HealtheconomicmodellingforNHSmarketaccess
For the NHS market entry of a new cartilage cell therapy, cost-effectiveness data over the patient lifetime was required, although no randomised long-term studies and no final reimbursement price were available. LinkCare developed a Markov model from an NHS perspective.
The challenge
Starting point and systemic barriers
Our client, manufacturer of a novel cartilage cell therapy (ATMP), was preparing to enter the UK market. For NHS reimbursement, the cost-effectiveness compared to established alternatives had to be proven. Randomised studies over the required observation period were not feasible: cartilage damage occurs predominantly in patients under 55 years of age, while the economically relevant follow-up treatment, especially knee arthroplasty, only occurs decades later. In addition, a finalised reimbursement price was not yet available. What was needed was a solid basis for decision-making in price and reimbursement negotiations.
Key question
How can cost-effectiveness be reliably proven if neither long-term studies nor finalised reimbursement prices are available?
The approach
Strategy development and market execution
LinkCare developed a Markov model from an NHS perspective over the lifetime of the patients. A cohort of fictitious patients progresses through health states in annual cycles from initial surgery to eventual knee arthroplasty. For each state, transition probabilities, quality of life scores and costs from clinical trials, national NHS reference costs and manufacturer data were integrated. The robustness of the model assumptions was validated via two sensitivity analyses: a deterministic analysis varied individual parameters by ±20 per cent; a probabilistic analysis performed 100,000 Monte Carlo simulations.
The result
Impact, resonance and next leverage point
The client technology proved to be a clearly cost-effective alternative: compared to conventional methods, the incremental cost-effectiveness ratio (ICER) was £5,147 per QALY gained, well below the NHS willingness to pay of £20,000-30,000. In addition, a value-of-information analysis quantified the expected benefit of additional evidence at £12,500-17,000 per patient. The costs of such a trial are likely to exceed this threshold so that reimbursement decisions in the NHS can be made robustly on the basis of the available evidence. The results were published in the Journal of Medical Economics in a peer-reviewed publication with eight clinical experts from five countries. They provide a robust health economic decision-making basis for price and reimbursement negotiations with the NHS.
"In our collaboration with LinkCare, we were particularly impressed by their modelling expertise, their experience with HTA processes and their confident handling of our group of clinical authors." André Roeder Head Commercial Operations EU TETEC AG
