Title: The Secretarys Advisory Committee on Blood Safety and Availability Update September 19
1The Secretarys Advisory Committee on Blood
Safety and AvailabilityUpdateSeptember 19 20,
2005
2Issues 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
3Varicella 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
4IGIV A Perfect Storm or Market Adjustment to the
MMA?
5Manufacturers
- 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
6Change 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
7Update on Immune Globulin Intravenous (IGIV)
- Manufacturers
- Distributors
- Plasma Protein Therapeutic Association
- CMS
- Patient Communities (i.e., Immune Deficiency
Foundation) - Providers
- Pharmacist
- Patients
8Status 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
9Findings 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
10Findings 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.
11Action 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
-
12ACBSA 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.
13Strategic Plan for Improving Blood Safety Against
Known and Unknown Transfusion Transmitted
Complications in the 21st Century
14- 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),
15- 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,
16- 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,
17- 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
18Blood Response in Disasters
Wilma
Katrina
Rita
Ophelia
19Assessment
- 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
20Katrina 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
21Lessons 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
22National Response Plan
- Secretary Ridge signed, December 2004
- Base Plan
- Support Annexes
- Emergency Support Functions
- ESF 8 Public Health and Medical Services
- Incident Annexes
- Appendixes
23ESF 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
24ESF 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
25Blood 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.
26RECOVERY
CRISIS
EVENT
AABB TF
HHS
27Event
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
28Event
Hospital
Affected Blood Collector
AABB TF
Hospital
Hospital
A A B B
Level I Task Force
Level 2 Task Force
Assist Affected Blood Collector
29Event
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