challenges and innovation in canadian access to treatments and innovation

Challenges and Innovation in Canadian Access to Treatments and Innovation

November 19, 2015

• George Wyatt • Stephen Frank • Suzanne Lepage • Lisa Callaghan

AGENDA

• Panel A Canadian Public and Private

Access Environment

2

• Panel B Access and Innovation –

International Access to Innovative Therapies

• Neil Palmer • Sandra Anderson • Glenn Monteith

Followed by Qs and As

Followed by Qs and As

Public Drug Plan

Reimbursement

in Canada

November 19, 2015

George Wyatt

Flow of Public Drug Plan

Reimbursement in Canada

© Wyatt Management Consulting Inc., Oakville, Ontario, 2015. All Rights Reserved

Health Canada

Manufacturer

CDR/INESSS (non-cancer) pCODR/INESSS (cancer)

Public Plans

pCPA

PMPRB

CDR vs. Quebec (INESSS)

Recommendations


11

189

141

52

157

89

0

20

40

60

80

100

120

140

160

180

200

Positive Conditional Negative

CDR Quebec (non-cancer)

Conditional recommendations include:

List in a Similar Manner, List with Criteria, List with Criteria/Condition, Not at Submitted Price

pCODR vs. Quebec (INESSS)

Recommendations


Condition for INESSS means conditional of improved cost-effectiveness

Positive for INESSS means conditional (no financial restrictions)

9 8

27

11

*

19

0

5

10

15

20

25

30

Positive Conditional Negative

pCODR Quebec (cancer)

CDR Recommendation Codes


2003 to October 2012

List (LIST) List in a Similar Manner (LSM)

List with Criteria (LWC) Do not List (DNL)

November 2012 To Present

List (LIST) List with Criteria/Conditions (LWCC)

Not at Submitted Price (NSP) Do not List (DNL)

Under Consideration

Fund (LIST) Fund with Conditions (FWC)

Do not Fund (DNL)

www.cdrtracker.com

http://www.cdrtracker.com

CDR Patient Input


Voluntary Pipeline Notification/ Mandatory Notification of Submission/Resubmission

CDR notifies Patient Groups for Input

Deliberation/Recommendation

CDR Review Process (Clinical/Economic/Patient Input)

CDR Patient Input

https://www.cadth.ca/about-cadth/what-we-do/products-services/cdr/patient-input












pCODR Patient Input


Mandatory Notification of Submission/Resubmission

pCODR notifies Registered Patient Groups for Input

Initial Recommendation

pCODR Review Process (Clinical/Economic/Patient Input)

Final Recommendation

Patient Groups can only provide feedback on the initial

recommendation if they first provided input in the early

stages of the review.

pCODR Patient Input


https://www.cadth.ca/pcodr/patient-input-and-feedback








Pan-Canadian Pharmaceutical

Alliance (pCPA) – 2015-09-30


80

2

22

11

33

148

54%

1%

15% 7%

22%

100%

0

20

40

60

80

100

120

140

160

Complete Closed(agreement not

reached)

Ongoing Province No Negotiation Total

Number Percent

CADTH Newsletter

https://www.cadth.ca/subscribe


0

50

100

150

200

250

NL NS PEI NB QC ON MB SK AB BC NIHB Avg.

CDR – Public Plan Reimbursement Based on CDR Recommendations from 2004 through 2014

Reimbursed Do Not Reimburse No Decision Yet Removed from Formulary


pCODR – Public Plan Reimbursement Based on pCODR Recommendations from 2012 through 2014


Average Completion Time


203.4 203.1

392

247.1

340.4

0

50

100

150

200

250

300

350

400

450

CDR (Submission toRecommendation)

pCODR (Submission toRecommendation)

pCPA (CDRRecommendation to

Completion)

pCPA (pCODRRecommendation to

Completion)

pCPA (AllRecommendation to

Completion)

Day

s

Time from NOC to

Public Reimbursement


676 628

835

721

800

590

773

1057

404

653 699 712

930

773

1005

1082

981

1094

875

1021 969

738

*

927

0

200

400

600

800

1000

1200

AB BC MB NB NL NS ON PEI QB SK NIHB Average

Day

s

CDR pCODR

* NIHB currently only covers drug that were reviewed prior to pCODR (e.g. jODR)

Summary

• Quebec acts quicker than CDR / pCODR

• Patient input is important for

reimbursement recommendation

• pCPA process is delaying access to

medications

• Overall it takes almost 2 (non-cancer) to 3

(cancer) years from time of NOC to have

drug reimbursement

19

Presentation to Expert Patients Forum Private Payer Industry Trends & Emerging

Considerations

November 19, 2015

Stephen Frank Vice President, Policy Development and Health

19

Prescription Drugs: costs are rising again

• Recent cost growth – while at historical lows – remained higher for private payers than provinces

• Cost's are rising back to more of the historical average

• Specialty drugs driving much of this and pose serious concern

• New challenge: mass market + high costs = budget buster

• Private insurers drug pooling framework is helpful, but growing unexpectedly quickly

20

Employers are the ones who bear these costs – not insurer. They are increasingly looking for ways to limit their financial exposure to new, high cost drugs

Provincial gov't responses: program changes

• Across the board, provinces are responding with changes to their programs, although each on their own priorities and timelines

21

Provincial gov't responses: collaboration to reduce prices

• General view that prices are relatively high in Canada

• Provincial governments working together to negotiate lower prices for brand drugs and generics

– 9 provinces participate in pan-Canadian Pharmaceutial Alliance (PCPA)

• NB: Quebec joined in October; Federal plans will join in 2015/16

– PCPA completed 68 pricing negotiations – estimated $400 million per year in savings

– These rebates are confidential and do not apply to private payers

22

23

Insurers' responses: unprecedented innovation

Managed Formularies

Mandatory Generics

Step Therapy PPNs

Case Management

24

Insurers' responses: Advocating for system reform

Include all payers in PCPA

Continued reform of generic drug pricing

Fundamental reform to PMPRB

• In addition, individual insurers starting to engage in pricing agreements – varying degrees of energy around this at the moment

25

Thoughts on the future

26

Closing thoughts

• New specialty drugs will continue to strain sustainability and drive dialogue around major reform

• Government healthcare reform will continue and accelerate

• Insurers will continue to enhance their capabilities

• Only long-term solution is for greater collaboration between public and private sectors

• Without reform, unclear that the system is sustainable

27

Thank-you

REPRODUCTION REQUIRES PERMISSION OF SUZANNE LEPAGE CONSULTING INC. 28

Evolution of Private Payer Plans in Canada

Expert Patient Advocates and 21st Century Therapies Forum

Hyatt Regency Toronto Toronto, Ontario

November 19, 2015

Presented by: Suzanne Lepage, Private Health Plan Strategist

REPRODUCTION REQUIRES PERMISSION OF SUZANNE LEPAGE CONSULTING INC.

2014 Drug Trend Report • Average annual drug spending per claimant increased by 2.7% (up from

1.3% in 2013)

• Spending on traditional prescription medications declined by 0.3%

• 12.1% increase in spending for specialty medications

o 9.2% increase in cost per script

o Utilization grew 2.9%

o Represents only 2% of claims, but 26.5% of total spending

o Expected to reach 35% in the next four years.

• Top 1% of all claimants comprised 28% of total spending

o Total spending for the top 1% = bottom 85%

29

Express Scripts Canada 2014 Drug Trend Report


Hepatitis C Impact on Private Drug Plans

Green Shield (2013 to 2015)

• For all hepatitis C drugs combined

o Claims increased by 189%

o Spend increased by 424%.

Express Scripts Canada (2014 Drug Trend Report)

• Hepatitis C = therapy class with most growth in 2014

• Overall trend increased 252%

o Utilization increased by 132.7%

o Cost increased by 118.5%

• Spending on hepatitis C increased more than 10x in 15 months

http://www.greenshield.ca/sites/corporate/en/Documents/Follow%20the%20Script/2015/Follow%20the%20Script_Fall%202015.pdf

http://www.express-scripts.ca/sites/default/files/ESC_14101_annual_report_ENG3.pdf

http://www.greenshield.ca/sites/corporate/en/Documents/Follow the Script/2015/Follow the Script_Fall 2015.pdf




REPRODUCTION REQUIRES PERMISSION OF SUZANNE LEPAGE CONSULTING INC. 31

Private Drug Plan Trends

Impact on Specialty Drug Access

1. Case management of drug claims

2. Increased Prior Authorization

3. Preferred Pharmacy Networks (PPN)

4. Managed Formularies

5. Maximum Allowable Cost (MAC) Pricing

6. Step Therapy

7. Government Integration

8. Product Listing Agreements


Food for thought…. 1. How are private plans assessing drug value and comparing

treatments? What is the right price?

2. What is the purpose of a benefit plan? Cover every drug plan members need? Or protect from catastrophic illness?

3. Drug plan costs are a line item for plan sponsors to manage. Confidentiality impacts plan sponsors ability to assess the value of drug coverage, health outcomes or potential impact of plan design changes.

4. Where are the patient stories?

5. How to shift dialogue about drug plans from cost to investment?

32

Lisa Callaghan. MBA, MSc

AVP, Group Product

Manulife Financial

33

End of Panel A

34

Expert Patient Advocates & 21st Century Therapies Forum

International Access to Drugs for Rare Diseases W. Neil Palmer

Toronto November 2015

Australia – Challenges in Funding Rare Diseases

Issues

• Australians are generally waiting from 2 to 4 years longer for access to rare disease therapies available in comparable countries like the United Kingdom, Canada, Germany and the Netherlands.

• Some medications remain unavailable 8 years after becoming available overseas.

• No common definition of a rare disease across the Australian health system – Therapeutic Goods Act includes a limit of 2,000 patients for the

registration of orphan drugs - the equivalent of approximately 1 patient in 10,000 persons

Source: The McKell Institute, Funding Rare Diseases in Australia , November 2014

36

Australia - Recommendations

1. The Australian Government should develop a National Strategy for Rare Diseases that provides a holistic approach to rare disease management

2. Australia should be mindful of international practice and developments when designing rare disease policy frameworks.

3. A more flexible analysis of cost-effectiveness should be adopted in the assessment of new therapies that balances other considerations such as equity, the rule of rescue, community values, patient needs and the long-term costs avoided as a result of access to treatment.

4. The unique nature of therapies for rare diseases, including small patient populations and the implications this has for clinical trials, should be recognised in the evidence requirements for funding.

5. The process for assessing new therapies for rare diseases should be efficient, fit-for-purpose, transparent and informed by community and patient values.

Source: The McKell Institute, Funding Rare Diseases in Australia , November 2014

37

Germany

The Federal Joint Committee in Germany (GBA) commissions IQWiG to examine the benefits and harms of medical interventions and recommends level of additional benefit

Orphan Drugs often given “not quantifiable” benefit

Additional Benefit

Price Discount Negotiation

Implications for Pricing European Prices

Considered

Major

Yes Adjusted premium vs. the appropriate therapy in pricing negotiation

Yes Moderate

Marginal

Not Quantifiable Yes Similar to above Yes

None No (negotiation only if there is no reference group or comparator)

Reference price or at max. the price of the appropriate comparative therapy

No

Less Benefit Yes Discount vs. the appropriate comparative therapy

No

Adapted from: : Markus Jahn, Novartis Pharma GmbH, Pharma Pricing & Market Access Outlook, March 2012

38

England - NICE: Highly Specialised Technologies (HST)

• Highly specialised technology (HST) evaluations are recommendations on the use of new and existing highly specialised medicines and treatments within the NHS in England.

• The HST programme only considers drugs for very rare conditions.

• Most are identified by the National Institute for Health Research Horizon Scanning Centre at the University of Birmingham.

• They aim to notify the Department of Health of new / emerging technologies to be referred to NICE:

– New drugs, in development, at 20 months prior to marketing authorisation

– New indications, at 15 months prior to marketing authorisation

https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-highly-specialised-technologies-guidance

39



















Overview of NICE HST Process

1. Provisional evaluation topics chosen 2. Consultees and commentators identified 3. Scope prepared 4. Evaluation topics referred 5. Evidence submitted (clinical & cost effectiveness)

– Manufacturer submission – Statement from non-manufacturer consultees

6. Evidence Review Group (ERG) report prepared 7. Evaluation report prepared

– Includes all of the evidence that will be looked at by the Evaluation Committee: • the ERG report and any comments received on it • written submissions • personal statements from patient experts and clinical specialists.

8. Evaluation Committee – An independent advisory committee considers the evaluation report and hears evidence

from nominated clinical experts, patients and carers. Evaluation Committee discussions are held in public

9. Evaluation consultation document (ECD) if produced 10. Final evaluation determination (FED) produced 11. NICE Guidance issued


40



















Compliance with a NICE-approved medicine or treatment

• Commissioners (of the 200+ CCGs) have a statutory responsibility

– to make funding available for a drug or treatment recommended by a NICE TA or HST within the timeframe recommended in that guidance.

– Compliance is therefore achieved if a clinician and their patient think a health technology is the right treatment and it is available on the NHS without any local funding or local formulary restrictions.

• For the avoidance of doubt, when NICE recommends a drug as ‘an option’, this is an option for the clinician and patient to consider alongside other potential treatments, not an option for commissioners or providers to not make the treatment available.

https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/achieving-and-demonstrating-compliance

41























HTA / P&R Activities over Product Life Cycle

Market assessment

Pricing environment

NPV calculations

Business planning

Initial pricing scenarios

Market potential based on price scenarios

Early scientific advice with payers / HTA agencies

Pre-clinical Phase I Phase II Phase III Filing / Pre-marketing

Launch / Contracting Post Launch Price Mgmt

Identify comparators

Define outcomes, trial endpoints

HE study design

Identify P&R barriers

Monitor competitors

Quantitative research

Payer research

Analysis of value scenarios

Initial pricing strategy

Finalize global pricing strategy

Define price corridor / fix target and floor prices for each market

Define launch sequence

Develop global value / P&R dossier

Develop market specific dossiers for affiliates

Negotiate prices

Negotiate risk-sharing / price-volume agreements

Launch approval

Monitor launch process

Indication sequencing

Price change approval

Report / assess mandatory price changes

Monitor price trends globally

Assess impact of exchange rates

Assess impact of new indications

• Patient focused engagement typically not part of the early HTA planning process – should start much earlier – patient groups should be pro-active

• Horizon scanning

• Early advice process

Adapted from Simon - Kucher

<===== Patient Engagement =====>

42

Thank you

43

Biography

W. Neil Palmer

President & Principal Consultant PDCI Market Access Inc

[email protected] www.pdci.ca

Neil Palmer President and Principal Consultant of PDCI Market Access Inc. (PDCI) a leading pricing and reimbursement consultancy founded in 1996. He leads a senior team of market access professionals with pricing & reimbursement engagements covering Canada, Europe, and the United States. Prior to PDCI, Neil worked with the Canadian Patented Medicine Prices Review Board (PMPRB) where his responsibilities included policy development, overseeing the price review of patented medicines and conducting economic research. Prior to the PMPRB, he worked with the Health Division of Statistics Canada where he was responsible for economic and statistical analysis of health care costs and utilization. Neil also worked with RTI Health Solutions (Research Triangle Park, North Carolina) where he served as global vice president for pricing and reimbursement. After completing his studies at the University of Western Ontario, Neil began his career in Montreal with the research group of the Kellogg Centre for Advanced Studies in Primary Care. He has written extensively on pharmaceutical pricing and reimbursement issues and is a frequent speaker at conferences in North America and Europe. In January 2015, Neil was appointed Adjunct Assistant Professor at the University of Southern California School of Pharmacy graduate program in Health Care Decision Analysis where he lectures on health technology assessment, pricing and market access from a global perspective.

44

mailto:[email protected]

http://www.pdci.ca/

Customized Patient Care through Patient Support Programs for Rare/Orphan Drugs

Sandra Anderson

November 2015

Why Orphan Drugs are Different

Difficult to diagnose

Population size

Unique patient and caregiver needs

Cost

Reimbursement challenges

Wait times for Specialist

Large amount of stakeholders involved

to get patient on therapy

There is no clear path to get Orphan Drugs Funded

46

A Typical Journey of a Patient with a Common Disease

Insert visual of patient with high

blood pressure- ie asymptomatic

disease

Insert visual of a patient with asthma-

a symptomatic disease

Physician Office

The Patient Journey in Rare Disease

PSP Introduction

• Coverage information is captured

• Services explained

Enrolment in PSP

Demographics, clinical history

Prescription

Journey to Dx

$

Patient set up to

receive treatment Coverage is secured

SA submissions

Life time

Max

Injection/Infusion

Services? Copay?

Call – review

Coverage

decision

Infusion/Injection

Continued Care Calls

• Determine status

• Coach patient

Annual Renewals

Maintenance

Onboarding

Explore

Reimbursement

coverage

Rx

Key Trends for Orphan Drugs

Different reimbursement routes across Canada. Public reimbursement/Private

reimbursement – 50/50

Traditionally very high cost medication requires additional administrative work and numerous

stakeholders involved in treatment

Changes in Private Payer Marketplace ie PPNs

Small patient populations may have regional bias

The Patient Perspective

The high drug cost, and out-of-pocket component, (co-

payment or deductible) can be unmanageable for many

patients (especially for Orphan drugs ~hundreds of 000s/year)

Most income-based public plans such as Trillium in Ontario require patient contributions in

the form of co-payments/deductibles (~3-5%

of household income)

With complex therapies, the primary concerns for patients are access, convenience and the level of customer service

Private plans vary: range from 100% coverage to 50%

coverage, though the most commonly seen co-payments are set between 0 and 20%

Case Study: Real Life Patient Access Barriers Defined

Source: Berry SA, et al. Genet Med 2013:15(8):591–599

Condition and Therapy

Patient

Social and Economic

Healthcare System

Patient Support Programs Focus on Orphan/Rare Disease Drugs

Needs for Orphan Rare Disease PSPs

High Touch Require specific administration or monitoring requirements

before and ordering administration

High Support Education, counselling, compliance monitoring, and drug

information, Customized clinic needs

Special Distribution Special handling techniques; and / or require special handling, have special shipping requirements or need

complex reconstitution

Customized Patient Assistance Clinical , Diet and Lobbying/Financial Support to assist with

access to drug (i.e. co-pay assistance)

Customized Patient Support Programs Nurse Case Manager – One point of contact to deliver quality care at every touch-point

Pre Infusion

Checklist

(Program)

Enrolment

Reimbursement

Specialty

Pharmacy

Update on

Patient

Progress

Infusion Scheduled Patient Experience

*****

Infusion

Drug

Dispensed,

shipped to

clinic)

Nurse

completes

pre-infusion

checklist

Infusion Scheduled: Clinic chosen, Fax to physician, Pre-infusion checklist, Reminder call, Drug order

Enrolment: Entered in CRM, NCM

assigned, patient contacted

Reimbursement: Case Manager confirms coverage with the patient and sets up financial assistance

Specialty Pharmacy: Deferral of copay, Drug Order (Direct through Database), Warehouse sends drug to pharmacy, Drug delivered to Clinic

Infusion: Nurse confirms Drug is onsite, Pre-infusion assessment by nurse, Medical clarification needed?, Infusion, PIR

Patient experience touch-point

Innomar

Nurse Case Manager

Case Study: Coordination of Public Insurance

• Solution

– Public EAP requested

– Patient Advocacy: Lobby on behalf of

patient; media releases; Canada wide

petition; add pressure to decision makers;

weekly telephone conferences with

stakeholders

• Outcome

– Provincial compassionate program obtained

to start and then successfully gained full

approval from the province

Patient is still on therapy!

Challenge: Patient was hospitalized

with multiple organ failure.

The medication was still

under review by the

Province.

Case Study: Reimbursement Solutions in Rare Diseases

CLIENT SITUATION

Client was having challenges

obtaining coverage for their

orphan drug with a major

private payer.

OUR SOLUTION

Payer wanted real health outcomes data and a

negotiated a price per patient based on HO data.

Innomar worked with the manufacturer to obtain and

analyze relevant HO data from their patient support

program.

Innomar developed PLA scenarios and brokered the

meeting between manufacturer and payer to negotiate a

listing.

OUTCOME

Manufacturer was successful in obtaining their desired PLA

scenario

Program continues to report monthly HO data, and payer

continues to cover patients who meet agreed upon criteria.

KEY INSIGHT

Building a data strategy early-on and

utilizing relevant data through the PSP

will be critical to the overall market

access strategy

Conclusions and Key Insights to Consider

• Diagnosis

• Testing

• Reimbursement

• Financial assistance

• Ongoing treatment

• Monitoring

Rare diseases present unique

challenges for:

• Product focused, patient centric;

• Gather valuable real life data extremely useful for payers – useful for potential Adaptive Listing initiatives;

• Manufacturer funded with the opportunity to become more centralized to support overall Rare Disease Strategy

PSPs for Rare Diseases are:

Key Goal: Leverage your PSP to demonstrate

real world effectiveness value to gain access to payers

58

Rare diseases present unique challenges for:

- Diagnosis, Testing,

- Reimbursement, Financial assistance,

- Ongoing treatment

- Monitoring

PSPs for Rare Diseases are:

- Product focused, patient centric;

- Gather valuable real life data extremely useful for payers – useful for potential Adaptive Listing initiatives;

- Manufacturer funded

- Opportunity to become more centralized to support overall Rare Disease Strategy

Ultimate objective is to build a build a different framework for Orphan Drugs which will shorten the timelines to access

Health

Outcomes

Research

Value to

Payers

Patient

Support

Program

Demonstr

ate

Real

World

Effective

ness

and

Value

Presentation to Expert Patients Forum

Innovative Pathways to Drug Access in Private Drug

Coverage Plans

November 19, 2015

Glenn Monteith

Vice President Innovation and Health Sustainability

November 19, 015

60

Players involved in private market – insurers and

others

Plan Members

19 Million

Plan Sponsors

500,000+

Advisors & Consultants

3,000

Insurance Carriers

24

Pharmacy Benefit

Managers

3

Community Pharmacies

8,600

• Many players and decision-makers are involved in private

drug plans

Diseases Have Major Impacts on Canadian Economy

Diseases affect productivity at work, both physically and/or mentally

Examples:

62

1 Source: http://www.phac-aspc.gc.ca/media/nr-rp/2011/2011_0919-bg-di-eng.php 2 Source: Cranswick K., Dosman D. Eldercare: Canadian Social Trends. 2008, Vol. 86, pp. 48-56 and Fast, et al. A Profile of Canadian Chronic

Care Providers: A Report Submitted to Human Resources and Development Canada. Univ. of Alberta. Edmonton : s.n., 2002.

$7,000 / employee / year

Presenteeism

$10,000 / employee / year

Abstenteeism

Chronic Diseases Have a Big Impact on Productivity

and Absenteeism

Top 15 drivers of lost work time Total cost of condition of employees

with a primary condition

63

Source: Kessler’s HPQ—Adjusted to work Force (2007) Source: Collins et al, Assessment of chronic conditions

on work performance, absence and total economic

impact for employers, NEOJM, 2005

Cost containment measures

used by private drug plans

64

Generic substitution

• Not mandatory – physician may prescribe innovative medicine and

write “no substitution”

• Mandatory – in all cases, a generic drug, if available and considered

“interchangeable” then it will be dispensed, or, plan only pays up to

cost of generic drug and plan member must pay the difference in

price to access the innovative medicine *exceptions process for

some plans

Get to know your plan options and ask questions of your

pharmacist/pharmacy when getting a prescription filled.

65

Prior Authorization GWL 100+ Drugs

Tiered Formulary

Therapeutic Sub / Mac Price

Case Management

Summary of Scorecard Findings – 2013 Actuals

• PDP drug cost growth in 2013 is the lowest in recent years.

• Drug cost growth of 2.2% was in line with the Forecast CAGR (1.6% to 2.8%) for the 2013-2017 forecast period.

• Generic savings was higher than forecast; as anticipated generic pricing changes had the greatest impact.

• Impact from new medicine entry was lower due to a mix consisting of fewer specialty medicines than forecast.

• Though marginal, the aging event had a slightly higher impact than forecast due to growth in the number of older claimants and increase in utilization amongst these older claimants.

70

Closing thoughts

• Private drug plans are important to providing access to innovative

medicines and vaccines

• Get to know your plan and inform yourself of how plan design

features can impact access

• Coordination of benefits between plans (e.g. public and private or

two private plans) can be complex

Rx&D advocates for timely, quality access to innovative medicines and

vaccines so people get the treatments they need when they need them.

71

End of Panel B

72