Articles
Real-World Evidence, Digital Health, Insurance Coverage Reforms On Cures 2.0 Agenda (11/25, Derrick Gingery, Pink Sheet) reports “...All three areas need work following enactment of the original 21st Century Cures Act, authors Fred Upton and Diana DeGette write in vision statement...The document did not provide more detail on the RWE issues that could be addressed...Indeed, the proposed changes that could emerge as the bill is formulated will be interesting to watch. Many questions about RWE remain unanswered, especially with the FDA still gaining confidence in the usefulness of the data for regulatory purposes.” Paid Subscription Required
Upton and DeGette Begin Work on Cures Act Reprise (11/25, Michael Mezher, Regulatory Focus) reports “...In the vision for Cures 2.0, the biggest area that would impact FDA is a proposal to build on the RWE provisions of the first Cures, which called on FDA to develop a framework and issue guidance on RWE. ‘We would like to build on our initial RWE work, both at FDA and across the federal health care landscape,’ DeGette and Upton write.” Full
Payers Slow to Adopt Real-World Evidence in Rare Diseases (11/26, Laura Joszt, The American Journal of Managed Care) reports “...‘Our research reveals that payers are positively disposed to use RWE, but knowledge gaps around the validity and value of RWE must be closed to improve access for rare disease patients,’ Alistair Macdonald, chief executive officer of Syneos Health, said in a statement. ‘Multistakeholder feedback points to the need for collaborative, well-structured exercises and standard-setting for payers to advance at the same velocity as other industry stakeholders. Dialogue is key, and the time to facilitate these conversations is now.’” Full
ICER Gets on Board with AbbVie's Rinvoq for RA but Frets over 'Fair Pricing' of Next-Gen Drugs (11/26, Arlene Weintraub, Fierce Pharma) reports “...ICER determined that Rinvoq offers ‘a small to substantial net health benefit’ over AbbVie's older RA drug, Humira, according to a statement. Thus, a value-based price for the drug would be $44,000 to $45,000. Rinvoq's list price is $59,860, but if AbbVie is offering typical rebates and discounts, ICER said, the drug would end up in the value-based range. ICER also said that Xeljanz offers a clinical benefit over Humira, but that it lacked the data necessary to assess Olumiant's usefulness as a treatment.” Full
The Health Insurance System Would Collapse If Everyone Picked the Right Plan (11/26, Peter A. Ubel, The Washington Post) comments “...Well-designed co-pays can make it less likely that people seek unnecessary medical interventions. Ideally, Congress would push for coverage built on the idea of reducing co-pays for necessary, high-value services (such as statins, for people with a history of heart disease), while increasing co-pays for medical care of dubious value (such as MRIs for simple low-back pain) — an approach known as ‘value-based insurance design.’” Full
Video: Improving Patient Adherence (11/26, The American Journal of Managed Care) “A discussion on patient adherence and how to help improve compliance.” View Video
How a Billionaire Couple Greased the Skids for Nancy Pelosi's Drug Pricing Bill (11/26, Lev Facher, STAT) reports “...In the eyes of the drug industry, however, the Arnolds' deadliest sin comes in the form of grants worth $19.1 million to the Institute for Clinical and Economic Review. The Boston nonprofit's empirical value assessments have called into question the high price tags on a number of new drugs — and many pharmaceutical industry figures view those empirical value assessments as a gateway to more direct price-setting.” Full
UK: Mavenclad Granted Accelerated Access by NICE (11/26, Anna Smith, PharmaTimes) reports “Merck has announced good news for some multiple sclerosis patients, as its Mavenclad (cladribine) has been given a National Institute for Health and Care Excellence guidance update. The organisation's Technology Appraisal Guidance (TAG), which is effective immediately, will soon state that the MS drug can be used as an option for treating highly active versions of the disease in adults without the requirement of a gadolinium-enhanced MRI scan.” Full
Press Releases
ICER Releases Evidence Report on JAK Inhibitors to Treat Rheumatoid Arthritis (11/26, ICER Press Release) “The Institute for Clinical and Economic Review today released an Evidence Report assessing the comparative clinical effectiveness and economic value of JAK inhibitors for treating rheumatoid arthritis. These therapies include upadacitinib (Rinvoq®, AbbVie), tofacitinib (Xeljanz®, Pfizer), and baricitinib (Olumiant®, Eli Lilly).” Full