p t 8-29-13 minutes final 2 - partnershiphp.org committee 8-29-13min… · oct 2013 oct 2013 page 7...

PARTNERSHIP HEALTHPLAN OF CALIFORNIA

MEETING MINUTES of 7

Committee: Pharmacy & Therapeutics (P&T) Date / Time: August 29, 2013, 7:30 – 10:00am Members Present:

Tom Gracia, Pharm.D. Thomas Paukert, MD Kirsten Balano, Pharm.D. Kathy DeMaggio, RD, CDE David R. Gilliam, MD Richard Forde, MD Cristie Pellegrini, PharmD (TC) Peter Stuart, MD – Sonoma County Indian Health Project (TC)*

PHC Staff Present

Robert Moore, MD, MPH Gary Louie, Pharm.D. (Chair) Mark Glickstein, MD Marshall Kubota, MD * Richard Fleming, MD Michael Vovakes, MD David Crawford, MD Jeffery Ribordy, MD, MPH* Peggy Hoover, R.N.

Diane Wong, Pharm.D. Ominder Mehta, Pharm.D. Tina Ishida, Pharm.D. Lynette Rey, Pharm.D. Marlana Ogawa, Pharm.D. Jeannie Ngo, Pharm.D. Dina Haynes, CPhT Lynn Scuri, MPH* (TC)

Members Absent:

David Godwin, MD M. Tracy Johnson, MD

Members Excused:

*via Teleconference (TC)

AGENDA

ITEM DISCUSSION / CONCLUSIONS RECOMMENDATIONS / ACTION TARGET

DATE DATE

RESOLVED Quorum I. Approval of

Minutes II. Standing

Agenda Items 1. PHC Update

Robert Moore, MD, MPH reported that the Pharmacy QIP plan was approved by the Board. He explained that the program consists of a series of measures that pharmacies will report on and at the end of the year may be rewarded dependent on the quality of their measures. Dr. Moore also advised that the 340B policy for primary care practices is currently being revised with emphasis to insure that all the reporting occurs.

Committee Quorum requirements met.

Minutes of the 4/4/13 meeting were approved.

For Information only. No action required.

8/29/13

2. PHC Formulary:

Proposed Additions/ Changes

The following were presented for PHC formulary review: Medi-Cal, Healthy Kids and Healthy Families formulary:

• Ciclesonide (Alvesco) • Levalbuterol (Xopenex

HFA) MDI • Levalbuterol Nebulizer

soln. (Xopenex) • Budesonide Nebulizer

soln. (Pulmicort Respules)

• Mometasone Furoate/Formoterol Fumarate (Dulera)

• Budesonide/ Formoterol Fumarate

• Fluticasone Propionate/Salmeterol Xinafoate (Advair Diskus)

• Fluticasone Propionate/Salmeterol Xinafoate (Advair HFA MDI)

• Zileuton (Zyflo, Zyflo CR)

• Zafirlukast (Accolate) • Montelukast (Singulair) • Abatacept (Orencia)

Adalimumab (Humira)

• Anakinra (Kineret) • Certolizumab

(Cimzia) • Etanercept

(Enbrel) • Infliximab

(Remicade) • Golimumab (Simponi) • Rituximab (Rituxan) • Sodium Hyaluronate

(Hyalgan)/Fidia, (Supartz) • Escitalopram (Lexapro) • Desvenlafaxine ER tablets

(Pristiq)

• Duloxetine (Cymbalta) • Vilazodone (Viibryd) • Rizatriptan (Maxalt) • Naratriptan (Amerge)

Tablets • Zolmitriptan tablets

(Zomig) • Zolmitriptan,disintegrating

tab (Zomig-ZMT) • Rizatriptan, oral

disintegrating tabs (Maxalt MLT)

• Almotriptan tablets (Axert)

• Eletriptan tablets (Relpax)

• Frovatriptan tablets (Frova)

• Zolmitriptan Nasal (Zomig Nasal Spray)

• Hydrocodone-APAP (Norco)

• Megestrol Suspension (Megace)

• Pazopanib (Votrient) • Tamsulosin (Flomax) • Levetiracetam extended

release tablets (Keppra XR) • Irbesartan (Avapro) • Irbesartan-HCTZ

(Avalide) • Atorvastatin (Lipitor) • Amox/Lansoprazole/Clarit

hromycin (Prevpac) • Clomipramine (Anafranil) • Lansoprazole disintegrating

tab (Prevacid SoluTab) • Tadalafil (Cialis) • Dextromethorphan 20mg/

Quinidine Sulfate 10mg (Nuedexta)

Added to Formulary: Restrictions:

Ciclesonide (Alvesco) QL 1 unit/mo

Escitalopram (Lexapro)

Rizatriptan, oral disintegrating tabs (Maxalt MLT)

QL, 12/mo

Naratriptan (Amerge) tablets

QL, 9/mo; STE: prior use of Imitrex or Maxalt

Hydrocodone-APAP (Norco) 7.5-325mg tab

QL 8/day

Megestrol Suspension (Megace)

QL 20ml/day

Pazopanib (Votrient) QL 4/day, 2 wk supply, specialty phcy

Tamsulosin (Flomax) Levetiracetam ER tabs (Keppra XR)

Deleted from Formulary: Criteria Added:

Budesonide Neb. Soln. 0.25, 0.5mg

See prior authorization criteria

Prevpac none Clomipramine (Anafranil)


Advair Diskus See prior authorization criteria

Remains

on Formulary: With Changes:

Zafirlukast (Accolate) STEP chg from ICS to montelukast

Montelukast (Singulair)

STEP requirements removed

Irbesartan (Avapro) Removed STEP & QL

Irbesartan-HCTZ (Avalide) Removed STEP & QL

Atorvastatin (Lipitor) Removed STEP & QL

Target Date

10/15/13 unless noted

otherwise Escitalopram

added 8/31/13

Deletions effective 1/1/2014

Effective 8/31/13

3. Prior

Authorization Criteria

Prior Authorization Criteria additions/changes were presented for the following drugs: Medi-Cal and Healthy Kids: • Budesonide Neb.

Soln. • Fluticasone

Propionate/Salmeterol Xinafoate

• Tofacitinib • Tadalafil 5mg • Levalbuterol HFA • Levalbuterol

Nebulizer Solution • Mometasone

Furoate/Formoterol Fumarate

• Budesonide/ Formoterol Fumarate

• Etanercept • Adalimumab • Rituximab • Abatacept • Anakinra • Certolizumab

Tablets

• Infliximab • Golimumab • Sodium

Hyaluronate • Desvenlafaxine ER • Vilazodone • Duloxetine • Rizatriptan • Almotriptan • Eletriptan • Frovatriptan • Zolmitraptan • Prevpac • Prevacid Solutab • Nuedexta • Sumatriptan • Montelukast • Zafirlukast • Zileutron

Remains Non Formulary:

Criteria Added/Revised :

Budesonide Neb. Soln. 1mg (Pulmicort)


Fluticasone Propionate/Salmeterol Xinafoate (Advair HFA MDI)


Tofacitinib Citrate (Xeljanz)


Tadalafil (Cialis) See prior authorization criteria

Levalbuterol (Xopenex HFA) MDI


Levalbuterol Nebulizer soln. (Xopenex)


Etanercept (Enbrel) See prior authorization criteria

Adalimumab (Humira)


Rituximab (Rituxan)/


Abatacept (Orencia) See prior authorization criteria

Anakinra (Kineret) See prior authorization criteria

Certolizumab (Cimzia)


Infliximab (Remicade)


Golimumab (Simponi)


Sodium Hyaluronate (Hyalgan, Supartz)


Desvenlafaxine ER tablets (Pristiq)


Vilazodone (Viibryd) See prior authorization criteria

Duloxetine (Cymbalta)


New & Revised Criteria effective

9/12/2013 for items currently

NF

Rizatriptan ( Maxalt MLT)


Almotriptan tablets (Axert)


Eletriptan tablets (Relpax)


Frovatriptan tablets (Frova)


Zolmitriptan tablets (Zomig, Zomig ZMT, Zomig Nasal)


Lansoprazole ODT (Prevacid Solutab)


DM/Quinidine (Nuedexta)


Zileuton (Zyflo) See prior authorization criteria

On Formulary, with Criteria added for request

exceeding limits

Sumatriptan (Imitrex) See prior authorization criteria

Rizatriptan (Maxalt) See prior authorization criteria

Montelukast (Singulair tabs, chew)


Zafirlukast (Accolate)


Mometasone Furoate/Formoterol Fumarate (Dulera)


Budesonide/ Formoterol Fumarate (Symbicort)


Effective 9/12/13

III. Old Business 1. ADHD:

Pediatric preferential products/ implementation for expansion

2. Erythropoiesis

Stimulating Agents (ESA):

Reinstatement of long-acting methylphenidate products and mixed amphetamine salt products that were previously approved for step edit protocol Jan 2013 P & T but later denied by PAC in favor of implementing a preferred provider program. Implementing provider program has been delayed, so to ease transition of expansion counties to preferred long acting products, Step edits have been implemented as previously approved for generic Concerta, Ritalin LA, Metadate CD and Adderall XR. The following were presented and reviewed: • Methylphenidate CD (Metadate CD) • Methylphenidate LA (Ritalin LA) • Methylphenidate ER/OSM (Concerta) • Mixed Amphetamine Salts ER (Adderall XR) • Guanfacine ER (Intuniv) • Clonidine ER (Kapvay)

In addition Prior Authorization Criteria changes were presented for the following drugs: • Dexmethylphenidate ER (Focalin XR) • Lisdexamphetamine (Vyvanse) • Methylphenidate Patch (Daytrana)

Continued discussion regarding FDA advisory to lower the target Hgb for both treatment initiation and maintenance with ESA agents for patients with CKD, not on hemodialysis. Recommendation to lower the target Hgb is based on increased risk of cardiovascular events when higher doses are used to maintain higher Hgb levels. P & T Committee approved tx initiation to change from <11 to <10.5. Also approved goal to maintain </=11, rather than 11-12. See PA criteria for additional details. The following products were reviewed: • Epoetin alpha (Procrit) • Darbepoetin (Aranesp)

Added to Formulary: Restrictions:

Methylphenidate CD (Metadate CD)

QL 1/day, Age 4-17, Step; See prior authorization criteria.

Methylphenidate LA (Ritalin LA)


Methylphenidate ER/OSM (Concerta)


Mixed Amphetamine Salts ER (Adderall XR)


Remains Non-formulary

Guanfacine ER (Intuniv)

No change to existing status or criteria

Clonidine ER (Kapvay)

No change to existing status or criteria

Remains Non-formulary

Criteria Revised :

Epoetin alpha (Procrit) See prior authorization criteria

Darbepoetin (Aranesp) See prior authorization criteria

Effective 9/12/13

Effective 9/12/13

IV. New Business 1. MPRP4001

Pharmacy & Therapeutics Committee Policy

2. Implementatio

n of CMS Overutilization Monitoring

3. 2014

Partnership Advantage Formulary

V. Additional

Items VI. Pharmacy

Operating Report

1. 2Q2013 Report

to PHC Senior Management – August 1, 2013

VII. Adjournment

Updates to Policy Functions section J.1.b ( interim formulary update process) and J.1.h (drug/product not a benefit) were reviewed with committee. Clarification was suggested with Drugs not approved by the Food and Drug Administration ( FDA) for the treatment or diagnosis of any medical condition. Defer to next P&T meeting Defer to next P&T meeting The meeting was adjourned at 10am.

Submitted by Sonya Bell

The following change was approved to section J.1.h. The following types of products are not a benefit for PHC Medi-Cal or Healthy Kids members and are not included on the PHC Formulary or available by a Treatment Authorization Request (TAR), regardless of whether PHC is the secondary or primary payer: • Drugs not approved by the Food and Drug Administration (FDA) for the treatment or diagnosis of any medical condition. This does not preclude those drugs with an approved FDA indication used with “off label” indications.

For information only. No action required

Oct 2013 Oct 2013

Page 7 for Signature only

8-29-13 P & T FORMULARY PROPOSED ADDITIONS/CHANGES: Applies to Medi-Cal, Healthy Kids (ages 0-18) as indicated. below. Effective: 10/15/13 (unless otherwise noted) Drug

(Brand)/Manufacturer Class Reviewed

Indication $/Rx Current

Status Proposed

Status Applies

To Comments

Ciclesonide (Alvesco)/ Sunovion Pharmaceuticals

Inhaled Corticosteroid (ICS)

Asthma $208 NF F MC, HK 1Q13-2Q13: Class total $1,693,548, ave $168/Rx. Alvesco: $1,262. (78 Rx)

Levalbuterol (Xopenex HFA) MDI/ Sunovion Pharmaceuticals

Short-Acting Beta-Agonist (SABA)

Asthma $58 NF NF MC, HK 1Q12-4Q12: Total $23,000, 434Rx See prior authorization criteria. Effective 9/12/13 Formulary alternative: Ventolin HFA = $47.86

Levalbuterol Nebulizer soln. (Xopenex)/ Various

SABA Asthma $130 NF NF MC, HK 24 vials per Rx, MAC, 1Q12-4Q12: Total cost: $92,317. # Rx: 379. See prior authorization criteria. Effective 9/12/13

Budesonide Nebulizer soln. (Pulmicort Respules)/Various 0.25mg & 0.5mg

ICS Asthma $600 F, Age <9 NF MC, HK 1200 Rx in 2012, $720K See prior authorization criteria. Effective 1/1/14.

Budesonide Nebulizer soln (Pulmicort Respules)/AstraZenica

ICS Asthma $900 NF NF MC, HK 33 Rx in 2012 See prior authorization criteria. Effective 9/12/13

Mometasone Furoate/Formoterol Fumarate (Dulera)/ Merck/Dohme

ICS/Long-Acting Beta-Agonist (LABA)

Asthma $268 F, ST F, ST MC, HK No change in status: Prior paid claim for ICS in the last 180 days. See prior authorization criteria, if step requirement not met. Effective 9/12/13

Budesonide/ Formoterol Fumarate (Symbicort)

ICS/LABA Asthma $260 F, ST F, ST MC, HK No change in status: Prior paid claim for ICS in the last 180 days. See prior authorization criteria, if step requirement not met. Effective 9/12/13

Fluticasone Propionate/Salmeterol Xinafoate (Advair Diskus)/ GSK

ICS/LABA Asthma $258-422 F, ST NF MC, HK 1Q12-4Q12: Total: $2,200,000; 8500 Rx. See prior authorization criteria. Effective 1/1/14.

Fluticasone Propionate/Salmeterol Xinafoate (Advair HFA MDI)/GSK

ICS/LABA Asthma $258-422 NF NF MC, HK Increase cost from lower to higher strength. See prior authorization criteria. Effective 9/12/13

8-29-13 P & T FORMULARY PROPOSED ADDITIONS/CHANGES: Applies to Medi-Cal, Healthy Kids (ages 0-18) as indicated. below. Effective: 10/15/13 (unless otherwise noted)

Zileuton (Zyflo, Zyflo CR)/ Cornerstone Therapeutics

Leukotriene inhibitor (5-Lipoxygenase inhibitor)

Asthma $1900 NF NF MC, HK See prior authorization criteria. Effective 9/12/13

Zafirlukast (Accolate) Various

Leukotriene Receptor Antagonist (LTA)

Asthma $90 F, ST F, ST MC, HK 200 rx for 2012, MAC pricing. STEP Edit: requires claim for montelukast in last 120 days. (Previously only required ICS). Effective 1/1/14.

Montelukast (Singulair)/ Various Tablets, chewable (granules remain non-formulary)

Leukotriene Receptor Antagonist (LTA)

Asthma $12-17 F, ST F MC, HK Remove step requirements. MAC: $0.43/tab-$0.59/chewable.

Tofacitinib (Xeljanz)/Pfizer Immunomodulator RA $2466/mo NF NF MC, HK See prior authorization criteria. Effective 9/12/13

Etanercept (Enbrel)/Immunex

Immunomodulator RA $2836/mo NF NF MC, HK See prior authorization criteria. Effective 9/12/13

Adalimumab (Humira)/Abbvie


Rituximab (Rituxan)/Genentech


Abatacept (Orencia)/BMS Immunomodulator RA $2681/mo NF NF MC, HK See prior authorization criteria. Effective 9/12/13

Anakinra (Kineret)/SOBI Immunomodulator RA $3096/mo NF NF MC, HK See prior authorization criteria. Effective 9/12/13

Certolizumab (Cimzia)/UCB Immunomodulator RA $2664/mo NF NF MC, HK See prior authorization criteria. Effective 9/12/13

Infliximab (Remicade)/Janssen

Immunomodulator RA $1500-5000/mo

NF NF MC, HK See prior authorization criteria. Effective 9/12/13

Golimumab (Simponi)/Janssen

Immunomodulator RA $3042 SQ $2760 IV

NF NF MC, HK See prior authorization criteria. Effective 9/12/13

Sodium Hyaluronate (Hyalgan)/Fidia, (Supartz)/Smith &Nephew

Hyaluronic Acid derivative

OA (Knee) $1000 NF NF MC See prior authorization criteria. Effective 9/12/13

Escitalopram (Lexapro)/Various

Antidepressant/ SSRI MDD, GAD $10 NF F MC, HK Add to formulary, no restrictions. MAC for all strengths=0.34320/tab.


Desvenlafaxine ER tablets (Pristiq)/Wyeth

SNRI MDD $200

NF NF MC, HK See prior authorization criteria. Effective 9/12/13 Formulary Alternative(s): SSRI <$5/mo Mirtazapine <$10 Venlafaxine XR <$15 Bupropion XL <$25


SNRI MDD $200

NF NF MC, HK


SNRI MDD $200

NF NF MC, HK

Sumatriptan tablets (Imitrex)/Various

Vascular 5-HT inhibitor

Migraine treatment

$15

F, QL F, QL MC, HK Qty limit 9/mo (mfg states safety/efficacy of tx’ing of > 4 HA /mo has not been studied –true for all triptans). See PA criteria for requests > 9/mo.

Rizatriptan (Maxalt) /Various


Migraine treatment

$28 (MAC

$2.36/tab)

NF F, QL MC, HK Qty limit 12/mo (smallest package size). Formulary Alternative(s): Sumatriptan = $1.41/tab

Naratriptan (Amerge) tablets/Various


Migraine treatment

$65 (9)

NF F, STE, QL MC, HK Step Edit: Prior use of Sumatriptan or Rizatriptan in the last 120 days Qty Limit: 9 per month (smallest package size). Utilization data, 1Q13-2Q13: total $1,906 paid, 32 Rxs (low utilization). Formulary Alternative(s): Sumatriptan = $1.41/tab

Zolmitriptan tablets (Zomig)/Various Vascular 5-HT

inhibitor

Migraine treatment $152 (#12) NF NF MC, HK

See prior authorization criteria. Effective 9/12/13 Formulary Alternative(s): Sumatriptan = $1.41/tab (Rizatriptan $2.36, Naratriptan $7.76)

Zolmitriptan, disintegrating tab (Zomig-ZMT)/Various


Migraine treatment $155 (#12) NF NF MC, HK See prior authorization criteria.

Effective 9/12/13

Rizatriptan, oral disintegrating tabs (Maxalt MLT) /Various


Migraine treatment $290 (#12) NF NF MC, HK

See prior authorization criteria. Effective 9/12/13

Almotriptan tablets (Axert)/Janssen



Effective 9/12/13

Eletriptan tablets (Relpax)/Roerig



Effective 9/12/13


Frovatriptan tablets (Frova)/Endo


Migraine treatment

$370 (#9) NF NF MC, HK See prior authorization criteria.

Effective 9/12/13

Zolmitriptan Nasal (Zomig Nasal Spray)/Impax


Migraine treatment

$258 (6 sprays) NF NF MC, HK See prior authorization criteria.

Effective 9/12/13

Hydrocodone-APAP (Norco)/Various 7.5-325mg tab

Opioid Analgesic (C-III)

Pain $29 (#100)

NF F, QL, Age MC, HK QL: 240/mo Age limit: 18. Safety & efficacy in pediatric patients has not been established. Formulary Alternative: 5/325 & 10/325 = $27 (#100) Addition to formulary will provide alternative to high-cost non-Formulary Alternative(s): 7.5/300 = 2.44

Megestrol Suspension (Megace)/Various 40mg/ml oral susp.

Progesterone derivative

Appetite Enhancement/ Stimulation

$60 (600ml) NF F, QL MC Originally formulary, then in 2006 was removed for purposes of screening for Medicare coverage; however, now MedImpact blocks at POS if member has Medicare (Part D/B elig drug). Recommend add with QL 600ml/30d, to provide 800mg/day (max rec dose). Formulary alternative: Tablet equivalent (40mg): 20 tabs/day=$141/mo (vs 600ml, $60/mo for suspension).

Pazopanib (Votrient)/GSK

Tyrosine kinase inhibitor

Advanced Renal Cell Carcinoma

$3,354 (2 wk Rx) Cost per

day: $239

NF F, QL MC Limit 4 per day & 2 wk supply for first 2 mo of treatment. Formulary Alternatives: Sutent = $270/day Nexavar = $328/day Requires Diplomat Specialty Pharmacy; (Diplomat $ limit claim exempt)

Tamsulosin (Flomax)/Various

Alpha-1 blocker BPH <$10 NF F MC MAC-$0.25/cap

Levetiracetam extended release tablets (Keppra XR)/various

Antiepileptic Epilepsy $70 NF F MC MAC 500mg 0.57, 750mg 0.85. 6 mo Utilization: 32 Rxs, all 500mg ER. Class average=$44/Rx.

Irbesartan (Avapro)/Various Antihypertensive/ARB Hypertension, DM Nephropathy

$10 F, ST, QL F MC, HK Remove Step & ½ tab limitation


Irbesartan-HCTZ (Avalide)/Various

Antihypertensive/ARB Hypertension $15-20 F, ST, QL F MC, HK Removed Step & ½ tab limitation

Atorvastatin (Lipitor)/Various

HMG-CoA reductase inhibitor

Prevention of CVD, Hyper-lipidemia

$10 F, ST, QL F MC, HK Remove step & ½ tab limitation

Amox/Lansoprazole/Clarithromycin (Prevpac)/Takeda

PPI/Antibiotic combination

H. pylori $536 F NF MC, HK Individual ingredients are available on formulary. No criteria necessary, to be denied as combination product not covered. Requests will be denied as “use equivalent formulary ingredients, prescribed separately: Amoxicillin, Clarithromycin (code 1 for H. pylori) & OTC lansoprazole.” Effective 1/1/14.

Clomipramine (Anafranil)/Various

TCA OCD (Obsessive-Compulsive Disorder)

$1000 F NF MC, HK See prior authorization criteria.. Significant increase in MAC pricing in the last few months, now $11-12 per capsule, dosed at up to 4/day. 33 Rx’s filled in the last 6 months. Formulary Alternative(s): Fluvoxamine <$40/mo @ max dose SSRIs <$5/mo Effective 1/1/14.

Lansoprazole disintegrating tab (Prevacid SoluTab)/ Takeda

Proton Pump Inhibitor H. pylori, DU, GERD, GU, Erosive Esoph., Z. E.

$275 NF NF MC, HK See prior authorization criteria. Effective 9/12/13

Tadalafil (Cialis)/Lilly PDE5 inhibitor BPH $160 NF NF MC See prior authorization criteria. Effective 9/12/13

Dextromethorphan 20mg/ Quinidine Sulfate 10mg (Nuedexta)/Avanir

Sigma-1 receptor agonist & uncompetitive NMDA receptor ant.

Pseudobulbar Affect (PBA)

$700 NF NF MC See prior authorization criteria. Effective 9/12/13

8/29/13 P & T PRIOR AUTHORIZATION CRITERIA GUIDELINES, ADDITIONS/CHANGES: Medi-Cal/Healthy Kids, Effective 10-15-2013 (unless otherwise noted)

GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Levalbuterol HFA Effective 9/12/13

Xopenex HFA Rescue treatment of asthma in members who have tried and failed or have a contraindication to albuterol.

MC: Trial and failure intolerance to albuterol MDI (Ventolin HFA) with spacer. HK: As above, and in addition, TAR review is to include screening for CCS eligible conditions related to chronic lung disease (Asthma is not a CCS eligible condition). Internal CCS referral procedures will be followed as indicated.

Levalbuterol Nebulizer Solution Effective 9/12/13

Xopenex Nebulizer Solution

Rescue treatment of asthma in members who have tried and failed or have a contraindication to albuterol.

MC: On recommendation of specialist & trial and failure with intolerance to albuterol MDI (Ventolin HFA) with spacer, albuterol nebulizer and non-formulary levalbuterol (Xopenex HFA) with spacer. Provider may be requested to consider side effect management such as ½ vial trial of albuterol nebulizer solution. HK: As above, and in addition, TAR review is to include screening for CCS eligible conditions related to chronic lung disease (Asthma is not a CCS eligible condition). Internal CCS referral procedures will be followed as indicated.

Budesonide Neb. Soln. 1mg (NF), Effective 9/12/13; 0.25 & 0.5 (F until 1/1/14), Effective 1/1/14.

Pulmicort Neb. None (F, Age limit <9) MC: On recommendation of specialist* and trial and failure with formulary inhaled corticosteroid with spacer. *Pulmonologist or Allergist. If there is no specialist within the member’s geographic region, include that information on the TAR request. HK: As above, and in addition, TAR review is to include screening for CCS eligible conditions related to chronic lung disease (Asthma is not a CCS eligible condition). Internal CCS referral procedures will be followed as indicated.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Mometasone Furoate/Formoterol Fumarate Effective 9/12/13

Dulera STEP Therapy Requirement: Prior paid claim for formulary inhaled corticosteroid (ICS) in the last 180 days. Criteria if Step Edit not met (no prior paid claims for ICS): Documentation on TAR that member has T/F ICS.

Step Currently Effective (no change proposed): MC: STEP Therapy Requirement: Prior paid claim for formulary inhaled corticosteroid (ICS) in the last 180 days. MC: Criteria if Step Edit not met (no prior paid claims for prerequisite drug therapy): (1) Spirometry results and (2) TAR must include adequate documentation that the member previously received an adequate trial (minimum 2 weeks) of an oral ICS. Adequate documentation would include pharmacy dispensing records &/or clinic visit notes. HK: As above, and in addition, TAR review is to include screening for CCS eligible conditions related to chronic lung disease (Asthma is not a CCS eligible condition). Internal CCS referral procedures will be followed as indicated.

Budesonide/ Formoterol Fumarate Effective 9/12/13

Symbicort STEP Therapy Requirement: Prior paid claim for formulary inhaled corticosteroid (ICS) in the last 180 days. Criteria if Step Edit not met (no prior paid claims for ICS): Documentation on TAR that member has T/F ICS.

Same as Dulera


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Fluticasone Propionate/ Salmeterol Xinafoate HFA (NF), Effective 9/12/13; Diskus (F until 1/1/14), Effective 1/1/14)

Advair Diskus, Advair HFA

STEP Therapy Requirement: Prior paid claim for formulary inhaled corticosteroid (ICS) in the last 180 days. Criteria if Step Edit not met (no prior paid claims for ICS): Documentation on TAR that member has T/F ICS.

MC: 1. Must have adequate trial with ICS and

formulary/STEP products, Dulera AND Symbicort.

2. Verification of compliance: Clinic notes must document that patient has adhered to treatment plans and has demonstrated appropriate use of inhaler devices to the clinician.

3. TAR must include spirometry results and symptom assessment.

HK: As above, and in addition, TAR review is to include screening for CCS eligible conditions related to chronic lung disease (Asthma is not a CCS eligible condition). Internal CCS referral procedures will be followed as indicated.

Zileuton tablets & CR tablets Effective 9/12/13

Zyflo, Zyflo CR Treatment of asthma in adults and children who have tried & failed oral inhaled corticosteroids.

MC: Limited to those requests prescribed by, or on recommendation of a specialist. Trial and failure with inhaled corticosteroid (ICS) with spacer, Montelukast, Zafirlukast, and ICS/long-acting beta-agonist. Clinic notes must document that patient has adhered to treatment plans and has demonstrated appropriate use of inhaler devices to the clinician. HK: As above, and in addition, TAR review is to include screening for CCS eligible conditions related to chronic lung disease (Asthma is not a CCS eligible condition). Internal CCS referral procedures will be followed as indicated.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Zafirlukast Effective 10/1/13

Accolate STEP Therapy Requirement: Prior paid claim for formulary inhaled corticosteroid (ICS) in the last 120 days. Criteria if Step Edit not met (no prior paid claims for ICS): Documentation on TAR that member has T/F ICS.

MC: STEP Therapy Requirement: Prior paid claim for montelukast in the last 120 days. Criteria if Step Edit not met (no prior paid claims for montelukast): Documentation on TAR that member has T/F montelukast. Adequate documentation would include pharmacy dispensing records &/or clinic visit notes. HK: As above, and in addition, TAR review is to include screening for CCS eligible conditions related to chronic lung disease (Asthma is not a CCS eligible condition). Internal CCS referral procedures will be followed as indicated.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Etanercept Effective 9/12/13

Enbrel Treatment of: RHEUMATOID ARTHRITIS in

members who • are evaluated by a rheumatologist • Requires a current Disease Activity

Score • Treatment goal is low disease

activity* or remission • *Disease activity instruments and **

prognostic factors for RA per ACR 2008 Recommendations, *** formulary oral DMARDS: methotrexate(MTX) (injection recommended if GI side effects from oral MTX)), leflunomide (LEF),sulfasalazine(SSZ), hydroxychloroquine(HCQ). (note hydroxychloroquine alone will not be considered monotherapy)

• Had at least a 3 MONTH TRIAL of EACH listed formulary oral DMARD therapy*** with inadequate response (progressed to or remains at mod/severe disease activity) with the following conditions:

A) Documented diagnosis RA less than 6 months duration AND High disease activity* with 1 or more poor prognositc factors**AND had a trial of double or triple combination formulary oral DMARD therapy*** OR

B) Documented diagnosis RA with moderate/high disease activity* and were initially diagnosed and treated: a) <6mo duration/ low, moderate,

high disease activity without poor prognostic factors or

MC: (New Starts) Treatment of RHEUMATOID ARTHRITIS in members who have been evaluated by a rheumatologist. In addition: • Requires a current Disease Activity Score • Treatment goal is low disease activity* or

remission • *Disease activity instruments and **

prognostic factors for RA per ACR 2008 Recommendations, *** formulary oral DMARDS: methotrexate (MTX) (injection recommended if GI side effects from oral MTX)), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) have been utilized. (Note --hydroxychloroquine alone will not be considered monotherapy).

• Had at least a 3 MONTH TRIAL of EACH listed formulary oral DMARD therapy*** with inadequate response (progressed to or remains at mod/severe disease activity) with the following conditions: A) Documented diagnosis RA less than 6

months duration AND High disease activity* with 1 or more poor prognositc factors**AND had a trial of triple combination formulary oral DMARD therapy*** OR

B) Documented diagnosis RA with moderate/high disease activity* and were initially diagnosed and treated: a) <6mo duration/ low, moderate, high

dz activity without poor prognostic factors or

b) >6mo duration/ with low dz activity without poor prognostic factors

AND had inadequate response to triple oral DMARD combination therapy


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA

C) Documented diagnosis of RA with moderate/high disease activity* and were initially diagnosed and treated: a) <6mo duration/ moderate dz

activity*with poor prognostic factors** or high dz */ without prognostic factors or

b) >6mo duration / low dz activity* with poor prognostic factors* OR moderate/high dz* regardless of prognostic factors

AND had inadequate response to trials of:

1) Methotrexate (or Leflunomide) monotherapy and ADD/or switch to second formulary oral DMARD*** OR

2) Combination (double or triple) formulary oral DMARD therapy and ADD/or switch to a second formulary oral DMARD***.

C)Documented diagnosis of RA with moderate/high disease activity* and were initially diagnosed and treated:

i. <6mo duration/ moderate dz activity*with poor prognostic factors** or high dz */ without prognostic factors or

ii. >6mo duration / low dz activity* with poor prognostic factors* OR moderate/high dz* regardless of prognostic factors

AND had inadequate response to trials of:

1) Methotrexate (or Leflunomide) monotherapy and ADD TWO formulary oral DMARDs (total 3)*** OR

2) Combination triple formulary oral DMARD therapy.

Internal Reviewer Note: Will allow continuing care, and will allow switch from one biologic to another, without documentation of T/F 3 DMARDs.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Tofacitinib Effective 9/12/13

Xeljanz None Requires diagnosis of rheumatoid arthritis, meeting PHC criteria for biologics per Enbrel/Humira criteria, and in addition, clinic notes documenting trial and failure of (or contraindication to) Enbrel or Humira (dosed every other week).

Adalimumab Effective 9/12/13

Humira RHEUMATOID ARTHRITIS-Same prior authorization criteria for RA as Enbrel (May be considered if tried and failed Enbrel) AND Authorization for 40mg every week dosing requires that the member has tried and failed a 3 month trial of 40mg every other week.

RHEUMATOID ARTHRITIS-Same prior authorization criteria for RA as Enbrel (May be considered if tried and failed Enbrel); limited to every other week dosing. Failure to control disease at QOW should have consideration of other therapy with alternative mechanism of action.

Abatacept Effective 9/12/13

Orencia Non-formulary. Enbrel and Humira are the preferred anti-TNF agents. Trial and failure of at least 3 month trials of Enbrel and Humira (anti-TNF therapies.) Requires Disease Activity Score.

Non-formulary. Enbrel and Humira are the preferred anti-TNF agents. Trial and failure of at least 3 month trials of Enbrel, Humira (anti-TNF therapies) & Xeljanz (JAK inhibitor). Requires Disease Activity Score.

Anakinra Effective 9/12/13

Kineret Non-formulary. Enbrel and Humira are the preferred anti-TNF agents. Trial and failure of at least 3 month trials of Enbrel and Humira (anti-TNF therapies). Restricted to members 18 yrs or older; Requires Disease Activity Score.


Certolizumab Effective 9/12/13

Cimzia Non-formulary. Enbrel and Humira are the preferred anti-TNF agents. RHEUMATOID ARTHRITIS: Case by case review if patient unable to tolerate an adequate 3 month trial with Enbrel and Humira.



GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Infliximab Effective 9/12/13

Remicade Non-formulary. Enbrel and Humira are the preferred anti-TNF agents. RHEUMATOID ARTHRITIS- Case by case review if patient unable to tolerate an adequate 3 month trial with Enbrel and Humira.


Golimumab Effective 9/12/13

Simponi Non-formulary. Enbrel and Humira are the preferred anti-TNF agents. RHEUMATOID ARTHRITIS- Case by case review if patient unable to tolerate an adequate 3 month trial with Enbrel and Humira


Rituximab Effective 9/12/13

Rituxan Trial and failure of at least 3 month trials of Enbrel and Humira (anti-TNF therapies) and Orencia (non-TNF inhibitor); Must be used in conjunction with methotrexate/MTX (or leflunomide if MTX is not tolerated). Requires Disease Activity Score.

Trial and failure to at least 3 month trials of Enbrel and Humira (anti –TNF therapies) and Orencia (non-TNF inhibitor). Effective 9/12/13, also requires trial/failure of XELJANZ. Must be used with Methotrexate (MTX) (or in case of MTX intolerance/side effect-use leflunomide). Requires Disease Activity Score. Healthy Kids will include standard statement of CCS screening/referral.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Sodium Hyaluronate Effective 9/12/13

Supartz, Hyalgan Approvable Hyaluronic acid derivatives are Brand Supartz or Hyalgan. Other products are not covered. Treatment of Osteoarthritis of the knee in which the following are met: (1) members who have been evaluated by an appropriate specialist, (2) condition is not controlled with physical therapy, NSAIDs and trial of at least three steroid injections to affected knee within 1 year and (3) knee replacement surgery is contra-indicated.

MC: Approvable Hyaluronic acid derivatives are Brand Supartz or Hyalgan. PHC will only approve the preferred products if patient meets criteria for viscosupplementation therapy. Other products are not covered. Criteria: Treatment of Osteoarthritis of the knee in which each of the following are met: (1) Members who have been evaluated by an appropriate specialist; (2) Documentation of trial and failure of, or contraindication to, at least 2 prescription strength NSAIDs at adequate doses for 3 months each of consistent usage; (3) If intolerant to NSAIDs, must have 3 month trial of topical NSAID (TAR required) and formulary tramadol; (4) Trial and failure to physical therapy; (5) Documentation of at least 3 intra-articular steroid injections within the last year or documentation of complete lack of response to less than 3 injections; (6) knee replacement surgery is contra-indicated and (7) BMI < 25. If BMI >/= 25: (a) Include documentation with TAR that member has lost 10% body weight or (b) resubmit TAR at a later date showing member has lost weight to achieve BMI < 25, and procedure is still indicated (symptoms persist despite weight loss). HK: Not indicated for use in children, therefore is not a covered benefit.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Clomipramine Effective 1/1/14

Anafranil None MC, HK: New Starts: Member has been diagnosed by specialist as having obsessive compulsive disorder, and has failed adequate trial of or has contraindications to formulary alternatives: fluvoxamine, fluoxetine, paroxetine and sertraline. (Internal review notes: ask for dose consolidation; may also approve but ask prescriber if other therapies may be considered)

Desvenlafaxine Effective 9/12/13

Pristiq

New starts: Treatment of Depression for members who have had a trial and failure of a formulary SSRI (citalopram, fluoxetine, paroxetine, sertraline) AND venlafaxine-ER.

MC, HK: New Starts: Prior authorization is considered for members in whom multi-drug resistance is apparent following failure with multiple therapeutic trials: Must have failure to remission with 4 prior agents (SSRI, SNRI, Mirtazapine, Venlafaxine, Bupropion, MAO-I (carve-out), alone &/or in combination; also adjunctive cognitive therapy, consideration of Lithium, T3, aripiprazole (carve-out). A Psychiatric Consult is required for re-evaluation of diagnosis. Submission of PHQ9 Score is required: Prior Authorization allowed with psychiatrist confirmation of diagnosis and PHQ9>14; Prior Authorization allowed for non-psychiatrist if psychiatrist is not available for consult and PHQ9>20 and other criteria have been met. Continuing Care: For new member’s without significant claim history to show continuation of care, TARs should include the pharmacy’s refill history &/or clinic notes documenting member’s history with the medication.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Vilazodone Effective 9/12/13

Viibryd Trial and failure or intolerant to 2 formulary generic SSRI and 1 other antidepressant from another class. Limit 1 /day, 30/mo.

Same as above

Duloxetine Effective 9/12/13

Cymbalta Depression: New Starts: For members who have had a trial & failure of two or more of the following: fluoxetine, paroxetine, citalopram, sertraline, bupropion IR/SR/XR, mirtazapine or venlafaxine IR/ER. (Other criteria for OA/musculoskeletal pain, diabetic neuropathy & fibromyalgia remain unchanged).

Same as above

Formulary Imitrex & Maxalt tablets Inadvertently omitted from P & T packet; please review as part of Triptan PA Group for PAC:Sumatriptan Effective 9/12/13

Imitrex tablets

None (on formulary) Requests exceeding formulary quantity limit (#9/30 days) will require documentation that member has had a consult with a neurologist and is receiving adequate prophylactic therapy.

Rizatriptan Effective 9/12/13

Maxalt tablets Trial & failure of sumatriptan Added to formulary, effective 10/15/13, limited to #12/month. Requests exceeding #12/month will documentation that member has had a consult with a neurologist and is receiving adequate prophylactic therapy.

Zolmitriptan Effective 9/12/13

Zomig and Zomig-ZMT tablets

Trial and failure of formulary sumatriptan. MC, HK: Documentation of trial and failure of formulary sumatriptan, and rizatriptan oral tablets. Requests are limited to #12/month. Requests exceeding #12 per month will require documentation that member has had a consult with a neurologist and is receiving adequate prophylactic therapy.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Rizatriptan disintegrating tablets Effective 9/12/13

Maxalt-MLT Trial and failure of formulary sumatriptan. MC, HK: Documentation of trial and failure of formulary sumatriptan and rizatriptan oral tablets as well as non-formulary/preferred zolmitriptan orally disintegrating tablets (TAR required). Limit #12 per month. Requests exceeding #12 per month will require documentation that member has had a consult with a neurologist and is receiving adequate prophylactic therapy.

Almotriptan tablets Effective 9/12/13

Axert tablets Trial and failure of formulary sumatriptan. MC, HK: Documentation of trial and failure of formulary sumatriptan, & rizatriptan oral tablets, as well as preferred-Non-Formulary agent Zolmitriptan (TAR required). Requests are limited to #12/month. Requests exceeding #12 per month will require documentation that member has had a consult with a neurologist and is receiving adequate prophylactic therapy.

Eletriptan tablets Effective 9/12/13

Relpax tablets Trial and failure of formulary sumatriptan. Same as above

Frovatriptan tablets Effective 9/12/13

Frova tablets Trial and failure of formulary sumatriptan. Same as above

Zolmitriptan Nasal Spray Effective 9/12/13

Zomig nasal spray Trial and failure of formulary sumatriptan MC, HK: Documentation of trial and failure of formulary sumatriptan nasal spray and Zolmitriptan ODT (TAR required). Request limited to 1 unit per month (6 doses). Requests exceeding 1 per month will require documentation that member has had a consult with a neurologist and is receiving adequate prophylactic therapy.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Amoxicillin Lansoprazole Clarithromycin Effective 1/1/14

Prevpac None (formulary) No prior auth criteria published, as combination product will not be covered. Internal guidelines will be to deny, instructing provider to use separate ingredients (on formulary), prescribed separately.

Lansoprazole disintegrating tablet Effective 9/12/13

Prevacid Solutab None MC: Reserved for members unable to swallow capsules. Must have documentation of trial and failure of both formulary lansoprazole suspension and lansoprazole capsules sprinkled on food. HK: Potentially CCS eligible, TAR review shall include CCS screening & referral procedures as indicated.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Tadalafil 5mg Effective 9/12/13

Cialis 5mg tablets Limited to: • 5mg dose only • The treatment of benign prostatic

hyperplasia (BPH); and • Previous treatment failure with

formulary alpha blockers (doxazosin, terazosin), and

• Alpha-blocker in combination with formulary finasteride.

• Non-formulary tamsulosin trial (alone and in combination with finasteride) should be tried if formulary alpha blockers are not effective or contraindicated (TAR required for tamsulosin).

Note: This drug is not covered for the treatment of impotence or erectile dysfunction, per Federal Regulation and State Operating Instruction letter as of 1/1/06. It is a violation of Federal and State regulations to submit requests for BPH treatment if in fact the patient is being treated for impotence/ED.

Limited to: • 5mg dose only • The treatment of benign prostatic hyperplasia

(BPH) • Previous treatment failure following adequate

trials with formulary doxazosin (or terazosin) and formulary tamsulosin, alone AND in combination with formulary finasteride

• Member has been evaluated by an urologist Note: This drug is not covered for the treatment of impotence or erectile dysfunction, per Federal Regulation and State Operating Instruction letter as of 1/1/06. It is a violation of Federal and State regulations to submit requests for BPH treatment if in fact the patient is being treated for impotence/ED.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Dextromethorphan 20mg, Quinidine Sulfate 10mg Effective 9/12/13

Nuedexta None Limited to the treatment of Pseudobulbar Affect (PBA) in members with Multiple Sclerosis or Amyotrophic Lateral Sclerosis who have been evaluated by a neurologist and only have episodic outbursts of crying or laughing which are involuntary and are incongruent with the member’s emotional state. Must have psychiatric consult to rule out depression or other emotional disorders, manifested as either intermittent or prolonged crying episodes. Treatment of other emotional labilities is not FDA indicated. Notes: • Studies to support the effectiveness of

Nuedexta were performed in patients with ALS (amyotrophic lateral sclerosis) and MS (Multiple Sclerosis).

• Nuedexta has not been shown to be effective in the types of emotional lability that occur in Alzheimer’s disease and other dementias.

• PBA occasionally spontaneously improves; therefore patients should be periodically reassessed for the need for continued treatment.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Methylphenidate, ER capsules 50-50 Effective 9/12/13

Ritalin LA Non-formulary, but with preference over other long-acting products due to pricing. New Start authorization is limited to those requests which include documentation (eg, prescriber notes, pharmacy profile) showing: • Adequate trial & unsatisfactory result

with formulary methylphenidate ER/Methylin ER/Metadate ER (generic forms of Ritalin SR tablets), AND o Documented need for longer duration

or less frequent dosing, OR Documentation of swallowing difficulties

Reverts to Step (per Jan 2013 P & T) for ages 4-17, with PA criteria when step edit is not met and for adults: Prior Authorization Criteria when Step edit is not met (no prior paid claims): TAR must include adequate documentation that the member previously received an adequate trial (minimum 2 weeks) of formulary first-line therapy (generic Ritalin, Ritalin SR). Adequate documentation would include pharmacy dispensing records &/or clinic visit notes. Adults (Ages 18 +): New Start (New TAR) authorization is limited to those requests which include documentation (eg, prescriber notes, pharmacy profile) showing: Adequate trial & unsatisfactory result with formulary methylphenidate ER/Methylin ER/Metadate ER (generic forms of Ritalin SR tablets), AND a documented need for longer duration or less frequent dosing, OR documentation of swallowing difficulties.

Methylphenidate ER (Osmotic release tabs) Effective 9/12/13

Concerta (New Starts) Authorization is limited to those requests with documentation (eg, prescriber notes, pharmacy profile) showing: • Adequate trial & unsatisfactory result with

both formulary methylphenidate IR & formulary methylphenidate ER/Methylin ER/Metadate ER (generic forms of Ritalin SR tablets), AND

Adequate trial & unsatisfactory result with preferred (Prior Auth Required) methylphenidate LA capsules (Ritalin LA).

Same as above

Methylphenidate ER capsules 30-70 Effective 9/12/13

Metadate CD Same as above Same as above


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Mixed Amphetamine Salts Effective 9/12/13

Adderall XR New start authorization limited to requests which include documentation (eg, prescriber notes, pharmacy profile) showing: For Pediatric use, ages 3-16: • Adequate trial & unsatisfactory result

with formulary methylphenidate products AND

• Adequate trial of non-formulary generic Adderall IR, with Rx being effective but effect does not last through the needed treatment period (ie, wears off too soon).

For Adults, ages >/= 17: Documentation that member had partial effect at max dose, side effects or no effect after adequate trial with formulary methylphenidate ER.

Reverts to Step (per Jan 2013 P & T) for ages 4-17, with PA criteria when step edit is not met and for adults: Pediatric use (ages 4-17) is formulary, with step edit: prior paid claim for immediate, intermediate release methylphenidate (Ritalin, Ritalin SR) as a minimum 2 week trial in the last 120 days. (May also step from Long Acting Methylphenidate to Adderall XR). Prior Authorization Criteria when Step edit is not met (no prior paid claims): TAR must include adequate documentation that the member previously received an adequate trial (minimum 2 weeks) of formulary first-line therapy (generic Ritalin, Ritalin SR). Adequate documentation would include pharmacy dispensing records &/or clinic visit notes. Adults (Ages 18 +): New Start (New TAR) authorization is limited to those requests which include documentation (eg, prescriber notes, pharmacy profile) showing: Documentation that the member had partial effect at max dose, side effects or no effect after adequate trial with formulary intermediate methylphenidate (generic Ritalin SR).

Methylphenidate Patch Effective 9/12/13

Daytrana New Starts: Limited to those with documentation (eg, prescriber notes, pharmacy profile) showing: • Adequate trial & unsatisfactory result with

both formulary methylphenidate IR & formulary methylphenidate ER/Methylin ER/Metadate ER (generic forms of Ritalin SR tablets), such as being effective, but effect does not last through the treatment period (wears off too soon) & multiple daily doses cannot be given, AND

• Adequate trial & unsatisfactory result with preferred (Prior Auth Required) methylphenidate LA capsules (Ritalin LA), OR

Member is unable to swallow. (Note that the contents of LA capsules can be sprinkled on food).

(Removed “new starts’, will attempt to convert continuing care new members to oral long-acting formulary/step) • Adequate trial & unsatisfactory result with both

formulary methylphenidate IR & formulary methylphenidate ER/Methylin ER/Metadate ER (generic forms of Ritalin SR tablets), such as being effective, but effect does not last through the treatment period (wears off too soon) & multiple daily doses cannot be given, AND

• Adequate trial & failure with formulary/step 2nd line long-acting methylphenidate products: generic Ritalin LA, Concerta or Metadate CD

• In the case of swallowing difficulties, trial of sprinkling capsule contents on applesauce is also required. Generic Ritalin LA and Metadate CD can be sprinkled.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Lisdextroamphetamine Effective 9/12/13

Vyvanse New Start authorization limited to those requests with documentation (eg, prescriber notes, pharmacy profile) showing: • History of abuse or diversion in member

or a family member, OR • Adequate trial & unsatisfactory result

with formulary methylphenidate ER/Methylin ER/Metadate ER (generic forms of Ritalin SR), AND

Adequate trial & unsatisfactory result with non-formulary dextroamphetamine SR capsules (generic Dexedrine Spansules) or mixed amphetamine salts ER (generic Adderall XR).

(Removed “new starts’, will attempt to convert continuing care new members to oral long-acting formulary/step) Pediatric use (Ages 4-17): • History of abuse or diversion in member or a

family member, OR • Adequate trial & unsatisfactory result with

formulary/step methylphenidate product (generic Ritalin LA, Concerta, Metadate CD) AND

• Adequate trial & unsatisfactory result with formulary/step mixed amphetamine salts ER (generic Adderall XR).

Adults (Ages 18+): • History of abuse or diversion in member or a

family member, OR • Adequate trial & unsatisfactory result with

formulary methylphenidate ER/Methylin ER/Metadate ER (generic forms of Ritalin SR), AND

• Adequate trial & unsatisfactory result with non-formulary dextroamphetamine SR capsules (generic Dexedrine Spansules) or mixed amphetamine salts ER (generic Adderall XR).


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Dexmethylphenidate ER Effective 9/12/13

Focalin XR

New Start authorization is limited to those requests with documentation (eg, prescriber notes, pharmacy profile) showing: • Adequate trial of formulary generic

methylphenidate ER/Metadate ER/Methylin ER (generic Ritalin SR), with product being effective but effect does not last through the needed treatment period (ie, wears off too soon), OR

Adequate trial with unsatisfactory result which is a treatment failure due to no effect of the following formulary & non-formulary medications: Formulary methylphenidate ER/Methylin ER/Metadate ER (generic Ritalin SR) and either preferred Non-Formulary methylphenidate ER capsules (generic Ritalin LA) or methylphenidate ER (OSM type) tablets (generic Concerta).

(Removed “new starts’, will attempt to convert continuing care new members to oral long-acting formulary/step) Pediatric (Ages 4-17): • Adequate trial & unsatisfactory result with both

formulary methylphenidate IR & formulary methylphenidate ER/Methylin ER/Metadate ER (generic forms of Ritalin SR tablets), such as being effective, but effect does not last through the treatment period (wears off too soon) & multiple daily doses cannot be given, AND

• Adequate trial & failure with formulary/step 2nd line long-acting methylphenidate products: generic Ritalin LA, Concerta or Metadate CD.

Adult (18+): • Adequate trial of formulary generic methylphenidate

ER/Metadate ER/Methylin ER (generic Ritalin SR), with product being effective but effect does not last through the needed treatment period (ie, wears off too soon), OR

• Adequate trial with unsatisfactory result which is a treatment failure due to no effect of the following formulary & non-formulary medications: Formulary methylphenidate ER/Methylin ER/Metadate ER (generic Ritalin SR) and either preferred Non-Formulary methylphenidate ER capsules (generic Ritalin LA) or methylphenidate ER /OSM type tablets (generic Concerta) or Metadate CD.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Epoetin Alfa EPOGEN, PROCRIT

Injection (Specialty Pharmacy Item)

Chronic Kidney Disease (CKD) in dialysis centers – No PA required: documentation must be submitted on the Clinical Justification Worksheet. CKD – Epoetin Alpha not administered in dialysis center – PA required:

• Maintain Hgb/HCT between 11 and 12g/Dl (33% and 36%) based on a recent measurement within the last month. • Appropriate indications for administering

Epoetin Alpha if the Hgb/HCT is >12/36 include:

o Reduction of the dose by 25% o A dose of 1000 units or less.

-or- o Co-Morbid conditions such as CHF/Pulmonary Disease

Oncology – Anemia associated with malignancy, chemotherapy or myelodysplastic syndrome—PA required:

• For pts receiving cancer chemotherapy and for pts with low grade myelodysplasia not receiving chemotherapy:

o Hgb/HCT less than 10 g/dl (30%) within the previous month

• For pts with anemia associated with other hematologic malignancies in the absence of chemotherapy:

o trial and failure of conventional therapy for anemia

• Starting dosage: 150u/kg per week.

Elective, noncardiac, nonvascular surgery when patient is unable or unwilling to donate autologous blood – PA required:

• Hgb/HCT between 10 and 12g/dl (30-39%) and pt is unwilling or unable to donate autologous blood; the recommended dose of recombinant human erythropoietin is 300 units/kg/day subcutaneously for 10 days prior to, on the day of, and for four days post-surgery. An alternate dose schedule is 600 units/kg of recombinant human erythropoietin subcutaneously in once-a-week doses (21, 14 and 7 days prior to surgery) plus a fourth dose given on the day of surgery.

Anti-retroviral therapy for HIV infected patients – PA required: • Case by case review. Co-morbid conditions. • Hgb/HCT between 10 and 12g/dl (30-36%) and a

serum erythropoietin of less than 500 Mu/ml.

Note – In all cases the cause of the anemia is not due to correctable/treatable factors. such as:

Iron deficiency (it is recognized that patients on EPO

may still require supplemental iron therapy.) Underlying infectious or inflammatory processes.

Only the section pertaining to CKD/not on dialysis was presented for updating (other criteria remain unchanged): CKD – Epoetin Alpha not administered in dialysis center – PA required: New STARTS: 1)Any preexisting iron deficiencies must be resolved as evidenced by submitted lab work: Iron Studies, EGFR<60 2) Hgb</=10.5 within the last month. Renewals:

1) Maintain Hgb/HCT </= 11g/Dl (HCT</= 33%) based on a recent measurement within the last month. 2) Appropriate indications for administering Epoetin Alpha if the Hgb is 11-12 g/dL include:

o Reduction of the dose by 25% o A dose of 1000 units/week or less.


GENERIC BRAND CURRENT PA CRITERIA RECOMMENDED PA CRITERIA Darbepoetin ARANESP injection

(Specialty pharmacy item)

Chronic Kidney Disease (CKD) in dialysis centers – No PA required: documentation must be submitted on the Clinical Justification Worksheet.

CKD – Epoetin Alpha not administered in dialysis center – PA required:

• Maintain Hgb/HCT between 11 and 12g/Dl (33% and 36%) based on a recent measurement within the last month. • Appropriate indications for administering

Epoetin Alpha if the Hgb/HCT is >12/36 include:

o Reduction of the dose by 25% o A dose of 1000 units or less.

-or- o Co-Morbid conditions such as CHF/Pulmonary Disease

Oncology – Anemia associated with malignancy, chemotherapy or myelodysplastic syndrome—PA required:

• For pts receiving cancer chemotherapy and for pts with low grade myelodysplasia not receiving chemotherapy:

o Hgb/HCT less than 10 g/dl (30%) within the previous month

• For pts with anemia associated with other hematologic malignancies in the absence of chemotherapy:

o trial and failure of conventional therapy for anemia

• Starting dosage: 150u/kg per week.

Elective, noncardiac, nonvascular surgery when patient is unable or unwilling to donate autologous blood – PA required:

• Hgb/HCT between 10 and 12g/dl (30-39%) and pt is unwilling or unable to donate autologous blood; the recommended dose of recombinant human erythropoietin is 300 units/kg/day subcutaneously for 10 days prior to, on the day of, and for four days post-surgery. An alternate dose schedule is 600 units/kg of recombinant human erythropoietin subcutaneously in once-a-week doses (21, 14 and 7 days prior to surgery) plus a fourth dose given on the day of surgery.

Anti-retroviral therapy for HIV infected patients – PA required: • Case by case review. Co-morbid conditions. • Hgb/HCT between 10 and 12g/dl (30-36%) and a serum

erythropoietin of less than 500 Mu/ml.

Note – In all cases the cause of the anemia is not due to correctable/treatable factors. such as:

Iron deficiency (it is recognized that patients on EPO may still require supplemental iron therapy.)

Underlying infectious or inflammatory processes. Occult blood loss. Underlying hematologic diseases (i.e., thalassemia) Vitamin deficiencies: (i.e., folic acid or vitamin B12) Hemolysis

Only the section pertaining to CKD/not on dialysis was presented for updating (other criteria remain unchanged): CKD – Darbepoetin not administered in dialysis center – PA required: New STARTS: 1)Any preexisting iron deficiencies must be resolved as evidenced by submitted lab work: Iron Studies, EGFR<60 2) Hgb</=10.5 within the last month. Renewals:

1) Maintain Hgb/HCT </= 11g/Dl (HCT</= 33%) based on a recent measurement within the last month. 2) Appropriate indications for administering darbepoetin if the Hgb 11-12 include:

o Reduction of the dose by 25% o A dose of 25mcg every other week or less.

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