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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Patient Advocates Should Have Fought For Affordable Duchenne Drug as More Insurers Deny Coverage

Patient Advocates Should Have Fought For Affordable Duchenne Drug as More Insurers Deny Coverage | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The story of Exondys 51 raises complex and emotionally charged questions about what happens when the F.D.A. approves an expensive drug based on a lower bar of proof. In practice, health insurers have taken over as gatekeeper in determining who will get the drug.

 

Disputes like the one over the Duchenne drug are likely to become more commonplace in the coming months. A federal law, passed last year, directs the agency to remove barriers to approving drugs and medical devices, and its new commissioner, Dr. Scott Gottlieb, has called on the F.D.A. to be more lenient, especially when it comes to rare pediatric diseases.

 

While insurers once covered drugs for rare diseases as a matter of course, that may be changing now that a wave of expensive drugs have reached the market. The pharmaceutical industry has been in hot pursuit of an increasingly enticing demographic target: An estimated 30 million people in the United States — about 10 percent of the population — are living with one of roughly 7,000 rare diseases.

 

The agency’s approval of Exondys 51, though, prompted a rebellion among some insurers, who are refusing to play along and saying they are concerned about the cumulative impact of such breathtakingly expensive drugs on health care costs. Anthem, one of the nation’s largest insurers, calls Exondys 51 “investigational” because the F.D.A. reserved the right to withdraw it from the market if future clinical trials fail to show it works.

 

Another insurer, Premera Blue Cross, went so far as to tie coverage to an invasive procedure — a muscle biopsy — but then rescinded the requirement.

 

“I’m reading a lot of denial letters,” said Christine McSherry, who until recently served as executive director of the Jett Foundation, an advocacy group that guides families through the insurance appeal process. Her insurer, Blue Cross Blue Shield of Massachusetts, is covering the drug for her son, Jett, through next April. “It’s very disheartening to have worked that hard, and to have sacrificed that much, and to now have to battle the insurance companies.”

 

The drug’s high cost is driving the resistance. While the drug manufacturer, Sarepta, has said Exondys 51 costs about $300,000 a year per child, the price, based on a child’s weight, can be much higher. For the dozen boys in the main clinical trial, the average list price would be more than double Sarepta’s quote — $750,000 each, according to an analysis by the drug benefit firm Prime Therapeutics.

 

“I think a lot of the advocates in this space maybe thought that getting a drug on the market was the goal of their advocacy,” said Dr. Aaron S. Kesselheim, an associate professor of medicine at Harvard University who voted against the drug’s approval as part of an F.D.A. advisory committee. “The goal of the advocacy should have been getting a product on the market, and making sure that it’s available at a reasonable cost.”

 

Further Reading:

  • “2nd Largest Health Insurer – Anthem – Won’t Pay for FDA-Approved Duchenne Drug”; http://sco.lt/6hlYP3
  • “FDA’s Approval of Exondys 51 for DMD Was Primarily Based on Money, Not Efficacy”; http://sco.lt/62xNoH
Pharma Guy's insight:

This article also points out that this may be a trend for expensive drugs that are approved for rare diseases: "While insurers once covered drugs for rare diseases as a matter of course, that may be changing now that a wave of expensive drugs have reached the market. The pharmaceutical industry has been in hot pursuit of an increasingly enticing demographic target: An estimated 30 million people in the United States — about 10 percent of the population — are living with one of roughly 7,000 rare diseases."

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#Pharma "Price Gougers" Are Hiding Under "Veil That They Are Saving Lives," Say Health Insurers

#Pharma "Price Gougers" Are Hiding Under "Veil That They Are Saving Lives," Say Health Insurers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

When asked why health care spending in Massachusetts continued to grow, insurers and hospital systems pointed the finger in a familiar direction: toward the pharmaceutical industry.

 

The discussion occurred at the fourth annual Cost Trends Hearings, a two-day event held by the state’s health care watchdog, The Health Policy Commission, that seeks to understand the drivers of health care spending with expert testimony from the state’s biggest players.

 

Health insurers and providers spoke with the Health Policy Commission at its annual Cost Trends Hearing on Monday.

 

Despite the state’s laser focus on health care spending, total medical spending in Massachusetts has continued to rise above the state’s 3.6 percent goal. Initial estimates for 2015 showed health care spending went up 4.1 percent.

 

Why? Drug costs, health care heavyweights said.

 

“We’re fortunate to have the pharma industry in the U.S.,” said Eric Schultz, president and CEO of Harvard Pilgrim Health Care. But he said he wants to "put a spotlight on those gougers" — those in the industry that are engaged in price gouging, systematically raising the prices of older drugs.

 

"They are behaving poorly and hiding under a veil that they are saving lives… if we don’t legislate something that demands transparency for the bad payers… we need to hold them accountable. If we don’t we will see these trends continue,” he said.

Pharma Guy's insight:

Of course, the gougers blame the insurance industry! Read, for example, “Mylan CEO Bresch Says Healthcare in Crisis No DIfferent Than 2007 Financial Crisis!”; http://sco.lt/6sIX1F and “Pharma CEO Rips Insurance CEOs a New One! Exposes Salaries, Blames Them for High Drug Prices”; http://sco.lt/6kN065

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Secretive Boards of HCPs Control Access to Rx Drugs. Should There Be More Transparency?

Secretive Boards of HCPs Control Access to Rx Drugs. Should There Be More Transparency? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Each year, Express Scripts releases a list of prescription drugs it will exclude from coverage for the upcoming year, and that list is determined by a secretive board of doctors and a pharmacist.

 

The nation’s largest pharmacy benefit manager, which is based in St. Louis County, does not disclose the names of the board members or any actual or potential conflicts of interest they may have.

 

Express Scripts is not alone. Its rivals also exclude drugs from their own annual drug formularies — the list of drugs they will cover — based on the recommendations of unidentified experts.

 

The reason behind the secrecy is to shield experts from the “tremendous” influences of lobbyists, Express Scripts executives say. But some critics say the process should be more transparent, as it is in many other countries.

 

The secrecy remains when the rest of the industry is required to publicly disclose its financial relationships. For example, drugmakers and device makers must report how much they pay doctors for perks such as food and beverage, travel and speaking engagements.

 

“All of us are subject to reporting on what money we receive. These folks should do the same,” said Dr. Adrian Di Bisceglie, co-director of St. Louis University Liver Center.

 

The list, or what Express Scripts calls its national preferred formulary, is a major tool to curb the rising costs of prescription drugs. The threat of being excluded pressures drug makers to lower their prices.

 

Other countries are much more transparent with this process of selecting drugs, and the secrecy is not common in other parts of the world, said Steve Morgan, professor of health policy at the University of British Columbia and an expert on international pharmaceutical policy.

 

“The professionals who are on these committees are put under enormous pressure — political pressure, lobbying pressure from patient groups and industry,” Morgan said.

 

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More Kids with Health Insurance + High Drug Prices = No Net Gain?

More Kids with Health Insurance + High Drug Prices = No Net Gain? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

As reported by STAT Morning Rounds:


"The number of people without health insurance in the US has continued to tumble: In the first nine months of 2015, just 9.1 percent of people didn’t have coverage. That means there are 16 million fewer uninsured people than in 2013, according to new data from the CDC. One group that’s seeing a big boost: children. The share of kids without insurance has dropped to just 4.5 percent, from 14 percent in 1997."


Aside from these children (and adults), who has benefited from Obamacare? (Read my "insight" below for the answer, as if you didn't already know this).

Pharma Guy's insight:

Insurance companies and the pharmaceutical industry have benefited from Obamacare because millions more people have bought health insurance and can afford their medicines. Counteracting that, however, is the collusion between these two industries to raise drug prices and jack up the deductibles insured patients must pay!

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Insurance is Driving Physicians Mad; Nearly Half Now Say They’d Prefer Single-Payer

Insurance is Driving Physicians Mad; Nearly Half Now Say They’d Prefer Single-Payer | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Nearly half of the 500 doctors who responded to a February LinkedIn survey said they would support a single-payer healthcare system, or Medicare-like coverage for everyone, not just the elderly, instead of the current patchwork model of insurance coverage.

 

The reasons that patients delay care until they can’t wait any longer are complex. But a barrier doctors said they consistently see is a fragmented system: People either don’t have health insurance or can’t find a doctor who accepts their coverage.

 

The physician sentiment comes as Congress is locked in a debate about what to do about the Affordable Care Act. Republicans in the House last week pulled a bill that would have significantly altered the insurance landscape.

 

But for many physicians, the issue comes down to efficiency. In their responses, they cited the administrative hassle of working with multiple insurance companies, each with its own rules and billing procedures. And they pointed to some of the less visible costs, like patients who bounce from one healthcare provider to another as their health plans change.

 

A total of 48% of physicians said they would be in favor of single-payer healthcare, while 32% were opposed and 21% said they didn’t know.

 

Our survey was conducted Feb. 7-19 and reached 511 physicians in the U.S. A total of 449 respondents are currently practicing in patient care. They were chosen at random, and reflect a number of different specialties and years of experience.

 

Further Reading:

  • “Kaiser Poll: 63% Positive About ‘Medicare-for-All’ vs 44% for ‘Single Payer’"; http://sco.lt/5ZAj45
Pharma Guy's insight:

Pharma's strategy to position insurance companies as the culprit causing high drug prices may have backfired if this survey is any indication. 

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Pharma CEO Rips Insurance CEOs a New One! Exposes Salaries, Blames Them for High Drug Prices

Pharma CEO Rips Insurance CEOs a New One! Exposes Salaries, Blames Them for High Drug Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The major contributor to soaring drug list prices is continual and progressive rebating demands by Big Insurance and the PBMs.

 

Without at all justifying Mylan (they need to account for their own actions), do you not find it noteworthy that they raised price on EpiPen by 31% in 2015 and also saw a 7% increase in prescriptions, yet net revenue from EpiPen actually DECLINED by 2%? That implies that Mylan did not keep a dime of the 31% increase and actually went backward in sales, which would have declined even more without the 7% increase in units sold.

 

Where did that money go? It went to rebates and fees to the PBMs, wholesalers, etc. We are stuck in a vicious, escalating circle of rising rebates, requiring drug innovators to take ever higher list prices, of which they only keep some fraction or even none. There is no transparency so everyone can know who is taking what part of the drug dollar (“Secretive Boards of HCPs Control Access to Rx Drugs. Should There Be More Transparency?”).

.

 

Written by: Ron Cohen- Ron Cohen, M.D., President and Chief Executive Officer, founded Acorda Therapeutics, Inc.

Pharma Guy's insight:

This is not the first time a pharma representative implied that  insurers have been throwing the pharma and biotech industry under the bus. For more on that, read “Former Washington Pol, Now CEO of BIO, Says Insurers Discriminate Against #Pharma”; http://sco.lt/7NhS53

 

Also read “Secretive Boards of HCPs Control Access to Rx Drugs. Should There Be More Transparency?”; http://sco.lt/65BMHp

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Stronger Together, Pharma & Health Insurer Pay for Snoop Dogg To Perform At the DNC

Stronger Together, Pharma & Health Insurer Pay for Snoop Dogg To Perform At the DNC | Pharmaguy's Insights Into Drug Industry News | Scoop.it

When celebrities, high-level party operatives and the blue blazer-and-khaki crowd of staffers and journalists join together for the highly publicized Snoop Dogg concert immediately following presumptive nominee Hillary Clinton’s acceptance speech at the Democratic National Convention, they’ll be doing so thanks to funding from two of the biggest lobbying forces in Washington.

Through a fundraising committee called Unity Convention 2016, three super PACs are organizing the Snoop Dogg Unity event and a concert with the band Los Lobos. So far, the two biggest donors for the events are the Pharmaceutical Research and Manufacturers of America (PhRMA), the lobbying arm of the drug industry, and Anthem, Inc., a major health insurer.

PhRMA and Anthem each contributed $50,000 to the committee, according to a filing with the Federal Election Commission.

Unity Convention 2016 raises money for Priorities USA Action, the super PAC backing Clinton’s presidential campaign; Senate Majority PAC, which supports Democratic Senate candidates and is closely tied to Senate Minority Leader Harry Reid; and House Majority PAC, which is close to House Minority Leader Nancy Pelosi and is tasked with electing Democrats to the House.

Each of these super PACs contributed $10,000 to help cover the cost of their convention events. 

PhRMA and Anthem are major lobbying forces in Washington with significant policy interests that will arise in the next administration and Congress. PhRMA and Blue Cross Blue Shield, of which Anthem is a member, are perennially two of the top 10 lobbying groups that spend the most, according to the Center for Responsive Politics. Super PACs and dark money nonprofits are closely connected to donors with important lobbying interests, The Huffington Post has previously reported. 

PhRMA was the key player in the Washington influence industry to help the Obama administration push the Affordable Care Act through Congress. The lobbying group made a behind-the-scenes agreement to support the legislation as long at it did not include long-standing Democratic Party policies allowing Medicare to negotiate drug prices for seniors or allow cheaper drugs to be imported from Canada and other countries.

A draft of the 2016 Democratic Party platform, however, calls for Medicare to negotiate drug prices and allows for such drug importation. In addition, the platform calls for capping the price of prescription drugs, including how much Americans pay out-of-pocket for drugs, as well as expanding community health centers that can obtain cheaper drugs and increasing how quickly generics reach the market.

Pharma Guy's insight:

I thought pharma and health insurers blamed each other for high drug prices and at least one industry lobby group contends that insurers have been throwing the pharma and biotech industry under the bus. For more on that, read “Former Washington Pol, Now CEO of BIO, Says Insurers Discriminate Against #Pharma”; http://sco.lt/7NhS53

 

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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 | Scoop.it
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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