From the desk of Mitchell Stein
Good morning. Did you hear there was an election this week? Well, there was, and the changes it brings may have an impact on pharma. We’ll take a look a look at several pieces discussing the ramifications as well as the rest of the week’s news. Here’s the full lineup:
ICER in the News – Novartis talks $5 million drug and researchers researching the researchers
Inside the Beltway – Election coverage (special section), new opioid approved, and the FDA’s office of criminal investigation
Industry Trends – CVS/Aetna moves forward, priority review voucher price drop, AbbVie tax savings, and Alzheimer’s news (2 stories)
Now, on to the news.
ICER in the News
Novartis referenced ICER’s work on other drugs when stating that the company’s forthcoming gene therapy to treat spinal muscular atrophy is worth $4 to $5 million. An Endpoints story is below; there was also similar coverage in Pharmaphorum.
In Health Affairs this week, a group did research on ICER, which happens to be a group that does research – meta enough for you? Peter J. Neumann, ScD, director of the Center for the Evaluation of Value and Risk in Health, along with Madison C. Silver and Joshua T. Cohen (who also work at the Center) took a look at the collective results of ICER’s value assessments. The piece concludes with this statement: “ICER’s reports help to inform that discussion and provide a laboratory to explore the profound economic, social, and ethical issues involved in how much we pay for prescription drugs.”
Should A Drug’s Value Depend On The Disease Or Population It Treats? Insights From ICER’s Value Assessments
A central question facing ICER – and by proxy all of us as health plan enrollees, taxpayers, and patients – is whether a drug’s value should depend on not only its “generic benefit” – e.g., as measured by quality adjusted life years (QALYs) gained – but also on which disease or population it treats.
Inside the Beltway/State Regulatory Developments
So about that election… Lots being written about the impact on health care in general and pharma specifically. Let’s take a look:
Right away, Senate Majority Leader Mitch McConnell says that drug prices are on the agenda, and he will work with the new Democratic leadership in the House (Bloomberg).
Past and potentially future Speaker of the House Nancy Pelosi seemed to echo those sentiments (The Hill).
Despite the initial statements, real questions remain if this will come to pass.
Writing in Axios, Drew Altman goes so far as to say, “No new health legislation of any significance will pass in this Congress. “
On the state level, NASHP takes a look at the possible ramifications of the elections. About halfway down is a section focused on pharmacy issues.
Ned Pagliarulo, writing in BioPharma Dive provides one of the best summations I’ve seen. He doesn’t think this week’s words of Kumbaya will last, but he does expect to see some state activity.
Now, on to the rest of the news.
To the dismay of some, the FDA approved a new, powerful opioid. NPR reports on the objections and the explanations provided by FDA chief Scott Gottlieb after the approval.
Critics, including some leading anesthesiologists, say the drug is unnecessary, and they worry it will be diverted and abused. The Food And Drug Administration says it is addressing safety concerns.
I had no idea there was an office of criminal investigations in the FDA. For those who did know, some support the mission, but some find it out of place. STAT takes a look.
The FDA’s criminal investigations team investigates counterfeit drugs with raids and search warrants, much like their counterpart agents at FBI and DEA.
According to FierceHealthcare, CVS expects its Aetna deal to close shortly. There are also indications the company will experiment with different PBM models once the acquisition is complete.
CVS Health said it expects to finalize its $69 billion acquisition of Aetna by Thanksgiving, noting that five states are close to approving the deal. Executives also hinted that the company is rethinking its PBM model to place a greater emphasis on drug mix.
The price of priority review vouchers is plunging. BioPharma Dive reports that, from a high of $350 million, the most recent one was sold for “only” $80 million
FiercePharma reports that AbbVie got an early Xmas present stemming from the corporate tax cut: “In the first nine months of 2018, the Illinois pharma has paid just 4.5% of the income taxes it shelled out the same period last year.”
AbbVie is known as one of the largest pharma beneficiaries of the U.S. tax reform. Just how much has it gained? Over the first nine months of 2018, the Illinois pharma has paid just 4.5% of the income taxes it shelled out over the same period last year.
A new Alzheimer’s prize was announced this week (STAT). It comes just as Eli Lilly announced the company was completely stopping work on its BACE program (Endpoints).
A Texas businessman who lost family members to dementia will reward combing the scientific literature and synthesizing one explanation of the disease.
Eli Lilly sweeps the rest of the BACE work out of the pipeline following their latest major setback on Alzheimer’s
Eli Lilly has suffered through the biggest setbacks in late-stage drug development work for Alzheimer’s – piling up high-profile failures for semagacestat, solanezumab and just months ago lanabecestat after it became apparent that the BACE approach was a non-starter in symptomatic patients. Today, it’s signaling that the company is now