disclosure the basics of the canadian anticancer drug funding … · 2019-09-27 · 2019-09-27 2...

2019-09-27

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The Basics of the Canadian Anticancer Drug Funding Process

Danica Wasney, B.Sc.Pharm., ACPR, BCOP

CancerCare Manitoba

Disclosure

• I have no conflict of interest to disclose

• I will receive an honorarium for development and delivery of this presentation from CAPhO

• This program has received no financial or in-kind support from any commercial or other organization

Question #1

• After confirming safety and efficacy is acceptable, which of the following is responsible for authorizing the sale of new oncology-hematology therapies in Canada?

A. CADTH (Canadian Agency for Drugs and Technology in Health)

B. Health Canada

C. pCODR (pan-Canadian Oncology Drug Review)

D. pCPA (pan-Canadian Pharmaceutical Alliance)

E. Drug manufacturer

Meet “CAPhOlizumab”• Humanized monoclonal antibody directed against PD-L1

• Administered as a flat dose of 100 mg intravenously over 30 minutes once every 4 weeks

• Currently being studied across multiple indications for use

• Trial results are now available for CAPhOlizumab vs. Standard of Care “Bananumab” in Resected Melanoma (Adjuvant therapy)

• Median RFS: 42 months (C) vs. 41 months (B)

• Toxicity: Immune-related Adverse Events: 32% (C) vs 37% (B)

• QOL: No significant differences between the two arms

• List Price: $15,000 per 100 mg dose

Objectives

1. Understand the processes used in Canada to consider a new oncology-hematology therapy for potential public funding.

2. Recognize the different roles and responsibilities of the organizations/individuals involved in oncology-hematology drug funding (e.g. Health Canada, CADTH, provincial cancer agencies, etc.).

3. Identify advantages and disadvantages to the present oncology-hematology drug funding processes in Canada.

4. Distinguish between the drug funding processes for anti-cancertherapies and supportive care therapies.

Definitions• Jurisdiction –province, territory, or federal (P/T/F); refers to the

“owner” of a drug program/budget; makes drug funding decisions

• Funding – refers to whether a drug plan/program provides coverage for eligible patients for a particular therapy/indication for use

• Reimbursement – may be used interchangeably with ”funding”; term used in CADTH recommendation documents created for jurisdictions

• Health Technology Assessment (HTA) – comprehensive assessment of the clinical and/or economic evidence for health technologies; evaluates benefits/consequences/value for money for a new intervention versus existing intervention; helps stakeholders make informed decisions

• Compassionate Access – supply of drug provided at no cost from a manufacturer for a therapy that does not have alternate funding sources (public or private insurance)

• Bridge Funding – often refers to the time between when a therapy is under review/recommended for reimbursement, but does not yet have public funding (e.g. is undergoing price negotiations)

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Acronyms of InterestAcronym Name Primary Role

CADTH Canadian Agency for Drugs and Technologies in Health Health Technology Assessment

pCODR pan-Canadian Oncology Drug Review (at CADTH; est 2011)Drug Reimbursement Recommendations (Hem-Onc)

CDR Common Drug Review (at CADTH) Drug Reimbursement Recommendations

INESSSInstitut national d’excellence en santé et en services sociaux (est. 2011)

HTA/Drug Reimbursement Recommendations (Quebec)

PAG Provincial Advisory Group (at pCODR) Drug Adoption and Implementation

pERC pCODR Expert Review Committee Drug Reimbursement Recommendations

pCPA pan-Canadian Pharmaceutical Alliance (est. 2010) Drug Contract Negotiations

NOC or NOC/c

Notice of Compliance; Notice of Compliance with conditionsApproval/authorization to market drug for a specific indication for use in Canada

PSP Patient Support Program Manufacturer-Sponsored Program providing access/bridge funding for emergent systemic therapies

Who Does What?

Health Canada

Regulatory (Effect & safety)

Nianda Penner

Who Does What?

Health Canada


CDR (CADTH)

pCODR (CADTH)

INESSS (Quebec)

HTA (Assess value)

Nianda Penner

Who Does What?

Health Canada


CDR (CADTH)

pCODR (CADTH)

INESSS (Quebec)

HTA (Assess value)

Pan Canadian Pharmaceutical Alliance (pCPA)

Price negotiator

Nianda Penner

Who Does What?

Health Canada


CDR (CADTH)

pCODR (CADTH)

INESSS (Quebec)

HTA (Assess value)

Pan Canadian Pharmaceutical Alliance (pCPA)

Price negotiator

F/P/T Ministries of Health

Decision maker/funder

Nianda Penner

The Road to Hematology-Oncology Drug Funding in Canada

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Clinical Benefit for New Drug/Indication


Health Canada Review for New Drug/Indication


CADTH-pCODR Process



CADTH-pCODR Process



CADTH-pCODR Process


NOC/NOCcreceived


CADTH-pCODR Process

Manufacturer-Sponsored Patient Support Program


NOC/NOCcreceived

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CADTH-pCODR Process



NOC/NOCcreceived


CADTH-pCODR Process



NOC/NOCcreceived

Positive* Recommendation


CADTH-pCODR Process


pCPA Contract Negotiation


NOC/NOCcreceived



CADTH-pCODR Process




NOC/NOCcreceived



CADTH-pCODR Process




NOC/NOCcreceived


Listing Agreement Completed


CADTH-pCODR Process




Therapy Funded by Jurisdictions

NOC/NOCcreceived



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Clinical Benefit – Clinical Trial Results

• New drug/therapy or existing drug/therapy for a new indication/combination shows:• Improved clinical outcomes vs. existing therapy

• Improved Progression-Free or Relapse-Free Survival• Improved Tolerability/Safety

• Improved Quality of Life/Patient Reported Outcome• Improved Overall Survival

• Ideally the comparator therapy in the clinical trial is relevant (i.e. used in Canada in this clinical situation)

Clinical Benefit - CAPhOlizumab

• Indication: Resected Melanoma

• Intervention: 100 mg IV every 4 weeks x 1 year (13 doses)

• Comparator: Bananumab 100 mg IV every 3 weeks x 1 year (18 doses) – For this case study, bananumab is funded and considered standard of care in Canada

• Recurrence-Free Survival: Non-significant difference (42 vs. 41 months)

• Toxicity: Appears slightly better tolerated for irAEs; no concerning safety signals identified to date via ADR reporting

• QOL: Non-significant difference vs. comparator therapy

• Manufacturer submits application to Health Canada for Notice of Compliance (NOC) and initiates Drug Review process with CADTH-pCODR (i.e. “pre-NOC”)


Clinical Benefit for New Drug/IndicationCAPhOlizumab

Clinical Benefit for New Drug/IndicationCAPhOlizumab✔️



✔️

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Health Canada Review for New Drug/IndicationCAPhOlizumab

✔️Clinical Benefit for New

Drug/Indication

CADTH-pCODR Process


✔️


CADTH-pCODR Process


CAPhOlizumab

✔️Clinical Benefit for New

Drug/Indication

CADTH-pCODR Process


CAPhOlizumab

✔️

✔️


CADTH-pCODR Process


CAPhOlizumab

✔️

✔️

Health Canada Approval

• Regulatory step required before authorization to market a new drug or new indication for existing drug

• Evaluation efficacy and and safety based on submitted clinical data

• Health Canada may issue a:• Notice of Compliance (NOC)• Notice of Compliance, with conditions (NOC/c)• Notice of Deficiency

• NOC/c: authorization with the condition that the sponsor undertake additional studies to verify the clinical benefit

• NOC or NOC/c authorizes product for sale in Canada and for manufacturer to market product for sale only according to the approved indication(s) for use

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Health Canada• What does Health Canada approval of a drug mean?

• allows drug to be marketed and sold in Canada

• allows drug to be prescribed and used in Canada

• What does Health Canada approval of drug not mean?• does not mean that the drug is better than existing treatments

• does not mean that the drug is cost effective

• does not mean that the drug is covered by the federal, provincial or territorial public drug plans

Nianda Penner

Health Canada - CAPhOlizumab

• Notice of Compliance (NOC) issued for Resected Melanoma

• While CAPhOlizumab is under review by CADTH-pCODR, the Manufacturer opens a Patient Support Program (PSP) for physicians and patients

• This allows for interim access to CAPhOlizumab for Resected Melanoma while the CADTH-pCODR review process continues

• As CAPhOlizumab only has NOC for Resected Melanoma, the PSP will not provide CAPhOlizumab for other indications for use


CADTH-pCODR Process


CAPhOlizumab

✔️

✔️


CADTH-pCODR Process


CAPhOlizumab

✔️

✔️


CADTH-pCODR Process


CAPhOlizumab

NOC/NOCcreceived

✔️

✔️


CADTH-pCODR Process


CAPhOlizumab

NOC/NOCcreceived


✔️

✔️

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CADTH-pCODR Process


CAPhOlizumab

NOC/NOCcreceived


CAPhOlizumab

✔️

✔️Question #2

• How does CAPhOlizumab show better value versus its comparator therapies?

A. Less Frequent Administration

B. Improved Survival

C. Improved Tolerability

D. Lower Cost

E. All of the above

F. A and C only

Health Technology Assessment (HTA)

• Comparative evaluation of new therapy to existing therapies to determine overall value of the new intervention over existing• Encompasses clinical, economic, patient and resource use factors

• Value is not the same as price

• Determining value includes an assessment of cost, quality, and sustainability of a particular intervention compared to an alternative• What is the cost of the drug, health system resource use, adverse effects?

• Does this meet expectations and/or requirements? How or how not?

• Can we implement this? Can we afford this?

• Is there a trade off for using this instead of something else?

HTA in Canada for Hematology-Oncology:CADTH-pCODR

• pCODR evaluates new hematology-oncology drugs and/or new indications for existing hematology-oncology drugs

• Independent, not-for-profit organization; established by P/T/F jurisdictions in 2011 (after iJODR from 2007-2011)

• Mandate: Provide objective evidence and recommendations to jurisdiction to help make informed decisions about the optimal use of drugs

• Review process involves multiple stakeholders, with the aim to include the spectrum of those involved with cancer treatments

pCODR Review Process in Brief

Provincial Advisory Group

Sponsor

Patient Advocacy Group

Registered Clinician

Review Team

Registered Clinician

Provincial Advisory Group

Patient Advocacy Group

pCODR Expert Review Committee

Sponsor

INPUT

SUBMISSION

REVIEW

DELIBERATIONS

FEEDBACK

Initial Recommendation

Final Recommendation

Review Team:•Clinical Guidance Panel•Economic Guidance Panel•Health Research Methodologist

Helen Mai, pCODR-CADTH

pCODR Expert Review Committee

➢Purpose: “to make cancer drug funding recommendations to participating provincial/territorial Ministries of Health, provincial cancer agencies and federal drug programs that can be used by these jurisdictions to guide their cancer drug funding decisions. The pERC recommendations must consider the evidence-based reviews of the clinical effectiveness and cost effectiveness of cancer drug products conducted by pCODR and the input provided by patient advocacy groups and jurisdictions.”

➢Multidisciplinary committee comprised of the following members:➢6-8 cancer specialists (oncologists/hematologists)➢1 “non-oncology” physician➢3 health economists➢1-2 pharmacists➢2 patient representatives and 1 patient representative alternate➢At least one member must have expertise in health ethics

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pCODR’s (pERC) Deliberative Framework

Clinical Benefit• Effectiveness• Safety• Burden of Illness• Need



Patient Values



Patient Values

Economic Evaluation

Adoption Feasibility

• Economic feasibility• Organizational feasibility



Patient Values

Economic Evaluation

pCODR Provincial Advisory Group (PAG)

• PAG consists of representatives from the provincial and territorial ministries of health, provincial cancer agencies, federal drug programs participating in CADTH programs and services, a representative from CAPCA, physicians and an ethicist.

• PAG provides input to CADTH to ensure that pERC recommendations address local needs and issues

• PAG members consider all issues related to implementation of recommendations

• Implementation of a new therapy may be complicated by issues such as:• sequencing of therapies,

• dose schedule variations (mg/kg vs. flat dose),

• missing clinical information (i.e. short-term follow-up, unknown duration of treatment)

Provincial Advisory Group (PAG)• In 2019, the role of PAG has expanded to involve more input and earlier in the

pCODR review process• Identifying potential issues or outcomes if a new therapy/indication receives a positive

reimbursement recommendation

• “Provisional Algorithms” are being developed and integrated into pCODR reviews• What would the systemic treatment of this disease/stage/therapeutic target look like if the

therapy receives a positive recommendation?’

• PAG members identify individual expert clinicians to support the development of this provisional algorithm and provide feedback on the algorithm as related to potential implementation

• PAG members continue to facilitate consultation and information exchange between their respective jurisdictions and CADTH, including important trends in the development and utilization of cancer drugs, and significant issues relevant to their assessment.

https://www.cadth.ca/sites/default/files/pcodr/pCODR-provincial-advisory-group-terms-of-reference.pdf

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HTA - CAPhOlizumabCompared to existing therapies, CAPhOlizumab provides advantages:

• Less frequent administration• Fewer visits for the patient• Fewer pharmacy admixtures• Less chair time in treatment• Fewer clinic visits with prescriber• Fewer blood tests

• May have a different or slightly better safety profile than existing therapies

• Not a new patient population – this group is already receiving treatment

• Not an “add on” therapy - this would be a replacement to bananumab

HTA - CAPhOlizumab

Compared to existing therapies, CAPhOlizumab appears neutral:

• Clinical outcomes • Recurrence-free survival• Safety• Quality of Life

• List price of CAPhOlizumab vs. Bananumab ($15,000 x 13 is equivalent to $10,833 x 18; $195,000 per patient)• Note: Cost-effectiveness of CAPhOlizumab is not worse than Bananumab BUT that is

misleading about whether CAPhOlizumab provides value; the economic analysis will evaluate the differences in costs and the differences in effects between options; no long term outcomes (e.g. Overall Survival) have been reported yet so it is difficult to know if there is a difference in effect between B or C; price of one year of treatment is the same (and both options are very expensive)

HTA - CAPhOlizumab

Compared to existing therapies, CAPhOlizumab provides disadvantages:

• ”Me too” agent in this clinical space

• Resources would be required to implement this therapy• pCPA contract negotiation• Education for patients/caregivers, and health care providers (HCPs)• Systemic Therapy administration, preparation, and monitoring tools for HCPs

• May not provide improved value for money versus existing alternatives• “Opportunity Cost” – trade off – health system resource use to provide this as

an option

• Budget impact would be very high, even with limited numbers of eligible patients ($158,400 per patient)

pERC Recommendation - CAPhOlizumab

• “Conditionally recommends reimbursement if the following conditions are met…• The public drug plan cost of CAPhOlizumab should not exceed the public drug plan

cost of other available immune checkpoint inhibitors.

• Feasibility of adoption is addressed (budget impact).”

• Note: pERC did not make a condition of “improving cost-effectiveness to an acceptable level” because bananumab was used as the comparator in the economic analysis (not placebo).

• Based on the “conditionally positive” recommendation, pCPAnegotiation process begins


CADTH-pCODR Process


CAPhOlizumab

NOC/NOCcreceived


CAPhOlizumab

✔️

✔️


CADTH-pCODR Process


CAPhOlizumab

NOC/NOCcreceived


CAPhOlizumab

✔️

✔️

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CADTH-pCODR Process


CAPhOlizumab

NOC/NOCcreceived


CAPhOlizumab

✔️

✔️



CADTH-pCODR Process


NOC/NOCcreceived




✔️

✔️

CAPhOlizumab

CAPhOlizumab


CADTH-pCODR Process


NOC/NOCcreceived




✔️

✔️

CAPhOlizumab


CADTH-pCODR Process


NOC/NOCcreceived




✔️

✔️

CAPhOlizumab

CAPhOlizumab


CADTH-pCODR Process


NOC/NOCcreceived




✔️

✔️

CAPhOlizumab

CAPhOlizumab

✔️

Question #3

• For what type of medications does pCPA coordinate drug negotiations?

A. Parenteral anti-cancer agents

B. Oral anti-cancer agents

C. Supportive care agents

D. Non-oncology prescription agents

E. A and B only

F. All of the above

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Pan-Canadian Pharmaceutical Alliance (pCPA)• “Conducts joint provincial/territorial/federal negotiations for brand name

and generic drugs in Canada to achieve greater value for publicly funded drug programs and patients through the use of the combined negotiating power of participating jurisdictions”.

• The pCPA member jurisdictions include public drug plan and/or cancer agency participation from: British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Québec, New Brunswick, Nova Scotia, Prince Edward Island, Newfoundland & Labrador, Yukon, Northwest Territories, Non-Insured Health Benefits (NIHB), Correctional Services of Canada (CSC) and Veterans Affairs Canada (VAC).

• pCPA mandate is to enhance patient access to clinically relevant and cost-effective drug treatment options. It serves this mandate by conducting collective, expert-informed negotiations for drugs.

http://www.canadaspremiers.ca/pan-canadian-pharmaceutical-alliance/

Pan-Canadian Pharmaceutical Alliance (pCPA)• pCPA Office coordinates the negotiation process; PAG members

participate in negotiations with Manufacturers

• Negotiation will involve a review of the issues identified in the pERC recommendation, including any conditions outlined

• When an agreement is reached, a Listing Agreement is available for participation jurisdictions • Includes specific wording on the eligible patient population

• Any modifications to the list price of a drug that were the result of negotiations are kept strictly confidential

• Once the listing agreement signed, jurisdictions have a contract with the manufacturer, subject to renegotiation after expiry

Back to CAPhOlizumab• During the negotiation process, the Manufacturer continued to

provide bridge funding for CAPhOlizumab via the Patient Support Program

• Negotiations between the Manufacturer and pCPA representatives took 5 months to complete – a Listing Agreement is now signed by your jurisdiction

• After completing the Listing Agreement, the Manufacturer announces the Patient Support Program will close once public funding is available


CADTH-pCODR Process


NOC/NOCcreceived




✔️

✔️

CAPhOlizumab

CAPhOlizumab

✔️


CADTH-pCODR Process


NOC/NOCcreceived




✔️

✔️

CAPhOlizumab

CAPhOlizumab

✔️


CADTH-pCODR Process


NOC/NOCcreceived




✔️

✔️

CAPhOlizumab

CAPhOlizumab

✔️


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CADTH-pCODR Process


NOC/NOCcreceived




✔️

✔️

CAPhOlizumab

✔️



CADTH-pCODR Process


NOC/NOCcreceived




✔️

✔️

CAPhOlizumab

✔️


✔️


CADTH-pCODR Process


NOC/NOCcreceived




✔️

✔️

✔️


✔️


CADTH-pCODR Process


NOC/NOCcreceived




✔️

✔️

✔️


✔️✔️


CADTH-pCODR Process


NOC/NOCcreceived




✔️

✔️

✔️


✔️✔️

CAPhOlizumab


CADTH-pCODR Process


NOC/NOCcreceived




✔️

✔️

✔️


✔️✔️


CAPhOlizumab

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Differences by Route and Treatment Intent

• Oral vs. Parenteral administration

• Active Cancer Therapy vs. Supportive Care

The Road to Hematology-Oncology Drug Funding in Canada – Oral Agents


CADTH-pCODR Process





NOC/NOCcreceived



Anticancer Drug Funding In Canada

Hospital Cancer Agency Provincial Drug Plan

BCX

(oral and intravenous)

ABX


SKX


MBX

(intravenous)X

(oral)

ONX

(intravenous drugspre-2005)

X(intravenous drugs

post-2005)

X(oral)

NBX

(intravenous)X

(oral)

NSX

(intravenous)X

(oral)

NLX

(intravenous)X

(oral)

PEIX

(intravenous)X

(oral)

Oral Anticancer Agents• Same regulatory process as parenteral agents (Health Canada)

• Same drug review process as parenteral agents (CADTH-pCODR)

• Same contracting process as parenteral agents (pCPA)

• Same or Different drug budgets from parenteral agents• Variable by jurisdiction• Budget may be administered by Cancer Agencies vs. Provincial Drug Plans

(”centralized” vs. “de-centralized”)• Private insurance involved to differing extents depending upon funding model

• CancerCare Ontario Guideline – April 25, 2019:

• https://www.cancercareontario.ca/sites/ccocancercare/files/guidelines/full/1_CCO_THCD_Report_25Apr2019.pdf

• ***Appendix B (p.59-70) – Jurisdictional Scan – Key Features of Different Models for Take-Home Cancer Drugs

The Road to Drug Funding in Canada –Supportive Care Agents

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https://www.cancercareontario.ca/sites/ccocancercare/files/guidelines/full/1_CCO_THCD_Report_25Apr2019.pdf

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CADTH--CDR Process





NOC/NOCcreceived




CADTH--CDR Process





NOC/NOCcreceived




CADTH--CDR Process





NOC/NOCcreceived



Supportive Care Agents

• Same regulatory process as parenteral agents (Health Canada)

• Different drug review process as parenteral agents (CADTH-pCODR)

• Same contracting process as parenteral agents (pCPA)

• Same and/or Different drug budgets from anticancer agents• Variable by jurisdiction

• Budget may be administered by Cancer Agencies vs. Provincial Drug Plans (”centralized” vs. “de-centralized”)

• Private insurance involved to differing extents depending upon funding model

ProviderAnticancer –Parenteral Agents

Anticancer – Oral Agents

Supportive Care –Parenteral Agents

Supportive Care –Oral Agents

Regulatory Approval Health Canada Health Canada Health Canada Health Canada

HTA pCODR pCODR CDR CDR

Drug contracting pCPA pCPA pCPA pCPA

Drug FundingCancer Agency ORTreatment Hospital

Cancer Agency ORTake Home Drug Program

Cancer Agency OR Treatment Facility

Take Home Drug Program OR Treatment Facility

Bird’s Eye View Public Funding is Generally Not Available When…

• Therapy does not have Notice of Compliance• Special Access Programme may release in exceptional cases

• “Do Not Reimburse” (aka Negative) recommendation from HTA organization• No pCPA negotiation will proceed• Jurisdictions will not pursue a listing agreement/list on drug program formulary

• New indication/combination for existing therapy has not completed the drug review process

• Listing Agreement cannot be reached• A conditional recommendation is issued by HTA organization• Parties cannot arrive at agreement

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Advantages to our Processes as of 2019

• pan-Canadian: drug reviews and price negotiations are harmonized wherever possible

• Consistent, thorough: Extensive and standardized review process; standardized listing agreements (eligible patient population)

• Collaborative: Incorporates clinical, economic, patient, and implementation factors in recommendation process and involves multiple jurisdictions and stakeholders

• Improved efficiencies: Reduced replication of effort by jurisdictions

Disadvantages to our Processes as of 2019

• Fractures remain: Differences in parenteral vs. oral anticancer drug budgets increases complexities for patients, caregivers, pharmacy staff

• Clinical data gaps: Implementation issues often expose where new drugs may be difficult to incorporate into existing treatment algorithms

• Limits to capacity and resources: number of new drugs/new indications is burgeoning; access to Patient Support Programs may assist with drug access, but has resource implications of its own; Drug Access Navigators are not available in every jurisdiction

• Prioritization and Sustainability- Need to balance of best evidence with feasibility and capacity in current climate; how do we prioritize our efforts in a fair, equitable, appropriate way?

Thank you for attending

Questions?

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disclosure the basics of the canadian anticancer drug funding … · 2019-09-27 · 2019-09-27 2...

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