Today's News and Commentary

About pharma

U.S. states accuse Teva, other drugmakers, of price-fixing: Today’s top story is in all news media: Teva apparently led a conspiracy (with 19 other drug manufacturers) “to divide up the market for drugs to avoid competing and, in some cases, conspire to either prevent prices from dropping or to raise them…” 44 states filed a lawsuit on Friday in the U.S. District Court in Connecticut.

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Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry: Biosimilars are the equivalent of generic drugs for biological compounds. Definition and handling of generic drugs are straightforward; but because biologicals are more complex, their evaluation has not been clear. The FDA issued this document (called a “nonbonding recommendation”) for evaluating these drugs. The guidance is expected to help biosimilar manufacturers gain easier approvals.

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CBO Says Bill to Curb Pay-for-Delay Would Cut the Deficit by $613 Million Over 10 Years: On a related note, Senators Amy Klobuchar, D-Minnesota, and Chuck Grassley, R-Iowa. are cosponsoring a bill that would prohibit brand-name drug makers from delaying the entry of generics or biosimilars by compensating competitors to keep their products off the market for a period of time (a practice called pay-for-delay). If the bill passes, the Congressional Budget Office (CBO) says because of cheaper drugs and higher fees it will reduce the deficit by $613 million by 2029.

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Delivery Might Be Key to Gene Therapy’s Orphan Status, CBER Official Says: The FDA says it is open to granting orphan drug status to an established genetic therapy if the mode of delivery is different than the other treatment.

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Lessons from UnitedHealthcare's [UHC] stalled plan to get oncologists to prescribe generics: In an attempt to encourage oncologists to use generic medications, UHC offered a voluntary program to pay these physicians a higher rate for these drugs. Bottom line: it did not have any notable impacts on prescribing rates or spending. Two possibilities for this failure: 1) the extra payment was still not enough to compensate for gains from using more expensive medications and 2) this payer was one of many, so overall habits did not change from a focused, voluntary program. The solution would be for the insurer to buy the drugs from the manufacturer or wholesaler and supply them to the oncologist. As usual, this process is not new— just waiting for someone to “rediscover it.”

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About health insurance

Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, 2018: This governmental study provides a wealth of information about health insurance coverage. Among the findings:

“In 2018, 30.4 million persons of all ages (9.4%) were uninsured at the time of interview—not significantly different from 2017, but 18.2 million fewer persons than in 2010…

Among adults aged 18–64, 68.9% (136.6 million) were covered by private health insurance plans at the time of interview in 2018. This includes 4.2% (8.4 million) covered by private health insurance plans obtained through the Health Insurance Marketplace or state- based exchanges.

The percentage of persons under age 65 with private health insurance enrolled in a high-deductible health plan increased from 43.7% in 2017 to 45.8% in 2018.”

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DOJ asks Supreme Court to toss payers' suits seeking $12B in risk corridor payments: The federal government enticed insurance plans to participate in ACA exchanges by providing some time-limited financial guarantees. One of the guarantees was implementation of risk corridors: If a plan made more than a certain profit it would  pay the government; if the plan lost more than a target, the government would subsidize that loss. This scheme was designed to be budget neutral. What happened was there were not a lot of profitable plans to subsidize the ones who lost money. (Recall the problems signing up healthy people and erroneous actuarial assumptions about the covered populations.) Insurers appealed earlier court decisions, claiming they are owed $12 billion in risk corridor payments. The Justice Department is asking the Supreme Court to deny the appeals.

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Washington to offer first ‘public option’ insurance in US: “Washington is set to become the first state to enter the private health insurance market with a universally available public option.

A set of tiered public plans will cover standard services and are expected to be up to 10% cheaper than comparable private insurance, thanks in part to savings from a cap on rates paid to providers. But unlike existing government-managed plans, Washington’s public plans are set to be available to all residents regardless of income by 2021.”

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Bob Menendez proposes bill to help NJ save Obamacare insurance gains: Other states, like NJ, Pennsylvania, New Mexico, Nevada, Oregon and Minnesota are also considering public exchanges.

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