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Wednesday, February 6, 2019

MS Drug Costs Skyrocket After Medicare Rules Change

Medicare rule changes could trigger a spike in out-of-pocket drug costs for patients with multiple sclerosis (MS).
Due to rules that restrict access and require patients to cover more of the cost, those without low-income subsidies can expect to spend almost $6,900 a year out of pocket for MS medicines, researchers reported.
“It’s a dysfunctional market that lacks the typical incentives for most other consumer products,” said lead author Daniel Hartung. “Aside from the public optics, there are few incentives for companies not to raise prices. Most intermediaries in the drug distribution channel, including drug companies, benefit from higher prices.”
Hartung is an associate professor at the College of Pharmacy of Oregon Health and Science University (OHSU) and Oregon State University.
MS is an unpredictable disease of the central nervous system, resulting in symptoms that include vision problems, muscle weakness, tremors and difficulty with balance and coordination.
Out-of-pocket drug costs are often tied to undiscounted list prices, and there appears to be a link between rising prices for MS drugs and more use of restrictive policies by Medicare drug plans, according to the researchers.
For example, they found that patients who are prescribed the only generic drug in one class — glatiramer acetate — will pay more out of pocket than patients using any brand-name drugs in the same class.
Medicare rule changes last year were meant to reduce patients’ out-of-pocket costs through increased discounts from brand-name drug manufacturers. But the change resulted in higher out-of-pocket costs for users of certain generic products.
“This is a pernicious effect of the release of a generic and an unfortunate effect of Medicare rules,” study co-author Dr. Dennis Bourdette said in an OHSU news release. Bourdette is chairman of neurology at the OHSU School of Medicine in Portland.
A Trump administration proposal to address this incentive disparity between brand-name and generic drugs could reduce patients’ total out-of-pocket spending, according to the researchers.
“Despite increases in the number and diversity of disease-modifying therapies for MS, prices have risen rapidly over the past two decades,” Bourdette’s team wrote. “The rise in high coinsurance cost-sharing models, coupled with escalating drug prices, means that patients will increasingly face prohibitive out-of-pocket spending.”
The study appears in the February issue of the journal Health Affairs.
More information
The U.S. National Institute of Neurological Disorders and Stroke has more on multiple sclerosis.
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Trump’s Goal of No New HIV Cases by 2030 Is Possible, Health Officials Say

In his State of the Union address Tuesday night, President Donald Trump announced his administration’s plan to rid the United States of new transmissions of HIV by 2030.
“Together, we will defeat AIDS in America and beyond,” the president told the nation.
At a follow-up media briefing Wednesday morning, leading federal health officials outlined just how that mission might be accomplished.
“We’re going to diagnose all people as early as possible, we’re going to treat the infection rapidly and effectively, we’re going to protect those at highest risk, we’re going to respond to any outbreaks with overwhelming force, and we’re going to create a public health work force throughout this country with the specific goal of reducing new diagnoses by 75 percent within five years and by 90 percent within 10 years,” said Admiral Brett Giroir.
He’s assistant secretary of the U.S. Department of Health and Human Services.
Over 1 million Americans are currently living with HIV.
Federal government scientists have been coordinating for months on the new plan, which combines broader efforts to stem transmission of HIV with better treatment for people who are already infected.
Getting more people tested for the virus is vital, Giroir told reporters Wednesday.
“We have tremendous strategies of how we can detect and bring people into treatment early,” he said, “and we know 90 percent of new infections are transmitted by people who are undiagnosed and not in effective care.”
But new infections often cluster in certain “high-risk” communities, added Dr. Robert Redfield, director of the U.S. Centers for Disease Control and Prevention.
In 2018, “there were a little over 38,500 new infections in the United States,” he said. To help pinpoint where the need for testing and treatment was greatest, “we actually lifted the number of infections in each county, and that allowed us to sort of rank the counties in terms of how they were contributing to the annual infections in America.”
Redfield said he was “shocked” to see that just 48 out of 3,000 counties in the United States accounted for half of all new HIV infections.
“It showed we had a very geographically focused outbreak, that if we could augment the capacity of those 48 counties to respond to new infections we could drastically reduce the number of new infections,” he said.
HIV researchers and patient advocates have long known that the virus hits certain groups hardest, most notably gay and bisexual men of color. Communities with high levels of this subgroup may benefit the most from targeted interventions, experts say.
Then there’s the issue of treatment — both to prevent new infections and control existing infections.
One recent advance has been the emergence of drugs like Truvada, which are used for both treating active infection and as “pre-exposure prophylaxis” (PrEP) — a preventive strategy for people deemed at high risk for infection.
Dr. Anthony Fauci directs the U.S. National Institute of Allergy and Infectious Diseases and has long been on the forefront of the fight against HIV/AIDS.
Speaking at the Wednesday briefing, he stressed that “if you treat an individual and bring their viral load to below detectable levels, they will not transmit their virus to another individual.”
“We know pre-exposure prophylaxis works in more than 97 percent of the cases,” Fauci said. So, “if you put those two together, you could theoretically end the epidemic as we know it. That’s our goal.”
The path to such hope has been an arduous one.
In the 1980s and 1990s, HIV/AIDS became a seemingly unstoppable epidemic. The virus crippled the immune systems of otherwise healthy people, leaving them vulnerable to lethal “opportunistic” infections.
Millions of people worldwide have died from HIV, but the advent of potent antiretroviral drug cocktails in the mid-1990s revolutionized care, keeping viral levels down to undetectable levels and stopping the onset of AIDS.
HIV transmission levels also fell sharply, although thousands of new infections still occur in the United States each year.
Brian Mustanski directs the Institute for Sexual and Minority Health and Wellbeing at Northwestern University’s Feinberg School of Medicine in Chicago. He agreed that the elimination of new cases of HIV infection by 2030 is possible — given certain conditions.
“If we are going to end HIV transmissions in the U.S., we need research to help understand how to effectively deliver the right interventions to the right communities at the right time,” he said.
“Every 44 minutes, a 13- to 29-year-old gay or bisexual man in the U.S. gets diagnosed with HIV,” Mustanski added. “These diagnoses are disproportionally among young men of color — the only group in the U.S. to show increases in the rate of annual diagnoses. Any plan to end HIV transmission in the U.S. must center on the needs of young gay and bisexual men of color in order to be successful.”
Mustanski believes that any plan aimed at eradicating HIV transmission within a decade must make PrEP available to these underserved communities.
“We have highly effective approaches to preventing HIV transmission today, but they are not effectively reaching the communities who need them most,” he said.
More must also be done to raise HIV testing rates, because undiagnosed carriers of HIV are more likely to infect others.
“Only a quarter of sexually active teen gay and bisexual boys have ever had an HIV test,” Mustanski noted. “As a result, only about half of young people in the U.S. who are HIV-positive know their status, which is the entry point to lifesaving treatment that can also eliminate transmission.”
Community outreach aimed at encouraging safe sex behaviors is another crucial step in getting transmissions down to zero, he said.
More information
There’s more on HIV/AIDS at amFAR.
SOURCES: Feb. 6, 2019, news briefing with: Admiral Brett Giroir, HHS Assistant Secretary for Health, Anthony Fauci, M.D., director, U.S. National Institute of Allergy and Infectious Diseases, and Robert Redfield, M.D., director, U.S. Centers for Disease Control and Prevention; Feb. 5, 2019, State of the Union address, President Donald Trump; Brian Mustanski, Ph.D., director, Institute for Sexual and Minority Health and Wellbeing, Northwestern University Feinberg School of Medicine, Chicago; The New York Times
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Digital Pill May Improve Adherence to Oral Cancer Drugs

Oral chemotherapy has changed the paradigm of cancer treatment, moving it from the inpatient to the outpatient setting. Although more convenient for the patient, adherence can sometimes be problematic.
A new “digital pill” may allow clinicians to better monitor their patients.
In a small pilot study, colorectal cancer patients are being administered capecitabine (Xeloda, Hoffman-LaRoche) that has been embedded with a sensor. The sensor can alert the oncologist, nurse, or caregiver when the pill has been taken.
Developed by Proteus Digital Health, the product can securely capture, record, and share information about the time, dose, and type of oral chemotherapy medication taken. The goal is to help optimize treatment regimens while maintaining the patient’s privacy, the company says.
The study, which is currently underway, includes seven patients with stage III or IV colorectal cancer. The technology is being developed in collaboration with the University of Minnesota Health and Fairview Health Services.
“We were interested in making oral chemotherapy safer and more practical,” said Edward Greeno, MD, professor of medicine, Division of Hematology, Oncology and Transplantation, the University of Minnesota, Minneapolis, who is leading the pilot project. “Historically, chemotherapy has been given intravenously — first in the hospital, and then it moved to the clinic — but there were a lot of safety mechanisms in place that were all tied to physical presence in the infusion center.”
The situation is very different with oral chemotherapy, he explained. “Once we started using oral chemotherapy at home, I would write a prescription and hand it to the patient, and that was it. Everything was invisible to us.”
Mechanisms were put in place to help monitor patients receiving oral therapy, Greeno continued, such as having pharmacists check in with the patient. “But we really don’t have that direct connection as we did in the clinic, when patients are treating themselves at home,” he said.
Adherence can be challenging. For example, the regimen for capecitabine is complex. To complete one of eight cycles of chemotherapy, a patient must take four pills twice a day, with 2 weeks on therapy and 1 week off therapy.
Another problem that can arise is anxiety.
It can be frightening for patients not to have support when they are receiving chemotherapy, explained Greeno. “They are basically on their own at home, but this system gives them more of a connection to their doctors,” he said.
So far, feedback has been very positive. “We were worried that patients would not want to do it, but they all think it’s a great,” Greeno said. “They no longer have to worry if they forgot their pill, like waking up at midnight and wondering whether or not they took it.”
The digital system also allows providers and caregivers to find out about potential problems in real time. During the trial, the system notified the team that one of the patients had not taken her dose. When they subsequently checked up on her, she said that her “hands hurt and she couldn’t open the bottle,” Greeno explained.
“We quickly found out what the problem was and remedied it,” he said. “We were not only able to find out that she had not taken her dose, but the reason for it.”
The device not only monitors adherence but also measures patient activity and rest, as well as heart rate. “This enables us to get a better idea of what is happening with the patient in real time,” he said.

Provides Info on Pill and Patients

The digital pill system consists of an ingestible sensor that is about the size of a grain of sand. It is placed inside a gel cap along with the active drug. The patient wears a sensor patch measuring about 1″ × 3″ on their torso. After the pill is swallowed, the sensor is activated when it reaches the stomach. It then sends a signal to the patch, which in turn sends a digital record to an app on the patient’s mobile device. The record is also sent to the Proteus cloud, where it can be shared with designated providers and caregivers.
Although this is the first foray of the digital pill into chemotherapy, the technology itself is not brand new.
Scooter Plowman, MD, senior director of franchise development at Proteus Digital Health, explained that the sensor is already being used, either commercially or in clinical trials, in about 40 medications for the treatment of hypertension, hyperlipidemia, diabetes, hepatitis C infection, HIV, and tuberculosis.
“There isn’t any oral therapeutic that it can’t be used with,” Plowman told Medscape Medical News. “Thousands of patients have been treated — over 180,000 patients have ingested the sensor to date.”
In more than 60 clinical trials that have been conducted since 2004, the patch and sensor have been demonstrated to be accurate and safe. In one study that involved 20,993 ingestions in 412 study participants, there was a 97.3% detection rate of the ingestible sensor and 100% accuracy, with no false positive signals. Only four participants (1% of the cohort) reported experiencing nausea or vomiting, and during 6407 patch-use days among 492 volunteers, 61 individuals (12.4%) reported a self-limited rash around the sensor site.
The trials with various digital pills show that adherence rates are higher than are seen with standard therapy. “The digital drugs have an average adherence rate of 80%, while the literature shows that only about 50% of prescriptions are taken as directed,” said Plowman. “This is a way to help physicians keep a closer eye on their patients and for the care to be more precise and personal.”
So far, the company has produced products that combine an active FDA-approved drug with the sensor in a single capsule. Because they are separate components, they did not need to receive an additional approval from the regulatory agency.
However, one product involves a different technology, explained Plowman. The Abilify MyCite aripiprazole tablet, for use in the treatment of schizophreniaand bipolar disorder, was developed in collaboration with Otsuka Pharmaceuticals. It represents a kind of “next generation” of ingestible sensors, he said.
In this case, “the sensor is actually embedded in the pill,” explained Plowman, “so it is different and required FDA review and approval, which was received in 2017.”
The FDA noted that this was the first digital medicine system to be approved as a pharmaceutical. Thus, said Plowman, it can be prescribed like any other drug; previous regulatory clearance for the Proteus technology was obtained through the medical device pathway.
The Abilify MyCite system is not yet available commercially. Plowman explained that the delay is largely because the drug is the first of its kind, and it took several years to obtain FDA approval. “Part of the process now is also to establish a new payment model for it, so that has also been taking some time,” he explained.

Next Moves

The company plans to expand digitalizing supportive medications and to develop products that cancer patients can use to manage side effects. A larger trial with digital capecitabine is also planned, Plowman said. Patients are currently being enrolled at two sites. The goal is to enroll 750 patients over 2 years.
“This is going to be a registry study, so it will be ongoing,” he said. “And we want to use real-world data, which is more beneficial and enhances quality.”
The focus will continue to be on the treatment of gastrointestinal cancers with capecitabine.
Approached for comment, William Blackstock, MD, chair of radiation oncology and program director of the Comprehensive Cancer Center at Wake Forest Baptist Health, Winston-Salem, North Carolina, commented that he was quite excited to read about this new technology.
“We are going to be seeing more and more cancer drugs moving to oral therapy,” he told Medscape Medical News. “And you know patients don’t like to disappoint their doctors. If you ask them if they took all their medicine, they’ll tell you, ‘Sure, of course I did.’ And you never really know if that’s true or not, because they don’t want to disappoint you.
“I think this is a good way to tell if the therapy that we’re prescribing is actually being taken by the patient,” he said.
Blackstock also thinks that manufacturers should consider using this technology for new drugs in clinical trials. “You don’t want a study to be negative because the patients weren’t taking the drug and you just didn’t know it,” he said. “I worry about that. I’ve done studies with patient logs, and you have to just trust them.”
He also noted that the population is getting older. “We need strategies to make sure that elderly individuals who are living independently are taking their medications as prescribed. So this technology will be a great help to family members. It has a lot of applications,” he said.
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Biogen says ‘514 patent getting appeal board review

In a regulatory filing, Biogen (BIIB) noted that in July of 2018, Mylan (MYL) filed a petition with the U.S. Patent Trial and Appeal Board seeking inter partes review of Biogen’s U.S. Patent No. 8,399,514, or the ‘514 Patent. The ‘514 Patent includes claims covering the treatment of MS with 480 mg of dimethyl fumarate per day as provided for in Biogen’s Tecfidera label. On February 6, 2019, the U.S. Patent Trial and Appeal Board instituted inter partes review of the ‘514 Patent.
https://thefly.com/landingPageNews.php?id=2860513

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Novartis CEO says U.S. rebate plan will return cash to patients

Novartis AG Chief Executive Vas Narasimhan said his company’s prescription drug prices have been “flat to negative” over the last three years, and directed blame for high costs for U.S. patients on industry middlemen that manage drug benefits.
In an interview with Reuters in New York on Wednesday Narasimhan, a 42-year-old U.S. doctor who has headed the Swiss drugmaker since Feb. 2018, threw his support behind a U.S. government proposal to end a system of rebates drugmakers pay to pharmacy benefit managers (PBMs) and health insurers in order to get products on their lists of covered medicines..
“We (Novartis) pay almost 50 percent of our gross revenues in the United States into rebates,” Narasimhan said. “If you return those rebates to patients, so patients pay less out of pocket, I think that is something that makes a lot of sense and will correct a distortion in the marketplace.”
Narasimhan also acknowledged the industry and company reputational challenges stemming from anger over rising prices, kickback scandals and last year’s revelation that Novartis paid U.S. President Donald Trump’s former attorney, Michael Cohen, $1.2 million.
“It’s hard to call them outlier events, when there’s enough of the outlier events,” he said.
He described efforts to regain respect for the company that now has the world’s highest prescription drug sales as “the great journey of my time as CEO.”
Last month, U.S. Health and Human Services Secretary Alex Azar announced a plan that would end rebates now paid to PBMs and other payers and instead pass along savings to consumers covered by U.S. government health plans. Trump, in his State of the Union address on Tuesday, again called for lower U.S. prescription drug prices.

PBMs, which administer drug benefits for employers and health plans, argue that they are passing sufficient savings to patients and contend that rebates help keep down insurance premiums.
Narasimhan, echoing arguments of many large drugmakers, said the existing system obscures the true price of drugs and leaves patients on the hook, in the form of higher co-pays, or co-insurance payments.

‘ZERO TRANSPARENCY’

He noted that changes in the decades-old rebate system could eventually affect insurance plans offered by U.S. employers, potentially leading to premium hikes.
“We have zero transparency into the billions we pay in rebates,” the Novartis CEO said. “You could see some adjustment in premiums. But I think that’s another area where we should get transparency.”
Novartis, which had 2018 global sales of $51.9 billion and net profit of $12.6 billion, gets more than a third of its revenue in the United States. But despite all the talk about rising list prices, Narasimhan said since 2016 net prices for its prescription drugs fell about 1 percent.
“At Novartis, we no longer see net price growth as a meaningful contributor,” he said.
Instead, the company is counting on recent and upcoming launches of new drugs to fuel 2019 growth of 4 percent to 6 percent, a forecast Narasimhan reiterated on Wednesday.
Since his elevation to CEO last year, Narasimhan sold off over-the-counter and generic drugs units and plans to spin off the Alcon eyecare business before July as he focuses on new, often very pricey transformative treatments.
These include a gene therapy for spinal muscular atrophy, a one-time treatment Novartis has said could be cost-effective at up to $5 million per patient, and Kymriah, a CAR-T cell cancer immunotherapy with a list price of $475,000.
Narasimhan said the extensive reliance on direct-to-consumer television advertising for medicines in the United States, a practice in which Novartis engages, may also be hurting the industry’s image. TV ads for prescription drugs are not allowed in most countries.
“Our use of the television and television media has eroded some of the trust in the fact that we’re a science-based industry,” Narasimhan said.
Some image problems, however, are specific to Novartis.
Since 2015, it has paid hundreds of millions of dollars in settlements and fines following kickback allegations in South Korea, the United States and China. It also faces an upcoming trial in the United States over alleged doctor bribery.
Last year, Narasimhan disavowed the 2017 consulting deal with Trump’s ex-attorney struck by his predecessor, Joe Jimenez, amid accusations that Novartis had inappropriately sought favor with the new administration.
But the CEO believes negative feelings toward his company and the industry can be reversed.
“It’s a long journey back, but hopefully through consistent action over a decade, we can get there.”
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Baird Starts Iovanace Biotherapeutics (IOVA) at Outperform


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Alnylam Publishes Phase 1 Givosiran Data in New England Journal of Medicine

Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) announced today that results from the Phase 1 study of givosiran, an investigational, subcutaneous RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the treatment of acute hepatic porphyria (AHP), were published online today in The New England Journal of Medicine (NEJM). The full manuscript, titled “Phase 1 Trial of an RNA Interference Therapy for Acute Intermittent Porphyria,” will appear in the February 7, 2019 issue of NEJM.
In the Phase 1 study, the proportion of patients reporting adverse events (AEs) was similar across treatment groups with no clear relationship with givosiran dose. The majority of AEs were mild or moderate; the most common AEs included nasopharyngitis, abdominal pain, and diarrhea. Serious AEs (SAEs) were reported in six patients treated with givosiran (N=33), including – as previously reported – one fatal SAE of hemorrhagic pancreatitis, assessed as unlikely related to study drug by the study investigator. Additional unrelated SAEs included influenza infection, opioid bowel dysfunction, miscarriage, and two patients with abdominal pain. No SAEs were reported in the placebo group (N=10).
Results showed that basal ALAS1 messenger RNA (mRNA), aminolevulinic acid (ALA), and porphobilinogen (PBG) levels were associated with disease activity, with higher levels noted in those with recurrent attacks, confirming the central importance of liver ALAS1 induction and ALA and PBG in the pathophysiology of acute intermittent porphyria (AIP). Monthly givosiran administration resulted in sustained reductions of ALAS1 mRNA, urinary ALA, and PBG to near normal levels. In exploratory analyses, these reductions were associated with a 79 percent decrease in mean annualized attack rate and an 83 percent decrease in mean annualized hemin usage, compared with placebo.
“We are pleased to have our givosiran Phase 1 findings published in such a highly esteemed, peer-reviewed journal. Indeed, we are encouraged by the emerging safety and tolerability profile for givosiran, as well as the results of exploratory analyses suggesting favorable effects on porphyria attack rate and hemin use for acute attacks,” said Akin Akinc, Ph.D., Vice President and General Manager, Givosiran Program at Alnylam. “With no treatment options currently approved for the prevention of porphyria attacks, we believe givosiran has the potential to make a meaningful difference in the lives of AHP patients.”

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