Voluntary licensing of long-acting HIV prevention and treatment regimens: using a proven collaboration- and competition-based mechanism to rapidly expand at-scale,sustainable, quality-assured and affordable supplies in LMICs

Introduction

Emerging long-acting (LA) prevention and treatment medicines, technologies and regimens could be game-changing for the HIV response, helping reach the ambitious goal of halting the epidemic by 2030. To attain this goal, the rapid expansion of at-scale, sustainable, quality-assured, and affordable supplies of LA HIV prevention and treatment products through accelerated and stronger competition, involving both originator and generic companies, will be essential. To do this, global health stakeholders should take advantage of voluntary licensing of intellectual property (IP) rights, such as through the United Nations-backed, not-for-profit Medicines Patent Pool, as a proven mechanism to support broad access to existing HIV medicines across low- and middle-income countries (LMICs).

Discussion

While voluntary licensing may unlock the possibility for generic competition to take place ahead of patent expiry, there are additional elements—of amplified importance for more complex LA HIV medicines—that need to be taken into consideration. This paper discusses 10 enablers of voluntary licensing of IP rights as a model to rapidly expand at-scale, sustainable, quality-assured, and affordable supplies of LA HIV prevention and treatment regimens in LMICs:

1. Identifying promising LA technology platforms and drug formulations at an early developmental stage and engaging with patent holders
2. Consolidating a multidisciplinary network and strengthening early-stage coordination and collaboration to foster innovation
3. Embedding public health considerations in product design and delivery
4. Building innovative partnerships for product development and commercialization
5. Raising awareness of and creating demand for emerging LA products
6. Estimating the market size, ensuring sufficient competition and protecting sustainability
7. Using technology transfer and hands-on technical support to reduce product development timelines and costs
8. Exploring de-risking mechanisms and financial incentives to support generic manufacturers
9. Optimizing strategies for generic product development and regulatory filings
10. Aligning and coordinating efforts of stakeholders across the value chain.

     

Without Affordable,Accessible, and Adequate Housing,Health Has No Foundation

Policy Points

• Today's housing disparities are rooted in the increasing commodification of housing that has taken precedence over the need for shelter, a basic human right.
• With rising housing costs across the country, more residents are finding their monthly income going to rent, mortgage payments, property taxes, and utilities, leaving little for food and medication.
• Housing is a determinant of health, and with increasing housing disparities, action must be taken to ensure no individual is displaced, communities remain intact, and cities continue to thrive.

     

Designing a Value-Based Formulary for a Commercial Health Plan: A Simulated Case Study of Diabetes Medications

ObjectivesThe healthcare expenditure for managing diabetes with glucose-lowering medications has been substantial in the United States. We simulated a novel, value-based formulary (VBF) design for a commercial health plan and modeled possible changes in spending and utilization of antidiabetic agents.MethodsWe designed a 4-tier VBF with exclusions in consultation with health plan stakeholders. The formulary information included covered drugs, tiers, thresholds, and cost sharing amounts. The value of 22 diabetes mellitus drugs was determined primarily in terms of incremental cost-effectiveness ratios. Using pharmacy claims database (2019-2020), we identified 40 150 beneficiaries who were on the included diabetes mellitus medicines. We simulated future health plan spending and out-of-pocket costs with 3 VBF designs, using published own price elasticity estimates.ResultsThe average age of the cohort is 55 years (51% female). Compared with the current formulary, the proposed VBF design with exclusions is estimated to reduce total annual health plan spending by 33.2% (current: $33 956 211; VBF: $22 682 576), saving $281 in annual spending per member (current: $846; VBF: $565) and $100 in annual out-of-pocket spending per member (current: $119; VBF: $19). Implementing the full VBF with new cost shares, along with exclusions, has the potential to achieve the greatest savings, compared with the 2 intermediate VBF designs (ie, VBF with prior cost sharing and VBF without exclusions). Sensitivity analyses using various price elasticity values showed declines in all spending outcomes.ConclusionDesigning a VBF with exclusions in a US employer–based health plan has the potential to reduce health plan and patient spending.     

The Impact of Sharing Drug Rebates at the Point of Sale on Out-of-Pocket Payments for Enrollees in Employer-Sponsored Insurance

ObjectivesThis study aimed to estimate the impact of sharing drug rebates at the point of sale on out-of-pocket spending by linking estimated rebates to administrative claims data for employer-sponsored insurance enrollees in 2018.MethodsWe applied the drug rebate rate to the retail price of each brand name drug fill, allocated the reductions to out-of-pocket spending based on cost-sharing provisions, and aggregated each individual’s out-of-pocket spending across drug fills. We assumed that generic drugs have no rebates for employer-sponsored insurance. We assessed the impact of sharing rebates at the point of sale on out-of-pocket spending overall, for the therapeutic classes and specific drugs with the highest average out-of-pocket spending per user, and by health plan type.ResultsAcross 4 simulations with different assumptions about the degree of cross-fill effects, we found that 10.4% to 12.2% of enrollees in our sample would have realized savings on out-of-pocket spending if rebates were shared to the point of sale. Among those with savings, approximately half would save $50 or less, and 10% would save > $500 annually. We calculated that a premium increase of $1.06 to $1.41 per member per month among the continuously enrolled, insured population would be sufficient to finance the out-of-pocket savings in our sample.ConclusionsOur study suggests that, for a small percentage of enrollees, sharing drug rebates at the point of sale would likely improve the affordability of high-priced brand name drugs, especially drugs that face significant competition.     

An Analysis of Accessibility of Representative Psychotropic Medicine From the World Health Organization Model List of Essential Medicines in Developing Countries With Different Income Levels

ObjectivesThe objective of this study was to analyze the accessibility of psychotropic medicine in developing countries based on the availability, price, and affordability indicators to create international evidence to guide the development of policies on the accessibility of medicines.MethodsThis study included 5 types of psychotropic medicines listed in the 22nd edition of the World Health Organization Model List of Essential Medicines published by the World Health Organization in 2021. Derived from 84 surveys in 59 countries, this study summarizes the availability, price, and affordability of originator branded drugs (OBs) and lowest-price generic drugs (LPGs) in the public and private sectors and compares them based on income levels in different countries.ResultsThe average availability of psychotropic medicine was 45% in low- and lower-middle-income countries (LLMICs) compared with 49% in high- and upper-middle-income countries (HUMICs) whereas the availability of LPGs was higher than that of OBs in all country groups. The average patient price for OBs and LPGs was 94.0 and 23.2, respectively, and the overall patient price of psychotropic medicine in LLMICs was higher than that in HUMICs. The affordability of psychotropic medicine in LLMICs was lower than that in HUMICs.ConclusionsPsychotropic medicines in lower-middle-income countries have lower availability, a higher average patient price, and lower average affordability than in HUMICs, which requires lower-middle-income countries to take effective and various measures to improve the accessibility of psychotropic medicine.