ICER Weekly View: February 22, 2019

From the desk of David Whitrap

Hello, everyone. It’s a busy day here at ICER. In addition to releasing our revised Evidence Report on treatments for spinal muscular atrophy later this afternoon, we will also announce the topic for our next drug assessment. Stay tuned…

But this morning, let’s take a look at:

  • ICER in the News: Our final New Evidence Update for alirocumab, and an industry analyst suggests the end is near for high prices on drugs that don’t represent significant innovation.
  • Pharmaceutical News: CAR-T in Medicare, spending trends over the next decade and the financial toxicity that could follow, Maryland’s failed bid to prohibit “unconscionable” price gouging, the long backstory on how the insulin market became so entrenched, what to expect next week when pharma execs go to Washington, and a trio of industry kickbacks.

ICER in the News

Last Friday, ICER issued our Final New Evidence Update for alirocumab (Praluent®, Regeneron/Sanofi), an injectable PCSK9 inhibitor used for the treatment of high cholesterol in certain patient populations. This New Evidence Update is based on further analysis of results from the ODYSSEY Outcomes trial, which have now undergone peer review and were published recently in the New England Journal of Medicine.

ICER Publishes Final New Evidence Update for Alirocumab, a PCSK9 Inhibitor for Treating High Cholesterol

Earlier this week, analysts from Morningstar alluded to ICER’s value-based assessments as one of several factors that are placing drug companies under more pressure to think differently about how they price their products. The analysts went on to write: “Given the pricing pressure overhang, firms need higher levels of innovation in their pipelines to justify pricing… Slight dosing advantages and minor improvements in efficacy in crowded therapeutic areas will not support the innovation needed for pricing power as was the case in the 1990s and early 2000s.”

Pfizer, Merck, J&J well-positioned for M&A and Biogen and BioMarin are prime targets: report

M&A will help the biopharma industry deal with significant new challenges, Morningstar said in a new report, including pressure from lawmakers and payers to lower prices. As companies look for deals to boost their pipelines, oncology, neurology and rare-disease therapeutics will emerge as sought-after assets, the analysts predicted.

Pharmaceutical News

Fair drug prices should result in both fair access and incentives for future innovation. Remember last year when ICER’s assessment concluded that the CAR-T therapies Kymriah and Yescarta were cost-effective despite prices that approached $500,000? And remember how we recommended that all patients be entered into a registry for planned long-term follow-up? Well, CMS is now proposing that Medicare cover all FDA-approved CAR-T therapies as long as data is collected about how the patients fare for at least two years following treatment.

Medicare would provide national coverage for CAR-T under new proposal

W ASHINGTON – Under a new proposal, the Medicare program would pay for expensive new cancer therapies known as CAR-T for patients across the country. The Centers for Medicare and Medicaid Services on Friday released a so-called national coverage determination for the therapies that lays out exactly when, and for whom, Medicare will cover a given drug.

Even without any further expansion of Medicare or Medicaid, new estimates suggest that government will be paying for nearly half of the nation’s health care in less than 10 years. And during that same timeframe, prescription drug spending is expected to rise 6.1% each year.

Government headed for close to half of nation’s health tab

WASHINGTON (AP) – Even without a history-making health care remake to deliver “Medicare-for-all,” government at all levels will be paying nearly half the nation’s health care tab in less than 10 years, according to a federal report released Wednesday.

Drug spending could rise 6.1 percent annually by 2020, federal projections show – STAT

W ASHINGTON – Spending on prescription drugs is expected to increase at an accelerating rate over the next 10 years, according to government estimates released Wednesday – ramping up to as much as 6.1 percent growth by 2020.

And while all of these numbers can seem too abstract after a while, Susan Gubar writes in The New York Times about how “financial toxicity” can be a very real thing for people who have cancer.

The Financial Toxicity of Illness

Living With cancer While medicine transforms cancer into a chronic disease with which patients can live for an extended period of time, financial toxicity threatens to turn chronic, too. It sometimes seems baffling to me: I put my life on the line for research to produce a cancer medication that – if and when it is put on the market – I probably could not afford.

But don’t worry – Martin Shkreli can rest easy this week. On Tuesday, the US Supreme Court rejected Maryland’s bid to prohibit “unconscionable” price increases on essential, off-patent drugs.

U.S. top court rejects Maryland bid to revive drug price-gouging law

WASHINGTON (Reuters) – The U.S. Supreme Court on Tuesday rejected Maryland’s bid to revive a law aimed at preventing price gouging by pharmaceutical companies, dealing a setback to the power of states to rein in prescription drug costs.

And speaking of essential medicines that have been available for years, do you ever wonder how the $27 billion annual market for insulin has been dominated by only three companies over an entire century? Several policy experts spoke with STAT News about how we got here, and options the government could consider to spur additional competition. (And it’s always nice to see older ICER reports helping inform conversations like these.)

With insulin prices skyrocketing, there’s plenty of blame to go around

W ASHINGTON – Fifteen years ago, a patient with diabetes might have paid $175.57 for a 20-milliliter vial of the long-acting insulin Humulin R U-500. Today, he’d shell out $1,487 for the same tiny vial, according to wholesale acquisition cost data from Elsevier’s Gold Standard Drug Database.

Well, a bill introduced by Democratic Congressman Peter Welch (VT) on Wednesday would let patients import cheaper insulin from Canada. And in Florida, Republican Governor Ron DeSantis is thinking about taking a similar approach, but he doesn’t want to stop with just insulin.

Bill would let patients buy cheaper insulin from other countries

A bill introduced by Rep. Peter Welch (D-Vt.) on Wednesday would let patients import cheaper insulin from Canada and other countries.

FL governor wants to import cheaper drugs from Canada | Miami Herald

prescription, drug, Canada, Congress, DeSantis, Trump, HHS, Florida, healthcare, cost, import

Next Tuesday, seven pharmaceutical executives are planning to testify in front of the Senate Finance Committee on the topic of drug pricing. STAT News raises the curtain on the event by profiling the major players and speculating on the questions each should expect.

The seven executives who will defend pharma before Congress – STAT

W ASHINGTON – One’s a college dropout. One’s a self-proclaimed street fighter. And one survived a presidential tweetstorm. Meet pharma’s new Gang of Seven, a disparate group of executives about to face congressional questions on what they have in common: Their companies sell drugs, and drugs keep getting more expensive.

And finally, this week brings a collection of stories about three different types of industry kickbacks that can create conflicts of interest that ultimately increase health costs. Alexion becomes the latest pharmaceutical company to settle after being accused of using patient assistance programs to illegally cover Medicare patients’ out-of-pocket expenses. Gilead is accused of funneling money to physicians through programs that helped boost sales of the company’s hepatitis C and HIV drugs. And ProPublica unpacks how the lucrative commissions insurers pay brokers may represent a perverse incentive that could lead to increased premiums.

Alexion to pay $13m for using charities to pay Medicare patients – STAT

A s federal authorities scrutinize relationships between drug makers and patient charities, Alexion Pharmaceuticals ( ALXN) is the latest company to agree to settle allegations that donations amounted to kickbacks paid to Medicare patients as a way to cover their out-of-pocket costs.

Are drugmaker marketing practices to physicians false claims? Gilead Sciences is the latest to come under fire.

The drugmaker Gilead Sciences has been hit with a whistle-blower suit accusing it of paying healthcare providers to boost sales of its hepatitis and HIV drugs.

Behind the Scenes, Health Insurers Use Cash and Gifts to Sway Which Benefits Employers Choose – ProPublica

The insurance industry gives lucrative commissions and bonuses – from six-figure payouts to a chance to bat against Mariano Rivera – to the independent brokers who advise employers. Critics call the payments a “classic conflict of interest” that drive up costs.

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