Department of Health and Human Services
MaineCare Services
442 Civic Center Drive
# 11 State House Station
Augusta, Maine 04333-0011
Tel: (207) 287-2674; Fax: (207) 287-2675
TTY: 1-800-423-4331
PHARMACY BENEFIT UPDATE
Fall 2008 Issue
Preferred Drug List (PDL) News
A. EXPLANATION OF MAJOR PDL CHANGES
The design analysis concluded a need to promote generic utilization much more
aggressively. Current generic use is at 65%. Considering the number of generics that
are scheduled to occur over the next year, we predict that the generic use rate will
increase to over 70%. The average brand drug costs nearly $140 while the average
generic now costs only $15 to $20. As you will note below, more than a few PDL
categories will only have generics as preferred choices. Most notably this affects the
SSRIs with both Lexapro and Paxil CR becoming non-preferred for new starters.
Clinically we know from comparative studies that no one of the SSRIs is superior to all
other SSRIs. (For an excellent thorough review, please visit the website of the Oregon
Evidence-based Practice Center at the Oregon Health and Science University @
www.ohsu.edu/ohsuedu/research/policycenter/customcf/derp) Established brand users
will be grandfathered.
Two of the three manufacturers of potent brand statins (Crestor, Lipitor and Vytorin)
only submitted bids to have their drug become exclusively preferred or one of two
potent brand statins. Fewer preferred brand drugs would result in increased usage of
the least expensive potent statin, simvastatin. Crestor and Lipitor have much more
published outcomes data than Vytorin. Both Crestor and Lipitor are considered to be
therapeutically comparable with neither being inferior nor superior to the other. And
finally, there are four times as many MaineCare members currently using Lipitor than
Crestor.
Most of the other PDL moves were designed to increase generic usage. The preferred
beta blockers and calcium channel blockers are now exclusively generics. The generic
for Requip, ropinirole, is now preferred over both Requip and Mirapex. Parkinson’s
patients using Mirapex will be grandfathered. In the Sedative/Hypnotic non-benzo class,
zolpidem becomes preferred and both Ambien CR and Lunesta become non-preferred.
The Federal government put a price cap of $0.07 on zolpidem pills so they have
become extraordinarily less expensive than the brand sleepers. As a consideration, the
quantity limit on zolpidem has been raised from 12 to 30 per month.
Because Medicaid receives mandatory rebates from manufacturers that are affected by
“Best Price” regulations, some brand drugs become oddly priced to states over time.
Best Price means that manufacturers must give Medicaid Programs the same best deal
that they offer to any nongovernmental customer. The manufacturers are also penalized
whenever they increase drug prices faster than the rate of inflation. These requirements
sometimes make different strengths of a drug more cost effective than other strengths.
Collectively, these “brand preferred over generic” and “preferred strengths” save the
state several million dollars annually.
B. PDL CHANGES EFFECTIVE JANUARY 1, 2009
The State of Maine has recently completed the annual review of all PDL
categories and the drugs within those categories. The following is a list of the
major changes to the PDL for 2009. For a complete list of the Preferred Drug List
please refer to www.mainecarepdl.org
Preferred
Drugs with Positive Change in PDL Status
Notes/Conditions
Androgel
Azor
Bupropion XL
Cefdinir
Cimzia
Creon
Humalog/Humulin
Lantus
Levaquin
Tazorac Gel
Wellbutrin SR TBCR
Zaleplon
Zolpidem
Co-preferred transdermal testosterone with Androderm.
Co-preferred ARB/CCB with Exforge.
The brand Wellbutrin XL becomes non-preferred.
The brand Omnicef becomes non-preferred.
As with other preferred biological drugs, step drug therapy is also
required to obtain Cimzia without prior authorization
Co-preferred with Ultrase and Viokase
Certain Humalog/Humulin products will now be preferred, please
refer to MaineCare PDL for specific versions
Lantus is now a co-preferred basal insulin with Levemir.
Co-preferred with ciprofloxacin and Avelox. Dosing limits will apply
Now a preferred acne agent.
This brand will be co-preferred with the generic.
Step 2 medication after zolpidem, dosing limits will apply
Quantity limits increased from 12 to 30 per month.
Drugs with Negative Change in PDL Status
Non-preferred
Notes/PA Criteria
Ambien CR
Cardizem LA TB24
Coreg CR
Cozaar 50 & 100 mg
Crestor
Daytrana
Differin
Lexapro
Lunesta
Quantity limits will apply
Use generic CCBs instead.
Use generic carvedilol instead.
Please use multiple preferred 25mg tabs.
Use Lipitor or simvastatin.
Use other preferred stimulants.
Use other preferred acne therapies.
Use preferred generic SSRIs. Current users of Paxil CR and Lexapro
will be grandfathered.
Quantity limits will apply
Mirapex
Omnicef
Paxil
CR
Prilosec OTC
Rebetol Caps
Vytorin
Wellbutrin XL
Current Parkinson’s Mirapex users will be grandfathered.
Use generic cefdinir.
Use preferred generic SSRIs. Current users of Paxil CR and Lexapro
will be grandfathered.
Please use generic omeprazole
Use generic ribavirins.
Use Lipitor or simvastatin, with other adjunctive cholesterol reducers
Use generic bupropion xl instead.
C. Drug benefit management:
The Department will institute strategies to ensure cost effectiveness through the use of
an enhanced Drug Benefit Preferred brand drugs will no longer be preferred in any PDL
drug category where preferred generic drugs are also available. It is expected that
preferred generics will be used prior to any preferred brands. This will be operated as a
form of step care. Preferred brands in these categories will require prior authorization
for these high utilization / high cost members. Prescribing physicians will receive a list of
their MaineCare members (and their brand drugs) affected by this change. As with
Medicaid members, limited benefit members using the brand antidepressants Lexapro
and Paxil CR will be grandfathered. Brand Duragesic use will also be allowed without
PA.
D. PDL PA EXEMPTIONS
Physicians qualified for a total of over 500 PDL category exemptions. These exemptions
will remain valid for three months and are dependent on continued utilization of the
preferred products on the MaineCare PDL. Several categories qualify for DEA
exemption and the criteria are supplied on the individual exemption reports. Any
provider maintaining an exemption in a particular category for 3 out of 4 quarters will
qualify for a 12 month exemption. For Providers who lose their exemption, any member
that would not have qualified for a non-preferred medication but obtained it due to the
exemption will be subject to prior authorization requirements.
E. CHANTIX AND OTHER SMOKING CESSATION THERAPIES
Use of Chantix, which had increased to a peak of 2,000 scripts per month in early 2008,
has now declined to 1,200. The reasons are fairly apparent. The drug has had bad
press over a variety of worrisome side effects, especially CNS, that were not noted
during the initial drug studies. The head to head trials against bupropion created an
expectation that Chantix might be superior to single drug therapies which has so far not
been borne out in the real world. Critics of the original studies have pointed out the
problematic high drop out rates and inconsistent endpoint outcomes. It is clear that
speaking of the long-term, that no single agent exceeds a 30% abstinence rate. At worst
or at best depending on your point of view, while Chantix may or may not be better than
single agent therapy with NRT or bupropion, quitting cessation rates between Chantix
and combination NRT are broadly similar. The combined use of bupropion and Chantix
is presently being studied. Until results become available, the best option for those
disillusioned with any single agent is the combination of nicotine replacement therapy
with bupropion and educational counseling.
F. GENERIC OXYCONTIN
For the past year, the generic form of Oxycontin has been available as Oxycodone ER
and CR, and has been preferred on the PDL. The brand version, Oxycontin, has always
been non-preferred. Recently most of the manufacturers have stopped producing the
generic and currently only one “so called” generic manufacturer continues to produce a
version that is available sporadically. As a result of the limited production, the cost of
generic oxycontin continues to rise and makes this product difficult for continued
preferred status. Oxycontin will continue to be non-preferred but made available to
current users of the generic product through the prior authorization process. All others
will need to follow the PA criteria including trials of preferred long acting narcotics before
brand Oxycontin will be covered.
G. FLUOROQUINOLONE AND TENDON RUPTURE
The State wants to inform providers that the FDA will be adding a BOXED WARNING
and Medication Guide to the prescribing information to strengthen existing warnings
about the increased risk of developing tendinitis and tendon rupture in patients taking
fluoroquinolones for systemic use.
This risk of tendinitis and tendon rupture is further increased in those over age 60, in
kidney, heart, and lung transplant recipients, and with use of concomitant steroid
therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or
inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the
affected area, and to promptly contact their doctor about changing to a nonfluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or
prevention of an infection should be limited to those conditions that are proven or
strongly suspected to be caused by bacteria.
The State will be including edits on the fluorquinolones for patients over the age of 60,
on immunosuppressants, or currently taking steroid therapy to strengthen this new
BOXED WARNING when prescriptions are filled at the pharmacies.
H. OTC UPDATE
As of 02/28/08, the State began limiting the use of OTC “over the counter” drug
products. A new list of State covered OTC’s and their corresponding NDC numbers is
now available on the State’s web site www.mainecarepdl.org. This list of covered OTC’s
will correspond with the CMS quarterly rebate file. If the NDC is not listed then it will
not be covered. Many “store brand” OTC’s are not listed on this file and therefore will
not be covered by the state. The list will be updated on a quarterly basis to reflect any
updates from the CMS rebate file.
I. DIABETIC SUPPLIES
The State of Maine is looking to expand upon the preferred diabetic supplies to include
lancets, lancet devices, alcohol swabs and syringes. Please look forward to
communication later this year or early in 2009 for specific details to which products will
be preferred.
J. PA STATISTICS
For the third quarter of 2008, there were 19,352 unique PA requests, 76% were
approved. The top five most frequently requested drugs were: aripiprazole/Abilify
(1141), quetiapine/Seroquel (863), venlafaxineHCL/EffexorXR (733), amotoxetine (588),
and nutritionals (541). The average determination time was 3.1 hours.
K. MAIL ORDER
The Department would like to once again remind providers of the mail-order option that
is available to MaineCare members. Prescriptions may be obtained in quantities up to a
90 day supply. Cost savings and conveniences to the MaineCare members are greater
when prescriptions are written in 90 day quantities when using mail-order.
MaineCare Mail Order Pharmacies
E. I-Care Pharmacy: 1-888-422-7319
F. Walmart Mail Order: 1-800-273-3455
L. NEXT DUR COMMITTEE MEETING
The next DUR meeting will be held on Jan 13, 2009 at OMS (442 Civic Center Drive) in
Augusta. Comments on the PDL or any PA’s, either proposed or already in effect, may
be made at these meetings or by e-mail, letter or phone if more convenient.
For DUR questions you may contact:
Jennifer Cook, Pharmacy Unit Manager at OMS [email protected]
Timothy Clifford, MD at [email protected]
For PA/PDL questions you may contact:
Laureen Biczak, DO at [email protected]
Michael Ouellette, R.Ph at [email protected]