The U.K.’s National Institute for Health and Care Excellence (NICE) is launching a five-year strategy to provide quicker patient access to new treatments and innovative technologies. The strategy calls for rapid, robust and responsive technology assessments; dynamic guideline recommendations that integrate the latest evidence, technologies and practice; increased use of the guidance, with monitoring and measuring of the impact it has on health outcomes; and the use of real-world data to fill gaps in knowledge and drive patient access to innovations. Noting how COVID-19 has changed the U.K.’s health care landscape, NICE said the “pandemic provided a catalyst for the type of change that we already knew we needed to make.” The goal is to ensure NICE is more proactive and engaged with the life science industry earlier in the innovation pathway so patients will have access to new treatments faster.
Enhertu gets first nod in Europe
NICE issued draft guidance April 20 recommending Enhertu (trastuzumab deruxtecan) for use in the Cancer Drugs Fund as a third-line treatment for HER2-positive breast cancer that can’t be surgically removed or that’s metastatic. The decision makes the U.K. the first European country to cover the drug, which was developed and commercialized by Tokyo-based Daiichi Sankyo Co. Ltd. and Astrazeneca plc, of Cambridge, U.K. NICE cited a lack of clinical trial data directly comparing Enhertu with chemotherapy, which is the current third-line standard of care for such cancers, but concluded “that data from ongoing trials of trastuzumab deruxtecan and from NHS practice would help address the uncertainty about clinical effectiveness.” Final guidance is expected next month.
At-home COVID-19 remedies sought
In the search for drugs that can be repurposed to treat mild to moderate COVID-19 symptoms, the U.S. NIH is funding a large, randomized, placebo-controlled phase III trial evaluating up to seven already approved prescription and over-the-counter medications that can be taken orally or through an inhaler at home. Part of the Accelerating COVID‑19 Therapeutic Interventions and Vaccines (ACTIV) public–private partnership, the ACTIV-6 trial will randomly assign participants to receive either a placebo or one of the treatments, which will be sent to them by mail. Up to 13,500 participants are expected to be enrolled in the trial. They must be at least 30 years old, have tested positive for COVID-19 and have experienced two or more mild to moderate symptoms for no more than seven days. The trial will assess changes in symptoms over a 14-day period and hospitalizations and deaths over a 28-day period. It also will assess long-term COVID-19-related symptoms 90 days after treatment begins. Enrollment is expected to start within a few weeks. “While we’re doing a good job with treating hospitalized patients with severe disease, we don’t currently have an approved medication that can be self-administered to ease symptoms of people suffering from mild disease at home and reduce the chance of their needing hospitalization,” NIH Director Francis Collins said.
Fed Circuit: Appeal based on misreading of court’s decision
Saying it was based on an “erroneous premise,” the U.S. Court of Appeals for the Federal Circuit dismissed an unusual appeal brought by Sebela Ireland Ltd. involving invalidated patent claims related to methods of using paroxetine (Paxil) to treat thermoregulatory dysfunction associated with menopause. Rather than challenging the district court’s decision invalidating several claims in two patents based on obviousness, Sebela asked the Federal Circuit to affirm that decision but to make clear that it didn’t “reach the district court’s findings as to written description and utility,” thus shutting down any alternative invalidity holding based on written description or utility grounds against related patent claims Sebela has asserted in a separate patent infringement action. Sebela misread the lower court’s decision, the Federal Circuit said in its April 20 opinion dismissing the appeal for lack of standing. “While the district court briefly discussed those two potential invalidity grounds, it did so in an inconclusive, contingent manner that did not result in additional, alternative holdings to the obviousness ground for invalidity,” the appellate court added.
Russia expands access to certain pediatric treatments
As part of its Circle of Kindness Foundation, the Russian government approved a process for the purchase of drugs and medical devices, including those not registered in Russia, for a specific child with a serious life-threatening and chronic disease, including rare diseases, or for groups of such children. The government developed a list of products it will cover under the program.