Updates to the Drug Benefit List - Summer 2008

• Additions to the Drug Benefit List
  • Open Benefits
  • New Limited Use Benefits
• Not Added to Formulary
• Drug Discontinued by the Manufacturer
• Name Changes
• Manufacturer Changes
• Corrections to the Drug Benefit List

---

Benefit Definitions

Open Benefits

Open benefits are the drugs listed in the NIHB Drug Benefit List (DBL) which do not have established criteria or prior
approval requirements.

Limited Use Benefits

Limited use drugs are those that have been found to be effective in specific circumstances, or which have quantity and frequency limitations. For drugs in this category, specific criteria must be met to be eligible for coverage.

Not Added To Formulary

Drugs not added to formulary are those which are not listed in the NIHB DBL after review by the national Common Drug Review (CDR) process and/or the Federal Pharmacy and Therapeutics Committee (FP&T). These drugs will not be added to the NIHB drug list because published evidence does not support the clinical value or cost of the drug relative to existing therapies. Coverage may be considered in special circumstances upon receipt of a completed "Exception Drugs Request Form". These requests are reviewed on a case by case basis.

Exclusions

Certain drug therapies for particular conditions fall outside of the NIHB mandate and will not be provided as benefits under the NIHB Program (e.g., cosmetic and anti-obesity drugs). As well, certain drugs will be excluded from the NIHB Program as recommended by the CDR and the FP&T because published evidence does not support the clinical value, safety or cost of the drug relative to existing therapies, or there is insufficient clinical evidence to support coverage.

Note: The appeal process and the emergency supply policy will not apply to excluded drugs.

Additions to the Drug Benefits List

Open Benefits

Single-Source Drug Products

DIN	MFR	BRAND NAME	Effective date
80001869	DDP	BABY D-DROPS 400IU DROPS	06/07/2008
02296152	ORY	CTP 30MG TABLET (CITALOPRAM)	06/07/2008
80001791	DDP	D-DROPS 1,000IU DROPS	06/07/2008
80001792	DDP	D-DROPS 400IU DROPS	06/07/2008
02243894	ALL	TAZORAC 0.05% CREAM	24/06/2008
02243895	ALL	TAZORAC 0.1% CREAM	24/06/2008

Multi-Source Drug Products

DIN	MFR	BRAND NAME	Effective date
02285398	APX	APO-MODAFINIL 100MG TABLET	26/05/2008
02244130	RIV	CALCITE 500 + D 400 TABLET	26/05/2008
02244161	RIV	CALCIUM 500 + D 400 TABLET	26/05/2008
02263866	COB	CO ETIDROCAL COMBO KIT	01/05/2008
02304333	COB	CO VENLAFAXINE 150MG XR CAPSULE	28/05/2008
02304317	COB	CO VENLAFAXINE 37.5MG XR CAPSULE	28/05/2008
02304325	COB	CO VENLAFAXINE 75MG XR CAPSULE	28/05/2008
02009889	RIV	CODEINE 15MG TABLET	26/05/2008
02009757	RIV	CODEINE 30MG TABLET	26/05/2008
02281627	DOM	DOM-SIMVASTATIN 10MG TABLET	24/04/2008
02281635	DOM	DOM-SIMVASTATIN 20MG TABLET	24/04/2008
02281643	DOM	DOM-SIMVASTATIN 40MG TABLET	24/04/2008
02281619	DOM	DOM-SIMVASTATIN 5MG TABLET	24/04/2008
02281651	DOM	DOM-SIMVASTATIN 80MG TABLET	24/04/2008
02305011	GEN	GEN-CLOZAPINE 200MG TABLET	05/06/2008
02305003	GEN	GEN-CLOZAPINE 50MG TABLET	05/06/2008
02247323	GEN	GEN-ETI-CAL CAREPAC	01/05/2008
02248293	GEN	GEN-FLUCONAZOLE 100MG TABLET	24/04/2008
02304694	MIN	MINT -CITALOPRAM 40MG TABLET	01/06/2008
02304686	MIN	MINT-CITALOPRAM 20MG TABLET	01/06/2008
02239029	RIV	NADRYL 25MG CAPSULE	26/05/2008
02302799	NOP	NOVO-MORPHINE SR 100MG TABLET	11/04/2008
02302802	NOP	NOVO-MORPHINE SR 200MG TABLET	11/04/2008
02302780	NOP	NOVO-MORPHINE SR 60MG TABLET	11/04/2008
02307898	NOP	NOVO-OXYCODONE ACET 5/325MG TABLET	05/06/2008
80004281	PMS	PMS-CALCIUM 500 + D 125 TABLET	24/04/2008
02274086	PMS	PMS-HYDROCHLOROTHIAZIDE 12.5MG TABLET	05/06/2008
02245287	PMS	PMS-MORPHINE SR 100MG TABLET	24/04/2008
02245288	PMS	PMS-MORPHINE SR 200MG TABLET	24/04/2008
02303175	PMS	PMS-OLANZAPINE IR 10MG TABLET	24/04/2008
02303183	PMS	PMS-OLANZAPINE IR 15MG TABLET	24/04/2008
02303116	PMS	PMS-OLANZAPINE IR 2.5MG TABLET	24/04/2008
02303159	PMS	PMS-OLANZAPINE IR 5MG TABLET	24/04/2008
02303167	PMS	PMS-OLANZAPINE IR 7.5MG TABLET	24/04/2008
02294559	PMS	PMS-PROPAFENONE 150MG TABLET	25/04/2008
02294575	PMS	PMS-PROPAFENONE 300MG TABLET	25/04/2008
02299372	PMS	PMS-RAMPIPRIL 1.25MG CAPSULE	24/04/2008
02255332	PMS	PMS-RAMPIPRIL 10MG CAPSULE	24/04/2008
02255316	PMS	PMS-RAMPIPRIL 2.5MG CAPSULE	24/04/2008
02255324	PMS	PMS-RAMPIPRIL 5MG CAPSULE	24/04/2008
02298457	PMS	PMS-VALACYCLOVIR 500MG CAPSULE	01/06/2008
02247217	RIV	RIVA-AMIODARONE 200MG TABLET	20/04/2008
02277379	RIV	RIVA-ATENOLOL 25MG TABLET	26/05/2008
02275309	RIV	RIVA-AZITHROMYCIN 250MG TABLET	20/04/2008
02275317	RIV	RIVA-AZITHROMYCIN 600MG TABLET	20/04/2008
02303256	RIV	RIVA-CITALOPRAM 10MG TABLET	20/04/2008
02243976	RIV	RIVA-D 400IU CAPSULE	01/12/2007
02271516	RIV	RIVA-FLUCANAZOLE 100MG TABLET	24/04/2008
02265923	RIV	RIVA-FOSINOPRIL 10MG TABLET	20/04/2008
02265931	RIV	RIVA-FOSINOPRIL 20MG TABLET	20/04/2008
02259796	RIV	RIVA-GABAPENTIN 600MG TABLET	20/04/2008
02259818	RIV	RIVA-GABAPENTIN 800MG TABLET	20/04/2008
02272288	RIV	RIVA-LOVASTATIN 20MG TABLET	20/04/2008
02272296	RIV	RIVA-LOVASTATIN 40MG TABLET	20/04/2008
02202360	RIV	RIVASA FC 80MG TABLET	26/05/2008
02179547	RIV	RIVASOL HC OINTMENT	26/05/2008
02262924	RIV	RIVA-TERBINAFINE 250MG TABLET	20/04/2008
02307790	RIV	RIVA-VENLAFAXINE 150MG CAPSULE	28/05/2008
02307774	RIV	RIVA-VENLAFAXINE 37.5MG CAPSULE	28/05/2008
02307782	RIV	RIVA-VENLAFAXINE 75MG CAPSULE	28/05/2008
02248082	RIV	RIVA-VERAPAMIL SR 240MG TABLET	26/05/2008
02302179	SDZ	SANDOZ CEFPROZIL 250MG TABLET	01/04/2008
02302187	SDZ	SANDOZ CEFPROZIL 500MG TABLET	01/04/2008
02303396	SDZ	SANDOZ METOPROLOL SR 100MG TABLET	27/04/2008
02303418	SDZ	SANDOZ METOPROLOL SR 200MG TABLET	27/04/2008
02303655	SDZ	SANDOZ RISPERIDONE 0.25MG TABLET	24/04/2008
02303663	SDZ	SANDOZ RISPERIDONE 0.5MG TABLET	24/04/2008
02310333	SDZ	SANDOZ VENLAFAXINE 150MG CAPSULE	01/06/2008
02310317	SDZ	SANDOZ VENLAFAXINE 37.5MG CAPSULE	01/06/2008
02310325	SDZ	SANDOZ VENLAFAXINE 75MG CAPSULE	01/06/2008

New Limited Use Benefits

Multi-Source Drug Products

DIN	MFR	BRAND NAME	Effective date
02301407	COB	CO-CABERGOLINE 0.5MG TABLET	01/04/2008

Prior approval required.
For the treatment of hyperprolactinemia in patients who have failed therapy with or are intolerant to bromocriptine.

Multi-Source Drug Products

DIN	MFR	BRAND NAME	Effective date
02292920	APX	APO-PANTOPRAZOLE 40MG TABLET	26/03/2008
02299585	GEN	GEN-PANTOPRAZOLE 40MG TABLET	01/07/2008
02285487	NOP	NOVO-PANTOPRAZOLE 40MG TABLET	01/06/2008
02305046	RAN	RAN-PANTOPRAZOLE 40MG TABLET	28/03/2008
02308703	RPH	RATIO-PANTOPRAZOLE 40MG TABLET	01/07/2008
02301083	SDZ	SANDOZ PANTOPRAZOLE 40MG TABLET	01/07/2008

Prior approval required.
Coverage will be provided:

• as part of multi-drug therapy (maximum 7-14 day coverage) for eradication of Helicobacter pylori in individuals with peptic ulcer disease (diagnosed by urea breath test, serology or endoscopically).

Coverage will also be provided if the following prerequisites are met:

• patient has tried at least 60 days of Apo-Omeprazole®(Generic) and
• patient has tried at least 60 days of Rabeprazole sodium (Pariet®).

Total trial of 120 days will be confirmed against medication history:

• for treatment of confirmed gastric and duodenal ulcers. Or
• for mild to moderate gastroesophageal reflux disease (GERD) in patients who have failed on or not tolerated and 4-week trial of histamine-2 receptor antagonists. Or
• for severe gastroesophageal reflux disease (GERD) and complications as first-line therapy for a maximum period of 3 months.
• Patients should be reassessed endoscopically or with step-down therapy using a histamine-2 receptor antagonist. Or
• for treatment of nonsteroidal anti-inflammatory drug (NSAID)-induced ulcers where the NSAID must be continued. Or
• for prevention of NSAID-induced ulcers in patients who have a history of ulcer complications, are over the age of 65 years, have comorbid disease such as cardiovascular disease or coagulopathies or are on concomitant medications which increase risk of ulcers or bleeding. Or
• Zollinger-Ellison Syndrome*. Or
• Barrett's Esophagus*. Or
• esophagitis associated with connective tissue disease. Or
• other exceptional circumstances, evaluated on an individual basis.

* Diagnosis must be confirmed by a specialist qualified to diagnose and treat condition.

Not Added to Formulary

The following drug products will not be added to the NIHB Drug Benefit List:

DIN	MFR	BRAND NAME
02298953	APX	APO-CICLOPIROX TOPICAL SOLUTION (CICLOPIROX)
02296616	GEN	GEN-ZOPICLONE 5MG TABLET (ZOPICLONE)
00307912	RIV	PSEUDOFRIN 60MG TABLET (PSEUDOEPHEDRINE)
02242149	RIV	RIVA-BUSPIRONE 10MG TABLET (BUSPIRONE)
00557102	RIV	RIVA-DICYCLOMINE 10MG TABLET (DICYCLOMINE)
00852163	RIV	TRIATEC 8 (ACETAMINOPHEN, CAFFEINE, CODEINE)
01977881	RIV	TRIATEC 8 STRONG (ACETAMINOPHEN, CAFFEINE, CODEINE)

The following drugs are excluded from the NIHB Drug Benefit List:

DIN	MFR	BRAND NAME
02292912	APX	APO-PANTOPRAZOLE 20MG TABLET (PANTOPRAZOLE)
02245592	RIV	DAMYLIN WITH CODEINE SYRUP
02285479	NOP	NOVO-PANTOPRAZOLE 20MG TABLET (PANTOPRAZOLE)
02305038	RAN	RAN-PANTOPRAZOLE 20MG TABLET (PANTOPRAZOLE)
02308681	RPH	RATIO-PANTOPRAZOLE 20MG TABLET (PANTOPRAZOLE)
02301075	SDZ	SANDOZ PANTOPRAZOLE 20MG TABLET (PANTOPRAZOLE)
01971387	RIV	TRIANAL C1/2 CAPSULE (BUTALBITAL, CAFFEINE, ASA, CODEINE)
02242406	RIV	TRIANAL C1/4 CAPSULE (BUTALBITAL, CAFFEINE, ASA, CODEINE)
01971417	RIV	TRIANAL CAPSULE (BUTALBITAL, CAFFEINE, ASA)
01971409	RIV	TRIANAL TABLET (BUTALBITAL, CAFFEINE, ASA)

Drugs Discontinued by the Manufacturer

DIN	MFR	BRAND NAME
02278677	APX	APO-MIDODRINE 2.5MG TABLET
02278685	APX	APO-MIDODRINE 5MG TABLET
02243828	APX	APO-SALVENT 0.5MG/ML STERULES
02231488	APX	APO-SALVENT 1MG/ML STERULES
02231678	APX	APO-SALVENT 2MG/ML STERULES
02266393	APX	APO-SALVENT-IPRAVENT 1MG & 0.2MG/ML STERULES
00507989	ABB	DEPAKENE 500MG CAPSULE
02232872	NOP	NOVO-CYPROTERONE 50MG TABLET
02197456	NOP	NOVO-LEVOBUNOLOL 0.25% OPHTH SOLUTION
02197464	NOP	NOVO-LEVOBUNOLOL 0.50% OPHTH SOLUTION
00769991	ABB	PCE 333MG TABLET
00583405	ABB	PEDIAZOLE 40MG & 120MG/ML ORAL SUSPENSION

Name Changes

DIN	MFR	OLD BRAND NAME	NEW BRAND NAME
00873292	JBL	DERMA-SMOOTHE 0.01% SCALP LOTION	DERMA-SMOOTHE 0.01% BODY OIL
00568392	RIV	ZAPEX 10MG TABLET	RIVA-OXAZEPAM 10MG TABLET
00568406	RIV	ZAPEX 15MG TABLET	RIVA-OXAZEPAM 15MG TABLET
00568414	RIV	ZAPEX 30MG TABLET	RIVA-OXAZEPAM 30MG TABLET

Manufacturer Changes

DIN	BRAND NAME	OLD MFR	NEW MFR
02042304	MICRO-K EXTENCAPS 600MG CAPSULE	WAY	PAL

Corrections to the Drug Benefit List

The following are the correct limited use criteria for the April 2008 edition of the NIHB Drug Benefit List:

DIN	MFR	BRAND NAME	Effective Date
01981501	ALL	BOTOX 100IU INJECTION	01/09/2007

Prior approval required.

1. Treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorder in patients 12 years of age or older
2. Treatment of cervical dystonia (spasmodic torticollis)
   

The following are the correct limited use criteria for the April 2008 edition of the NIHB Drug Benefit List:

DIN	MFR	BRAND NAME	Effective Date
02280795	PFI	SUTENT 12.5MG CAPSULE	01/09/2007
02280809	PFI	SUTENT 25MG CAPSULE	01/09/2007
02280817	PFI	SUTENT 50MG CAPSULE	01/09/2007

Prior approval required.
Criteria for initial six month coverage of Sutent:
For patients with histologically proven unresectable or recurrent/metastatic GIST who have failed or are unable to tolerate imatinib therapy. Sunitinib will not be funded concomitantly with imatinib.

Criteria for assessment at every six months:
There is no objective evidence of disease progression.