CADTH Drug Portfolio 1 December, 2016 Drug Access: Who Does What? - - PowerPoint PPT Presentation

Overview of the CADTH Drug Portfolio

1 December, 2016

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Drug Access: Who Does What?

Health Canada

Regulator (Effect & safety)

CDR (CADTH) pCODR (CADTH) Quebec (INESSS)

HTA (Assess value)

Pan Canadian Pharmaceutical Alliance (pCPA)

Price negotiator

F/P/T Ministries of Health and Cancer Agencies

Decision maker/ funder

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About CADTH

CADTH Drug Portfolio

Programs

• Common Drug Review (CDR)
• Pan-Canadian Oncology Review (pCODR)
• Optimal Use

Products

• Single technology reviews
• Therapeutic Reviews
• Optimal/Appropriate Use studies
• Rapid Responses/HTAs
• Environmental Scans
• Horizon Scans

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Recommendations

CADTH CDR and pCODR

• Pan-Canadian HTA processes that provide formulary listing

recommendations to publicly-funded drug plans

• 18 CDR-participating drug plans
• CDR established in 2003 to reduce duplication across

jurisdictions, maximize the use of limited resources, and enhance the consistency of drug reviews

• pCODR established in 2010 to replace JODR process
• CDR reviews non-cancer drugs
• pCODR reviews cancer drugs

CADTH Drug Review Process

Submission accepted for review Review teams established

• ≥2 clinical reviewers
• 2 economic reviewers
• Project (clinical) owner
• Economic owner
• Project manager
• Information specialist
• ≥1 clinical expert

Clinical Review Economic Review Clinical Report Economic Report Manufacturer comments and reviewer responses Manufacturer’s submission to CDR

Review Process

Patient Input All above information used by Expert Committee to make recommendations

Types of Reviews

Regular reviews

• New drugs
• New indications

Tailored reviews

• Combination products
• Biosimilars

Who Makes Recommendations?

Canadian Drug Expert Committee (CDEC) pCODR Expert Review Committee (pERC)

• Members from across Canada, including:
• Physicians, pharmacists, clinical researchers, patient

representatives

• Meet in-person monthly
• Supported by, but independent of, CADTH

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Recommendation Options

Options* Description and Considerations Reimburse

• The drug under review demonstrates comparable or added clinical benefit and acceptable cost/cost-

effectiveness relative to one or more appropriate comparators to recommend reimbursement in accordance with the defined patient population under review, which is typically the patient population defined in the Health Canada–approved indication (as applicable). Reimburse with clinical criteria and/or conditions Scenarios that could be considered under this category include:

• The drug under review demonstrates comparable or added clinical benefit and acceptable cost/cost-

effectiveness relative to one or more appropriate comparators in a subgroup of patients within the approved indication. In such cases, the subgroup is specified through “clinical criteria.”

• The drug under review demonstrates comparable clinical benefit and acceptable cost/costeffectiveness

relative to one or more appropriate comparators. In such cases, a condition may include that the drug be listed in a similar manner to one or more appropriate comparators.

• The drug under review demonstrates comparable or added clinical benefit, but the cost/cost-

effectiveness relative to one or more appropriate comparators is unacceptable. In such cases, a condition may include a reduced price.

• The drug under review demonstrates clinical benefit, with a greater degree of uncertainty and an

acceptable balance between benefits and harms, in a therapeutic area with significant unmet clinical

• need. In such cases, if the cost/cost-effectiveness relative to one or more appropriate comparators is

unacceptable, a condition may include a reduced price. Do not reimburse There is insufficient evidence identified to recommend reimbursement. Scenarios that typically fit this recommendation category include:

• The drug under review does not demonstrate comparable clinical benefit relative to one or more

appropriate comparators.

• The drug under review demonstrates inferior clinical outcomes or significant clinical harm relative to
• ne or more appropriate comparators.

(*Recommendation Framework Categories: Guidance for Drug Expert Committees, TABLE 1: RECOMMENDATION CATEGORIES, p3)

CDEC Recommendations

(Nov 2012 to Oct 2016)

127 (73%) 32 (19%) 10 (6%) 4 (2%) 20 40 60 80 100 120 140 Reimburse with clinical criteria and/or conditions * Do not reimburse** Do not list at the submitted price Reimburse

*Includes the old nomenclature "List with clinical criteria and/or conditions" and "List with criteria/condition" CDEC recommendations issued **Includes the old nomenclature "Do not list" CDEC recommendations issued

pERC Recommendations

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pCODR has issued 72 notification to implement as

• f September 30, 2016

9 (13%) recommend to reimburse 50 (69%) recommend to reimburse with clinical criteria and/or conditions 13 (18%) do not recommend to reimburse

13% 69% 18%

Column1

Positive Recommendation Conditional Recommendation Negative Recommendation

Challenges

Prioritization

• Current model: first in, first out—does this address the

needs of the health system? Volume of submissions Implementation

• How recommendations are implemented in jurisdictions
• e.g. limited or no evidence on sequencing
• e.g. comparator in the pivotal clinical trial isn’t the standard of care

in Canada

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Orphan Drugs

Background

• Canada does not have a specific orphan drug regulatory

framework as of April 2015

• Since its inception in 2004, the CDR has reviewed 57

applications for drugs that have been granted orphan disease status by the FDA

• 49 unique drugs indicated for 57 different indications
• 30% of drugs had an estimated annual cost above

$100,000 per patient and 70% below $100,000 per patient

Orphan Drugs

Challenges

• Lack of robust evidence to assess comparative effectiveness and

cost-effectiveness using traditional HTA approaches

• Application of a common deliberative framework to orphan drugs

is not always optimal Initiatives

• Early pre-submission meetings to assist manufacturers in

preparing their submission

• Unmet need condition: If there is uncertainty with the clinical

evidence, the available evidence must reasonably suggest that the drug could substantially reduce morbidity and/or mortality associated with the disease

• If there are no organized patient groups that could represent the

interests of patients, submissions from individual patients can be considered eligible for consideration by the committee.

Biosimilars

• Generics are not reviewed by CADTH
• Biosimilars are currently eligible for review by CDR/pCODR
• However, to date pCODR has not received any

submissions for biosimilars

• Discussions are underway to determine what the best

approach is to reviewing biosimilars

Companion diagnostic tests

• Companion diagnostics not currently reviewed by

CDEC/pERC

• Proposal to review companion diagnostic tests

concurrently with drug reviews (currently under going stakeholder consultation)

Transparency Initiatives

The following information is posted by CADTH:

• Submission Status Reports
• CDEC/pERC deliberative framework
• CDEC/pERC recommendation options
• Clinical and Pharmacoeconomic Review Reports
• Patient group input
• All patient input received (in development)
• CADTH-prepared summaries of patient input

The following information is provided by CADTH:

• Feedback provided to patient groups
• Rationale provided in response to priority review requests

Operations Initiatives

120 day mandatory notification period introduced

• Allows for better planning and efficient resource use
• Potential issues with changes in dates due to NOC

changes CDR / pCODR alignment

• More efficient and consistent processes and procedures

CDR / pCODR / Health Canada alignment

• An initiative is underway to speed up HTA reviews relative

to regulatory approval