Happy Independence Day to all of our American readers! In this week’s Innovation Partners BioBlog, we take a look at several updates from the pharmaceutical world. AstraZeneca is the first company to participate in a new FDA program to disclose all patient-reported symptoms during drug trials. The Trump administration is asking SCOTUS to weigh in on the repeal of the ACA. And, drug prices have actually gone up a bit since the start of the COVID-19 pandemic while prices in many other areas of the economy have gone down. This and more are in this week’s Innovation Partners BioBlog.
The Trump administration has officially asked SCOTUS to strike down the ACA. What comes next?
The Trump administration filed a briefing with the Supreme Court, asking the court to affirm that the Affordable Care Act was officially struck down in 2017. The concept at the center of the debate is “severability.” Everything goes back to the issue of the individual mandate. When the penalty was nullified in 2017, the law was, according to some, made invalid. In the brief, the Department of Justice stated that there is no evidence that Congress intended for the remainder of the law to stand. Opponents state the opposite is true; if Congress intended to get rid of the entire law, they would have done so in 2017. Now, it is up to the highest court in the land to make the final decision.
Novartis announces MET inhibitor Tabrecta™ approved in Japan for advanced non-small cell lung cancer with METex14
Novartis Pharma announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Tabrecta™ (capmatinib, formerly INC280) for MET exon 14 skipping (METex14) mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC). Tabrecta demonstrated an overall response rate of 68% and 41% in treatment-naive and previously treated non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping (METex14) respectively. Lung cancer is the most common type of cancer in Japan. Approximately 3,000 patients are diagnosed with METex14 metastatic NSCLC which is a particularly aggressive form of the disease in Japan each year. The drug has already been approved in the United States.
Not even COVID-19 can cause drug prices to go down: report
Researchers from GoodRx found that drug prices declined by only 0.6% since February, the start of the coronavirus pandemic in the United States. The study reports that despite the impact of the coronavirus on many other areas of the economy, it has not impacted drug prices much. Drugmakers are expected to raise their prices July 1 with no sign they will waive the increases during the pandemic.
CMS issues its first proposal to continue telehealth flexibilities, in home health proposed rule
The Centers for Medicare and Medicaid Services is proposing to make temporary telehealth provisions under COVID-19 permanent. This is the first time the organization has proposed to make the changes permanent. The rule proposes to permanently finalize, beginning January 1, 2021, the amendment to the home health regulations outlined in a March 30 interim final rule responding to the COVID–19 public health emergency. Although the use of telehealth services cannot substitute for home health visits, home health agencies may continue using the services to check in on patients. The use of technology may change the frequency, duration, and type of home visits in the future.
American Hospital Association to appeal ruling on price transparency lawsuit
The American Hospital Association is appealing a federal court ruling that states that hospitals must disclose to the public their privately negotiated rates with insurers. Opponents of the ruling state that it does nothing to help people understand their rights and costs, while proponents believe that all transparency is a good thing and a step towards helping people understand their healthcare choices. The AHA stands behind their opposition, stating they have always supported hospitals’ efforts to help patients and their families understand their fees for medical care.
Coronavirus tracker: U.S. calls dibs on remdesivir supplies; Sinopharm doubles shot capacity with new Wuhan plant
While global COVID-19 cases have climbed to 10.5 million on Wednesday, countries are making strategic moves to assist their people. In Japan, Fujifilm has partnered up with Indian drugmaker Dr. Reddy’s to sell doses of the flu med Avigan for COVID-19 treatment around the world except for Japan, where the medication is still in clinical trials. The U.S. appears to be betting on Gilead’s remdesivir, buying out Gilead’s supply for the next three months. And in China, the country’s state-owned Sinopharm completed a new vaccine manufacturing site in Wuhan, increasing capacity to more than 200 million doses per year.
AstraZeneca first to join FDA’s push for patient-reported symptoms in cancer trials
A new pilot program finds the FDA publishing patient-reported symptoms during a clinical trial. The first reports will be from AstraZeneca’s late-stage AURA3 trial that compared Tagrisso to platinum-based chemotherapy. So far, AstraZeneca is the only company participating. There are 28 additional patient-reported symptoms that will be included in the disclosure, with the percent of patients reporting each symptom also included. The company states that many patients have requested this level of transparency, saying it would help them and their doctors understand possible side effects better.