On behalf of everyone at Innovation Partners, a Happy Passover Holiday and Happy Easter to all!
We’re all struggling to navigate the “new normal” during this time of uncertainty, and the healthcare industry is no exception. Drug companies have delayed or stopped many new drug launches since clinical trials have been stopped, approvals delayed, and in-person provider visits and demonstrations halted. Additionally, insurers are trying to ease the burden on providers and their customers by adding telehealth services, speeding claims processing, and more. This and more are the top stories in this week’s Innovation Partners BioBlog.
PARP Inhibitor Drugs Can be “Tuned” for Better Killing of Tumor Cells
Researchers from Penn State have discovered that a drug which showed lukewarm promise can be structurally modified or “fine-tuned” to better kill cancer tumor cells. The PARP Inhibitor drug did not perform as expected in clinical trials, but the Penn team found that inhibitor compounds in the PARP drug can be “tuned” in the opposite way so that they inhibit PARP-1 enzymes without killing cells. This makes the class of drugs potentially more useful for treating heart disease and other non-cancer conditions where inhibiting PARP-1 is the goal.
FDA’s Hahn: No sign China has affected U.S. drug supply during coronavirus pandemic
The FDA reported it saw no signs that China has intentionally disrupted the U.S. drug supply during the coronavirus pandemic. The agency has not seen any shortages of active pharmaceutical ingredients (APIs) but continues to monitor the situation closely. Last week, the FDA reported shortages of hydroxychloroquine and chloroquine, two antimalarial drugs being tested as a potential treatment for the novel coronavirus and often cited by President Trump in his speeches and updates.
Providers want a cash infusion to fight COVID-19. But payers say they’re doing plenty already
The American Hospital Association sent a letter last week to major national payers asking them to offer accelerated or interim payments. Medicare has already begun a similar initiative. America’s Health Insurance Plans (AHIP), the largest lobbying group for payers, stated that health plans are waiving cost-sharing for telehealth and treatments and that they’re easing administrative burdens and claims processing. Many have not waived pre-authorization and similar administrative roadblocks.
Ex-FDA chief says regulator needs to up pace on COVID-19 drugs
Former FDA chief Scott Gottlieb has called on regulators to allow COVID-19 drugs to take the same path as drugs for rare and deadly cancers. Gottlieb believes that the drugs must be available in the summer to restart the American economy and avoid a fall surge in COVID-19 cases. Gottlieb penned a piece for the Wall Street Journal in which he outlined how the FDA could use approaches including real-time reviews, which enable the regulatory evaluation of data from ongoing clinical trials, to cut the time it takes to get drugs against COVID-19 to patients.
Researchers harness new technology for rapid COVID-19 vaccine development
A spinoff of Massachusetts General Hospital, Voltron Therapeutics, has partnered with Hoth Therapeutics to create a joint venture called HaloVax. Their mission: to use a vaccine technology developed at MGH to find a possible COVID-19 vaccine. HaloVax is expected to begin animal trials on a potential vaccine in late April. The experimental COVID-19 vaccine uses a heat shock protein to activate the immune system, rather than one of the chemical adjuvants that are commonly employed by vaccine developers, the company said. The vaccine will also include a variable component that targets specific characteristics of COVID-19.
COVID-19 is bad news for new drug launches. Which will suffer most?
The COVID-19 pandemic has halted or slowed many clinical trials. Regulatory timelines for drugs nearing decisions have also been impacted, and in-person demonstrations of drugs, halted. Rollouts of new drugs by smaller companies are likely at the greatest risk, although both Bristol-Myers-Squibb and Novartis are also putting the brakes on two new MS drugs. Nearly all drug makers have been affected, either directly, as BioGen has by several key staff members contracting the virus, or by the stay-at-home and shutdown orders.
Humana is expediting claims processing and prior authorization during COVID-19 pandemic
Humana is expediting both prior authorization and claims processing during the COVID-19 pandemic to help get much-needed cash to providers. The company is also suspending prior authorization and referral requirements, instead requesting notification within 24 hours of inpatient (acute and post-acute) and outpatient care. This is applicable for all providers regardless of network affiliation for patient care related to COVID-19 and for in-network providers for patient care not directly related to COVID-19. Some exceptions will apply. These policies are applicable for covered plan benefits under individual and group Humana Medicare Advantage, Medicaid, and commercial employer-sponsored plans.