The Pharmaceutical Research and Manufacturers of America (PhRMA) is urging the Biden administration to immediately remove last-minute changes the Trump administration made to the Part D Payment Modernization Model for calendar year 2022.
The changes give participating plan sponsors the flexibility to treat five of the six protected drug classes – anticonvulsants, immunosuppressants, antidepressants, antipsychotics and antineoplastics – as they would other Part D drug classes, meaning they wouldn’t have to cover all the drugs in those classes. Another change would allow sponsors to include just one drug for other drug classes instead of the current requirement for two drugs per class.
In announcing the changes last month, the Centers for Medicare & Medicaid Services said they were intended to reduce beneficiary out-of-pocket costs and overall Part D prescription drug spending. PhRMA disagreed, saying the changes “would ultimately impact the most vulnerable patients, including those with cancer, mental illness and HIV, in the middle of a global health pandemic.”
The trade group said the current six protected classes policy is “one of the most important and successful aspects of the Part D program,” as it ensures that seniors have access to a range of therapies to treat serious health conditions. The group noted that many of the drugs in the protected classes are not interchangeable, with several of them having complex interactions, contraindications, side effects and other factors that must be considered in identifying the best treatment for an individual patient.
Previous proposals to weaken the protected classes have been dropped in the face of opposition from lawmakers, patient groups and disability advocates, PhRMA said.
FDA weighing Xeljanz safety results
Preliminary results from a safety clinical trial showed an increased risk of serious heart-related problems and cancer with the use of Pfizer Inc.’s Xeljanz (tofacitinib) compared with tumor necrosis factor inhibitors, the FDA said Feb. 4.
The agency required the postmarketing safety trial, which also investigated other potential risks with the JAK inhibitor such as blood clots in the lungs and death. Although those final results aren’t available yet, the FDA said it will evaluate the results it’s received to date and will work with Pfizer to get more information as soon as possible.
In the meantime, the FDA said patients should not stop taking Xeljanz without first consulting with their doctor.
Last month, the New York-based Pfizer reported the co-primary endpoint results for the safety study that compared Xeljanz with TNF inhibitors in 4,362 people with rheumatoid arthritis who were at least 50 years old and who had at least one cardiovascular risk factor. The trial missed the co-primary endpoints of noninferiority for major adverse cardiovascular events and malignancies.
EMA initiates OPEN collaboration
The EMA reported Feb. 4 on its OPEN initiative pilot to increase international collaboration on the evaluation of COVID-19 vaccines and therapeutics.
Regulators from Australia, Canada, Japan, Switzerland and the World Health Organization are participating in the pilot under the terms of existing confidentiality arrangements, the EMA said.
The collaboration allows the regulators to share scientific expertise when evaluating COVID-19 vaccines and therapeutics, promoting transparency and building public trust in the products. The pilot is expected to foster better understanding of regulatory outcomes, while retaining the scientific and regulatory independence of the participating agencies, according to the EMA.
NICE evaluating guidance processes
The U.K.’s National Institute for Health and Care Excellence (NICE) Feb. 4 launched the third in a series of public consultations on proposed changes to the processes it uses to develop guidance on drugs, medical devices, diagnostics and digital health technologies.
The proposals outline how NICE aims to focus its health technology evaluations “on not just final guidance as the main ‘output,’ but on moving towards ‘health technology management,’ where support for early development, early advice, adoption, real-world performance and reassessment are targeted to ensuring that the needs of patients and the NHS are front and center in our activities,” said Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Assessment at NICE.
One of the goals is to ensure that the U.K. remains a first-launch country for promising new health technologies.
The consultation will be open until April 15.
TGA seeking comments
Australia’s Therapeutic Goods Administration (TGA) opened two consultations Feb. 4 seeking comments on user fees for the 2021-22 financial year and on obstacles or potential incentives to repurposing prescription drugs for new conditions.
The TGA also said it plans to open a consultation in April on updates to its human tissue specific standards, biologicals labeling standard and the infectious disease minimization standard.
USPTO extends program with Japan’s, Korea’s patent offices
The U.S. Patent and Trademark Office (USPTO) extended the Expanded Collaborative Search Pilot program with the patent offices of Japan and South Korea.
The extended pilot program, which will now end Oct. 31, 2022, allows applicants to request that the three patent agencies exchange the results of their individual searches for prior art before a final action is issued on an application. That could reduce delays and costs.
Each of the participating agencies will accept no more than 400 requests per year per partner office.
NICE recommends Keytruda in NSCLC
NICE issued draft guidance Feb. 4 recommending that Merck & Co. Inc.’s Keytruda (pembrolizumab), in combination with pemetrexed and platinum chemotherapy, be used as a first-line treatment option for people with nonsquamous, non-small-cell lung cancer (NSCLC) whose tumors have no epidermal growth factor receptor-positive or anaplastic lymphoma kinase-positive mutations.
The combination treatment had been available to patients through the Cancer Drugs Fund, where it demonstrated the potential for longer survival. Final guidance is expected in March, according to NICE.
Florida researcher indicted
Lin Yang, a former University of Florida professor and researcher who is now living in China, was indicted on six counts of wire fraud and four counts of making false statements to a U.S. agency.
According to the December grand jury indictment that was unsealed Feb. 3, Yang received a $1.75 million NIH grant to develop and disseminate Muscleminer, an imaging informatics tool for muscles, and served as the principal investigator for the grant at the university from 2014 to 2019.
During that time, he established a business in China and promoted it by saying the products were the result of years of research supported by the U.S. government, according to the U.S. Department of Justice (DoJ). He also was accepted into China’s Thousand Talents Program, a government program that encourages the transfer of ideas, technology and intellectual property from foreign universities.
The indictment alleged that Yang, on multiple occasions, submitted financial disclosures to the NIH that contained false statements and omitted his conflicts of interest and other support related to his business in China, participation in the talent plan and affiliation with a Chinese research university. He also falsely stated in a 2019 University of Florida disclosure that he had no affiliation with any business, entity or university in China.
The maximum sentence for each count of wire fraud is 20 years in prison and a $250,000 fine. Each count of making false statements to a U.S. agency carries a maximum penalty of five years in prison, as well as a $250,000 fine, DoJ said.