From the desk of Mitchell Stein
Good morning. It would be easy to get distracted by the Administration’s ongoing issues, yet the world continues to revolve on its axis, the sun continues to shine (yesterday a bit too warmly if you ask me) and the world of prescription drugs continues to function. So I persevere, sharing the news of interest while sneaking glances at Twitter. With that in mind, this week we’ll look at:
ICER in the news – Patient engagement, Atopic Dermatitis revised evidence report, value pricing and adherence, and coverage of the ADO draft report
Inside the Beltway – FDA user fee reauthorization bill (2 stories), the Gottlieb era begins (2 stories), NIH funding, and backlash re Price’s comments on MAT
Industry Trends – Recent upheaval in world of immuno-oncology, Amazon considers the online pharmacy business, insulin pricing, David Mitchell & Patients for Affordable Drugs, and docs don’t talk costs w/ cancer patients
Company/Drug Specific – Sanofi’s Zika vaccine and Bayer’s blood cancer drug
Weekly View In-depth – Several pharma marketing stories
Now, on to the news.
ICER In The News
ICER’s Chief Medical Officer Dr. David Rind and Chief Operating Officer Sarah Emond wrote a piece for AJMC.com outlining how ICER works with patients.
ICER has released an Evidence Report assessing the comparative clinical effectiveness and value of dupilumab and crisaborole for the treatment of atopic dermatitis. This Evidence Report will be the subject of the upcoming public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) on May 25, 2017. The release was covered in thepharmaletter (subscription required).
Dan Ollendorf, ICER’s Chief Scientific Office is quoted in this article on value-pricing and adherence: “If the price is too high at the outset, then even if an arrangement looks good and makes sense as a way to demonstrate how a product is working, it may not be the value demonstration that it is cracked up to be.” This is part of BioPharma Dive’s spotlight issue on adherence: Biopharma Dive Spotlight: ADHERENCE
In the summer of 2015, two new cholesterol-lowering medicines launched to high expectations, demonstrating impressive efficacy in high-risk patients. The drugs, Repatha (evolocumab) from Amgen and Praluent (alirocumab) from Sanofi and Regeneron, were the first in a class of treatments known as PCSK9 inhibitors.
A story on ICER’s release of the the Draft Evidence Report covering abuse deterrent opioids.
By Pat Anson, Editor In 2013, the U.S. Food and Drug Administration put drug makers on notice that they should speed up the development of abuse deterrent formulas for opioid pain medication. “(The) abuse and misuse of these products have resulted in too many injuries and deaths across t
Inside the Beltway
Weekly View favorite Rachel Sachs takes a detailed look at the user fee reauthorization bill that cleared the Senate HELP committee last week and the House Energy & Commerce health subcommittee on Thursday.
May 15, 2017 On Thursday, May 11, the Senate Committee on Health, Education, Labor and Pensions marked up the proposed Food and Drug Administration (FDA) user fee reauthorization bill and voted 21-2 to advance it to the full Senate. The bill would reauthorize the fee system for the FDA’s approval of drugs, medical devices, generic drugs, and biosimilars.
The Administration wants to change the user fees already negotiated, however, there seems to be little appetite in Congress for the change.
Two publications take a look at the beginning of the Gottlieb era at the FDA.
FDA commissioner Scott Gottlieb sets some goals: Find ways to lower drug prices, use new tech to speed development
Scott Gottlieb started his first full week as FDA commissioner by laying out some goals and guidelines for the agency now under his direction, hoping to alleviate some concerns he’s been hearing about the future. In an all-hands speech to staff on Monday, Gottlieb reiterated some now familiar themes on
NIH funding seems to be secure for now.
Lawmakers are making clear that they have no intention of carrying out President Trump’s proposal to decrease funding for the National Institutes of Health (NIH), the nation’s medical research agency. In a hearing Wednesday, Rep. Tom Cole (R-Okla.)
The scientific community is aghast at Secretary Price’s comments on medication-assisted treatment for opioid addiction. (Need a review of the scientific evidence showing it works? ICER has a report for that.)
Addiction experts are up in arms over remarks by Health and Human Services Secretary Tom Price in which he referred to medication-assisted treatment for addiction as “substituting one opioid for another.” Nearly 700 researchers and practitioners sent a letter Monday communicating their criticisms to Price and urging him to “set the record straight.”
The phrase “crazy 2 weeks” could have a lot of meaning, but this article focuses on immuno-oncology, not that other stuff.
It’s been just a couple of weeks since we wrote up AstraZeneca’s Imfinzi approval in bladder cancer. But so much has happened in the immuno-oncology field over that short stretch that, frankly, we at FiercePharma aren’t sure we even recognize the field anymore.
Is being an online pharmacy next up for Amazon? What impact could that have on the market?
Investors sold off shares of pharmacy giant CVS Health and Walgreens on Wednesday amid renewed speculation that Amazon would enter the business of selling prescription drugs. CVS and Walgreens shares had dropped more than 3 percent just ahead of closing on Wednesday.
An in-depth look at insulin pricing.
Diabetics need insulin to stay alive. Increasingly, they can’t afford it.
Marketplace profiles David Mitchell who started Patients for Affordable Drugs.
David Mitchell loves to sing. He thought he may spend his retirement with the National Philharmonic chorale. Or maybe head back to school to become a professor. Ultimately, Mitchell decided to use his voice differently. He’s started a national organization, Patients for Affordable Drugs, to channel the public’s growing frustration about high drug prices and campaign to make them more affordable.
While we discuss the cost of drugs all the time, often doctors don’t mention cost at all – this study looked at interactions between physicians and cancer patients.
Concern over potential pricing of Zika vaccine after much of the development was supported by federal funds.
anofi Pasteur has rejected a request from the US Army to set an affordable US price for a Zika virus vaccine that the company is developing with American taxpayer funds, prompting an angry response from Senator Bernie Sanders.
Bayer received priority review status for its blood cancer drug Copanlisib.
FRANKFURT, Germany German drugmaker Bayer won the U.S. Food and Drug Administration’s priority review status for an experimental drug for a difficult to treat type of blood cancer, bolstering its development pipeline.
Weekly View In-depth
Creating awareness, or creating artificial demand?
An overhead light drawing attention to his face, actor Danny Glover starts to cry, dropping his head into one hand – then, he abruptly switches over to deep belly laughs, before resuming a straight face.
Detailing is an effective form of marketing…
Points for originality, and insidiousness.
The long-running show wrote a rare disease into its plot at the behest of a pharmaceutical company.