Charles Agte Medicaid Pharmacy Administrator Health Care Services October 16, 2013

1. Prior Authorization Criteria for PDL Classes:Alzheimer’s Anti-emeticsHigh Potency StatinsHormone Replacement TherapyMultiple Sclerosis – Tysabri Charles Agte Medicaid Pharmacy Administrator Health Care Services October 16, 2013

2. Alzheimer’s Medications Limited to 18 years of age or older • Use in children not supported in FDA labeling. • Use for autism or psychiatric disorders not supported in labeling or compendia. • The previous Medical Director consulted with pediatric psychiatrist at Children’s Hospital who did not support use of these drugs in children.

3. AntiemeticsPreferred ondansetron • Preferred drug (generic ondansetron) on expedited authorization (EA) for non-endorsers • EA required for ensorsers without DAW • EA requirement bypassed if endorser DAW • Criteria is FDA indications • Off-label diagnoses require call or fax for authorization • Limited to maximum dose 24 mg/day

4. Antiemetics - Nonpreferred • OHSU studied and DUR Board reviewed products not subject to criteria when written DAW by endorser • Criteria applies for unstudied products by any prescriber, or non-preferreds by non-endorsers • If prescribed by an endorser without DAW, therapeutic interchange applies

5. Antiemetics - Nonpreferred • Aloxi: Administered as a single dose in conjunction with cancer chemotherapy treatment. • Anzemet: Prevention of nausea or vomiting associated with moderately to highly emetogenic cancer chemotherapy • Granisetron/Kytril/Granisol: Prevention of nausea or vomiting associated with moderately to highly emetogenic cancer chemotherapy.Prevention of nausea or vomiting associated with radiation therapy. • Sancuso: Prevention of nausea or vomiting associated with moderately to highly emetogenic cancer chemotherapy.

6. Statins • Previously approved as a Generics First drug class • Tried and failed a preferred drug • If branded high-potency (Crestor or Lipitor) and new start in class, must show need for ≥ 30% reduction in LDL from baseline

7. Multiple Sclerosis - Tysabri • PA for safety • Black box waring regarding PML • Restricted distribution program (REMS) called the TOUCH Prescribing Program

8. Multiple Sclerosis - Tysabri Indications: • Monotherapy for relapsing forms of multiple sclerosis. Generally recommended for patients who have had an inadequate response to, or are unable to tolerate an alternate MS therapy. • Moderate to severe Crohn’s disease with evidence of inflammation in patients who have had inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α . Should not be used in combination with immunosuppressants or inhibitors of TNF-α

9. Multiple Sclerosis - Tysabri Authorization criteria: • FDA approved diagnosis, • FDA approved dosing • Previously tried other alternatives • Patient and physician are enrolled with TOUCH Prescribing Program. • Patient is not immunocompromised

10. Multiple Sclerosis - Tysabri Authorization criteria: For MS only: • MRI before start of therapy. • Monotherapy • Prescriber is neurology specialty

11. Multiple Sclerosis - Tysabri Authorization criteria: For Crohn’s only: • No corticosteroids or corticosteroids are being tapered. • No other immunosuppressants of TNF inhibitors. • Prescriber is gastroenterology specialty • 3 month authorization given initially. After first 3 months prescriber is faxed for documentation of clinical benefit from Tysabri therapy. After first 6 months the prescriber is faxed to document that they are no longer on corticosteroids.

12. Hormone Replacement Therapy • Preferred generic options • Significant utilization of branded products • Consider requiring generic trial for new starts

13. Source of Criteria • Current criteria in these drug classes was established through HCA’s internal Drug Evaluation Matrix Committee, prior to selection as PDL classes • Not previously brought to the DUR Board under Authorization program because criteria are specific to FDA labeling and use of less costly alternatives

14. Questions? Clinical questions specific to Newer Anticoagulants?

15. Agency Recommendations • Alzheimer’s • Support restriction to require prior authorization when prescribed to children • Antiemetics • Remove expedited authorization requirements from preferred generic ondansetron • Enforce Expedited Authorization requirements for non-preferred products when written DAW

16. Agency Recommendations • High Potency Statins • Under generics first, continue to require justification of need for a high potency agent • Tysabri • Maintain current authorization criteria for safetu • Hormone Replacement Therapy • Apply Generics First

17. Stakeholder Input • Alzheimer’s • Antiemetics • High Potency Statins • Tysabri • HRT

18. Motions • Alzheimer’s • Antiemetics • High Potency Statins • Tysabri • HRT

19. Questions? More Information: http://www.hca.wa.gov/medicaid/billing/pages/prescription_drug_program.aspx or http://www.hca.wa.gov/medicaid/pharmacy/Pages/index.aspx Charles Agte Medicaid Pharmacy Administrator Health Care Services charles.agte@hca.wa.gov Tel: 360-725-1301