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PEC Pipeline: Looking into the Crystal Ball

PEC Pipeline: Looking into the Crystal Ball . LCDR Joe Lawrence, MSC, USN Dr. Julie Liss DoD PEC Conference 2007. PEC Pipeline 2007 Objectives. Describe different strategies used to identify a drug class review for the Uniform Formulary

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PEC Pipeline: Looking into the Crystal Ball

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  1. PEC Pipeline: Looking into the Crystal Ball LCDR Joe Lawrence, MSC, USN Dr. Julie Liss DoD PEC Conference 2007

  2. PEC Pipeline 2007Objectives • 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Strategies for Drug Class ReviewExamples • 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

  8. Strategies for Drug Class ReviewExamples • 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)

  9. Strategies for Drug Class ReviewExamples • 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

  10. Strategies for Drug Class ReviewExamples • 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

  11. 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.

  12. Uniform Formulary Class ReviewsOct 05 – Sep 06

  13. 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 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 Upcoming UF Class Reviews

  14. Resources For Uniform FormularyWebsites • RxNet • PEC Website • TMA website • Formulary Search Tool • Pharmacy Administration Cost Evaluation Reports (PACER)

  15. Take Away Messages for MTF Pharmacy Community • Understand Pharmacy Program Environment • Know your contributions toward meeting program objectives • Educate those around you!

  16. Questions?

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