HESA Committee Report
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1. Is the CDR Accountable to Governments?
Government officials explained to the Committee that CADTH is a corporation owned by the Conference of F/P/T Deputy Ministers of Health (CDM) and is governed by a 13-member jurisdictional Board of Directors, which reports to the CDM. All F/P/T governments participate except Quebec. Each member of the CADTH Board of Directors has an equal vote in overseeing the affairs of the corporation. The 13 Directors are each appointed by a Deputy Minister of Health who is a member of the CDM. The Committee was also told that, while CEDAC is an independent committee, it is appointed by and accountable to CADTH Board of Directors. Thus, the CDR is accountable to the CDM through CADTH Board of Directors. CADTH and provincial government representatives argued that this corporation meets the primary criteria for accountability through annual reporting of investments by F/P/T partners and by its ability to assign responsibility, to fulfill objectives and to provide consistent reporting.
During the Committee hearings, the pharmaceutical industry and patient advocacy representatives raised concerns about a lack of accountability of the CDR and CADTH to governments. They contended that CADTH and the CDR have no formal reporting relationship to a single government body. Further, they indicated that neither CADTH nor the CDR are subject to review or audit by any one government or a single oversight body. They also noted that they are not bound by access-to-information legislation. Furthermore, they told the Committee that it is unclear how federal funding for the CDR is allocated.
These witnesses recommended that the federal share of CDR funding be frozen immediately and that, in the meantime, an independent review of the CDR be undertaken to assess its objectives, accountability, value for money and health outcomes. Several other witnesses knowledgeable about the CDR and other drug review processes acknowledged that, now that the CDR has been in place for almost four years, a comprehensive evaluation is necessary to determine the value of the review process.
The Committee heard considerable testimony in regard to accountability. However, as the CDR is a F/P/T entity, the Committee understands that the federal government is limited in its scope of authority. Members of the Health Committee have requested that the federal Office of the Auditor General (OAG) conduct an audit of the CDR and the OAG has agreed to consider this request. In the absence of direct accountability to the federal government, the Committee feels that ongoing, external, performance evaluations at regular intervals, coupled with increased public involvement and greater access to the technical and scientific evidence used for recommendations,(as recommended below) will serve to address many of the accountability concerns.
Therefore, the Committee recommends that:
The federal government work with its provincial and territorial CDR counterparts to require an independent, external performance evaluation of the CDR within a year, and at five year intervals, and to make them immediately available to the public.
2. Is the CDR Process Open and Transparent?
CADTH representatives told the Committee that pharmaceutical manufacturers currently review and provide feedback on CDR reports. Prior to the CDR, federal and provincial drug plans did not provide an opportunity for manufacturers to comment on their reviews, and none of them publicly released reasons for their recommendations.
Furthermore, some information is posted on the CADTH website, including: CDR procedures and submission guidelines, which were all developed in consultation with the participating drug plans, the industry and the public; a search tool for drugs reviewed by the CDR; weekly reports on the status of each drug submission; biographies and conflict of interest disclosures for each CEDAC member; and, CEDAC recommendations and reasons for each of the recommendations.
B. More Accessible Information Needed
Despite these improvements introduced by the CDR, representatives of the pharmaceutical industry and patient advocacy groups were critical of the openness and transparency of the CDR process. In their view, information about policies, practices and decisions is not communicated in an open and timely manner. For example, they told the Committee that there is no way for the pharmaceutical industry and the general public to know which specific experts the CDR consulted before making their listing recommendation, even after the drug review process has been completed and the recommendation made public. CADTH officials emphasized that, while CEDAC names and biographies are publicly available, revealing the names of reviewers would jeopardize the process by exposing them to external influences by the pharmaceutical industry and harassment by patient advocates.
Patient advocacy groups also called for more access to the information used to make formulary listing recommendations. They indicated that Canadians cannot readily find which published articles the CDR used in their review to make the listing recommendation. CADTH officials told the Committee that, to further enhance transparency and better communicate decisions and recommendations to the general public, they will publish in the coming year lay versions of the CDR recommendations, the review materials considered by CEDAC and the CEDAC minutes.
Researchers familiar with centralized drug review processes in other countries emphasized that more transparency would be possible if the pharmaceutical industry was willing to disclose the clinical trial data, prices, and other information that is currently protected under confidentiality agreements with CADTH. The Committee heard that in the United Kingdom, the National Institute for Health and Clinical Excellence (NICE) — which is CADTH’s counterpart — posts the initial assessments and final appraisal recommendations on its website, and that these detailed documents contain some cost, clinical and economic data.
The Committee acknowledges that the CDR involves signing confidentiality agreements with the manufacturers who make submissions. Therefore, public participation, input and information sharing must be balanced against the manufacturers’ need to protect confidential or proprietary information. Despite some published reports, most data from various phases of clinical trials on drugs remain confidential and unavailable to the broader public. Pharmaceutical companies argue that confidentiality is essential to limit the acquisition of knowledge by their competitors. The confidentiality requirement leaves no avenue for Canadians to assess the completeness or reliability of data submitted to the CDR and used for the final listing recommendation.
The Committee supports the CDR’s intent to publish more information regarding its decisions, including lay-language versions of its recommendations, it agrees that greater transparency is needed in the CDR process. It understands that CADTH would like to increase the level of transparency but is somewhat restricted by the limitations put on it by the pharmaceutical industry. However, this obstacle has been addressed by NICE in the United Kingdom and the Committee therefore feels that a reasonable level of disclosure should be negotiable with industry as they have already agreed to such in the United Kingdom.
Therefore, the Committee recommends that:
The federal government work with its provincial and territorial CDR counterparts to enhance transparency by increasing the level of scientific and price information disclosure through discussions with pharmaceutical manufacturers at the time of submission.
3. Is the General Public Involved in the CDR Process?
A. Current Public Participation in CEDAC
During the hearings, several representatives of patient advocacy groups and the pharmaceutical industry called for greater public participation in the CDR. The Committee was told that, in response to the concern about the lack of public involvement in the CDR process, CADTH appointed two public representatives to CEDAC in November 2006. These two members were selected from a diverse group of applicants. They are expected to represent the broader public interest and to serve as a member of the general public, not as a representative of any specific interest group or organization. These two members, who were trained as participants, have full CEDAC membership, with similar responsibilities and expectations, and are subject to the same terms and conditions as other committee representatives.
Although witnesses welcomed the addition of two public representatives on CEDAC, many felt that this was not sufficient. Some suggested that specific patient advocacy groups participate in the CDR, arguing that individuals affected by the CEDAC recommendations on formulary listing currently have no access to the decision-making process that will assess the value of new drugs to them. They recommended that CEDAC meetings become completely public, allowing Canadians to fully follow CDR deliberations and/or express their views by making presentations to CEDAC.
B. Other Jurisdictional Examples of Public Participation
Other witnesses told the Committee that Australia, Sweden and the United Kingdom include public members in some part of their review process. In the United Kingdom, NICE works with its Citizens Council in making formulary recommendations on new drugs. The Citizens Council is made up of 30 members, representative of diverse age, ethnic, socio-economic and other groups. Its role is to insert social value judgements into the Institute’s decision-making process. It does not get involved in the technical and scientific review of individual drug therapy and does not make decisions about the final listing of drugs. The Committee also heard that the Ontario government is in the process of establishing a similar citizens’ council that will advise the executive officer who oversees the decisions for inclusion or removal of drugs from the provincial formulary.
The Committee supports the recent appointment of two members of the public to CEDAC. It also heard from CADTH that the Conference of Deputy Ministers of Health — the owners of the CDR — could be asked to consider the cost and process implications of more enhanced public involvement in the CDR process. All members of the Committee agree that public participation could create greater understanding of the CDR process, provide increased input of individual and societal values, and foster expanded trust in the CDR. By engaging members of the broader public in the process and in the determination of criteria for making recommendations on formulary listing, they can understand how decisions are made in a process that must weigh scientific, cost and quality of life evidence. They will gain a clearer knowledge of the calculations and trade-offs that are part of decision-making in the health care sector.
Therefore, the Committee recommends that:
The federal government work with its provincial and territorial CDR counterparts to increase the current level of public involvement in the CDR through public attendance at open CEDAC meetings and the creation of a public advisory body.
4. Is there an Appeal Process under the CDR?
A. Manufacturer Reconsideration
In Canada, every manufacturer whose drug is the subject of a CDR recommendation has the right to file a request for reconsideration. The Committee was told that such a request may be made on the following grounds: 1) the CDR failed to act fairly and in accordance with its procedures in conducting the review; or 2) the recommendation is not supported by the evidence that had been submitted or the evidence identified in the reviewers’ reports. In the United Kingdom, decisions by NICE can be appealed by the sponsoring company, other drug manufacturers, health professionals, patient advocacy groups and the Department of Health.
Representatives from the pharmaceutical industry cited concerns about the request for reconsideration process. In particular, they told the Committee that the current appeal process appears unfair as the manufacturer’s appeal is made directly to the same people on CEDAC who made the initial listing recommendation. They suggested that an independent administrative appeal process for CEDAC recommendations be established. CADTH officials acknowledged this concern and indicated that a reassessment of this process might be appropriate.
Patient advocacy groups were concerned that any appeal of a recommendation to list or not to list is limited to the industry manufacturer who submitted the initial application for review. In contrast to the United Kingdom, there is currently no formal process for Canadians to raise their concerns or ask questions about why or how the CDR reached their conclusion in a recommendation. In their view, organizations who speak on behalf of millions of Canadians should have the ability to appeal a CDR recommendation given the immediate impact on their members and patients.
While the Committee appreciates that appeal processes are at present not the norm in centralized drug review processes around the world, it nonetheless feels strongly that such a process should be in place. Currently, manufacturers are limited to an appeal for reconsideration to the same individuals who did the initial review. Moreover, there is no mechanism for consumers to substantively dispute a CDR recommendation. The Committee believes that the limits placed on manufacturers and the absence of an appeal process for the affected public are adding to frustrations over the perceived lack of transparency and accountability. However, the Committee is aware that a process that is completely external to the CDR could be costly and time-consuming for the federal, provincial and territorial partners.
Therefore, the Committee recommends that:
The federal government work with its provincial and territorial CDR counterparts to create a set of specific appeal criteria which, if met, would lead to a new and distinct appeal process for CEDAC recommendations which will:
· Require a separate group of expert reviewers;
· Extend requests for appeal beyond manufacturers to the public; and,
· Establish a clear timeframe for an appeal decision.
5. Are Separate Processes Needed For Some Categories of Drugs?
In March 2007, provincial and territorial drug plans established the interim Joint Oncology Drug Review (JODR). It was explained that the CDR reviews only a small subset of new oncology drugs — oral agents. However, most cancer drugs, as they are delivered by injection at cancer clinics or within a hospital setting, are reviewed outside of the CDR. As such, drug plan administrators felt that the JODR would help address the inconsistent review of cancer drugs across the country. The JODR will be undertaken by the Ontario Committee to Evaluate Drugs, in collaboration with Cancer Care Ontario.
The Committee was told that the CDR has an observer seat on the JODR Steering Committee and will continue to provide its clinical and economic reviews of new oral cancer drugs (the subset of cancer drugs that previously would have been submitted directly to the CDR) to both the JODR and the federal plans. In these instances, the CDR reviews will be provided to the JODR which will make the formulary listing recommendation. The JODR will publicly release their recommendations on cancer drugs and the federal plans will be able to use these recommendations to make formulary decisions. An independent evaluation of the JODR will be conducted after one year with the intent of developing a permanent national review of oncology drugs. One option will be that this be a part of the CDR.
The Committee heard that there are also other categories of drugs that do not fit as well within the existing CDR process, and for which different assessment tools might be more appropriate. This is particularly true for drugs for rare diseases (orphan drugs). Patient advocacy groups and industry representatives expressed frustration that the CDR has recommended very few of the orphan drugs reviewed. They explained that clinical trials are more difficult to design, undertake and complete for drugs for rare diseases than for more common disorders. They also questioned whether cost-effectiveness can be appropriately measured for these drug therapies. This is due in part to the nature of rare diseases, as they affect only a very small proportion of the population at any time. The frequency of many disorders is so low that it is almost impossible in the short term to gather enough patients to measure statistically significant clinical benefits or harms of a therapy.
Some witnesses suggested that international cooperation should be encouraged so that patient groups can be pooled for clinical trial data. The Committee was told that the National Pharmaceuticals Strategy set up a task group to examine the issues surrounding drugs for rare diseases; this task group is expected to present its report to the Conference of Deputy Ministers of Health in June 2007.
C. First-in-Class or Breakthrough Drugs
In addition, the Committee heard that the CDR process for reviewing first-in-class or breakthrough drugs may not be appropriate, and that a separate process for these drug therapies should also be considered. The CDR compares the drug under review with an existing drug therapy to assess its clinical benefit and cost-effectiveness. Manufacturers told the Committee that first-in-class drugs do not always have an appropriate drug comparator and, in their view, the CDR is unfairly assessing these breakthrough drugs.
On the one hand, the Committee welcomes the JODR process and the subsequent evaluation of its effectiveness. On the other, members understand the frustrations expressed by those who suggested that the current CDR process is inappropriate for certain types of drugs. It agrees that different review processes need to be considered if the weight of evidence or a comparator drug is not available when reviewing drugs for rare diseases or first-in-class drugs.
Notwithstanding the National Pharmaceuticals Strategy task group report, the Committee recommends that:
The federal government work with its provincial and territorial CDR counterparts to urge CADTH to establish a specifically designed approach for the review of drugs for rare disorders and for first-in-class drugs.