The SPARCL Study and Number Needed
to Harm Analysis; Value of High Dose Atorvastatin in Preventing Recurrent
Stroke Risk May be Uncertain
The recently published SPARCL (Stroke
Prevention by Aggressive Reduction in Cholesterol Levels[1])
trial reports a modest reduction in the risk of stroke over
a 5-year period with atorvastatin 80 mg daily versus placebo. At
a recent presentation of the SPARCL results in
Europe, Dr. Michael Welsh, one of the study authors, concluded
that atorvastatin showed a “very clear overall benefit” in
patients with a recent stroke and that “these results support using
atorvastatin at 80mg/day in stroke and TIA patients as soon as
possible after the event.”[2] Dr.
Welsh stated that SPARCL results are
“anticipated to have a significant impact on the treatment of patients
with a recent stroke.”[3]
However, an independent benefit versus
risk analysis review of the SPARCL data by RegenceRx indicated the following
for atorvastatin v. placebo over a five-year treatment period:
· the
Number Needed to Treat (NNT) to prevent one recurrent stroke equaled
46 patients;[4]
· the
Number Needed to Harm (NNH) for increased liver function tests greater
than three times the upper limit of normal was equal to 58 patients;[5]
· the
NNH for discontinuation due to adverse events was equal to 33 patients.
Based on this analysis, the chance that
a patient will discontinue atorvastatin due to an adverse event
is actually greater than the chance of preventing a recurrent stroke
over a five-year period. Accordingly, the overall value for the use of atorvastatin
at 80mg/day in stroke and TIA patients based on the results of the trial
is uncertain. Application of the SPARCL trial to clinical practice
should be carefully weighed by the individual provider when
evaluating lipid lowering therapy in these patients.
Medication
Review in Brief: Opana® and Opana ER®
RegenceRx
recently reviewed published and unpublished clinical trial
data for Opana® (oxymorphone) and Opana ER® (oxymorphone
extended release). Review of this data showed that although Opana
and Opana ER may be similar in action to other narcotic analgesic medications
in relieving pain, there are serious safety concerns with Opana and
Opana ER. In clinical trials up to 50% of patients were unable
to complete the trials due to side effects.[6]
Other
safety concerns with oral oxymorphone products arise from the
potential risk for patient harms that are not easily predictable. These
potential risks include:
· oxymorphone
levels can increase by 50% if taken with food;[7]
· potentially
fatal increases in oxymorphone drug levels observed when the medication
is combined with alcohol;[8]
· oxymorphone
clearance may be decreased up to 40% in patients over 65 years
of age;[9]
· dosage
reductions are required in the presence of mild renal impairment;[10] and
· oxymorphone
is contraindicated in moderate and severe hepatic impairment.[11]
RegenceRx
concluded that because of Opana’s safety profile, it does not
offer any additional clinical benefit over other extended release
or immediate release opioid analgesics in the treatment of chronic pain.
The
RegenceRx Pharmacy and Therapeutics Committee unanimously voted to:
· To
maintain Opana and Opana ER as non-formulary, non-preferred status due
to safety and tolerability issues.
· Warn
prescribers about the safety concerns regarding Opana and Opana ER
Food and Drug Administration (FDA)
Alert
– Tamiflu®
In November 2006, the manufacturer of
Tamiflu®, Roche Pharmaceuticals, and the FDA notified healthcare
professionals of revisions to the prescribing information for
Tamiflu®. Post
marketing reports have indicated that people with the flu,
particularly children, may be at an increased risk of self-injury and
confusion shortly after taking this product and should be closely monitored
for signs of unusual behavior. A healthcare professional should
be contacted immediately if the patient taking Tamiflu® shows
any signs of unusual behavior. Read the letter sent to healthcare
professionals regarding this prescribing information revision
at:
http://www.fda.gov/medwatch/safety/2006/Tamiflu_dhcp_letter.pdf
Tamiflu®
was recently added to the RegenceRx Preferred Medication List/Formulary. Tamiflu® is
indicated for the treatment and prevention of influenza, viruses type
A and B, in persons ≥ 1 y.o.
The above FDA alert and other MedWatch
2006 Safety Summaries can be found at: http://www.fda.gov/medwatch/safety/2006/safety06.htm
RegenceRx
P&T Decisions
The following medications were added to the RegenceRx Preferred Medication
List/Formulary:
Tamiflu® – indicated for the prevention and treatment of influenza types
A and B in persons ≥ 1 y.o.
Atripla™– indicated
for the treatment of HIV-1 infection alone as a complete regimen, or
in combination with other antiretroviral agents in adult patients.
Prezista™– indicated for the treatment of HIV-1 infection in combination with
ritonavir and other antiretroviral agents in antiretroviral treatment-experienced
adult patients.
The following medications will remain Non-Preferred/Non-Formulary
at this time:
Chantix® - indicated
for smoking cessation treatment. Preferred Medication List/Formulary
alternatives include: bupropion SR.
Daytrana® - indicated for the treatment of Attention
Deficit Disorder. Preferred
Medication List/Formulary alternatives include: methylphenidate, methylphenidate
ER tablets, and methylphenidate ER capsules (Metadate CD®).
Exubera® - indicated
for the treatment of diabetes mellitus, Type 1 and Type 2. Preferred
Medication List/Formulary alternatives include: insulin aspart
(Novolog®)
and insulin lispro (Humalog®). For more information on this
medication, please see the see the RegenceRx
Therapeutic Class ReviewSM Summary for
this medication.
IPLEX® - indicated for
long-term treatment of growth failure in children with severe
primary IGF-1 deficiency or growth hormone gene deletion with neutralizing
antibodies. Preferred
Medication List/Formulary alternatives include: mecasermin (Increlex®).
Opana®/Opana® ER – indicated
for the relief of moderate to severe acute pain when use of an
opioid medication is appropriate/for the relief of moderate
to severe pain in patients requiring continuous, around the
clock treatment for an extended duration. For Preferred Medication
List/Formulary alternatives for immediate and sustained release opioid
pain relievers, please see our RxPrice
Guide.
Sprycel® –
indicated for the treatment of
Philadelphia positive acute lymphoblastic leukemia with
resistance or intolerance to prior therapy and for chronic
myeloid leukemia with resistance or intolerance to prior therapy. Preferred Medication
List/Formulary alternatives include: imatinib mesylate (Gleevac®)
and cytarabine (Cytosar-U®; covered under the medical benefit).
YAZ® - indicated for the prevention of
pregnancy. For
Preferred Medication List/Formulary oral contraceptive alternatives,
please see our RxPrice
Guide.
For more information, please see our Preferred
Medication List/Formulary.
Medication
Policy Updates
The following medications have new or updated Medication Policies:
Brand Proton Pump Inhibitors (PPI) Medications - Nexium®, Aciphex®,
Protonix®, and Prevacid®. As
of November 1, 2006, RegenceRx has introduced a generics
first initiative for the PPI medication class requiring that either
omeprazole or Prilosec OTC® be tried first for new start PPI patients. New start,
brand name, prescription PPI's require prior authorization and will
only be authorized if generic omeprazole or Prilosec OTC® is not
an option. For members on a brand PPI prior to November 1, 2006,
prior authorization will not be necessary.
Please note, eligible members may receive
their first prescription for generic omeprazole or Prilosec
OTC® at
no charge under our voluntary Generic Incentive Program. See below
for more information on this member program.
For more information please see our Medication
Policies.
Generic
Medications
New Generic Medications at the
Pharmacy or Coming Soon! [12]
Consumers stand to save billions of
dollars in prescription drug costs in the next few years as
a wave of brand name medications come off of patent. The chart
below includes a list of generic medications already at the pharmacy
or coming soon to a pharmacy near you!
Asthma/Allergy
cetirizine (Zyrtec®) – Fall/Winter 2007
fluticasone (Flonase®) –
March 2006
nedocromil (Tilade®) –
Spring/Summer 2007
olopatadine (Patanol®) – Winter 2006 |
Women’s Health
estradiol transdermal (Climara®) – Winter
2006
ethinyl estradiol/levonorgestrel (Seasonale®) – September
2006 |
Cardiology
colestipol (Colestid®) –
May 2006
metoprolol XL (Toprol XL®)
– Spring/Summer 2007
pravastatin (Pravachol®) –
April 2006
simvastatin (Zocor®) – June 2006 |
Other
fentanyl citrate lollipop (Actiq®) - October
2006
finasteride (Proscar®) –
June 2006
meloxicam (Mobic®) –
September 2006
methylphenidate ER (Concerta®) –Spring/Summer
2007
ondansetron (Zofran®) - Winter 2006
oxybutynin XR (Ditropen XR®) – Winter
2006
terbinafine (Lamisil®) – Winter 2006 |
Mental Health/Sleep
Disorders
sertraline (Zoloft®) –
August 2006
venlafaxine (Effexor®) –
August 2006
zolpidem (Ambien®) – Spring 2007 |
Special
Member Program Spotlight
RegenceRx Generic Incentive Program
This voluntary program permits eligible
members to receive the first prescription (up to a month’s supply)
of certain medications at no charge. The following medications
are included under the program:
Antidepressants
citalopram (Celexa®)
fluoxetine (Prozac®)
bupropion SA (Wellbutrin SR®)
Antidiabetic Agents
glipizide (Glucotrol®)
glipizide XL (Glucotrol XL®)
glyburide (Diabeta®, Micronase®)
metformin (Glucophage®)
metformin ER (Glucophage XR®)
Antihypertensives
metoprolol (Lopressor®)
lisinopril (Prinivil®, Zestril®)
lisinopril/HCTZ (Prinzide®, Zestoretic®)
felodipine ER (Plendil®) |
Anti-Inflammatories
etodolac (Lodine®)
ibuprofen (Motrin®)
nabumetone (Relafen®)
naproxen (Naprosyn®)
Antiviral
acyclovir (Zovirax®)
Endocrine/Thyroid
levothyroxine (Synthroid®)
Gastric Acid Agents
omeprazole (Prilosec®)
Prilosec OTC® |
Hormone Replacement Therapy
estradiol (Estrace®)
Lipid Lowering Agents
fenofibrate (Lofibra®)
gemfibrozil (Lopid®)
lovastatin (Mevacor®)
Neurology
gabapentin (Neurontin®)
Urinary Agents
oxybutynin (Ditropan®) |
For more information on the Generic
Incentive Program, and all of the RegenceRx special member programs,
please see:
http://www.regencerx.com/programs/physicianPrograms/index.html
Provider
Feedback
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