Efforts to advance bipartisan drug pricing legislation continued in Washington March 16 with a new Congressional Budget Office cost estimate that finds an updated version of the bipartisan Prescription Drug Pricing Reduction Act would reduce out-of-pocket drug spending by $72 billion, diminish premiums by $1 billion, and save taxpayers nearly $95 billion by 2030. "Americans are tired of talk and are ready for action," said Senate Finance Committee Chairman Chuck Grassley (R-Iowa), a co-author of the bill with Ranking Member Ron Wyden (D-Ore.).
The Institute for Clinical and Economic Review (ICER) posted draft scoping documents for bladder cancer and digital apps for opioid use disorder. The document for bladder cancer treatments outlines the planned review of the comparative clinical effectiveness and value of two proposed therapies to treat Bacillus Calmette-Guerin (BCG)-unresponsive, non-muscle invasive bladder cancer. Instiladrin (nadofaragene firadenovec, FKD Therapies Oy/Ferring Pharmaceuticals SA) uses the polyamide surfactant Syn3 to enhance transfer of the recombinant adenovirus into cancer cells. Vicinium (oportuzumab monatox, Sesen Bio Inc. ) is a recombinant fusion protein with a humanized anti-epithelial cell adhesion molecule, or EpCAM, single-chain antibody linked to Pseudomonas exotoxin A. The review will compare the candidates to each other and to Intravesical therapy with gemcitabine with or without docetaxel and to the checkpoint inhibitor Keytruda (pembrolizumab, Merck & Co. Inc.), approved by the FDA in the indication. The ICER review will examine evidence on patient-important outcomes such as quality of life, mortality, cystectomy, metastatic disease, recurrence requiring repeat treatment, sexual function and adverse events along with other outcomes such as progression-free survival, complete response and disease-free and event-free survival. The document for digital apps used for opioid use disorder outlines the planned review of the comparative clinical effectiveness and value of the reSET-O app (Pear Therapeutics Inc.) used in conjunction with best supportive care, including medication-assisted treatment. Intermediate and short-term outcomes of interest include short- and long-term abstinence from misuse and abuse of opioids; diminishing illicit use of opioids; opioid withdrawal syndrome; infectious, injection reactions and other complications from continued use of injectable opioids; functional and mental health outcomes; opioid craving/desire; and accidental pediatric exposure. Other patient-reported outcomes include adherence/treatment discontinuation and key outcomes to patients such as mortality and health-related quality of life. ICER encouraged stakeholders to submit comments to the documents by 5 p.m. Eastern time on April 2, 2020, by emailing email@example.com. In addition to such comments, ICER is accepting stakeholder submissions on examples of low-value care practices within both clinical areas to inform sections in each report on strategies to reduce waste and preserve resources for high-value, potentially higher-cost treatments. Following the comment period, ICER expects to post a revised scoping document for each review around April 10, 2020.