Overview of the CADTH Drug Portfolio 1 December, 2016
Drug Access: Who Does What? Regulator (Effect & Health Canada safety) HTA (Assess CDR pCODR Quebec value) (CADTH) (CADTH) (INESSS) Price Pan Canadian Pharmaceutical negotiator Alliance (pCPA) Decision F/P/T Ministries of Health and maker/ Cancer Agencies funder 1
About CADTH 2
CADTH Drug Portfolio Programs • Common Drug Review (CDR) • Pan-Canadian Oncology Review (pCODR) • Optimal Use Products • Single technology reviews • Therapeutic Reviews Recommendations • Optimal/Appropriate Use studies • Rapid Responses/HTAs • Environmental Scans • Horizon Scans 3
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 Manufacturer’s submission Review Process to CDR Patient Clinical Economic Input Review Review Submission accepted for review Economic Clinical Report Report Review teams established • ≥2 clinical reviewers Manufacturer comments • 2 economic reviewers and reviewer responses • Project (clinical) owner • Economic owner • Project manager • Information specialist All above information used by Expert • ≥1 clinical 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 7
Recommendation Options Options* Description and Considerations • The drug under review demonstrates comparable or added clinical benefit and acceptable cost/cost- Reimburse 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 Scenarios that could be considered under this category include: • The drug under review demonstrates comparable or added clinical benefit and acceptable cost/cost- with clinical effectiveness relative to one or more appropriate comparators in a subgroup of patients within the criteria approved indication. In such cases, the subgroup is specified through “clinical criteria.” • The drug under review demonstrates comparable clinical benefit and acceptable cost/costeffectiveness and/or conditions 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 There is insufficient evidence identified to recommend reimbursement. Scenarios that typically fit this reimburse 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 one or more appropriate comparators. (*Recommendation Framework Categories: Guidance for Drug Expert Committees, TABLE 1: RECOMMENDATION CATEGORIES, p3)
CDEC Recommendations (Nov 2012 to Oct 2016) 140 127 (73%) 120 100 80 60 40 32 (19%) 20 10 (6%) 4 (2%) 0 Reimburse with Do not reimburse** Do not list at the Reimburse clinical criteria submitted price and/or conditions * *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 Column1 pCODR has issued 72 Positive Recommendation notification to implement as of September 30, 2016 69% 18% 9 (13%) recommend to Conditional 13% Recommendation reimburse 50 (69%) recommend to Negative reimburse with clinical Recommendation criteria and/or conditions 13 (18%) do not recommend to reimburse 10
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 11
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
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