The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 7-5 Tuesday in support of the risk-benefit assessment for Astrazeneca plc’s Lynparza (olaparib) tablets as a maintenance treatment for adults with metastatic pancreatic ductal adenocarcinoma who have germline BRCA-mutations (gBRCAm) and whose disease has not progressed on first-line platinum-based chemotherapy. Panelists supporting approval noted the unmet need in the patient population and the duration of response to the drug, which was a median of 24 months, with potential for a longer response for certain patients in the ongoing POLO trial. Another plus ODAC members cited is that some trial participants were able to pause or discontinue their chemotherapy treatment while taking Lynparza. Approved to treat patients with gBRCAm advanced ovarian and other cancers, Lynparza is already being used off-label, at substantial cost to patients, to treat gBRCAm metastatic pancreatic ductal adenocarcinoma. Approving the drug for the indication would ease the cost burden for patients, some panel members said. ODAC members who didn’t support approval noted a lack of overall survival (OS) data thus far and pointed out that overall quality of life was not demonstrated, an important factor especially in the absence of OS as an endpoint. They also expressed concern that patients would choose to take Lynparza first rather than chemotherapy, which could impact OS. Astrazeneca, of Cambridge, U.K., said it expects to have additional OS data available by the end of next year. Later in the day, ODAC voted 9-4 to recommend approval of Merck & Co. Inc.’s Keytruda (pembrolizumab) as a treatment of patients with bacillus Calmette-Guérin-unresponsive, high-risk, non-muscle-invasive bladder cancer. Panelists on both sides of the vote indicated they struggled with their decision, given the limited data from a small, single-arm trial. Some of those voting for the new indication said they found the response data clinically meaningful. Those voting against approval said the data was too early and longer follow-up is needed.
Results from a months-long survey of 400 pharmacies across the U.S. showed Eli Lilly and Co.’s launch of an authorized generic of Humalog (insulin lispro) earlier this year is having little impact on patient out-of-pocket (OOP) cost for the drug, mainly because the generic is not widely available. According to a report from Sens. Elizabeth Warren (D-Mass.) and Richard Blumenthal (D-Conn.), 83% of the pharmacies surveyed did not have the less expensive, authorized generic in stock. In 14 states, none of the pharmacies surveyed had the generic, and in 17 states, the generic was available in only one surveyed pharmacy. Additionally, 69% of the pharmacies that didn’t have the generic in stock indicated they couldn’t order the drug. Even when pharmacies have the generic, they may not proactively offer it to consumers. Only half of the pharmacies with the generic in stock offered it as a first option for consumers. The report faults Indianapolis-based Lilly for apparently failing “to take basic steps, such as educating patients and pharmacists about the authorized generic or working with supply chain partners to properly stock pharmacies, in order to make the lower cost version more accessible.” It adds that the “authorized generic, rather than expanding access to low-cost insulin, appears instead to be a public relations move intended to ease scrutiny on the rising price of insulin.” The report concluded that the survey findings raise questions about the ability of authorized generics to deliver real savings and said that Congress ultimately must enact systemic change to reduce the costs of drugs nationwide.
Despite a pressing deadline, the U.S. Congress has yet to address consequences of its previous action that will raise OOP costs for some Medicare Part D beneficiaries by $1,250 next year. Under the current Part D program, once beneficiaries hit the annual OOP threshold of $5,100, they pass in to catastrophic coverage, which allows them to pay significantly less for prescription drugs. But under the congressional design of the program, that threshold is scheduled to increase to $6,350 in January. A letter from 72 health organizations to House and Senate leadership pointed out that more than 1 million Medicare beneficiaries exceeded the $5,100 threshold in 2017. Citing initial estimates, the groups said if Congress fails to act on the issue, the higher threshold will increase prescription drug costs next year by more than $2 billion for people with Medicare.
The EMA and its European and international partners launched a pilot program to increase their cooperation in the inspection of manufacturers of sterile drugs. The collaboration will allow the EMA, EU national authorities, the U.S. FDA, Australia's Therapeutic Goods Administration, Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency and the World Health Organization to share information on good manufacturing practice (GMP) inspections of manufacturing sites outside the participating countries and to organize joint inspections for manufacturing sites of common interest. The pilot program, which will last for at least two years, will focus on sterile chemical drugs and certain biologics, including monoclonal antibodies and recombinant proteins. It will not include vaccines, cell and gene therapies, and plasma-derived pharmaceuticals.
The U.S. IRS proposed regulations to implement changes made by the Tax Cuts and Jobs Act (TCJA) that would limit publicly held corporate federal income tax deductions for certain employee remuneration that exceeds $1 million. The proposed regulations include numerous examples to illustrate how they will be applied. The IRS will hold a public meeting on the regulations March 9 and will accept comments on the proposal through Feb. 18, according to a notice slated for publication in Friday’s Federal Register.