2020 Policy Talk: Healthcare

[Anastasis 23700]

13 minutes ago, Captainant said:

No, I'm saying I'm not dumb enough to trust that people (you) looking to make a buck off of sick people will have their best health outcomes at heart. 

 My dad, an advanced Parkinson's patient, has to fight tooth and nail to get fucking physical therapy so be he doesn't regress more than he already does. I'm sure your little sales pitch goes over great with people who don't have to live with and fight against insurance companies though.  What you're describing should be covered by the doctors and people who actually take an oath to do no harm, not by the fucking accountants in the back and doublespeaking sales douchebags in the front like yourself. 

Sorry that you are having that experience, I can understand your anger.  I have plenty of frustrations that I can account regarding the system and my families experiences with it, and have shared some of those from time to time here. I can also share a full suite of frustrations from my experience across the spectrum of healthcare care delivery, inpatient hospital, outpatient clinic, and med management clinics. I know that you won't take me up on this, but I would be happy to help share any possible insights I could wrt your personal situation if you wanted.  One of my biggest pet peeves from the Hornfans days was when it came out that they mods were readings people's PMs.  I had helped a number of posters with some sensitive things in terms of navigating the system, getting meds for family members, and some really serious med related questions and concerns. All I can share with you is my observations and experiences at this point in a policy discussion. If you choose to dismiss those and call me names, I can understand where you are coming from with it.  

[Anastasis 23700]

And Ant, if you think that I am not being sincere or that I as an individual either personally or professionally don't care, please understand that one of the lines where I have conducted some research is specifically on understanding the impact of neurological conditions and cancers not only on patients, but the halo effects they have on caregivers and family members. I get it, as best as I can without having lived the same situation. 

Edited April 22, 2019 by Anastasis

[JimmyHoffa 1188]

6 hours ago, Captainant said:

Nope, I'm saying using payout rates as an indicator is flawed because insurance companies are incentivized to pump up insurance payouts so they can charge a larger premium to their "customers" and reap a larger bottom line - because they are capped at what percentage they can charge to their customers for their "services". I've no doubt that medicare reimbursement isn't covering all costs, but we shouldn't be using such a heavily gamed and manipulated figure to argue policy.

Take a look at healthcare costs in the country, even for basic shit that we've had figured out for a while. Like epipens or fucking insulin. It's not weird to you how those prices are increasing at a geometric rate while in every other industry, existing products and services tend to get cheaper to produce over time? 

 

I agree Big pharma is bending over the american public but they are being helped by the FDA and their fucking idiotic rules that allow them to do such things. Like adding a meaningless additive to a current medication that delays it going generic. Or taking a fucking piece of plastic and wrapping it around a needle and charging 40 times what it cost for just the needle and medication. 

[JimmyHoffa 1188]

DP

Edited April 23, 2019 by JimmyHoffa

[bad_teammate 13481]

What Medicare for All can do for poor Americans is prefaced by what Medicare did for black Americans

 

[TwiceHorn 31994]

On 4/22/2019 at 9:45 PM, JimmyHoffa said:

 

I agree Big pharma is bending over the american public but they are being helped by the FDA and their fucking idiotic rules that allow them to do such things. Like adding a meaningless additive to a current medication that delays it going generic. Or taking a fucking piece of plastic and wrapping it around a needle and charging 40 times what it cost for just the needle and medication. 

Most importantly, keeping off-patent drugs off the market with obtuse generic rules and manufacturing certifications.

[Anastasis 23700]

14 hours ago, TwiceHorn said:

Most importantly, keeping off-patent drugs off the market with obtuse generic rules and manufacturing certifications.

Yeah, it's ridiculous the games played.  Few things that could help:

1. Ban DTC advertisements

2. End patent protection for me-too drugs

3. For second in class agents require head to head trials during registration program to inform comparative and cost effectiveness analyses 

Edited April 26, 2019 by Anastasis

[Captainant 28405]

The fucked up thing though is that pharma law is just as fucked up as IP law generally. Shit that should pass into the public domain, given enough corporate interest, will be delayed indefinitely. And also because of corporate interest through "insurance" and pharma companies, likely never will. Shareholder value is more important to them than the health of their customers. 

[TwiceHorn 31994]

13 hours ago, Anastasis said:

Yeah, it's ridiculous the games played.  Few things that could help:

1. Ban DTC advertisements

2. End patent protection for me-too drugs

3. For second in class agents require head to head trials during registration program to inform comparative and cost effectiveness analyses 

As we've discussed previously, "me-too" drugs used to be a thing patent-wise.  Now they are not.  As of 1995, all patents in a family claiming priority to an application expire when the priority application expires.  It is conceivable, but highly unlikely, that a "me too drug" gets a different priority date.

[Anastasis 23700]

24 minutes ago, TwiceHorn said:

As we've discussed previously, "me-too" drugs used to be a thing patent-wise.  Now they are not.  As of 1995, all patents in a family claiming priority to an application expire when the priority application expires.  It is conceivable, but highly unlikely, that a "me too drug" gets a different priority date.

I am not familiar with the terminology in this area, "family", "priority application" etc. Let's use a real world example, Seroquel and Seroquel XR. Seroquel's patent expired in 2012.  The XR formulation extended patent protection through 2017, or so.  I would also consider me-too in the broader sense of single enantiomer derivatives from a racemic mixture and active metabolite derivatives. I think that these derivatives should be required to demonstrate that they differentiate from the original product.  The argument for exclusivity is that the company needs to recoup the R&D investment and profit from the risk that they took to bring innovation to market.  OK, then demonstrate the innovation in the course of the registration trials.  The risk associated with developing many of these derivatives is extremely low. Many of these strategies amount to double dipping the revenue generation ability of the initial R&D investment.  

[Lidig8r 1904]

For the most part, the Cloak Room/Politics board has the reputation of being a joke, occupied mostly by people incapable of collaborative thought. Pretty much every thread breaks down to pedantic naming calling like children playing in a sand box who end up throwing mud pies at each other.

However, this thread has had some very insightful posts, thoughts and exchanges of ideas. Yes, there have been some, not unexpected, name calling replacing intelligent discourse of the issues, but some good ideas from both sides of the aisle.

Keep it up Gentlemen.

[Lurch 5949]

occupied mostly by people incapable of collaborative thought.

 

 

pedantic naming calling like children playing in a sand box who end up throwing mud pies at each other.

 

Way to stay above it.

 

[bad_teammate 13481]

"I choose to pay for hers and go without mine."

 

[Lidig8r 1904]

3 hours ago, Lurch said:

 

 

 

 

Way to stay above it.

 

The difference is that no, one individual poster was singled out.

And that particular opinion has been set forth on this site, and the Shag beforehand, it is pretty much its own meme now.

In any event, hope to see more intelligent conversation on this thread.

[tucker 238]

For anyone advocating for the private market

[Anastasis 23700]

15 minutes ago, tucker said:

For anyone advocating for the private market

The relevant LCDs for proton radiation therapy:

https://www.cms.gov/medicare-coverage-database/search/search-results.aspx?CoverageSelection=Local&ArticleType=All&PolicyType=Final&s=All&CptHcpcsCode=77520&bc=gAAAAAAAAAAA&=&

 

[Anastasis 23700]

The UHC medical coverage policy for comparison:

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/proton-beam-radiation-therapy.pdf

 

[GSU&UT 1799]

 

 

[Captainant 28405]

16 hours ago, Anastasis said:

The relevant LCDs for proton radiation therapy:

https://www.cms.gov/medicare-coverage-database/search/search-results.aspx?CoverageSelection=Local&ArticleType=All&PolicyType=Final&s=All&CptHcpcsCode=77520&bc=gAAAAAAAAAAA&=&

 

 

16 hours ago, Anastasis said:

The UHC medical coverage policy for comparison:

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/proton-beam-radiation-therapy.pdf

 

you know, being a shill expert for the profits or death industry, maybe you could actually tell us what you're linking us to and help us understand it? 

[Bozo_Casanova 26773]

2 hours ago, GSU&UT said:

 

 

That's awful and I know that people make those choices but please, if your toddler took a dangerous drug, go to the ER and do not wait for seizures in the parking lot. 

[Anastasis 23700]

Ant, the links are to the coverage policies for both Medicare and a private insurer (UHC). These were provided in response to the tweet and attached post that suggested that a coverage determination by UHC regarding proton radiation therapy was a compelling argument against a private market solution in health insurance.  What the CMS site shows is that 1) there is no national coverage determination related to proton beam therapy; 2) there is regional variability in coverage of proton therapy; 3) the local coverage determinations (LCDs) cover PBT for treatment of only select cancers, but restrict PBT coverage for treatment of prostate cancer; 4) The LCDs are extremely similar to the coverage policy of UHC.

In other words, Medicare appears to have a very similar coverage perspective wrt the use of PBT in prostate cancer. Which ties back to some of my comments up thread.  Utilization management, such as this case example related to PBT, is one of the primary pain points often touted in this discussion by people advocating a single payer solution, but in reality these same pain points are going to continue to exist whether we are talking about a single payer system or a private insurance based system.  Except in a single payer system there will be even less consumer driven options and more bureaucracy. That judge that threatened to sue UHC for reimbursement...how do you think that story goes when he is threatening to sue the federal government instead? Simple slogans will clash with reality at some point.  

Oh, and for those who think that Medicare for All is going to really move the needle on paperwork reduction, also from those LCDs:

Quote

Associated Information

Documentation Requirements

All documentation must be maintained in the patient’s medical record and available to the contractor upon request.

Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the physician or non-physician practitioner responsible for and providing the care of the patient.

The submitted medical record should support the use of the selected diagnosis code(s). The submitted CPT/HCPCS code should describe the service performed.

Each claim must be submitted with diagnosis codes that reflect the condition of the patient, and indicate the reason(s) for which the service was performed. Claims submitted without diagnosis codes will be returned.

Documentation in the patient medical record must support the reasonable and necessary requirements as outlined under the Coverage Indication, Limitations, and/or Medical Necessity section of this LCD.Documentation must include the planned course of therapy, type and delivery of treatment, level of clinical management involved and ongoing documentation of any changes in the course of treatment, and DHV as noted in the covered indications section.

 

Proton beam therapy will be considered medically reasonable and necessary for the following conditions (Group #1 of ICD-10-CM Codes that Support Medical Necessity):

Group #1 Conditions
 

• Benign or malignant conditions otherwise not suitable for intensity modulated radiation therapy (IMRT) or 3-dimensional conformal therapy involving the base of the skull or axial skeleton, including but not limited to chordomas and chondrosarcomas. 
   
• Solid tumors in children up to age 18.
   
• Benign or malignant central nervous system tumors to include primary and variant forms of medulloblastoma, astrocytoma, glioblastoma, arteriovenous malformations, acoustic neuroma craniopharyngioma, benign and atypical meningiomas and pineal gland tumors.
   
• Intraocular melanomas

Because many radiological oncologists believe that proton beam therapy is a legitimate treatment option in certain circumstances where 3-dimensional conformal or intensity modulated radiation therapy (IMRT) is deemed medically necessary, proton beam therapy will be considered as medically reasonable and necessary for certain other conditions (i.e., Group #2 of ICD-10-CM Codes that Support Medical Necessity) not listed above, as long as the following criteria are met:

Either #1, #2, or #3 must be present and

Either #4 or #5 must be present and

#6 must always be present.

1. When dose constraints to normal tissues limit the total dose of radiation safely deliverable to the tumor with other indicated methods

2. When there is a reason to believe that doses generally thought to be above the level otherwise attainable with other methods might improve control rates

3. In circumstances when the higher levels of precision associated with proton beam therapy as compared to other radiation methods are necessary, i.e clinically relevant

4. For the treatment of primary lesions, the intent of treatment must be curative

5. For the treatment of metastatic lesions, there must be
 

• a. the expectation of a long-term benefit (> 2y) that could not have been attained with conventional therapy
  
  b. the expectation of a complete eradication of the metastatic lesion that could not have been safely accomplished with conventional therapy, as evidenced by a dosimetric advantage for proton beam radiotherapy over other forms of radiation therapy

6. The patient’s record demonstrates why Proton beam radiotherapy is considered the treatment of choice for the individual patient. Specifically, the record must address the lower risk to normal tissue, the lower risk of disease recurrence, and the advantages of the treatment over IMRT or 3-dimensional conformal radiation. Dosimetric evidence of reduced normal tissue toxicity and/or improved tumor control must be maintained.

If the above provisions are met and the patient is treated in a protocol that is designed for evidence development and for future publication, it is expected that future published data will support an outcome advantage for patients for continued coverage of the specific diagnosis. The protocol in and by itself does not constitute criteria for coverage. The presence of an Institutional Review Board review, when appropriate, and patient informed consent are also expected.

Proton beam treatment of the following conditions may be considered medically reasonable and necessary only if the above criteria are met as specified (see Group #2 of the ICD-10 Codes that Support Medical Necessity).

 

Edited April 30, 2019 by Anastasis

[Incredulity 11861]

7 minutes ago, Bozo_Casanova said:

That's awful and I know that people make those choices but please, if your toddler took a dangerous drug, go to the ER and do not wait for seizures in the parking lot. 

Reading that doesn't invoke empathy,  it invokes anger.

A good portion at the moron who wouldn't get their kid treatment.

 

[Captainant 28405]

Thanks, I appreciate the breakdown

[Incredulity 11861]

15 minutes ago, Anastasis said:

Ant, the links are to the coverage policies for both Medicare and a private insurer (UHC). These were provided in response to the tweet and attached post that suggested that a coverage determination by UHC regarding proton radiation therapy was a compelling argument against a private market solution in health insurance.  What the CMS site shows is that 1) there is no national coverage determination related to proton beam therapy; 2) there is regional variability in coverage of proton therapy; 3) the local coverage determinations (LCDs) cover PBT for treatment of only select cancers, but restrict PBT coverage for treatment of prostate cancer; 4) The LCDs are extremely similar to the coverage policy of UHC.

In other words, Medicare appears to have a very similar coverage perspective wrt the use of PBT in prostate cancer. Which ties back to some of my comments up thread.  Utilization management, such as this case example related to PBT, is one of the primary pain points often touted in this discussion by people advocating a single payer solution, but in reality these same pain points are going to continue to exist whether we are talking about a single payer system or a private insurance based system.  Except in a single payer system there will be even less consumer driven options and more bureaucracy. That judge that threatened to sue UHC for reimbursement...how do you think that story goes when he is threatening to sue the federal government instead? Simple slogans will clash with reality at some point.  

Oh, and for those who think that Medicare for All is going to really move the needle on paperwork reduction, also from those LCDs:

I read this and think about all of the times I have ran into conflicting/ambiguous/unclear rules or regulations or codes on job sites while the bureaucrat inspector stands there and plays dumb.

[Bozo_Casanova 26773]

15 minutes ago, Incredulity said:

Reading that doesn't invoke empathy,  it invokes anger.

A good portion at the moron who wouldn't get their kid treatment.

 

Yes and no. She should have taken the kid in. Full stop. 
On the other hand, I've been in the waiting room of Dell Children's hospital while a family worried over their child's health  mixed in with a discussion of possible homelessness and hunger as a result of medical bills, collections, and damaged credit. Fear, frustration, depression, anxiety, defeat, all mixed up with concern over a sick kid.
Back in the late 90s when I was collecting on subprime auto loans for a living one of the major buckets our customers fell into were people who were doing fine until they had medical expenses they couldn't pay, which resulted in their auto financing being very expensive and their housing being further from their work, which made their commute more expensive and made getting a better job harder to do, which made their medical bills even harder to pay. 

She made a terrible choice and gambled on something she never should, but I understand the motivation. 

Edited April 30, 2019 by Bozo_Casanova

[Incredulity 11861]

2 minutes ago, Bozo_Casanova said:

Yes and no. She should have taken the kid in. Full stop. 
On the other hand, I've been in the waiting room of Dell Children's hospital while a family worried over their child's health  mixed in with a discussion of possible homelessness and hunger as a result of medical bills, collections, and damaged credit. Fear, frustration, depression, anxiety, defeat, all mixed up with concern over a sick kid.
Back in the late 90s when I was collecting on subprime auto loans for a living one of the major buckets our customers fell into were people who were doing fine until they had medical expenses they couldn't pay, which resulted in their auto financing being very expensive and their housing being further from their work, which made their commute more expensive and made getting a better job harder to do, which made their medical bills even harder to pay. 

She made a terrible choice and gambled on something she never should, but I understand the motivation. 

I agree.  Its awful.

Cutting to the god awful core, I can't imagine how stuffed full emergency rooms would be if the service is "free".  

 

[bad_teammate 13481]

I'd go party in an ER right now if it wasn't so damned expensive

i LOVE hanging around there!

[Bozo_Casanova 26773]

14 minutes ago, Incredulity said:

I can't imagine how stuffed full emergency rooms would be if the service is "free".  

No fuller than they should be. The demand for healthcare isn't price elastic, but the elasticity of consumption varies with criticality. The macroeconomic impact is the same either way, but the human impact is much worse than it should be because the consumption happens at more expensive points. If her kid was having a seizure, the cost to you and me for that unpaid bill is a hell of a lot higher than it would be if she doesn't wait. So why are we billing her at  list price at the most expensive point of sale when we already know she can't possibly pay? Because WE, the payers in the system want to pay even more? 

In countries with a more accessible and cost effective system than ours (so thats almost every non-third world country) you have both higher utilization AND lower costs, and the result is better outcomes in the aggregate. We really do have the worst form of socialism possible.

Edited April 30, 2019 by Bozo_Casanova

[TwiceHorn 31994]

On 4/26/2019 at 10:57 PM, Anastasis said:

I am not familiar with the terminology in this area, "family", "priority application" etc. Let's use a real world example, Seroquel and Seroquel XR. Seroquel's patent expired in 2012.  The XR formulation extended patent protection through 2017, or so.  I would also consider me-too in the broader sense of single enantiomer derivatives from a racemic mixture and active metabolite derivatives. I think that these derivatives should be required to demonstrate that they differentiate from the original product.  The argument for exclusivity is that the company needs to recoup the R&D investment and profit from the risk that they took to bring innovation to market.  OK, then demonstrate the innovation in the course of the registration trials.  The risk associated with developing many of these derivatives is extremely low. Many of these strategies amount to double dipping the revenue generation ability of the initial R&D investment.  

Most "me too" drugs do something obvious, like add an extended release buffer or composition to a known drug.  Because that combination would be obvious and thus unpatentable if the earlier patent for Seroquel was prior art, then the XR patent is made part of the patent family, which prevents earlier patents and application from being prior art.  It is an add-on to the basic Seroquel patent.  Prior to 1995, it would have had a longer term, 17 years from it's issue date.  Post-1995, patents in the same family, that have to be "add-ons" (the proper term is continuation-in-part) of a prior application to be patentable, now expire on the same day, 20 years from the filing date of the earliest patent in the family.

That's not including court-granted extensions for delays in FDA approval.  But again, that's one of those FDA-related things.

It's rather highly likely that the Seroquel and Seroquel XR patents had terms established under the pre-1995 regime (they were both filed before 1995).  And are among the last drugs you will see with expiration dates like that.  There are a couple of other features of patent law, too complex for here, that make such scenarios unlikely now.

Plus, it's really of not much moment.  Once the patent on Seroquel expires, Seroquel is public domain.  Certainly XR is not, but that does not inhibit the availability, FDA notwithstanding, of quietapine fumarate.

The rest of your post has to do with patentabiliy of chemical compositions.  In that case, it's a question purely of chemistry:  is the second or derivative composition easily derived from known information to a person of ordinary skill in the art?  With pharmaceuticals, if you are going to claim a human benefit, you have to be able to demonstrate it, but nothing more.  The Patent Office cannot possibly put itself in the position of evaluating the efficacy of drugs.  It doesn't evaluate the relative merits of widgets, just whether one widget design is patentable over another.

[TwiceHorn 31994]

And, l checked, and lo, the Seroquel patent was granted a seven year extension due to FDA approval delay.

It would appear that we could eliminate that aspect of the Hatch-Waxman Act, or curtail it significantly, and cut down the length of the patent monopoly while still maintaining a robust patent system that doesn't create entirely different regimes for different technologies.  Arguably, things like Hatch-Waxman do that in the other direction.

[Anastasis 23700]

Appreciate your insights Twice. 

I can't really go toe to toe on the legal aspects of patent law, but I can quote from WSJ.

I don't know what the right way is to fix this stuff from legal perspective, I just know that it is not right and rather than promoting innovation it stifles it.  

https://www.wsj.com/articles/biosimilar-humira-goes-on-sale-in-europe-widening-gap-with-u-s-1539687603

 

By Adding Patents, Drugmaker Keeps Cheaper Humira Copies Out of U.S.

Less expensive versions of world’s biggest-selling drug go on sale in Europe, but AbbVie extends its shelf life in U.S. with a ‘patent thicket’

 

By Adding Patents, Drugmaker Keeps Cheaper Humira Copies Out of U.S.

Less expensive versions of world’s biggest-selling drug go on sale in Europe, but AbbVie extends its shelf life in U.S. with a ‘patent thicket’

 

 

Humira is the world’s biggest-selling drug. PHOTO: JOE BUGLEWICZ FOR THE WALL STREET JOURNAL

By 

Peter Loftus and 

Denise Roland

Oct. 16, 2018 7:00 a.m. ET

 

Cheaper copies of the world’s biggest-selling drug will roll out across Europe this week after a key European patent for Humira expires Tuesday, but U.S. patients and insurers will have to wait to access less-expensive versions of the blockbuster drug.

The reason: a formidable wall of patents built up by Humira-maker AbbVie Inc., that prevents the developers of “biosimilar” versions launching their products in the U.S.

Biosimilars are near-copies of biologic drugs, such as Humira, that are made from living cells in a process that resembles brewing. They are analogous to generic copies of traditional pill-form medicines.

Biologic drugs are some of the costliest in the world, and the availability of lower-cost versions as patents expire promises big savings. Humira—a drug used to treat diseases from rheumatoid arthritis to gut disorders—alone has more than $18 billion in global sales.

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Companies haven’t revealed pricing for the Humira biosimilars, but they’re expected to sell at a 10% to 25% discount to Humira’s $10,000 to $22,000 annual price tag in Europe’s biggest drug markets, according to Alexandra Annis, an analyst at health-care-market intelligence firm GlobalData.

The main U.S. patent for Humira expired in 2016. But AbbVie has obtained more than 100 additional U.S. patents, a number legal experts describe as exceptional for a single drug. The shelf lives of those patents extend into the 2020s and 2030s.

AbbVie cited these newer patents, which cover manufacturing processes and other aspects of the drug, in lawsuits to block the two biosimilar versions approved in the U.S. Other companies say that has deterred them from bringing biosimilars to market quickly.

Critics, including lawmakers and industry officials, say AbbVie has created a “patent thicket” that abuses the U.S. patent system in order to preserve its profits.

AbbVie says it is protecting investments it made developing an innovative drug. “There’s nothing about our intellectual property around Humira, or the licensing agreements we’ve done ... that’s anything close to gaming the system,” AbbVie Chief Executive Richard Gonzalez said on a conference call with analysts in July.

“We invested a tremendous amount in research and development” to test Humira in a range of diseases and gain regulatory approval for those uses, Mr. Gonzalez said. “And we’ve improved and refined the manufacturing and the formulation of Humira over time, and there’s nothing inappropriate about protecting that investment in innovation,” he added.

In Europe, over 20 biosimilar drugs have gone on sale since the first approval in 2006, in what industry observers say is a more friendly legal environment to challenge patents. In the U.S., where the FDA has approved 12 biosimilar drugs since 2015, only five are available for sale.

 

“Europe has a much more robust and effective and time-tested means to challenge the validity of patents,” said Robert Cerwinski, a New York-based intellectual property lawyer specializing in pharmaceuticals at Goodwin Procter LLC. “So the companies were able to challenge AbbVie patents in the so-called patent thicket earlier and more effectively than in the U.S.”

AbbVie said in a statement that it welcomes the introduction of biosimilars in Europe but patients who are stable on their existing drugs shouldn’t be switched to another product for nonmedical reasons.

 

Amgen Inc. and Novartis AG plan to start selling their biosimilar versions of Humira—Amgevita and Hyrimoz respectively—on Tuesday as soon as the European patent expires. Samsung Bioepis Ltd. and Mylan NV are expected to start selling their versions soon after.

Since Humira generates an estimated $4 billion in annual sales in Europe, its second-biggest market after the U.S., the discounted prices should yield hundreds of millions of dollars in annual savings for the continent’s health systems.

 

England’s National Health Service, which currently spends more than £400 million ($526 million) a year on Humira, says it hopes to save at least £150 million a year by 2021 by switching to biosimilars.

But in the U.S., extra patents have pushed biosimilar developers to delay bringing their products to market until the next decade.

 

Amgen and Boehringer Ingelheim GmbH developed the two Humira biosimilars approved in U.S., but they haven’t so far gone on sale. Amgen settled litigation with AbbVie and agreed to wait until 2023 to launch its version. Boehringer Ingelheim says it plans to introduce a biosimilar Humira in the U.S. before 2023, but it hasn’t specified a date while it defends itself against a patent-infringement lawsuit brought by AbbVie.

At least three more AbbVie rivals-—Samsung Bioepis, Mylan and Novartis AG—have agreed in legal settlements with AbbVie not to sell their coming biosimilars in the U.S. until 2023.

For now, AbbVie has a U.S. monopoly on a drug whose price has risen to more than $60,000 annually for some patients in the 15 years since it launched, and which racked up more than $12 billion in U.S. sales last year.

Slow approval of biosimilars, as well as limited uptake once such drugs do go on sale in the U.S., is costing the American health-care system an estimated $15 billion-$18 billion a year in missed savings, according to Gary Stibel, founder and CEO of the New England Consulting Group.

A decade ago, the best-selling non-biologic drugs in the U.S. had an average of five patents each, according to Lisa Larrimore Ouellette, a law professor at Stanford University. Now, the 12 top-selling drugs in the U.S., many of which are biologics, have an average of 71 patents per drug, according to a recent study from I-MAK, a group that files legal challenges against the validity of brand-name drug patents.

Some elected and appointed officials have raised questions about patents as impediments.

FDA Commissioner Scott Gottlieb in July criticized “patent thickets” for brand-name biologic drugs “that are purely designed to deter the entry of approved biosimilars,” saying they’ve thwarted competition. He didn’t identify companies he believes are doing so.

AbbVie in particular has attracted sharp criticism over its patenting activities. In December 2017, Sen. Susan Collins (R-Maine), said AbbVie’s patents have “blocked competitors from coming to the market” and called for ways to counter such practices.

“It’s billions of dollars that this costs the U.S. health-care system,” said Dennis Lanfear, chief executive of Coherus Biosciences, which has pushed back its planned U.S. launch date for a Humira biosimilar to 2022 from 2018 because of AbbVie’s patents. “The market would be served if there was more competition.”

Write to Peter Loftus at peter.loftus@wsj.com and Denise Roland at Denise.Roland@wsj.com

[Incredulity 11861]

3 hours ago, Bozo_Casanova said:

No fuller than they should be. The demand for healthcare isn't price elastic, but the elasticity of consumption varies with criticality. The macroeconomic impact is the same either way, but the human impact is much worse than it should be because the consumption happens at more expensive points. If her kid was having a seizure, the cost to you and me for that unpaid bill is a hell of a lot higher than it would be if she doesn't wait. So why are we billing her at  list price at the most expensive point of sale when we already know she can't possibly pay? Because WE, the payers in the system want to pay even more? 

In countries with a more accessible and cost effective system than ours (so thats almost every non-third world country) you have both higher utilization AND lower costs, and the result is better outcomes in the aggregate. We really do have the worst form of socialism possible.

The ER/kid anecdote most definitely demonstrates the demand for healthcare is price elastic.  

[TwiceHorn 31994]

2 hours ago, Anastasis said:

Appreciate your insights Twice. 

I can't really go toe to toe on the legal aspects of patent law, but I can quote from WSJ.

I don't know what the right way is to fix this stuff from legal perspective, I just know that it is not right and rather than promoting innovation it stifles it.  

https://www.wsj.com/articles/biosimilar-humira-goes-on-sale-in-europe-widening-gap-with-u-s-1539687603

 

By Adding Patents, Drugmaker Keeps Cheaper Humira Copies Out of U.S.

Less expensive versions of world’s biggest-selling drug go on sale in Europe, but AbbVie extends its shelf life in U.S. with a ‘patent thicket’

 

 

  Hide contents

 

By Adding Patents, Drugmaker Keeps Cheaper Humira Copies Out of U.S.

Less expensive versions of world’s biggest-selling drug go on sale in Europe, but AbbVie extends its shelf life in U.S. with a ‘patent thicket’

 

 

Humira is the world’s biggest-selling drug. PHOTO: JOE BUGLEWICZ FOR THE WALL STREET JOURNAL

By 

Peter Loftus and 

Denise Roland

Oct. 16, 2018 7:00 a.m. ET

 

Cheaper copies of the world’s biggest-selling drug will roll out across Europe this week after a key European patent for Humira expires Tuesday, but U.S. patients and insurers will have to wait to access less-expensive versions of the blockbuster drug.

The reason: a formidable wall of patents built up by Humira-maker AbbVie Inc., that prevents the developers of “biosimilar” versions launching their products in the U.S.

Biosimilars are near-copies of biologic drugs, such as Humira, that are made from living cells in a process that resembles brewing. They are analogous to generic copies of traditional pill-form medicines.

Biologic drugs are some of the costliest in the world, and the availability of lower-cost versions as patents expire promises big savings. Humira—a drug used to treat diseases from rheumatoid arthritis to gut disorders—alone has more than $18 billion in global sales.

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Companies haven’t revealed pricing for the Humira biosimilars, but they’re expected to sell at a 10% to 25% discount to Humira’s $10,000 to $22,000 annual price tag in Europe’s biggest drug markets, according to Alexandra Annis, an analyst at health-care-market intelligence firm GlobalData.

The main U.S. patent for Humira expired in 2016. But AbbVie has obtained more than 100 additional U.S. patents, a number legal experts describe as exceptional for a single drug. The shelf lives of those patents extend into the 2020s and 2030s.

AbbVie cited these newer patents, which cover manufacturing processes and other aspects of the drug, in lawsuits to block the two biosimilar versions approved in the U.S. Other companies say that has deterred them from bringing biosimilars to market quickly.

Critics, including lawmakers and industry officials, say AbbVie has created a “patent thicket” that abuses the U.S. patent system in order to preserve its profits.

AbbVie says it is protecting investments it made developing an innovative drug. “There’s nothing about our intellectual property around Humira, or the licensing agreements we’ve done ... that’s anything close to gaming the system,” AbbVie Chief Executive Richard Gonzalez said on a conference call with analysts in July.

“We invested a tremendous amount in research and development” to test Humira in a range of diseases and gain regulatory approval for those uses, Mr. Gonzalez said. “And we’ve improved and refined the manufacturing and the formulation of Humira over time, and there’s nothing inappropriate about protecting that investment in innovation,” he added.

In Europe, over 20 biosimilar drugs have gone on sale since the first approval in 2006, in what industry observers say is a more friendly legal environment to challenge patents. In the U.S., where the FDA has approved 12 biosimilar drugs since 2015, only five are available for sale.

 

“Europe has a much more robust and effective and time-tested means to challenge the validity of patents,” said Robert Cerwinski, a New York-based intellectual property lawyer specializing in pharmaceuticals at Goodwin Procter LLC. “So the companies were able to challenge AbbVie patents in the so-called patent thicket earlier and more effectively than in the U.S.”

AbbVie said in a statement that it welcomes the introduction of biosimilars in Europe but patients who are stable on their existing drugs shouldn’t be switched to another product for nonmedical reasons.

 

Amgen Inc. and Novartis AG plan to start selling their biosimilar versions of Humira—Amgevita and Hyrimoz respectively—on Tuesday as soon as the European patent expires. Samsung Bioepis Ltd. and Mylan NV are expected to start selling their versions soon after.

Since Humira generates an estimated $4 billion in annual sales in Europe, its second-biggest market after the U.S., the discounted prices should yield hundreds of millions of dollars in annual savings for the continent’s health systems.

 

England’s National Health Service, which currently spends more than £400 million ($526 million) a year on Humira, says it hopes to save at least £150 million a year by 2021 by switching to biosimilars.

But in the U.S., extra patents have pushed biosimilar developers to delay bringing their products to market until the next decade.

 

Amgen and Boehringer Ingelheim GmbH developed the two Humira biosimilars approved in U.S., but they haven’t so far gone on sale. Amgen settled litigation with AbbVie and agreed to wait until 2023 to launch its version. Boehringer Ingelheim says it plans to introduce a biosimilar Humira in the U.S. before 2023, but it hasn’t specified a date while it defends itself against a patent-infringement lawsuit brought by AbbVie.

At least three more AbbVie rivals-—Samsung Bioepis, Mylan and Novartis AG—have agreed in legal settlements with AbbVie not to sell their coming biosimilars in the U.S. until 2023.

For now, AbbVie has a U.S. monopoly on a drug whose price has risen to more than $60,000 annually for some patients in the 15 years since it launched, and which racked up more than $12 billion in U.S. sales last year.

Slow approval of biosimilars, as well as limited uptake once such drugs do go on sale in the U.S., is costing the American health-care system an estimated $15 billion-$18 billion a year in missed savings, according to Gary Stibel, founder and CEO of the New England Consulting Group.

A decade ago, the best-selling non-biologic drugs in the U.S. had an average of five patents each, according to Lisa Larrimore Ouellette, a law professor at Stanford University. Now, the 12 top-selling drugs in the U.S., many of which are biologics, have an average of 71 patents per drug, according to a recent study from I-MAK, a group that files legal challenges against the validity of brand-name drug patents.

Some elected and appointed officials have raised questions about patents as impediments.

FDA Commissioner Scott Gottlieb in July criticized “patent thickets” for brand-name biologic drugs “that are purely designed to deter the entry of approved biosimilars,” saying they’ve thwarted competition. He didn’t identify companies he believes are doing so.

AbbVie in particular has attracted sharp criticism over its patenting activities. In December 2017, Sen. Susan Collins (R-Maine), said AbbVie’s patents have “blocked competitors from coming to the market” and called for ways to counter such practices.

“It’s billions of dollars that this costs the U.S. health-care system,” said Dennis Lanfear, chief executive of Coherus Biosciences, which has pushed back its planned U.S. launch date for a Humira biosimilar to 2022 from 2018 because of AbbVie’s patents. “The market would be served if there was more competition.”

Write to Peter Loftus at peter.loftus@wsj.com and Denise Roland at Denise.Roland@wsj.com

 

Can't quite tell what's going on there.  Part of it, though, is Hatch-Waxman Act shenanigans.  As you probably know, a generic maker must obtain FDA approval for the generic and can shortcut it a little with an ANDA, a shorthand approval application.  Same applies with biosimilars.  Under Hatch-Waxman, filing of an ANDA constitutes an act of patent infringement, giving rise to a patent infringement lawsuit before anything is approved or sold (the classic act of patent infringement).

The European/English litigation is fairly bizarre and confined to their procedures, so drawing a comparison between what's happening there and what's happening here is fairly spurious.

This statement, given the current environment of US patent law, is fucking bizarre, and frankly wrong:

“Europe has a much more robust and effective and time-tested means to challenge the validity of patents,” said Robert Cerwinski, a New York-based intellectual property lawyer specializing in pharmaceuticals at Goodwin Procter LLC. “So the companies were able to challenge AbbVie patents in the so-called patent thicket earlier and more effectively than in the U.S.”

If it were 10 years ago, it might be somewhat more accurate.

[Anastasis 23700]

https://www.cbo.gov/system/files/2019-05/55150-singlepayer.pdf

A reasonable overview of the issues from CBO.

 

 

[Bozo_Casanova 26773]

The ER/kid anecdote most definitely demonstrates the demand for healthcare is price elastic.  

No. It means the DEMAND is inelastic but the CONSUMPTION is price elastic depending on criticality. You missed the point.

[Captainant 28405]

On 4/22/2019 at 4:30 PM, Anastasis said:

And Ant, if you think that I am not being sincere or that I as an individual either personally or professionally don't care, please understand that one of the lines where I have conducted some research is specifically on understanding the impact of neurological conditions and cancers not only on patients, but the halo effects they have on caregivers and family members. I get it, as best as I can without having lived the same situation. 

My sister sent me this op-ed on the experience of trying to support a failing family member and what it's like realizing that every single aid program available has a requirement of having nothing else. It's not about a Parkinson's patient, but this article really nicely outlines the how fucked my parents are.

https://www.huffpost.com/entry/divorce-or-death-a-real-l_b_11183296?fbclid=IwAR1QSqB-qUGQG33FXNSDs1yTfwnXO5rYi8MnuLrpEd51llcr3XHiwTgSwzE

Here's the most salient bit that I'd appreciate your input on:

Quote

It’s estimated that the care for an ALS patient is over $200,000 a year. I ran my own company for ten years and while I always chose a new hire over a pay raise, I was able to bring in enough to convince my wife to “give it another year.” I put away a few thousand dollars each year into my retirement and paid my fair share into social security, both as an employee and employer. So when I could no longer work because of ALS, I applied for social security disability and Medicare. When I found out that I would only collect around $20,000 a year we thought, okay my wife will go back to work and Medicare will cover the medical expenses. I was wrong, almost dead wrong.

I now require a full time caretaker while my wife is at work, which is not covered by insurance. As my breathing continues to decline, I can extend my life for a very long time with a tracheotomy and ventilator, but at what cost? I will require 24-hour care, more sophisticated technology, not to mention a $30,000 used wheelchair-accessible minivan, none of which are covered by Medicare. There are government programs to help cover these costs, but not for middle class families. So my choices are to give up everything and declare bankruptcy, divorce my wife, or just accept death.

My dad isn't safe to be in the house by himself anymore. He requires full time caregiving and monitoring because he cannot understand that he isn't safe to stand up from his wheelchair. The last time I saw him, his face was covered in bruises from being too weak to protect himself when he falls, despite having a wheelchair and a home filled with structural grab bars that I installed myself. Seemingly every program that exists to help get in-home care requires you to be destitute before you can qualify. And insurance doesn't give a fuck about the quality of life for their profit centers patients customers, because they have shareholders to report back to. What the fuck should my parents do? Divorce after 35 years of marriage just to qualify for a slightly less meager set of benefits? Give up and let my dad die from a fall when nobody is home? 

Please, what does your for-profit playbook say about that?

[Anastasis 23700]

I can understand your sincere frustration Ant.

Regarding your ALS excerpt, I had a friend that I love die last year after a battle with ALS, so I can empathize on some small level with the example.

43 minutes ago, Captainant said:

Please, what does your for-profit playbook say about that?

My playbook in terms of an approach to reshaping the healthcare system has been outlined previously, numerous times in a variety of threads over the years here, and also up thread in a response to one of your posts. 

On 4/22/2019 at 3:41 PM, Anastasis said:

I've laid out my thinking about how to best implement universal coverage, incorporating a national backstop and the benefits of market forces, reforming regulatory agencies, patent law and investing in the right types of policy and outcomes research.  I won't belabor it (for once) by outlining it again.

Additional detail, relevant to the ALS excerpt in particular, regarding my thoughts on a national catastrophic coverage backstop:

 

I think that we would both agree that caregiver support is an important aspect of healthcare, not only in terms of home health services, but support for non-professional caregivers and family members. Also, I know that your personal dislike for my posting persona, especially as it relates to other topics, makes it hard for you to engage on this policy discussion; however, I will just highlight the below sentence from the article that you link.  Seems relevant to a discussion of Medicare 4 All as a solution to the problem you have framed.

 I will require 24-hour care, more sophisticated technology, not to mention a $30,000 used wheelchair-accessible minivan, none of which are covered by Medicare.

Edited May 8, 2019 by Anastasis

[American Swindle 102]

[bad_teammate 13481]

@Bozo_Casanova

Quote

This has been enough of a threadjack and it’s clear you aren’t all that interested in the weeds of healthcare policy so I’m not going to get further into it here than I already have, but w/r/t your last point -I don’t give a fuck how healthcare reforms or anything else is “characterized” by Republicans. The GOP has called every Democrat president since 1917 a socialist and will characterize anything as socialism. They even characterized cap and trade and ACA (their own plan) as socialism. Who cares?

I would imagine someone who talks constantly about "feasability" and who promoted a Democrat-Republican combo bill cares about what Republicans think, otherwise you wouldn't be so focused on those issues. Being completely dishonest, yet again.

Quote

It’s the job of elected Democrats to sell a plan to the public on the merits and use the power they have at points of maximum leverage, not persuade people intractably opposed to progress and compassion to change their minds.

How do you square this with your stated vision of what is "feasible"? Your idea of what is "feasible" is entirely about whether or not Republicans will support whatever bill there is. Your chosen example was Wyden-Bennett, for Christ's sake.

If you really don't care about bipartisan compromise on this and you really think it is solely about the need for Democrats to sell a plan to the public on that plan's merits, why are you so combative and hostile towards single-payer?

[Bozo_Casanova 26773]

@bad_teammate

Quote

I would imagine someone who talks constantly about "feasability" and who promoted a Democrat-Republican combo bill cares about what Republicans think, otherwise you wouldn't be so focused on those issues. Being completely dishonest, yet again.

You said it, man. You would imagine. Listen to yourself. I care about policy, period. I'm focused on the feasibility of policy because doing important things is the point. 
 

Quote

How do you square this with your stated vision of what is "feasible"? Your idea of what is "feasible" is entirely about whether or not Republicans will support whatever bill there is. Your chosen example was Wyden-Bennett, for Christ's sake.
If you really don't care about bipartisan compromise on this and you really think it is solely about the need for Democrats to sell a plan to the public on that plan's merits, why are you so combative and hostile towards single-payer?

I am not hostile to an exclusive Single Payer or any other system that results in cost pressure on overhead and universality of coverage. I am 100% focused on implementation and outcome. 

Edited July 1, 2019 by Bozo_Casanova

[bad_teammate 13481]

Can you make an argument as to how single-payer is less feasible?

[Bozo_Casanova 26773]

Here's an OK summary of the 9 most prominent Democrat plans on offer:

https://www.vox.com/2018/12/13/18103087/medicare-for-all-explained-single-payer-health-care-sanders-jayapal

[Hugo Stiglitz 23367]

Now do the Republicans plan to fix healthcare...

[Bozo_Casanova 26773]

Here you go:

 

[David Dennison 19441]

The sooner employer provided healthcare is gone, the better.

[Bozo_Casanova 26773]

7 minutes ago, David Dennison said:

The sooner employer provided healthcare is gone, the better.

I agree. It's the biggest distortion we have. That was the main advantage of Wyden-Bennett. Not only was it fast, but it went directly at the biggest cost growth drivers.

From the analysis, bolded by me:

Quote

The basic thrust of your modified proposal is to require individuals to purchase private health insurance and to establish state-run purchasing pools and a system of federal premium collections and subsidies to facilitate those purchases. The systems premium collection and subsidy mechanisms would be based largely on income tax filings, and the required benefits would initially be based on the Blue Cross/Blue Shield standard plan offered to federal workers in 2011 and then allowed to grow at the rate of growth of the economy. Although employers would have the option of continuing to offer coverage to their workers, nearly all individuals who were not enrolled in Medicare would obtain their basic health insurance coverage through this new system. Most enrollees in Medicaid and all enrollees in the State Childrens Health Insurance Program (SCHIP) would have their primary insurance coverage shifted to the new system.

Your proposal also would replace the current tax exclusion for employer-based health insurance premiums with a fixed income tax deduction for health insurance. (In addition, employers that had provided health insurance would be expected to "cash out" their workersthat is, to increase workers wages by the average contribution that the employers would have made for their health plan.) The proposal also would require new tax payments from employers to the federal government and further would seek to recapture the savings to state governments from reduced expenditures on Medicaid and SCHIP.

 

Edited July 1, 2019 by Bozo_Casanova

[bad_teammate 13481]

lol @ the plan that includes tax increases but doesn't cover everyone

Any plan that doesn't automatically cover everyone isn't worth talking about.

[bad_teammate 13481]

Dem Establishment, 2007, @ 14.6% uninsured: "This is a god damned national emergency."

Dem Establishment, 2019, @ 13.7% uninsured: "We just need to tinker around the edges a little and adjust the sliding scales. Maybe a new type of tax-advantaged savings account? Oh, I don't know, what do you think, insurance industry?"

 

[Bozo_Casanova 26773]

It’s unacceptable. We need a universal system that covers everyone, and we can’t really pressure costs down without it. Our cost problem is our coverage problem and vice versa.

[bad_teammate 13481]

And unlike Obama, Beto, and Pete... he isn't lying when he says it...

If there is only one healthcare plan in the entire nation, then doctors will either accept that plan, go full cash concierge, or leave the industry. While I'm sure the last two options will be non-zero, the VAST majority of doctors will remain available to their patients.

And since this isn't a nationalization scheme, doctors can still select their own patients.

Which means, with Medicare For All, IF YOU LIKE YOUR DOCTOR, YOU CAN KEEP YOUR DOCTOR.

Leaving health insurance "choice" in the hands of employers and private insurers is the choice to make if you want to be at risk of losing access to your doctor.