ADVANTAGES |
- most straightforward
- all drug is ‘new’
-allows for adjustments to new composition over shortest time |
- Allows a ‘wait and see’ approach for 2 years
- Replaced stock with 7 year shelf-life (in 2 years time) may last until generics likely available at a lower cost
- Can be used to transition from adult to paediatric doses, after 2 years
- Postpones disposal issue for 2 years, waste perception is minimized
- least expensive in the short term |
- Buys time for new developments (e.g. resistance monitoring, reprocessing, generics available, H5N1 vaccine etc)
- Can be used to transition from adult to paediatric doses sooner
-Allows the purchase of new antivirals at reduced price
- least wasteful as drug is returned to Roche for pilot test
-Supports new production opportunities and subsequently reduced price for reprocessed antivirals |
All of the advantages listed in Option 2 & 3, plus:
- Levels out financial burden and allows governments to stagger purchases thereby preventing cost surges
- By staggering purchases, jurisdictions are less vulnerable to inadequate supply, financial pressures and/or less quantity of stock to be used through an Interim Order if necessary |
DIS-
ADVANTAGES |
- “locks in” purchase of antivirals for another 7 years (possible resistance issue)
- potential storage limitations if ‘redundant’ stock is held
- perceived as wasteful if potentially useable stock is discarded
- most expensive option as new drug would be purchased at full cost and disposal costs would be applied |
- If widespread oseltamivir resistance develops, stock may not be used.
- Will likely have to buy stock at full cost in the future - a 2nd “surge” of expiries
- Stock would still have to be disposed of in 2 years time
- Additional costs to stability test the held stock
- Potential that IO may not be issued
- Communications challenges re: using ‘expired’ stock.
- Official “size” of new stock in the stockpile will decline temporarily as stock is held for 2 years and permitted to expire. |
- Becomes challenging to manage and describe various types of stock (bulk, exchanged, potentially reprocessed)
- Must provide certification that returned stock has been properly stored
- Roche must ensure returned stock is used only for the Pilot project, or alternatively, discarded properly |
- Perception of using expired stock
- Potential that IO may not be issued
- If widespread oseltamivir resistance develops, it is possible that replaced stock may be unusable
- Communications challenges re: perception of a portion of the stockpile “falling short” of national targets
- Disposal costs for portion of unused stock that is held and not exchanged
- Additional costs to stability test and hold a portion of the stock
- Potential storage constraints for the portion of stock “held”
- Perception that the National Stockpile is fragmented
- Stockpile management challenges to Exchange, hold, replace stock. |
