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pharmaphorumuk · 5 years ago

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Federal court puts kibosh on Trump plan for drug prices in TV ads

A federal judge has blown a hole in an attempt by the Trump administration to force drugmakers to put the list prices of their medicines in TV advertising.

The measure – which had been due to come into effect just a few hours after the verdict – would have required the wholesale acquisition price (WAC) of any medicine that costs more than $35 per month to be revealed during the commercial, in the hope of shaming drugmakers into lowering their process.

The pharma industry has insisted that it is unfair as the list price does not take into account discounts or rebates that might be offered, did not give a reflection of patient out-of-pocket costs, and that the Department of Health and Human Services (HHS) overstepped its regulatory powers in ordering the move.

This week, District Judge Amit Mehta, presiding over a court in Washington, DC, agreed and in a ruling called an immediate halt to the initiative.

In the judgment, Mehta wrote that the policy “could very well be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiralling drug costs may be, HHS cannot do more than what Congress has authorised.”

The court didn’t rule on another argument levelled by the industry that disclosing the WAC violated the First Amendment right to freedom of speech, so that objection is held in reserve if HHS decides to appeal the decision.

Critics of the move had also pointed out that the proposal contained no mechanism to enforce the WAC rule in ads, and would rely on industry self-regulation.

Placing prices in direct-to-consumer (DTC) TV ads was just one of a basket of measures proposed by Trump in his American Patients First blueprint published last year, along with seeking an end to the rebate system for medicines to prevent middlemen taking a cut of the price, and requiring hospitals and insurers to disclose negotiated rates for services.

The White House is incensed by the advertising ruling, with a spokesman telling the New York Times that “it is outrageous that an Obama-appointed judge sided with big pharma to keep high drug prices secret from the American people, leaving patients and families as the real victims.”

The setback comes hard on the heels of another White House initiative seeking to drive down medicine prices in the US. Trump has said he is drawing up an executive order that includes a clause that would match the price of drugs in the US to the lowest among a list of ‘favoured nations’.

Earlier this month, a report from RX Savings Solutions claimed that more than 3,400 medicines in the US had their prices raised in the first six months of 2019, an increase of 17% on the number of drug hikes from a year earlier.

The average price increase was 10.5%, or around five times the background rate of inflation, and suggest Trump’s claims to have had an impact on drug pricing since the blueprint was published last year have no weight.

The Pharmaceutical and Research Manufacturers of America (PhRMA) claims however that the data reflect list price increases and ignore the “significant rebates and discounts on medicines.”

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maxihealth · 5 years ago

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Large Employers’ Focus on Prescription Drugs: Costs, Coupons and Communication

As large employers’ annual health care costs for an employee are expected to exceed $15,000 in 2020, companies are focusing in on managing the pharmacy line-item, we learn from the 2020 Large Employers’ Health Care Strategy and Plan Design Survey from the National Business Group on Health (NBGH).

I covered large employers’ perspectives and future plans to deal with health care services for workers in 2020 in Health Populi here earlier this week. In this post, I’ll dive deep into the study’s Section VII on Pharmacy Costs and Strategies.

Employers’ most daunting challenge and uncertainty when it comes to dealing with pharmacy spending is the specialty drug impact — specifically, new million-dollar therapies getting approved by the FDA.

Examples of these in the current news cycle are Zolgensma, which is priced about $2 million to treat spinal muscular atrophy, and CAR-T therapy which can run as high as $1 million all-in for the treatment and hospital service costs for the patient.

Eight in ten employers are concerned about new high-cost therapies (generally considered “specialty drugs) that the FDA is expected to approve in the next few years as these medicines come out of the research pipeline into commercial launch phase.

Opiods are the second- most concerning pharmacy issue, for three-quarters of large employers, followed by the impamct of coupons and patient access programs on consumer behavior when lower-cost alternatives are available in the market.

This third point brings up the finding in the second pie chart: that two in three large employers believe that direct-to-consumer advertising (DTC) is inappropriate. This is a huge issue for pharma companies because DTC ads for prescription drugs are legal only in the U.S., unique among all the developed countries in the world with the exception of New Zealand.

DTC promotion is a big industry in the American health care ecosystem: pharma companies spend over $6 billion on DTC ads for drugs, compared with half that amount (about $3 billion) by health care providers promoting health care services directly to consumers. Medical marketing, and particularly pharma marketing, is a major business in America and big slice of the “Mad Men” advertising industry.

Among large employers who fell into the 28% of companies that thought DTC communication was indeed appropriate, acceptable topics for comms were medication side effects and indications of the drug. What wasn’t seen as acceptable topics for communicating DTC were patient assistance programs.

After “costs” and “communication” was a third “C” of concern among large employers vis-a-vis prescription drugs: that was the impact of drug coupons. Employers cited several main tactics to address coupon cards looking forward from 2019 to 2022. The top tactic employers identified to manage their concerns about coupons was to review coupon utilization data with the company’s pharmacy benefit manager (PBM). One-third of employers were already doing this in 2019, with another 20% adding in 2020 and 16% considering for 2021-22.

34% of employers are already using a copay card accumulator program that does not allow manufacturer coupons or copay cards to count toward the employee’s dedutible and out of pocket maximum costs. Some 15% of companies will consider this tactic in 2021-22.

Several other areas for dealing with coupon cards will be considered in 2021-22 including education campaigns to help workers understand the costs and benefits of coupons; copay “maximizer” programs that work with patients to take advantage of manufacturer coupns for high-cost drugs, copay card accumulator programs for special drugs only; and, not covering medications that include a consumer coupon when a lower-cost therapy is available.

Co-pay accumulators are being discussed across health plan types, including government-sponsored plans like Medicare along with commercial health insurance programs. This mechanism prevents a co-pay card or funds from a patient assistance program that discount the patient’s drug(s) to be applied to a deductible. In the NBGH survey, 34% of large companies have adopted co-pay accumulator programs that don’t allow manufacturer coupons or copay cards to count toward the workers’ deductibel and out of pocket maximum; another 19% are either adding in 2020 or considering in 2021-22.

As you would imagine, there has been quite a lot of push-back against co-pay accumulators, particularly from patient advocates and organizations who say these programs are essentially a way to shift costs onto sicker people (in this case, the employees who are dealing with acute or chronic conditions).

In addition to co-pay accumulators, the topic of rebates is on the front-burner of large employers. Typically, rebates are paid by a pharmaceutical manufacturer to a pharmacy benefits manager (PBM), who shares a portion of the rebate monies with the health plan or employer (as a self-insured health plan).

Large companies have begun to view the rebate funds at the patient’s point-of-sale (POS), shown in the pie chart.

A POS rebate passes the rebate to a patient-consumer at the point-of-sale when filling a prescription — thereby sharing the incentive payment with the worker who is the end-user consumer of the prescription drug. (In contrast, employers have used rebate payments to defray premium costs).

18% of large eployers offered rebates at POS in 2019, and 40% are considering incorporating this patient-Rx payment tactic in 2021-22.

In addition to considering POS rebate programs, most employers like the idea of a “net price model” of drug costs to the patient. This is based on the net price of medicines with no rebates — and is part of a U.S. Federal government Blueprint for reducing prescription drug costs.

It’s specialty drugs that will be a significant wild-card for companies’ prescription drug spending: prior authorization, a time-tested tactic on the health services side of cost management, is the prevailing method among large companies looking to manage high-cost therapy spending. Virtually all large companies use prior authorization to consider coverage for specialty medicines billed under a worker’s pharmacy benefit.

The last chart details other strategies adopted for managing specialty drug costs, including site-of-care management which establishes protocols for where drugs are administered; limiting the supply of drugs; case management and medication management; and, requiring biosimilars to be used first as step therapy before approving the more expensive specialty therapy.

Health Populi’s Hot Points: Prescription drug costs are a front-of-mind, kitchen table issue for Americans in 2019 and looking forward. Across party identification, U.S. health citizens favor government intervention to manage down drug prices, the Kaiser Family Foundation Health Tracking Poll found earlier this year which I discussed here in Health Populi.

Fully 8 in 10 Americans say the government should be allowed to negotiate lower prices with drug companies for people enrolled in Medicare, shown in the bar chart from the KFF poll. Note, too, that 63% said the government should levy taxes on drug companies whose prices are “too high,” and over half of U.S. adults think the government should end the tax break on advertising spending for drugs.

As I wrote to @Cascadia (Sherry Reynolds) in a Twitter conversation on my first NBGH post discussing the 2020 employer survey, large companies are a political lobby when it comes to health care spending and services. As a major payor, with government and consumers, the largest employers’ operating structures depend on current tax policy regarding how healthcare spending is treated in the tax code. In addition, some industries heavily depend on attracting and retaining employees based on a carefully curated mix of benefits, of which health care in the current environment is a much-desired line item.

The NBGH data, on both health care services and prescription drugs, is useful information to mix into our forecasts on health care reform scenarios for the coming 1-3-5 years. Much now depends on the U.S. macroeconomy — signs of which this week point to a very real possibility of recession and economic downturn. The margins between voters’ demands for single payer versus Medicare4All versus public option/ACA update may become increasingly thin.

The post Large Employers’ Focus on Prescription Drugs: Costs, Coupons and Communication appeared first on HealthPopuli.com.

Large Employers’ Focus on Prescription Drugs: Costs, Coupons and Communication posted first on https://carilloncitydental.blogspot.com

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currenthealtheventsblog-blog · 6 years ago

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Brainstorm Health: Xarelto TV Ads, Paid for Staying in Bed, Bristol Myers Celgene Deal

New Post has been published on https://currenthealthevents.net/awesome/brainstorm-health-xarelto-tv-ads-paid-for-staying-in-bed-bristol-myers-celgene-deal/

Brainstorm Health: Xarelto TV Ads, Paid for Staying in Bed, Bristol Myers Celgene Deal

Happy Friday, readers!

I’m running around prepping for our upcoming Brainstorm Health conference( hey, I’ve mentioned that’s happening next week and is going to be awesome, right ?) so it’ll have to be a short one this beautiful Friday afternoon.

But here’s something worth noting–Johnson& Johnson is reportedly getting ahead of the regulatory curve to become the first drug company in the U.S. to spell out a treatment’s cost in direct-to-consumer television ads, for the blood thinner. The Trump administration has been preparing rules along these lines to mandate the disclosures in pharma ads.

J& J is also addressing one of the main criticisms of the proposed rules–that list prices are often substantially different from what patients actually pay for their medication. So the company will be including brand name blood thinner Xarelto’s nearly $450 list price, alongside the net prices the company says three in four consumers pay( i.e ., somewhere between nothing and $47 ).

The idea here is to increase transparency( a woefully missing element in American health care ). But the natural followup question here is: How much will this actually move the needle on patients’ medical costs, or the high costs of drugs in general? DTC ads, by definition, put the onus on the consumer, basically building them messengers who then need to bring up therapy selections with their doctors. It’s an open question whether such an indirect series of events can eventually bend the cost curve.

Read on for the day’s news, and have a wonderful weekend.

Sy Mukherjee

@the_sy_guy

sayak.mukherjee @fortune. com

DIGITAL HEALTH

Get paid to stay in bed( for 2 month ). Ah, science, wherein you can get paid to remain in bed for … an uncomfortably long quantity of period. German researchers are trying out female volunteers aged 24 to 55 to, basically, remain bed ridden for two months in a quest to see how weightlessness affects the human body( for a payout of about $18,522 ). Sound like a good deal?( Fortune)

INDICATIONS

Bristol Myers gets a boost for its Celgene bid. Key shareholder advisory boards recommended that biotech giant Celgene investors approve a blockbuster takeover bid by Bristol-Myers Squibb, sending Celgene’s stock up 8% in Friday trading. Both Institutional Shareholder Services and Glass Lewis endorsed the deal, leading to activist Bristol shareholder Starboard Value to drop its proxy fighting in the matter( while expressing frustration ).( The Street)

REQUIRED READING

S& P Global CEO: ‘I Think the Correction Is Over’, by Susie Gharib

A Crypto ‘Dividend’ ? by Jeff John Roberts

Lyft Kicks Off Highly-Anticipated ‘Year of the IPO’, by Danielle Abril

Wells Fargo, Mastercard CEOs Still Skeptical About Blockchain’s Impact, by Don Reisinger

[ ceo_attribution author= “Produced by Sy Mukherjee” email= “sayak.mukherjee @fortune. com” twitter= “the_sy_guy”] Find past coverage. Sign up for other Fortune newsletters.

Read more: fortune.com

#health

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kristinsimmons · 6 years ago

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All for One, One For All

By MIKE MAGEE MD

Within the ever-widening array of Democratic contenders for the Presidency, the “Medicare-for-all” debate continues to simmer. It was only six weeks ago that Kamala Harris’s vocal support drew fire from not one, but two billionaire political rivals. Michael Bloomberg, looking for support in New Hampshire declared, “I think we could never afford that. We are talking about trillions of dollars… [that] would bankrupt us for a long time.” Fellow billionaire candidate Howard Schultz added, “That’s not correct. That’s not American.”

Remarkably, neither man made the connection between large-scale health reform’s potential savings (pegged to save 15% of our $4 trillion annual spend according to health economists) and the thoughtful application of these newly captured resources to all U.S. citizens without discrimination. Bloomberg’s own 2017 Health System Efficiency Ratings listed the U.S. 50th out of 55, trailed only by Jordan, Columbia, Azerbaijan, Brazil, Russia. Yet he seemed unable to connect addressing waste with future affordability.

Schultz was similarly short sighted. While acknowledging that the manmade opioid epidemic, mental health crises, and income inequality are “systemic problems” and at levels “the likes of which we have not had in a long time”, he failed to connect the cause (a remarkable dysfunctional and inequitable health care system) with these effects.

As I outline in “Code Blue: Inside the Medical Industrial Complex” (Grove Atlantic/ June 4, 2019), today’s greatest risk to continued progress and movement toward universal coverage and rational health planning is sloppy nomenclature. To avoid talking past each other, we need to define the terms of this debate while agreeing on common end points.

“Universal health care” is an end point goal that reinforces the principle that health is a human right rather than a privilege for the most entitled. It is an expression of national solidarity and reflects a shift in our culture.

“Single payer” is one strategy or tactic often associated with the Canadian health care system. However, the Canadian system is not technically a “single payer” system, in that provision of insurance (set to national standards) and the delivery of the care are the responsibilities of individual provinces, not the national government. A more accurate label for their system would be “Single Oversight/Multi Plan”.

Canada has choice and also maintains an active private health insurance market that provides supplemental health care plans purchased by 70% of citizens to cover roughly 30% of health costs including optical, dental and drugs which are not covered by government plans. Private insurers in the U.S. in the future might play a similar role.

The Canadian government’s role is focused on formalized government health planning as well as insurance standards and oversight. It also outlaws DTC drug advertising and sets prices annually for all essential drugs. The national government is the guardian of universality and (often overlooked) simplicity. Providers provide. Provincial government pays. Patients concentrate on health and wellness, and are not plagued by insurance gamesmanship and endless bill bickering on the local level.

The U.S. has no such government-directed, national health planning apparatus. Service levels and reimbursement vary widely across an endless array of private and public offerings that have devolved into a “free-for-all.” Our profit-driven, scientific research community regularly diverts resources from health planning and patient care, and our insurance system harbors an enormous number of health system middlemen to support “non-real” work (16 positions for every one physician – half with no clinical role).

What we do have are $4 trillion already committed (albeit badly misallocated), a remarkable array of educational institutions, a dedicated network of public health schools and practitioners, under-utilized nurses and pharmacists, and a testing ground of 50 different states.

The true impact of spiraling health care costs and their secondary effects—including stagnant wages, income inequality, a lack of job mobility, high rates of medical bankruptcy, the closure of rural hospitals, an inability to invest in infrastructure repairs, and our growing national debt – is staggering. We are the only developed nation in the world that spends more on health care than all other social services combined.

Warren Buffett, a man who knows something about sustainable growth, said recently: “The health care problem is the number-one problem of America and of American business. . . . Medical costs are the tapeworm of American economic competitiveness.”

For far too long, our leaders have focused on how to make American corporations wealthy. But let us be clear – there is another way. We could have the courage and the will to reapply our more than ample health care assets and reject the status quo. We could vote in change on a large scale. We could elect leaders willing to honestly address a simple, long overdue question that is at the very center of Code Blue: “How do we make Americans healthy?”

Mike Magee is a Medical Historian and author of “Code Blue: Inside the Medical Industrial Complex” (Grove Atlantic/June, 2019).

All for One, One For All published first on https://wittooth.tumblr.com/

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lauramalchowblog · 6 years ago

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All for One, One For All

By MIKE MAGEE MD

Mike Magee is a Medical Historian and author of “Code Blue: Inside the Medical Industrial Complex” (Grove Atlantic/June, 2019).

All for One, One For All published first on https://venabeahan.tumblr.com

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isaacscrawford · 6 years ago

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All for One, One For All

By MIKE MAGEE MD

Mike Magee is a Medical Historian and author of “Code Blue: Inside the Medical Industrial Complex” (Grove Atlantic/June, 2019).

Article source:The Health Care Blog

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shsincorporated · 6 years ago

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princeashy · 6 years ago

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FDA to Study Drug Risk Information in DTC Print Ads

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Posted 13 August 2018 | By Ana Mulero

The US Food and Drug Administration (FDA) said Monday it plans to conduct an experimental study on consumer impact from the amount and placement of risk information in prescription drug ads. Sponsors tend to include risk information in both the “Important Safety Information” (ISI) section in direct-to-consumer (DTC) print ads and in a…

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pharmaphorumuk · 5 years ago

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Three drugmakers challenge Trump’s price disclosure ruling

Amgen, Merck & Co and Eli Lilly have launched a legal challenge to a new rule that will require them to disclose medicine list prices in direct-to-consumer (DTC) television ads.

Last month, the Trump administration confirmed that list prices will be required on all DTC television ads for prescription drugs and biological products, one of the elements of a wide-ranging blueprint for reducing drug prices in the US published last year.

The new requirement is due to come into effect on 9 July and requires adverts to include the wholesale acquisition cost of a drug if it is equal to or greater than $35 for a month’s supply or the usual course of therapy.

While some companies have already started complying with the requirements – including Johnson & Johnson for its Xarelto (rivaroxaban) anticoagulant – the move is being resisted by other pharma companies.

They say that providing the list price doesn’t take into account other factors such as the rebates and discounts that may be offered for medicines, as well as assistance programmes offered to some patients to make them more affordable.

The joint lawsuit, supported by the Association of National Advertisers (ANA), is trying to block the requirement from coming into force, arguing that it will be confusing for patients and is unlikely to have any impact on drugs costs.

Amgen said in a statement: “Not only does the rule raise serious freedom of speech concerns, it mandates an approach that fails to account for differences among insurance, treatments and patients themselves, by requiring disclosure of list price.”

It went on to say that “most importantly, it does not answer the fundamental question patients are asking: ‘What will I have to pay for my medicine?”

Merck said meanwhile that it was concerned patients might be discouraged from seeking treatment in the first place if they fear they would be unable to afford a drug “when in fact many patients do not pay anything near the list price.”

Other measures proposed by the White House include doing away with the current rebate system for medicines altogether – to prevent middlemen taking a cut of a medicine’s price – and setting US prices for drugs covered by Medicare Part B with reference to prices in other industrialised countries.

When the list price proposal was firmed up last month, Health and Human Services Secretary Alex Azar said it was “the single most significant step any administration has taken toward a simple commitment: American patients deserve to know the prices of the healthcare they receive.”

“Making those prices more transparent is a significant step in President Trump’s efforts to reform our prescription drug markets and put patients in charge of their own healthcare,” he added.

The post Three drugmakers challenge Trump’s price disclosure ruling appeared first on Pharmaphorum.

from Pharmaphorum https://pharmaphorum.com/news/three-drugmakers-challenge-trumps-price-disclosure-ruling/

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megatechcrunch · 7 years ago

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The FDA is entering a new era of regulation as whole genome sequencing becomes more accessible to consumers.

Why do consumers seek direct-to-consumer (DTC) genetic testing? Consumers purchase services that sequence and analyze portions of their DNA to understand their risk for familial cancer, plan a safer pregnancy, optimize diet and fitness routines, and satisfy their curiosity about the secrets of their genome and ancestry. The diversifying reasons for consumer interest in DTC genetic testing are estimated to increase its global market value to $350 million by 2022.

With such a valuable market at stake, regulation of DTC genetic testing by the U.S. Food and Drug Administration (FDA) has been under intense surveillance by the biotech industry, health care providers, and consumers alike.

The FDA has been regulating medical devices since 1976 when Congress passed the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. A medical device is defined as anything that can be used to diagnose, cure, treat, mitigate, or prevent disease, including an instrument, reagent, or “similar or related article.” In vitro genetic tests are therefore considered medical devices.

The FDA regulates both genetic tests that are ordered and performed at home (DTC) and those that are ordered and performed in a health care setting or laboratory (a laboratory-developed test, or LDT). These two types of tests require different levels of FDA regulation.

LDTs are ordered by a physician, developed by and performed in a single laboratory, are not sold to other laboratories, and are not marketed to consumers. In theory, this reduces the risk of misunderstanding the results and the possibility of erroneous health-related decision-making by the consumer.

On the other hand, DTC tests must pass a higher regulatory bar and demonstrate that they clearly and safely relay information to consumers in the absence of a medical professional. DTC tests do not provide an “informed intermediary” such as a physician or trained expert to explain results, reduce stress, and discuss follow-up options, while physician-delivered reports from LDTs do.

Before the FDA began regulating DTC tests, consumers were purchasing these tests to learn about their risk for Parkinson’s disease, how they might respond to certain types of drugs, if they were likely to develop Alzheimer’s disease, their ancestry, and more. Many of these results were diagnostic in nature, which prompted the FDA to intervene.

FDA crackdown on DTC testing

The FDA watchfully waited as DTC genetic testing companies developed products. The FDA assessed the potential risks and impacts of the products on the consumer, and did not regulate the conduct of DTC genetic testing companies until the companies brought products to market that could be classified as medical devices.

In May 2010, the FDA notified Pathway Genomics that their product was a medical device, and therefore needed FDA approval. In June 2010, the FDA followed by sending warnings to four additional DTC genetic testing companies: 23andMe, deCODE Genetics, Inc., Navigenics, Inc., and Knome, Inc.

When these companies were notified of the FDA approval requirement for their genetic tests, they were all marketing similar at-home saliva collection kits that were used for DNA analysis and the generation of personal health reports. These reports included information that could be used to diagnose disease; screen for carrier status of inherited disease; assess cancer risk; and, in the case of Pathway Genomics and 23andMe, predict response to certain drugs.

These five companies pursued very different paths to profitability after their FDA warning.

Knome was acquired by Tute Genomics in 2015, but continued to market genome services under its own name. On September 13, 2016, Knome advertised a Kickstarter campaign for DTC whole genome and whole exome sequencing services. On September 15, they pulled the campaign after receiving a warning letter from the FDA that expressed concern over their DTC marketing. A month after this FDA warning, Tute accepted an offer for acquisition by PierianDx, which offers clinically oriented next-generation sequencing services to medical centers. After the acquisition, no products were produced under the Knome or Tute names.

Navigenics continued to sell DTC genetic testing until it was acquired by Life Technologies in 2012, when it ceased producing consumer-facing products. Thermo Fisher Scientific acquired Life Technologies in 2014.

deCODE Genetics sold its deCODEme personalized genome service until the company was purchased by Amgen in 2012. deCODE still exists as a privately-held company, but now only performs genomics research on Icelandic volunteer participants.

Only 23andMe and Pathway Genomics have stayed in the DTC genetic testing space, and they have done so through different approaches.

A pivot to remain profitable

23andMe

23andMe, which started selling its personal genome service in 2007, continued to sell DTC tests after their first FDA warning in 2010. Ultimately, this led to the company being banned from providing any health-related genetic testing services in November 2013.

During this ban, 23andMe was still able to provide users with ancestry data and uninterpreted genomic data, but this change in service attracted fewer new users.

Despite this reduction in user growth, 23andMe genotyped its millionth person in June 2015. With 85% of its customers consenting for their de-identified genotypic and phenotypic data to be used for research, 23andMe has amassed a massive, profitable data repository that facilitates internal research and industry partnerships. In 2013, 23andMe announced its first industry partnership with Pfizer to study the genetic basis of disease in 23andMe’s data.

Additionally, 23andMe used this opportunity to open a therapeutics division. This division aims to mine existing 23andMe user data to identify drug targets for disease treatment and develop drugs for current and future targets.

23andMe worked to comply with the FDA, which resulted in an approval to market a DTC carrier test for Bloom’s Syndrome in February 2013. This ruling demonstrated an important proof of concept: 23andMe was able to accurately and reliably detect a rare Bloom’s syndrome variant in nearly 200 samples in two laboratories. Additionally, 23andMe clearly labeled their home testing kits as non-diagnostic, proved that customers were able to understand how to provide a sample for the DNA test, and showed that users could understand the meaning of their results.

Most importantly, the FDA used this opportunity to establish clear guidelines for DTC autosomal recessive carrier status testing. These guidelines make it easy for companies to add autosomal recessive carrier status tests to their portfolio when using FDA-approved sample collection and processing devices. In October 2015, 23andMe added additional carrier status reports to its genome service.

In April 2017, 23andMe had its greatest FDA success when it earned approval to market 10 genetic health risk (GHR) reports. These reports give users an approximate genetic risk for developing a disease, but do not diagnose a lifetime risk of disease. FDA-approved GHR reports may influence minor lifestyle changes, but are not allowed to influence a treatment.

The FDA announced that these tests were backed by strong evidence in the scientific literature and that they met the FDA’s newly established criteria for accuracy, reliability, and clinical evidence during the de novo premarket review process. The FDA plans to exempt future 23andMe GHR tests from premarket review, as long as the test does not yield results that may be “the sole basis” for a major treatment decision.

Despite 23andMe’s regulatory struggles with the FDA, they persevered and were instrumental in establishing the regulation of the DTC genetic testing marketplace. In doing so, they have positioned themselves to be a lasting power in DTC genetic testing.

Their regulatory successes have paved the way for speedier approvals for other genetic testing companies. A fruitful partnership with Pfizer has yielded studies on lupus, inflammatory bowel disease, major depressive disorders, and bipolar disorders. Pfizer’s success with 23andMe data has encouraged others to seek partnerships with 23andMe for data usage. As a result, 23andMe’s therapeutics division has additional genetic mutations to investigate for pharmaceutical targeting.

Pathway Genomics

Pathway Genomics had a plan to market their genetic health report through Walgreens in 2010, but that plan quickly fell apart after the warning letter from the FDA. As a result, Pathway Genomics split their genetic testing into two categories: those that contain health-related information, and those that do not.

Their health-related tests, like a hereditary cancer panel, a weight loss program guided by DNA, and carrier status reports, were developed by Pathway Genomics to be performed in a laboratory upon the referral of a physician, which categorizes them as an LDT.

Pathway Genomics’ LDTs are still subject to FDA approval but are less strictly regulated than their DTC products. While the health-related tests are advertised to consumers, they still require the order of a physician, and the results are delivered by a health professional.

Pathway Genomics also offers DTC genetic tests that do not contain possibly actionable health data. These tests provide insights into fitness parameters and skin qualities, and can be ordered on the internet by the consumer without physician referral.

Moving their genetic tests to a physician-ordered and physician-delivered model allows Pathway Genomics to test for genetic variants with medically significant outcomes, such as those associated with forms of hereditary cancer, because a physician can guide the consumer through the results and discuss future actions.

In addition to changing the regulatory designation of some tests, Pathway Genomics partnered with IBM in 2014 to work on a consumer-facing mobile app, later named OME, to help users understand and interact with their personal genomic information. OME is still not available to consumers but promises to integrate artificial intelligence with genomic data to help consumers act on their personal genomic information.

Even though Pathway Genomics significantly changed their business strategy by moving many of their DTC tests to physician-ordered LDTs, they received a second warning from the FDA about a new DTC liquid biopsy cancer detection test in September 2015. The device was not registered with the FDA, and the FDA had concerns that it was a high-risk test that lacked proper clinical validation. Pathway Genomics subsequently pulled it from the market.

Current landscape of DTC genetic testing

While 23andMe and Pathway Genomics have remained strong players in the DTC genetic testing field, other companies offering unique approaches to personalized genomics have sprung up in the wake of regulatory shake-ups.

Ancestry and aging

There are many companies in the market that provide ancestry information, or the geographical origins of one’s DNA. These companies, like Ancestry.com, Inc. ($ACOM), MyHeritage, and Family Tree DNA($GENE), are unregulated by the FDA.

TeloYears offers to measure consumers’ telomere length to determine their “cellular age,” which aims to provide information about aging and healthy habits. Because this test is not diagnostic, it is not regulated by the FDA.

DNA product marketplace

Helix, a spinoff of Illumina and a relative newcomer to the space, has a very novel take on DTC genetic testing. Helix sells next-generation sequencing and storage of a customer’s DNA, but does not provide any direct analysis. Instead, Helix has partnered with many companies to provide a wide variety of DNA-powered services to their customers, without the need for re-sequencing for each service added.

Some services available for purchase through Helix’s DNA product marketplace are for serious health conditions, like inherited diabetes and cholesterol tests through Admera Health, or carrier screening through Sema4. Other tests provide ancestry information from National Geographic, or food sensitivity testing with EverlyWell. Any test with medical implications is done upon physician order and with accessibility to genetic counselors. The partner company, not Helix, manages FDA compliance.

Helix may interest new types of customers in genetic testing through partners like Vinome, which curates wine for clients based on their DNA and taste preferences, and Dot One which designs personalized art and textiles based on a person’s unique DNA sequences.

Helix has many partnerships pending with well-known organizations like the Mayo Clinic, and other DTC genetic testing companies, like Invitae. Owning all of that genomic data will provide a rich research resource for Helix as their customer base grows.

Advertised to consumers, ordered by physicians

Genetic testing companies in the health, family planning, and cancer spaces are currently employing an interesting business model: they market their services to consumers, but require a physician to order and deliver the tests results. As such, they are not true DTC companies, but sell LDTs that are still regulated by the FDA.

Counsyl offers carrier status reports, prenatal screening, and hereditary cancer tests, all provided with a physician’s order and access to genetic counselors. Counsyl has never executed a DTC approach.

Color Genomics provides physician-ordered hereditary cancer testing with genetic counseling.

Veritas Genetics is one of a few companies that currently advertises whole-genome sequencing. They are the first to offer the sub-$1,000 genome, at $999. Veritas also offers targeted cancer, carrier status, prenatal, and pediatric tests. All of their products require physician approval.

Invitae ($NVTA), founded in 2010, had an initial public offering in 2015 and is positioning itself to be a major player in the field. Invitae offers whole exome sequencing, hereditary cancer risk analysis, gene panels for specific concerns like cardiac health, and broader screening for multiple diseases. All of Invitae’s products require a physician referral and include genetic counseling.

Invitae has expanded its operations into the fertility market. They recently acquired Good Start Genetics, which specializes in pre-implantation and carrier status diagnostics, and CombiMatrix, which provides prenatal diagnostics, pediatric disorders, and miscarriage analysis. Invitae is poised to take advantage of a specialized market with its pregnancy-associated tests.

How will the FDA continue to regulate DTC genetic testing?

As the body of scientific literature supporting the genetic basis of disease grows, the FDA will need to dynamically evaluate its regulation of DTC tests. The determination of how risky particular information may be to a consumer, and if a certain genetic mutation is considered diagnostic or not, will likely change.

Currently, there is a spectrum of low-risk/non-diagnostic to high-risk/diagnostic genetic testing.

Genetically determining that a woman is at high risk for breast cancer may lead her to prophylactically remove her breasts and ovaries, which is a clear example of a diagnostic genetic test that may lead to a significant medical intervention. But what level of medical intervention determines if a test is diagnostic?

The FDA has not explicitly stated how it determines if a medical device is diagnostic. This broad categorization of “diagnostic” allows the FDA to protect consumers from risky products and testing as it sees fit.

However, as consumer scientific literacy improves, medical technologies evolve, and as do-it-yourself tools become available online, consumers are able to glean more from their uninterpreted genomic data than ever before. How long will it be before all consumers of DTC genetic testing can mine their genomes on their own?

The FDA is entering a new era of regulation as whole genome sequencing becomes more accessible to consumers. Because a large portion of the human genome has yet to be decoded, the level of “diagnostic” information it contains, and therefore how the dissemination of that information to consumers should be controlled, is unclear.

Successful DTC genetic testing companies must not only work within the FDA’s current regulatory framework but also be poised to quickly move into new markets as new types of genomic information are determined to be useful to consumers and as the criteria of what is considered “diagnostic” by the FDA continues to evolve.

Continue reading FDA regulation defines business strategy in direct-to-consumer genetic testing.

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kristinsimmons · 6 years ago

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All for One, One For All

By MIKE MAGEE MD

Mike Magee is a Medical Historian and author of “Code Blue: Inside the Medical Industrial Complex” (Grove Atlantic/June, 2019).

All for One, One For All published first on https://wittooth.tumblr.com/

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