Jill Sanders
President & CEO
Canadian Coordinating Office for Health Technology Assessment
953 Green Valley Drive
Suite 110
Ottawa, Ontario K2C 3V4

March 21, 2003

Dear Ms. Sanders:

RE: Common Drug Review (CDR) Policy and Process

The Best Medicines Coalition (BMC), Canadian Treatment Action Council (CTAC) and the Consumer Advocare Network (see attachment for introductions) thank CCOHTA for the opportunity to respond to the proposed CDR process and to the public stakeholders meeting of March 4, 2003. We hope that our views will contribute to the positive development of the Common Drug Review which will benefit all Canadians.

We are providing a number of recommendations. One overarching recommendation which would be of great potential benefit to the CDR process, is the addition of consumers or patients on each of the committees and the CCOHTA Board. The BMC, CTAC and the Consumer Advocare Network strongly recommend that informed consumers be involved in a meaningful way as CCOHTA finalizes the CDR process and moves it forward. The CDR policy and process must ensure that consumers have a say in what medicines are available under the public reimbursement system to treat their disease or condition. The value-added role of public participation was discussed at some length in the Romanow and Kirby reports, which formed the basis for the First Ministers’ discussions and Accord.

OUR RECOMMENDATIONS/SUGGESTIONS

The purpose of the CDR is to help ensure that Canadian patients access quality treatment and care in a timely manner. Further, the mandate of the Common Drug Review is to provide recommendations regarding the inclusion of new drugs into the 19 participating federal, provincial, and territorial drug plans in a timely fashion, following receipt of the clinical benefits review. To achieve this mandate, the process for CDR must be transparent and accessible to the public, as well as objective and open to appeal. The process for conducting the clinical reviews must include the best clinical data as well as information from relevant stakeholders and other experts. Relevant stakeholders include those who fund, supply, and utilize the drugs.

We are pleased to comment in detail on a number of important themes and principles, as follows:

Timeliness of Process

Timely access to safe and effective medications means the CDR process should not add review time to existing processes. In fact, it should streamline the process and eliminate any unnecessary barriers to make it more effective and timely. For example, it takes some provinces approximately 12 additional months to complete their own cost effectiveness reviews following the main review. This is unacceptable.

While the timelines proposed for each phase of the process as presented at the Information Session (March 4th) appear reasonable, we have some concerns. First, experience with government review processes, whether the Therapeutic Products Directorate or the provincial drug plans, has shown target timelines are more often breached than achieved. To address this concern, we recommend the following:

1. CDR should set public performance targets that will assure the total timeline (including the estimated time for provinces to approve CEDAC recommendations) does not exceed the timeliest process currently in place in any of the provinces. We note that several provinces work within a timeframe of four months from submission to approval. These targets should be agreed to at the outset by all relevant stakeholders including governments, CDR Directorate of CCOHTA, reviewers, industry and consumers.

2. Actual results should be compared against targets every six months, commencing with the first six months after implementation. As part of the review, the CDR Directorate should identify, as objectively and as quickly as possible, the barriers to meeting these targets.
Timeliness must also be understood in relation to the urgency of the need for a drug. The proposed first-come, first-served approach must be supplemented by a “fast-track” process for drugs for life –threatening illnesses and breakthrough drugs, as defined or determined by the scientific or subspecialty community. Resubmissions in these categories should not go back to the end of the line as “new submission” considerations.

3. CDR should develop a policy and process that recognizes priority reviews for drugs for life-threatening illnesses and for breakthrough drugs for chronic, debilitating illnesses. Adequate qualified staff should be hired (or contract staff available) to ensure expedited reviews for these classes of drugs while continuing to ensure other reviews within the established performance targets.

We are very concerned that the process of requests from CDRC and drug plans will also slow up the process of ensuring a timely review of new submissions. While we recognize the need for such work, we feel strongly that work done in this area should not take away from the main role of reviewing drug submissions from manufacturers. Therefore we recommend that:

4. CDR staff adequately meet the demand of submission requests as well as requests from CDRC and drug plans. This may require some form of flexible contract arrangement with some staff.
Timeliness may also be impacted by additional and possibly unnecessary information requirements. The first concern relates to possible duplication of the information gathered during the review process. It is our understanding that required data in the areas of safety and clinical will be the same as those required by the TPD or the Biologics and Genetic Therapies Directorate (BGTD) at Health Canada. The process should assure that the information is available immediately upon TPD approval so as not to delay the CDR process.

Another potential concern is that the participating drug plans have not made any commitment to dismantle their administration or expert review committees. If these committees continue to work in their usual ways, there is clearly duplication of data collection and increased potential for delays. Therefore we recommend the following:

5. CDR shall receive from Health Canada (TPD or BGTD) the necessary safety and clinical data of common interest on an automatic and timely basis immediately upon receiving TPD or BGTD approval.

6. CDR shall obtain agreement from each participating province that as an interim measure the aggregate of their two processes will not be greater than four months time.

7. CDR shall obtain agreement from the participating provinces/territories that the provinces will dismantle their review administration and expert review committees as soon as CDR is fully operational; this should, occur no more than three months after CDR becomes operational.

We agree with the recommendation in the introduction document that “for accountability, average timelines [for all drug reviews and recommendations to drug plans] should be publicly available.”

Openness, Accessibility and Accountability

To meet the objectives of patient access to new drugs in a timely fashion, the CDR process must be open, accessible, and accountable (i.e., transparent) to all stakeholders, including consumers. Moreover, in order to be credible and valuable to those who ultimately rely on its decisions, the CDR must fully engage consumers or consumer groups in all aspects of the decision making process.

8. To be accountable to those whose health and lives depend on the decisions made, information related to the review and recommendation must be available to consumers through an established and efficient access-to-information process . It is recommended that the CDR develop an electronic tracking system, accessible to the public, consumer, and applicant, to track the review throughout its progress as well as the rationale for the recommendation made by CEDAC.

9. Consumers need to be represented on all of the committees of the CDR, as participating (voting) members. Representation of consumers on CEDAC acknowledges that the expertise of a consumer with regard to the value of new medicines is as legitimate in deciding whether to fund the drug as that of other experts, such as physicians, health economists, or pharmacists. There are examples of consumers on expert committees within and outside of government. Moreover, the consumer representatives should be selected from nominees put forth by the organizations representing healthcare consumers. The CDR should establish an additional Consumer Advisory Committee that is composed of consumers to provide timely input and to advise the CDR on its policies and procedures, as well as decisions, and their impact on patients.

The Consumer Advisory Committee should report directly to CEDAC. There are a number of good models from which to choose. It would be important to have a list of informed consumers from different disability and disease groups from which to draw depending on the drugs being reviewed.

In addition, consumers should have observer status, as does the PMPRB, at the Board level.

Objective and Informed Process

A third area of concern is the need for the assurance that CDR will be an objective and well-informed process.

Of particular concern in this area is the proposal that the applicant will provide the pharmacoeconomic data relied on for the review. This process will not necessarily provide objective information nor will it necessarily provide all of the information required to balance the issues of cost, clinical outcomes and quality of life. Other sources of information must be relied upon, independent of the information provided by the applicant. More over, information provided by the applicant must undergo independent analysis. To ensure an objective and well-informed process we recommend the following:

10. CDR should ensure that a thorough and independent analysis of pharmcoeconomic information be undertaken of data provided by the applicant. The costs and benefits analysis should be based on costs and benefits from various perspectives, not just the drug plan. Costs and benefits to the overall healthcare system would take into consideration not only the costs of drugs but also the benefits to other aspects of healthcare, including hospital care, physician visits, and recovery. Costs and benefits based on a social perspective will include benefits such as ability to return to work, care for family, or participate in society. From a patient perspective, costs should include individual costs of dealing with side effects or being unable to work or to care for self.

11. In addition, informed consumers, as part of the CDR process should analyze and comment on the data provided by the applicant as well as contribute additional data. Consumers may comment on cost, clinical outcomes and quality of life from the perspective of those who rely upon the medicines for life, health and well-being. It is important to include evidence from community-based, qualitative studies, and where appropriate, experiential evidence.

Process for Appeal

A fourth area of concern for consumers is the opportunity within CDR for a quasi-judicial appeal of the recommendation made by CDR about the listing of a drug. As such, all relevant stakeholders including consumers must be permitted to take part in the process. We therefore recommend the following:

12. CDR develops a quasi-judicial review process involving all relevant stakeholders, including consumers. While the first stage of appeal may be made to the CDR Directorate, there should be a process for taking the appeal to the Common Drug Review Committee. The appeal process should be open and accessible to all stakeholders and written documentation of submissions and considerations provided to all.

13. If the recommendation is made for a drug to be on restricted access, or not listed, as opposed to open listing, there should be an automatic process of review to determine if the restrictions are appropriate. There should be a process for appeal of the restrictions recommended.

Best Clinical Data

To assure patient access to the best medicines, CDR must base its review on the latest high quality clinical data. This means that as new information (clinical trial outcomes) becomes available, these data should also be taken into consideration. Use of published clinical data should not exclude other data that may inform the value of the medicines for specific consumer populations, such as clinical practice guidelines, specialist guidelines for specific populations, and international experience with medicines under review. Finally, the process must also ensure that all patients, including those with rare diseases and conditions, benefit from access to the best medicines. This means the criteria for quality data may need to reflect the size and characteristics of specific patient groups. To these ends, we recommend the following:

14. CDR should include the most up-to-date clinical data from high-quality trials. While randomized, double-blind trials represent the conclusive evidence, these are not feasible in all situations and the review should not disregard high-quality community-based trials where appropriate. Clinical data may also include consensus practice guidelines or specialist guidelines, especially for subpopulations where sufficient numbers of patients for randomized clinical trials are not feasible. Data need not be limited to published studies if more recent high-quality information is relevant. Where necessary, the reviewers should be able to directly query researchers or experts, rather than rely solely on written documentation. In all cases, oral communications should be documented and included as part of the case file.

15. Any potential conflicts of interest either in the conducting of clinical trials or in the review of the data should be declared and open to public scrutiny.

16. Clinical data from independent sources (especially data which lead to other conclusions than those of the manufacturer) should be sought and considered.

17. In the second stage CEDAC review, the committee may seek additional information or data to help to decide whether the drug should be recommended for open listing, restricted listing, or ‘not to be’ listing. Expert testimony based on clinical experience may be valuable in this respect.

18. It is expected that a mechanism for sharing post-market surveillance data with CCOHTA so that CDR can evaluate its on-going relevance and effectiveness.

Relevant Stakeholders

It is critical that all relevant stakeholders have an active role in the CDR process. Deciding whether to make a new medicine available to patients who are reliant on government drug plans is an important process for all: provincial governments, physicians and especially patients.
The stated purpose of the proposed CDR is to allow drug plans to focus on the most therapeutically beneficial and cost-effective drugs. Current cost-effectiveness models lack both the validity and sophistication to take into consideration a wide range of factors. To meet the needs of all stakeholders, the following recommendations are made:

19. The CDR must engage in a consultative process with all stakeholders, including governments, healthcare providers, industry, and consumers, to clearly articulate how the assessment of costs-benefits will be made and the relative weight that will be placed on “benefit to the patient” and “benefit to the healthcare system” as compared to “cost of medication.”

20. The CDR must be governed by the overriding principle that individual patients have timely access to medications deemed appropriate by his/her prescribing physician, in consultation with the patient.

In conclusion, the Best Medicines Coalition, CTAC and Consumer Advocare Network provide a voice for consumers. These groups represent millions of Canadians living with, or dealing with illness and have a mandate to advocate for timely and consistent access to best medicines for all Canadians and encourage active participation of citizens in all aspects of decision-making in access to best medicines. As such, we are determined to work towards moving informed consumers and patients into the policy development process along with government, academia, the scientific community and industry, and recommend that the CDR program evolve and revolve around the above named principles.

Again, we thank you for this opportunity to submit our comments and suggestions, and hope that we can contribute to making the CDR process effective, efficient, and successful in meeting the needs of not only patients and consumers, but also others who have an invested interest in the outcomes. We look forward to engaging in future discussions and working more closely with you and others to make this possible.

Sincerely,

Kathy Kovacs Burns
Co-Chair, BMC

Denis Morrice
Co-Chair, BMC

Louise Binder
Chair, CTAC

Durhane Wong-Rieger
Chair, Advocare

C.C. Barb Shea, Director Common Drug Review