ICER Weekly View 03-23-18

From the desk of Mitchell Stein

 

Good morning. We have a budget. Early this morning the Senate voted to approve the Omnibus that the House had approved on Thursday (The President is expected to sign later today). From a health care perspective, the surprises are what’s not included in the bill (we’ll take a look below). I also feel compelled to note that it’s officially Spring, although if you are on the East Coast as I am, you probably thought its arrival was just a cruel joke. But like the post office, neither snow nor rain nor heat nor gloom of night stays us from our appointed rounds – which in our case is talking pharma news. This week we’ll look at:

ICER in the news – Dr. Pearson publishes on ICER’s value framework, Luxturna’s first commercial patients, coverage of ICER’s work on nondrug treatments for low back, neck pain, and more on ODYSSEY

Inside the Beltway – Spending bill passes, Right-to-try passes House, New head for CDC, Administration to release beautiful plan on drug prices, transparency database not updated, Creates Act progress stalls, new bill on user fee program for OTC meds

Industry Trends – Drug prices going up, public thinks pharma has too much influence, lots of hospital systems interested in new generic manufacturer, blockbuster list, reciprocal approvals of generics, biosimilars help in Britain but stall in US, a look ahead for immunotherapies, and the potential of mRNA

Company/Drug Specific – AbbVie, GSK, Roche, Pfizer, and CVS

Weekly View In-depth – Shingles vaccine and Alzheimer’s

Now, on to the news.


ICER In The News

Dr. Steven D. Pearson, ICER’s President, published the following article in the peer-reviewed journal Value in Health. The article looks at the distinction between cost-effectiveness and affordability, with the evolution of the ICER value framework used to demonstrate how to address the issue. (Free access until May 9, 2018.)

The ICER Value Framework: Integrating Cost Effectiveness and Affordability in the Assessment of Health Care Value

 

In case you missed it last week, Dr. Pearson co-authored this blog post with Len Nichols and Amitabh Chandra. It is one of three Policy Options Papers examining factors driving prescription drug prices published in Health Affairs.

Policy Strategies For Aligning Price And Value For Brand-Name Pharmaceuticals

 

This week doctors began the first treatments of Luxturna outside of clinical trials. Vox includes a quote from ICER’s Dr. Pearson and discussion of the drug’s price. ICER’s work on the topic can be found here.

Doctors just used a brand new gene therapy to try to save a child’s vision

Jack Hogan has never been able to play baseball because of his poor eyesight. Now 13, Jack was born with a rare genetic disorder that has eaten away at his vision. At night, he’s fully blind, so before dark he has to leave his friends behind and return to his family’shome in Fair Haven, New Jersey.

AJMC reports: With much of the nation talking about alternatives to opioids and other medicines for pain relief, including the possibility of using cognitive and mind-body therapies, ICER recently released a report about 5 interventions for chronic low back and neck pain, as well as the value of those interventions in chronic low back pain.

ICER Finds Some Benefit to Nondrug Treatments for Low Back, Neck Pain

 

More coverage of the ODYSSEY trial and ICER’s updated review based on the results.

ACC 2018: The Skeptical Cardiologist’s Three Practice-Changing Presentations


Pharmaceutical News

Inside the Beltway/State Regulatory Developments

Early this morning (Friday 3/23), the Omnibus spending package passed the Senate after passing the House on Thursday; it will be signed later today by the President. Concerning the drug industry, perhaps the most significant items are those that are not included. Despite industry lobbying, there is no change to the Administration’s plan to close the Medicare Donut hole more quickly, there is also no version of the Creates Act (that would help speed the approval of generics – more on this topic below). So what is included? Donna Young gives us a rundown.

Biomedical research, opioid crisis to get billions under ‘omnibus’ spending bill

On its second try, the House passed the Right-to-Try bill. It now goes back to the Senate who can either vote on this version or go to conference with the House to create a new version (the Senate passed a very different bill earlier). Senator Johnson attempted to get the bill through the Senate by unanimous consent after the Senate voted on the Omnibus. The attempt was thwarted by Democratic objections. When asked, Senator McConnell would not comment on leadership’s plans for the bill. The House version remains unpopular with several constituencies including four former heads of the FDA.

House approves ‘right-to-try’ bill, sending legislation to Senate – STAT

WASHINGTON – House Republicans easily passed a controversial bill aimed at helping some dying patients get new access to experimental therapies Wednesday, resurrecting legislation that suffered a major setback just a week ago. Passage of the bill, on a largely party-line vote of 267-149 , is a step forward for the”right-to-try” movement, after House Republicans failed to pass the legislation last Tuesday.

As expected, Dr. Redfield was appointed head of the CDC despite some questions about his actions earlier in his career. This post does not require congressional approval so, for now, the objections are moot.

Robert Redfield, CDC’s controversial new director, explained

After a major shake-up at the Centers for Disease Control and Prevention with the resignation of its former director over her ownership of tobacco stocks, the Trump administration on Wednesday appointed Robert Redfield, a Baltimore-based virologist and physician, as the agency’s new leader.

The President and HHS Secretary say that plans to reduce drug prices will be “beautiful” and will be rolled out in about a month.

Trump says proposals targeting high drug prices coming soon

The administration will unveil a slate of proposals soon to address high prescription drug costs in the U.S., President Trump Donald John Trump House expected to vote on omnibus Thursday afternoon House passes ‘right to try’ drug bill Spending bill rejects Trump’s proposed EPA cut MORE announced Monday.

Meanwhile, a database introduced to provide more transparency into drug prices has not been updated by the Administration.

Trump admin keeping drug price info under wraps

The database has been instrumental for researchers, journalists and non-profit groups who keep tabs on trends in drug prices and abuses by physicians, and was considered to be a step toward transparency and accountability for an industry that historically keeps its prices in the dark.

Almost everyone wants to see the Creates Act become law – but that almost may be enough to prevent a vote from ever taking place.

Everyone wants to kill this generic drug loophole – except drug makers and some GOP leaders – The Boston Globe

WASHINGTON – It’s so unpopular that lawmakers from both parties and President Trump’s top drug regulator want to kill it. But the pharmaceutical industry, flexing its powerful lobbying muscles, is successfully fighting back efforts to end a loophole that costs taxpayers and consumers billions of dollars a year.

Bipartisan bill introduced to create user fee program for OTC drugs.

Bipartisan House Bill Revives Idea of Creating User Fee Program for OTC Drugs

Posted 20 March 2018 | By Zachary Brennan Representatives from both sides of the aisle introduced a bill late Monday that would create a user fee system to better the US Food and Drug Administration’s (FDA) oversight and approval process for over-the-counter (OTC) drugs.

Industry Trends

So about those drug prices not going up…  turns out, they are.

Drug prices are still going through the roof

Congressional leaders and the White House failed to come to an agreement on temporary protections for Dreamers over the past week as part of the giant spending bill, leaving the issue unresolved. Why it matters: After all of the fighting over President Trump’s decision to end DACA – including a government shutdown over it – the White House and Congress ended up with nothing.

A new Kaiser tracking poll is out this morning. Interestingly, despite recent events, people still feel the pharmaceutical industry has more power in DC than the NRA.

Poll: Americans Aghast Over Drug Costs But Aren’t Holding Their Breath For A Fix

The recent school shootings in Florida and Maryland have focused attention on the National Rifle Association’s clout in state and federal lobbying activities. Yet more than the NRA or even Wall Street, it’s the pharmaceutical industry that Americans think has the most muscle when it comes to policymaking.

Nearly one-third of the country’s hospital systems are now involved in this non-profit’s effort to produce generic drugs. An idea whose time has come?

Nonprofit generic drug venture could include third of hospital market

A nonprofit generic drug company led by some well-known U.S. hospital systems and the Department of Veterans Affairs is trying to expand the market for inexpensive medicines – fast. The nonprofit aims to fulfill two needs. It wants to produce generic drugs that are in short supply.

The potential blockbusters list is worth a look – some surprises included.

12 blockbusters: The surging list of $1B-plus drugs rolling out on the market this year might surprise you

What exactly qualifies as a success in drug R&D may be discussed and disputed in many ways, but nothing lays an argument to rest quite as decisively as the real possibility of blockbuster status. The data analysts at Clarivate Analytics have just assembled their annual list of all the drugs

Would reciprocal approvals of some generic drugs help with prices and shortages? Some think it would.

Researchers Call for Allowing Importation, Reciprocal Approvals for Some Generic Drugs

Allowing the importation or reciprocal approvals of generic drugs for those with limited competition in the US could help the country better manage price spikes and shortages, researchers from Johns Hopkins, the Council on Foreign Relations, Yale University and Harvard Medical School, said in a new observational study published in the BMJ .

Biosimilars making progress in Britain still facing obstacles here in the US.

Britain’s use of copycat biotech drugs takes off while U.S. lags

LONDON (Reuters) – Cut-price copies of an expensive Roche biotech drug for blood cancer have taken 80 percent of the British market since launching last year, saving the healthcare system 80 million pounds ($113 million) a year, experts said on Wednesday.

A look ahead for immunotherapies.

What’s next for cancer immunotherapies

One of the most urgent themes in technology is the global rivalry for dominance of the evolving sector of artificial intelligence – geopolitical and economic supremacy is said to be at stake. Experts view the U.S. and China as the top contenders, but other nations, including Russia, are working on AI, too.

There is still so much we don’t know about how our bodies work. Will mRNA turn out to be the fertile ground this article discusses?

Novartis, UNC study suggests mRNA structures are a common, untapped pool of drug targets

In drug discovery, proteins may be king-they are the target of nearly all small-molecule drugs. But there remains an even larger untapped drug target: RNA. The classic view of RNA is one of a long, floppy molecule, lacking the characteristic, highly ordered structure that makes some proteins druggable with small molecules.

Company/Drug Specific

Bad news for AbbVie.

AbbVie shares tank on Rova-T flop, sudden retreat from accelerated approval pitch

AbbVie’s stock $ABBV is getting hammered this morning after its $10 billion Rova-T program posted poor mid-stage results for third-line small cell lung cancer, forcing the company to scuttle any plans to seek an accelerated approval for the closely-watched drug after talks with skeptical regulators. After fanning hopes – amid

Changes ahead at GSK.

GlaxoSmithKline prescribes commercial reboot for pharma division

LONDON (Reuters) – In January, GlaxoSmithKline’s () new head of pharmaceuticals Luke Miels issued a blunt challenge to his managers: find budget savings of 20 percent. The plan was to pool the savings and reallocate the money to priority medicines and markets for Britain’s biggest drugmaker, according to people familiar with the meeting.

Good news for Roche (and NSCLC patients).

Tecentriq combo success boosts Roche in lung cancer

A combination of Roche AG’s immunotherapy Tecentriq with two older cancer drugs bested chemotherapy in extending progression-free survival (PFS) among previously untreated patients with squamous non-small cell lung cancer (NSCLC), the Swiss pharma announced March 20.

The second major suiter also pulled out of contention to purchase Pfizer’s consumer business. It’s unclear where Pfizer goes from here.

GSK pulls out of $20 billion race for Pfizer assets

LONDON (Reuters) – GlaxoSmithKline () said on Friday it had withdrawn from the race to buy Pfizer’s () consumer healthcare business, which the U.S. drugmaker believes could be worth as much as $20 billion. The British company was seen as the front runner to buy the assets after its main rival Reckitt Benckiser () quit the race on Thursday.

CVS is the latest PBM to look to the drug industry for leadership personnel.

Another pharma executive jumps to the payer sphere, this time ex-Lilly CFO Derica Rice to CVS

Retirement was short-lived for former Eli Lilly CFO Derica Rice, who’s now planning to head up a pharmacy benefit manager. And his move to CVS Caremark follows just a week after UnitedHealth’s Optum unit said former GSK chief Andrew Witty would be taking its helm.

Weekly View In-depth

Shingles Vaccine

Although all the evidence is there, uptake of the new vaccine is slow.

Adults Skipping Vaccines May Miss Out On Effective New Shingles Shot

This story also ran on This story can be republished for free ( NPR. details). KHN contributing columnist Michelle Andrews writes the series Insuring Your Health , which explores health care coverage and costs. To contact Michelle with a question or comment, click here.

GlaxoSmithKline works to expand availability of the new (and better) vaccine hoping to increase uptake.

GlaxoSmithKline’s Shingrix launch gets a jump-start with CVS move to stock thousands of pharmacies

GlaxoSmithKline has a lot riding on Shingrix, its new shingles vaccine. It’s one of the key products CEO Emma Walmsley cited as growth drivers for the languishing company. And that launch just got a major boost from CVS. The pharmacy chain said Monday that nearly 10,000 of its pharmacies in the U.S.

Alzheimer’s (and yes I know this has often been an in-depth topic, but seems justified since there’s a lot going on and it impacts so many)

Celgene invests in the topic.

Celgene goes all-out on neurodegeneration and Alzheimer’s, triggering blockbuster deal with $150M in cash for Prothena

After quietly building up an experienced team of investigators to tackle neurodegeneration, Celgene has begun to aggressively in-license new drugs that can go after Alzheimer’s and other key diseases in the field. Just days after Celgene fronted $50 million for a discovery deal with Vividion Therapeutics that includes neurodegeneration, the

A “hail Mary” pass indeed. One has to wonder what investors are thinking if they participate in funding additional trials for this already failed drug. I’m not the only one asking that question: Beware Biotech IPOs Bearing Alzheimer’s Retreads.

Alzheon files for $80M IPO to take once-failed Alzheimer’s drug into PhIII

A company based just outside Boston is joining the parade to the public markets, hoping to raise $80.5 million to develop an Alzheimer’s drug that’s a true Hail Mary, considering the field’s recent implosions. The drugmaker, Alzheon, filed a notice with the SEC signaling its upcoming IPO, but the company

Will Denali’s unique delivery mechanism make a difference?

Denali launches a clinical quest on Alzheimer’s drug, banking $155M in Takeda cash and scoring monkey data on BACE

After all the setbacks and failures we’ve seen in Alzheimer’s research over the past 15 years, can a startup boasting better technology beat the terrible odds against them and score with a new drug? We’re at the early stages of getting an answer to that question. Denali $DNLI announced today

Need a reminder of why this topic is so important? Look at the current amount being spent and the number of individuals impacted.

Alzheimer’s Costs Reach $277 Billion

The cost of providing care for Americans with Alzheimer’s disease has hit $277 billion – eclipsing a quarter of a trillion dollars – as baby boomers age and the U.S. healthcare system struggles to find people to care for this fast-growing population.

 

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