Pharmacy and Therapeutics Committee Meeting Summary - June 10, 2009

Agenda and Introduction

The Medicaid Pharmacy & Therapeutics Committee met on Wednesday June 10, 2009 from 8:15 a.m. to 4:30 p.m. in Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.

William Scheer, RPh, (acting Chairperson) asked that the focus of the comments and presentations for the re-reviewed classes be on new, evidence-based information since the last review of the therapeutic classes.

A. Background Materials Provided:

The Committee was provided copies of written materials submitted by interested parties in advance of the meeting.

B. Public Comment Period:

The following speakers provided comment to the committee:

1. Affonso, J. Mario, Medical Affairs, Astellas Pharmaceuticals, Deerfield, IL
2. Perrotta, Vincent, RPh, Senior Area Manager, Allergan Inc., Plainview, NY
3. Zonderman, Jeffrey, MD, Board Certified Eye Physician and Surgeon, Albany Eye Physicians and Surgeons, Latham, NY
4. Baran, Daniel, MD, Senior Regional Medical Director, Merck & Co. Inc., North Wales, PA
5. Schroeder, Scott, MD, Director, Pediatric Pulmonary Medicine and Cystic Fibrosis Center, Albany Medical Center, Albany, NY
6. Shprecher, Adam, PharmD, Medical Science Liaison, Schering-Plough, Phoenix, AZ
7. Price, Arlene, PharmD, Senior Scientific Affairs Liaison, Ortho McNeil Janssen, Randolph, NJ
8. Shostak, Laura, PhD, Regional Medical Scientist, GlaxoSmithKline, Rochester, NY
9. Duarte, Robert, MD, Director, LIJ Pain and Headache Treatment Center, Manhasset, NY
10. Kitaj, Madeleine, MD, Kitaj Headache Center, LLC, Yorktown Hgts., NY
11. Bakker, William, PharmD, Senior Medical Science Liaison, UCB Inc., Smyrna, GA
12. Amato, Paul, PharmD, Regional Medical Scientist, GlaxoSmithKline, RTP, NC
13. Cole, Michele, PharmD, Medical Science Liaison, Schering-Plough Corp., Southampton, PA
14. Goldstein, Stanley, MD, Director of Allergy and Asthma Care of Long Island, Rockville Centre, NY
15. Vashee, Urvashi, PharmD, Senior Medical Science Liaison, Global Medical Affairs, Shire Pharmaceuticals, Wayne, PA
16. Amerling, Richard, MD, Director of Outpatient Dialysis and Continuous Renal Replacement, Beth Israel Medical Center, New York, NY
17. Cannito, Maria, PharmD, MS, Medical Outcomes Specialist, Pfizer Inc., Pittsford, NY

C. Key issues raised by interested parties and the Pharmacy and Therapeutics Committee pertaining to the clinical review of the following therapeutic classes/drugs:

Public comments:

Topical Immunomodulators:

• The Committee was asked to consider information regarding clinical trial results including indications, safety, effectiveness, the Black Box Warning, comparative trials between the drugs in this class, and long term trials with regard to incidence of malignancy.

Ophthalmic Fluoroquinolones:

• The Committee was asked to consider information regarding clinical trial results including indications, spectrum of coverage, and the use of the fourth generation ophthalmic fluoroquinolones to treat bacterial conjunctivitis, bacterial keratitis and for surgical prophylaxis.

Ophthalmic Antihistamines:

• The Committee was asked to consider information regarding clinical trial results including three head to head trials between the drugs in the class, antihistaminic and mast cell stabilizing properties, efficacy, tolerability, and adverse events.

Leukotriene Modifiers:

• The Committee was asked to consider information regarding clinical trial results including indications, safety, efficacy, dosing, use in pediatric patients, and the ongoing questions and concerns regarding suicide and behavioral problems with the use of montelukast. The Committee was also asked to consider the National Institutes of Health (NIH) and the Global Initiative for Asthma (GINA) guidelines and the American College of Allergy, Asthma, and Immunology statement regarding the safety of montelukast.

Ophthalmic Alpha-2 Adrenergic Agonists:

• The Committee was asked to consider information regarding clinical trial results including efficacy as mono- or combination therapy, safety in patients with comorbidities, particularly those taking systemic beta-blockers, and reduction in intraocular pressure.

Oral Fluoroquinolones:

• The Committee was asked to consider information regarding clinical trial results from the CAPRIE and MOTIV trials, indications, dosing, safety, spectrum of coverage, compliance and resistance/susceptibility, and the Infectious Diseases Society of America (IDSA) guidelines, particularly in the management of community-acquired pneumonia (CAP).

Serotonin Receptor Agonists - Triptans:

• The Committee was asked to consider information regarding clinical trial results for triptans and the triptan/NSAID combination product including efficacy at various time-points, sustained efficacy, consistency and tolerability, use of rescue medications, adverse events, dosage formulations, and tablet consumption per attack.

Injectable Immunomodulators:

• The Committee was asked to consider information regarding clinical trial results including indications, dosing frequency, dosing devices, and use as monotherapy or in combination with methotrexate to achieve remission.

Nasal Corticosteroids:

• The Committee was asked to consider information regarding clinical trial results including efficacy, safety, tolerability, adverse events, use in seasonal and perennial allergic rhinitis and in treatment of nasal polyps, use in pediatrics, adolescents, and adults, ocular effects, and use of concomitant allergy medications.

Phosphate Binder/Regulators:

• The Committee was asked to consider information regarding indications, efficacy, safety, tolerability, adverse events, and the importance of controlling hyperphosphatemia in end-stage renal disease.

Ophthalmic Prostaglandin Agonists:

• The Committee was asked to consider information regarding clinical trial results including efficacy in lowering intraocular pressure and achieving target pressures, tolerability, safety, persistency, adverse events, and use as monotherapy or in combination with other agents.

Pharmacy and Therapeutics Committee Comments:

• The Committee members discussed the difference in penetration into the skin between the cream and ointment formulations of the Topical Immunomodulator products.
• A Committee member and the presenter discussed the difference between the olopatadine products with regard to once a day versus twice a day dosing.
• A Committee member and presenter discussed the use of the leukotriene modifiers versus the orally inhaled corticosteroids as initial treatment for asthma.
• A Committee member and presenter discussed the MOTIV trial, and cardiac effects of second generation fluoroquinolones.
• A Committee member and presenter discussed the nasal biopsy results in the study between fluticasone furoate and mometasone furoate nasal sprays.
• A Committee member asked for clarification of the difference between Veramyst and generic fluticasone and of the difference in ocular effects between the two products. A question was also raised regarding ocular effects of Nasonex.
• A committee member and presenter discussed sodium bicarbonate levels in dialysis and non-dialysis renal patients.

D. Clinical Presentation and Discussion

Barbara Rogler, PharmD, MS, First Health Services Corporation; Robert Correia, PharmD, NYS Department of Health, Office of Health Insurance Programs; Fred Doloresco, PharmD, University at Buffalo, School of Pharmacy and Pharmaceutical Sciences; Joseph Paladino, PharmD, University at Buffalo, School of Pharmacy and Pharmaceutical Sciences

Inclusion of the Topical Immunomodulator therapeutic class, which includes pimecrolimus (Elidel) and tacrolimus (Protopic), in the Clinical Drug Review Program (CDRP)

Dr. Doloresco presented a clinical review of the Topical Immunomodulators to the Committee. The presentation included data specific to the NY Medicaid program and focused on utilization outside of the FDA approved indications, overuse and public health issues. Dr. Doloresco noted that Topical Immunomodulators are indicated for second-line, short term and non-continuous treatment of atopic dermatitis.

Dr. Paladino, chairperson of the NYS Medicaid Drug Utilization Review (DUR) Board, presented the DUR Board's recommendations regarding the Topical Immunomodulators review from their meeting on March 23, 2009. He noted that based on clinical information and utilization within the NY Medicaid program, the Board determined that tacrolimus and pimecrolimus met the criteria for inclusion into the CDRP, and recommended that the Medicaid Pharmacy & Therapeutics Committee consider the drug class for inclusion in the CDRP. Dr. Paladino presented the prior authorization criteria recommended by the DUR Board.

Re-review of Preferred Drug Program Therapeutic Classes

1. Re-review of the Sedative Hypnotic/Sleep Agent therapeutic class

Drugs Affected: Ambien (zolpidem), Ambien CR (zolpidem CR), chloral hydrate, Dalmane (flurazepam), Doral (quazepam), estazolam, flurazepam, Halcion (triazolam), Lunesta (eszopiclone), Prosom (estazolam), Restoril (temazepam), Rozerem (ramelteon), Somnote (chloral hydrate), Sonata (zaleplon), temazepam, triazolam, zaleplon, zolpidem

Dr. Rogler provided the class labeling revisions for triazolam and temazepam related to safety warnings for the risk of complex behavior. It was noted that no other new clinical information was found since the last review.

Dr. Correia also noted the FDA warning regarding the risk of complex behaviors, which increases similarities in labeling between the drugs in the class. No new clinical information was found to change previous conclusions for the class.

2. Re-review of the Serotonin Receptor Agonist (Triptan) therapeutic class

Drugs Affected: Amerge (naratriptan), Axert (almotriptan), Frova (frovatriptan), Imitrex (sumatriptan), Maxalt (rizatriptan), Relpax (eletriptan), sumatriptan, Treximet (sumatriptan/naproxen), Zomig (zolmitriptan)

Dr. Rogler noted the availability of generic sumatriptan and also described the new indication for almotriptan (Axert), noting that almotriptan is now indicated for the acute treatment of a specific type of migraine headache in adolescents 12 to 17 years of age.

Dr. Correia also noted the availability of generic sumatriptan and also described the new indication for almotriptan (Axert). The sumatriptan/naproxen combination product (Treximet) was discussed including the advantages and disadvantages of the combination product. No clinical evidence was found or submitted to the Committee that would substantiate claims of altered pharmacokinetic properties of either sumatriptan or naproxen when combined in a single tablet formulation. It was noted that the comparison of the drugs in the class is complicated by many different factors including timed response rates, short term measures, non-equivalent dosing and subjective patient assessments. No new clinical information was found to change previous conclusions for the class.

3. Re-review of the Phosphate Binder/Regulator therapeutic class

Drugs Affected: calcium acetate, Eliphos (calcium acetate), Fosrenol (lanthanum), Phoslo (calcium acetate), Renagel (sevelamer HCL), Renvela (sevelamer carbonate)

Dr. Rogler noted the new product Eliphos (calcium acetate), the availability of a new generic, calcium acetate capsules, and the discontinuation of sevelamer hydrochloride later this year. Comparative information associated with sevelmer hydrochloride and sevelamer carbonate was provided. Sevelamer carbonate (Renvela) was shown to be equivalent to sevelamer hydrochloride (Renagel) in reducing serum phosphorous in dialysis patients.

Dr. Correia also noted the new generic calcium acetate product and the availability of sevelamer as a hydrochloride and a carbonate salt. The advantages and disadvantages of administering a calcium based versus a non-calcium based product was discussed. Dr. Correia also presented an overview of sevelamer and lanthanum including bioavailability, administration and adverse effects. It was noted that no new comparative information was found to differentiate between the products. In general, the drugs in the class represent two major treatment approaches and it would be preferable to have drugs from both groups represented on the PDL.

A Committee member raised a question regarding whether there is any clinical evidence of lanthanum toxicity.

4. Re-review of the Leukotriene Modifier therapeutic class

Drugs Affected: Accolate (zafirlukast), Singulair (montelukast)

Dr. Rogler noted that the FDA has not reached a definitive conclusion regarding mood and behavioral adverse events associated with these drugs in clinical trials. Updated guidelines concerning the diagnosis and management of rhinitis as well as the Global Strategy for Asthma Management and Prevention guidelines were also reviewed.

Dr. Correia reiterated the new potential safety issue raised by the FDA for montelukast that was discussed during the last review of the class but as noted by Dr. Rogler, this issue remains under investigation. No new comparative or relevant clinical information was found to differentiate the drugs in the class.

A Committee member commented on the use of the leukotriene modifiers in both asthma and allergic rhinitis.

5. Re-review of the Intranasal Corticosteroid therapeutic class

Drugs Affected: Beconase AQ (beclomethasone dipropionate), Flonase (fluticasone propionate), flunisolide, fluticasone propionate, Nasacort AQ (triamcinolone acetonide), Nasarel (flunisolide), Nasonex (mometasone furoate), Omnaris (ciclesonide), Rhinocort Aqua (budesonide), Veramyst (fluticasone furoate)

Dr. Rogler presented information regarding ciclesonide (Omnaris) including indications, dosing and clinical trials. The expanded indication for triamcinolone acetonide (Nasacort AQ) for children two years of age and older was noted as well as the updated guidelines for the diagnosis and management of rhinitis.

Dr. Correia restated information regarding the new product, ciclesonide (Omnaris) and the approval of triamcinolone use in children as young as two years of age. It was noted that there are now three products approved for children as young as two years of age, while the other drugs in the class are approved for children over four or six years of age. There was no new clinical information found which would change the previous evaluation of the drug class.

A Committee member discussed with Dr. Rogler the ocular effects of the intranasal corticosteroids.

6. Re-review of the Oral Antihistamine therapeutic class

Drugs Affected: Allegra/Allegra-D (fexofenadine), cetirizine/cetirizine-D OTC, Clarinex/Clarinex-D (desloratadine), Claritin/Claritin-D OTC (loratadine), loratadine/loratadine-D OTC, fexofenadine, Semprex-D (acrivastine), Xyzal (levocetirizine)

Dr. Rogler noted the new formulation loratadine (Claritin) liquid gel capsules. The updated guidelines for the diagnosis and management of rhinitis were discussed with regard to the drugs in this class.

Dr. Correia stated that clinical information continues to suggest an association between the antihistamine effect with increased adverse reactions. New guidelines state no single agent has superior response overall. There is no significant new clinical information demonstrating overall superiority for any drugs in the class since the previous review.

A Committee member asked for clarification regarding the difference between cetirizine and levocetirizine.

7. Re-review of the Injectable Immunomodulator therapeutic class

Drugs Affected: Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), Kineret (anakinra)

Dr. Rogler noted new information regarding tumor necrosis factor blocking agents and the risk of herpes zoster infections when compared to conventional disease modifying agents. Information associated with a new drug, certolizumab (Cimzia) was presented including indications, dosing and clinical trial results.

Dr. Correia presented a brief overview of the two main cytokine immune processes impacted by these drugs. A general review of the indications was provided including the commonalities across products. As described during the previous review of the class, evidence suggests anti-TNF products are more effective than anakinra but also have been associated with more serious side effects. No new comparative effectiveness evidence was found for this class.

8. Re-review of the Otic Fluoroquinolone therapeutic class

Drugs Affected: Cipro HC (ciprofloxacin/hydrocortisone), Ciprodex (ciprofloxacin/dexamethasone), Floxin (ofloxacin), ofloxacin

Dr. Rogler noted that no new clinical information was found for the class since the last review.

Dr. Correia also noted that no new information was found. There are only two different fluoroquinolones in the class. All products are effective with none demonstrating an overall advantage.

Several Committee members discussed the use of otic fluoroquinolones with a steroid component, otic polymyxin/neomycin with a steroid component, and oral amoxicillin for ear infections, noting that the steroid component provided anti-inflammatory activity.

9. Re-review of the Oral Fluoroquinolone therapeutic class

Drugs Affected: Avelox (moxifloxacin), ciprofloxacin, ciprofloxacin ER, Cipro (ciprofloxacin), Cipro XR (ciprofloxacin ER), Factive (gemifloxacin), Levaquin (levofloxacin), Noroxin (norfloxacin), ofloxacin, Proquin XR (ciprofloxacin)

Dr. Rogler noted a new black box warning associated with the increased risk of tendonitis and tendon rupture and a class label change for moxifloxacin (Avelox). No other new information was found since the last review.

Dr. Correia reiterated the increased level of warning associated with the risks for tendon pathology with the class overall. It was noted that all of the fluroquinolones are effective, although their utility continues to erode through resistance due to overuse. No new evidence was found to suggest any of the drugs demonstrate an overall advantage. As discussed during previous reviews of this class, it is suggested that both second and third generation drugs be represented on the PDL.

In response to a question from the Committee, Dr. Rogler indicated the warning regarding tendon rupture was for all the drugs in the class.

10. Re-review of the Third Generation Cephalosporin therapeutic class

Drugs Affected: Cedax (ceftibuten), cefdinir, cefpodoxime proxetil, Omnicef (cefdinir), Suprax (cefixime), Spectracef (cefditoren), Vantin (cefpodoxime proxetil)

Dr. Rogler noted that no new clinical information was found for the class since the previous review.

Dr. Correia also stated that no new comparative evidence was found to differentiate effectiveness between the drugs in the class. The drugs in the class may be grouped according to gram-negative and gram-positive activity and it is suggested that drugs covering both spectrums of activity be represented as preferred agents.

11. Re-review of the Topical Immunomodulator therapeutic class

Drugs Affected: Elidel (pimecrolimus), Protopic (tacrolimus)

Dr. Rogler noted that no new clinical information was found for the class since the previous review.

Dr. Correia noted the drug class contains an ointment and a cream. The products are second line therapy for patients who have failed other topical agents, or for use due to safety issues with drugs considered to be first line treatment of atopic dermatitis. No new clinical information was found to indicate that either of these products is preferential overall.

The Committee again discussed the difference in penetration, moisturizing capability and appearance for the cream and ointment preparations.

12. Re-review of the Ophthalmic Antihistamine therapeutic class

Drugs Affected: Elestat (epinastine), Emadine (emedastine), ketotifen Rx, Optivar (azelastine), Patanol (olopatadine), Pataday (olopatadine)

Dr. Rogler noted the ketotifen prescription products are no longer available and no other new information was found for the class since the last review.

Dr. Correia noted that clinical information reviewed revealed no significant comparative new clinical information since the last time this drug class was reviewed. Information that was presented during previous reviews was reiterated including drugs with the same FDA labeled indications and drugs with both antihistaminic and mast cell stabilizing effects. He concluded that any of the products are effective for the treatment of allergic conjunctivitis, with none of these drugs demonstrating overall advantages for all cases.

13. Re-review of the Ophthalmic Non-Steroidal Anti-Inflammatory Drug therapeutic class

Drugs Affected: Acular (ketorolac), Acular LS (ketorolac), Acular PF (ketorolac), diclofenac, flurbiprofen, Nevanac (nepafenac), Ocufen (flurbiprofen), Voltaren (diclofenac), Xibrom (bromfenac)

Dr. Rogler noted that no new clinical information was found for the class since the previous review.

Dr. Correia mentioned that there is a new generic product, diclofenac. The clinical review of the class revealed no significant new information since the last review of the class.

14. Re-review of the Ophthalmic Alpha-2 Adrenergic Agonist therapeutic class

Drugs Affected: Alphagan P (brimonidine), brimonidine, Iopidine (apraclonidine)

Dr. Rogler noted that no new clinical information was found for the class since the previous review.

Dr. Correia noted that the clinical review revealed no new comparative clinical information. Information that was presented during previous reviews was reiterated. This information included a reiteration of each product's preservative, effectiveness related to dosing regimens, tolerability, and the discrepancy between the relative and actual decrease in allergic conjunctivitis.

15. Re-review of the Ophthalmic Prostaglandin Agonist therapeutic class

Drugs Affected: Lumigan (bimatoprost), Travatan (travoprost), Travatan Z (travoprost), Xalatan (latanoprost)

Dr. Rogler noted that no new clinical information was found for the class since the previous review.

Dr. Correia noted that the clinical information submitted was either not new or of poor quality and did not add to or change previous findings. As discussed during the previous review of the class, clinical practice guidelines from professional organizations do not indicate any one of these drugs as better than another or recommend one as a first choice. Small differences between study results of absolute change in intraocular pressure may be statistically significant but not clinically significant, once patient physical variability is accounted for. There are claims of marginal differences for each of the products but these appear to balance between slight study variations in intraocular pressure and tolerability. None of the products demonstrate an overall clinical advantage.

16. Re-review of the Ophthalmic Fluoroquinolone therapeutic class

Drugs Affected: Ciloxan (ciprofloxacin), ciprofloxacin, IQUIX (levofloxacin), Ocuflox (ofloxacin), ofloxacin, Quixin (levofloxacin), Vigamox (moxifloxacin), Zymar (gatifloxacin)

Dr. Rogler noted that no new clinical information was found for the class since the last review.

Dr. Correia reviewed the spectrum of activity associated with the second, third and fourth generation classification structure. The clinical review revealed no significant new clinical or comparative information using approved doses or indications since the last review. Since there is an overall differential in spectrum of activity between the second versus the third and fourth generation products it is suggested that both groups are represented on the PDL.

E. Executive Session:

The Committee recessed the public session at 11:30 AM to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: Sedative Hypnotics/Sleep Agents,Triptans, Phosphate Binders/Regulators, Leukotriene Modifiers, Intranasal Steroids, Oral Antihistamines, Injectable Immunomodulators, Topical Immunomodulators, Otic Fluoroquinolones, Oral Fluoroquinolones and Third Generation Cephalosporins. The Committee also reviewed patient cases related to the Topical Immunomodulators and the CDRP. No official action was taken in the executive session. The executive session was recessed at 1:30 PM.

The Committee recessed the public session at 2:00 PM to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: Ophthalmic Antihistamines, Ophthalmic NSAIDS, Ophthalmic Alpha-2 Adrenergic Agonists, Ophthalmic Prostaglandin Agonists, and Ophthalmic Fluoroquinolones. The executive session was recessed at 2:20 PM.

F. Recommendations of the Pharmacy and Therapeutics Committee:

The following recommendations developed by the P&T Committee are to be submitted to the Commissioner of Health for final determination.

Description of Recommendations	Commissioner's Final Determination
Proposal: Inclusion of the Topical Immunomodulators in the Clinical Drug Review Program A. The Committee unanimously recommended that Medicaid include the Topical Immunomodulators in the Clinical Drug Review Program. B. The Committee unanimously recommended the following questions be asked in the prior authorization process of the Topical Immunomodulators: Is the patient diagnosed with atopic dermatitis? Did the patient attempt using a topical corticosteroid for four (4) weeks? Has the patient experienced a treatment failure, a clinically significant adverse reaction, or does the patient have a contraindication to a topical corticosteroid? Is the patient immunocompromised? If yes, does the patient have HIV with facial seborrheic dermatitis?	Approved as recommended
Proposal: Identification of preferred drugs in the category of Sedative Hypnotics/Sleep Agents A. Based on the submitted or presented clinical information andon the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs chloral hydrate, estazolam, flurazepam, temazepam, triazolam, zolpidem Non-preferred Drugs Ambien (zolpidem), Ambien CR (zolpidem CR), Dalmane (flurazepam), Doral (quazepam), Halcion (triazolam), Lunesta (eszopiclone), Prosom (estazolam), Restoril (temazepam), Rozerem (ramelteon), Somnote (chloral hydrate), Sonata (zaleplon), zaleplon B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process. Q: Has your patient experienced treatment failure with preferred drugs in the class? Q: Has your patient experienced an adverse drug reaction with preferred drugs in the class? Q: Is there a documented history of successful therapeutic control with a non-preferred drug and transition to a preferred drug is medically contraindicated?	Approved as recommended
Proposal: Identification of preferred drugs in the category of Serotonin Receptor Agonists (Triptans) A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Imitrex (sumatriptan), Maxalt (rizatriptan), Relpax (eletriptan), sumatriptan, Treximet (sumatriptan/naproxen) Non-preferred Drugs Amerge (naratriptan), Axert (almotriptan), Frova (frovatriptan), Zomig (zolmitriptan) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as recommended
Proposal: Identification of preferred drugs in the category of Phosphate Binders/Regulators A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs calcium acetate, Fosrenol (lanthanum), Phoslo (calcium acetate), Renagel (sevelamer HCL), Renvela (sevelamer carbonate) Non-preferred Drugs Eliphos (calcium acetate) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as recommended
Proposal: Identification of preferred drugs in the category of Leukotriene Modifiers A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Accolate (zafirlukast), Singulair (montelukast) Non-preferred Drugs None B. The Committee unanimously recommended the standard clinical questions be used as the basis for approving use of a non-preferred drug, should the Commissioner's final decision include a non-preferred drug.	Approved as recommended
Proposal: Identification of preferred drugs in the category of Intranasal Corticosteroids A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs fluticasone propionate, Nasonex (mometasone furoate) Non-preferred Drugs Beconase AQ (beclomethasone dipropionate), Flonase (fluticasone propionate), flunisolide, Nasacort AQ (triamcinolone acetonide), Nasarel (flunisolide), Omnaris (ciclesonide), Rhinocort Aqua (budesonide), Veramyst (fluticasone furoate) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as recommended
Proposal: Identification of preferred drugs in the category of Oral Antihistamines A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs cetirizine/cetirizine-D OTC, loratadine/loratadine-D OTC Non-preferred Drugs Allegra/Allegra-D (fexofenadine), Clarinex/Clarinex-D (desloratadine), fexofenadine, Semprex-D (acrivastine), Xyzal (levocetirizine) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process and again recommended one additional clinical question for specific product pediatric indications: Q: Is the patient under twenty-four (24) months of age?	Approved as recommended
Proposal: Identification of preferred drugs in the category of Injectable Immunomodulators A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Enbrel (etanercept), Humira (adalimumab) Non-preferred Drugs Cimzia (certolizumab pegol), Kineret (anakinra) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as recommended
Proposal: Identification of preferred drugs in the category of Topical Immunomodulators A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Elidel (pimecrolimus), Protopic (tacrolimus) Non-preferred Drugs None B. The Committee unanimously recommended the standard clinical questions be used as the basis for approving use of a non-preferred drug, should the Commissioner's final decision include a non-preferred drug.	Approved as recommended
Proposal: Identification of preferred drugs in the category of Otic Fluoroquinolones A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Ciprodex (ciprofloxacin/dexamethasone), ofloxacin Non-preferred Drugs Cipro HC (ciprofloxacin/hydrocortisone), Floxin (ofloxacin) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as recommended
Proposal: Identification of preferred drugs in the category of Oral Fluoroquinolones A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Avelox (moxifloxacin), ciprofloxacin, Cipro suspension (ciprofloxacin), ofloxacin Non-preferred Drugs ciprofloxacin ER, Cipro tablets (ciprofloxacin), Cipro XR (ciprofloxacin ER), Factive (gemifloxacin), Levaquin (levofloxacin), Noroxin (norfloxacin), Proquin XR (ciprofloxacin) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as recommended
Proposal: Identification of preferred drugs in the category of Third Generation Cephalosporins A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs cefdinir, cefpodoxime proxetil, Suprax (cefixime) Non-preferred Drugs Cedax (ceftibuten), Omnicef (cefdinir), Spectracef (cefditoren), Vantin (cefpodoxime proxetil) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as recommended
Proposal: Identification of preferred drugs in the category of Ophthalmic Antihistamines A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Patanol (olopatadine), Pataday (olopatadine) Non-preferred Drugs Elestat (epinastine), Emadine (emedastine), Optivar (azelastine) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as recommended
Proposal: Identification of preferred drugs in the category of Ophthalmic Non-steroidal Anti-inflammatory Drugs (NSAIDs) A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Acular (ketorolac), Acular LS (ketorolac), Acular PF (ketorolac), diclofenac, flurbiprofen Non-preferred Drugs Nevanac (nepafenac), Ocufen (flurbiprofen), Voltaren (diclofenac), Xibrom (bromfenac) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as recommended
Proposal: Identification of preferred drugs in the category of Ophthalmic Alpha-2 Adrenergic Agonists A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Alphagan P (brimonidine), brimonidine Non-preferred Drugs Iopidine (apraclonidine) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as recommended
Proposal: Identification of preferred drugs in the category of Ophthalmic Prostaglandin Agonists A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Travatan (travoprost), Travatan Z (travoprost), Xalatan (latanoprost) Non-preferred Drugs Lumigan (bimatoprost) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as recommended
Proposal: Identification of preferred drugs in the category of Ophthalmic Fluoroquinolones A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs ciprofloxacin, ofloxacin, Vigamox (moxifloxacin) Non-preferred Drugs Ciloxan (ciprofloxacin), IQUIX (levofloxacin), Ocuflox (ofloxacin), Quixin (levofloxacin), Zymar (gatifloxacin) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as recommended

G. Additional Discussion:

Dr. Eglowstein expressed appreciation to DOH staff for their efforts in effectively organizing and coordinating P&T Committee meeting proceedings.

The meeting adjourned at 2:30 PM

Meeting Summary Posted 6/30/09

H. Final Determinations

The Commissioner has determined that the Medicaid program will require prior authorization under the Clinical Drug Review Program (CDRP) for the Topical Immunomodulators.

The impact of this final determination is as follows:

1. State Public Health Population:
   • Products requiring prior authorization under the CDRP continue to be covered by the Medicaid program. The prior authorization requirement will have a minimal effect on Medicaid enrollees, and will ensure the product is being used in a medically appropriate manner.
2. Program Providers:
   • There will be a minimal impact on prescribers and pharmacies as they are familiar with the prior authorization process. The prior authorization process is simple to use and available twenty-four hours a day, seven days a week.
   • Prescribers will need to initiate the prior authorization process and will be asked for clinical information to support appropriate use of the product when ordering these medications. Pharmacies will need to complete the prior authorization process prior to submitting the claim.
3. State Health Program:
   • Prior authorization through the CDRP will reinforce appropriate use and will also provide an additional means to detect and deter overuse.
   • During CY08, total expenditure for the Topical Immunomodulators was approximately $8 million. The fiscal impact will depend on changes in utilization associated with assuring the appropriate use of the product. Expenditures will be expected to decrease subsequent to the implementation of the prior authorization requirement.

The Commissioner has determined that the Medicaid program will require prior authorization under the Preferred Drug Program (PDP) for non-preferred drugs in each of the drug classes as listed in Section F.

Preferred Drugs will not require prior authorization

The impact of this final determination is as follows:

1. State Public Health Population:
   • Minimal effect on Medicaid enrollees, as a large majority of enrollees currently utilize preferred products.
   • Non-preferred products remain available when prior authorized.
2. Program Providers:
   • No impact on prescribers or pharmacies when utilizing preferred products. Prescribers, or their agents, will need to initiate the prior authorization process when ordering non-preferred products. Pharmacies will need to complete the prior authorization process for non-preferred products.
3. State Health Program:
   • Annual gross savings associated with these therapeutic classes under the PDP are estimated at $35M. The savings are achieved through changes in utilization to equally effective and less expensive drugs including the receipt of supplemental rebates from pharmaceutical manufacturers.

Final Determinations Posted 8/21/09