Posts Tagged “PhRMA”

USA: The Fight To Lower Soaring Drug Prices Turns Bitter Between States And The Feds

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USA: The Fight To Lower Soaring Drug Prices Turns Bitter Between States And The Feds

Frustrated by federal inaction, state lawmakers in 41 states have proposed detailed plans to lower soaring prescription drug costs. Some measures would give state Medicaid agencies more negotiating power. Others would disclose the pricing decisions of the drug manufacturers and the companies that administer prescription drug plans.

The more ambitious proposals would bump up against federal authority, such as legislation that would allow importing drugs from Canada or alter federal statutes on the prices states pay for drugs in Medicaid. They likely would have to survive a challenge in federal court. And many likely would face resistance from a deep-pocketed pharmaceutical industry.

According to the National Institute on Money and Politics, a nonprofit that collects campaign finance data, the pharmaceutical industry in 2018 contributed nearly $19 million to state campaigns, and $56 million to federal ones.

“States are limited in power in this area,” said Rachel Sachs, a health law expert at Washington University in St. Louis School of Law. “But one of the impacts of these efforts is to put pressure on the federal government, and force it to justify its actions to stymie the states.”

President Donald Trump has criticized soaring drug prices, and on Thursday the Department…

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USA: Trump wants to slash drug rebate deals. Will it make a difference?

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USA: Trump wants to slash drug rebate deals. Will it make a difference?

Few consumers have heard of the secret, business-to-business payments that the Trump administration wants to ban in an attempt to control drug costs.

But the administration’s plan for drug rebates, announced Thursday, would end the pharmaceutical business as usual, shift billions in revenue and cause far-reaching, unforeseen change, say health policy authorities.

In pointed language sure to anger middlemen who benefit from the deals, administration officials proposed banning rebates paid by drug companies to ensure coverage for their products under Medicare and Medicaid plans.

“A shadowy system of kickbacks,” was how Health and Human Services Secretary Alex Azar described the current system in a Friday speech.

The proposal is a regulatory change applying only to Medicare plans for seniors and managed Medicaid plans for low-income people. But private insurers, who often take cues from government programs, might make a similar shift, administration officials said.

Drug rebates are essentially discounts off the list price. Outlawing them would divert $29 billion in rebates now paid to insurers and pharmacy benefit managers into “seniors’ pocketbooks at the pharmacy counter,” Azar said.

The measure already faces fierce opposition from some in the industry and is unlikely to be implemented as presented or by the…

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USA: Proposed Medicare reforms spark comments about drugs

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USA: Proposed Medicare reforms spark comments about drugs

The Centers for Medicare and Medicaid Services, part of the Department of Health and Human Services has proposed a reform titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.” Many are arguing for and against the reforms, which some mentioning how HIV care would be threatened.

PhRMA have commented that ‘overall, the changes to the six protected classes should not be finalised: PhRMA strongly opposes proposed changes to the six protected classes policy.  The protected class policy affords access to vital and life-saving medicines for patients with serious and debilitating conditions. The administration is proposing to weaken the current six protected class policy in several ways, notably by allowing health plans to force patients who are stable on a medicine to go through prior authorisation or step therapy. We have several concerns with these proposed changes. The proposed changes could have serious health consequences for patients and are unnecessary given that plans already have tools to manage utilisation in these classes and significant savings from the proposed changes are unlikely. We also have legal concerns with the proposed changes, which are inconsistent with Part D’s non-discrimination protections.’

The National Association of Specialty Pharmacy has also…

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Will Democrats’ Plan to Lower Drug Prices Actually Work?

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Will Democrats’ Plan to Lower Drug Prices Actually Work?

Vermont Senator Bernie Sanders and California House Representative Ro Khanna have proposed new legislation seeking to drastically reduce the price of pharmaceutical drugs in the United States.

It’s a popular goal. According to a Kaiser Health Tracking Poll released last April, 60 percent of Americans said that lowering the price of prescription drugs should be a “top priority” for Congress and the Trump administration.

The current administration’s efforts to curtail drug prices have worked to some extent. There were 57 percent fewer price increases on brand-name drugs last year compared to 2017, according to Health and Human Services Secretary Alex Azar.

But they’re still rising.

“Some manufacturers are still in denial about whether bringing down list prices is even an important goal,” Azar said at an event by the Council for Affordable Health Coverage. “They claim that these skyrocketing prices don’t matter. But these prices do matter to patients, in a number of important ways.”

The Proposal

The Sanders-Khanna legislation, the “Prescription Drug Price Relief Act of 2019” would attempt to lower drug prices across the board by using three levers.

The first is linking the United States’ prescription drug prices to the median price among five countries: France, Germany,…

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USA: results of the midterm elections and how they will impact pharma

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USA: results of the midterm elections and how they will impact pharma

Elizabeth Carpenter, SVP, Avalere

Both Republicans and Democrats are likely to use the next session of Congress to position their parties for 2020. For Democrats, this will likely mean a continued focus on protecting key portions of the Affordable Care Act, lowering healthcare costs, and potentially expanding access to public programs.

Meanwhile, Republicans will consider whether they will renew efforts to repeal and replace the Affordable Care Act or turn to more incremental reforms. Democratic control of the House will likely heighten focus on drug prices and potentially increase the likelihood that biopharmaceutical companies could be at risk to offset or “pay-for” government spending. Importantly, the administration’s aggressive agenda on drug pricing will continue, regardless of the leadership change in the House.

Jon Bigelow, Executive Director, Coalition for Healthcare Communications

Divisiveness was the real winner in the midterms, and there will be few areas in which the two parties will collaborate productively in the year ahead. With power divided, each party has a stronger incentive to stake out positions for 2020 than to find bipartisan solutions now.

One issue where President Donald Trump, Senate Republicans, and House Democrats may find common ground is in concern over high drug prices —…

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Leverage, Transparency, and Competition suggested goals for lowering drug prices in the U.S

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Leverage, Transparency, and Competition suggested goals for lowering drug prices in the U.S

The issue isn’t new: Drug prices in the U.S. keep going up. Manufacturers justify these increases based on the high price of R&D, pharmacy benefit managers (PBMs) negotiate rebates while pocketing a large percentage of the savings, and insurers pass down costs to patients via higher deductibles and copays.

As more innovative and expensive therapies enter the market, the issue of affordability vs. value—both on an individual and system-wide level—has taken on a new urgency. While related, they are not the same. A medicine can be “worth it,” in terms of eventual cost-savings and effects on patients, but if a patient or health system can’t afford it, “it doesn’t matter how much it’s worth,” said Gary Pisano, a professor at Harvard Business School.

Pisano was one of five panelists who convened to discuss strategies for “making medicines affordable” at the 2018 Galien Forum, which was held in New York in October.

While the panelists brought a variety of perspectives and suggestions to the table, more than anything else, the discussion highlighted just how far the U.S. is from implementing a solution.

Below are three potential big-picture goals to strive for, nonetheless.

Leverage. There’s been a lot of discussion around why…

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Failures in pharma R&D may pave the way for medical breakthroughs of the future.

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Failures in pharma R&D may pave the way for medical breakthroughs of the future.

Nobody wants to experience failure, but everybody does occasionally. Some experience failure more than others. This is the case for those who work in medical research, as failure is so often a part of the job while on the road to scientific discovery. While many consider failure to be a completely negative experience, that’s not always the case, as every failure is still a lesson learned. Occasionally, these failures can even lead to some of the biggest breakthroughs in medical history.

Turning failure into innovation

In a recent article, the former president of Pfizer Global Research and Development details just how failures in the pharmaceutical industry can actually lead to innovations later down the line. In his article, he talks about how the study of a drug that was designed to raise HDL-cholesterol ended up failing to show that the drug was able to help prevent heart attacks and stroke. But this failure turned out to be a pretty big breakthrough for the pharmaceutical industry, as it ended up proving that elevating levels of HDL-cholesterol through medication had little to no impact on heart attacks and strokes, thus ending the theory that increasing one’s amount of “good cholesterol” could help prevent such…

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The mid-term elections in the US may usher new drug-pricing reforms

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The mid-term elections in the US may usher new drug-pricing reforms

HOW THE MIDTERMS COULD IMPACT PHARMA — As you’ve probably heard, voters across the United States of America head to the polls Tuesday, and could shake up the power structure of Congress. Most interesting to us is what could flow from a Democratic takeover of the House coupled with continued Republican control of the Senate. That dynamic could up the chances for drug-pricing reform, one of the most significant areas where President Donald Trump has signaled he might reach across the aisle.

Big vs. little stuff: That doesn’t mean we should expect a big breakthrough on, say, negotiating drug prices in Medicare. But impactful incremental reforms, like increasing transparency around drugmakers’ relationships with pharmacy benefit managers to ensure there is no collusion to keep prices high, could get bipartisan support. The expansive Medicare Part B drug payment pilot that HHS rolled out two weeks ago also is likely to get more support from congressional Democrats than Republicans. Refresh your memory on the landscape for drug pricing collaboration with this story for Pros here.

Despite the long odds, Democrats won’t give up without a fight on bold moves like government negotiation of drug prices, which Trump supported on the campaign trail…

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USA: requiring drug pricing in ads is a complicated affair, but some transparency is essential

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USA: requiring drug pricing in ads is a complicated affair, but some transparency is essential

Since the release of President Trump’s “Blueprint to Lower Drug Prices” this spring, there has been chatter about the Trump Administration requiring drug manufacturers to publicize the list price of their medications in direct-to-consumer (DTC) advertising. Sensing that the administration was ready to move on such a proposal, the Pharmaceutical Research and Manufacturers of America (PhRMA) preemptively released a “new approach to DTC television advertising” on Monday promising to provide more information on drug prices, apparently in the hopes of curtailing action by the administration.

Nevertheless, later that Monday Health and Human Services Secretary Alex Azar announced new requirements for DTC television advertising for prescription drugs that are available through the Medicare or Medicaid programs. The proposed rule would require ads to include the list price of the drug advertised. The rule would allow for either the list price for a 30-day supply or for the typical course of treatment, whichever is most appropriate. The price must also be current as of the broadcast date of the ad. Finally, the requirement would not apply to drugs with a list price of less than $35.

How valuable would this information be to consumers? There is considerable debate. Critics of the rule…

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PhRMA members announce new commitment to improve transparency in medicine costs, but will it be enough?

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PhRMA members announce new commitment to improve transparency in medicine costs, but will it be enough?

To help patients make more informed health care decisions, Pharmaceutical Research and Manufacturers of America (PhRMA) member companies today announced their commitment to providing more transparency about medicine costs. PhRMA member companies’ direct-to-consumer (DTC) television advertisements will soon direct patients to information about medicine costs, including the list price of the medicine, out-of-pocket costs or other context about the potential cost of the medicine and available financial assistance. The biopharmaceutical industry will also launch a new platform that will provide patients, caregivers and providers with cost and financial assistance information for brand-name medicines, as well as other patient support resources.

“Our member companies are taking a new approach to how they communicate about medicines in DTC television advertisements to make it easier for patients to access information about medicine costs,” said Stephen J. Ubl, president and chief executive officer of PhRMA. “The Administration and Congress have called on our industry to provide cost information in DTC advertisements, and our members are voluntarily stepping up to the plate.”

On October 2, the PhRMA Board of Directors adopted enhancements to PhRMA’s voluntary DTC principles, Guiding Principles on Direct-to-Consumer Advertisements About Prescription Medicines (originally adopted in 2006). The DTC Principles have been expanded…

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