ICER Weekly View 08-17-18

From the desk of Mitchell Stein


Good morning. This week we launched a probe to the sun. No, not connected to this week’s newsletter, but how cool is that? Or how hot is that, which in this case may be more appropriate… Back in the pharmacy world, lots to talk about – from CVS offering a QALY limit option to new gene therapy guidance from the FDA to Ohio getting ahead of the curve by doing away with rebates for its Medicaid program. We’ll look at all of that and more with this week’s full line-up including:  

ICER in the news – CVS makes use of ICER reviews, Xconomy nominates ICER, Onpattro approved, and Part D look includes Sarah Emond comments

Inside the Beltway – revised gene therapy and seamless trial protocols (2 articles), Rachel Sachs on step-therapy, and Ohio Medicaid changes PBM reimbursement

Industry Trends – No savings when combining 2 pills, PBMs react to rebate discussions, Express Scripts as specialty pharmacy, misogyny in health care investing, Armored CAR-Ts, why we don’t have a Lyme vaccine but our dogs do, quest for a better flu shot, EpiPen finally has a real competitor, and another elephant story

Now, on to the news.

ICER In The News

CVS announced that it would make use of ICER reviews in their assessments of drugs and offer clients the option of excluding drugs that were determined to have a cost per QALY of greater than $100,000. The announcement was reported by on by BioPharmaDive (below) as well as by FiercePharma, The Pink Sheet (subscription required), The HillBecker’s Hospital Review, EndPoints News, AJMCSTAT Plus (subscription required), The PharmaLetter (subscription required), PMLive,  and The Center for Biosimilars.

CVS adopts ICER metrics in shift to value-based drug pricing

CVS Caremark will use the value-based drug pricing system of the Institute for Clinical and Economic Review to exclude some high-cost drugs from plans, the company announced in a recent white paper. The pharmacy benefit manager (PBM) will incorporate ICER’s quality-adjusted life years (QALY) measure.

ICER has been recognized by Xconomy by being nominated as an X of the year finalist.

Xconomy: ICER, CRISPR, Biotech Activism & More: The X of the Year Finalists

Xconomy Boston – With so many stellar Xconomy Award nominees this year, we wanted to recognize several who don’t fit neatly into the other categories, so we’ve created categories just for them. One of these nominees for X of the Year is gaining influence in the drug industry with its evaluations of drug cost effectiveness.

The FDA approved the first ever treatment based on RNA interference, Onpattro (patisiran produced by Alnylam Pharmaceuticals). The average annual list price for the drug will be $450,000. STAT reports (link below) on approval of the drug and notes that ICER has released a draft report evaluating the new drug. Outlets including Forbes noted that Alnylam was entering into value-based pricing agreements with Harvard Pilgrim, Express Scripts, and others.

FDA approves first-ever RNAi-based therapy

ICER’s Sarah Emond is quoted in this article in the San Diego Union-Tribune looking at changes to Medicare Part D (the piece was picked up by other news outlets).

Is Medicare’s latest change a step too far?

Though its name sounds like a trendy workout craze, Medicare ‘s new “step therapy” policy has nothing to do with getting people in their 60s to move their feet. Sometimes called “fail first,” step therapy is the term used when a health insurance company forces doctors to prescribe the cheapest medication first, providing access to more expensive alternatives only if the first option doesn’t get results.

Careers at ICER

ICER is growing! Interested in joining the ICER team? Check out our open positions in research, health economics, program management, and more on ICER’s Careers Page

This week’s job spotlight:

Research Lead

The Research Lead, Evidence Synthesis will participate in multiple scientific activities, including developing strategy for and performing literature searches, critically evaluating the research methods and statistical findings of health outcome studies from the medical literature, and conducting qualitative and quantitative synthesis of evidence from literature and other sources.  

Pharmaceutical News

Inside the Beltway/State Regulatory Developments

Writing in the New England Journal of Medicine, Francis S. Collins and Scott Gottlieb announce the removal of special protocols for gene therapy trials. (Here’s a Washington Post story reporting on the changes.)

The Next Phase of Human Gene-Therapy Oversight

The FDA released guidance on seamless trials.

FDA rolls out guidance for seamless cancer trials

FDA released draft guidance Friday outlining how companies can use seamless trial designs to consolidate the traditional three-phase approach into one first-in-human study to expedite development of cancer drugs and biologics. Seamless trials use a single protocol that runs continuously and is amended to expand cohorts and/or add new ones until there is enough evidence to approve a candidate, or scrap its development.

Rachel Sachs (WV favorite, Law Professor, and Midwest CEPAC member) writing in Health Affairs discusses the MA step therapy proposal and how it fits into the Administration’s broader drug pricing strategy.

Drug Pricing Policy: HHS Introduces Step Therapy In Medicare Advantage

Ohio Medicaid is changing the way they pay PBMs. Personal comment, transparency is good, but it will be interesting to see how much money is saved. (Modern Healthcare subscription required after a quota of free articles).

Ohio Medicaid to try out transparent PBM pricing model

Industry Trends

Two pills that individually cost less than $20 cost thousands when combined. You can start by asking why they are produced, but keep going and ask even if they are produced, why are they prescribed? Bob Herman of Axios reports.

Combining common drugs with a high price tag

Common medications like ibuprofen or naproxen don’t cost a lot on their own. But in several instances, drug manufacturers blend those kinds of medicines into one tablet and then sell the combined drug for hundreds or even thousands of dollars.

PBMs disagree with the Administration on how responsible rebates are for high drug prices, pointing out that prices go up in places (Part B) where rebates are not allowed. (Additionally, a study commissioned by America’s Health Insurance Plans (AHIP) minimized the impact of rebates – read about that study on Modern Healthcare, subscription required after a quota of free articles.)

Drug middlemen push back that rebates are to blame for high drug prices

Drug middlemen are pushing back on the Trump administration’s effort to end drug rebates, which the administration claims are a major driver of high drug prices. The Pharmaceutical Care Management Association, which represents drug middlemen called pharmacy benefit managers, released a report on Wednesday that laid the blame for high drug prices on drugmakers.

Speaking of PBMs, Reuters looks at how Express Scripts has branched out and is also a specialty pharmacy entering into deals to be the exclusive provider of certain drugs.

Express Scripts staking out million-dollar gene therapies

(Reuters) – Express Scripts Holding Co () built a multi-billion enterprise pressuring drug companies to lower their prices for U.S. patients. Now it is quietly building a side business: getting paid to help drug companies dispense a new generation of high-priced drugs.

Misogyny knows no bounds as exemplified in this report from STAT.

A women’s health startup tried to drum up interest for a much-needed drug. Many men didn’t get it

Endpoints reports on the incorporation of checkpoint inhibitors to this CAR-T therapy. The only thing missing is how blockchain fits in.

Armored CAR-Ts? Memorial Sloan Kettering engineers CAR-T loaded with checkpoint inhibitors

Scientists at Memorial Sloan Kettering have engineered a hybrid cancer therapy that might just bring two of hottest areas of oncology science together in one package: CAR-T and checkpoint inhibitors. That’s the hope of a team of MSK researchers working in the labs of Renier Brentjens, a renowned physician-scientist in

A sad tale of the original Lyme vaccine pulled from the market due to public outcry based on fear, not science.

Lyme Disease Is Spreading Fast. Why Isn’t There a Vaccine?

We’ve all heard the advice about avoiding Lyme disease. If you walk through wooded or grassy areas where it’s prevalent, you should use insect repellent. Cover exposed skin. Check yourself thoroughly once you return home, and take a shower. If you see a tick, pluck it off your skin with tweezers.

The quest for a better flu shot continues – this time Pfizer forks over $425 million in its search for the holy grail (Reuters).

Pfizer bets on biotech flu vaccine in $425 million BioNTech alliance

FRANKFURT (Reuters) – Pfizer has agreed to pay German biotech firm BioNTech up to $425 million in an alliance to develop more effective influenza jabs, the latest among several major pharma companies to bank on a promising new genetic approach.

Mylan finally has a competitor (other than itself) for the EpiPen. Other reports confirm that Teva’s product is AB-rated, meaning directly substitutable by the pharmacist when the prescription is written for EpiPen.

FDA approves Teva’s generic EpiPen after yearslong delay

U.S. regulators cleared the first generic competitor to Mylan’s EpiPen, after a yearslong delay that many said contributed to the emergency allergy drug’s rapid rise in price. Teva Pharmaceuticals received Food and Drug Administration approval for generic versions of both the EpiPen and EpiPen Jr, the agency said in a statement Thursday.

Did you forget about our elephant cancer story from a few weeks ago? Not being an elephant (they never forget), you may have – no matter, here’s another one where the NY Times discusses another reason they may be better protected from cancer than people are.

The ‘Zombie Gene’ That May Protect Elephants From Cancer

matter With such enormous bodies, elephants should be particularly prone to tumors. But an ancient gene in their DNA, somehow resurrected, seems to shield the animals. Elephants ought to get a lot of cancer. They’re huge animals, weighing as much as eight tons. It takes a lot of cells to make up that much elephant. 
@mhstein  |

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