From the desk of Mitchell Stein
Good morning. Lots to cover today (isn’t there always), but first a public service announcement: Tomorrow (Saturday 4/28) is a national prescription drug take-back day. I’ve highlighted these in the past, but tomorrow’s promises to get more attention than ever as Google prepares to feature it on its homepage and maps due to the ongoing opioid crises and the benefits of people getting unneeded drugs out of their homes. Don’t be the cobbler whose children go unshod – if you have unneeded drugs at home, take advantage of the opportunity to get rid of them tomorrow. Now on to the news where this week we’ll look at:
ICER in the news – Topic announcement on Asthma, draft scoping document on medication-assisted treatments for opioid use disorder, NY state board seeks rebate based on ICER’s work, more on ICER’s work re Keytruda and CAR-T (2 stories), and migraine developments
Inside the Beltway – President’s drug policy (speech change and policy review), FDA developments (2 stories), PhRMA lobbying, proposed 340B changes, right-to-try legislation update (2 stories), states accelerate drug price work (2 stories)
Industry Trends – SCOTUS on patents, charges near for generic firms, drug price strategy review, Europe’s drug price benchmarks, pharma 1st quarter profits, a look at hereditary angioedema, selling clinical trials crosses a marketing line, suggestions for Part D cost escalation, docs in front of the evidence on immunotherapy, an implantable chemo pump works but may be discontinued, a look at survival odds
Company/Drug Specific – Takeda/Shire marriage, Fresenius/Akorn divorce, Biogen, Glaxo, and AstraZeneca
Weekly View In-depth – Migraine market developments
Now, on to the news.
ICER In The News
ICER announced plans to develop a review assessing the comparative clinical effectiveness and value of biologic therapies for moderate-to-severe asthma. The report is set to be reviewed during a November 2018 public meeting of the Midwest Comparative Effectiveness Public Advisory Council. ICER’s report is expected to include five therapies: dupilumab (Dupixent®, Sanofi/Regeneron), omalizumab (Xolair®, Genentech/Novartis), mepolizumab (Nucala®, GlaxoSmithKline), reslizumab (Cinqair®, Teva), and benralizumab (Fasenra™, AstraZeneca). The announcement was covered in The Pharma Letter: Asthma biologics to come under ICER microscope.
Institute for Clinical and Economic Review to Assess Biologic Treatments for Asthma in Upcoming Assessment
ICER has posted a Draft Scoping Document outlining a planned review of the comparative clinical effectiveness and value of several newer options for medication-assisted treatment (MAT) of opioid use disorder. ICER’s upcoming review is expected to assess a recently-approved monthly buprenorphine injection (Sublocade™, Indivior), a buprenorphine implant (Probuphine®, Braeburn/Titan), and an investigational buprenorphine extended-release injection (CAM2038, Braeburn) currently under review by the FDA. These new therapies will be compared to medications commonly used in MAT such as methadone, buprenorphine/naloxone sublingual film (Suboxone®, Indivior), and injectable naltrexone (Vivitrol®, Alkermes).
Institute for Clinical and Economic Review Posts Draft Scoping Document on Medication-Assisted Treatments for Opioid Use Disorder
In a meeting filled with firsts, the NY Drug Utilization Review Board voted unanimously that the state’s Medicaid program should pay under $57 per unit for Orkambi (Vertex Pharmaceuticals CF drug). The target price was derived from ICER’s work on the topic and is based on the price threshold utilized in ICER’s work of $150,000 per QALY. This is the first use of a new state law meant to help lower drug costs of the Medicaid program and the first time a state entity used an evidence-based approach to get to the appropriate price for a drug. After the meeting, Vertex essentially said no dice, the price currently paid by NY is fair (I may be paraphrasing a little). So stay tuned, lots more to come. In addition to the article below, the meeting was also covered by STAT Plus (subscription required): New York panel votes to lower the cost of a pricey Vertex drug for cystic fibrosis.
ALBANY – The state Drug Utilization Review Board on Thursday recommended Medicaid pay just under $57 per unit for Orkambi, a cystic fibrosis drug made by Vertex Pharmaceuticals that lists for more than $186 per unit.
A look at Keytruda, lung cancer, and CAR-T therapies includes discussion of ICER’s work.
Image courtesy of Merck When Edith Pelka was diagnosed with advanced non-small cell lung cancer last summer, the retired New York nurse, yoga instructor, and self-described “straight shooter” thought her life was over.
Report on new JAMA paper regarding the true cost of CAR-T therapy references ICER’s work.
Patients treated with chimeric antigen receptor T-cell therapy will incur on average $30,000 to $36,000 in additional costs aside from drug expenses, according to a research letter published in JAMA Oncology.Patients who present with severe cytokine release syndrome may pay up to $56,000 more.
For more ICER related stories see “In-Depth” below where this week’s topic is migraine market developments.
Inside the Beltway/State Regulatory Developments
The President’s speech on drug pricing has been delayed until May 8. In advance of the speech, Kaiser took a look at the rhetoric vs. the reality of the Administration’s policy on drug pricing.
This story also ran on This story can be republished for free ( USA Today. details). President Donald Trump has railed against the high price of prescription drugs and famously bemoaned how pharmaceutical companies are “getting away with murder.” Yet, many Americans aren’t seeing a change in what they pay out-of-pocket.
The FDA continues its breakneck pace of innovations (2 articles).
Digital health is taking the stage at the US Food and Drug Administration (FDA). From the launch of a premarket digital safety program and an internal data science incubator, to the release of drafted policies for multi-function device products and a working model for FDA’s digital health Pre-Certification program, Commissioner Scott Gottlieb left audience members in a daze with a plethora of announcements at the Health Datapalooza conference Thursday.
The Food and Drug Administration (FDA) is moving to encourage the use of artificial intelligence (AI) in health care, the agency’s chief said Thursday. “AI holds enormous promise for the future of medicine,” FDA Commissioner Scott Gottlieb said in prepared remarks to the Health Datapalooza conference in Washington, D.C.
Lots of spending on lobbying by PhRMA (and everyone else, but this article is mostly about PhRMA).
The drug industry set several quarterly records for lobbying spending in the first three months of 2018 as it faced pressure from President Donald Trump’s administration and lawmakers on drug pricing, generic medicines and trade. The Pharmaceutical Research and Manufacturers of America spent $9.96 million on federal lobbying, according to disclosures filed Friday with the government.
Another bill introduced to increase reporting for hospitals participating in the 340B program.
Congressman Earl Carter (R-Ga.) introduced legislation Tuesday to increase transparency into the 340B drug pricing program by requiring hospitals to report low-income utilization rates for outpatient services, as well as for inpatient services in the main hospital and child sites.
We haven’t heard the last of the right-to-try legislation as supporters plan a large media campaign.
WASHINGTON – The Koch-backed group Americans for Prosperity is pouring hundreds of thousands of dollars into a renewed push for federal “right-to-try” legislation that aims to give terminally ill patients a new way to access experimental therapies.
Or have we?
Advocates for White House-backed legislation intended to make it easier for sick patients to get access to experimental drugs are frustrated, believing that congressional momentum behind “right to try” has ground to a halt.
States accelerate their activity to reign in drug costs. Two articles, first from The Hill, then a piece by NASHP’s Executive Director Trish Riley.
Congress hasn’t done much to rein in the costs of prescription drugs, so states are taking matters into their own hands. While lawmakers have railed against pharmaceutical executives and accused them of jacking up prices, they haven’t passed major legislation on the issue.
As the country awaits the Administration’s plan to curb Rx drug costs, states take the lead, proposing and passing legislation to lower costs, despite industry opposition. As we await the details of President Trump’s proposals to curb escalating drug prices, states are continuing to push legislation to lower the cost of prescription drugs, despite the strong headwinds of industry opposition.
What does a patent case about a piece of oil drilling equipment have to do with pharma? Turns out a lot; the Supreme Court upheld the constitutionality of the IPR process (administrative patent reviews) in a 7-2 decision.
WASHINGTON (Reuters) – The U.S. Supreme Court on Tuesday gave its stamp of approval to a government review process prized by high technology companies as an easy and cheap way to combat “patent trolls” and others that bring patent infringement lawsuits. The justices ruled 7-2 that a type of in-house patent review at the U.S.
In a different type of court case, charges seem to be near for some generic drug manufacturers in the ongoing investigation into price fixing.
U.S. prosecutors are nearing their first charges against companies in an almost four-year-old criminal investigation into alleged price-fixing by generic-drug makers, according to people familiar with the matter. At least two companies are on track to be indicted in the coming months, in addition to several executives, said two people, who spoke on condition of anonymity because the investigation is confidential.
Axios’s Sam Baker looks at the various strategies to reduce drug prices currently in play.
President Trump’s upcoming speech on drug prices will probably stick to small-ball ideas. But small-ball doesn’t necessarily mean no impact. Reality check: There are a lot of legitimate ways to bring down drug costs; there are also a lot of empty gestures masquerading as real change.
Complex drug pricing strategies are not unique to the US.
If you want to conquer Europe, start from the north. That’s the winning strategy many pharmaceutical companies are using to lock in the highest prices for new medications across the Continent.
Meanwhile, pharma profits soar.
Mike Pompeo, who was confirmed as Secretary of State today, will visit Israel on Sunday as part of his first trip in this new role, Israeli officials told me and a senior State Department official has confirmed.
An in-depth look at a patient with hereditary angioedema, the drugs she takes, and how they get paid for by private insurance (which is paid for by patient charities funded by pharma). To quote Twitter user Steve Joffe (@SteveJoffe) “One could teach an entire health policy class from the article, identifying everything that’s wrong with our health care system and the social context in which it sits.” ICER will look at treatments for this condition in an upcoming review.
There is a lot of money in cancer treatments – does that motivate some centers to cross the line with their marketing?
n a promotional video, the MD Anderson Cancer Center advertises clinical trials alongside immunotherapy and proton-beam therapy as one of its many ways of “fighting cancer.” Cancer Treatment Centers of America promotes clinical trials as part of its “commitment to bringing our patients new and innovative cancer treatment options.”
Here’s one idea on how to reduce Medicare Part D drug costs.
Some doctors role the dice with immunotherapy despite the (very) long odds.
Dr. Oliver Sartor has a provocative question for patients who are running out of time. Most are dying of prostate cancer. They have tried every standard treatment, to no avail. New immunotherapy drugs, which can work miracles against a few types of cancer, are not known to work for this kind.
An implantable chemo pump is being discontinued – what happens to patients who could benefit?
“They’ve increased survival more than anything else in this disease,” Dr. Kemeny said. At least 10 operations to implant the pump at Sloan Kettering have been postponed, according to Dr. Michael D’Angelica, a liver surgeon at the hospital. Other medical centers have also advised patients with advanced cancer that the pump may no longer be an option.
We often deal with broad population-based statistics. But how does that translate for individuals? This column looks at survival odds. (Take this as your periodic reminder that everything we talk about impacts individuals who are often facing grave personal circumstances.)
Takeda seems close to a deal to buy Shire for $65 billion. However, markets are not thrilled at the prospect, driving down Takeda’s share price.
UPDATED: Can Takeda actually close its $65B deal to buy Shire? Maybe, but analysts aren’t sure they should
Takeda has upped its offer to buy Shire $SHPG for a mix of stock and cash worth close to $65 billion, which is good enough for the Lexington, MA-based biotech to extend the deadline on their talks to May 8 after determining they were close to finalizing a pact. Late
Calling off a four billion dollar deal could get messy.
A year after inking its $4.3 billion Akorn buyout agreement, Fresenius plans to scrap the deal, citing “material breaches of FDA data integrity requirements.” Akorn, though, isn’t having it, and analysts are skeptical, too. The upshot? A “legal battle royale” could be on the horizon.
One billion dollar deal includes an immediate $375 million upfront payment.
Biogen Inc. will hand $1 billion in cash to Ionis Pharmaceuticals Inc., betting in a wide-ranging research deal that the biotech, which developed the rare disease drug Spinraza, can discover other blockbuster medicines like it.
A generic version of Advair won’t make it to market in 2018.
Novartis’ prospects for launching a copy of GlaxoSmithKline’s Advair this year just went from highly unlikely to not happening. Rejected by the FDA earlier this year, the copycat needs a small bridging study before the agency can take another look, CEO Vas Narasimhan said.
Bad lung cancer news for AstraZeneca.
A closely watched drug combination of AstraZeneca plc’s immunotherapies Imfinzi and tremelimumab fell short of its goal in a Phase 3 study of previously treated lung cancer patients, likely narrowing the regimen’s future potential and raising the stakes for a key trial readout later this year.
Weekly View In-depth
Migraine market developments
The migraine drugs discussed are currently being reviewed by ICER.
These two looks at Amgen’s results include discussion of ICER’s work on the topic that was brought up on Amgen’s quarterly earnings call.
Amgen Inc.’s first quarter 2018 revenue increased 2% from the year-prior quarter to $5.6 billion. Net income came in 12% higher at $2.3 billion. New and recent launches, including Repatha (evolocumab), Kyprolis (carfilzomib), Prolia (denosumab) and Xgeva (denosumab) have shown double-digit growth. “We’re looking forward to launching Aimovig, our first neuroscience therapeutic.”
Amgen’s migraine drug Aimovig isn’t even approved by the FDA yet, but questions about its insurance coverage overshadowed the company’s better-than-expected quarterly earnings. One reason why, perhaps? Pharmacy benefits manager Express Scripts is urging the company to rethink its expected $8,000 to $10,000 list price.
Express Scripts looks to upend pharma manufacturers’ current pricing strategy starting with the new migraine entrants: ““If your expectation is that you are not going to actually get that high list price, then don’t do that to patients who have high co-pays,” Chief Medical Officer Steve Miller said in an interview, describing his message to Amgen and its rivals.”
LOS ANGELES (Reuters) – The largest U.S. manager of prescription benefits is telling drugmakers that the current pricing model is broken, and taking aim at Amgen Inc, Eli Lilly and Co and other makers of new migraine medicines to try and fix it.