Understanding how the PMPRB
applies its excessive price guidelines is crucial to ensuring that product
pricing is neither too high, nor too low. Pricing too high will inevitably
lead to enforcement actions by the Board, including demands for repayment
of excess revenues and price reductions.
As the Board reports publicly on
its enforcement actions, excessive pricing can also cause public relations
concerns. Increasingly, companies are setting prices below optimal levels
because of uncertainty over how the Board will apply its Guidelines. This
“margin of error” can result in substantial lost revenues year after
year.
For new medicines, planning should begin
in concert with seeking Health Protection Branch approval of the new drug
and its product monograph. This is particularly important for medicines
with multiple indications and in cases where selection of comparable
medicines or determination of dosage regimens may not be straightforward.
Planning should consider how the Board will review the new medicine and
should be consistent with claims or submissions made to the Board.
For existing medicines, planning can be equally complex. The Board’s three year CPI
methodology often makes offering discounts and free goods problematic.
Furthermore, unusually low inflation and poor CPI projections from the
Department of Finance may result in price reductions for some products. A
further complication for all medicines is the international price
guideline, 36 month exchange rates, and the requirement to include US FSS/DVA
prices in the calculations. This analysis must be factored into the
planning process.
An effective strategic plan will consider various options and recommend an approach
that best meets your company’s objectives. PDCI Market Access can assist patentees
prepare for new and existing medicines that are consistent with corporate
goals and with the PMPRB Guidelines. We can facilitate the strategic
planning process by providing expertise on the PMPRB’s Guidelines,
Procedures and Policies—expertise gained through extensive experience
directing the Board’s regulatory process. Strategic planning services
range from telephone advice to preparation of detailed strategic
plans—whatever is appropriate for the situation.
