Pricing methods in outcome-based contracting: δ6: adherence-based pricing

Abstract

Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The sixth dimension (d6) estimates prices on the basis of adherence to the prescribed regimen, whereby manufacturers provide payers with adherence-enhancing programs and whereby payers implement these programs and provide adherence data to the manufacturer. We describe this dimension's methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib. Materials and methods: We propose two paybacks based on adherence: in-advance (based on clinical trial data) and in-arrear (based on real-world data). The risk of efficacy failure pricing dimension utilizes a 7-step method: 1) defining efficacy endpoints; 2) extracting data; 3) predicting models; 4) estimating in-advance and in-arrear paybacks; 5) suggesting ranges for in-advance and in-arrear paybacks; 6) adjusting for medical inflation; and 7) performing Monte Carlo Simulation (MCS) to estimate the DSP Adherence. A proof-of-concept exercise with osimertinib in NSCLC was performed for two hypothetical outcome-based contracts: 1-year (2019-2020) and 2-year (2019-2021). The 2018 wholesale acquisition cost (WAC) for a 30-day prescription was used and inflated as needed. Herein, the DSP Adherence is estimated exclusively in terms of in-advance payback because real-world data about osimertinib are not yet available and thus the in-arrear payback cannot yet be estimated.

The six Delta platform for outcome-based contracting for pharmaceuticals

“…The sixth and final dimension, adherence-based pricing 24 , is a derived from dimension 5 23 as patient adherence to a medication is a major determinant of treatment efficacy and outcome. In this dimension, adherence is defined as maintaining patients, and especially the highly benefiting patients, on their drug by incentivizing payers with price adjustment in return for demonstrated adherence.…”

“…As in the fifth dimension, this percentage may not fully or accurately address the uncertainty generated by the analysis. Here too, we encourage using the term of "up to" the estimated percentage as a range for payment; specifically, from zero percent to the estimated percent 24 .…”

“…For each efficacy measure, two price bounds are developed: one using the lower bound of the differential between upper and mean probability; and one using the upper bound of 0% price change. The lower and upper bounds are then averaged for MCS to derive the DSP Adherence 24 . As a caution, in our proof-of-concept exercise, real-world data were not yet available for the drug of interest and inarrear incentives cannot be estimated at this time.…”

“…As a caution, in our proof-of-concept exercise, real-world data were not yet available for the drug of interest and inarrear incentives cannot be estimated at this time. Thus, the DSP Adherence reflects the price of the drug of interest considering the in-advance incentives 24 .…”

Exploration of an alternative reconstructed individual patient data-based approach for budget impact analysis of anticancer drugs

“…In response to these problems in relation to existing BIAs for anticancer drugs, we propose an alternative in the form of a reconstructed IPD-based approach. Furthermore, the objective of this study aligns with some previous researches’ efforts, namely using K-M curves to enhance the accuracy of predicted economic results for innovative drugs, for better value-based evaluation and related decision-makings [ 28 , 29 ].…”