Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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JAMA Health Policy Infographic Spotlights Public Opinion on Health Care Reform

JAMA Health Policy Infographic Spotlights Public Opinion on Health Care Reform | Pharmaguy's Insights Into Drug Industry News |

this Visualizing Health Policy infographic spotlights public opinion on health reform in the United States as of 2017. The largest percentage of Democrats and Republicans give top priority to lowering out-of-pocket costs for health care. However, other priorities vary by political party: 63% of Republicans vs 21% of Democrats view Affordable Care Act (ACA) repeal as a top priority, while 67% of Democrats vs 55% of Republicans view lowering the cost of prescription drugs as a top priority. Although opinions about the ACA have varied over the years, in March 2017, 49% of the public view the ACA favorably and 44% view it unfavorably. The majority of individuals in both political parties feel positively about many ACA provisions, including allowing states to expand Medicaid and prohibiting denial of insurance coverage due to preexisting conditions. However, only 21% of Republicans and 30% of independents favor the individual mandate that requires paying a fine in the absence of health insurance. The public is divided on what should happen to the ACA: just more than half say they don’t want lawmakers to repeal the law, about a quarter want a repeal only after replacement plan details are announced, and only 19% favor an immediate repeal in advance of a replacement plan. Sixty-four percent of the public supports guaranteeing a certain level of health coverage for seniors and low-income people, even if the federal government’s spending and role in health care increases.

Pharma Guy's insight:

Lower Rx drug costs #2 on the list.

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Trump's Plan to Make Healthcare Great Again

Trump's Plan to Make Healthcare Great Again | Pharmaguy's Insights Into Drug Industry News |

Congress must act. Our elected representatives in the House and Senate must:

  • Completely repeal Obamacare. Our elected representatives must eliminate the individual mandate. No person should be required to buy insurance unless he or she wants to.
  • Modify existing law that inhibits the sale of health insurance across state lines. As long as the plan purchased complies with state requirements, any vendor ought to be able to offer insurance in any state. By allowing full competition in this market, insurance costs will go down and consumer satisfaction will go up.
  • Allow individuals to fully deduct health insurance premium payments from their tax returns under the current tax system. Businesses are allowed to take these deductions so why wouldn’t Congress allow individuals the same exemptions? As we allow the free market to provide insurance coverage opportunities to companies and individuals, we must also make sure that no one slips through the cracks simply because they cannot afford insurance. We must review basic options for Medicaid and work with states to ensure that those who want healthcare coverage can have it.
  • Allow individuals to use Health Savings Accounts (HSAs). Contributions into HSAs should be tax-free and should be allowed to accumulate. These accounts would become part of the estate of the individual and could be passed on to heirs without fear of any death penalty. These plans should be particularly attractive to young people who are healthy and can afford high-deductible insurance plans. These funds can be used by any member of a family without penalty. The flexibility and security provided by HSAs will be of great benefit to all who participate.
  • Require price transparency from all healthcare providers, especially doctors and healthcare organizations like clinics and hospitals. Individuals should be able to shop to find the best prices for procedures, exams or any other medical-related procedure.
  • Block-grant Medicaid to the states. Nearly every state already offers benefits beyond what is required in the current Medicaid structure. The state governments know their people best and can manage the administration of Medicaid far better without federal overhead. States will have the incentives to seek out and eliminate fraud, waste and abuse to preserve our precious resources.
  • Remove barriers to entry into free markets for drug providers that offer safe, reliable and cheaper products. Congress will need the courage to step away from the special interests and do what is right for America. Though the pharmaceutical industry is in the private sector, drug companies provide a public service. Allowing consumers access to imported, safe and dependable drugs from overseas will bring more options to consumers.
Pharma Guy's insight:

Absent from the plan is allowing Medicare to negotiate drug prices, which he backed earlier in New Hampshire: "We don't do it. Why? Because of the drug companies," he said.  

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Ich beim Arzt - Fünf Tipps aus Pfizer

Ich beim Arzt - Fünf Tipps aus Pfizer | Pharmaguy's Insights Into Drug Industry News |

Fünf Tipps für Ihr Gespräch mit dem ArztEin gutes Gespräch mit meinem Arzt – was kann ich dafür tun?Unser Crash-Kurs für eine bessere Kommunikation hilft.

Als Patient wünscht man sich Ärzte, die zuhören und alle Fragen, die man in die Sprechstunde mitbringt, in einer patientenverständlichen Sprache beantworten. Doch die Realität sieht leider manchmal anders aus. So manche Patientenfrage bleibt unbeantwortet. Die gute Nachricht: Patienten können selbst viel dafür tun, dass die Kommunikation mit dem Arzt funktioniert.

Unser kleiner Crashkurs hilft Ihnen, sich auf das Arztgespräch vorzubereiten. Das Gute daran: Unsere Tipps für eine bessere Kommunikation können Sie sich leicht merken und später in der Sprechstunde an einer Hand abzählen.

Es lohnt sich. Denn ein gutes Gespräch mit dem Arzt hilft.

Pharma Guy's insight:

(Translation into English with help from Google):

Five tips for your discussion with the doctor

A good conversation with my doctor - what can I do?

Our crash course for better communication helps.

As a patient you wish for doctors who listen and answer any questions that you bring into the clinic, in a patient-friendly language. But unfortunately the reality is sometimes different. Thus, some patients' questions remain unanswered. The good news: Patients can even do much to ensure that the communication is working with the doctor.

Our little crash course helps you prepare for the medical consultation. The good news: You can easily remember Our Tips for better communication and count them off later in the clinic on one hand (when doing so, please note proper German way of indicating #3 with fingers).

It's worth it. A good conversation with the doctor helps.

The Pfive tips from Pfizer are:

  1. Eins: Prepare questions in advance
  2. Zwei: Tell all - dare to ask questions.
  3. Drei: (please note proper German way of indicating #3 with fingers) Demand answers (I think)
  4. Vier: Takes notes
  5. Fünf: Make sure all is clear to you.

I once saw this tweet from @AstraZenecaUS:

"September is National Cholesterol Education Month. See your doctor and visit for a list of questions to ask."

There are about 16 questions in AZ's list! Given that the average time a patient has with a physician during an office visit is maybe 10 minutes, that's about 38 seconds to ask each question and get an answer! Is AZ kidding? No wonder we don't remember what the physician told us!

One question that AZ left out was "How can I get my personal health record online so that I remember all this and can use it?" 

It's also amusing that AZ suggests you print out the pdf version of its list of questions and bring it with you to the doctor's office. How quaint! Shouldn't there be a "Share This With Your Physician" button on the page so that you can send the questions immediately to your physician before you even see her? Now that's when the online health revolution will truly begin

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FDA's Social Media Guidances Provide Little That's New, Says Coalition for Healthcare Communication

Indeed, at the Drug Information Association Annual Meeting held last week in San Diego, Abrams noted that he expected minimal use of space-limited media because of the agency’s requirements on risk information. Cooke wrote that OPDP’s call for risk information that includes the most serious risks associated with the product, as well as all boxed warnings, makes it “difficult to imagine a product that has fatal or life-threatening risk, contraindications or boxed warnings that could be contained within the space-limited context of a Tweet, which has a 140-character limitation.” For example, he cited one product’s boxed warning, which alone contains 692 characters.

This approach “would limit the availability of space-limited communications to the small subset of prescription products whose risk and benefit information” meet the agency’s requirements, Cooke said, adding that the framework set forth by the draft guidance “seems more amenable to the participation of products with limited risks and short benefit statements.” He told the Coalition that the agency “could have suggested some approved abbreviations to help companies meet the requirements in a limited space – such as using ‘risks incl death’ instead of ‘risks include’ and listing all possible inclusions –but it chose not to.”

In an e-mail to Bloomberg BNA June 17, James N. Czaban, chairman of the FDA Practice Group at Wiley Rein LLP, said that the risk/benefit guidance “is actually very limited in scope” because it does not address many other types of online activity. He also told BNA that “The idea that FDA would allow a black box warning to be condensed for use in the format of Google Sitelinks or even Twitter is quite surprising given existing promotional limitations on black box products, and the length and seriousness of such warnings for many drugs,” Czaban told BNA. “Will any company risk such an approach from a liability perspective, even if it could meet the space limitations?”

Czaban said that “the bottom line is that FDA’s guidance leaves many questions unanswered, and its examples are of limited utility.”

Pharma Guy's insight:

Here's how I believe pharma can create a compliant tweet INCLUDES a 692-character boxed warning: A Type of Rx Drug Tweet FDA Did Not Consider in its Recent Guidance

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Health Insurers to Drug Companies: Bargain or Be Banned

Health Insurers to Drug Companies: Bargain or Be Banned | Pharmaguy's Insights Into Drug Industry News |

In dealing with health plans, drug companies are facing a new imperative — bargain or be banned.

Determined to slow the rapid rise in drug prices, more health plans are refusing to cover certain drugs unless the companies charge less for them.

The strategy appears to be getting pharmaceutical makers to compete on price. Some big-selling products, like the respiratory medicine Advair and the diabetes drug Victoza, have suffered precipitous declines in market share because Express Scripts, the biggest pharmacy benefits manager, recently stopped paying for them for many patients.

“There’s clearly more price competition in the marketplace,” Andrew Witty, chief executive of GlaxoSmithKline, said, talking about Advair in a recent company earnings call.

Executives of pharmacy benefit management firms say they must do something to cope with rising prices, particularly for so-called specialty pharmaceuticals, which are used to treat complex diseases like cancer and multiple sclerosis.

Spending on specialty drugs rose 14.1 percent last year and by even greater amounts in previous recent years, according to Express Scripts. Most of that increased spending comes not from new drugs or new patients, but from price increases on older drugs that can often exceed 10 percent year after year.

Many other countries control drug prices in some manner, so drug companies have become dependent on increasing prices in the United States to grow.

Pharmaceutical companies rarely talk in detail about how they set prices or decide on price increases. They generally say that the price reflects the value of the medicine, which in some sense is a measure of what the market will bear.

They also say that insurers and government programs like Medicaid typically pay less than list price, though how much is usually kept confidential. If health plans are now winning bigger discounts or rebates, it will not show up in list prices but will help relieve pressure on insurance premiums.

That appears to be happening to some extent. Analysts at Credit Suisse estimate that the collective discounts and rebates for 15 large drug companies amounted to 31.9 percent of gross United States sales in 2013, up from 30.2 percent in 2012 and 19.7 percent in 2007.

How much bigger and broader discounting will become remains to be seen. Tim Anderson, pharmaceutical analyst at Sanford C. Bernstein & Company, said he had always been skeptical that pharmacy benefit managers could rein in prices.

Pharma Guy's insight:

Sovaldi - A Cure for the One to Ten Percenters

Gilead, for example, only needs 15,000 patients to generate $1 Billion in sales of its recently approved HCV treatment, Sovaldi. There are an estimated 3.2 million Americans with chronic Hepatitis C infection. Gilead only has to provide 0.5% of them with Sovaldi to reach the magic $1 Billion in sales. Of course, Gilead would like to make more than $1 Billion from Sovaldi, maybe even $20 Billion, which would require treating 10% of current Hep C sufferers. OK, not quite "one percent," but close enough for all practical purposes!

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Consumers' Healthcare Costs Continue to Rise - Drug Costs First & Foremost

Consumers' Healthcare Costs Continue to Rise - Drug Costs First & Foremost | Pharmaguy's Insights Into Drug Industry News |

The key contributors to health care spending by percentage were, first and foremost, prescription drugs which rose 9% in the year — notably, specialty medicines like anti-infective drugs (such as those for Hepatitis C and HIV) costing on average $83 per “filled day.” This cost doubled from $53 per person in 2012 to $101 per person in 2015.

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"Heavy regulation makes healthcare a painful business," Says Google's Brin

"Heavy regulation makes healthcare a painful business," Says Google's Brin | Pharmaguy's Insights Into Drug Industry News |

The heavily regulated healthcare technology environment makes it a difficult business to pursue, according to Google's two co-founders, but they remain entranced by its possibilities.

"Generally, health is just so heavily regulated. It's just a painful business to be in," Sergey Brin told technology venture capitalist Vinod Khosla, adding: "I think the regulatory burden in the US is so high that think it would dissuade a lot of entrepreneurs.

Pharma Guy's insight:

But Brin said he was very excited about Google's glucose reading contact lenses, which "should be coming along pretty well".

I'm not surprised by Brin's comments. Google and the Brin family (including the Mrs. - Anne Wojcicki) have had run-ins with the FDA.  Google, for example, settled a U.S. criminal investigation into allegations it made hundreds of millions of dollars by accepting ads from online pharmacies that break U.S. laws (see "How FDA, in Cahoots with DOJ, Brought Google Down"). That's a serious felonious offense, yet nobody from Google went to jail!

And Mrs. Brin was caught trying to sell a genetic test kit with unproven accuracy. She just decided to ignore all of FDA's many inquiries until FDA had no choice but to shut down her business, at least temporarily (see "FDA Orders 23andMe to Immediately Discontinue Marketing "Spit for Cancer" Kit"). Even then, she remained defiant to the point where one wonders if wealth gives her the feeling of superiority uber alles. Nowadays, however, she is greasing the wheels with her wealth to get the FDA more in line with her business plan. Now, that wasn't so painful, Anne, was it?

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What Impact Will Hepatitis C Drugs Have on Medical Costs?

What Impact Will Hepatitis C Drugs Have on Medical Costs? | Pharmaguy's Insights Into Drug Industry News |
Just what impact will hepatitis C treatments have on medical spending over the next few years? A new estimate suggests that, for private insurers, the impact of new hepatitis C treatments – including Sovaldi and any forthcoming medications – on medical costs will eventually decline, as will the impact on the growth in spending on overall health care.
Pharma Guy's insight:

Good to know that burden on insurers will "eventually decline," but one issue remains: even with private insurance, many privately-insured Hep C patients won't be able to afford the co-pay for Sovaldi (& many simply do not have insurance). I'd be surprised if more than 10% of the 3.2 million Hep C patients in the U.S. will receive this drug -- something I do not think this analysis takes into account. For more on that, read: 

Sovaldi - A Cure for the One to Ten Percenters
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Using electronic health records to help advance drug development and safety monitoring

Using electronic health records to help advance drug development and safety monitoring | Pharmaguy's Insights Into Drug Industry News |

Not long ago, electronic health records (EHRs) were an idea solely for the future. Today, they’re a reality. Paper records are becoming part of the past. These days, when patients go to their physician’s offices, they are much more likely to have their care documented electronically. EHRs give health care professionals more data to provide patients higher levels of quality care and safety.

Now that EHRs are more widely used, they collectively represent huge amounts of important data about the medical products and prescription drugs patients are using. Significant amounts of information in patient EHRs may be used in clinical research, with appropriate protection of patient privacy, to aid the development of new and more effective medical therapies or to provide information on using existing treatments more effectively and safely. These data, combined with other sources of electronic healthcare data such as information from healthcare claims, are being used to better understand the performance of medical products.

A key challenge for the research community is to effectively harness the data contained in EHRs.

Pharma Guy's insight:

It seems to me that the FDA can reverse the dramatic rise in adverse event reports it receives by approving fewer new drugs with serious side effects. Case in point: The approval of Endo Pharmaceuticals' testosterone replacement therapy drug Aveed (read more here).

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