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HTA recommendations for biosimilars implementation in oncology field in MENA region
Background
With the presence of concept of biosimilar products at last decade which defined by WHO as a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product. Implementation of practice framework for biosimilars implementation in oncology field putting the following objectives (patient’s safety, efficacy, health care resources, NOCEPO Effect and finally patient compliance and adherence) are challenges facing every health system. as model used to assess bioequivalence for generics does not apply to biosimilars. Since 2006, the EMEA has approved several biosimilars. With special nature of oncology field including (disease nature, patient profile) When WHO (World Health Organizations) developed HTA definition (the systematic evaluation of properties, effects and/or impacts of health technology. It is a multidisciplinary process to evaluate the social, economic, organizational and ethical issues of a health intervention or health technology. The main purpose of conducting an assessment is to inform policy decision-making. To solve a health problem and improve quality of life. Need was raised for developing evidence-based tools for informing and supporting for managing and overcoming previous challenges. The main objective for this study is to determine the how can HTA body support Health care decision makers The appropriate ways for establishing an evidence based frame work of biosimilars implementation in oncology field taking into consideration patient’s needs and health system needs.
Methods
Integration between a systematic literature review and descriptive analysis of FDA, WHO EMA, local guidelines and local data from regulatory body for efficacy, safety, quality for biosimilars & ISPOR plus WHO guidelines for HTA plus 68 websites of HTA organizations. Of these, 50 HTA organisation websites had at least one document discussing biosimilar content. Interviews were conducted with Key stock holders for health system in Egypt, Tunisia, Jordan, and Saudi Arabia, United Arab Emirates, Spain, Turkey, Germany and industry representatives.
Results
A framework was proposed for biosimilars reimbursement decision making which included price and four non-price criteria. Pharmaceutical price (20% weight), quality module (33%), regulatory body approval for interchangeability (25%) post marketing studies (11%) clinical decision (11%).
Conclusions
Biosimilars should not be treated as generic products. In terms of HTA there is a need to conduct a selection criteria specialized for biosimilars, pricing process should be on case by case basis due to the nature of technology of biosimilars. The need for evidence base data for switching from innovator products to biosimilars should be mandatory during marketing authorization process. An integration between regulatory body and HTA should be initiated as both bodies differ for their prospective and they need to integrate in order to minimize time consumption and unifying concepts for biosimilars. Effective assessment and evaluation for biosimilars the comparator of HTA should be different standard of care may and may be not contain the reference product or second generation of biosimilar. In the presence of validated and strong evidence comparing different generations of biosimilars should be conducted otherwise payers will facing a lot of challenging to conduct effective health policy.
Legal entity responsible for the study
The author.
Funding
Has not received any funding.
Disclosures
The author has declared no conflicts of interest.
