Doctors Nudged by Overdose Letter Prescribe Fewer Opioids

In a novel experiment, doctors got a letter from the medical examiner’s office telling them of their patient’s fatal overdose. The response: They started prescribing fewer opioids.

Other doctors, whose patients also overdosed, didn’t get letters. Their opioid prescribing didn’t change.

More than 400 “Dear Doctor” letters, sent last year in San Diego County, were part of a study that, researchers say, put a human face on the U.S. opioid crisis for many doctors.

“It’s a powerful thing to learn,” said University of Southern California public policy researcher Jason Doctor, lead author of the paper published Thursday in the journal Science.

Researchers used a state database to find 861 doctors, dentists and others who had prescribed opioids and other risky medications to 170 people who died of an overdose involving prescription medicines. Most states have similar databases to track prescribing of dangerous drugs, where doctors can check patients’ previous prescriptions.

Most of the deaths involved opioid painkillers, many taken in combination with anti-anxiety drugs. On average, each person who died had filled prescriptions for dangerous drugs from five to six prescribers in the year before they died.

Half the prescribers received letters that began: “This is a courtesy communication to inform you that your patient (name, date of birth) died on (date). Prescription drug overdose was either the primary cause of death or contributed to the death.”

The letters offered guidance for safer prescribing. The tone was supportive: “Learning of your patient’s death can be difficult. We hope that you will take this as an opportunity” to prevent future deaths.

Then the researchers watched what happened over three months.

Letter recipients reduced their average daily opioid prescribing — measured in a standard way, morphine milligram equivalents — by nearly 10 percent compared to prescribers who didn’t get letters. Opioid prescribing in the no-letter group didn’t change.

Recipients put fewer new patients on opioids than those who didn’t get letters. They wrote fewer prescriptions for high-dose opioids.

The strategy is original, helpful and could be duplicated elsewhere, said pain medicine expert Dr. David Clark of Stanford University, who wasn’t involved in the study. He was surprised the letter’s effect wasn’t larger.

“It may have been easy for physicians to feel it was somebody else prescribing who got the patient in trouble,” Clark said, adding that changing even one patient’s care takes time, requiring “very difficult conversations.”

Opioid prescribing has been declining in the U.S. for several years in response to pressure from health systems, insurers and regulators.

Yet deaths keep rising. Nearly 48,000 Americans died of opioid overdoses last year, according to preliminary numbers released last month, a 12 percent increase from a year before.

Now illegal fentanyl, another opioid, is the top killer, surpassing pain pills and heroin. Lead author Doctor said reducing the number of prescribed opioids will, over time, close off a gateway to illicit drugs by shrinking the pool of dependent people.

The study didn’t analyze whether the deaths were caused by inappropriate prescribing or whether the prescribing changes resulted in patients doing better or worse.

That’s a flaw in an otherwise careful study, said addiction researcher Dr. Stefan Kertesz of University of Alabama at Birmingham, who has raised red flags about policies that cause doctors to take patients off opioids too fast and without a plan for treating addiction.

Patients can fall into despair or contemplate suicide if they are involuntarily tapered off opioids without support, he said.

“What actually happens to patients should be our concern, rather than just making a number go down,” Kertesz said.

Study co-author Dr. Roneet Lev, chief of emergency medicine at Scripps Mercy Hospital in San Diego, discovered her own name in the data.

Lev prescribed 15 opioid pain pills to an ER patient with a broken eye socket, without knowing the patient got 300 painkillers from another doctor a day earlier. Lev didn’t get a “Dear Doctor” letter because the patient’s death fell outside the timeline of the study, July 2015-June 2016.

Still, she felt the impact and believes she could have done better. Said Lev: “It was an opportunity to look at all the records on that patient and say, ‘Wow, I’m really worried about you.'”

https://bit.ly/2Om8Jdo

Facebook ads to require treatment centers to be certified by monitoring firm

Facebook on Thursday announced that, effective immediately, it will require addiction treatment centers to obtain certification from monitoring firm LegitScript before being approved to advertise in-person addiction treatment services in the United States.

To advertise on all of Facebook’s properties—Facebook, Instagram, Messenger and Audience Network— treatment centers will follow a process similar to the one announced by Google for its AdWords advertising platform in April. LegitScript will review a facility’s background, qualifications, compliance with state laws and regulatory licensing requirements, and privacy practices. In total, treatment centers must meet 15 requirements to earn its certification. Once certified, the treatment center can then apply to advertise on Facebook. The social media giant says it will work quickly to verify LegitScript certification and clear treatment centers for advertising.

“Today’s announcement is the next step in our efforts to support our community on Facebook in response to rising addiction rates in the US,” Facebook’s Avra Siegel said in a statement emailed to Behavioral Healthcare Executive. Siegel is on the policy team coordinating Facebook’s effort to respond to the opioid epidemic.

“We’re expanding our policies to restrict ads for drug and alcohol addiction treatment centers because when facing addiction, people should be able to avoid scams and predatory behavior as they find support for themselves and loved ones in need,” Siegel continued.

For Facebook, the partnership with LegitScript is the latest in a series of moves to address the opioid epidemic and connect its users with treatment services. In June, Facebook launched a module that provides users who are searching for opioids—or for treatment—with the option to connect to the Substance Abuse and Mental Health Services Administration (SAMHSA) national crisis help line. The initiative was also created in conjunction with the recovery advocacy group Facing Addiction.

LegitScript developed its 15 requirements for certification with input from multiple industry organizations, including the National Association of Addiction Treatment Providers (NAATP). Treatment centers are subject to continuous monitoring to maintain their certification.

https://bit.ly/2AXkmWj

Cancer Groups Say No to Step Therapy for Medicare Part B Drugs

Cancer groups have reacted negatively to an announcement from the Centers for Medicare & Medicaid Services (CMS) about allowing Medicare Advantage plans to use a “step therapy” approach to Part B drugs. The policy is part of an effort to rein in prescription drug costs.

This is a “dangerous nightmare for cancer patients,” said the Community Oncology Alliance (COA), which sees it as a step toward the government’s dictating what cancer treatments Medicare recipients can or cannot receive.

The American Society of Clinical Oncology (ASCO) also said it “strongly objects” to the plan, which it believes will delay access to appropriate treatments.

Such delays could result in irreversible disease progression — and for cancer patients, this could mean the difference between life and death.

Step therapy generally requires a patient to begin treatment with the most cost-effective drug option and to then move on to the costlier treatments. COA refers to this as a “fail first” policy that forces patients and their clinicians to use cheaper and often older and less effective treatments before they are allowed access to state-of-the-art, newer therapies, which are often more expensive. This would happen despite the recommendations of treating physicians who believe the cheaper treatment will not work, the group warns.

“When treating cancer patients, there are very few situations where you have truly interchangeable therapies like a biosimilar and a brand, or between brand and generic, or even two closely aligned therapeutic alternatives,” said Ted Okon, executive director of COA. “They’re taking Part B — injectable drugs — and Part D — oral drugs — and giving power to a middleman to make decisions on therapy.”

Okon told Medscape Medical News that cancer treatment is becoming increasingly personalized and that not all therapies produce the identical result from patient to patient. “You can have two men who are very similar as far as age, cancer type, and stage, but the same treatment may not work because of different genetic makeup,” he said. “This action from CMS is going ten steps backward, and not where personalized cancer treatment is going. This is old-school, one-size-fits-all, cookbook medicine that treats every patient the same way.”

Will Be Optional

Medicare Advantage plans are private health insurance plans that provide Medicare benefits to 20 million beneficiaries, or about one third of all people receiving Medicare.

In 2012, the Obama administration issued a memo indicating that step therapy is legally forbidden in Medicare Advantage. CMS has now said that it is rescinding that policy and is issuing new guidance that allows Medicare Advantage plans to use step therapy for Part B drugs beginning January 1, 2019.

According to CMS, this new policy “empowers patients with more choices and takes action to lower drug prices.” CMS also claims that it is “providing flexibility through private sector tools to negotiate lower prescription drug prices on behalf of beneficiaries.”

Beneficiaries will now have the option of negotiating for Part B drugs “in a way that lowers costs and improves the quality of care.” Medicare Advantage plans that also offer a Part D benefit will be able to manage across Part B and Part D, so that patients will be able to receive the best therapy, whether it is physician-administered or self-administered.

The program will begin next year, but it is not mandatory for Advantage plans to opt in. If a plan does decide to offer this approach, CMS stated that the decision must be explicitly communicated to beneficiaries through annual notice of change and evidence of coverage documents. Beneficiaries who do not wish to participate in this type of plan will have the option of choosing a different one.

This new approach, said CMS, “must be coupled with care coordination services” that include “discussing medication options with beneficiaries; providing beneficiaries with education and information about their medications; and implementing adherence strategies for beneficiaries on their medication regimen.”

“Really Scary Stuff”

Although CMS has framed their press releases around cost savings and said that this new strategy is going to provide better value, competition, and great savings to patients, Okon pointed out that step therapy requirements are driven by financial interests to save money and not by what is in the best medical interest of patients. “These are public companies for the most part, and their goal at the end of the day is to maximize shareholder revenue and not worry about individual patients being treated correctly,” he said. “They are concerned about the bottom line and not patient outcomes.”

They are concerned about the bottom line and not patient outcomes. Ted Okon

For cancer patients, this can mean the difference between life and death if they are forced to first try out an inferior but cheaper therapy, he noted. Such restrictions are already occurring through the actions of pharmacy benefit managers (PBMs), the third-party administrators of prescription drug programs for commercial health plans, self-insured employer plans, and Medicare Part D plans.

“PBMs are already restricting access to care, and we are seeing delays and switches in therapy all over the map,” he said. “This is really scary stuff.”

CMS also said that participating plans will be required to pass more than half of the savings generated to the patients. Okon pointed out that although PBMs are required to share savings with the patient, that can be problematic.

“The middleman has to share the savings with the patient, but they can’t let the patient pay less,” he said. “The patient still has to put out the money, and they can’t give it back, and they can’t rebate it. So they say — literally — they are going to give ‘gift cards’ to patients.”

CMS has not specifically outlined how patients will receive these savings, but said in its press release that such savings can occur through lower coinsurance payments and rewards programs, which provide patients with benefits such as gift cards.

In its statement, COA noted that it is “perplexed and concerned by the guidance put forth for sharing savings via gift cards.”

Okon was also perplexed that CMS believes that offering cancer patients gift cards is going to make up for denying them proper therapy and making them jump through hoops. “If the middleman gets a large enough discount and decides the patient should get an oral drug rather than an infusion, the patient may end up paying more if they don’t have coinsurance, and may be pushed into the donut hole faster,” he said. “But they’ll get a gift card.”

Reverse the Decision

ASCO has also expressed strong opposition to the new CMS plan. In a statement, ASCO President Monica M. Bertagnolli, MD, said the society objects to the plans’ employing step therapy across physician-administered and self-administered drugs under Medicare Part B and Part D.

She also echoed COA in emphasizing that there is frequently a lack of interchangeable treatment options in modern cancer care. “The optimal care requires patient access to the most medically appropriate drug at the most opportune time, based on the highest quality evidence,” she said. “Step therapy requires patients to try and fail to have a desired clinical outcome on a lower-cost medication before they can access the medication prescribed by their healthcare provider.”

Bertagnolli added that ASCO “strongly urges CMS to reverse this decision” and that ASCO will continue to oppose any payers’ management policy that restricts patient access to high-quality cancer care.

Industry Opines

The professional organizations were joined by the Pharmaceutical Research and Manufacturers of America (PhRMA) in voicing opposition to this move by CMS.

In a statement given to the Regulatory Affairs Professional Society, the group noted that “PhRMA has serious concerns with the new CMS guidance regarding Medicare Advantage coverage of Part B medicines and the implications for patients suffering from complex conditions. Step therapy will delay many patients’ access to medicines they need, interfere with the patient-physician relationship, and increase burdens on physicians to comply with new, more complicated requirements.”

On the other side of the coin, at least one organization believes that this is a step in the right direction.

“We applaud the administration’s focus on bringing down drug prices and increasing access to biosimilar medications,” said the Campaign for Sustainable Rx Pricing in a press statement. “The fundamental cause of this crisis is the price that is set by drug manufacturers and drug manufacturers alone, and we will continue our work with the administration, Congress, and other stakeholders to develop additional policies that address the incentives towards ever-higher list and launch prices.”

https://wb.md/2nq3u0R

‘Middlemen’ Account for One Third of US Drug Costs: Health Affairs

About one third of drug spending in the United States goes to pharmacies, pharmacy benefit managers (PBMs), and hospitals or clinics that dispense drugs, according to an analysis published by Health Affairs.

US healthcare spending is a critical economic and political issue, with skyrocketing drug costs reaching crisis levels. Now, Nancy Yu, BA, MBA, a biopharma industry analyst from the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York City, and colleagues estimate that the United States spent $480 billion on drugs in 2016, including the profits of pharmacies and other intermediaries.

That is nearly 50% higher than the Centers for Medicare & Medicare Services’ 2016 estimate of $328 billion in US drug spending, which did not include drugs dispensed in hospitals or clinics.

The authors note that President Trump and the pharmaceutical industry “have stressed that supply chain intermediaries, or ‘middlemen,’ are capturing much of the money that is often categorized as drug spending.” Yu and colleagues crunched the numbers and found these intermediaries account for about one third of the spending.

“A clearer understanding of the total market size, as well as the revenues retained from the purchase, distribution, and payment of prescription drugs throughout the US supply chain, may be useful for policy makers as they seek reforms while working to preserve incentives for innovation and efficiency,” Yu and colleagues write in a Health Affairs blog post published July 31.

In May, President Trump announced a raft of possible initiatives to reign in drug prices, including creating tools for Medicare to negotiate some drug prices, speeding approval for over-the-counter drugs, and promoting competition between drug makers. He also said he’d like to eliminate “middlemen,” who have “become very, very rich.”

The estimates by Yu and colleagues suggest that two thirds of US drug spending ($323 billion) goes to drug manufacturers’ net revenues. Of the remaining $157 billion retained as gross profit by intermediaries in the supply chain, about half ($73 billion) goes to retail or specialty pharmacies and 20% ($35 billion) goes to hospitals or physicians’ offices. PBMs bring in $23 billion and drug wholesalers another $18 billion, together accounting for slightly more than 25%.

“Our intent is not to infer or draw conclusions on where there are outsize profits or how difficult it would be to reduce spending within the supply chain, nor do we opine on the consequences of reducing that spending,” the authors write. “But a recent policy focus on the supply chain suggests that understanding those consequences will be important.”

Allan Coukell, senior director of health programs at The Pew Charitable Trusts, called the analysis useful in detailing where in the drug chain money is being spent. He said the findings largely align with a similar analysis by Pew that has yet to be published. However, he noted that PBMs pass a portion of the profits they make back to the health plans they work for, which isn’t accounted for in Yu’s analysis.

Much of the policy debate in Washington about the potential role of “middlemen” in driving up costs has focused on the role of PBMs in drug costs, Coukell explained. But he noted that they also provide several services including paying claims, designing drug formularies, and negotiating rebates with drug manufacturers.

“In terms of turning the tide of overall drug spending, that’s not the thing driving drug spending,” Coukell said. “The evidence shows PBMs are playing an important role in keeping drug costs down.”

Instead, Coukell said most of the growth in drug spending is driven by high prices on new drugs and year-to-year increases on the prices of drugs still under patent with no competition. To reign in these costs, he suggested optimizing drug discounts for government programs, introducing competition in Medicare B, or boosting use of generics or biosimilars.

One study coauthor reports receiving personal fees from the American Society for Hospital Pharmacy, Gilead Pharmaceuticals, WebMD, Goldman Sachs, Defined Health, Vizient, Foundation Medicine, Anthem, Excellus Health Plan, Hematology Oncology Pharmacy Association, Novartis Pharmaceuticals, Janssen Pharmaceuticals, Third Rock Ventures, and JMP Securities unrelated to the study. The other authors and Coukell have disclosed no relevant financial relationships.

Health Aff Blog, Published online July 31, 2018. Full text

https://wb.md/2Mwk4XT

HHS Chief Urges States to Ease Scope-of-Practice Rules

States should consider relaxing restrictions on scope of practice and lessening Certificate of Need requirements in order to broaden the free market for healthcare, Health and Human Services (HHS) Secretary Alex Azar told state lawmakers Thursday.

“I would urge all of you to take a look at how state and local regulations can be impeding healthcare competition, raising costs for American patients, and depriving them of choices,” Azar said at a meeting of the American Legislative Exchange Council, a group of conservative state legislators. “Regulations like Certificates of Need and scope of practice can have a legitimate purpose. But too often, these rules can be a significant barrier to new competition and lower-cost market disruptors.”

“Fundamentally, when we wonder why American healthcare costs so much, why patients feel so disempowered, so often the answer is that government rules are standing in the way of necessary innovation,” Azar said. “As we undertake our efforts to free up competition from the federal level, we hope all of you will examine what can be done in the states.”

Azar was interrupted by applause several times in his 20-minute speech, after which the audience gave him a standing ovation. The first applause came when he said, before outlining his department’s top priorities, “In each of these areas, one of our first steps is to see how we at HHS can get out of the way: how we might be inhibiting innovation by state governments and private actors.”

He also received a warm response when he mentioned the department’s new rules allowing for short-term insurance plans. “We look forward to offering states all the flexibility possible under the law to craft solutions that promote affordability, fiscal sustainability, private coverage, and consumer choice. As one example, we recently finalized new regulations for short-term, limited-duration insurance plans that are free from most Obamacare regulations and, therefore, as much as 50% to 80% cheaper than Obamacare plans.”

But he chided some states “[that] place restrictions on these plans that can limit their usefulness, like limiting the initial contract period to around 6 months, rather than up to a year. We believe sensible state regulation of these plans is important. But millions of Americans are in need of affordable insurance options, and states can help build this market outside of Obamacare’s broken regulations.”

Azar also used the speech as an opportunity to announce a new HHS policy regarding the rebates that drugmakers pay to the Medicaid program. “I am pleased to announce … that HHS is issuing a guidance today to drug manufacturers that will ensure they are paying the full Medicaid rebates they owe on certain prescription drugs,” he said.

“When drug manufacturers roll out what’s called a ‘line extension’ for a drug, like an extended release, once-daily form of a pill they already sell, some of them have used it in the past to reset the price that’s used to calculate the inflation rebates they have to pay,” Azar explained. “This meant they could pay less than they would otherwise owe, just by introducing a new drug formulation.”

“This is the kind of abusive behavior from drug companies that this administration will not tolerate. Starting today, we’ve made clear that manufacturers must pay the full amount of rebates that they owe under the law.”

https://bit.ly/2AWVga3

Spectrum Pharma Q2 revenue -30%, product sales -24%; stock +5% after hours

Spectrum Pharmaceuticals (NASDAQ:SPPI) Q2 results ($M): Revenues: 24.2 (-29.4%); product sales: 23.8 (-23.7%).

Net income: 13.7 (+164.1%); non-GAAP net loss: (21.6) (-151.2%); EPS: 0.13 (+148.1%); non-GAAP loss/share: (0.21) ( -90.9%).

Presentation of Phase 2 data on poziotinib in NSCLC, including EGFR and HER2 patients with exon 20 mutations on September 24 at World Conference on Lung Cancer in Toronto. Company considers it a pivotal study to support registration.

Pre-BLA meeting with FDA this quarter for ROLONTIS (eflapegrastim). Marketing application to be filed in Q4.

2018 guidance: Revenues: $95M – 115M. Cash and equivalents should be sufficient to fund operations into 2020.

https://bit.ly/2vQjwFa

Puma Bio shares jump 19% on narrower quarterly loss, bigger sales

Shares of Puma Biotechnology Inc. PBYI, +17.16% rose more than 19% in the extended session Thursday after the company reported a narrower-than-expected quarterly loss and sales came in above forecasts. Puma said it lost $44.3 million, or $1.17 a share, in the second quarter, compared with a net loss of $77.8 million, or $2.10 a share, in the year-ago period. Sales hit $50.8 million. Analysts polled by FactSet had expected a loss of $1.26 on sales of $45.7 million. Puma in July got approval from the U.S. Food and Drug Administration for Nerlynx, used in the treatment of breast cancer, and the company began shipment to wholesalers at the end of that month. Before the launch of Nerlynx, Puma had no product revenue, as Nerlynx is the company’s first and only commercial product to date. Shares had ended the regular session up 0.7%.

https://on.mktw.net/2vXdySQ