more quickly than men. • Methadone is stigmatized as maintenance medication for addicts. Methodology • • • • • N=110 HMC Adult Medicine Clinic (AMC) patients with chronic, nonmalignant pain controlled on OxyContin®. Payor blend of D.S.H.S., other third-party insurers and uninsured – clinic pharmacists recommended switching pain regimens for all patients. All patients fill prescriptions at HMC pharmacy. Confidentiality agreement to be filed with UW HSD. Data from PCSI pharmacy database and chart-review. Primary analysis of patient charge data for analgesics from 4/1/03 – 9/30/03 paired with those from 12/1/03 – 5/31/04. Representative search of chronic long-term pain medications including opiates, NSAIDs, non-acetylated salicylates, TCAs, gabapentin, muscle relaxants, lidocaine patches, diazepam and clonazepam used during the two periods. All charges will be adjusted to 4/1/2003 prices. Secondary analyses: clinic, ER, and UCC visits coded for pain during study periods, pain scales administered during AMC visits, SEs, breakthrough pain medication use, patients successfully converted to other therapies, patients willing to pay cash for OxyContin®, and patients lost to follow-up. Attempting to track AMC pharmacist time during November and December 2003. Limitations • Literature suggests equipotent dosing is possible with narcotic analgesics, however the possibility of side-effects, temporary discomfort, and inconvenience to all involved make a CMA impractical. • No warning of policy change. Ideally, we would like to track pharmacy and clinic staff time spent on conversion issues to ensure accurate costing. What expenses does DSHS accrue to implement this change? • Study is not designed to track costs resulting from side-effects (hospitalizations, time off work, etc.). • No time to find and administer quality of life batteries to clinic patients. Retrospective questionnaires will be prone to bias. We cannot determine accurately determine effectiveness or utility of program. • Also, how do we account for stress to pharmacy staff from irate patients? A Possible Measure of Program Success? • OxyContin® billed to DSHS (All HMC Ambulatory Prescriptions): – September 2003 = $11603.25 – November 2003 = $1555.10 • Would like a chance to “fully” analyze a DSHS formulary decision to determine the impact of DSHS’s cost-silo mentality on state pharmacies. • Pharmacy paid $4.22/prescription no matter how much time and effort it takes to fill it. Are we losing money? Questions? Let the Grilling Commence