prior authorization criteria for pdl classes: alzheimer’s anti-emetics high potency statins...

Prior Authorization Criteria for Prior Authorization Criteria for PDL Classes:PDL Classes:

Alzheimer’s Alzheimer’s Anti-emeticsAnti-emetics

High Potency StatinsHigh Potency StatinsHormone Replacement TherapyHormone Replacement Therapy

Multiple Sclerosis – TysabriMultiple Sclerosis – Tysabri

Charles AgteMedicaid Pharmacy AdministratorHealth Care ServicesOctober 16, 2013

Alzheimer’s MedicationsAlzheimer’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.

2

AntiemeticsAntiemeticsPreferred ondansetronPreferred 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

3

Antiemetics - NonpreferredAntiemetics - 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

4

Antiemetics - NonpreferredAntiemetics - 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.

5

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

6

Multiple Sclerosis - Tysabri

• PA for safety• Black box waring regarding

PML• Restricted distribution

program (REMS) called the TOUCH Prescribing Program

7

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

8

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

9

Multiple Sclerosis - Tysabri

Authorization criteria: For MS only: •MRI before start of therapy. •Monotherapy•Prescriber is neurology specialty

10

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.

11

Hormone Replacement Therapy

• Preferred generic options• Significant utilization of

branded products• Consider requiring generic

trial for new starts

12

Source of CriteriaSource 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

13

Questions?Questions?

Clinical questions specific to Newer Anticoagulants?

14

Agency RecommendationsAgency 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

15

Agency RecommendationsAgency 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

16

Stakeholder InputStakeholder Input

• Alzheimer’s• Antiemetics• High Potency Statins• Tysabri• HRT

17

MotionsMotions

• Alzheimer’s• Antiemetics• High Potency Statins• Tysabri• HRT

18

Questions?Questions?

More Information:http://www.hca.wa.gov/medicaid/billing/pages/prescription_drug_program.aspx orhttp://www.hca.wa.gov/medicaid/pharmacy/Pages/index.aspx

Charles AgteMedicaid Pharmacy AdministratorHealth Care Servicescharles.agte@hca.wa.govTel: 360-725-1301

19