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Securing an Adequate Drug Supply for each TB Patient

Securing an Adequate Drug Supply for each TB Patient. Jennifer Flood MD, MPH University of California, San Francisco Jennifer.Flood@cdph.ca.gov. Essential Components of a National TB Program. International Standards for TB Control programs

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Securing an Adequate Drug Supply for each TB Patient

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  1. Securing an Adequate Drug Supply for each TB Patient Jennifer Flood MD, MPH University of California, San Francisco Jennifer.Flood@cdph.ca.gov

  2. Essential Components of a National TB Program International Standardsfor TB Control programs • An uninterrupted supply of good quality anti-TB drugs Essential Componentsof a Tuberculosis Prevention and Control Program, ACET • Ensure patients who have TB receive appropriate treatment until they are cured • Treat patients without consideration of their ability to pay

  3. Background Why are we discussing in 2012? • TB patients and U.S. programs have experienced recurring difficulty accessing MDR TB drugs Issues: • Drug shortages • Climbing costs • Multi-step processes for procurement • Out-of-reach for uncovered patients

  4. 2010 NTCA Survey:Interruptions in TB Drug Supply • 21 of 33 (64%) faced challenges obtaining MDR drugs in the United States • 95% experienced barriers due to a nationwide shortage • 62% indicated drugs too expensive fro program

  5. TB Drug Shortages since 2005 • INH cycloserine • Rifabutin ethionamide • Rifapentine cycloserine • Amikacin • Capreomycin • Kanamycin • Streptomycin

  6. What factors impede MDR TB drug access? The Short List: • Single manufacturer for most TB drugs • Drug not profitable and not prioritized for production • FDA inspection overseas pending • Materials to make drug in short supply • Not FDA approved, requires lengthy IRB investigational drug (IND) process • Drugs have very short time to expiration • Cost of drugs puts drug out of reach

  7. Which drugs have a tenuous supply? DrugsReason for supply barriers Amikacin materials short for production overseas FDA inspection pending Capreomycin company change  huge cost increase Cycloserine company changecost increase Clofazimine manufacturing halted; restricted to Hansen’s disease requires IND /IRB for each patient

  8. How much does an MDR TB treatment regimen cost? Drug Cost per dose No. doses Total cost Capreomycin $136.00* 137** $18,632 Linezolid $50.30 790 $39,737 Levofloxacin $29.9 790 $23,621 Cycloserine $14.76 790 $11,661 Ethionamide $10.38 790 $8,200 • 8 months of above multidrug regimen with injectable • Followed by regimen without injectable X 18 months • Assumes culture conversion at 3 months (treatment: 24 mos. post conversion) TOTAL MDR TB DRUG COSTS: $ 56,049 (340 B clinic) or $101,851 (common hospital) ____________________________________________________________ Pricing Source: 2011 California and Nevada local health departments *Cost varies : $136.00 per 1 gram vial to $350 for 1 gram vial **Injectable given 5 days/week X3.5 months; 3 days/week X 4.5 months

  9. Less expensive regimen* Amikacin $630 Levofloxacin $15,721 Ethionamoide $6,952 Ethambutol $2048 PZA $2212 _______________________________ TOTAL: $27,490 *No linezolid or capreomycin; common hospital cost

  10. Who cannot afford TB treatment? Patients with MDR TB • Working with co-pay or limit • Not covered: students, temp workers, undocumented • Indigent, not Medi-caid eligible Programs • Drug costs larger than TB programs’ budget

  11. Procedure to obtain Clofazimine • Patients to fill out a “simple form “ • Provider completes application through hospital IRB • Submits individual IND to FDA for patient requiring drug • Required Documents • FDA Forms: • Form FDA 1571 (PDF) Ι Form FDA 1571 Instructions • Form FDA 1572 (PDF) Ι Form FDA 1572 Instructions • Form FDA HFD-590 (DOC) • Download forms from the FDA's Official Website • Doctor's CV • Current lab results for patient (CBC, chem, sensitivity data) • Signed informed consent document • IRB approval letter • For your information -Clofazimine Treatment Protocol • Once IRB approved • send forms to FDA • Once approved, clofazamine provided to patient through Hansen's Division/Novartis free of cost • Usually takes about 10-14 days from time FDA receives fax to arrival of clofazimine

  12. Do TB drug shortages affect patient outcomes? National TB Controllers survey: • 58% of respondents reported that drug shortages led to treatment delays • 32% reported treatment lapses • 26% reported changing to less optimal regimen

  13. Who pays? Impact of interrupted supply of MDR TB Drugs • Impact felt by patient, programs, providers • Lack of access to optimal drug regimen can lead to further drug resistance • Prolonged infectiousness • Increased spread • Poorer outcomes for patients

  14. Example 1 • 26 yo on work visa from European country with high MDR/XDR incidence • Smear negative, culture-positive cavitary MDR TB diagnosed 2 wks prior to travel • Given 10 day supply of medications through Green Light Committee • Told by physician- not to worry because “TB medications are free everywhere in the world”

  15. Example 1 -continued • On arrival smear positive • Patient had employer insurance but payment disallowed given pre-existing condition • Prescribed initial regimen but capreomycin cost to program = $140.00/dose • Unable to afford drug regimen, in addition to MD, nurse care, DOT, isolation • Patient on MDR drugs without injectable ~ 2 weeks • Receiving jurisdiction reports ~10 TB cases/year • Through diplomatic channels, arranged delivery of GLC medications from originating country

  16. Example 2: The perfect storm • County X reports ~6-10 MDR TB cases/year • All MDR TB patients need injectable agent • Given price of capreomycin, this county changed regimen and pharmacy contract to amikacin • When amikacin had protracted shortage, TB controller became concerned

  17. Steps for TB programs:Securing drugs for your patient • Ask pharmacy to check with other distribution centers/wholesalers • Call manufacturer directly • Is drug in stock? • How can it be obtained? – through wholesalers or directly from manufacturer • If drug is on allocation (requires special request ) • Is drug short-dated? • If out of stock, anticipated date available? 3) Contact local hospitals to share supply • View FDA website

  18. Requirement: Lot’s of time • 1)Maintain contacts • Distributers and manufacturers • Customer service and hospital team • 2)Staff time • Hands-on, time-intensive, shoe-leather telephone/email investigation • 3)Track and maintain • Up-to-date information on drug availability

  19. How to Maintain a Strong Regimen when drug supply is interrupted? Injectable: • Replace with alternate injectable, if can Quinolone: • Use less expensive of levoflox or moxiflox Add to oral agents: • linezolid, clofazamine, cycloserine, PAS, ethionamide

  20. Response to Drug Shortages • Not a new problem (ref. 1994 IUATLD) • Multiple agencies, programs, individuals exert effort to resolve • Response has been case by case • Time from shortage detection to drug reaching patient is long

  21. FDA Drug Shortage Website http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050792 drugshortages@fda.hhs.gov

  22. 2011 President’s Executive Order President Obama issued Executive Order directing FDA and Dept. of Justice to: • Broaden reporting of manufacturing discontinuations • Expedite FDA regulatory review if help avoid a shortage • Report to Department of Justice if FDA finds price gauging or illegal stockpiling

  23. Possible Solutions • Central mechanism for accessing drugs • Federal drug stockpile (eg. Botulism anti-toxin) • Centralized IRB mechanism for old drugs • Streamlined process to obtain investigational drugs for compassionate use • Remove cost as barrier for all patients/programs • Remove copays

  24. Expedite Investigational Drug Process • Secure centralized IRB • National (CDC • In place in some states (eg California,Texas) • Reduce burden of stepwise process and secure more rapidly for individual patients

  25. More Direct Solutions Access • Direct support of TB and MDR TB drug production • Distribute drugs • Track supply, demand, and distribution Cost • Expand entitlement and adopt model of HRSA HIV drug access (eg TB medi-caid for all TB patients)

  26. Advisory Council on Elimination of TB • MDR Workgroup charged to describe extent of problem and potential interventions • Survey conducted • Problem statement and fact sheet created • ACET Resolution • Identify interventions that ensure each TB patient has uninterrupted supply of TB treatment in U.S.

  27. Acknowledgements • ACET MDR TB Working Group • California MDR TB Service • Lee Reichman MD • Ann Cronin

  28. When Drugs are Hard to Come By:Obstacles for Patients Receiving TB Treatment in the United States

  29. Drug Shortages in the United States • The number of drug shortages annually has tripled from 61 in 2005 to 178 in 2010. • Many drugs in short supplyare sterile injectables • More than 90% of US hopsitals in June 2011 reported drug shortage in previous 6 months

  30. Manufacturer Contacts: Injectable agents CAPREOMYCIN Akorn: 800-932-5676 ask for hospital team, drug is on allocation, must complete request form

  31. Injectable Access continued STREPTOMYCIN X-Gen 607-562-2700 • Available by wholesalers and distribution centers AMIKACIN Teva(short supply) and Bedford(none) Teva: 800-545-8800 • For drop shipment

  32. Tuberculosis and Drug Shortages Red= Unavailable, Orange = Allocation on emergency basis only, Yellow= Short dated or not available at wholesalers, Green= Available, Purple= Investigation Drug requires prior authorization

  33. What are the challenges to an uninterrupted supply of anti-TB medications?

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