Formulary Update - December 2011

u Formulary Additions . . . 1
u No Initial Fill Medications2
u Standing Orders . . . . . . . . 2
u Criteria Restricted
Medications . . . . . . . . . . . . 2
ISSUE 5
V O LU M E 6
DECEMBER 2011
u Quantity Limits . . . . . . . . . 3
uM
edicare Formulary . . . .
3
u Drug Benefit Update: 2012
Medicare Part D Changes 4
u Floorstock Medications
u Clinical Updates . . . . . . .
u Medications Reviewed At
5
5
P&T, But Not Added To The
Formulary . . . . . . . . . . . . . 5
Formulary
Update
A P U B L I C AT I O N O F T H E G E O R G I A P H A R M A C Y A N D T H E R A P E U T I C S ( P & T )
C O M M I T T E E . The Formulary Update contains information regarding formulary additions,
deletions, exclusions, brief descriptions of products, and current drug related news. It also lists items
to be discussed at upcoming P&T meetings. Please refer to the web site http://kpnet.kp.org:81/ga/
healthcare/formularies.html or providers.kp.org for the full KP GA Drug Formulary. If you have
Lexi-Comp PDA access to the KPGA Online Formulary, remember to sync
your device for the most current
information.
Formulary Additions
Testosterone (Androderm) 2
mg/24 hours and 4 mg/24 hours
transdermal patches were added
to the Commercial Formulary
and the Medicare Part D (MPD)
Formulary on December 6, 2011.
Androderm is FDA approved for the
treatment of male hypogonadism.
Androderm 2.5 mg and 5 mg
patches have been discontinued
by the manufacturer. Patients can
be adequately controlled on lower
strengths of Androderm, which reduces
the possibility of testosterone blood
concentrations outside the upper limit
of normal. Androderm 2 mg and 4 mg
patches are smaller in size and contain
20% less testosterone than the 2.5 mg
and 5 mg patches, respectively. As
supplies of Androderm 2.5 mg and 5
mg patches dwindle, patients will need
to be converted to the newer strengths.
Providers will need to provide a signed
Androderm prescription for patients
when converting to the 2 mg or 4 mg
patches.
Calcium
acetate
(Phoslyra) 667 mg/5
ml oral solution
was added to the
Commercial
and
MPD Formularies
December 6, 2011.
Currently, there is a shortage of
PhosLo (calcium acetate) tablets. In
order to continue to have a calcium
acetate product available during the
shortage, Phoslyra has been added to
the formulary. Phoslyra is available to
members for a brand copay.
Dasatinib (Sprycel) 100 mg tablet
is currently available on the MPD
Formulary and will be added
to the Commercial Formulary
effective December 20, 2011.
Dasatinib is a tyrosine kinase inhibitor
indicated in the treatment of certain
types of leukemias. Currently, dasatinib
20 mg, 50 mg, and 70 mg tablets are
available on the KPGA Commercial
formulary. The addition of dasatinib
100 mg tablets to the Commercial
Formulary allows for more dosing
flexibility in patients requiring a higher
dose of the medication. Page 1
Formulary Additions, Cont .
Olanzapine (generic Zyprexa Zydis) 5 mg, 10 mg, 15 mg and 20 mg
orally disintegrating tablets (ODT) are available on the Medicare Part
D Formulary will be added to the Commercial Formulary effective
December 20, 2011. Olanzapine is a thienobenzodiazepine antipsychotic
C riteria
R estricted
M edications
indicated for the treatment of schizophrenia, acute or mixed mania episodes
associated with bipolar I disorder (as monotherapy or in combination with lithium
or valproate), maintenance treatment of bipolar disorder, and in combination with
fluoxetine for treatment-resistant or bipolar depression. Olanzapine and Olanzapine ODT became
available generically in October and offers a significant cost savings over the branded products,
Zyprexa and Zyprexa Zydis. Olanzapine ODT will be available to members for a generic co-pay.
Olanzapine ODT offers an additional dosage from for those patients needing treatment with
olanzapine who are unable to swallow tablets.
Gabapentin (generic Neurontin) 250 mg/5 ml oral solution is available
on the Medicare Part D Formulary and will be added to the Commercial
Formulary effective December 20, 2011. Gabapentin is a GABA analog indicated
for adjunctive therapy for treatment of partial seizures with and without secondary
generalized seizures in patients >12 years of age with epilepsy; adjunctive therapy for
treatment of partial seizures in pediatric patients 3-12 years of age; and management
of postherpetic neuralgia (PHN) in adults. Gabapentin 250 mg/ml oral solution became
generically available in May 2011 and has been approved for use in place of Neurontin 250 mg/ml
oral solution by the KP National Pharmacy product evaluation process. Gabapentin oral solution
offers an additional dosage form for those patients needing treatment with gabapentin who are
unable to swallow tablets or capsules.
New No Initial Fill Medications
No initial fill medications are Commercial non-formulary medications that require review by the
Pharmacy Consult Service (PCS) prior to the first fill of the medication under the drug benefit.
These Commercial non-formulary medications are not eligible for a thirty day courtesy supply from
the pharmacy prior to PCS authorization. No initial fill only applies to Commercial members with a
closed formulary benefit.
Rivaroxaban (Xarelto) 15 mg and 20 mg tablets: Rivaroxaban 15 mg and 20 mg tablets are
an oral factor Xa inhibitor indicated to reduce the risk of stroke and systemic embolism in patients
with nonvalvular atrial fibrillation (AF). Guidelines for the use rivaroxaban 15 mg and 20 mg tablets
have been developed and reviewed by the P&T Committee. Rivaroxaban 15 mg and 20 mg tablets
will be added to the Criteria Restricted Medications (QRM) list April 1, 2012.
Sitagliptin and simvastatin (Juvisync) tablets: Sitagliptin and simvastatin (Juvisync™) tablets are FDA approved for use in patients for whom treatment with sitagliptin and simvastatin is
appropriate. Sitagliptin is FDA approved as an adjunct to diet and exercise for the treatment of
type 2 diabetes mellitus and simvastatin is indicated an as adjunct to diet for the management of
lipid disorders. Other sitagliptin containing products, Januvia (sitagliptin) and Janumet (sitagliptin/
metformin) are currently on the QRM list on the Commercial formulary. The guidelines for the use
of sitagliptin/simvastatin align with the current guidelines for the other sitagliptin containing products. Sitagliptin/simvastatin will be added to QRM April 1, 2012.
New Standing Orders
Approved standing orders are written instructions issued by medical practitioners, in accordance
with the regulations, authorizing pharmacy personnel at pharmacies owned or operated by Kaiser
Foundation Health Plan to supply and administer specified medications under circumstances
specified in the order.
Colchicine: Distribution of generic colchicine was discontinued in September 2010. Prior to the
distribution being stopped, KP was able to obtain supplies. After the existing supplies of generic
colchicine are exhausted, only FDA approved brand colchicine (Colcrys) will be available. A standing order has been developed to help promote efficient prescribing of colchicine and to help preserve the existing supplies.
Page 2
Criteria restricted medications
require review by Quality Resource
Management (QRM) prior to
coverage. The prior authorization
process and criteria apply to the
Commercial formulary, not the
Medicare Part D formulary.
Providers must call QRM to
request authorization consideration
at 404-364-7320 (Option 2).
A complete listing of prior
authorization medications and their
corresponding criteria is available
on the intranet under Healthcare
Delivery/ Guides & Reference/
Formularies/ Criteria Restricted
(QRM) Medications.
The following medications will
be added to the list of Criteria
Restricted Medications (QRM)
effective January 1, 2012:
•
•
•
Provenge (sipuleucel-T)
Soliris (eculizumab)
Tradjenta (linagliptin)
New Quantity Limits
Q uestions
and
C oncerns ?
For certain medications, KP establishes quantity limits for Commercial Coverage to
help ensure safe and appropriate use or when there is a market place shortage of a
medication.
Oxycontin (oxycodone controlled release) is FDA approved for every 12 hour
If you have any questions or
concerns, please contact any of the
following P&T Committee members
and designated alternates:
P&T Chair:
Daniel Lee, MD, FACS
Physician Program Director of
Pharmacy
P&T Committee Members:
Seeme Ahmad, MD
Behavioral Health
Debbi Baker, PharmD, BCPS
Clinical Pharmacy
Gary Beals, RPh
Director of Pharmacy
Karen Bolden, RN, BSN
Clinical Services
Deborah Burzotta, PharmD
Pharmacy Operations
Alyssa Dayton, MD
Obstetrics and Gynecology
Carole Gardner, MD
Elder Care
Patrice Gaspard, MD
Pediatrics
Kelly Degraffenreid, MD
Ambulatory Medicine
Donald Hanchett, MD
Ambulatory Medicine
David Jones, MD
Pediatrics
Felecia Martin, PharmD
Pharmacy/Geriatrics
Susan Moon, MD
Hospitalist
dosing. Within our region, 63% to 72% of patients purchase > 60 tablets of Oxycontin
per month which is inconsistent with the product labeling. On November 1, 2011, the
Centers for Disease Control and Prevention (CDC) published a report on “Overdoses of
Proscription Opioid Pain Relievers.” As part of the report, the CDC recommends insurers
identify and take action to reduce both inappropriate and illegal prescribing. The CDC
also recommends insurers limit reimbursement in ways that reduce inappropriate
prescribing, discourage efforts to obtain opioids from multiple health-care providers,
and improve clinical care. Implementation of a quantity limit on Oxycontin aligns with
the recent recommendations from the CDC. Beginning January 2nd, a quantity limit
will be imposed on Oxycontin so that coverage is limited to no more than 60 Oxycontin
tablets, across all strengths, per 30 days.
Xarelto (rivaroxaban) 10 mg tablets are FDA approved for prophylaxis of deep
vein thrombosis (DVT ) in patients undergoing hip and knee replacement surgery.
Rivaroxaban 10 mg tablets are taken once daily for 12-14 days for DVT prophylaxis
following hip replacement surgery and once daily for 35 days following hip replacement
surgery. To help ensure the appropriate use of rivaroxaban 10 mg tablets, a quantity
limit of up to 35 tablets will be activated beginning January 2nd, 2012.
Medicare Part D Formulary
Kaiser Permanente has a National Medicare Part D (MPD) Formulary. Each regional P&T
Committee reviews drugs and decides on formulary status. Regional P&T chairs are voting
members of an interregional committee that addresses the relatively few drugs for which regional
decisions differ. This committee is called MPD Formulary Reconciliation Committee (MPD
FoRCe). MPD FoRCe resolves differences in formulary decisions. Regional P&T chairs convey
the decision(s) back to their respective regional P&T Committees to finalize the National MPD
Formulary decision(s).
The following medications were added to the MPD Formulary on the corresponding effective date:
Medication Name
Brand or Generic?
Effective Date
Hycet Solution 7.5-325 mg
Generic
11/1/2011
Hydrocodone/Acetaminophen solution 10-325 mg
Generic
11/1/2011
Hydromorphone Hcl Tablet 8 mg
Generic
11/1/2011
Methotrexate Sodium Injection 50 mg/2 ml
Generic
11/1/2011
Adcentris Injection 50 mg
Brand
12/6/2011
Androderm 2 mg/24 hr & 4 mg/24 hr
Brand
12/6/2011
Complera tablet
Brand
12/6/2011
Creon Capsule 3000 Unit
Brand
12/6/2011
Levofloxacin in D5W Injection 250 mg/50 ml
Generic
12/6/2011
Levofloxacin in D5W Injection 500 mg/100 ml
Generic
12/6/2011
Levofloxacin in D5W Injection 750 mg/150 ml
Generic
12/6/2011
Designated Alternates:
Levofloxacin Injection 25 mg/ml
Brand
12/6/2011
Jacqueline Anglade, MD
Obstetrics and Gynecology
Levofloxacin Solution 25 mg/ml
Generic
12/6/2011
Brand
12/6/2011
Lesia Jackson, RN
Clinical Services
Trospium Chloride Tablet 20 mg
Generic
12/6/2011
Xalkori Capsule 200 mg & 250 mg
Brand
12/6/2011
Zelboraf Tablet 240 mg
Brand
12/6/2011
Margaret Shugart, MD
Behavioral Health
Phoslyra Solution
Page 3
Drug Benefit Update:
2012 Medicare Part D Changes
This section contains a brief overview of some of the Medicare Part D drug benefit changes
that will go into effect January 1, 2012.
A dditional
C linical
A lerts
• Initial coverage threshold amount in Total Drug Costs (TDC) will increase to $2,930 (from $2,840
in 2011). TDC is the annual accumulation of covered Part D pharmacy charges (what the Part D
plan and member pay).
•• Total Out of Pocket (TrOOP) will increase to $4,700 (from $4,550 in 2011) in the Coverage Gap
(donut hole). TrOOP is the annual accumulation of copayments, coinsurance, brand discount payments (and deductible, if any) paid by the member or by anyone on his/her behalf.
•• Part D Drug Benefit featuring six drug tiers for Kaiser Permanente Senior Advantage Individual
Plan (KPSA DPA) members. Each drug on our Part D formulary is assigned a drug tier that will have
a different cost sharing. Our KPSA DPA members pay the cost sharing according the coverage
stage they are in (i.e., initial coverage, coverage gap and catastrophic coverage).
Tier 1 – Preferred generic (Value Generic) drugs – new tier that will feature lower generic copays
for select chronic condition drugs
Tier 2 – Non-preferred generic (Generic) drugs – new tier for other generics
Tier 3 – Preferred brand-name (Brand) drugs – new tier for current formulary brand-name drugs
Tier 4 – Non-preferred brand-name drugs – new tier for current non-formulary brand drugs
that will be available at a higher cost sharing in 2012 (without the need for a formulary
exception)
Tier 5 – Specialty Tier – new tier level, no change in cost sharing
Tier 6 – Injectable Part D vaccines – new tier for injectable vaccines, $0 copay (these vaccine
costs count toward the Part D TDC accumulation)
•• Group members will continue to have a two-tier generic/brand drug benefit with different coverages and cost sharing.
• Medicare Part D members may have prescriptions filled at KP pharmacies and SELECT Rite Aid
pharmacies. For specific locations, refer to the 2012 Pharmacy Directory located on Knowledge
Base (pharmacy, benefits, Medicare).
KPSA Individual Part D Cost Sharing*
Initial Coverage
(to $2,930 TDC)
Up to 30-day supply
Coverage Gap
Catastrophic Coverage
(up to $4,700 in TrOOP) (over $4,700 in TrOOP)
Up to 30-day supply
Per Prescription
Tier 1
Preferred Generics
KP: $5-7 copay
Rite Aid†: $12 copay
MOI: $10-14 copay
KP: $5-7 copay
Rite Aid†: $12 copay
MOI: $10-14 copay
Tier 2
Non-preferred
Generics
KP: $10 copay
Rite Aid†: $20 copay
MOI: $20 copay
KP: $10 copay
Rite Aid†: $20 copay
MOI: $20 copay
Tier 3
Preferred Brands
KP: $45 copay
Rite Aid†: $50 copay
MOI: $90 copay
Tier 4
Non-preferred
Brands
KP: $65 copay
Rite Aid†: $75 copay
MOI: $130 copay
Drug Tier
Tier 5
Specialty Drugs
Tier 6
Part D Injectable
Vaccines
Coverage Gap Brand
discount payment**
$2-5 copay
$10-15 copay
25% coinsurance
$0
† Medicare Part D members can only have prescriptions filled at SELECT Rite Aid Pharmacies.
* Actual copay will depend on whether member has selected the Basic or Enhanced Individual Plan.
** 50% of the drug price less the brand dispensing fee.
Abbreviations: MOI = Mail-order incentive - two copays for up to 90-day supply; TDC = Total Drug Costs; TrOOP = Total Out-of-Pocket
Page 4
Tumor Necrosis Factor (TNF)
blockers, Azathioprine and/or
Mercaptopurine: Update on Reports
of Hepatosplenic T-Cell Lymphoma
in Adolescents and Young Adults
http://www.fda.gov/Safety/
MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/
ucm251443.htm
Stimulant Medications used
in Children with AttentionDeficit/Hyperactivity Disorder Communication about an Ongoing
Safety Review
http://www.fda.gov/Safety/
MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/
ucm166667.htm
Selective Serotonin Reuptake
Inhibitor (SSRI) Antidepressants:
Drug Safety Communication - Use
During Pregnancy and Potential
Risk of Persistent Pulmonary
Hypertension of the Newborn
http://www.fda.gov/Safety/
MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/
ucm283696.htm
Xigris [drotrecogin alfa (activated)]:
Market Withdrawal - Failure to Show
Survival Benefit
http://www.fda.gov/Safety/
MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/
ucm277143.htm
Methylene Blue: Drug Safety
Communication - Serious CNS
Reactions Possible When Given to
Patients Taking Certain Psychiatric
Medications
http://www.fda.gov/Safety/
MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/
ucm265476.htm
Zyvox (linezolid): Drug Safety
Communication - Serious CNS
Reactions Possible When Given to
Patients Taking Certain Psychiatric
Medications
http://www.fda.gov/Safety/
MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/
ucm265479.htm
Floorstock Additions
U p C oming
F ormulary
D ecisions :
Department Name
Medication Added
Cardiology
Epinephrine 0.15 mg and 0.3 mg auto injector
Endocrinology
Novolin R 100 units/ml, 10 ml vial
Oncology/Infusion
Prevnar 13, 0.5 ml SDV
Clinical Updates
FDA Drug Safety Communication: Review Update of Trilipix (Fenofibric Acid) and the ACCORD Lipid Trial. FDA notified healthcare profes-
An important aspect of the formulary
process is the involvement of all
practitioners. So that each of you has
an opportunity to participate in the
process, upcoming P&T agenda items
are listed below. Please contact your
P&T Committee representative or your
clinical service chief by January 1, 2011
if you wish to comment on any of the
medications, class review, or other
agenda items under consideration. To
make formulary addition requests, you
must submit a Formulary Additions/
Deletions Form and Conflict of Interest
Form to Drug Information Services or
call (404) 949-5331.
Formulary
Reviews
Formulary Reviews
(February
2012):
(August 2011):
• Formulary status of the
•Formulary
status
of the following
following
medications
will be
medications
will
be
reviewed:
reviewed: Zytiga,
Rifapetine,
Nuedexta
and Viibryd
and Estrace
• The criteria for Prior Authorization
medications
(QRM)
willRbe
Medication
Class
eviews
reviewed.
Antianxiety Agents
Antiasthmatics
Anticonvulsants
Antidepressants
Antimyasthenic
Antiparkinsons
Antipsychotics/Antimanic Agents
Genitourinary - Misc.
Hematological agents - Misc.
Hypnotics
Migraine Products
Neuromuscular Blockers
Psychotherapeutics - Misc.
Stimulants/ADHD
Urinary Anti-infectives
Urinary Antispasmodics
sionals the cholesterol-lowering medication Trilipix (fenofibric acid) may not lower a
patient’s risk of having a heart attack or stroke. FDA reviewed the data from the Action
to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. The ACCORD Lipid trial
found no significant difference in the risk of experiencing a major adverse cardiac event
between the group treated with fenofibrate plus simvastatin compared with simvastatin alone. Trilipix was approved by the FDA in 2008 as an adjunct to dietary therapy
to lower triglycerides and low-density lipoprotein (LDL) cholesterol, and to increase the
high-density lipoprotein cholesterol. Fenofibrate at a dose equivalent to 135 mg of Trilipix was
not shown to reduce coronary heart disease morbidity and mortality in two large randomized controlled trials. Trilipix is non-formulary at KP. Generic fenofibrate 54 mg and 160 mg strength tablets
are available on the Commercial and Medicare Part D Formularies.
Directives
• Healthcare professionals should consider the benefits and risks of Trilipix when deciding to
prescribe the drug to patients, and counsel patients about those benefits and risks. FDA MedSafety Alert: Serious Bleeding Events with Dabigatran
(Pradaxa). The FDA is evaluating post-marketing reports of serious bleeding
evens in patients taking dabigatran (Pradaxa). Dabigatran is an anticoagulant
used to reduce the risk of stroke in patients with non-valular atrial fibrillation
(AF). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. In a large clinical trial, (18,000 patients) comparing dabigatran and warfarin, major bleeding events occurred at similar rates between the two
groups. FDA is working to determine whether the reports of bleeding in patients taking dabigatran
are occurring more commonly than would be expected, based on observations in the large clinical
trial that support the approval of dabigatran. Dabigatran is designated as a Criteria Restricted Medication (QRM) on the Commercial formulary. Dabigatran is not on the Medicare Part D Formulary.
Guidelines for the use of dabigatran have been developed and approved by the P&T Committee
and are available on the intranet under Health Care Delivery, Guides and Reference, Formularies,
QRM Guidelines.
Directives:
• At this time, FDA continues to believe that dabigatran provides an important health benefit
when used as directed. FDA recommends healthcare professionals who prescribe dabigatran
follow the recommendations in the approved drug label.
• Patients with AF should not stop taking dabigatran without talking to their healthcare professional. Stopping use of blood thinning medications can increase the risk of stroke, which can
lead to permanent disability and death.
Medications Reviewed at the P&T Meeting,
but NOT Added to the Formulary
•
•
•
•
•
•
•
Ticagrelor (Brilinta) 90 mg tablet, decision pending for MPD
Gapapentin enacarbil (Horizant) 600 mg extended-release tablet, decision pending for MPD
Clonidine (Kapvay) 0.1 mg and 0.2 mg extended-release tablets, decision pending for MPD
Incobotulinumtoxin A (Xeomin) 50 unit and 100 unit injection, decision pending for MPD
Simvastatin/sitagliptin (Juvisync) tablets
Rivaroxaban (Xarelto) 10 mg, 15 mg, and 20 mg tablets
Gatifloxicin (Zymaxid) 0.5% opthalmic solution, decision pending for MPD
Page 5