Antiviral Stockpiling for Novel Strains of Influenza

Background for Stockpiling

Strategic National Stockpile ( Administered by the Centers for Disease Control and Prevention) The SNS is designed to provide supplies for a disaster The SNS is designed to provide supplies for a disaster Currently comprised of 12-hour Push Packages and Vendor Managed Inventory for rapid response measures Currently comprised of 12-hour Push Packages and Vendor Managed Inventory for rapid response measures Other special supplies available Other special supplies available

SNS Antiviral Stockpile Creation Lack of effective vaccine creates an immediate need for antiviral drugs Lack of effective vaccine creates an immediate need for antiviral drugs Antiviral drugs are limited in supply and may be cost prohibitive Antiviral drugs are limited in supply and may be cost prohibitive Two types of antiviral medications stockpiled and recommended for novel influenza use Two types of antiviral medications stockpiled and recommended for novel influenza use

SNS Antiviral Stockpile Utah has been given an SNS allotment of 350,518 courses (held by CDC) Utah has been given an SNS allotment of 350,518 courses (held by CDC) This allotment would treat approximately 13.6% of the State’s current population This allotment would treat approximately 13.6% of the State’s current population

State Antiviral Stockpiles CDC has allowed states to purchase of additional courses at their contracted price with a 25% subsidized match CDC has allowed states to purchase of additional courses at their contracted price with a 25% subsidized match Total courses available to Utah for subsidized purchase - 246,956 Total courses available to Utah for subsidized purchase - 246,956 Total cost estimates for subsidized allotment is about $3.6 million dollars (does not include storage expenses) Total cost estimates for subsidized allotment is about $3.6 million dollars (does not include storage expenses)

SNS and State Stockpiles The sum of the SNS allotment for Utah and the subsidized courses provides a total of 597,475 courses The sum of the SNS allotment for Utah and the subsidized courses provides a total of 597,475 courses This would treat 23.1% of the current Utah population (one course per patient) This would treat 23.1% of the current Utah population (one course per patient)

Issues

Stockpiling Expenses Effectiveness of antiviral drugs is not clearly established for novel influenza virus strains Effectiveness of antiviral drugs is not clearly established for novel influenza virus strains Stockpiles may not effectively be rotated to extend shelf-life Stockpiles may not effectively be rotated to extend shelf-life Shelf-life extension programs are not currently allowed at the state level Shelf-life extension programs are not currently allowed at the state level

Assumptions for Public Concern The public likely expects preparation efforts to be comprehensive The public likely expects preparation efforts to be comprehensive Antiviral drugs may save lives Antiviral drugs may save lives Fairness in rationing and policies for use Fairness in rationing and policies for use Lack of a significant influenza event may discredit the use of funds – pumps at the Great Salt Lake Lack of a significant influenza event may discredit the use of funds – pumps at the Great Salt Lake

Allowances for Purchasing States may pool money from local governments or other private organizations to purchase antiviral drugs under the federal contract States may pool money from local governments or other private organizations to purchase antiviral drugs under the federal contract The State is responsible for the purchase payment and is allowed one delivery The State is responsible for the purchase payment and is allowed one delivery A letter of intent is required by December 29, 2006 for purchase A letter of intent is required by December 29, 2006 for purchase

Priorities for Use Multiple stakeholders need to be unified on antiviral drug priorities for administration Multiple stakeholders need to be unified on antiviral drug priorities for administration The National Vaccine Advisory Committee has developed guidance to assist in prioritizing administration protocols The National Vaccine Advisory Committee has developed guidance to assist in prioritizing administration protocols Limited supplies dictate antiviral drugs should be used primarily for treatment and limited prophylaxis Limited supplies dictate antiviral drugs should be used primarily for treatment and limited prophylaxis

Equity in Rationing Initial patients may exhaust stockpiles Initial patients may exhaust stockpiles Some communities may have outbreaks at later dates Some communities may have outbreaks at later dates Antiviral medications in the State stockpile might be distributed for use follows: Sixty percent (60%) to be distributed according to the population of each district Twenty percent (20%) distributed according to the number of general medical beds in each jurisdiction A reserve of 20% be maintained at the State for distribution according to need, including coverage of priority groups identified, or for outbreak control

Planning Adaptations Uncertainty requires plans be flexible, coordinated, and approved effectively Uncertainty requires plans be flexible, coordinated, and approved effectively Stakeholder coordination requires an efficient decision making process Stakeholder coordination requires an efficient decision making process

Recommendations Pursue funding for antiviral drug purchase Pursue funding for antiviral drug purchase Approve recommendations of the National Vaccine Advisory Committee for use of antiviral drugs Approve recommendations of the National Vaccine Advisory Committee for use of antiviral drugs Allocate purchased stockpiles based on health district population, hospital beds, and retain a State reserve Allocate purchased stockpiles based on health district population, hospital beds, and retain a State reserve Recommend that hospitals, healthcare providers, and others be allowed to purchase under the federal contract through the State Recommend that hospitals, healthcare providers, and others be allowed to purchase under the federal contract through the State Develop an integrated State plan including storage, management, distribution, dispensing, accountability of use, assessment of efficacy, and adverse events Develop an integrated State plan including storage, management, distribution, dispensing, accountability of use, assessment of efficacy, and adverse events