Prior Authorization Criteria for PDL Classes: Alzheimer’s Anti-emetics High Potency Statins Hormone Replacement Therapy Multiple Sclerosis – Tysabri Charles Agte Medicaid Pharmacy Administrator Health Care Services October 16, 2013

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.

Antiemetics Preferred 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

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

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.

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

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

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

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

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

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.

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

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

Clinical questions specific to Newer Anticoagulants?

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

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

Stakeholder Input Alzheimer’s Antiemetics High Potency Statins Tysabri HRT

Motions Alzheimer’s Antiemetics High Potency Statins Tysabri HRT

Questions? More Information: Charles Agte 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