The U.K.’s National Institute for Health and Care Excellence (NICE) published draft guidance Thursday recommending Roche Holding AG’s Kadcyla (trastuzumab emtansine) for some people with HER2-positive early breast cancer. The guidance cited clinical trial evidence showing that Kadcyla increases progression-free survival in people who had cancer cells remaining after chemo was used to shrink their tumor and other HER2-targeted treatment. However, NICE said Kadcyla’s impact on overall survival won’t be known until final trial results are available. To make the drug available in the U.K., Roche agreed to a confidential discount. At its full list price, Kadcyla costs on average of £51,000 (US$63,096) per patient. NICE said its final guidance on Kadcyla is due to be released in June.
The FDA finalized a 2018 draft guidance aimed at helping sponsors develop drugs to treat or prevent cytomegalovirus (CMV) disease in patients who have undergone solid organ or hematopoietic stem cell transplantation. The guidance discusses the overall development program and clinical trial designs for those specific indications. The draft was updated to reflect the current literature on preventing CMV in transplant recipients, to clarify the use of CMV DNAemia as a validated surrogate endpoint for use in certain clinical trials and to clarify that nonclinical combination studies are generally not needed for drugs to be used in combination, according to a notice set for publication in the May 8, 2020, Federal Register.
With many Medicare beneficiaries confined to their homes due to the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) needs to temporarily expand the list of U.S. health care providers eligible to buy, bill and administer Part B drugs, the Pharmaceutical Research and Manufacturers of America (PhRMA) said in a comment this week to an interim final rule CMS released March 30. The rule relies on “physician supervision via telemedicine, but there are limitations with telemedicine that are overlooked,” the trade group said. To give doctors as much support as possible during the public health emergency, PhRMA advised that CMS allow them to refer patients to a nurse practitioner, home health agency, home infusion therapy supplier, durable medical equipment supplier, or other individual/entity such as specialty pharmacies that often employ qualified nurse practitioners. “These entities should be allowed to bill Medicare directly for both the drug and the administration,” PhRMA said. It also recommended that CMS clarify its temporary expansion of coverage of drugs administered through the durable medical equipment benefit under Part B, which covers drugs typically administered in a health care setting. CMS should explain that Medicare “will cover drugs and biologicals that can safely be administered through external infusion pumps (as well as the pumps themselves) for all reasonable and necessary indications, regardless of whether the drugs and indications are currently listed in the external infusion pump [local coverage determination],” PhRMA said.