The Catalyst

Improving FDA’s combination product review process could increase epinephrine auto-injector competition

Posted by Stephen J. Ubl on August 30, 2016 at 10:00 AM

Combination products that consist of a medicine and delivery device are important treatment options for patients and have the potential to improve public health. Innovator companies invest in pioneering research to bring new combination products and medicines to patients, and over time those medicines become available as lower-cost generic versions. With nearly 90 percent of all prescriptions filled in the United States with generics, their timely approval is critical to patient access and long-term sustainability of our health care system.

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Topics: FDA, Drug Development, PDUFA, FDA Modernization, Policy Solutions

Medicare Monday: Who qualifies for Part D Extra Help?

Posted by Nicole Longo on August 29, 2016 at 12:35 PM

Over the past couple months, we’ve taken a look at three hypothetical Medicare beneficiaries who qualify for the Extra Help program, also known as the low-income subsidy. Learn more about the different ways patients benefit from Extra Help.

  • Katie is a hypothetical patient who has been living with end-stage renal disease and is now six months post-kidney transplant, which qualifies her for Medicare before the age of 65.
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Topics: Part D, Medicare, Medicare Monday

Empowering consumers and improving access to important clinical information

Posted by Allyson Funk on August 29, 2016 at 9:00 AM

Even though more Americans are insured than ever before, many are facing insurance barriers that may interfere with a doctor’s prescribed course of treatment and impact their care. We recently examined how improving access to out-of-pocket cost information is one policy solution that can help engage and empower patients to make more informed choices about their coverage.

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Topics: Access, Access Better Coverage, ABCs of Coverage, Policy Solutions, Empower Consumers

Fact Check Friday: The truth about biopharmaceutical patents

Posted by Mark Grayson on August 26, 2016 at 2:59 PM

MYTH: Biopharmaceutical companies use government-protected monopolies to raise costs on medicines.

FACT: Patent-protected medicines routinely face competition from other brand name medicines, which helps drive down costs while patent protection and intellectual property rights allow the biopharmaceutical industry to develop life-saving medicines and cures.

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Topics: Innovation, Patents, IP, Patent Protections

Medicare Monday: Increased rebate levels in Part D show robust negotiation continues

Posted by Nicole Longo on August 22, 2016 at 9:00 AM

A key component of the success of Part D is the negotiation and competition that occurs, helping to keep costs low for beneficiaries and taxpayers.

The way the program works is Part D purchasers negotiate discounts and rebates with prescription drug manufacturers. Because these large, powerful purchasers represent as many as 60 to 120 million covered lives, they have significant leverage to negotiate large discounts and rebates with manufactures on behalf of Part D plans. These savings are used to help reduce premiums, deductibles and cost sharing for Part D beneficiaries.

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Topics: Part D, Medicare, Medicare Monday

New report highlights more than 250 vaccines in development

Posted by Hannah Mooney on August 18, 2016 at 12:00 PM

More than 200 years ago, the first vaccine was developed for smallpox, and now, the disease has been eradicated worldwide. And in the United States, the transmission of poliovirus, measles and rubella have been eliminated. These are examples of tremendous scientific progress, and through our growing understanding of how these and other diseases work at the molecular level, many new therapeutic and preventative vaccines have been developed.

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Topics: Medicines in Development, Vaccines, Prevention

In biopharmaceutical research, if at first you don’t succeed, try again

Posted by Andrew Powaleny on August 17, 2016 at 2:23 PM

In case you missed it, an article in STAT News today profiles setbacks inside the process of researching new treatments and cures for patients. For America’s biopharmaceutical research companies, setbacks are far more common than success, but these stumbling blocks provide invaluable knowledge that help guide and direct researchers to get one step closer to the next scientific advancement.

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Topics: Drug Development, Neurological Disease

340B Spotlight: Retail pharmacies continue to expand the 340B program

Posted by Rebecca Davison on August 17, 2016 at 9:00 AM

One area of needed reform in the 340B program is the use of contract pharmacy arrangements. A new analysis by Drug Channels  found more than one-in-four retail, mail and specialty pharmacies in the United States is a participating contract pharmacy. Walgreens remains the biggest player in the contract pharmacy space, as they have the same number of locations as Walmart, CVS, Rite Aid, Kroger and Albertsons combined

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Topics: 340B, 340B Spotlight, Policy Solutions, Market Distortions

Study finds actual cost of 14 new medicines is billions less than predicted

Posted by Holly Campbell on August 16, 2016 at 5:00 PM

In case you missed it, a forthcoming study will disprove – once again – misleading claims pharmacy benefit managers and insurers, among others, routinely make about spending on new innovative medicines.

The Partnership for Health Analytics Research (PHAR) conducted an analysis of predictions of health care costs made prior to the introduction of 14 new medicines and found they were often dramatically overestimated.

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Topics: drug cost, Value-Driven Health Care

Medicare Monday: Concerns still abound about Part B proposal

Posted by Allyson Funk on August 15, 2016 at 9:00 AM

We’ve covered many of the concerns about the government’s overreaching proposal to change Medicare Part B payments and negatively impact seniors’ access to treatment. A lack of patient protections, use of one-size-fits-all treatments and mandatory changes across Medicare are just a few.

Patients, physicians and policy experts alike are continuing to raise the alarm about the proposal. Here’s a look at what some have been saying.

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Topics: Access, Medicare, Medicare Monday, seniors, Part B, CMMI

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