Pharmaceutical developers are combining genetic sequencing and precision medicine to create new drug therapies and cancer treatments designed for specific patients
Most anatomic pathologists are aware of the rapid advances in the field of cancer immunotherapy—sometimes also called immune-oncology. This is an area of healthcare where precision medicine and personal genetics become crucial elements in developing more effective drug regimens.
Scientists are combining those two areas of research to develop vaccines designed for specific individuals based on the genetic characteristics of their DNA. This is why there are great hopes that cancer immunotherapy can be used to artificially stimulate the immune system to treat cancer and improve the system’s natural ability to fight cancer.
San Francisco-based Genentech, a subsidiary of Swiss pharmaceutical giant Roche (OTCMKTS:RHHBY), is working with German company BioNTech to develop such personalized vaccines for cancer patients. Each vaccine would be based on the unique deoxyribonucleic acid (DNA) of a patient’s tumor.
Unlike typical vaccines, Genentech’s drug would not be taken
as a preventative measure. Instead, patients receive it after being diagnosed
with cancer.
Though
still being tested, this new line of research indicates that development of personalized
cancer treatments is progressing, as scientists strive to customizetreatments tumor by tumor.
Creating One-Off Vaccines
To create each vaccine, a patient first undergoes a tumor biopsy. The sample tissue is then sent to a genetics laboratory for full genome sequencing. Sophisticated algorithms analyze the genetic data and locate targets within the tumor that have the most potential for training the patient’s immune system to attack the existing cancer. A customized vaccine is then created for and administered to the patient.
“What’s truly revolutionary about this approach is that each vaccine uses a common molecular backbone—mRNA—that is uniquely tailored to an individual patient,” said Todd Renshaw, former Global Head of Clinical Contract Manufacturing at Genentech, in an article posted on the company’s website. “It’s the next step in personalized medicine.”
Vaccines are typically used to train the body’s immune
system to attack specific diseases that infiltrate the body from the outside. However,
cancer tumors are formed within the body’s own tissues, making it difficult for
the immune system to detect them. Thus, vaccines haven’t shown much promise for
treating cancer.
“Vaccines work by exposing the immune system to ‘non-self’ proteins known as antigens, priming it to recognize and eliminate the invaders. But in the case of cancer cells, most proteins are the same as those on healthy cells,” said Lélia Delamarre, Senior Scientist in Cancer Immunology at Genentech, in the online article. “This makes it hard to identify which antigen to use in a vaccine.”
Global
testing on the vaccine has commenced with a focus on ten cancers in upwards of
560 patients.
Barriers to Creating Individual Vaccines
The American Cancer Society estimates there were 1,735,350 new cancer diagnoses in the US in 2018—and 609,640 cancer deaths—making it the second leading cause of death in the US after heart disease.
A
truly customized cancer treatment in the form of a vaccine could be a major
breakthrough in treating this deadly disease. However, there are significant
barriers to developing such a vaccine.
For
starters, the vaccines cannot be manufactured in batches, packaged, warehoused,
or delivered to pharmacies in bulk. The personalized vaccines must be
manufactured in single patient doses, which could be prohibitively costly.
Nevertheless, this research represents an exciting
opportunity for anatomic pathologists and clinical laboratories with genetics
capabilities which would be needed to secure and sequence tumor biopsies for
guiding the creating of the customized vaccines.
Pathologists should track this trend closely and work within
their group practices to ensure they have the analyzers, informatics, and
expertise required to perform this type of testing for patients within their
communities.
While clinical laboratories may not be directly affected by copay accumulators, anything that affects patients’ ability to pay for healthcare will likely impact lab revenues as well
Here’s a new term and strategy that some big employers are
deploying in an attempt to control the choice of health benefits provided to
their employees. The term is “copay accumulator” and it is intended to offset
efforts by pharmaceutical companies to minimize what consumers must pay
out-of-pocket for expensive prescription drugs.
Clinical laboratory managers and pathologists will have a front row seat to watch this next round in the struggle between industry giants for control over how patients pay for drugs and treatment regimes.
Pharmaceutical companies on one side and health insurers and employers on the other side have played brinksmanship over medication copays for years. Now at the center of this struggle are copay accumulators, a relatively new feature of plans from insurers and pharmacy benefit managers (PBMs) on behalf of the large employers they serve.
More than 41-million Americans use copay accumulators, and about nine million use similar though limited copay maximizer programs, Zitter Health Insights, a New Jersey-based pharma and managed care consultancy firm, told Reuters.
Now, big employers are getting in on the game. Walmart
(NYSE:WMT) and Home Depot (NYSE:HD) are among a growing number of companies using
copay accumulators and copay maximizers to keep their healthcare costs down and
encourage employees to seek lower-cost alternatives to expensive brand
prescriptions (generic drugs).
About 25% of employers currently use such programs, and 50% of employers are anticipated to be doing so in just two more years, the National Business Group on Health told Reuters.
What Are Copay
Accumulators and How Do They Work?
In response to popular drug company discount cards,
insurance companies developed the “copay accumulator.” Here’s how it works.
Typically, patients’ insurance plan deductibles can be thousands
of dollars. Thus, even after plan discounts, patients often pay hundreds, even
thousands of dollars each month for prescribed medications. Insurance companies
see a beneficial side to this, stating the cost encourages patients to be aware
of their medications and motivates them to try lower-cost non-branded
alternatives (generic drugs), all of which saves insurance plans money.
However, many patients with high-deductibles balk at paying
the high cost. They opt to not fill prescriptions, which costs pharmaceutical
companies money.
To encourage patients to fill prescriptions, drug companies
provide discount cards to help defray the cost of the drugs. The difference
between the discounted payment and the full price of the drug is paid by the
pharmaceutical company. But these discount cards interfere with insurance
companies’ ability to effectively track their enrollees’ drug usage, which
impacts the payers’ bottom lines.
When a patient uses a drug discount card at the point-of-sale, the sale is noted by the patient’s health insurer and the insurer’s copay accumulator program kicks in. It caps the total accumulated discount an enrollee can take for that medication and prevents any patient payments to apply toward the plan’s deductible. Once the drug company’s discount card threshold is reached, the patient bears the full cost of the drug, a ZS Associates Active Ingredient blog post explained.
Critics of copay accumulators point out that patients could
end up paying full price for extremely expensive prescriptions they previously
accessed with discount cards, while simultaneously making no progress toward
fulfilling their insurance deductibles. Or, they will simply stop taking their
medications altogether.
“A medication which previously cost $7 may suddenly cost hundreds or even thousands of dollars because the maximum amount of copay assistance from the [drug] manufacturer was reached,” noted Ken Majkowski, Pharm.D, Chief Pharmacy Officer at FamilyWize (a company that offers its own prescription savings programs), in a blog post. “Since the health plan will no longer allow the copay amounts to contribute to the patient’s deductible, the cost of the medication remains very high.”
Major Employers Implement
Their Own Copay Accumulator Programs
Enter the next goliath into the fray—the large employer. Executives
at Walmart and Home Depot say discount drug coupons drive up healthcare costs
and give their employees and their family members no incentive to explore lower
cost alternatives, Reuters reported.
Walmart’s pharmacy benefits are managed by Express Scripts, a prescription benefit plan provider that fills millions of prescriptions annually, according to the company’s website. Meanwhile, Home Depot’s pharmacy benefits are operated by CVSHealth, which focuses on therapies for cystic fibrosis, hepatitis C, cancer, HIV, psoriasis, pulmonary arterial hypertension, and hyperlipidemia, Reuters noted.
Insurance Associations
Weigh-In
Health insurance company representatives say the need for copay accumulators begins with the high price of pharmaceuticals. Insurers are not the only ones concerned about these costs. The American Hospital Association (AHA), the Federation of American Hospitals (FAH), and the American Society of Health-System Pharmacists (ASHP) recently released a report showing total drug spending per hospital admission increased by 18% between 2015 and 2017, and some drug categories rose more than 80%.
“The bigger question is why do we need copay coupons at all? It’s very important to recognize the problem starts with the [drug] price. This is the real underlying problem,” Cathryn Donaldson, Director of Communications, America’s Health Insurance Plans (AHIP), told the Los Angeles Times.
In their blog post, ZS Associates advised drug companies to
“push-back” on the copay accumulators. The Evanston, Ill.-based consultancy
firm recommends pharma executives change the way they run the discount cards—such
as paying rebates directly to patients instead of working through pharmacies.
Medical laboratory leaders need to be aware of programs,
such as copay accumulators, and the associated issues that affect patients’
ability to pay for their healthcare. Because large numbers of patients struggle
to pay these high deductibles, it means clinical laboratories will be competing
more frequently with hospitals, physicians, imaging providers, and others to
get patients to pay their lab test bills.
Experts are skeptical of the value of public price lists based on hospital chargemasters due to complexity and poor reflection of actual costs
In another big step toward helping consumers view prices of medical procedures when selecting providers, the Centers for Medicare and Medicaid Services (CMS) passed the IPPS/LTCH PPS final rule, which requires hospitals to post a full list of hospital pricing information on their websites starting January 1, 2019.
Clinical laboratories, anatomic pathologists, and other diagnosticians doing business with their local health networks will now find their prices for tests and procedures listed on the hospitals’ chargemasters available to the public.
To meet rule requirements, pricing information posted by hospitals
must be:
• Published online in a publicly accessible place;
• Machine-readable;
• Downloadable to a spreadsheet; and,
• Updated at least once per year.
Outside of these requirements, the guidelines are vague. However,
based on coverage of initial pricing lists, additional revisions are expected.
A fact sheet discussing the major provisions of the final rule (CMS-1694-F), can be downloaded from the Federal Register.
Are the Price Lists
Accurate?
One of the biggest issues cited by the media relates to the
accuracy of pricing information. As most hospitals are posting data directly
from their chargemaster listings, the numbers listed for the public are likely
to differ from the actual prices billed. Final charges depend on each patient’s
insurance plan and the network status of the healthcare facility rendering the services.
While hospitals are now required to post their price lists in a machine-readable format, MedCity Newsreports that many facilities use medical codes and terminology in price lists that the average consumer might not understand.
To further compound the issue, many items are listed
individually. This requires consumers to go through thousands of price listings
and combine the listed prices one by one to get an estimate of total costs for
a procedure.
Brenda L. Reetz, CEO of Green County General Hospital in Indiana also spoke with the NYT, saying, “We’ve posted our prices, as required. But I really don’t think the information is what the consumer is actually wanting to see.”
“While many hospitals have said chargemaster information can be confusing for consumers, let me be clear, hospitals don’t have to wait for us to go further in helping their patients understand what care will cost. We look forward to more facilities exceeding our requirements,” Seema Verma (above right), Administrator, Center for Medicare and Medicaid Services (CMS), told Modern Healthcare. (Photo copyright: Fox Business.)
Concerns of Increased
Risk for Both Hospitals and Consumers
“There is no more powerful force than an informed consumer,” said Alex Azar II, Secretary of the US Department of Health and Human Services (HHS) during a speech to the Federation of American Hospitals (FAH). “There is no turning back to an unsustainable system that pays for procedures rather than value. In fact, the only option is to charge forward—for HHS to take bolder action, and for providers and payers to join with us,” he concluded.
But with the higher rates found on most hospital chargemasters,
and the difficulty in finding true costs using the new public pricing lists, some
experts are concerned the lists might cause an adverse reaction.
“We do not want patients to forgo needed care,” Tom Nickels, Executive Vice President for Government Affairs and Public Policy at the American Hospital Association (AHA), told Newsweek. “Especially if the quoted price is for the total cost of the service and not what the patient will be expected to pay out-of-pocket.”
This is a real risk. Hospitals and other healthcare
providers already are experiencing reduced volumes due to patients opting out
of important procedures because of cost worries. Chargemaster lists that do not
reflect the true impact of insurance, charity programs, and other variables could
exacerbate that problem.
And there is specific risk for clinical laboratories, as
they rarely have a public-facing element within hospitals. Physicians order medical
laboratory tests and patients either do or do not comply. There is no
opportunity for laboratories to explain that prices listed on the hospital site
might not reflect actual out-of-pocket costs. Could this be an opportunity for
enterprising clinical laboratory managers?
Future Transparency
Trends
“I think putting those prices out there—even with the acknowledgment that these aren’t the prices anyone pays unless they’re uninsured—may indeed still provoke conversations with hospital administrators,” Michael Abrams, Managing Partner of Healthcare Consultancy at Numerof and Associates, a strategic management consultant for the global healthcare sector, told MedCity News.
While experts might not find much value in the current
iteration of price lists, and the latest attempt to improve pricing
transparency by CMS, it offers medical laboratories and hospitals an
opportunity to assess current pricing models and decide how to best communicate
value to consumers as pricing transparency continues to mature and the US
shifts to value-based healthcare.
The researchers also found unnecessarily confusing policies and procedures for requesting medical records, such as clinical laboratory test results
Clinical laboratories and anatomic pathology groups looking for ways to improve their customers’ experience should give high priority to ensuring patients have easy, accurate access to their own health records. This would, apparently, set them apart from many hospital health networks if a recent study conducted by Yale University School of Medicine is any indication.
Conducting their research from August 1 through December 7, 2017, Yale researchers evaluated the medical records processing policies of 83 top-ranked hospitals located across 29 states. They found that patients attempting to obtain copies of their own medical records from various hospitals often faced unnecessary and confusing hurdles. They also found serious noncompliance issues with regards to the HealthInsurance Portability and Accountability Act of 1996 (HIPAA).
Overwhelming Inconsistencies in Policies
and Procedures
“There were overwhelming inconsistencies in information relayed to patients regarding the personal health information [PHI] they are allowed to request, as well as the formats and costs of release, both within institutions and across institutions,” said Carolyn Lye, a medical student at the Yale School of Medicine and first author of the study, in a Yale News article. “We also found considerable noncompliance with state and federal regulations and recommendations with respect to the costs and processing times associated with providing access to medical records.”
“Stricter enforcement of the patients’ right of access under HIPAA is necessary to ensure that the medical records request process across hospitals is easy to navigate, timely, and affordable,” study first author Carolyn Lye (above), told Yale News. “We are also in an era in which patients are participants in their own healthcare. Inhibiting access for patients to their own medical records with complicated, lengthy, and costly request processes prevents patients from obtaining information that they may need to better understand their medical conditions and communicate with their physicians.” (Photo copyright: Twitter.)
The researchers collected release authorization forms from
the hospitals by calling each hospital’s medical records department. During the
simulated patient experience, they questioned the hospital policies regarding:
Requestable information (including entire
medical records, medical laboratory test results, medical history, discharge
summaries, physician orders, consultation reports);
Available release formats (pick up in person,
mail, fax, e-mail, CD, online patient portal);
Costs associated with obtaining the records;
and,
Processing times.
The team found inconsistencies between information provided
on written authorization forms and the simulated patient telephone calls, as
well as a lack of transparency.
On the paper forms, only 44 hospitals (53%) had an option
for patients to acquire their entire medical record. However, on the telephone
calls, all 83 of the surveyed hospitals provided that option.
The researchers also discovered discrepancies in the
information regarding the formats available for patient records. For example,
69 (83%) of the hospitals stated during the phone calls that patients could
pick up their records in person, while only 40 (48%) of the hospitals said patients
could do so on the written release forms. Fifty-five (66%) of the hospitals
told callers that medical records were available on CD and only 35 (42%) of the
hospitals provided that option on the written forms.
Similar discrepancies between information provided in phone
calls versus paper authorization forms were found relating to other formats
included in the study as well.
Excessive Fees Exceed
Federal Recommendations
Hospitals are allowed to charge a modest fee for the release
of medical records. But the researchers found quoted costs varied widely among
surveyed hospitals.
On the written authorization forms, only 29 (35%) of the
hospitals disclosed the exact costs associated with obtaining medical records.
The costs for a hypothetical 200-page record from these hospitals ranged from
$0.00 to $281.54. During the phone calls, 82 of the hospitals disclosed their
fees, with quotes for obtaining a 200-page record ranging from $0.00 to
$541.50.
The federal government, however, recommends charging
patients a flat fee of $6.50 to obtain electronically maintained medical
records. Forty-eight (59%) of the hospitals surveyed exceeded that charge.
Access Times Also Vary
The time hospitals needed to release patients’ medical
records also varied, ranging from same-day to 60 days—with electronic data
tending to be delivered fastest. Federal regulations require medical records to
be released within 30 days of the initial request, though HIPAA provides for an
additional 30-day extension. However, six of the 81 hospitals that provided
turn-around times to medical records requests were noncompliant with federal processing
time requirements.
Congress
passed HIPAA primarily to modernize the flow of healthcare information. An
important part of the Act was to make it easier for patients to receive their
medical records and clinical data from hospitals, medical offices, clinical
laboratories, etc. The Yale study, however, indicates that obtaining medical
records can still be a cumbersome and perplexing process for patients.
The United States Government has spent upwards of $30 billion since 2010 in incentives to encourage hospitals and physicians to implement and use electronic health record (EHR) systems. One goal of issuing these incentives was to make it easy and inexpensive to move patient data between providers to support improved clinical care, as reported by the Commonwealth Fund.
This
research demonstrates that the internal policies of some hospitals and health
systems are contrary to federal and state laws because patients are often
struggling to gain access to their own medical records. The results of the Yale
study present an opportunity for clinical laboratories and pathology groups to
adopt and offer patient-friendly access to obtain lab test data.
Even more compelling was the discovery of DNA from the Staph bacteria on the stethoscopes even after they were cleaned. Though the tests could not differentiate between live and dead bacteria, the researchers found other non-Staph bacteria as well, including Pseudomonas and Acinetobacter.
Similar conditions could no doubt be found in most
healthcare settings in America, highlighting the critical importance for
rigorous cleaning procedures and protocols.
“The study underscores the importance of adhering to rigorous infection control procedures, including fully adhering to CDC-recommended decontamination procedures between patients, or using single-patient use stethoscopes kept in each patient’s room,” said Ronald Collman, MD (above), the study’s senior author and Professor of Medicine, Pulmonary, Allergy, and Critical Care at UPenn’s Perelman School of Medicine, in a news release. (Photo copyright: Penn Medicine.)
The researchers acknowledged that previous culture-based bacterial
studies looked at stethoscopes, but noted the results fell short of the view
next-generation sequencing technology can offer for identifying bacteria, as
well as determining the effectiveness of cleaning chemicals and regiments.
“Culture-based studies, which focus on individual organisms,
have implicated stethoscopes as potential vectors of nosocomial bacterial
transmission [HAI]. However, the full bacterial communities that contaminate
in-use stethoscopes have not been investigated,” they wrote in Infection Control and Hospital Epidemiology.
• 20 worn by physicians, nurses, and respiratory therapists;
• 20 single patient-use disposable stethoscopes available in ICU patient rooms; and,
• 10 unused single-use disposable stethoscopes to serve as a control.
All stethoscopes worn and/or used in the ICU were found to be contaminated with abundant amounts of Staphylococcus DNA. “Definitive” amounts of Staph was found by researchers on 24 of 40 tested devices, noted MedPage Today.
“Genera relevant to healthcare-associated infections (HAIs)
were common on practitioner stethoscopes, among which Staphylococcus was ubiquitous
and had the highest relative abundance (6.8% to 14% of containment bacterial
sequences),” the researchers noted in their paper.
Cleaning Methods Also
Examined
The researchers also studied the hospital’s cleaning agents
and procedures:
• 10 practitioner stethoscopes were examined before and after a standard 60-second cleaning procedure using hydrogen peroxide wipes;
• 20 additional stethoscopes were assessed before and after cleaning by practitioners using alcohol wipes, hydrogen peroxide wipes, or bleach wipes.
All methods reduced bacteria. But not to the levels of a new
stethoscope, the study showed.
“Stethoscopes used in an ICU carry bacterial DNA reflecting complex microbial communities that include nosocomially important taxa. Commonly used cleaning practices reduce contamination but are only partially successful at modifying or eliminating these communities,” the researchers concluded in their paper.
Prior Studies to Find
and Track Dangerous Bacteria
Studies tracking bacteria where people live, work, and
travel are not new. For years, medical technologists and microbiologists have
roamed the halls of hospitals and other clinical settings to swab and culture
different surfaces and even articles of clothing. These efforts are often
associated with programs to reduce nosocomial infections (HAIs).
This new study by UPenn Perelman School of Medicine researchers—published
in a peer-reviewed medical journal—will hopefully serve as a contemporary
reminder to doctors and other caregivers of how bacteria can be transmitted and
the critical importance of cleanliness, not only of hands, but also
stethoscopes (and neckties).
Hospital-based medical laboratory leaders and microbiology professionals also can help by joining with their infection control colleagues to advocate for CDC-recommended disinfection and sterilization guidelines throughout their healthcare networks.
Pharmaceutical tourism, like medical tourism, casts light on healthcare’s true costs and identifies patient populations that bear the brunt of growing drug prices
You’ve heard of medical tourism, where patients travel to other countries to receive low-cost, high-quality medical care. Now the State of Utah is introducing “pharmaceutical tourism” to state employees, who will be paid to make trips to Mexico to purchase certain prescription drugs.
The State of Utah is not alone in its use of this strategy. Prescription medication costs are skyrocketing for many critical drugs. To reign in those costs, several organizations are incentivizing their employees to purchase those drugs less expensively outside of the US. Clinical laboratories and anatomic pathology groups that perform companion diagnostic tests associated with certain high-priced therapeutic drugs might see more of their patients decide to cross international borders to access the drugs they need.
This pharmaceutical tourism highlights how complex US laws
hide the true cost of prescription drugs from patients and their employers. It also
raises the question: how might pharmaceutical tourism impact retail pharmacies
in this country?
Saves Patients Money,
but at What Cost?
The Public Employees Health Plan (PEHP) for Utah state employees recently announced a pharmacy tourism program. Its members can receive free air travel and $500 in cash to fill 90-day prescriptions in Mexico for certain higher-cost medications.
“The prescription drugs received in Mexico are the same quality and from the same manufacturer as those sold in the US,” said Travis Tolley, Clinical Management Director at PEHP Health and Benefits, in a news release. “The difference is the price you pay. For example, a 90-day supply for the average cost of an eligible drug in the US is over $4,500 per month and is 40-60% less in Mexico. The substantial savings allow us to reward our members for seeking lower-cost options.”
Participants in the program receive round-trip airfare from Utah to San
Diego for themselves and a companion, followed by transportation to a clinic in
Tijuana where their prescriptions are filled. They also can receive a taxable
$500 cash bonus for each trip—up to four trips/year. The airfare from Salt Lake
City to San Diego typically costs around $300.
In 2018, Utah passed the “Health Insurance Right to Shop Amendments” bill (H.B. 19), which requires PEHP to offer incentives and a savings reward program to members who seek out and utilize low-cost options for healthcare. State Representative Norman Thurston (above right) sponsored the bill. “Why wouldn’t we pay $300 to go to San Diego, drive across to Mexico, and save the system tens of thousands of dollars? If it can be done safely, we should be all over that,” he told Becker’s Hospital Review. (Photo copyright: Daily Herald.)
PEHP, which covers 160,000 public employees and family
members, offers the pharmacy tourism program for 13 specific medications where
a vast disparity in cost exists between the US and Mexico.
The drugs that qualify for the program along with the most
common illnesses they treat are:
One of the more expensive drugs on the list, Avonex, costs
approximately $6,700 for a month’s supply in the US compared to only about
$2,200 at the contracted clinic in Tijuana. That’s a savings of approximately
$13,500 for a three-month supply, which compensates for the program’s $500 cash
reward and transportation costs.
Not the First Time
PEHP Tried Medical Tourism
PEHP previously offered free
airfare to members willing to fly to other countries for medical procedures and
prescriptions. However, without the cash incentives, participation was low. The
health plan hopes the lure of $500 per trip will increase participation rate.
UnitedHealthcare (UHC) also is experimenting with ways to lower prescription drug costs. Last year, they introduced My ScriptRewards. The program incentivizes members to opt for less expensive medications. Participants in this program receive up to $500 in prepaid debit cards to help defray their medical costs.
Currently, My ScriptRewards can only be used for select antiviral medications (Cimduo plus Isentress or Cimduo plus Tivicay) to treat human immunodeficiency virus (HIV). And, it’s only available to UHC commercial plan members who are covered by group plans. However, UHC plans to expand the program to include other high-cost specialty medications in the future.
According to the Centers for Disease Control and Prevention (CDC), prescription medications account for 9.8% of national health expenditures. And in 2017, Quintiles and IMS Health, Inc. (now IQVIA), a company that compiles data for the pharmaceutical industry, estimated that prescription spending in the US will reach an annual cost of $580-$610 billion by 2021.
And, with prescription costs soaring, it’s likely insurance
providers will continue to seek new ways to curtail costs. In an era when many medical
laboratory companies are charging sky-high prices for their proprietary tests
and test panels, might “clinical laboratory tourism” be the next trend to
emerge?
