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| |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 @ 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

Drugs with Positive Change in PDL Status

|Preferred |Notes/Conditions |

|Androgel |Co-preferred transdermal testosterone with Androderm. |

|Azor |Co-preferred ARB/CCB with Exforge. |

|Bupropion XL |The brand Wellbutrin XL becomes non-preferred. |

|Cefdinir |The brand Omnicef becomes non-preferred. |

|Cimzia |As with other preferred biological drugs, step drug therapy is also required to obtain Cimzia without prior |

| |authorization |

|Creon |Co-preferred with Ultrase and Viokase |

|Humalog/Humulin |Certain Humalog/Humulin products will now be preferred, please refer to MaineCare PDL for specific versions |

|Lantus |Lantus is now a co-preferred basal insulin with Levemir. |

|Levaquin |Co-preferred with ciprofloxacin and Avelox. Dosing limits will apply |

|Tazorac Gel |Now a preferred acne agent. |

|Wellbutrin SR TBCR |This brand will be co-preferred with the generic. |

|Zaleplon |Step 2 medication after zolpidem, dosing limits will apply |

|Zolpidem |Quantity limits increased from 12 to 30 per month. |

| | |

|Drugs with Negative Change in PDL Status |

|Non-preferred |Notes/PA Criteria |

|Ambien CR |Quantity limits will apply |

|Cardizem LA TB24 |Use generic CCBs instead. |

|Coreg CR |Use generic carvedilol instead. |

|Cozaar 50 & 100 mg |Please use multiple preferred 25mg tabs. |

|Crestor |Use Lipitor or simvastatin. |

|Daytrana |Use other preferred stimulants. |

|Differin |Use other preferred acne therapies. |

|Lexapro |Use preferred generic SSRIs. Current users of Paxil CR and Lexapro will be grandfathered. |

|Lunesta |Quantity limits will apply |

|Mirapex |Current Parkinson’s Mirapex users will be grandfathered. |

|Omnicef |Use generic cefdinir. |

|Paxil CR |Use preferred generic SSRIs. Current users of Paxil CR and Lexapro will be grandfathered. |

|Prilosec OTC |Please use generic omeprazole |

|Rebetol Caps |Use generic ribavirins. |

|Vytorin |Use Lipitor or simvastatin, with other adjunctive cholesterol reducers |

|Wellbutrin XL |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 non-fluoroquinolone 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 . 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 jennifer.cook@

Timothy Clifford, MD at tclifford@

For PA/PDL questions you may contact:

Laureen Biczak, DO at lbiczak@

Michael Ouellette, R.Ph at mouellette@

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