Ontario Public Drug Programs / Cancer Care Ontario Policy: Reimbursement of Publicly Funded Cancer Drugs within the Context of Clinical Trials

Transcription

1 Ontario Public Drug Programs / Cancer Care Ontario Policy: Reimbursement of Publicly Funded Cancer Drugs within the Context of Clinical Trials Version: 2.0 Effective Date: January 29, 2016 Replaces Policy: Version dated May 17, 2013 Policy Owner: Provincial Drug Reimbursement Programs

2 Contents A. INTRODUCTION...3 B. INTENT...3 C. PRINCIPLES...3 D. SCOPE...4 E. APPLICATION PROCESS...4 F. APPLICATION CRITERIA...5 G. REVIEW PROCESS...5 H. RESUBMISSION AND RECONSIDERATION...6 I. APPLICATION OF THE POLICY P age

3 A. INTRODUCTION The Ministry of Health and Long-Term Care (MOHLTC) and Cancer Care Ontario (CCO) are strongly supportive of clinical trial research as an important component of high quality care where the goal is to improve the outcomes for cancer patients in Ontario. MOHLTC and CCO recognize that clinical trials help to advance scientific understanding and that patients may be given the option to enter into clinical trials at some point in their cancer treatment journey. Increasingly, public payers are being asked to reimburse publicly funded drugs when used as a component of clinical trials research, or after the patient has participated in a clinical trial, even when the patient is no longer eligible under the existing funding criteria. This has raised questions about how to ensure publicly-funded cancer drugs can be used to deliver the greatest benefits to patients while supporting the generation of new knowledge through use in clinical trials. This has led to the development of a draft policy that clarifies the principles, criteria, and review process related to the reimbursement of publicly funded cancer drugs when patients participate in clinical trials as part of their therapy. B. INTENT Ontario has an established process for evaluating drugs for public reimbursement. In general, the funding criteria for cancer drugs are aligned with the clinical trial(s) that established its benefit, in order to ensure drugs are used in ways that are aligned with the evidence. Ontario Public Drug Programs (OPDP)/CCO provides funding for cancer drugs for eligible patients when they are used in accordance with the specific criteria on which the funding decision was made. This could be a typical outpatient setting or a standard of care arm in a randomized trial. The intent of this policy is to clarify how public drug funding eligibility may be impacted by participation in a clinical trial, either within the trial, or subsequent to the trial. C. PRINCIPLES I. The Overarching Principles of this policy are: a. Ensure that patients have timely and equitable access to treatments that are safe, offer maximum clinical benefits, and align with best practices; b. Ensure that coverage decisions are evidence-based and are consistent with the policies of the Ontario Public Drug Programs (OPDP); c. Have a fair, transparent, efficient, and accountable process; and d. Proactively identify clinical situations that could preclude access to cancer drug(s) as a result of participation in a clinical trial. 3 P age

4 II. The Specific Principles associated with this policy are: a. Ensure that Ontario citizens participating in a clinical trial have access to publicly funded cancer drugs provided when: i. Existing criteria for access to the funded drug are met; and ii. The clinical trial complies with standard regulatory and ethical requirements. b. Ensure that Ontario citizens participating in a clinical trial will have subsequent access to publicly funded cancer drugs if: i. Existing criteria for access to the funded drug are met; ii. The clinical trial complies with standard regulatory and ethical requirements. c. Enhancing the informed consent process by advising investigators when a trial design will affect patient s ability to access publicly funded cancer drugs. D. SCOPE I. This policy will: a. Provide clarity and transparency regarding whether patients can access publicly funded cancer drugs within a trial or subsequent to trial; and b. Provide interpretations to clarify under which circumstances publicly funded drugs used within or post clinical trials are aligned with the policy. c. Enhance and support the patient informed consent process for clinical trials. II. This policy will not: a. Promote the expansion of funding beyond the original intent from which current drug funding criteria have been based; b. Provide interim drug funding for indications that are currently being reviewed or expected to be reviewed for public funding in Ontario; c. Approve or fund clinical trials; and d. Enable modifications of current funding criteria for clinical trial patients. E. APPLICATION PROCESS I. CCO will accept an application from a single Applicant who is applying on behalf of all investigators in the province. The designated Applicant must be a practicing clinician affiliated with a hospital or cancer centre. II. III. A clinical trial request intake form must be completed in full for each trial and submitted to clinicaltrials@cancercare.on.ca Upon receipt of a completed clinical trial request intake form, CCO will aim to provide a full assessment to the Applicant within 30 days. CCO s turnaround time may be extended if additional information is required to complete the assessment. 4 P age

5 F. APPLICATION CRITERIA I. The application may be submitted for review prior to Research Ethics Board (REB) approval but the trial must have REB approval prior to patient recruitment. Applications will only be considered if the clinical trial complies with standard regulatory and ethical requirements. II. At a minimum, CCO requires a completed clinical trial request intake form, which includes, the clinical trial schema, the cancer drugs and indications that are being requested for funding as well as the cancer drugs and indications being provided by the clinical trial sponsor and the dosing schedule. III. The Applicant must clearly identify the treatment algorithm for all study arms subsequent to trial participation. This includes an explanation of patient management in case of: a. The patient is withdrawn from study due to excessive toxicity; b. There is disease progression; c. The patient refuses further participation on the trial; and d. There is disease recurrence after the trial is completed IV. All Policy implications associated with the clinical trial participation, particularly those related to the use of publicly funded drugs after participating in a clinical trial, must be identified by the applicant. V. It is important to note that funding criteria can change over time. Screening for congruency with the current funding criteria does not equate to pre-approval of subsequent lines of therapy in the future when patients are off the clinical trial. VI. CCO will review all complete applications and in certain circumstances will consult with OPDP. These circumstances can include where requests involve products listed under the Exceptional Access Program and/or Limited Use or where interpretation is required. G. REVIEW PROCESS The review process consists of the following: I. CCO will screen each application for completeness. In case of missing information, CCO will contact the Applicant as necessary. Requests will not be reviewed until the application is deemed complete. The onus is on the Applicant to provide complete and accurate information. II. Upon receipt of a complete application, CCO will assess the request against the application criteria and policy principles. a. Requests that do not meet any one of the application criteria are ineligible and will not be further assessed; and 5 P age

6 b. CCO (in some cases where required together with OPDP) will evaluate the policy implications as a result of trial participation, both with respect to the trial in question and the subsequent patient treatment. III. IV. Eligible applications are reviewed by CCO staff, Clinical and Disease Site Team Leads (and/or the Drug Advisory Committees), clinicians familiar with or specializing in treatment of the specific cancers, and OPDP as appropriate. CCO will prepare the final assessment and notify the Applicant. The application will be deemed aligned, partially aligned or not aligned with public drug funding criteria. Where applicable, CCO will provide the Applicant with information on the potential funding implications. The Applicant is responsible for communicating the outcome of assessment and relevant information to affiliated investigators and patients. V. It is important to note that funding criteria can change over time. Patients must meet funding criteria at the time any drug funding is sought. An assessment completed under this policy does not guarantee funding of subsequent therapies after participation in a clinical trial. H. RESUBMISSION AND RECONSIDERATION An Applicant may file a resubmission or request a reconsideration if one of the following circumstances is met. a. RESUBMISSION The Applicant may submit additional or missing information to clinicaltrials@cancercare.on.ca using the original submitted application form and highlight the new information Upon receipt of the original submitted application form, CCO will aim to provide a full reassessment to the Applicant within 30 days. CCO s turnaround time may be extended if additional information is required to complete the assessment. b. RECONSIDERATION Within thirty days of the date of the final assessment, an Applicant may file a submission for reconsideration of a negative assessment where the Applicant believes the Clinical Trials policy was incorrectly applied. The Applicant must file a submission for reconsideration to clinicaltrials@cancercare.on.ca with the following information: a. Identify and explain which element of the clinical trial policy was wrongfully applied; b. Describe how the drug funding criteria was incorrectly applied or interpreted; c. No new information or evidence will be allowed in the case of reconsideration. 6 P age

7 I. APPLICATION OF THE POLICY The following table describes some of the possible scenarios that may occur within or subsequent to a patient s participation in a clinical trial and the policy interpretation. Funding within context of clinical trial permitted: Use of a publicly funded drug within the conduct of a clinical trial Clinical trial use of drug is identical to the current funding policy The drug will be funded (e.g., control arm therapy in a Phase III trial) for eligible patients. Clinical trial use of drug is for same population as a drug that is The drug will be funded funded. for eligible patients. a. The drug prescription may be altered (e.g., dose, schedule)*; or b. may be combined with another agent (e.g., experimental arm therapy in a Phase III trial)** Use of a publicly funded drug subsequent to patient participation in a clinical trial Drug tested in clinical trial is associated with funding criteria that permit re-treatment; circumstance associated with subsequent use of drug meets criteria for provision for re-treatment * Subject to a cost analysis. ** Provided a negative funding recommendation does not exist for the combination. Funding within context of clinical trial not permitted The drug will be funded for eligible patients. Use of a publicly funded drug within the conduct of a clinical trial Clinical trial use of drug is for an indication The drug will not be publicly funded. that is not currently funded (e.g., drug is tested in a clinical trial for line of therapy that does not meet funding criteria) Clinical trial involves re-treatment with a The drug will not be publicly funded. previously funded drug. The current funding criteria for that drug do not include retreatment. The drug is in the process of being The drug will not be publicly funded. considered (e.g., by the pan-canadian Oncology Drug Review for the same indication). 7 P age

8 Funding within context of clinical trial to be informed with content expertise: Use of a publicly funded drug within the conduct of a clinical trial Clinical trial includes use of drug within a Health Canada licensed indication but funding for the drug has not been implemented because additional realworld evidence is required. Decision process will be guided by content expertise. Use of a publicly funded drug subsequent to patient participation in a clinical trial The clinical trial drug has the same pharmacologic class as the publicly funded drug. The clinical trial drug has a different pharmacologic class as the publicly funded drug. As a general principle, treatment received during a clinical trial is considered a line of therapy. In certain circumstances, e.g., in the absence of known biologic similarities and action of cross-resistance, it may be reasonable to consider the novel agent not a line of therapy. As a general principle, treatment received during a clinical trial is considered a line of therapy. In certain circumstances, e.g., in the absence of known biologic similarities and action of cross-resistance, it may be reasonable to consider the novel agent not a line of therapy. Decision process is to be informed with content expertise. Anticipated outcomes are that drug will not be provided if crossresistance is expected and a refractory state to the clinical trials agent exists. Drug may be provided if clinical trials drug is associated with beneficial effect and a period off of treatment has passed (i.e., retreatment with same class of agent). Decision process is to be informed with content expertise. Due consideration for cross-resistance and expected benefit will be applied. Decision process is to be informed with content expertise. These cases are individually reviewed and may require additional assessments with the Ministry of Health to align on interpretation. 8 P age