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The Challenge of Formulary Management in the DoD – UF 101

The Challenge of Formulary Management in the DoD – UF 101. Dr. Dave Bretzke, Dr. Angela Allerman, and Major Wade Tiller PEC Conference 2007. Objectives. Describe the UF decision making process Differentiate the roles and responsibilities of the DoD PEC and the DoD P&T

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The Challenge of Formulary Management in the DoD – UF 101

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  1. The Challenge of Formulary Management in the DoD – UF 101 Dr. Dave Bretzke, Dr. Angela Allerman, and Major Wade Tiller PEC Conference 2007

  2. Objectives • Describe the UF decision making process • Differentiate the roles and responsibilities of the DoD PEC and the DoD P&T • Explain why UF decisions apply across both the direct care and purchased care points of service • Discuss the key elements that must be considered in all Uniform Formulary decisions

  3. Uniform Formulary • Intended to provide ‘uniform’ availability across DoD dispensing venues • Legislated and published regulation • Must do • How to do it • Introduce 3rd tier (pay for preference) • Copays governed by law • Limits ability to increase spread • Difficult to change

  4. Uniform Formulary • Decisions apply across dispensing venues • Defined role of DoD P&T Committee • Types of decisions • Formulary status • PA, QL, MN • Moved decision from DoD P&T Committee to TMA Executive Director (Dr. Winkenwerder) • Introduced visibility through Beneficiary Advisory Panel (BAP)

  5. Uniform Formulary • Must review all drug classes • Implement one at a time • New drugs • P&T defines class – complete freedom • Class set as BCF or ECF • Within every class, at least one agent must be BCF / ECF

  6. Loading the hopper • Mandate to review every drug class • Identify drug class candidates • DoD high spend, high use • Competition • New drugs / generics

  7. Loading the hopper (con’t) • Feasibility • Current situation • Likely constituents • Likely outcomes • Cover BCF/ECF requirement • Determine priority • Staff workload • Industry considerations • Put on calendar

  8. Uniform Formulary Decision Cycle • Preliminary review (T-180 270) • P&T Committee meets (T-90 180) • Defines class, BCF or ECF • Request for Pricing Info (T-75 100) • Price Quotes Received (T-20 30) • P&T Committee meets (T) • Final review, recommendations • BAP meets (T+45) • Comments to TMA • TMA Director reviews & signs minutes (T+60) • Implementation of decisions (no later than T+240) 90-Day Decision Cycle

  9. Everything Happens at Once… Aug 063 Classes

  10. Why review Statin Class now? • Statin contract set to expire • Simvastatin available in a generic version • Exclusivity? • #1 MHS drug class • 1M users • $550M / year (9% of MHS total) • How would you define the class?

  11. Antilipidemic I Class

  12. Antilipidemics-I Evaluation Strategy • Developed by the PEC • Factors considered • Clinical needs of the DoD population • Generic availability • Market competition within the therapeutic class • Approved by DoD P&T Committee • Develop bidding scenarios • Put it on the street

  13. PEC Process for Determining Relative Clinical Effectiveness • UF Rule: DoD P&T Committee considers information regarding safety, effectiveness, and clinical outcomes when comparing drugs in the class

  14. Relative Clinical Effectiveness ProcessAntilipidemic I agents • Team approach • Developed key questions to answer • Class divided into intensive LDL lowering (>45%  in LDL) and low to moderate LDL lowering (<45%  in LDL) drugs • Efficacy differences • Surrogate outcomes (LDL , HDL ) • Clinical outcomes (myocardial infarction, acute coronary syndromes, mortality, revascularization, stroke) • Safety / Tolerability differences • Common adverse effects • Serious: elevated liver enzymes, proteinuria, myopathy, rhabdomyolysis • Drug interactions, special populations (pediatric, pregnancy) • Other Factors (pleiotropic effects, dosing initiation schedules) • Initial assessment of DoD population needs

  15. Intensive vs. low to moderate % LDL lowering Combination agents follow their parent statin

  16. 85% of the population 85% of the patients Will use simvastatin < 40mg/day 45% LDL Reduction Majority of DoD population can meet LDL goals with simvastatin

  17. Relative Clinical Effectiveness ProcessAntilipidemic I agents • Define search strategy for evidence • FDA website • MEDline search for approved and off-label uses • Evidence Based Medicine (EBM) sites searched • Existing guidelines (ACC, AHA, NCEP ATP III, VA/DoD) • Database, retrospective cohort studies (safety) • Solicit provider opinion • Survey development • SG Consultants teleconference • Survey to providers and pharmacists • Invited pharmaceutical manufacturer presentations • Ongoing discussion with cost-effectiveness expert

  18. Relative Clinical Effectiveness ProcessAntilipidemic I agents • Evidence Based Medicine (EBM) • Integrating best research evidence with needs of patient/population • EBM principles • Helps to assess the quality of clinical evidence • rigorous study design • appropriate statistical tests • inclusion of patients similar to DoD • appropriate inclusion and exclusion criteria • appropriate objective clinical endpoints • appropriate definition of adverse events • valid conclusions based on studied outcomes and statistical tests • Goal for relative clinical effectiveness section is to use the best quality evidence when determining the differences between the class members

  19. Relative Clinical Effectiveness ProcessAntilipidemic I agents • Systematic process to identify best evidence available • Hierarchy of levels of evidence • Systematic reviews • Condense the results of several trials (10s-100s) into an understandable format • Can help determine differences in efficacy, safety between drugs • Sources: Cochrane, UK, Canada, Oregon • Some limitations: different patient populations, different background medications • Randomized, double-blind, controlled trials • Head-to-head trials • Placebo controlled trials • Non-randomized trials: unequal allocation of drug treatment • Cohort studies, case control studies: no intervention given • Case reports, anecdotal reports: lowest level of evidence; small numbers of patients

  20. Relative Clinical Effectiveness Process Sections of class review • Efficacy • Discuss key issues in efficacy differences between class members or limitations in the available evidence • Safety • How likely will each drug in the class cause harm? • Often need evaluation of sources other than clinical trials • Well-designed retrospective health claims database study • Published FDA data available • Required lab monitoring • Tolerability assessment: How likely will patients take the drug? • Drug discontinuations due to adverse effects • Other Factors: anything else we can think of • Overall clinical effectiveness conclusion

  21. Antilipidemics I: Clinical Evidence Summary * = Active control trial • Most studies compared a statin to placebo • Update to ATP III NCEP guidelines primarily based on 5 major clinical trials: ALLHAT-LLT,ASCOT-LLA, HPS, PROSPER, and PROVE-IT

  22. Antilipidemic I agents: Efficacy Conclusion • No head-to-head trials of equivalent doses of different statins for reducing coronary events or mortality • Meta-analysis (Zhou et al): In low to moderate doses of atorva = prava = simva in long-term cardiovascular prevention using adjusted indirect comparison • Evidence summary:  = statistically significant RRR; X = available trials, but no statistically significant difference shown

  23. Relative Clinical Effectiveness ProcessAntilipidemic I agents • First draft of written class review • Assess military readiness issues if applicable • Gather additional clinical information • Evaluate feasibility of classifying one or more drugs as non-formulary under the UF • Requires input from PEC management, clinical staff, economic experts, and procurement experts • Initial consideration of medical necessity criteria • Final written draft completed, edited by PEC staff • Revisions completed, slides developed for meeting • Ongoing process; steps are not necessarily sequential

  24. Challenges of Relative Clinical EffectivenessAntilipidemic I agents • Lack of comparative head-to-head trials overall, or problems when available • Is the comparison drug inferior? • Comparison of non-equivalent doses of statins • PROVE-IT trial compared 80 mg atorvastatin with 40 mg pravastatin in ACS patients • What to do in absence of head-to-head trials • Calculate NNT • Compare hazard ratios, odds ratios, confidence intervals • Similar point estimates? Overlapping confidence intervals • Efficacy vs. Effectiveness • Strict study conditions may not reflect use of drug in “real world” • Co-morbid conditions not represented in RCTs

  25. Challenges of Relative Clinical EffectivenessAntilipidemic I agents • Safety • Safety data for new market entry is often incomplete and based on 1,000s of patients, rather than 1,000,000s of patients • Length of time on the market and provider experience can determine provider confidence in a drug’s safety profile • Provider opinion • Past experiences and perceptions play a role • Degree of therapeutic interchangeability within the drug class • Difficult to conclusively determine that “Drug A is better than Drug B” • Can usually say “Drug A is no worse than Drug B

  26. Introduction Relative Cost-Effectiveness • The UF final rule states • “If a pharmaceutical agent in a therapeutic class is not cost-effective relative to other pharmaceutical agents in that therapeutic class, it may be classified as a non-formulary agent” (Federal Register / Vol. 69, No. 63 / Thursday, April 1, 2004 / Rules and Regulations) • Applies to • Therapeutic class reviews • New agents in classes already reviewed

  27. Relative Cost-effectiveness Process • PEC performs two different types of economic analyses • Pharmacoeconomic Analysis • “Identifies, measures, and compares the costs (i.e., resources consumed) and consequences (clinical, economic, and humanistic) of pharmaceutical products and services” (Bootman, et al., Principles of Pharmacoeconomics 2nd Ed., New York, St. Martin’s Press,1996) • Budget Impact Analysis • By definition, a BIA estimates the impact on annual healthcare use and cost for the first, second and subsequent years after the introduction of the new product for a national or health plan population (Mauskopf, JA et al.)

  28. Pharmacoeconomic AnalysisProcess • What type or types of analyses performed? • Clinical team provides insight as to how the agents differ in terms of relative clinical effectiveness and to identify significant clinical outcomes • The type of pharmacoeconomic analysis performed is dependent upon the how the outcomes are measured and the extent that these outcomes differ between the agents within a therapeutic class • Scour the literature for every pharmacoeconomic analysis that has ever been performed on the agents within the class • Industry for any published or unpublished pharmacoeconomic models they use to support their respective agents • Synthesize the information and develop pharmacoeconomic models to critically evaluate the cost-effectiveness of the agents within the class.

  29. Pharmacoeconomic Analysis ProcessAntilipidemic I Agents • Strong intermediate outcome evidence • Mean % LDL reduction by drug and strength • Total cholesterol/HDL ratios • Head-to-head RCT • Long-term clinical outcomes evidence • There are no head-to-head trials comparing equivalent doses of statins that evaluate clinical outcomes for reducing mortality or other clinical outcomes (e.g., myocardial infarction, stroke, need for revascularization)

  30. Pharmacoeconomic AnalysisModels • The Annual Cost per 1% LDL Decrease decision analytic model. • The Annual Cost per Patient Treated to Goal Monte Carlo simulation model • The Medical Cost Offset Model (industry) • Compared the cost-effectiveness of these agents based on their predicted outcomes and total predicted health care expenditures for CHD and CHD risk-equivalent patients. • The Cost per Event-Free Patient decision analytic model • Based on the results of the IDEAL Trial, compared the cost-effectiveness of the agents included in that trial—high-dose (80mg) atorvastatin (Lipitor) vs. low-dose (20-40 mg) simvastatin (Zocor, generics)

  31. Pharmacoeconomic AnalysisResults • Results of the first three cost-effectiveness analyses showed ezetimibe/simvastatin (Vytorin) to be the most cost effective high % LDL lowering agent. • Results of the fourth analysis revealed that high-dose (80 mg) atorvastatin (Lipitor) was more effective but considerably more costly compared to low dose (20-40mg) simvastatin (Zocor, generics).

  32. Budget Impact AnalysisAffordability Affordability Cost-Effectiveness Quality Efficacy Safety

  33. Budget Impact Analysis Overview • Models the MHS budget impact dynamics of a UF decision • Factors included in the model • Market growth • Market share migration • Change in utilization among therapeutic class agents as beneficiaries migrate from NF to UF agents • Point of Service Migration • Change in utilization among POS • Costs associated with migration from NF to UF agents • Medical necessity processing fees • Provider costs associated with switching patients from NF to UF agents • Lab costs • Cost reduction associated with NF $22.00 copay

  34. Budget Impact AnalysisMethodology Overview • Dynamic Markov Model • Differs from static model in that it incorporates the element of time • Migration transitions from NF to UF occur gradually overtime…no longer assumes instantaneous migration • Open not closed…beneficiaries enter and exit model over time…allows for market growth • Allows for providers/beneficiaries to change agents over time (migrate back and forth between Markov states)

  35. Budget Impact Analysis Results • Interesting • All scenarios that included Lipitor on the UF were more favorable compared to scenarios without Lipitor on the UF • Ultimately • The Uniform Formulary scenario that included atorvastatin (Lipitor), ezetimibe/simvastatin (Vytorin), and simvastatin (Zocor, generics) 80 mg as the high % LDL lowering agents on the UF was the most cost effective UF scenario.

  36. P&T Committee DecisionFactors Considered • Relative Clinical Effectiveness • Relative Cost Effectiveness • Pharmacoeconomic Analysis • Vytorin the most cost-effective agent intensive dose statin • No economic benefit to exclude any of the low to moderate % LDL lowering agents from the UF • Budget Impact Analysis • The UF scenario that included Vytorin, Lipitor, and Simvastatin 80mg along with the low to moderate % LDL lowering agents was the most cost-effective UF scenario • Market Conditions • Potential Impact/Disruption to Beneficiaries

  37. Distribution of Unique Users (UUs) by Agent and POS UUs Source: Utilization Data - PDTS; BPA - Manufacturers; Current – MTF (Prime Vendor), Retail & TMOP from PDTS; FSS - VAPBM

  38. After the P&T Meeting • BAP meeting • Minutes from DoD P&T & BAP meetings presented to TMA Executive Director and signed • Minutes posted • MTF formulary management (pushout) documents • Medical Necessity criteria • Finalize forms and submit to ESI / post • Real work begins – implementation!

  39. MTF Implementation • Review decisions • Develop implementation plan • Provider education • New vs. existing patients • Confirm prices loaded • Follow-up MUE / DUE • Execute

  40. PEC Monitoring • Develop monitoring plan • Ongoing • Specific targets • Monthly trend analysis • Combined • By Point of Service • Monthly cost per ???? tracking • Rx, 30-day Eq Rxs, Treatment day, Tab/cap • Prime Vendor availability

  41. PEC Monitoring • Field alerts • Add to PACER • Return and Report • DoD P&T Committee • BAP • Dr. Winkenwerder • Conferences • ??????

  42. PEC Monitoring - Example • Statins • Ongoing analysis • Trend by drug by month • Cost per day by month • Specific targets • Simvastatin cannibalization • Equipotent doses (e.g. Lipitor 10 & 20mg) • Up prescribing • Brand over-marketing (e.g. Lipitor + Vytorin vs. class) • Cost effective • High Potency Use (Crestor vs. Lipitor 40 & 80mg vs. Vytorin)

  43. Summary - Statins • Extremely important drug class for DoD • Use Vytorin in patients who need > 45% reduction in LDL • “Our efforts to sustain…the TRICARE Rx benefit require that MTF prescribers continue using simvastatin…” • “I strongly encourage MTF commanders, doctors and pharmacists to maximize the use of simvastatin” Dr. Winkenwerder, ASD-HA

  44. Summary - Overall • The UF process and drug class reviews are comprehensive and (sometimes painfully) thorough • Best real world application of EBM reviews and pharmacoeconomic analyses • MTF input is extremely valuable • Strives to find the best balance of access vs. costs • Future offers depend on today’s performance

  45. Contact Info • Major Wade Tiller, RPh, MHA, PhD Biomedical Sciences Corp Deputy Director, DoD Pharmacoeconomic Center kevin.tiller@amedd.army.mil • David R. Bretzke, PharmD Procurement / Informatics Pharmacist DoD Pharmacoeconomic Center david.bretzke@amedd.army.mil • Angela Allerman, PharmD, BCPS Clinical Pharmacy Specialist DoD Pharmacoeconomic Center angela.allerman@amedd.army.mil

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