PMPRB and Access to Medicines Spring 2020 Webinar Series Webinar 1: Patients Speak Out

1. PATIENTS SPEAK OUT!
Webinar Series on the
PMPRB Changes
April 29, 2020
1

2. At this time when all Canadians are uniting to fight the worst global pandemic of our lifetimes, when
most businesses have ground to a standstill, when most people do not even venture from their homes,
why is the Patented Medicine Prices Review Board refusing to stop or at least delay the implementation
of the most drastic price reductions of new prescription medicines?
The Canadian Organization for Rare Disorders (CORD) has led the patient voices deploring these
changes, laying out the titanic risk to all patients, but especially those with rare and common conditions
whose lives and wellbeing are dependent on access to innovative medicines in Canada.
CONTEXT FOR PMPRB SPRING WEBINAR SERIES

3. 1. Durhane Wong-Rieger – President & CEO, Canadian Organization for Rare
Disorders
2. Susi Vander Wyk – Executive Director, Cure SMA Canada
3. Joan Paulin – PHA Canada Ambassador (pulmonary arterial hypertension)
4. Chris MacLeod – Founder, Canadian Cystic Fibrosis Treatment Society
5. Q’s and A’s / Discussion
PANEL & AGENDA

4. What Does Patented Medicine Prices Review Board Do?
• PMPRB = Quasi-judicial federal agency
• Mandate = protect Canadians from excessive drug prices;
NO mandate to improve patient health or health system
effectiveness
• Sets (Non-excessive) Maximum List Price based on:
- independent assessment of treatment’s therapeutic
value versus alternatives
- prices for same medications in seven other countries:
PMPRB7
FRANCE UK GERMANYITALY SWEDEN USASWITZERLAND

5. BIG Changes in PMPRB Federal Regulations
• Changes on How PMPRB Sets Prices:
- NEW: List of comparator countries to set Maximum
List Price: Drop 2 highest and add 5 lower priced
countries
- NEW: Regulated Maximum Rebated Price (MRP)
unilaterally set by PMPRB using new economic
factors
- NEW: Arbitrary, uniquely Canadian MRP Cap set at
$60k/QALY or $90k/QALY for Rare Disease Drugs
New list (PMPRB11)
FRANCE UK
GERMANY ITALY
SWEDEN AUSTRALIA
BELGIUM
JAPAN
NORWAY
NETHERLANDS
SPAIN
USA
SWITZERLAND
Aug. 21, 2019
Regulations adopted
Spring 2020
Finalized guidelines
Consultation period on
the Draft Guidelines
Nov.
21
2019
Feb.
14
2020
Jul. 1, 2020
Implementation

6. Multi-Step Process to Regulate Maximum Prices
Maximum List Price (MLP):
All drugs Median of
PMPRB 11
(and may be LOWER based on
Therapeutic Class Comparison
Test or LOWEST of PMPRB11)
Maximum Rebated Price
(MRP):
Category 1 Drugs subject to
max $60K/QALY for first
$25M in sales
(Rare Disorders Meds with sales less
than $12.5M allowed $90K/QALY)
MRP then further adjusted:
for each $25M in sales over
$25M, mandated price
reductions of 10% up to 50%
reduction of MRP
Reassessments when:
Global prices drop by
10%, new indication,
market size changes,
updated cost/QALY
analysis, etc.

7. Moving Canada to the lower end of OECD
3.21
1.06 1.00 0.97 0.94 0.94 0.92 0.89 0.88 0.86 0.85 0.84 0.83 0.83 0.81 0.81 0.80 0.80 0.79 0.79 0.78 0.76 0.74 0.72 0.71 0.70 0.69 0.69 0.67 0.67
0.54
0.34
USA
Sw
itzerlandCanadaGerm
any
New
ZealandM
exico
Japan
ChileAustriaSw
eden
ItalyFinland
UKIreland
OECD
M
EDIAN*Hungary
Spain
NetherlandsBelgium
Luxem
bourgNorw
ayFranceAustraliaPortugalSlovakia
Czech
RepublicPolandGreeceEstoniaSlovenia
South
KoreaTurkey
Average Foreign-to-Canadian Price Ratios, Patented Medicines, OECD, 2017
Calculated at medicine level for medicines with prices available in at least three foreign markers
Source: From Figure 21 of the PMPRB Annual Report 2017; MIDASTM database, 2017, IQVIA. 40-70%
Current comparator
New comparator
Canadian regulated public prices
drop by 20% and potentially further
based on therapeutic class
comparison (TCC) test
Further reductions of net (confidential)
prices bring total regulated reductions
to as much as 50% off median
international price (MIP)
PMPRB 11 median = 0.80

8. Health Canada approvals and submissions have dropped precipitously
Rawson, N., Fewer new drug approvals in Canada: early indications of unintended consequences from new PMPRB regs, Canadian Health Policy, March 2020:
https://www.canadianhealthpolicy.com/products/fewer-new-drug-approvals-in-canada--early-indications-of-unintended-consequences-from-new-pmprb-regs.html
Comparison: FDA approvals versus New Drug Submissions in Canada – updated to April 2, 2020

9. Clinical trial starts also 50% lower than in previous periods
PDCI Analysis of Health Canada Clinical Trial Registrations

10. Where we now are on this issue

12. FOR PMPRB
• Lives matter. Explore impact of pricing policies on patients’ lives and build polices
to support drugs getting to Canadian patients.
• PMPRB should act less like a punitive body and more like a “public good” agency.
Collaborate with patients, clinicians, payers, and other stakeholders to arrive at
pricing guidelines that work for all.
FOR POLICY MAKERS
• This next generation of drug are revolutionary. Ensure that Canada’s pharmaceutical policies,
including pricing policies, will allow Canadians to have access as soon as possible.
• STOP the PMPRB … until all of the proper consultations and considerations have been conducted.
KEY RECOMMENDATIONS

13. MAY
6
Federal Price Controls and Access
to Medicines Webinar Series
APRIL
29
MAY
13
Patients Speak Out
at noon at noon at noon
Drug Launches:
What Influences the Decision
to Deploy New Medicines?
Alternative Approaches to
Innovative Drug Pricing
Rx