PEC Pipeline: Looking into the Crystal Ball LCDR Joe Lawrence, MSC, USN Dr. Julie Liss DoD PEC Conference 2007 Promoting high quality, cost effective drug therapy throughout the Military Health System PEC Pipeline 2007 Objectives • Describe different strategies used to identify a drug class review for the Uniform Formulary • Discuss key elements considered in all Uniform Formulary decisions • Identify online resources to support the Uniform Formulary DoD Pharmacoeconomic Center www.pec.ha.osd.mil Strategies for Drug Class Review • High expenditures – “80 / 20 Rule”: 20% of the drugs comprise 80% of the drug expenditures • Competitive forces – Generic availability, pharmaceutical detailing, new molecular agents DoD Pharmacoeconomic Center www.pec.ha.osd.mil Strategies for Drug Class Review • Contract expiration – DoD contract, DoD/VA joint contract, BPA • Patent life expectancy – Time to generic availability • Uniform formulary mandate – Requirement to review all drug classes DoD Pharmacoeconomic Center www.pec.ha.osd.mil Strategies for Drug Class Review • Utilization patterns – Evaluate usage at MTFs, TMOP, Retail Network – If one drug has 90% market share, can we expect a shift to other drugs, if the market leader is made non-formulary? • Operational considerations – Switches by pharmacy or MD, packaging issues, contractor requirements DoD Pharmacoeconomic Center www.pec.ha.osd.mil Defining the Drug Class • • • Flexibility to assign drugs to a particular class Drug class members are included based on therapeutic uses (including off-label uses), mechanism of action, market forces Decide whether the drug class is a Basic Core Formulary (BCF) vs. Extended Core Formulary (ECF) candidate – – – – Decide up-front which category will be appropriate Requirement of UF Rule BCF: likely to be used in primary care; ECF: used by specialists *MTF determines need / use of ECF class DoD Pharmacoeconomic Center www.pec.ha.osd.mil Strategies for Drug Class Review Examples • High expenditures across Military Health System (MHS) – Angiotensin Receptor Blockers (ARBs) Feb 05 – Proton pump inhibitors (PPIs) Feb 05 – ACE inhibitors (ACEs) Aug 05 – Calcium channel blockers (CCBs) Aug 05 – Antidepressants Nov 05 – Statins Aug 06 • Market competition within a class – Overactive Bladder Drugs Feb 06: 3 new drugs approved (Sanctura, Enablex, Vesicare) – PDE-5s May 05: Viagra, Levitra, Cialis – BPH drugs Aug 05: Uroxatral, Flomax DoD Pharmacoeconomic Center www.pec.ha.osd.mil Strategies for Drug Class Review Examples • Expiration / discontinuation of existing DoD contract – Gatifloxacin Nov 05 (Tequin) expired Feb 06 – Simvastatin Aug 06 (Zocor) expired Jan 07 – Zolmitriptan (Zomig) expires Jul 07 • Impending generic competition – Nasal steroids Nov 05 (Flonase 1st qtr 06) – Statins Aug 06 (Zocor June 06) – Anti-emetics May 06 (Zofran 4th qtr 06) DoD Pharmacoeconomic Center www.pec.ha.osd.mil Strategies for Drug Class Review Examples • New drug likely to replace a highly utilized generic and aggressive mfg marketing – GABA drugs (gabapentin, pregabalin) Feb 06 – Oral contraceptives May 06 • Previous UF decision prompts new drug class review – Miscellaneous Anti-hypertensive drugs (ACE/CCB combos; Lotrel) Feb 06 DoD Pharmacoeconomic Center www.pec.ha.osd.mil Strategies for Drug Class Review Examples • Uniform Formulary development – Requirement to review drug classes for inclusion or exclusion • Extended Core Formulary drug class – Multiple Sclerosis drugs Aug 05 – Alzheimers drugs Nov 05 • H2 blockers Aug 06 • Older sedative hypnotics Nov 06 DoD Pharmacoeconomic Center www.pec.ha.osd.mil Uniform Formulary (UF) Decision Process: A Refresher Course • Examine costs and effects of competing alternatives • Based on best value to entire enterprise (MTF, TMOP and Retail consideration) • Decision path – PEC completes analyses and provides recommendations to DoD P&T – DoD P&T considers all alternatives and forwards collective recommendation to TMA director – BAP comments on P&T Committee recommendations – TMA Director concurs or non-concurs with Committee recommendations. DoD Pharmacoeconomic Center www.pec.ha.osd.mil Uniform Formulary Class Reviews Oct 05 – Sep 06 Drug Class Name Antilipidemics PPIs (Acid Blockers) Antidepressants Narcotic analgesics Angiotensin Receptor Blockers Thiazolidinediones Calcium Channel Blockers Sleepers (newer + older) Nasal corticosteroids Contraceptives ACE Inhibitors Alzheimers ADHD/Narcolepsy Multiple Sclerosis Overactive Bladder GABA Anticonvulsants Ophthalmic glaucoma α-blockers Macrolides/Ketolide Antiemetics Misc Anti-Hypertension PDE5 Inhibitors 5α-reductase Inhibitors Growth hormone H-2 and Misc GI Topical Antifungals MAOIs Total of Completed or Scheduled Reviews Rank 1 2 3 8 10 11 13 15 21 21 24 25 26 27 31 32 34 42 42 43 46 50 51 62 75 86 341 $Millions % to Total Spend $650 $467 $323 $153 $143 $136 $117 $110 $69 $69 $60 $59 $58 $58 $54 $53 $51 ~$40 $39 $38 $36 $32 ~$31 $21 $10 $11 <$1 $2,888 10.51% 7.56% 5.23% 2.47% 2.31% 2.20% 1.90% 1.78% 1.11% 1.12% 0.98% 0.96% 0.95% 0.94% 0.87% 0.86% 0.83% 0.65% 0.63% 0.62% 0.58% 0.52% 0.50% 0.34% 0.16% 0.17% 0.00% 46.70% $6,181 100.00% Completed Drug Class Reviews Tenatively scheduled for 2007 Total spend FY 06 Totals & rankings are approximate DoD Pharmacoeconomic Center www.pec.ha.osd.mil Upcoming UF Class Reviews • Feb 07 – Monoamine oxidase antidepressants (MAOIs) – Glaucoma agents (topical) – Narcotic analgesics – Newer sedative hypnotics • May 07 (tentative) – Angiotensin receptor blockers (ARBs) – Proton pump inhibitors (PPIs) – Remaining anti-lipidemics (fibrates, bile acid sequestrants, fish oil) – 5-alpha reductase inhibitors DoD Pharmacoeconomic Center www.pec.ha.osd.mil • Next 12 months (tentative) – Growth hormone – RBC Growth Factors – Tumor necrosis factor-α blockers & similar agents – Tricyclic antidepressants (TCAs) – Cough/cold medications – Ophthalmic NSAIDs – Ophthalmic antihistamines & mast cell stabilizers – Diabetes agents Resources For Uniform Formulary Websites • RxNet • PEC Website • TMA website • Formulary Search Tool • Pharmacy Administration Cost Evaluation Reports (PACER) DoD Pharmacoeconomic Center www.pec.ha.osd.mil DoD Pharmacoeconomic Center www.pec.ha.osd.mil Take Away Messages for MTF Pharmacy Community • Understand Pharmacy Program Environment • Know your contributions toward meeting program objectives • Educate those around you! DoD Pharmacoeconomic Center www.pec.ha.osd.mil Questions? DoD Pharmacoeconomic Center www.pec.ha.osd.mil
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