Health Technology Assessment
In its best form, health technology assessment (HTA) is a multidisciplinary process that summarizes information about the medical, social, economic, and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner; its aim is to inform the formulation of health policies that are patient-focused and seek to achieve optimal health outcomes through access to best value safe and effective technologies.
HTA processes will continue to be used by public and private health systems to evaluate the value and appropriate use of pharmaceuticals and other health technologies in order to make their formulary and reimbursement decisions and to use their resources wisely. Ultimately, the outcomes of HTA should help support more integrated patient care.
Lilly believes that HTA processes should focus on improving patient outcomes and follow these key principles:
- The primary goal of HTA should be to improve patient care and physician decision making. HTA process should include participation from physicians and patients with direct knowledge of the therapeutic area and should formally incorporate their views in assessing the value of a medicine or other health technology.
- HTA guidance should also recognize that patient preferences and responses to medicines vary, so patients should have access to a variety of therapeutic agents for a given condition.
- Lilly is working to broaden stakeholder engagement in HTA processes to create greater awareness and ensure that patient needs are addressed in research and policy decision making.
- HTA processes should be objective, open, transparent, timely, and evidence based. Reviews, analyses and conclusions should be based on sound scientific principles and standards.
- HTA processes should consider the full range of value of new medicines for patients and all other stakeholders, including benefits to the greater society. Medicines should be evaluated holistically in the context of other available treatment options, including devices and procedures.
- HTA bodies should be willing to engage in open, voluntary dialogue with drug manufacturers during the drug development process to set mutually realistic expectations for research quality, data requirements and timeliness of reviews.
- HTA bodies should have a process to efficiently handle appeals of their decisions by a stakeholder, including patients and physicians. Appeals should include a process for stakeholders to challenge assumptions and conclusions, and should include review by an independent body or expert with experience in the therapeutic area being assessed. HTA bodies should have an efficient process to reconsider formulary or reimbursement decisions based on new information submitted by a sponsor.
- HTA processes should not be used to unnecessarily delay access to innovative medicines for purely economic reasons that do not account for both direct and indirect costs and benefits, as this denies the technology's benefits to patients.
- The regulatory approval of, and market access to, new medicines should continue to be based primarily on each product’s safety, efficacy, and quality. These considerations should remain separate from HTA processes.