The Secretarys Advisory Committee on Blood Safety and Availability Update September 19

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The Secretarys Advisory Committee on Blood
Safety and AvailabilityUpdateSeptember 19 20,
2005

• www.hhs.gov/bloodsafety

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Issues Discussed

• Varicella Zoster Immune Globulin (VZIG)
• Potential shortfall
• ACIP recommendations
• Immune Globulin Intravenous (IGIV)
• Strategic Plan for Improving Blood Safety Against
  Known and Unknown Transfusion Transmitted
  Complications in the 21st Century

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Varicella Zoster Immune Globulin (VZIG)

• Potential shortfall
• Use rate of 200 vials/month
• ACIP recommendations may lead to the use of IGIV
  as an alternate product until VZIG

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IGIV A Perfect Storm or Market Adjustment to the
MMA?
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Manufacturers

• Distributors
• Primary
• Secondary

Distributors are not part of calculation for
reimbursement
Hospitals Physician Offices Hospital Outpatient
MMA ASP 6, 56/g
AWP 83, 80/g
Wholesale and Sales prices reported to CMS
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Change in Service
Distributors
Non -Evidenced Based Use
Labeled Use
Evidenced Based Use
Manufacturers
Part B Oct 28 ASP for Q4 05 Lyophilized 45.57/
g Liquid 56.30/ g
MMA Reimbursement
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Update on Immune Globulin Intravenous (IGIV)

• Manufacturers
• Distributors
• Plasma Protein Therapeutic Association
• CMS
• Patient Communities (i.e., Immune Deficiency
  Foundation)
• Providers
• Pharmacist
• Patients

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Status on Immune Globulin Intravenous (IGIV)

• Providers indicate difficulty in obtaining
  specific brands of IGIV for some patients
• Privately insured
• Medicare
• Shift in treatment location
• Hospitals have reported difficulty in obtaining
  physicians IGIV product of choice for patient
• Upward trend in price, most notably in the
  secondary market

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Findings on Immune Globulin Intravenous(IGIV)
Availability

• Increase in off-label use of IGIV
• Industry
• Consolidation
• Changes in business practice
• Market correction
• Reduction in inventory
• Smaller number of distributors
• Medicare Modernization Act effective January 2005
  changed the Medicare Part B to 106 percent of the
  manufacturers average sales price.
• Medicare payment rate is updated quarterly
• Increased 9 for lyophilized IGIV as of July 2005

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Findings on Immune Globulin Intravenous (IGIV)
Availability

• Sufficient supply of IGIV for patients who need
  treatment
• Suggest that under the allocation process,
  physicians might best serve patients by
  communicating their supply needs directly to
  manufacturers.
• Ensure that IGIV treatment is prioritized toward
  FDA labeled use and those diseases or clinical
  conditions that have been shown to benefit from
  IGIV based on evidence of safety and efficacy.

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Action Plan

• Web Posting www.hhs.gov/bloodsafety
• Report denial of treatment, delay of treatment,
  forced reduction in dosage
• FDA
• CBER Product Shortage Number 800-835-4709
• CBERProductshortages_at_cber.fda.gov
• CMS
• 1-800-MEDICARE
• Supply Channel and Emergency Reserve
• Discussions with PPTA and manufacturers
• Hotline established
• Evidence Based Medicine Study -TBD
• CMS Reimbursement
• Monitor cost
• IG assistance

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ACBSA Recommendation

• We therefore recommend that the Secretary take
  immediate steps to
• Increase reimbursement for non-hospital IGIV
  therapy to a level consistent with current market
  pricing.
• Consider reclassifying IGIV as a biological
  response modifier.
• Consider declaring a public health emergency to
  address the short-term problem.
• Modify the current plan to change hospital
  outpatient reimbursement to ASP 8 in January
  2006 in such a way as to prevent any sudden and
  large decrease in reimbursement.
• Reexamine whether the current IGIV supplies are
  meeting patient needs.
• Work with Congress to establish a long term
  stable and sustainable reimbursement structure.

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Strategic Plan for Improving Blood Safety Against
Known and Unknown Transfusion Transmitted
Complications in the 21st Century
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• Committee finds that there are compelling needs
  for improvement in some areas
• Minimizing disruptions in the supply of and
  access to blood products and their analogues,
• Meeting the product development needs for
  patients with rare disorders,
• Timely funding to ensure appropriate utilization
  of new technologies,
• Integrating presently fragmented systems for
  monitoring blood safety and availability,
• Aligning reimbursement and funding policies with
  product approvals and other decisions intended to
  optimize blood safety and availability,
• Modifying reimbursement policies as needed to
  sustain access to blood products and their
  analogues for all patient groups (e.g. IGIV),

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• Reassessing policies and their related
  interventions based on evaluation of their
  impacts,
• Intensifying efforts to influence clinical
  practices related to blood transfusion and
  alternative therapies, based on scientific
  evidence,
• Accelerating responses to threats (e.g., patient
  /specimen/unit misidentification) for which there
  are available interventions,
• Utilizing formal risk communication strategies
  targeted to blood donors, patients, and care
  providers to enhance scientific comprehension and
  public trust,

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• Pursuing opportunities to enhance public health
  in the management of blood donors,
• Promoting comprehensive disaster planning
  including sustaining the inventories necessary
  for an effective crisis response,
• Establishing a proactive, prioritized, and goal-
  oriented research agenda,
• Utilizing formal assessment tools more routinely
  in policy development and decision making,
• Further clarifying the respective roles of
  government agencies and the private sector in
  management and oversight of the blood system,

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• Such a plan should encompass
• Structured process for policy and decision-making
• Integration of blood system within the PH
  Infrastructure
• Surveillance of adverse events related to blood
  donations and transfusions
• Risk communication
• Error prevention in blood collection centers,
  transfusion services and clinical transfusion
  settings
• Donor recruitment and retention
• Clinical practice standards for transfusion
• Strategic research agenda
• Disaster planning
• Stable and sustainable reimbursement
• Funding for promising new technologies

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Blood Response in Disasters
Wilma
Katrina
Rita
Ophelia
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Assessment

• Pre-planning
• Storage at hospitals
• Infrastructure protection
• Generators
• Fuel
• Hurricane aftermath
• Patient evacuation
• Blood needs unified public message
• Hemophilia Treatment Center relocated
• Tracking blood needs
• Tracking availability of anti-venom, HBIG,
  tetanus vaccine, Hepatitis A vaccine and
  tetanus vaccine

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Katrina and Rita

• Louisiana/Mississippi
• Blood Bank of New Orleans
• Serves 44 hospitals
• AABB TF coordinated resupply through various
  blood organization networks
• Texas
• Houston
• Good patient evacuation
• Resupply from days of closed blood centers
• Approximately 2000 units of RBC
• Approximately 1000 units of WB derived platelets
• Approximately 250 apheresis platelets

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Lessons Learned

• Awareness of local and state government
• Plan in place
• Early evacuation
• Patient evacuation if hospital can not sustain
  anticipated storm
• Patient tracking
• Educate State EOC regarding blood
• Push supplies, dont wait
• Priorities may not be local priority (i.e., fuel)
• Increase awareness of HTC and Tissue/Organ
  Procurement Organizations

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National Response Plan

• Secretary Ridge signed, December 2004
• Base Plan
• Support Annexes
• Emergency Support Functions
• ESF 8 Public Health and Medical Services
• Incident Annexes
• Appendixes

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ESF 8 Public Health and Medical Services Annex

• ESF Coordinator DHHS
• Primary Agency DHHS Support Agency
• Dept of Agriculture
• Dept of Defense
• Dept of Energy
• Dept of Homeland Security
• Dept of the Interior
• Dept of Justice
• Dept of Labor
• Dept of Transportation
• Dept of Veterans Affairs

• US Agency for International
  Development
• Environmental Protection Agency
• General Services Administration
• US Postal Service
• American Red Cross

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ESF 8

• ESF 8, when activated, is coordinated by the
  Assistant Secretary for Public Health Emergency
  Preparedness. Once activate, ESF 8 is
  coordinated by HHS through the Secretarys
  Operation Center

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Blood and Blood Products

• HHS monitors blood availability and maintains
  contact with the American Association of Blood
  Banks Inter-organizational Task Force on Domestic
  Disasters and Acts of Terrorism and, as
  necessary, its individual members to determine
• The need for blood, blood products, and the
  supplies used in their manufacture, testing, and
  storage.
• The ability of existing supply chain resources to
  meet these needs and
• Any emergency measures needed to augment or
  replenish existing supplies.

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RECOVERY
CRISIS
EVENT
AABB TF
HHS
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Event
HHS Blood Issues handled by the ASHs Office of
Blood Safety and Availability through
Secretarys Operation Center
Local EMA
State EOC
Hospital
Affected Blood Collector
Data
Hospital
Hospital
CDC
FDA
HRSA
CMS
Activate Critical Infrastructure
Protection Plans Supplies Electricity Communicatio
n Water
ASBPO
SOC contact points Primary Office of Blood
Safety and Availability
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Event
Hospital
Affected Blood Collector
AABB TF
Hospital
Hospital
A A B B
Level I Task Force
Level 2 Task Force
Assist Affected Blood Collector
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Event
HHS Blood Issues handled by the ASHs Office of
Blood Safety and Availability through
Secretarys Operation Center
Local EMA
State EOC
Hospital
Affected Blood Collector
Data
Hospital
Hospital
FDA
CDC
A A B B
HRSA
CMS
HHS Message to Public
Activate Critical Infrastructure
Protection Plans Supplies Electricity Communicatio
n Water
Message To Blood Community
Level I Task Force
SOC contact points Primary Office of Blood
Safety and Availability Secondary AABB Staff
Level 2 Task Force
Assist Affected Blood Collector
ASBPO