ICER Weekly View 04-06-18

From the desk of Mitchell Stein


Good morning. Before we get to the week’s news, let me tell you a story. Like many, I take a generic statin – my health insurer uses a PBM, and I order this maintenance drug through their mail order pharmacy. The cost of a 90 day supply recently went to $120, so I decided to shop around. Many of you will not be surprised to learn that I found a cash price (no insurance) at a local pharmacy for $40 for that same 90 day supply. We talk about the theory of drug prices all the time; it’s always a little different when you encounter these issues in the real world. There’s nothing surprising about my experience – maybe that’s the problem. Now on to the news where this week we’ll look at:

ICER in the news – ICER will make executable economic files available, ICER to review new MAT drugs, Ollendorf coauthors piece on impact of money back guarantees, Commonwealth Fund reviews Health Affairs papers, CAR-T pricing, and Luxturna

Inside the Beltway – CMS drug price activity, impact of Chinese tariffs on drug prices, future of right-to-try, the FDA’s new budget, MA Medicaid formulary dreams (2 updates), and Ohio disclosure order

Industry Trends – Axios dives into PBMs, Kaiser releases patient advocacy funding resource, Bloomberg looks behind the curtain at pricing strategies, copay coupons (2 articles), PhRMA doesn’t think transparency laws will help, what is a physician’s responsibility re costs, long-ignored stroke treatment proponent keeps trying, and nanobots fight cancer (some day)

Company/Drug Specific – Abbvie (Humira), Allogene, and GenSight

Weekly View In-depth – Supplements

Now, on to the news.

ICER In The News

ICER announced plans for the first phase of a new program in which ICER will work with its academic collaborators to share executable versions of draft cost-effectiveness models with relevant drug manufacturers during ICER evidence reviews. By directly viewing a model’s structure, estimates, key assumptions, and calculations, manufacturers may be better equipped to provide valuable feedback during the public comment period that follows the release of an ICER draft evidence report.

The program will be piloted during ICER’s two current reviews of therapies for migraine prevention and of the drug elagolix for endometriosis-associated pain. Academic collaborators from the University of Illinois at Chicago College of Pharmacy and the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, respectively, are developing the economic models for these reviews.

The Journal of Clinical Pathways reported on the announcement.

Institute for Clinical and Economic Review Announces New Program to Make Available Draft Executable Economic Models During Drug Assessment Review Process

ICER announced plans to develop a report assessing the comparative clinical effectiveness and value of several new options for medication-assisted treatment (MAT) of opioid use disorder. The report will be the subject of a public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) in November of 2018.

ICER’s upcoming review will assess the effectiveness and value of 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, as compared to medications commonly used in MAT such as methadone, buprenorphine/naltrexone sublingual film (Suboxone®, Indivior), and injectable naltrexone (Vivitrol®, Alkermes). This list is tentative and subject to change. ICER previously reviewed treatment strategies for opioid use disorder in a 2014 report.

Institute for Clinical and Economic Review to Assess Medication-Assisted Therapy for Treatment of Opioid Use Disorder

ICER’s Chief Scientific Officer Dan Ollendorf is one of the authors of this paper (subscription required for full text). The paper was also reported on in MedicalXpress and BioPharmaDive.

Effect of Money-Back Guarantees on the Cost-Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors

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The Commonwealth Fund discusses three Health Affairs papers that they supported on high drug costs, including one coauthored by ICER’s President, Steven Pearson.

Policy Prescriptions for High Drug Costs: Experts Weigh In

Story on the price of CAR-T treatments references ICER’s work on the topic.

Pricing adjustments for CAR-T therapies likely to take place in 2018,

Pricing adjustments for CAR-T therapies likely to take place in 2018, says analyst

A look at the Midwest CEPAC meeting and ICER’s work on Spark’s Luxturna.

The cost of curing blindness: Navigating challenges on the road toward curative treatment

In a massive ballroom in Kansas City in late January, a panel of medical experts with the Midwest CEPAC, a core program of the Institute for Clinical and Economic Review (ICER), reviewed the effectiveness and value of Spark Therapeutics’ new gene therapy Luxturna (voretigene neparvovec) for an ultra-rare eye disease.

Pharmaceutical News

Inside the Beltway/State Regulatory Developments

While CMS laid out several small drug price initiatives this week, it left out crediting rebates at the point of sale.

Medicare puts off decision on lowering drug prices patients pay

ASHINGTON – The Centers for Medicare and Medicaid Services laid out a bevy of initiatives Monday that officials said would reduce drug prices for patients covered by the Medicare Part D prescription drug program – but they have made no decisions yet on an issue that has confounded lawmakers and patients alike.

So about that trade war we’re not having? It could raise drug and other health care costs.

Trump Tariffs Target Key Ingredients for Dozens of Drugs

The Trump administration’s proposed tariffs on thousands of Chinese-manufactured products would target dozens of key products used by drugmakers, as well as medical devices including pacemakers and artificial joints. The 25 percent tariff would be placed on raw ingredients for drugs such as insulin used by diabetics, the anti-allergic-reaction drug epinephrine, as well as vaccines, blood products and antidepressants, according to the list.

With Congress still out on recess, time for some speculation. Will the “right to try” bill die in the Senate? Any momentum the bill had seems to be gone.

“Right to try” may die in the Senate

How will the FDA spend their budget increase?

FDA’s FY 2019 Justification: How Extra Funds Will be Used

An increase of more than $400 million for the US Food and Drug Administration (FDA) in fiscal year 2019 would help the agency advance drug, biologic and device manufacturing tech, better regulate drug compounders and over-the-counter medicines, among other initiatives unveiled in FDA’s 346-page fiscal year 2019 justification of estimates for appropriations committees.

To the shock of patient advocates, MA wanted to institute a drug formulary for Medicaid. Reports this week indicate that CMS is poised to deny the waiver request. Law Professors Nicholas Bagley and Rachel Sachs write in Health Affairs that the supposed reason for the supposed denial makes no sense. Stay tuned!

Massachusetts, a Health Pioneer, Turns Its Focus to Drug Prices. It’s in for a Fight.

Massachusetts officials said they were proud of coverage gains made since 2006, when the state adopted a health law that served in many ways as a model for the Affordable Care Act, signed four years later by President Barack Obama.

Massachusetts Wants To Drive Down Medicaid Drug Costs: Why Is The Administration So Nervous?

Ohio looks to assure consumers get lowest price while PBMs say they already do.

Ohio regulator orders insurers, benefit managers to give lowest…

The Ohio Department of Insurance said on Wednesday that pharmacy benefit managers and insurers would have to disclose the lowest price for a prescription drug for Ohio consumers, part of a move to prevent insured consumers potentially paying more than those without insurance.

Industry Trends

Axios has done a five-part series on PBMs, the rest of the series is linked to from this piece. (Don’t worry, they’ve also looked at manufacturers, it was just PBMs’ turn this week.)

The drug pricing contract Express Scripts doesn’t want you to see

Pharmacy benefit managers play an important but secretive role in controlling the prices of prescription drugs – and they’re working hard to keep it that way. After Axios obtained a document that shed new light on this opaque process, Express Scripts, the country’s largest PBM, forced that document to be taken down.

Kaiser Health News releases a patient advocacy funding resource: “Kaiser Health News has compiled and analyzed disclosures to shed light on the flow of money between the pharmaceutical industry and patient advocacy groups.”

Patient Advocacy Groups Take In Millions From Drugmakers. Is There A Payback?

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations. Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood.

Bloomberg looks behind the curtain at the pricing strategies of two “Pharma Bros.”

When These New Pharma Bros Show Up, Drug Prices Tend to Go Monumentally Higher

For at least the past three years, Todd Smith and Benjamin Bove have crisscrossed the U.S., offering a sure-fire fix for struggling pharmaceutical companies. And wherever they go, the price of prescription drugs tend to skyrocket.

Many talk about copay coupons increasing costs – here are some numbers to go with the theory.

Prescription Drug Coupons Actually Increase Healthcare Spending by Billions

Last year, the pharmaceutical company Mylan faced public outcry when it raised the price of the lifesaving allergy medication EpiPen to $609 a box. In response to the furor, Mylan pointed out it offers copay coupons that can reduce consumers’ out-of-pocket cost to less than $100.

PhRMA pushes back with ads touting the use of coupons.

Déjà vu? PhRMA rolls drug cost ads, insurers push back-this time on costly coupon rules

PhRMA’s latest round of drug cost advertising defends a favorite marketing technique-the copay coupon-against new payer programs that aim to thwart it. Caught in the middle, the ads point out? Patients and their out-of-pocket costs. Copay coupons make drugs less expensive for patients because drugmakers pitch in on their out-of-pocket costs.

PhRMA argues that transparency laws won’t help patients (to no one’s surprise).

PhRMA argues early notice of price hikes won’t benefit patients

Informing payers of looming drug price hikes hurts patients much more than it helps, industry trade group PhRMA argued in a blog post published last week. The post comes as a growing number of states are considering and passing legislation aimed at making drug pricing decisions more transparent.

What is a physician’s responsibility in controlling costs to individual patients and the system as a whole?

Doctors need to factor in cost when prescribing medications

r. Jones enters the pharmacy expecting to pick up his prescription. But when he gets to the window, he gets a rude awakening. His acne cream is $200, much too expensive for him to afford. Mr. Jones (not his real name) was told that his doctor needed to fill out paperwork for the insurance to pay for his medication.

Fascinating story – I can’t judge the merits of his science, but the idea that a promising treatment that might be safer than the current standard of care has been ignored all these years is frustrating.

Harvard doctor pursues a long-ignored treatment for strokes, heart attacks

e’s a professor at Harvard Medical School, but in many ways, Dr. Victor Gurewich is an outsider. His research is funded by a small family foundation, and he hasn’t tried for a federal grant in decades. He’s a primary care doctor whose work tramples on the terrain of cardiologists and neurologists.

This week in science or science fiction, nanobots to fight cancer. Come for the science, stay for the reference to 1966’s Fantastic Voyage.

These tiny robots could be disease-fighting machines inside the body

Call it another case of science fiction becoming scientific fact. Researchers have long dreamed of developing tiny robots that could roam about inside our bodies, delivering drugs with unprecedented precision, and hunting down and destroying cancer cells. We’re not there yet, but we’re getting close.

Company/Drug Specific

Humira, the world’s best selling drug, won’t see biosim competition in the US until 2023 thanks to a new agreement with Samsung Bioepis. The deal will be expensive for consumers and the government: Abbvie, Amgen Deal on Humira Biosimilars Likely to Cost CMS More Than $1B.

AbbVie’s Humira gets biosim reprieve-and Amgen wins copycat advantage-in patent deal with Samsung Bioepis

In a big win for AbbVie and its best-selling drug-which also happens to be the biggest drug in the world-the company scored another Humira biosimilars settlement that makes it “increasingly unlikely” copycats will launch in the U.S. before 2023. But in Europe, the threat will arrive much sooner.

Allogene makes deal for assets from Pfizer (Pfizer gets a stake in the company) and focuses on off-the-shelf CAR-T.

Kite Pharma veterans launching new firm to develop off-the-shelf CAR-T

he two former Kite Pharma executives behind a game-changing cancer-killing technology are launching their next act: a new company to develop a suite of so-called off-the-shelf CAR-T therapy assets, designed so that they do not need to be personalized for each cancer patient.

Confusing results from GenSight’s gene therapy trial.

Benefit of GenSight’s gene therapy not so clear

GenSight Biologics SA on April 3 announced topline results from the Phase 3 REVERSE trial that evaluated a single, intravitreal injection of its gene therapy candidate GS010 in 37 subjects with an inherited, degenerative eye disease who began losing their vision shortly before the start of the study.

Weekly View In-depth


Most are worthless.

Older Americans Are Hooked On Vitamins Despite Scarce Evidence They Work

In this series, “Treatment Overkill,” Kaiser Health News investigates the causes and consequences of medical overtreatment, both for patients and the health care system. When she was a young physician, Dr. Martha Gulati noticed that many of her mentors were prescribing vitamin E and folic acid to patients.

And some are dangerous.

In a first, FDA orders recall of a ‘contaminated food’ — kratom with salmonella 
@mhstein  |

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