Pfizer Inc.(NYSE:PFE) announced that the European Commission (EC) has approved XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.1 XELJANZ is the first and only oral Janus kinase (JAK) inhibitor to be approved in the European Union (EU) for the treatment of adults with active PsA. In 2017, XELJANZ in combination with MTX was approved in the EU for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs.2 “People living with psoriatic arthritis may experience a variety of symptoms, making the condition particularly difficult to diagnose and treat,” said Angela Lukin, Regional President, Inflammation and Immunology, Pfizer. “We are proud that we are now able to offer XELJANZ as an option to adult patients living with active psoriatic arthritis in the European Union.”
Thursday, July 12, 2018
J&J response to St. Louis damages verdict
Johnson & Johnson (NYSE: JNJ) issued the following statement regarding today’s verdict in the St. Louis court.
“Johnson & Johnson is deeply disappointed in the verdict, which was the product of a fundamentally unfair process that allowed plaintiffs to present a group of 22 women, most of whom had no connection to Missouri, in a single case all alleging that they developed ovarian cancer. The result of the verdict, which awarded the exact same amounts to all plaintiffs irrespective of their individual facts, and differences in applicable law, reflects that the evidence in the case was simply overwhelmed by the prejudice of this type of proceeding. Johnson & Johnson remains confident that its products do not contain asbestos and do not cause ovarian cancer and intends to pursue all available appellate remedies. Every verdict against Johnson & Johnson in this court that has gone through the appeals process has been reversed and the multiple errors present in this trial were worse than those in the prior trials which have been reversed.”
ObamaCare plan member costs increasing, networks narrowing
- A new Physicians for Fair Coverage report conducted by Avalere showed that Affordable Care Act plan members are paying more for health insurance as payers have increased premiums, deductibles and out-of-pocket costs in recent years.
- Nearly 90% of ACA plan enrollees are in high-deductible plans, according to the report.
- Avalere found that 68% of health plans in the exchanges offered narrow networks in 2017. That percentage is compared to 48% only three years previously.
Health plans have narrowed networks as a way to cut costs and push providers to accept value-based contracts in the exchanges. There are between 34% and 66% fewer providers in ACA plans compared to other markets, Avalere said.
One downside to this cost-saving trend is that narrower networks are leading to more out-of-network care and surprise billing. An example of physician network tightening is in the most popular type of plan in the marketplace: silver. The report found that 41% of silver plan physician networks in 2015 were defined as “small” or “extra small.”
There are also issues with specialists. Avalere said nearly 15% of insurance plans in the exchanges are “specialist deficit,” meaning they lack an in-network provider for at least one specialist, such as radiologists and anesthesiologists.
Avalere said the ACA’s provision for network adequacy isn’t enough. A 2017 Commonwealth Fund study found that most states don’t have laws that protect consumers from balance billing for out-of-network care delivered in emergency departments or in-network hospitals. In fact, only six states(California, Connecticut, Florida, Illinois, Maryland and New York) provide a “comprehensive approach to protect consumers in these situations.” Even those laws have loopholes. Another 15 states offer some protection against these surprise medical bills, but there are gaps.
Narrow networks aren’t the only issue for ACA plans. Premiums are also increasing faster than in the employer-sponsored market. The average ACA exchange premium increased by 28% between 2014 and 2017. The average silver plan premium rose from $434 in 2014 to $554 in 2017. That’s minor compared to what platinum plan members are seeing. Platinum average plan premiums skyrocketed from $555 in 2014 to $892 in 2017.
Members are also faced with high deductibles. Avalere said nearly 90% of ACA plan enrollees had deductibles above $1,300, which is the IRS definition of a high-deductible plan.
All of these rising costs are resulting in an increasing number of Americans not being able to afford care. The report said nearly one-third of insured Americans say they’re having trouble paying premiums and copays. Avalere warned this could lead to patients delaying or avoiding care.
Premiums are expected to rise again in 2019. Many payers in the ACA marketplace have proposed double-digit premium increases in the exchanges for next year. There are multiple reasons for the increase that go beyond normal healthcare costs: Congress ending the individual mandate penalty that required nearly all Americans have health insurance, President Donald Trump’s proposal to expand short-term plans and association health plans along with other efforts to weaken the ACA.
These efforts will likely cause people to leave the ACA marketplace, leaving ACA plans with a sicker risk pool. Payers, in turn, will increase premiums to offset the imbalance.
Employer health insurance cost growth cut in half
- Employer-sponsored health insurance costs have increased about 3% annually since 2012 after a decade of 6% or more yearly increases, according to Mercer’s new National Survey of Employer-sponsored Health Plans.
- Factors cited include preemptive moves by employers to avoid the Affordable Care Act’s excise tax on high-cost plans, cost-shifting and consumerism, such as the rise of high-deductible plans.
- Despite those cost controls, smaller employers are facing higher increases. The report found that 34% of smaller employers, defined as having between 10 and 499 employees, saw health insurance cost increases of more than 10% in 2017.
With more market leverage and resources to target costs, larger employers can control costs more easily.
That said, despite the added influence over costs, nearly one-fifth of employers with 500 or more employees and 11% of businesses with 20,000 or more workers saw health plan cost increases of more than 10% last year.
The report predicted added cost pressures in the coming years. Cost-drivers include medical advances, technology, high utilization, an aging population and the expected increase of uninsured Americans, according to the report.
The uninsured rate has dropped since the ACA, but the numbers have moved back in the other direction over the past year. Mercer warned that more uninsured will mean more uncompensated care and those costs will wind up getting passed onto employer plans.
Another issue that employers face is that there aren’t many cost-shifting levers left. Businesses have pushed more out-of-pocket costs onto consumers. That movement has led to PPO deductibles rising by about 9% annually since 2012 among mid-sized and large employers to $966 in 2017. Small employers have increased deductibles annually by 6% to an average of $1,917 in 2017.
Employers, particularly large and mid-sized companies, have pushed employees to consumer-directed plans that often have a health savings account. Those plans had a minimum deductible of $1,300 in 2017.
With those kinds of deductibles, members are struggling to afford healthcare, and employers can’t shift many more costs onto them. This will mean employers need to find other ways to cut costs.
One potential area of savings is prescription drugs, including specialty drugs. Annual spending on specialty drugs nearly doubled between 2011 and 2015. Mercer said that will get worse as new drugs enter the market over the next few years. In response, more than half of employers are steering workers to specialty pharmacies.
Another avenue tried by large and mid-sized companies are Centers of Excellence (COE) for orthopedics, cardiology and oncology. The report said 41% of businesses surveyed offer COE for women’s health, such as infertility and pregnancy.
Mercer said businesses use the centers because of better outcomes and cost. In many cases, this allows employers to contract directly with high-quality rated providers, who are willing to maintain a level of value-based care.
Suzanne Delbanco, executive director of Catalyst for Payment Reform, a nonprofit that works with more than 30 employers and purchasers of healthcare, recently told Healthcare Dive: “The interest in direct contracting is not a coincidence. It’s one of the few strategies that employers can use.”
Meanwhile, Mercer found most employers aren’t using accountable care organizations or narrow network strategies. Fewer than 10% of businesses are trying those strategies.
Employers told Mercer that they plan to implement other cost-saving strategies over the next five years, including monitoring/managing high-cost claimants, better managing cost for specialty pharmacy and focusing on creating a culture of health.
With Revlimid and Pomalyst price hikes, is Celgene next on Trump’s to-call list?
After public scrutiny and a phone call, President Donald Trump convinced Pfizer to at least defer its drug increases. But not all companies have flinched at the president’s “We will respond” threat, including makers of some of the world’s best-selling drugs.
Celgene increased the prices of two blockbuster cancer meds Revlimid and Pomalyst by 5% this month, according to SunTrust analysts. Roche raised the price of breast cancer drug Herceptin by 3%, and Avastin by 2.5%, Bloomberg reports. Novo Nordisk’s Tresiba, Levemir, Fiasp and NovoLog saw their prices up by 5%, while GLP-1 inhibitors Victoza’s and Ozempic’s jumped 7.9% in the same period, the diabetes specialist unveiled Wednesday.
While drugmakers are not raising prices at the same rate as some have in the past, they still fly in the face of the president’s threat.
In a statement to FiercePharma, a Celgene spokesman said the company made the increases “at less than the rate of anticipated U.S. healthcare spending growth for the year,” in line with CEO Mark Alles’ recent pledge.
A Roche spokeswoman, confirming those increases, said the company considers several factors when making decisions on drug prices, including “how well the medicine works and how it compares to other available treatments; the financial resources required to continue discovering new medicines for people with serious diseases; and how to ensure that the price doesn’t prevent our medicines getting to people who need them.”
Novo said in its notification Wednesday that the price increases “reflect the value our medicines offer in diabetes care and the current market dynamics to make sure patients’ insurance plans provide access to our medicines.” A Novo media aide told FiercePharma the company does intend to keep annual price increases within the 10% limit pledged in 2016.
Still, the timing of the latest round comes at a delicate time, as both the Trump administration and lawmakers have been criticizing high-rising drug prices in the U.S. Not to mention Pfizer’s Wednesday decision to bow to the government’s pressure and back down from its July increases after Trump called CEO Ian Read and swore to take action on those who raise prices without cause.
For Celgene, it comes right after CEO Mark Alles committed to limit the price increase of any medicine in its portfolio to only once a year, and at a level no greater than the projected growth in the U.S. healthcare expenditures. The current price increases are below the 5.3% rate predicted for this year, and also mean that Celgene has probably used up its annual quota for those two drugs.
But Alles’ statement also opened up room for exceptions where additional clinical or health economic evidence could support new increases. According to a Celgene spokesman, that is not on the company’s agenda, at least for now. “No further pricing actions for these or any of our other FDA-approved medicines are anticipated this year,” he said in a statement.
Price hikes aren’t a new tactic Celgene’s just adopted. In a Thursday note to investors, SunTrust analysts noted that the average yearly price increases Celgene had taken on those two multiple myeloma drugs in the U.S. are in the 10%-11% range over the last five years.
The U.S. big biotech raised eyebrows last year when it jacked up the price of Revlimid three times to an accumulative 19.8%, and the price on Pomalyst twice to reach a 17.7% jump. Revlimid’s $8.18 billion and Pomalyst’s $1.16 billion in 2017 sales represent a 17% and 23% jump, respectively. The company also admitted that price hikes boosted the company’s top line by 3.3% last year.
“[C]ontinued price increases in the U.S. (vs. continued price reductions ex-U.S.) on Celgene’s part could also bring CELG into the limelight (unfavorably),” SunTrust analysts wrote in their note.
Celgene, however, isn’t the only one who could put Trump’s typical Twitter fury to test. Goldman Sachs analyst Jami Rubin noted in a Wednesday note that Roche and Novo are the only other large-cap biopharma companies with a second price increase this year.
On July 3, Novo raised the price of some insulin products by 5%, and the price of its GLP-1 stars Victoza and Ozempic by 7.9%. The Novo spokeswoman noted that Tresiba and Levemir had a previous 4% increase this January, while the last increases for NovoLog, NovoLog Mix and Victoza happened over a year ago. Roche, for its part, increased cancer med Herceptin’s price by 3%, and Avastin’s by 2.5% in July, even though both drugs now face FDA-approved biosimilars.
CMS proposes to overhaul Medicare billing standards, pay for telehealth
The CMS on Thursday proposed paying doctors for virtual visits and overhauling Medicare billing standards it has had in place since the 1990s.
In a lengthy proposed rule, the agency said it would pay doctors for their time when they reach out to beneficiaries via telephone or other telecommunications devices to decide whether an office visit or other service is needed. In addition, the CMS also proposed paying for the time it takes physicians to review a video or image sent by patient seeking care or diagnosis for an ailment.
“This is a big issue for elderly and disabled population for which transportation can be a barrier to care,” CMS Administrator Seema Verma said. “We’re not intending to replace office visits but rather to augment them and create new access points for patients.”
Most physicians bill Medicare for patient visits under a relatively generic set of codes that distinguish level of complexity and site of care, known as evaluation and management visit codes.
Doctors long have been concerned about the codes’ documentation standards. The CMS has used evaluation and management visit codes since 1995.
The CMS proposed allowing practitioners to designate the level of a patient’s care needs using their medical decisionmaking or time they spent with the patient instead of applying the decades-old E/M documentation guidelines.
In addition, the agency wants to eliminate the requirement to justify the medical necessity of a home visit in lieu of an office visit and is considering eliminating a policy that prevents payment for same-day visits with multiple practitioners in the same specialty within a group practice.
“Today’s proposals deliver on the pledge to put patients over paperwork by enabling doctors to spend more time with their patients,” Verma said in a statement. “Physicians tell us they continue to struggle with excessive regulatory requirements and unnecessary paperwork that steal time from patient care. This administration has listened and is taking action.”
Elsewhere in the rule, the agency plans to continue a controversial site-neutral policy launched in 2018. For the second year in the row, off-campus facilities built after Nov. 2, 2015, will be paid 40% of the outpatient rates for the services they provide.
The policy “encourages fairer competition between hospitals and physician practices by promoting greater payment alignment between outpatient care settings,” the CMS said.
The proposed rule includes some significant changes to administration of MACRA including an opt-in option for physicians with a low volume of Medicare Part B enrollees or reimbursements and a waiver for clinicians who participate in a new Medicare Advantage demonstration.
In the wake of the Bipartisan Budget Act of 2018, the CMS is slowing implementation of the Merit-based Incentive Payment System (MIPS) and proposed slashing 34 quality measures that it deemed ineffective after hearing from stakeholders. The proposed rule adds 10 quality measures including four measures based on patients’ reporting of their outcomes. These are in line with HHS Secretary Alex Azar’s promise to keep rolling back paperwork and reporting requirements.
Physicians can opt into MIPS if they meet or exceed one or two of the following new-volume threshold criteria: incurring $90,000 or less in allowed charges under Medicare Part B; treating 200 or fewer Part B enrollees who are paid for through the Medicare physician fee schedule; or offering 200 or fewer covered services.
The CMS also moved forward with plans to have Medicare Advantage plans qualify as an alternative payment model through a demonstration program called the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI).
The demonstration would waive MIPS reporting requirements for clinicians who work within Medicare Advantage networks resembling advanced alternative payment models.
In the proposed rule, CMS officials focused on the exchange of digital health information, responding in part to the 21st Century Cures Act, which called for greater interoperability and an end to information blocking. The agency said there were still “significant obstacles” affecting that work, and it will push the matter with the 2019 requirements for certified electronic health record technology.
MIPS eligible clinicians will be required to use 2015 edition certified EHRs beginning next year, moving away from the 2014 edition products that some still use.
The CMS asserted that the move will save providers money. But some clinicians begged to differ.
“Today’s rule proposes to require physicians to deploy costly EHR upgrades for 2019 and takes further steps toward implementing burdensome appropriate use criteria,” said Anders Gilberg, Medical Group Management Association senior vice president for government affairs, in a statement.
Regulators also outlined new scoring methods and performance categories, including the overhauled “promoting interoperability” category, with which they’re pushing the digital exchange of health information between providers and also between providers and patients.
In general, regulators want to make the requirements of the MIPS promoting interoperability category similar to those of the promoting interoperability program for hospitals.
MIPS eligible clinicians will have to report on all measures for all objectives to receive scores in that category, according to the proposed rule.
Those measures are slated to change, the rule noted. The CMS wants to remove certain measures—including the patient-generated health data measure—that have been unduly “burdensome” for clinicians. It also wants to add measures, including one that would require clinicians to be able to query prescription-drug monitoring programs, in support of HHS’ work on the opioid epidemic.
JNJ ordered to pay $4.14B punitive damages in talc cancer case
This follows $550M in compensatory damages awarded earlier today. The report also states that this marks the biggest jury award of 2018.
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