ICER Weekly View 06-02-17

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From the desk of Mitchell Stein

Good morning.  The non-drug related news continues to heat-up in DC, and that trend will only increase with yesterday’s announcement.  Meanwhile, lots to talk about in the pharma world, not least of which is the start of the ASCO conference in Chicago today.  This week we’ll look at:

ICER in the news – New and Noteworthy for June

Inside the Beltway – Drug lobbyists, 2 CEOs expectations re drug price actions, and a review of drug price proposals before Congress

Industry Trends – ASCO meeting (3 stories), CRISPR not that precise, two pipeline stories, Health Affairs blog on ADOs, MD bill to restrict generic drug prices, two suits – one against Novo and OptimRX, the second Express Scripts sues Kaleo, the increase in value-based contracts for drugs, and a look at the temptation of positive results.

Company/Drug Specific –Mylan

Weekly View In-depth – Drug Importation and Medicare Part D

Now, on to the news.

ICER In The News

ICER’s New and Noteworthy for June has been posted.

Pharmaceutical News

Inside the Beltway

“It is an industry that was already spending nearly double what other business sectors in the United States economy allocate on lobbying, and those sums continue to rise.”

Drug Lobbyists’ Battle Cry Over Prices: Blame the Others

It is an industry that was already spending nearly double what other business sectors in the United States economy allocate on lobbying, and those sums continue to rise. President Trump has only heightened anxiety by accusing the drug industry of ” getting away with murder,” even though he has not weighed in with his own proposal.

The CEOs of two of the largest manufacturers expect the administration to end up suggesting industry-friendly drug pricing proposals.

Drugmakers Brace for Trump’s Proposals on U.S. Medicine Prices

Novartis AG Chief Executive Officer Joe Jimenez said he expects President Donald Trump ‘s administration to outline proposals to lower the burden of drug prices on patients within three months. Drugmakers have met with White House officials in recent weeks to offer their own ideas, including ways of removing barriers to drug-price contracts based on the results that medicines deliver for patients, Jimenez told investors in Boston on Wednesday.

The NY Times reviews the current drug price proposals before Congress.

A Look at Major Drug-Pricing Proposals

While both proposals address some of the practices that have grabbed headlines, critics have noted that they would leave the brand-name pharmaceutical industry unscathed. “This will have a minor impact,” said Ronny Gal, a Wall Street analyst for Bernstein who covers the drug industry. Requiring notice when drug prices go up.

Industry Trends

The American Society of Clinical Oncology’s annual meeting starts today (Friday) in Chicago.  Here are three stories:  First a look at the declining role of US scientists at the conference, second a preview from Reuters and finally one investor’s watch-list for the conference.

As Government-Funded Cancer Research Sags, Scientists Fear U.S. Is ‘Losing Its Edge’

Less and less of the research presented at a prominent cancer conference is supported by the National Institutes of Health, a development that some of the country’s top scientists see as a worrisome trend.

Cancer meeting to provide clues on future immunotherapy combos

As a wider range of drugs that enlist the body’s immune system to fight cancer become available, clues about which combinations will prove most effective are expected at the upcoming meeting of the American Society of Clinical Oncology. The ASCO meeting, which starts Friday in Chicago, draws tens of thousands of specialists from around the world.

Prepping for ASCO? Investor Brad Loncar offers his own breakdown of what to watch for

Everybody has their own special lineup of the most keenly anticipated events scheduled for the upcoming session of ASCO this weekend. Brad Loncar, an independent investor who set up the Loncar Cancer Immunotherapy ETF $CNCR, has been prepping for this all year long. Loncar wrote up a long list of

A reminder that CRISPR still has a long way to go:

“When correcting blindness in mice, researchers at Columbia University found that though CRISPR did manage to successfully edit the particular gene responsible for blindness, it also caused mutations to more than a thousand other unintended genes. The off-target effects of CRISPR have long been known, but this new research highlights just how extensive they can be, and highlights the importance of research to understand them.”

CRISPR May Not Be Nearly as Precise as We Thought

The revolutionary gene-editing technology CRISPR-Cas9 is often described as “molecular scissors” for its ability to turn previously improbable feats of genetic engineering into exercises in cutting and pasting.

Next, two pipeline stories – the first looks at the increasing number of checkpoint combo studies and the second looks at the overall increase in oncology studies.

Checkpoint combos for cancer are all the rage as trial sponsors line up hundreds of new studies – report

Number of Anti-PD-1/PD-L1 MAb combination studies 2015 vs. 2017 Source: Evaluate Ltd. May 2017 Over the last few months it hasn’t been unusual to see new combination studies being announced on a daily basis, matching one of the 5 approved PD-(L)1 checkpoint drugs with another cancer therapy. Some mornings they

New report heralds a revolution in cancer R&D trends – and the sticker shock that comes with it

There’s a revolution playing out in cancer R&D. Over the last decade drug developers focused on oncology have teamed with regulators on designing a shorter R&D path for new cancer drugs, using trial designs that have sped clinical work and slashed the number of patients needed to demonstrate safety and

A Health Affairs blog looks at coverage for abuse-deterrent opioids.  (ICER is in the midst of a review of these drugs.)

“It is tempting to see abuse-deterrent opioids as a powerful and singular solution that might go a long way toward addressing our nation’s opioid crisis. In that case, mandating coverage would seem to be a no-brainer. But, it is not so simple. Policy makers must evaluate both the benefits and overall cost of any potential decision, before acting.”

Mandating Coverage Of Abuse-Deterrent Opioids Would Be A Costly Distraction From More Effective Solutions

May 26, 2017 The devastating societal effects of the national opioid crisis are as far reaching as they are complex and require multimodal and highly coordinated interventions involving policy makers, public health, law enforcement, the medical community, payers, and community stakeholders.

Maryland’s Governor allows new generic drug price law to take effect without signing it.

A class action suit was filed naming both a drug manufacturer and a PBM as defendants.

Lawsuit says Novo, OptumRx ‘mutually benefited’ from rebate scheme, while consumers paid the price

Novo Nordisk is the target, along with pharmacy benefit manager OptumRX, of a new proposed class action lawsuit claiming a conspiracy to raise the price of diabetes medicines so that the drugmaker could pay rebates to the pharmacy benefit manager.

Meanwhile, Express Scripts sues Kaléo one of the makers of naloxone.  While the public version of the suit is has portions redacted, it does provide some insight into the PBM world.

Express Scripts Sues Maker of Overdose Drug, Intensifying Feud

The lawsuit, though heavily redacted, provides some tantalizing details about Express Scripts’ business dealings. Consultants and brokers – who advise employers on their prescription drug plans – said it showed that Express Scripts is collecting fees that keep rising as drug prices go up.

A report says more insurers and manufacturers are trying value-based contracts – but it seems like many are just dipping their toes in the water for now.

As Drug Prices Soar, Value-Based Pay Hits Pharmaceutical Industry

More health insurance companies are deciding to pay for a drug based on whether it’s effective and provides the patient a good outcome as value-based care inches toward the pharmaceutical industry, insurers and a new analysis indicate. One in four health plans now have “at least one outcomes-based contract” with a drug maker, an Avalere Health survey showed.

Midwest CEPAC member Dr. Aaron Carroll writes about sciences’ reproducibility problem.

Science Needs a Solution for the Temptation of Positive Results

Unfortunately, the rest of us have not been quite so careful. More and more data show we should be. In 2015, researchers reported on their replication of 100 experiments published in 2008 in three prominent psychology journals. Psychology studies don’t usually lead to much money or marketable products, so companies don’t focus on checking their robustness.

Company/Drug Specific

EpiPen, the story that keeps on giving.

Mylan May Have Overcharged U.S. for EpiPen by $1.27 Billion: HHS

NEW YORK – The U.S. government may have overpaid drugmaker Mylan N.V. by as much as $1.27 billion between 2006 and 2016 for its EpiPen emergency allergy treatment, the Department of Health and Human Services said on Wednesday. The amount is nearly three times a proposed settlement that the company announced in October.

Weekly View In-depth

Drug Importation

A SCOTUS decision on printer cartridges could have a profound impact on drug importation: “But the court’s decision will have ramifications far beyond ink, particularly for the import and resale of products like smartphones and name-brand drugs.”  Remember, I’m not a lawyer, but the basic idea is that once the product (drug) is sold, the manufacturer loses the right to set conditions (don’t sell this pill in the US).

Supreme Court Rules Patent Laws Can’t Be Used to Prevent Reselling

Lexmark sued for patent infringement, and the United States Court of Appeals for the Federal Circuit, a specialized court in Washington, accepted both of its main arguments, concerning domestic and international sales. The appeals court acknowledged that the general rule was that buyers of patented products could do with them what they wished.

The National Academy for State Drug Policy has two resources on the topic:

Medicare Part D

A new paper in JAMA looks at the impact of rebates in Medicare Part D and finds patients are often hurt by their presence.  Below is an article discussing the paper, you can find the original paper here.

Drug Rebates Reward Industry Players – And Often Hurt Patients

Medicare and its beneficiaries aren’t the winners in the behind-the-scenes rebate game played by drugmakers, health insurers and pharmacy benefit managers, according to a paper published Tuesday in JAMA Internal Medicine.

The Wall Street Journal (subscription required) took a look at Part D costs for patients.

“An analysis of government data by The Wall Street Journal found expensive medicines are increasingly denting the pocketbooks of seniors and other beneficiaries in Medicare’s prescription-drug program, known as Part D, despite federal legislation meant to reduce out-of-pocket costs and drugmakers’ increasing discounts.

The median out-of-pocket cost for a drug purchased through Part D was $117 in 2015, up nearly half from $79 in 2011, in inflation-adjusted dollars, the Journal’s analysis found. The analysis excluded low-income patients whose copays are paid primarily by the government.

Some 220 Part D drugs had annual out-of-pocket costs of $1,000 or more in 2015, up 86% from 118 drugs in 2011.”

High-Price Drugs Raise Costs for Seniors in Medicare Part D

Carole Siesser, a retiree in Delray Beach, Fla., started taking a bone-growth drug made by Eli Lilly & Co. after she fell and fractured her spine. After two years, the medicine helped to heal her back. It also cost her $5,600 of her own money to help cover the roughly $26,000 annual price, even though she has Medicare. 
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