Brock-finalP&T draft 1-20-06

Pharmacy and Therapeutics Committee Meeting Record
Date: 3/17/06 Time: 9:00 a.m. – 4:00 p.m. Location: 3232 Elder Street, Conference Room D
Moderator: Steve Montamat, M.D.
Committee Members Present: Catherine Gundlach, PharmD, Cindy Bunde, PA, Donald Norris, M.D., Phil Petersen, M.D., Richard Markuson, RPh, Rick Sutton, RPh, Selma Gearhardt, PharmD, Stan Eisele, M.D., Steve Montamat, M.D, Tami Eide, Pharm D, Thomas Rau, M.D., William Woodhouse, M.D.
Others Present: Selma Gearhardt, PharmD,Steve Liles, PharmD, Bob Faller, Cindy Brock
Committee Members Absent:. Robert Comstock, RPh
AGENDA ITEMS / PRESENTER / OUTCOME/ACTIONS

CALL TO ORDER

Introductions

/ Steve Montamat, M.D. / Dr. Montamat called the meeting to order.
Dr. Montamat introduced Dr. Donald Norris, the new Medicaid Medical Director and Robert Faller, Pharmacy Medical Program Specialist to the committee.

Committee Business

Roll Call
Reading of Confidentiality Statement
Approval of Minutes from January 20, 2006 Meeting
Review of Key Questions / Steve Montamat, M.D.
Steve Montamat, M.D.
Steve Montamat, M.D.
Steve Montamat, M.D. / Dr. Montamat called the roll. One voting member was absent.
Dr. Montamat read the confidentiality statement.
The minutes from the January 20, 2006 Committee meeting were approved.
Targeted Immune Modulators
#1 update
Psorasis was added as a diagnosis.
Inhaled Beta 2 Antagonists
#3 update
Review w/same key agents and key questions
Second Generation Antidepressants
#3 update
No additions or deletions
Triptans
#4 update
No new agents
same key questions

CALL TO ORDER

Roll Call
Reading of Confidentiality Statement
Committee Business
Approval of Minutes from September 19, 2005 Meeting
Drug Class Review
Targeted Immune Modulators
Discussion of Key Questions / Dr. Tamara Eide
Dr. Steve Montamat
Dr. Steve Montamat
Dr. Tamara Eide & Dr. Steve Montamat
Dr. Steve Montamat
Selma Gearhardt, PharmD
Dr. Eide & Dr. Montamat / Dr. Eide called the meeting to order. and introduced Dr. Steve Montamat as the new chair of the committee.
Dr. Montamat called the roll. All voting members were present. One non-voting member was absent.
Dr. Montamat read the confidentiality statement.
Dr. Montatmat introduced theIntroduced Dr. Steve Montamat as the new chair of the committee and the newest members of the Committee:, Dr. William Woodhouse Woodhouse. and Dr. Stan Eisele
The minutes from the November 20, 2005 Committee meeting were approved.
Dr. Gearhardt presented a review of the Targeted Immune Modulators. Her presentation included a quick review of traditional DMARD’s and data on the indications, pharmacology, pharmacokinetics, adverse effects, black box warnings, interactions, and contraindications in the Targeted Immune Modulators.
Drugs included:
infliximab (Remicade®)
etanercept (Enbrel®)
adalimumab (Humira®)
anakinra (Kineret®)
efalizumab (Raptiva®)
alefacept (Amevive®)
The key questions for the fourth update of the Triptans, s; initial review of the Inhaled Beta 2-Agonists;, and the first update for the Newer Sedative Hypnotics were discussed.
Public Comment Period / Steve Montamat, M.D. / 17 people signed up to speak during the public comment period. Public comment was received from the following:
Dr. Robert Calder speaking for Merck on Cozaar/Emend
Jason Alm speaking for Sankyo/Forrest on Benicar/Benicar HCT
Dr. Andy Weis speaking for Novartis on Diovan
Danny Icenhauz, PharmD speaking for King on Altace
John Frey speaking for Santarus on Zegerid
Don Moran speaking for Sandofi on Avapro/Uroxatral
Dr. Stephanie Greenstein speaking for Boehninger on Flomax
Dr. Derek Terada speaking for Boehringer Ingelheim on Micardis
Dr. Nancy Cherry speaking for GSK on Zofran
Dr. Many Hosford speaking for Astra Zenecca on Candesartan
Dr. Hartman speaking for himself on Diovan & Avapro
Monica Marcus speaking for Roche on newer antiemetics
Stephen Rozzo, PhD speaking for Abbott Laboratories on Humira/immune modulators
Dana Hurley, Pharm.D. speaking for Amgen on Enbrel/TIMS
Allen Christie speaking for GSK on Avodart/BPH
Fran Gander speaking on PPIs/Nexium
Dr. Donald Stott speaking for Astra Zeneca on valsartan
Review of Clinical Data
Targeted Immune Modulators / Gerald Gartlehner, MD, MPH / Dr. Gartlehner presented data on the effectiveness, efficacy, and safety of TIMs provided through the review of clinical trial data. The agents reviewed included:
infliximab (Remicade®)
etanercept (Enbrel®)
adalimumab (Humira®)
anakinra (Kineret®)
efalizumab (Raptiva®)
alefacept (Amevive®)
Benign Prostatic Hyperplasia (BPH) Agents / Steve Liles, PharmD / Dr. Liles presented data on the indications, dosage forms, interactions, precautions, AUA guidelines, beneficial/adverse effects provided through a review of clinical trial data. The agents reviewed included:
alfuzosin (Uroxatral®)
doxazosin (Cardura®)
tamsulosin (Flomax®)
terazosin (Hytrin®)
dutasteride (Avodart®)
finasteride (Proscar®)
Drug Class Review
Newer Antiemetics / Tami Eide, PharmD / Dr. Eide presented a review of the Newer Antiemetics Her presentation included data on the indications, off label uses, pharmacology, pharmacokinetics, adverse effects, interactions and contraindications.
Drugs included:
Aprepitant (Emend®)
Dolasetron(Anzemet®)
Granisetron(Kytril®)
Ondansetron(Zofran®)
Palonosetron (Aloxi® )
Review Clinical Data
Newer Antiemetics
DUR OUTCOME PRESENTATION
Loratidine Utilization in the Idaho Medicaid Population / Heather Brandt, PharmDKimberly Peterson, MS / Ms. Peterson presented data on the, efficacy, adverse events, tolerability, prevention of N/V and safety of Newer Antiemetics provided through a review of clinical trial data. The agents reviewed included:
aprepitant (Emend®)
dolasetron(Anzemet®)
granisetron(Kytril®)
ondansetron(Zofran®)
palonosetron (Aloxi® )
Dr. Brandt presented a review of the findings and outcomes since the implementation of the Prior Authorization for Loratidine OTC as the preferred second generation antihistamine on June 1, 2005.
The Purpose purpose of the review was to collect data regarding the clinical and financial outcomes resulting from the PAPDL implementation. The review indicated that females accounted for almost twice as many claims as males and that the total # of costs and number of and claims for second generation Antihistamines antihistamines significantly declined beginning in 2003. The data also indicated that the change in market share resulted in a $25 savings per claim before any rebates.. The utilization data indicated a similar visit rate for procedures, office and hospital visits withand an increase in ER visits from 2004 to 2005.
Several trends were identified among chronic allergy suffers,. they This included a :
Decreasedecrease in 2nd generation expenditures, and an Iincrease in overall drug and procedure costs., These Ffindings do not correspond with recent published outcomes studies.
The A need for further data study was identified.
Dr. Comstock requested a review of claims data from other carriers for comparison.
Dr. Brandt will follow up in 4-6 months with additional information.
Review of Clinical Data
Proton Pump InhibitorsPublic Comment Period / Susan Carson, MPH Dr. Steve Montamat / Ms. Carson presented updated data (update #3) on the healing of esophagitis or relief of symptoms; maintenance of healed esophagitis; healing rates, differences in efficacy and evidence of adverse events, and safety of Proton Pump Inhibitors provided through a review of clinical trial data. The agents reviewed included:
esomeprazole magnesium (Nexium®)
lansoprazole (Prevacid®)
omeprazole (Prilosec®,; Zegerid®)
pantoprazole (Protonix®)
rabeprazole (Aciphex®)
People signed up to speak during the public comment period. Public comment was received from the following:
1.Libby Neske (Ortho/McNeil/JensenJanssen)—Axert & Triplin®
2.Dr. Charles Novak ( (N/ASanofi)— )- Ambien CR®/hypnotics
3.Tyler Sommer (N/AKing Pharmaceuticals)—Sonata®
Nancy Nadolski (N/Anurse practitioner)—Lunestra®
4.Don Moran (AdventisSanofi-Aventis)—Ambien ® IR/CR & Lovenox
5.Dr. Robert Calder (Merck)—Maxalt®
Long Nguyen (Glaxo/Smith/Kline)—Coreg®
6.
Lisa Lawrence (N/Anurse practitioner)-—Rozerem®
7.9.
Jean Pham (Glaxo/Smith/Kline)- —Imitrex®,/Amerzge®
10,
Sylvia Foster (Glaxo/Smith/Kline)—fondaparinux (Arixtra®)
11,
Dr. Robert Lee (self)—Coreg®
12.
Gary Dawson, PhD (Takeda)—Rozerem®
13.
Sue Heineman, PharmD (Pfizer)—Triptans/Relpax®
14. Dr. Mandy Hosford (AstrazZeneca)—Toprol ® XL
15. Lawrence Hicks, MD (N/A)—Triptans/Relpax®
Review of Clinical Data
Angiotensin- 2 Receptor AntagonistsDrug Class Review
*Newer Sedative Hypnotics / Mark Helfand, MD, MPHSelma Gearhardt, PhdPharmD / Dr. Gearhardt presented a review of the Newer Sedative Hypnotics whose primary indication is for insomnia. Her presentation included data on the dosing, pharmacology, interactions, adverse effects, safety, , and contraindications., efficacy and controlled studies on:
Drugs included :
Dr. Helfand presented updated data (update #1) on the Angiotensin II Receptor Antagonists. He highlighted changes since the last review and updates in national guidelines for heart failure. His review included: comparative effectiveness, adverse effects, safety and efficacy of the following agents:
candesartan (Atacand®)
eprosartan (Teveten®)
ibesartan (Avapro®)
losartan (Cozaar®)
olmesartan (Benicar®)
yelmisartan (Micardis®)
valsartan (Diovan®)
Zolpiden zolpidem
Zaleplon zaleplon
Eszopicloneeszopiclone.
Special concerns noted included: memory problems, tolerance, dependence, changes in behavior/thinking, pregnancy/breastfeeding
Review of Clinical Data
Ace InhibitorsDrug Class Review
Clinical Data
*Newer Sedative Hypnotics / Mark Helfand, MD, MPHSusan Carson, MPH / Dr. Helfand presented updated data (update #2) on the ACE Inhibitor class. His review included: outcomes, safety/efficacy and adverse events of the following agents:
benazepril (Lotensin®)
captopril (Capoten®)
enalapril (Vasotec®)
fosinopril (Monopril®)
lisonopril (Prinivil®, Zestril®)
moexipril (Univasc®)
perindopril (Aceon®)
quinapril (Accupril®)
ramipril (Altace®)
trandolapril (Mavik®)
Ms. Carson attended via conference call and presented the Oregon Health Sciences Evidence-based Practice Center Original Class Review on Newer Sedative Hypnotics. The report was finalized in December 2005. The Committee accessed and reviewed a copy of the report prior to the meeting.presented information on a review of clinical data conducted by OHSU. The purpose of the study was to collect/analyze data on the efficacy, effectiveness, tolerability and safety of specific medications used for insomnia. collection/analysis for the purpose of determining
Included drugs, Literature search results—overview
Results from head to head trials indicated
No evidence that one newer sedative hypnotic is safer or more effective in subgroups based on gender or race
No significant difference in newborns exposed to the agents in-utero.
Mixed results were obtained with patients with comorbid conditions.
Triptans / Tami Eide, PharmD / Dr. Eide presented a information on a review of the Triptan drug class including indications, pharmacology, drug-drug interactions, availability, and dosing. This was presented in conjunction with the updated Drug Class Review of Triptans from the Oregon Evidence-based Practice Center.clinical data conducted by OHSU which included availability, dosing, efficacy, methods, a recap of previous conclusions by the Committee, head-to-head trial studies and safety of this class. Agents included in the study were:
almotriptan
The review was completed November 11, 2005. The Committee access and reviewed a copy of the report prior to the meeting.
Agents included:
eletriptan
frovatriptan
naratriptan
rizatriptan
sumatriptan
zolmitriptan
mitriptan
Review of Clinical Data
*Injectable Anticoagulants/Injectable
Beta Blockers
Ulcerative Colitis Agents / Steve Liles, PharmD / Dr. Liles presented data on the indications and clinical trials for injectible injectable anticoagulants. The agents reviewed included:
Dalteparindalteparin
Enoxaparinenoxaparin
Tinzaparintinzaparin
Fondaparinuxfondaparinux
Dr. Liles presented data on the indications, adverse affectseffects, beneficial affectseffects
and clinical trials for injectible anticoagulants the Beta Blockers.. Emphasis was placed on those agents shown to be effective in heart failure.The agents reviewed included:
bisoproltol
carvedilol
metoprolol succinate
Other Beta Blockers reviewed included:
acebutolol
atenolol
betaxolol
labetalol
metoprolol tartrate
nadolol
pindolol
propranolol
timolol
Dr. Liles presented a review on of the indications, pharmacology, dosing availability tolerances, maintenance of remission, clinical trials and adverse events of the following agents:
Asacol®
colazalColazal®
asacol
pentaseDipentum®
mesalamine generic enemas/suppositories
Pentasa®
Sulfasalazinesulfasalazine oral generics
asacol
sulfasalazine
dipentum
distal disease
mesalamine enemas/suppositories
DUR Sedative Hypnotics PresentationBoard Presentation on Appropriate Use of Sedative-hypnotic Agents / Chris Owens, PharmD / Dr. Owens reviewed results of an educational intervention completed by the DUR Board on the appropriate use of sedative-hypnotic agents. Ccomparison data, encompassing safety concerns, and interactions of these agents were sent in an educational leaflet to and specific pharmacist and /physician providers. responses to the questionnaire.
The conclusions were:
Significant increase in the use of sedative hypnotics over the past ten years.
Patients rarely had diagnosis of insomnia.
Committee Clinical Discussions and Conclusions / Newer Sedative Hypnotics
Targeted Immune Modulators
Based on the evidence that was presented, the Committee consensus was that they would like to recommend PA criteria to include: therapeutic guidelines for diagnosis.
there is no evidence that any of these drugs are more efficacious than another. The major differences are pharmacokinetic and the agent prescribed often depends on the problems with sleep that the patient is experiencing. No restrictions on agents at this time.
BPH DrugsTriptans
Based on the evidence that was presented , including the implementation of Medicare Part D, Tthe Committee noted that would not make any recommendations at this time.there was no new evidence since the last review to change previous conclusions. Recommendation was to remove Zomig (nasal) as a preferred agent and add Amerge(oralBased on the evidence that was presented, the Committee consensus was that there is no evidence that any of these drugs are more efficacious than another, nor do any provide any significant safety advantages.
).
Injectable Anticoagulants:
Based on the evidence that was presented, the Committee consensus was that there is no evidence that any of these drugs are more efficacious than another, nor do any provide any significant safety advantages.
Recommendation to make all agents preferred with no restrictions.
Ulcerative CollitisColitis
Newer Antiemetics
Based on the evidence that was presented, the Committee consensus was to leave the PA criteria as it currently exists.
that there is no evidence that any of these drugs are more efficacious than another, nor do any provide any significant safety advantages. Having dosage forms desirable for children available was discussed.
No new recommendations as this time.
Beta Blocker
Proton Pump Inhibitors
Based on the evidence that was presented, the Committee consensus was to not make any changes at this time based on therapeutics. The Committee noted that there was no new evidence since the last review to change previous conclusions. Based on the evidence that was presented, the Committee consensus was that there is no evidence that any of these drugs are more efficacious than another, nor do any provide any significant safety advantages.
The Committee still felt that Coreg should be restricted to its heart failure indication.
Recommendation was to add Inderal LA (oral) back to list and take off Innopran XL (oral)
Public Meeting Adjourned
Closed Executive Session / Randy May, Chief Deputy Administrator / Randy Mr. May presented the financial data on the selected drug classes.
Committee Final Recommendation for Therapeutic Classes / Steve Montamat, MD / Targeted Immune Modulators
  • The Committee recommended Amevive® (alefacept), Enbrel® (etanercept), Humira® (adalimumab), Kineret® (anakinra), Raptiva® (efalizumab) and Remicade® (infliximab) all be designated as preferred agents.
  • The Committee recommended no non-preferred agents.
Newer Antiemetics
  • The Committee recommended Zofran® (ondansetron) be designated as a preferred agent.
  • The Committee recommended Anzemet ® (dolasetron), Emend® (aprepitant) and Kytril® (granisetron) be designated as non-preferred agents and require prior authorization.
  • No recommendations were made for Aloxi® (palonosetron).
  • Current therapeutic prior authorization criteria will remain.
Proton Pump Inhibitors
  • The Committee recommended Nexium® (esomeprazole), Prevacid® (lansoprazole) capsules and granules for solution and Prilosec® OTC (omeprazole) be designated as preferred agents.
  • The Committee recommended Aciphex® (rabeprazole), omeprazole , Prevacid® SoluTab (lansoprazole), Prilosec® (omeprazole), Protonix® (pantoprazole),Zegerid ® (omeprazole) be designated as non-preferred agents and require prior authorization.
  • Current therapeutic prior authorization criteria will remain.
Benign Prostatic Hyperplasia (BPH) Treatment Agents
  • The Committee recommends Avodart® (dutasteride), doxazosin (generic), Flomax® (tamsulosin), Proscar® (finasteride), terazosin (generic) and Uroxatral® (alfuzosin) be designated as preferred agents.
  • The Committee recommends Cardura® (doxazosin) and Hytrin® (terazosin) be designated as non-preferred agents and require prior authorization.
Angiotensin-2 Receptor Antagonists
  • The Committee recommends Avapro® (irbesartan), Benicar® (olmesartan), Cozaar® (losartan), Diovan® (valsartan) and Micardis® (telmisartan) be designated as preferred agents.
  • The Committee recommends Atacand® (candesartan) and Teveten® (eprosartan) be designated as non-preferred agents and require prior authorization.
Angiotensin Converting Enzyme Inhibitors
  • The Committee recommends Altace® (ramipril), captopril (generic), captopril/hydrochlorthiazide (generic), enalapril (generic), enalapril/hydrochlorthiazide (generic), lisinopril (generic) and lisinopril/hydrochlorthiazide (generic) be designated as preferred agents.
  • The Committee recommends Accupril® (quinapril), Accuretic® (quinapril/hydrochlorthiazide), Aceon® (perindopril), benazepril, (generic) benazepril/hydrochlorthiazide (generic), Capoten® (captopril), Capozide® (captopril/hydrochlrthiazide) , fosinopril, fosinopril/hydrochlorthiazide, Lotensin® (benazepril), Lotensin- HCTZ® (benazepril/ hydrochlorthiazide), Mavik® (trandolapril), moexipril, Monopril ® (fosinopril) , Monopril- HCTZ ®
( fosinopril/hydrochlorthiazide), Prinivil ® (lisinopril) , Prinzide® (lisinopril/hydrochlorthiazide), quinapril, quinaretic, Uniretic® (moexipril/hydrochlorthiazide), Univasc® (moexipril), Vasorectic ® (enalapril/hydrochlorthiazide), Vasotec® (enalapril),
Zestoretic ® (lisinopril/hydrochlorthiazide and Zestril® (lisinopril) be designated as non-preferred agents and require prior authorization.
Newer Sedative Hypnotics
The Committee recommended that Ambien® and Lunesta® be designated as preferred agents and that
Ambien CR®, Rozerem® and Sonata® be designated as non-preferred agents and require prior authorization.