The Canadian Agency for Drugs and Technologies in Health (CADTH) is inviting stakeholder comments and feedback on the appropriate health technology assessment process (HTA) to be used in the context of the Common Drug Review (CDR) as it relates to biosimilars (known as "subsequent entry biologics" – SEBs - in Canada). Comments are due by October 7, 2013.
CADTH is the agency in Canada charged with assessment of drugs for recommendations for reimbursement by provincial formulary plans; all provinces participate except for the province of Quebec. CADTH has indicated in the past that it would review SEBs for the provinces; a review of SEBs is required because these products are not "generic" drugs (for which no HTA is conducted). CADTH notes in its consultation that, "Authorization of an SEB is not a declaration of pharmaceutical or therapeutic equivalence to the reference biologic drug." CADTH also notes that "there is considerable uncertainty regarding the cost-effectiveness of SEBs relative to the reference products."
CDR introduced a pilot project for SEB in fall of 2009 but only one SEB has been approved by Health Canada during the past four years. CADTH notes that it is expected that a number of new SEBs will be reviewed by Health Canada and marketed in the near future and that SEBs will be reviewed by Health Canada for multiple indications. The current consultation notes the need to establish a standardized procedure and process before CADTH will undertake further reviews of SEBs. The consultation document asks that stakeholders take into account the following considerations in their comments:
1. Pros and cons of the following two alternative submission procedures to address cases where an SEB has approval for multiple indications[a]:
- separate CDR submission for each approved indication
- single CDR submission for all approved indications.
2. The use of a tailored CDR review[b] for SEBs: Regulatory approval of SEBs relies in part on comparative and historical information for a product already approved based on a complete data package (i.e., a reference product[c]). Given this aspect of the regulatory approval pathway for SEBs, CADTH will consider the relative merit of conducting a tailored CDR review versus a comprehensive review for SEBs. The decision to conduct a tailored review would be made on a case-by-case basis and would involve the following considerations:
- The number of indications and the similarity of different indications.
- Indications that have been approved based on extrapolation[d] of clinical data.
- Whether an existing CDR review of the reference product for the same indication(s) is available.
- Formulary listing status of the reference product for the indication(s) under consideration in the CDR review.
- The use of a reference product that is not marketed in Canada.
3. The critical elements that need to be included in a CDR submission for an SEB for each of the following:
- pharmacokinetic and pharmacodynamic data
- clinical data (e.g., safety and efficacy studies)
- pharmacoeconomic data
- Cost-minimization analyses would likely be sufficient in the majority of scenarios for SEBs; however, cost-utility analyses may be required in some cases (e.g., indications for which no health technology assessment has been conducted by CDR and/or CDR-participating drug plans for the reference product).
4. CADTH considers the issue of interchangeability and substitutability of SEBs to be an implementation issue that is best addressed by the CDR-participating drugs plans.
Feedback is sought by email (by October 7, 2013) addressed to: email@example.com.
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