Search This Blog

Monday, May 7, 2018

Proton Centers Are Struggling Financially

The Maryland Proton Treatment Center chose “Survivor” as the theme for its grand opening in 2016, invoking the reality-TV show’s tropical sets with its own Tiki torches, palm trees and thatched booths piled with pineapples and bananas.
It was the perfect motif for a facility dedicated to fighting cancer. Jeff Probst, host of CBS’ “Survivor,” greeted guests via video from a Fiji beach.
But behind the scenes, the $200 million center’s own survival was less than certain. Insurers were hesitating to cover procedures at the Baltimore facility, affiliated with the University of Maryland Medical Center. The private investors who developed the machine had badly overestimated the number of patients it could attract. Bankers would soon be owed repayment of a $170 million loan.
Only two years after it opened, the center is enduring a painful restructuring with investors poised for huge losses. It has never made money, although it has ample cash to finance operations, said Jason Pappas, its acting CEO since November. Last year it lost more than $1 million, he said.
Volume projections were “north” of the current rate of about 85 patients per day, Pappas said. How far north? “Upper Canada,” he said.
For years, health systems rushed enthusiastically into expensive medical technologies such as proton beam centers, robotic surgery devices and laser scalpels — potential cash cows in the one economic sector that was reliably growing. Developers got easy financing to purchase the latest multimillion-dollar machine, confident of generous reimbursement.
There are now 27 proton beam units in the U.S., up from about half a dozen a decade ago. More than 20 more are either under construction or in development.
But now that employers, insurers and government seem determined to curb growth in healthcare spending and to combat overcharges and wasteful procedures, such bets are less of a sure thing.
The problem is that the rollicking business of new medical machines often ignored or outpaced the science: Little research has shown that proton beam therapy reduces side effects or improves survival for common cancers compared with much cheaper, traditional treatment.
If the dot-com bubble and the housing bubble marked previous decades, something of a medical-equipment bubble may be showing itself now. And proton beam machines could become the first casualty.
“The biggest problem these guys have is extra capacity. They don’t have enough patients to fill the rooms” at many proton centers, said Dr. Peter Johnstone, who was CEO of a proton facility at Indiana University before it closed in 2014 and has published research on the industry. At that operation, he said, “we began to see that simply having a proton center didn’t mean people would come.”
Sometimes occupying as much space as a Walmart store and costing enough money to build a dozen elementary schools, the facilities zap cancer with beams of subatomic proton particles instead of conventional radiation. The treatment, which can cost $48,000 or more, affects surrounding tissue less than traditional radiation does because its beams stop at a tumor rather than passing through. But evidence is sparse that this matter.
And so, except in cases of childhood cancer or tumors near sensitive organs such as eyes, commercial insurers have largely balked at paying for proton therapy.
“Something that gets you the same clinical outcomes at a higher price is called inefficient,” said Dr. Ezekiel Emanuel, a health policy professor at the University of Pennsylvania and a longtime critic of the proton-center boom. “If investors have tried to make money off the inefficiency, I don’t think we should be upset that they’re losing money on it.”
Investors backing a surge of new facilities starting in 2009 counted on insurers approving proton therapy not just for children, but also for common adult tumors, especially prostate cancer. In many cases, nonprofit health systems such as Maryland’s partnered with for-profit investors seeking high returns.
Companies marketed proton machines under the assumption that advertising, doctors and insurers would ensure steady business involving patients with a wide variety of cancers. But the dollars haven’t flowed in as expected.
Indiana University’s center became the first proton-therapy facility to close following the investment boom, in 2014. An abandoned proton project in Dallas is in bankruptcy court.
California Protons, formerly associated with Scripps Health in San Diego, landed in bankruptcy last year.
A number of others, including Maryland’s, have missed financial targets or are hemorrhaging money, according to industry analysts, financial documents and interviews with executives.
The Hampton University Proton Therapy Institute in Virginia has lost money for at least five years in a row, recording an operating loss of $3 million in its most recent fiscal year, financial statements show. The Provision CARES Proton Therapy Center in Knoxville, Tenn., lost $1.7 million last year on revenue of $23 million — $5 million below its revenue target. The center is meeting its debt obligations, said Tom Welch, its president. Centers operated by privately held ProCure in Somerset, N.J., and Oklahoma City have defaulted on debt, according to Loop Capital, an investment bank working on deals for new proton facilities. A facility associated with the Seattle Cancer Care Alliance, a consortium of hospitals, lost $19 million in fiscal 2015 before restructuring its debt, documents show. Patient volume is growing but executives “continue to be disappointed in the slower-than-expected acceptance of proton therapy treatment” by insurers, said Annika Andrews, CEO of SCCA Proton Therapy. A center near Chicago lost tens of millions of dollars before restructuring its finances in a 2013 sale to hospitals now affiliated with Northwestern Medicine, documents filed with state regulators show. The facility is “meeting our budget expectations,” said a Northwestern spokesman.
Representatives from ProCure and the facilities in San Diego and Hampton did not respond to repeated requests for interviews.
“In any industry that’s really an emerging industry, you often have people who enter the business with over-exuberant expectations,” said Scott Warwick, executive director of the National Association for Proton Therapy. “I think maybe that’s what went on with some of the centers. They thought the technology would grow faster than it has.”
In the absence of evidence showing protons produce better outcomes for prostate, lung or breast cancer, “commercial insurers are just not reimbursing” for these more common tumors, said Brandon Henry, a medical device analyst for RBC Capital Markets.
The most expensive type of traditional, cancer-fighting radiation — intensity modulated radiation therapy — costs around $20,000 per treatment, while others cost far less. The government’s Medicare program for seniors covers proton treatment more often than private insurers but is insufficient by itself to recoup the massive investment, analysts said.
The rebellion by private insurers “is very, very good” and may signal the health system “is finally figuring out how to say no to low-value procedures,” said Amitabh Chandra, a Harvard health policy professor who has called proton facilities unaffordable “Death Stars.”
Proton centers are fighting back, enlisting patients, legislators and nonprofits to push for reimbursement. Oklahoma has passed and Virginia has considered legislation to effectively require insurers to cover proton therapy in more cases.
An entire day at the 2017 National Proton Conference in Orlando was dedicated to tips on getting paid, including a session titled “Strategies for Engaging Health Insurance on Proton Therapy Coverage.”
Proton facilities tell patients the therapy is appropriate for many kinds of cancer, never mentioning the cost and guiding them through complicated appeals to reverse coverage denials. The Alliance for Proton Therapy Access, an industry group, has online software for generating letters to the editor demanding coverage.
In hopes of navigating a difficult market, many new centers are smaller — with one or two treatment rooms — and not as expensive as the previous generation of units, which typically have four or five rooms, like the Baltimore facility, and cost $200 million or more.
Location is also critical. Treatment requires near-daily visits for more than a month, which may explain why larger centers such as Maryland’s never attracted the out-of-town business they needed.
To make the finances work, hospitals are combining forces. The first proton beam center in New York City is under construction, a joint project of Memorial Sloan Kettering, Mount Sinai and Montefiore Health System.
Smaller facilities, which can cost less than $50 million, should be able to keep their rooms full in many major metro areas, said Prakash Ramani, a senior vice president at Loop Capital, which is helping develop such projects in Alabama, Florida and elsewhere.
Maryland’s center hopes to break even by year’s end, executives said. That will involve refinancing, converting to nonprofit, inflicting losses on investors and issuing municipal bonds.
But plans call for four centers soon to be open in the D.C. area.
“It’s a real arms race,” said Johnstone, the former proton-center CEO, who has co-authored papers on proton-therapy economics. He is now vice chair of radiation oncology at Moffitt Cancer Center in Tampa, which doesn’t have a proton center. “What places need now are patients — a huge supply of patients.”

Adults with ADHD See Symptom Improvement with Long-Acting Therapy

Extended-release SHP465 mixed amphetamine salts (MAS) improved attention-deficit hyperactivity disorder (ADHD) symptoms and executive function in adults regardless of baseline sleep quality, researchers reported here.
Although the effects of the treatment tended to be greater in patients with impaired sleep, SHP465 MAS (Mydavis) treatment was still favored over placebo for improvement in ADHD-RS-IV score over the 7-week analysis regardless of sleep disturbance at baseline (all nominal P<0.001), according to Craig B. Surman, MD, of Massachusetts General Hospital in Boston, and colleagues. Specifically:
  • Days dysfunctional due to sleepiness, impaired versus not impaired: Least squares mean (LSM) difference -9.5 (95% CI -13.7 to -5.3) versus –7.8 (95% CI -10.9 to -4.7)
  • Sleep disturbance: LSM -10.6 (95% CI -15.0 to -6.3) versus -6.8 (95% CI -9.8 to -3.7)
  • Sleep latency: LSM -7.7 (95% CI -11.7 to -3.7) versus -8.8 (95% CI -12.1 to -5.6)
The post-hoc analysis of the phase III randomized, placebo-controlled trial included participants with a confirmed diagnosis of ADHD, according to the DSM-IV-TR criteria, he said in a presentation at the American Psychiatric Association annual meeting.
Similarly, Brown Attention Deficit Disorder Scale (BADDS) total score also showed improvement among those with or without sleep impairment with SHP465 MAS treatment:
  • Days dysfunctional due to sleepiness, impaired versus not impaired: LSM -18.7 (95% CI -28.5 to -9.0) [impaired] versus -15.7 (95% CI -23.0 to -8.4)
  • Sleep disturbance: LSM -18.1 (95% CI –28.6 to –7.7) versus –15.2 (95% CI –22.1 to –8.2)
  • Sleep latency: LSM -14.3 (95% CI -23.7 to -4.8) versus -17.7 (95% CI -25.1 to -10.2)
The treatment contains an equal combination of dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate, and amphetamine aspartate monohydrate in immediate and delayed-release beads.
For the study by Surman’s group, 272 patients were randomized at 39 U.S. sites. The mean age of patients in the study arm was 36.1, 50.7% were men, and 86% were Caucasian. The majority had combined ADHD subtype (inattentive; hyperactive/impulsive).
Half received SHP465 MAS treatment beginning at a daily dose of 12.5 mg, and increasing each week to 25 mg, 50 mg, and then to 75 mg, until optimal dose was reached marked by at least a 30% decrease in baseline ADHD-RS-IV score.
Individuals were excluded from the analysis due to preexisting comorbid psychiatric diagnosis, cardiac conditions, a history of substance abuse, or if currently taking medications contraindicated with or that could confound the study.
Poor sleep quality is a common problem among adults with ADHD, explained Manisha Madhoo, MD, vice president of global medical affairs of neuroscience at Shire Development of Lexington, Massachusetts, the agent’s developer.
“It’s really helpful to the patients, and more important to the physicians, to have information that … shows whether baseline quality impacts response to treatment with Mydayis on ADHD symtpoms and executing function versus placebo,” said told MedPage Today.
The once-daily, sustained release triple-bead oral treatment for adults with ADHD was approved by the FDA in 2017 for use in patients ≥13 years. It delivers 16 hours of sustained therapy, filling an “unmet need” in ADHD treatment, Madhoo stated.
The study was funded by Shire Development.
Surman disclosed relevant relationships with Arbor, McNeil, Janssen, Janssen-Ortho, Novartis, Shire, and Reed/Massachusetts General Hospital (MGH) Academy, Global Medical Education, MGH Adult ADHD Program, NIH, Abbott, Cephalon, Hilda and Preston Davis Foundation, Eli Lilly, Magceutics, J & J/McNeil, Merck, Magceutics/Neurocentria, Nordic Naturals, Nestle/Pamlab, Pfizer, Organon, Takeda, NLS Pharma, Nutricia/Dannone, Rhodes, Shire, Somaxon, Sunovion, Supernus, Takeda, and Vaya, as well as book royalties from Fast Minds — How to Thrive If You Have ADHD [or Think You Might], ADHD in Adults — A Practical Guide to Evaluation and Management.

Veterans Choice program could get a makeover

  • The Veterans Choice program, which is designed for veterans who live far away from a VA clinic, will run out of funding next month. Legislation has been introduced in the House to make the program permanent and revamp it to lean more heavily on private sector providers.
  • The proposal would expand private healthcare options for veterans, allowing those who enrolled with the VA two visits per year to any outside physician without a copay. The legislation also offers caregiver benefits to aging veterans, expands telemedicine allowances, makes hiring speedier and shutters older VA facilities.
  • The bill, called the Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act, also includes $5.2 billion to keep the current Veterans Choice program alive for a year until a new one is implemented.

The Veterans Choice program was created through the Veterans Access, Choice and Accountability Act, a bipartisan bill signed by President Barack Obama in 2014 in response to the VA’s wait time scandal. The program allows veterans the option of receiving care from the private sector if they live more than 40 miles driving distance from a VA facility, or if they have to wait more than 30 days to get an appointment.
Funding for the program has proven to be tricky, as it was originally designed as a stop-gap measure with a life expectancy of two years. Before his ouster in March, former VA secretary David Shulkin warned that the program would run out of funding in June.
Lawmakers have been debating the program’s potential for giving the private sector more control over veterans’ healthcare. Republicans back expanding Veterans Choice to give more veterans the option of getting care through the private sector, while Democrats argue that expanding the program would give way to widespread privatization of the agency. It’s worth noting that about 70% of veterans enrolled in VA healthcare already receive most of their care outside the system, according to a 2014 report from the Congressional Budget Office.
The MISSION Act is largely seen as a compromise: It makes the program permanent within the VA while broadly expanding private sector options for veterans.
The bill is expected to be rolled into opioid legislation due to be introduced before Memorial Day. President Donald Trump took to Twitter last week to urge Congress to fix the choice program before the holiday, adding that he will “sign immediately.”
Meanwhile, VA leadership remains in a state of turmoil. Trump’s nominee for secretary, White House physician Ronny Jackson, withdrew from consideration recently following allegations about his professional behavior. A new nominee is yet to be announced.

Geisinger Health plans to make DNA sequencing ‘routine’ part of care

For years, health systems have been searching out the best ways to use DNA sequencing of individual patients to best guide their care.
Pennsylvania-based Geisinger Health announced Sunday it plans to make the testing a “routine” part of preventative healthcare at its facilities.
The idea is to make DNA sequencing part of its standard screening tests along the lines of the mammograms, colonoscopies and cholesterol checks that are regularly performed on patients to detect disease earlier. Officials said Geisinger patients will be able to work with their family physician to modify their lifestyle and minimize risks that may be revealed, they said.
“Understanding the genome warning signals of every patient will be an essential part of wellness planning and health management,” Geisinger President and CEO David T. Feinberg, M.D., said at the HLTH Conference in Las Vegas. “This forecasting will allow us to provide truly anticipatory healthcare instead of the responsive sick care that has long been the industry default across the nation.”

Feinberg’s announcement came the same day the National Institutes of Health kicked off its “All of Us” precision medicine initiative, which intends to gather genomic data from more than 1 million people across the U.S.
Geisinger officials said the new approach to offering clinical DNA sequencing would begin with a 1,000-patient pilot program within the next six months. They said they would expand the program throughout facilities across Pennsylvania and southern New Jersey.
Officials said they expect as many as 10% to 15% of patients might benefit from testing, but questions remain over how quickly other health systems may want to follow suit.

As FierceHealthcare has previously reported, precision medicine has been widely embraced by the medical community—particularly after President Barack Obama unveiled the Precision Medicine Initiative and Cancer Moonshot projects—as a way to offer better-tailored medical decisions to individual patients.
But challenges remain for the field of precision medicine. For instance, there is still much that is unknown about what certain findings mean in the emerging science.
It is also not clear who will pay for these tests; payers have been reluctant to pay for genomic testing. In a survey of some of the nation’s largest insurers released last year, payers said many of those tests don’t meet existing coverage frameworks because the tests are deemed “experimental.”

Tetraphase antibiotic reported effective

Shares of antibiotic developer Tetraphase Pharmaceuticals (TTPH) are higher on Monday after a report out of Contagion Live this past Friday. According to the Contagion Live report, Tetraphase Pharmaceutical’s Chief Medical Officer shared Ignite4 phase 3 trial results which indicated that eravacycline proved to be non-inferior to meropenem for the treatment of complicated intra-abdominal infections or cIAI. Tetraphase describes itself ass a clinical-stage life science company with a synthetic chemistry technology platform that has the potential to address the global health crisis caused by antibiotic resistance.The drug company went public in 2013 and its stock rose as high as $53 per share in the summer of 2015 on the hopes of its lead drug, eravacycline. PAST DISAPPOINTMENT:Shares of Tetraphase dropped precipitously in the fall of 2015 when the company said that in Ignite2, its phase-three clinical trial against complicated urinary tract infections, eravacycline did not compare well with standard treatment levofloxacin, known as Johnson & Johnson’s (JNJ) Levaquin. RECENT RESULTS: According to Friday’s Contagion Live report, Tetraphase’s Ignite 4 phase 3 trial study “successfully met its primary efficacy endpoint, which was to demonstrate non-inferiority of eravacycline to meropenem for the treatment of cIAI. Furthermore, the antibiotic was found to be well-tolerated. These data support the use of eravacycline for the treatment of cIAI, including infections caused by pathogens resistant to other antibiotics, the authors concluded. PRICE ACTION: Shares of Tetraphase Pharmaceuticals are up almost 15% to $3.71 in afternoon trading.

Walmart to restrict opioid dispensing at its pharmacies

Walmart Inc said on Monday it would restrict opioid prescriptions to no more than a seven-day supply as the retailer aims to curb an opioid epidemic that has plagued the United States.
The supply limit will begin within the next 60 days, the company said.
In January , Walmart said it would provide its customers filling prescriptions for opioids with a packet of powder that would help them dispose of leftover medication.
The U.S. Centers for Disease Control and Prevention (CDC) estimates that 115 Americans die on average every day from an opioid overdose.
The company also said on Monday that from Jan. 1, 2020 it would require e-prescriptions for controlled substances, noting that these prescriptions are proven to be less prone to errors and cannot be altered or copied.
The initiatives apply to all the pharmacies of Walmart and its Sam’s Club unit in the United States and Puerto Rico.

Pfizer putting vaccines front and center in R&D

On Pfizer’s first-quarter earnings call, CEO Ian Read drew up a long list of R&D programs the company’s expecting to drive future growth. But when Bernstein analyst Tim Anderson asked him to narrow it down, Read mentioned vaccines first.
“It’s difficult to pick out one specific product. But I would say when you look at the totality, I would focus on our vaccine franchise, especially C. difficile,” said Read. He maintained that Pfizer pipeline is “undervalued,” but the question is, could the collective vaccine pipeline make Pfizer watchers up their expectations?
After Sanofi abandoned its Clostridium difficile vaccine last December in light of ominous phase 3 interim data, Pfizer’s PF-06425090 took over as the leading C. diff hopeful. The recombinant vaccine is undergoing a 16,000-patient phase 3 scheduled to read out in September 2020.
Analysts have pegged the C. diff vaccine market at about $1 billion, but Pfizer might have to split it with French firm Valneva, which has also passed phase 2 with its own candidate. And as GlobalData analysts previously said, the Valneva vaccine’s contrasting method of action “could give it an advantage when it comes to successfully meeting phase 3 trial endpoints.”
Pfizer needs that C. diff boost to the top line, as its pneumococcal blockbuster Prevnar 13—the world’s best-selling vaccine—continues to decline. For the first quarter, global Prevnar 13 sales slightly decreased by 3% to $1.38 billion. While the precipitous 12% drop in the U.S. is particularly alarming, COO Albert Bourla turned to the 45% jump in emerging markets for a better picture.

“The most important is, we just launched in China, where we expect that we will have very good uptake,” said Bourla, who recently took the COO title. But growth from China might not last for long. Local firm Walvax recently submitted to Chinese authorities its version of a pneumococcal 13-strain recombinant shot, which was put under expedited review in March.
Planning to fill the gap left by Prevnar, the New York pharma has a next-generation candidate that could cover 20 serotypes of pneumococcal disease. It expects proof-of-concept data later this year and plans to begin a pivotal trial in 2019. But competition awaits there, too.
Merck & Co.’s 15-valent shot V114 has just embarked on two phase 3 trials. For one of them, investigators will test it against Pfizer’s 13-strain Prevnar shot, and Merck executives say they’re confident their version can triumph.

“The serology data … are really very, very strong for the V114 vaccine. And it provides the opportunity to both strengthen the response to serotypes covered by other pneumococcal conjugate vaccines, but also to add additional stereotypes which will be important in terms of preventing invasive pneumococcal disease,” said Merck R&D head Roger Perlmutter on the company’s Q1 call.
A partnership between Astellas and Affinivax is also working on a new challenger to Prevnar, but the competition between Pfizer and Merck seems more imminent. Bourla said he anticipates “launching in a competitive timeframe to Merck, a much broader spectrum of coverage quality.”
Other than those products, Pfizer has a phase 2 Staphylococcus aureus vaccine program, and the company is in discussions with the FDA about expanding that study into a phase 3 pivotal trial, Read said during the call.