Our team took a look at the most recent pharmaceutical developments from the week, including where we are with treatment options and how manufacturers are racing to find an effective treatment for COVID-19.

COVID-19 has had significant effects across the healthcare system

STAKEHOLDER:

TAKEAWAYS:

PATIENTS / PHYSICIANS

  • Coronavirus has infected millions of patients worldwide
  • Physicians and pharmacists are seeing increases in workload
Treating COVID-19 patients is a top priority, but it will also remain important to treat other chronic conditions

PAYERS

  • Payers are moving to virtual P&T committee meetings, but meetings are not being delayed
  • P&T conversations are being limited to business-critical issues
  • Health plans may be temporarily lifting some prior authorization criteria in certain scenarios
Manufactures can expect P&T review cycle to remain as is, but should consider bringing the most critical business issues into meetings

SUPPLIERS / LOGISTICAL

  • US market heavily relies on China and India for active pharmaceutical ingredients (API) exports for generics and will likely work to reduce reliance in the future
  • Supply shortages
  • Patients stockpiling drugs
Manufacturers will need to find new ways to navigate supply chain issues and generic ingredient sourcing and may need to increase resources dedicated toward generics

MEDICARE / MEDICAID

  • Physicians treating COVID-19 Medicare patients through telehealth will be reimbursed based on their usual site of care (e.g., a physician from a clinic setting will be reimbursed at the non-facility rate)
  • Medicare is allowing for real-time patient/physician audio and video technology during COVID-19
  • Medicare payments will remain the same for Part B medications
Medicare reimbursement will not change as a result of COVID-19 and Medicare patients will maintain access to doctor visits and critical medications

PHARMA / BIOTECH

  • Several companies are expediting clinical trials to find an effective vaccine for COVID-19
  • There are several potential drug treatment candidates
  • Some clinical trials for non COVID-19 treatments are being put on hold
  • Sales representatives unable to visit physician offices
It will remain important to prioritize innovative therapies as well as treatments and vaccines for COVID-19

There are several vaccines and drug candidates in development which could help prevent or treat COVID-19

VACCINES*

INO-4800 (Inovio) Inovio said its Phase 1 U.S. clinical test for INO-4800 is fully enrolled with all 40 healthy volunteers receiving their first dose, with interim immune responses and safety results expected in late June
Ad5-nCoV (CanSino) Genetically engineered vaccine building off the platform used to develop an Ebola vaccine; this vaccine recently entered Phase 2 clinical trials
mRNA-1273 (Moderna) The phase 2 study is expected to begin in the second quarter. That will evaluate the safety and any adverse reactions and immune responses of two mRNA-1273 vaccinations given 28 days apart
Pfizer & BioNTech (BNT-162) Pfizer announced a joint venture with BioNtech to develop and distribute BioNTech’s mRNA based COVID-19 vaccine candidate BNT-162
Dynavax Working with the University of Queensland to develop a vaccine for COVID-19. It would make its vaccine adjuvant technology available to other companies working on a vaccine through CEPI
Curevac Curevac has begun work on its COVID-19 vaccine and plans to enter clinical trials with its lead vaccine candidate in June 2020

TREATMENTS

Remdesivir (Gilead) Data from the open-label SIMPLE trial, show that remdesivir may accelerate recovery rates among patients with advanced Covid-19
Chloroquine (Rising Pharmaceuticals) Donated Hydroxychloroquine tablets in support of a Phase 2 trial exploring hydroxychloroquine as preventive treatment for COVID-19 in patients with cancer who are receiving radiation therapy
Actemra (Roche) FDA approved a Phase 3 trial of Actemra (tocilizumab) in COVID-19 patients with pneumonia
Kaletra/Aluvia (AbbVie) An HIV medication that showed promise but failed to meet endpoints in an early study; however, it is possible that this drug could be more effective if administered sooner after disease onset
Kevzara (Sanofi/Regeneron) Kevzara delivered disappointing results in their clinical studies, which would have helped ease the immune system’s overreaction to the virus
TAKE-888 (Takeda) A blood plasma derived therapy in development; this treatment depends on the company’s ability to obtain enough blood plasma of recovered patients
Vir (VIR-7831 & VIR-7832) The pair’s (GSK has invested $250 million) immediate focus will be VIR-7831 and VIR-7832 in which they plan to move the candidates into a phase 2 clinical trial in the next three to five months
Eli Lilly & AbCellera Lilly is working with biotechnology company AbCellera, to develop a treatment based on antibodies present in the blood of patients who’ve recovered from Covid-19, trials to start end of May
Emergent BioSolutions Begun the development of two candidate hyperimmune products against the disease. It will aim to leverage the immune response in order to combat COVID-19 and are derived from antibodies
Novartis (canakinumab) Novartis announced plans to initiate a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia. Treat a type of immune overreaction in people with COVID-19 pneumonia
Novavax Inc (NVX-CoV2373) The company has now identified its lead vaccine candidate, NVX-CoV2373 and will initiate a first-in-human trial
Incyte (Jakafi) Plan to test Jakafi in a second phase 3 trial for COVID-19 patients with acute respiratory distress syndrome. Jakafi’s safety and efficacy over standard of care in ARDS patients who need ventilators

*Non-exhaustive list. As of May 17, there were a total of 82 active Phase II trials; J&J/Janssen and Sanofi Pasteur are also developing vaccines.

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