1. 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

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. 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

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. 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: Charles Agte or
Charles Agte
Medicaid Pharmacy Administrator
Health Care Services
Tel: