BACKGROUND: Early HTA is an iterative evaluation alongside Phase I and II clinical trials used to reinforce pharmacoeconomic evidence in early-stage clinical development. Although rapidly developing, most health economics studies in Russia are carried out post drug approval.

OBJECTIVES: To analyze the internal HTA process in a Russian biotechnology company (BIOCAD) and identify best practices and gaps.

METHODS: We analyzed BIOCAD’s internal HTA process to improve project selection, future reimbursement and market access strategies. For our analysis, we selected BIOCAD’s innovative products currently in phase I and II trials or those planned for phase II and III trials.

RESULTS: We selected 9 case studies. Conducting brief pharmacoeconomic evaluation of a drug prior to clinical trial planning was the best practice. It facilitated trial design in regards to defining the comparator, outcome measures (including HRQoL estimates), patient profile, and trial duration, and incorporated clinical and health economics evidence into the decision making on pricing, reimbursement, and market access strategy.

For a biotechnology company focusing on particular therapeutic areas, it is important to consider the portfolio HTA. Evaluating all drugs under development in the same area helps identifying potential relative impact and informing stakeholders on the drug value to better manage product portfolio and uncertainty.

We identified the gaps we need to address to mitigate risks associated with market access and reimbursement. Lacking HTA when prioritising potential indications or choosing preferred route of administration may lead to errors in market access and reimbursement strategy, need for additional trials, and delays in bringing drug to patients.

CONCLUSIONS: Although early HTA is brief and may involve many assumptions, it helps making vital decisions on drug value, trial design, pricing, and market access strategy.