Page 1 Recording of this session via any media type is strictly prohibited. Opioids in Workers’ Compensation: PBM Solutions

Page 2 Recording of this session via any media type is strictly prohibited. The material in today’s presentation is based on the training and professional experience of the presenters, and is not intended to represent the opinions or policies of the City of Denver or Midwest Employers Casualty Company.

Page 3 Recording of this session via any media type is strictly prohibited. Ray Sibley Director of Risk Management City and County of Denver Marcos Iglesias MD, MMM, FAAFP, FACOEM Medical Director Midwest Employers Casualty Company Broad WC experience as treater, medical director, PBM director and others

Page 4 Recording of this session via any media type is strictly prohibited. What to Expect A review of the opioid problem in WC Latest developments - Zohydro ER, Moxduo CR PBM as gatekeeper Opioid strategies Patient opioid education as part of the strategy What to look for in a PBM

Page 5 Recording of this session via any media type is strictly prohibited. Opioids Opium (1500 BC) Morphine (1804) Codeine (1832) Heroin (1874) Dihydrocodeine (1908) Oxycodone (1916) Hydrocodone (1920) Hydromorphone (1924) Methadone (1937) Fentanyl (1960) Tramadol (1977) Buprenorphine (1980) Oxycodone ER (1996) Zohydro ER (March 2014)

Page 6 Recording of this session via any media type is strictly prohibited. Daily MED Morphine equivalence dose (MED) Fentanyl 100X more potent than morphine 10 morphine = 10 hydrocodone =7 oxycodone = 70 codeine

Page 7 Recording of this session via any media type is strictly prohibited. Scope of the problem 254 M opioid prescriptions: Enough to “medicate every American adult around the clock for a month” 16,500 deaths from overdose More than for all illegal drugs combined 285% increase (2000 – 2010) 32 ED visits for adverse effects per death CDC, 2011

Page 8 Recording of this session via any media type is strictly prohibited. Costs: WC

Page 9 Recording of this session via any media type is strictly prohibited. Costs: WC Use of a short acting opioid: 3X cost Use of a long acting opioid: 9X cost Older claims: up to 40% of medical cost NCCI, 2011

Page 10 Recording of this session via any media type is strictly prohibited. Costs: California Off work 3.6X longer 60% higher litigation rates Claim costs 2X more expensive WCRI, 2013

Page 11 Recording of this session via any media type is strictly prohibited. Adverse effects Itching Nausea/Vomiting Drowsiness Euphoria Constipation Bowel obstruction Depression Addiction Immune system Endocrine system Decreased sex drive Hyperalgesia Respiratory depression Death

Page 12 Recording of this session via any media type is strictly prohibited. Safety: MED Many have chosen 120 mg as a “red flag” Washington State: 120 mg Connecticut: 90 mg Ohio: 80 mg ACOEM Opioid Guidelines (2014): 50 mg

Page 13 Recording of this session via any media type is strictly prohibited. Safety: Other drugs Central nervous system (CNS) depressants Alcohol Benzodiazepines Sedatives

Page 14 Recording of this session via any media type is strictly prohibited. Evidence for use Little-to-none Short-term studies (1 to 4 months) Most are funded by industry High dropout rates Studies exclude patients with mental and substance abuse disorders

Page 15 Recording of this session via any media type is strictly prohibited. Zohydro ER Zogenix, Inc. Extended release pure hydrocodone – no APAP No abuse deterrent properties Capsules: 10, 15, 20, 30, 40 and 50 mg AWP $7.02 to $8.58

Page 16 Recording of this session via any media type is strictly prohibited. Zohydro ER Black Box Warning Abuse potential Life threatening respiratory depression Accidental fatal overdose, esp. in children Potential for neonatal opioid withdrawal syndrome Avoid alcohol

Page 17 Recording of this session via any media type is strictly prohibited. Zohydro ER: Concerns Do we need another opioid? No abuse deterrent properties Under the direction of Dr Margaret Hamburg the FDA went against its own advisory committee recommendation (11 to 2) when it approved Zohydro ER

Page 18 Recording of this session via any media type is strictly prohibited. Zohydro ER: Clinical Trials 302 subjects randomized to Zohydro ER or placebo 12 weeks Looking for 30% reduction in pain 67.5% vs. 31.1%

Page 19 Recording of this session via any media type is strictly prohibited. Other Purdue developing an extended release hydrocodone to compete with Zohydro ER Moxduo CR Combination morphine – oxycodone Rejected last week by an FDA advisory committee

Page 20 Recording of this session via any media type is strictly prohibited. Multi-stakeholder solutions IWMDPBMPAYER

Page 21 Recording of this session via any media type is strictly prohibited. PBM: Gatekeeper Formulary design Step therapy Real-time DUR (prospective) Prior authorization process Drug review (retrospective) Monitoring and identification of risk Data Education

Page 22 Recording of this session via any media type is strictly prohibited. Formulary Right drug for the right patient List of drugs that will be automatically filled State specific Acute vs chronic Injury specific Claimant specific

Page 23 Recording of this session via any media type is strictly prohibited. Step therapy Requires the use of a certain drug before escalating to another, more expensive or dangerous drug

Page 24 Recording of this session via any media type is strictly prohibited. Drug utilization review (DUR) Correct doses Early refills Duplicate fills Quantities Dangerous combinations Multiple or unauthorized prescribers or pharmacies Formulary Step therapy

Page 25 Recording of this session via any media type is strictly prohibited. Prior authorization Rx at pharmacy  Trigger  Rejection  P/A alert to payer  Decision  Action Time-sensitive Requires knowledge on part of the adjuster

Page 26 Recording of this session via any media type is strictly prohibited. Time sensitive Avoid frustration at pharmacy Avoid use of a third party payer P/A to NCM or UR department? Is the p/a alert truly real time? Is it batched (30+ minute delay)?

Page 27 Recording of this session via any media type is strictly prohibited. Knowledge and decision support Adjusters are not pharmacists or clinicians Educational and informational support Internal (NCM, MD, UR) and external Does the PBM help the payer make a good decision?

Page 28 Recording of this session via any media type is strictly prohibited. Prior authorization BENEFITS: Multiple user roles streamline the process Team collaboration Increased efficiency for nurses who data sift for potential abuse cases

Page 29 Recording of this session via any media type is strictly prohibited. E-Prescribing Point of care management Formulary integration Medication history Letter of medical necessity BENEFITS: Can eliminate prior authorizations at the pharmacy Patient safety Lower drug costs

Page 30 Recording of this session via any media type is strictly prohibited. PBM: Opioid interventions Risk identification Patterns Long acting opioids MED threshold Injured worker education Prescriber intervention

Page 31 Recording of this session via any media type is strictly prohibited. PBM: Prescriber education Assessment of function Use of PDMP Prescription Drug Monitoring Program Opioid agreement Urine drug screening Weaning

Page 32 Recording of this session via any media type is strictly prohibited. PBM: Peer interventions Pharmacist and peer review Peer interaction Alternatives Weaning Opioid detox Other interventions: CBT / FRP

Page 33 Recording of this session via any media type is strictly prohibited. Case Study: Alerts Alerts triggered Excessive duration of use Concurrent use of opioid and sedative Action Opioid program enrollment

Page 34 Recording of this session via any media type is strictly prohibited. Case Study: Clinical Interventions Letter sent to physician IW education sent Client enrolled in opioid management program Physician letter, opioid progress report, pain agreement, drug testing and medication history sent

Page 35 Recording of this session via any media type is strictly prohibited. Case Study: Outcomes Opioid and zolpidem discontinued Reduced risk of sedation Reduced risk of OD risk Savings > $2,500 annually

Page 36 Recording of this session via any media type is strictly prohibited. Typical results 38% reduction in opioid utilization (MED) 19% reduction in cost 12-13% of IWs are weaned 14% referral to an appropriate pain specialist

Page 37 Recording of this session via any media type is strictly prohibited. Main cost drivers in WC pharmacy 1.Cost of the drug 2.UTILIZATION – especially opioids PBM strategy Medical network Utilization review Physician education and intervention Injured worker education

Page 38 Recording of this session via any media type is strictly prohibited. What to look for in a PBM 1.What type of clinical programs do you have to monitor utilization management? Alerts Prospective review Retrospective review Patient education Prescriber education Opioid management programs Clinician reviews

Page 39 Recording of this session via any media type is strictly prohibited. What to look for in a PBM 2.Are your prior authorization alerts truly real time? 3.Can we customize who you send them to? 4.Do you have mobile apps for these? 5.How do you alert the adjuster about potential abuse? 6.How do you communicate with prescribers? With injured workers?

Page 40 Recording of this session via any media type is strictly prohibited. What to look for in a PBM 7.What tools do you use in managing opioids and other potentially harmful medications? 8.How will you educate my staff? 9.How will you keep me up to date on clinical and regulatory issues that affect my ability to manage opioids and other prescriptions?

Page 41 Recording of this session via any media type is strictly prohibited. Questions, Final Comments and Contact Information Ray Sibley – Marcos Iglesias MD – ask for patient education brochure

Page 42 Recording of this session via any media type is strictly prohibited. KEEP THIS SLIDE FOR EVALUATION INFORMATION/MOBILE APP ETC. Please complete the session survey on the RIMS14 mobile application.