Our Take: The pharmaceutical industry wages war on COVID-19
Mar 30, 2020
Big Pharma bands together to take on the coronavirus, with help from the Bill & Melinda Gates Foundation
To speed development of vaccines, tests, and treatments for COVID-19, more than a dozen of the world’s leading pharmaceutical companies — including powerhouses such as Boehringer Ingelheim, Bristol Myers Squibb, Eisai, Eli Lilly, Gilead, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Pfizer, and Sanofi — have committed to sharing part of their proprietary compound libraries with the COVID-19 Therapeutics Accelerator the Gates Foundation launched earlier this month in collaboration with Wellcome and MasterCard.
The accelerator platform will screen the libraries, looking for compounds that might be effective in treating COVID-19. Compounds that show potential will then proceed to in vitro testing within an estimated two-month time frame.
Vas Narashimhan, CEO of Novartis and co-chair of the consortium of life sciences companies, said in a press statement, “[C]ollective action is critical to ensure any promising studies into vaccines, drugs, and diagnostics are quickly scaled to people around the world who are affected by this pandemic.”
Drugmakers donate chloroquine and hydroxychloroquine, work to speed up production
Based on limited initial trial results, there’s hope that a relatively cheap malaria drug, which is also used to treat lupus and rheumatoid arthritis, could be effective against the novel coronavirus.
Chloroquine and its better-tolerated version, hydroxychloroquine, are being evaluated in larger studies, including one underway at the University of Minnesota, to see if they can prevent or reduce the severity of COVID-19.
Bayer announced earlier this month that it was donating 3 million tablets of Resochin (chloroquine phosphate), which the company discovered in 1934, to the U.S. government. Teva then said it would immediately donate 6 million doses of hydroxychloroquine to U.S. hospitals, followed by another 10 million within a month.
Soon after, Novartis said it would donate up to 130 million doses of hydroxychloroquine by the end of May. Mylan is working to ramp up production of 50 million tablets of hydroxychloroquine and said it could begin supplying the drug by mid-April. Amneal Pharmaceuticals also said it is increasing production of hydroxychloroquine, with a goal of producing 20 million tablets by mid-April.
East Brunswick, N.J.-based Rising Pharmaceuticals reversed course on the pricing of its chloroquine tablets, having nearly doubled the price between December and January. Subsequently, the company said it would cut the price in half and later announced that it would lower the price another 20%. Rising is also donating 1 million doses of hydroxychloroquine “to areas of greatest need.” The firm is collaborating with the University of Minnesota in the clinical trial mentioned above.
Meanwhile, shortages of hydroxychloroquine have been reported, causing concern among physicians who prescribe and patients who use the drug for its approved indications.
Of note, hydroxychloroquine did not outperform placebo in terms of clearing the coronavirus in a small clinical trial conducted in China, FiercePharma reported. Patients in those trials had mild cases of COVID-19.
Roche’s IL-6 inhibitor demonstrates potential, undergoes more testing
The FDA approved a clinical trial of Roche’s Actemra (tocilizumab) in patients with severe COVID-19 pneumonia, the company announced on March 19. Enrollment is expected to begin in early April, with a target of 330 patients. The study is being conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA).
China’s National Health Commission included Actemra in its updated treatment guidelines for patients with COVID-19 who have developed extensive lung damage and have elevated levels of interleukin 6 (IL-6). The drug was initially approved in the U.S. a decade ago as a treatment for rheumatoid arthritis. Roche said last week that it is working to boost its manufacturing capacity of Actemra in an effort to avoid shortages.
Sanofi and Regeneron recently started a clinical trial in New York to assess Kevzara (sarilumab), an IL-6 inhibitor like Actemra, in patients with severe COVID-19. The FDA approved Kevzara in 2017 for patients with rheumatoid arthritis.
AbbVie relinquishes patent rights to Kaletra, Mylan waives exclusivity
Numerous sources reported last week that AbbVie took a bold step by stating that it would not enforce its patents on HIV drug Kaletra (lopinavir/ritonavir), which also is being evaluated as a treatment for severe COVID-19. AbbVie’s decision will significantly increase supply of the drug by allowing generic drug companies to manufacture it as needed. Mylan waived its 180-day marketing exclusivity to distribute its generic version of Kaletra.
Results of a small study in China published March 18 by The New England Journal of Medicine showed that Kaletra did not improve upon standard care in patients infected with the coronavirus. An analyst with Evercore ISI pointed out, though, that Kaletra appeared to do better in patients who began treatment earlier in the course of the illness and said the drug shouldn’t be dismissed as a potential treatment.
Gilead expands access to remdesivir, asks FDA to rescind orphan drug designation
The most promising treatment so far, according to the World Health Organization (WHO), is Gilead Sciences’ remdesivir, an experimental antiviral drug originally developed to treat Ebola. Encouraging trial results have increased demand for the drug to such an extent that Gilead announced a week ago that it was temporarily halting emergency access through its compassionate use program — which is designed for a small number of individual cases to be reviewed one at a time — so it could transition to expanded access programs. On Saturday, the company posted an open letter from CEO Daniel O’Day about the expanded access programs, which will allow hospitals and physicians to apply for emergency use of remdesivir for multiple patients at the same time.
Last week Gilead asked the FDA to rescind the orphan drug designation it granted in early March. The designation gave the company seven years of market exclusivity for remdesivir, and critics pointed out that Gilead would be able to name its price for the drug. According to FiercePharma, Gilead said part of the reason it applied for the orphan drug designation was to have the FDA waive the company’s requirement to develop a pediatric study plan before submitting the New Drug Application, which could have delayed the review process by about seven months.
WHO starts the SOLIDARITY trial, Lilly scales back trial activity, Abbott works to ease lack of U.S. testing capacity
The World Health Organization is organizing a large-scale international trial, SOLIDARITY, to compare the effectiveness of various drugs as treatments for COVID-19. The trial will evaluate chloroquine, hydroxychloroquine, Kaletra, remdesivir, and a combination of Kaletra and interferon-beta. The first patient was enrolled in Norway on Friday. Currently, more than 45 countries are participating.
Eli Lilly announced last Monday that it is delaying the start of most new studies and suspending recruitment in most of its ongoing clinical trials, to ease the burden on participating facilities and free up physicians to focus on the coronavirus. Patients already enrolled in trials that are underway will continue to receive their treatments. The company is also “repurposing” its laboratories to conduct diagnostic testing for patients.
After the FDA issued Emergency Use Authorization for Abbott’s RealTime SARS-CoV-2 test, the company announced that it was immediately shipping 150,000 of the tests to hospitals and academic medical center laboratories in 18 states, including those states hit the hardest by early outbreaks of the coronavirus. The tests are used on Abbott’s m 2000 RealTime System, which can run up to 470 tests in a 24-hour period. Eventually, the company hopes to provide up to 1 million of the tests per week.
What else you need to know
Mayo Clinic is launching a coalition with Amazon and other health care organizations, technology companies, nonprofits, academia, and startups to respond to the coronavirus pandemic. Dr. John Halamka, president of Mayo Clinic Platform, is among the industry leaders and experts participating in the COVID-19 Healthcare Coalition, which is intended to develop an ecosystem of private sector capabilities that can help shift the burden from hospitals; connect personal protective equipment suppliers with health care organizations; rapidly accelerate ventilator supplies; share best protocols for treatment; and link the best sources of information to provide data and analytics. The coalition’s initial focus is on increasing COVID-19 testing capacity, coordinating early therapies, and accelerating vaccine development.
COVID-19 could end up costing insurers $93 billion in medical claims, Becker’s Hospital Review reported, citing an S&P analysis that took two scenarios into consideration. In the “moderate” scenario, 1 million people would be hospitalized; in the “severe” scenario, 4 million people would be. Medical claims costs could increase up to 12% in the severe scenario, the analysts estimated, resulting in total costs of $93.1 billion. Of that total, $80.4 billion would be hospital costs. The analysts said the moderate scenario would likely result in a 3% to 4% increase in claims costs.
CMS extended the 2019 reporting deadlines for ACOs in the Medicare Shared Savings Program (MSSP), as well as for the Merit-based Incentive Payment System (MIPS), from March 31 to April 30. MIPS-eligible providers who miss the deadline will not incur a financial penalty. In the press release announcing the extension, the agency also said reporting of Q4 2019 data for 11 hospital-based quality programs and six post-acute programs is optional. Additionally, CMS said data does not need to be submitted for the first six months of this year for the hospital performance and payment programs. The agency is still evaluating options for 2020 participation and reporting requirements for MIPS and MSSP. The press release did not mention the new direct contracting program for ACOs.
Kaiser Permanente is ditching its plans to build a $900 million, 29-floor office tower in Oakland, Calif., which would have served as the company’s headquarters, the San Francisco Chronicle reported last Tuesday. The company said delays and increasing costs — not the COVID-19 pandemic — led to its decision not to build the 1.6 million-square-foot tower, dubbed the Kaiser Permanente Thrive Center.
More than a dozen Blue Cross Blue Shield plans are suing Walgreens for allegedly overcharging for prescription drugs since 2007, Crain’s Chicago Business reported. The lawsuit, filed in an Illinois district court last Wednesday, claims that Walgreens defrauded the plans out of hundreds of millions of dollars by billing for “usual and customary prices” — the cost someone would pay without insurance — rather than using a lower rate that Walgreens customers can get through the company’s Prescription Savings Club. The plans are seeking nearly $10 million in the suit.
The Department of Justice filed a lawsuit against Anthem Thursday, claiming the insurer committed fraud by failing to update inaccurate diagnosis codes associated with its Medicare Advantage plans between early 2014 and early 2018. The court filing states that “Anthem made ‘revenue enhancement’ the sole purpose of its chart review program, while disregarding its obligation to find and delete inaccurate diagnosis codes, because Anthem prioritized profits over compliance.” The lawsuit indicates that Anthem “often generated $100 million or more a year in additional revenue” by not updating the inaccurate codes.
What we’re reading
Seeking Evidence-Based Covid-19 Preparedness: A FEMA Framework for Clinic Management. NEJM Catalyst, 3.25.20
The Inevitable Reimagining of Medical Education. JAMA Viewpoint, 2.28.20