Interferon beta-1a biosimilar(Biocad Medical, Inc.)

Current first-line disease-modifying therapies (DMT) for multiple sclerosis (MS) patients are injectable or oral treatments. The Optogenerapy consortium is developing a novel bioelectronic cell-based implant for controlled release of beta-interferon (IFNβ1a) protein into the body. The current study estimated the potential cost effectiveness of the Optogenerapy implant (hereafter: Optoferon) compared with injectable IFNβ1a (Avonex).

A Markov model simulating the costs and effects of Optoferon compared with injectable 30 mg IFNβ1a over a 9-year time horizon from a Dutch societal perspective. Costs were reported in 2019 Euros and discounted at a 4% annual rate; health effects were discounted at a 1.5% annual rate. The cohort consisted of 35-year-old, relapsing-remitting MS patients with mild disability. The device is implanted in a daycare setting, and is replaced every 3 years. In the base-case analysis, we assumed equal input parameters for Optoferon and Avonex regarding disability progression, health effects, adverse event probabilities, and acquisition costs. We assumed reduced annual relapse rates and withdrawal rates for Optoferon compared with Avonex. Sensitivity, scenario, value of information, and headroom analysis were performed.

Optoferon was the dominant strategy with cost reductions (- €26,966) and health gains (0.45 quality-adjusted life-years gained). A main driver of cost differences are the acquisition costs of Optoferon being 2.5 times less than the costs of Avonex. The incremental cost-effectiveness ratio was most sensitive to variations in the annual acquisition costs of Avonex, the annual withdrawal rate of Avonex and Optoferon, and the disability progression of Avonex.

Innovative technology such as the Optoferon implant may be a cost-effective therapy for patients with MS. The novel implantable mode of therapeutic protein administration has the potential to become a new mode of treatment administration for MS patients and in other disease areas. However, trials are needed to establish safety and effectiveness.

A review and commentary.The World Health Organization (WHO) Solidarity Trial is an adaptive, randomized, open-label trial designed to help determine whether any of four repurposed antiviral drugs (Remdesivir, Hydroxychloroquine, Lopinavir, and Interferon-β1a) could have an effect on in-hospital mortality of COVID-19 patients.In 405 hospitals in 30 countries, 11 266 adult patients (81% younger than 70 years, and 62% male) were randomized equally between whichever study drugs were locally available and open control (up to five options: four active and local standard-of-care).The intent-to-treat primary analyses were of in-hospital mortality in the four pairwise comparisons of each drug-treated group vs. its control (concurrently allocated the same management without that drug, despite availability).Secondary endpoints were initiation of ventilation and hospitalization duration.Overall, 1253 deaths were reported (at median Day 8, interquartile range 4-14).Kaplan-Meier 28-day mortality was 11.8% (39% if already ventilated at randomization, 9.5% otherwise).Log-rank death rate ratios (RRs) [with 95% confidence intervals (CIs) and numbers dead/randomized, each drug vs. its control] were stratified for age and ventilation at entry: Remdesivir, RR _≥ 0.95 (0.81¹1.11, P _≥ 0.50; 301/2743 active vs. 303/2708 control); Hydroxychloroquine, RR _≥ 1.19 (0.89-1.59, P _≥ 0.23; 104/947 vs. 84/906); Lopinavir, RR _≥ 1.00 (0.79¹1.25, P_≥ 0.97; 148/1399 vs. 146/1372); Interferon, RR _≥ 1.16 (0.96¹1.39, P _≥ 0.11; 243/2050 vs. 216/2050).No study drug definitely reduced mortality (in unventilated patients or any other subgroup of entry characteristics), initiation of ventilation or hospitalization duration.