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

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Presentation on theme: "Securing an Adequate Drug Supply for each TB Patient Jennifer Flood MD, MPH University of California, San Francisco 1."— Presentation transcript:

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

2 2 Essential Components of a National TB Program International Standards for TB Control programs –An uninterrupted supply of good quality anti-TB drugs Essential Components of 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 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 4

5 TB Drug Shortages since 2005 INHcycloserine Rifabutinethionamide Rifapentinecycloserine Amikacin Capreomycin Kanamycin Streptomycin 5

6 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 7 Which drugs have a tenuous supply? Drugs Reason 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 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 $ $39,737 Levofloxacin $ $23,621 Cycloserine $ $11,661 Ethionamide $ $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 : $ 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 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 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 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 InstructionsForm FDA 1571 (PDF)Form FDA 1571 Instructions –Form FDA 1572 (PDF) Ι Form FDA 1572 InstructionsForm FDA 1572 (PDF)Form FDA 1572 Instructions –Form FDA HFD-590 (DOC)Form FDA HFD-590 (DOC) –Download forms from the FDA's Official WebsiteDownload 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 ProtocolClofazimine 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 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 12

13 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 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 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 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 1)Ask pharmacy to check with other distribution centers/wholesalers 2)Call manufacturer directly 1)Is drug in stock? 2)How can it be obtained? – through wholesalers or directly from manufacturer 3)If drug is on allocation (requires special request ) 4)Is drug short-dated? 5)If out of stock, anticipated date available? 3) Contact local hospitals to share supply –View FDA website 17

18 Requirement: Lot’s of time 18 1)Maintain contacts Distributers and manufacturers Customer service and hospital team 2)Staff time Hands-on, time-intensive, shoe-leather telephone/ 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 19

20 20 Response to Drug Shortages Not a new problem (ref 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 ortages/ucm

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 22

23 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 24

25 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) 25 More Direct Solutions

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. 26

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

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

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

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

31 Injectable Access continued STREPTOMYCIN X-Gen Available by wholesalers and distribution centers AMIKACIN Teva(short supply) and Bedford(none) Teva: For drop shipment 31

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 MedicationsJune 2011July 2011Sept 2011Oct 2011 Kanamycin Streptomycin Amikacin Capreomycin Levofloxacin Moxifloxacin Cycoloserine PAS Ethionamide Linezolid Clofazamine

33 What are the challenges to an uninterrupted supply of anti-TB medications? MedicationsChallenges to an uninterrupted supply KanamycinNo US manufacturer StreptomycinSole US manufacturer; increased demand cause for Aug/Sept 2011 shortage. AmikacinMaterials short for production overseas FDA inspection pending CapreomycinSole US manufacturer. Price increase x 10 since change in manufacturer (2007: $11.7/1 gram vial; 2010: $137/1 gram vial after the manufacturer changed from Eli Lily to Akorn; 2011: New report of ~$300/1 gram vial) CycoloserineSole US manufacturer; price doubled when license transferred from Eli Lily PASSole US manufacturer EthionamideNot immediately available via wholesaler LinezolidVery expensive ClofazamineRequires IND and local IRB approval, process takes 8-10 wks


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