Senate committee leaders tangle over drug pricing reform

The Senate Finance Committee is still negotiating major pieces of legislation to lower drug costs, and leaders are staying mum on what’s holding up the bill as they seek to cut prices within Medicare Part B and Part D.

“There are a couple of very tough issues you have to work out,” Senate Finance Committee Chair Chuck Grassley (R-Iowa) said Wednesday. “But there’s one sure thing: I want cheaper drug prices and we’re going to do everything we can to work towards cheaper drug prices.”

The panel’s Ranking Democrat Ron Wyden of Oregon said he and Grassley are meeting daily and sometimes several times a day about the proposals, which are now expected to come after the July Fourth recess, but he also declined to discuss specifics.

“The bottom line here is you’ve got to have meaningful steps to rein in high drug prices,” Wyden said, adding that the “focus is on getting it right.”

Grassley also came out against the Trump administration’s international reference pricing model for Medicare Part B. He said he would only be interested in third-party negotiation within Medicare Part B for specialty drugs.

The Senate Finance Committee’s legislation is aimed at cutting prices in Medicare Part B and Part D and Medicaid, as Congress wrestles with how to deliver on a signature healthcare promise by both parties and the White House. The panel is also looking to restructure Medicare Part D’s catastrophic coverage phase, which U.S. House of Representatives leaders are planning as well, to put a stop to incentives that drive patients into the catastrophic phase faster.

Focus on the Finance Committee’s work is renewing now that the Senate health committee has finished its legislation on healthcare costs, with a panel vote scheduled for next week.

The House also hasn’t released its proposal for Medicare Part D prices yet, and a representative for House Speaker Nancy Pelosi (D-Calif.) didn’t have an update as to timing.

On Wednesday night, Pelosi told lawmakers that the list of drugs to be negotiated could exceed 250, according to Rep. Mark Pocan (D-Wis.), who co-chairs the Congressional Progressive Caucus and wants a “bold” proposal to lower prices. Pelosi also said she would start tasking the committees to work on the drug pricing proposal, accordingot Pocan, although he doubts a policy will be ready before the August recess.

This plan has shifted from the establishment of private-sector binding arbitration to authorizing the HHS secretary to negotiate with the manufacturers of about 250 particularly expensive drugs, using a tax penalty as leverage.

In addition to drug list prices, the Senate Finance Committee is looking at long-term financing of expensive gene therapies, which Grassley framed as an equity issue for people in poverty to have access to the same options as people with private insurance and high incomes.

“So many of these things end up saving money in the long term, but states can’t afford it all in one year or one payment,” he said. “So let’s spread it out, otherwise how are you going to guarantee equity for people who are on Medicaid compared to other people that have access?”

https://www.modernhealthcare.com/medicare/senate-committee-leaders-tangle-over-drug-pricing-reform

Rising prices to drive estimated 6% medical cost inflation in 2020

Medical costs are projected to rise 6% in 2020 as prices continue to swell and utilization stagnates, according to a new report.

Despite employers’ efforts to stem unnecessary care through high-deductible health plans, medical cost growth still outpaces general inflation, PricewaterhouseCoopers Health Research Institute’s analysis of employer-sponsored healthcare spending found. The 2020 projection aligns with the average medical cost inflation over the past five years and is down from double-digit spikes in the 2000s. That estimate lowers to a 5% net growth rate after figuring in health plan changes such as increased employee cost-sharing and network and benefit changes, HRI notes.

“Utilization is basically flat, and it is all on the price side,” said Benjamin Isgur, who leads the Health Research Institute. “Employers realize that it isn’t going to help if they put more cost-sharing on employees, and they are starting to get a bit of backlash.”

Prices have been a larger component of employer-benefit costs than utilization since 2004, according to HRI’s research, which is supported by related reports. Utilization has hovered around 0% growth since 2006. Last year’s report identified consolidation and physician employment driving prices up, which will likely continue in the short-term, the institute said.

This has hit consumers harder as deductibles for employer-sponsored plans have tripled between 2008 and 2018, outpacing wage growth. Thus, they have delayed or refused care. Twenty-eight percent of consumers surveyed by HRI with high-deductible health plans said they had $500 or less in emergency savings. For all deductible levels, across individuals and families, at least one-third did not have enough savings to cover their deductible.

Cost sharing has effectively limited utilization, but it is reducing both unnecessary care as well as needed care, Isgur said. The runway for high-deductible health plans may be running out as 84% of employers have implemented one, HRI notes.

“In many cases they could be delaying care and making it worse, especially in chronic-disease management,” Isgur said. A healthy individual costs an employer about $1,300 a year while someone with a chronic condition is about $4,700 and a person with multiple chronic conditions is nearly $11,000, he added. A person with a complex chronic condition and mental illness costs their employer about $15,000 annually.

Retail drug spending is projected to grow between 3% and 6% a year as the impact of generics plateaus and biosimilars continue to see slow uptake, PwC researchers said. Generic competition will not affect 46% of the estimated sales revenue of the top 100 drugs through 2023, according to the report. Generic utilization rates are hovering around 86%.

Also, the value of branded drugs coming off patent decreases through 2020. Many are particularly expensive biologics that will require biosimilars, of which there are only seven on the market. Seventy-three percent of clinicians surveyed by HRI said they rarely or never prescribe biosimilars in place of biologics, saying that they weren’t significantly cheaper for the patient.

The industry is at an inflection point with drugs in the pipeline, where new life-altering drugs bring a price tag of $1 million to $2 million per treatment, said Dan Rachfalski, senior vice president and chief actuary at Wellesley, Mass.-based Harvard Pilgrim Health Plan.

“As an industry, we have not figured out how to pay for these life-changing, extremely high-cost drugs,” he said in an interview with HRI.

Caring for those with chronic diseases will drive medical cost inflation, researchers said. Sixty-two percent of individuals with employer-based insurance have a chronic or complex chronic disease—increasingly diabetes and obesity—making up 85% of total employer-based healthcare spending, HRI found.

More access to mental health treatment aided in part by the Mental Health Parity and Addiction Equity Act will also increase costs, although the long-term impact will overshadow short-term costs, Isgur said.

Three-quarters of employers offer depression and mental health in 2018, up from 34% in 2014. But only 27% of individuals with employer-based insurance surveyed by HRI who face depression and mood disorders, post-traumatic stress disorder, addiction and/or suicidal thoughts as their primary health issue report participating in a mental health and well-being program over the last two years.

To combat rising costs, employers are more actively addressing medical costs by creating expansive work-site clinics that boost productivity, pushing narrow networks with lower-cost providers, urging home care and helping employees navigate the system, according to the report.

“For employers, compared to other players in the healthcare industry, it is now about inequity in cost and misaligned incentives across the board,” Michael Thompson, president and CEO of the National Alliance of Healthcare Purchaser Coalitions, said in an interview with HRI.

The institute’s analysis measures anticipated spending growth in the employer-based market, which covers about half of all Americans. PwC conducted 55 interviews with healthcare executives, health plan benefit experts and actuaries whose companies cover more than 95 million employer-sponsored large group members. Its research institute also pulled data from a national survey of 2,500 consumers as well as another survey polling more than 550 employers. The report did not factor in changes to government payers and ACA exchanges.

https://www.modernhealthcare.com/providers/rising-prices-drive-estimated-6-medical-cost-inflation-2020

Cardiologists Must ‘Get Up To Speed’ on Treating Diabetes

Physicians across all medical specialties are aware that cardiovascular disease (CVD) is the leading cause of morbidity and mortality among patients with type 2 diabetes.

With the advent of novel antihyperglycemic agents with cardioprotective effects, why then is the majority of cardiologists caring for patients with concomitant CVD and diabetes reluctant to prescribe these drugs to their patients?^{[1,2,3,4,5,6]}

Frequently Involved in Care More Than Ever Before

In both the inpatient and outpatient setting, cardiologists are frequently involved in the care of patients with diabetes. Robert Chilton, DO, at the University of Texas Health Science Center has seen a significant increase in the number of cardiology patients with diabetes. “I work in a cath lab as an interventional cardiologist, and 20 years ago, I would see one patient with diabetes every 2 weeks. Now, 80% of all my patients have diabetes.” He further noted that cardiologists will ultimately need to become more involved in diabetes care because there are not enough endocrinologists to care for the increasing number of patients diagnosed with the disease.

Cardiologists currently see more patients with diabetes than do endocrinologists, according to a study presented at the 2019 Endocrine Society Annual Meeting in New Orleans. Among 78,878 adults with diabetes, including 31,639 with CVD, visits to cardiologists outnumbered visits to endocrinologists almost threefold.^[7] When considering only patients with diabetes and CVD, there were five times more cardiologist visits (n = 43,482) than endocrinologist visits (n = 8,624).

Despite these figures, many cardiovascular (CV) specialists report being poorly equipped to address diabetes with novel agents.^[4] In response to this sentiment, there has been an increase in diabetes-related continuing education programs for cardiologists.

Opportunities for Collaboration

The American College of Cardiology (ACC) and the American Diabetes Association recommend specific diabetes therapies to decrease CVD risk.^[8,9]As such, a substantial opportunity exists to improve quality of care and outcomes for patients with diabetes through a more collaborative system-of-care model.

The availability of diabetes therapies to lower patients’ risks of major adverse atherosclerotic events, heart failure, progression to renal disease, and premature CV death has resulted in a substantial increased interest in diabetes management across all medical specialties, including cardiology. Gregg Fonarow, MD, director of the Ahmanson-UCLA Cardiomyopathy Center, asserted, “A paradigm shift is needed to ensure that all clinicians involved in the care of patients with diabetes provide patients with optimal, evidence-based, guideline-directed care. This includes cardiologists.”

New Agents, Added Cardioprotective Benefits

Newer antihyperglycemic therapies, such as glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose contransporter-2 (SGLT-2) inhibitors, have proven CV safety profiles and CV event reduction properties that are not yet fully elucidated and apparently not related to glycemic control.^[3,5,10,11] In addition to the cardioprotective benefits, SGLT-2s and GLP-1s are associated with weight loss, another modification that reduces morbidity in patients with CVD and diabetes.^{[12,13] [MORE]}

https://www.medscape.com/viewarticle/914378

Cancer in Children Born Through IVF: Is the Risk Real?

Assisted Reproduction and Cancer

Each year, the 1-2 million in vitro fertilization (IVF) treatments performed worldwide result in 8 million children.^[1] The safety of fertility treatments has been evaluated from the early days of assisted reproduction technology (ART), and reports about the risk for cancer among children conceived through ART have been conflicting.^[2,3]

A recent study^[4] assessed the risk for cancer among the offspring of subfertile women seen in fertility clinics in the Netherlands. Of 47,690 live-born children, 231 (93 conceived with ART and 138 conceived without ART) were diagnosed with cancer during a median of 21 years of follow up.

The study’s findings included the following:

• The overall cancer risk was not increased among ART-conceived children compared with naturally conceived children from subfertile women or in the general population.
• The risk for cancer was not increased among the offspring of mothers exposed to fertility drugs compared with naturally conceived offspring.
• A slight but nonsignificant increased risk for cancer was observed among children conceived by intracytoplasmic sperm injection or cryopreservation.
• The risks for lymphoblastic leukemia and melanoma were nonsignificantly increased for ART-conceived children compared with naturally conceived children.

Viewpoints

Conflicting reports have been published with respect to cancer risk among children born through ART.^[2,3] These reports are typically limited by the low numbers of cancers involved, short follow-up periods, and the use of inappropriate comparison groups.

This study used a large cohort of ART-exposed women and a long follow-up period, and compared outcomes with the general population as well as with a cohort of subfertile women who did not undergo ART. This allowed the study of the role of fertility drug exposure and in vitro manipulations alone after controlling for subfertility.

There are plausible reasons to be concerned about cancer in children born through ART. During ART, embryos are kept outside the female reproductive tract for a few days, which may affect their epigenetic programming.^[5]Differences in epigenetic programming could influence the activity of various genes that may impact the health of the offspring.

This study cohort underwent ART treatments between 1983 and 2000. ART treatments have changed significantly since that time. Extended embryo culture to the blastocyst stage has become more widespread. Longer in vitro culture may further alter gene methylation, and therefore it will be important to compare outcomes with cleavage versus blastocyst stage transfer. Cryopreservation of embryos, oocytes, and even ovarian tissue is increasingly used. Some trends for higher cancer risk were observed in this study after frozen embryo transfer, but the number of cases was too small to analyze subgroups.

This study did not find an increased cancer risk in children conceived after ART or after fertility drug exposure, but as new technologies are introduced and the number of treatment cycles increases, further studies will be needed to confirm their safety.

https://www.medscape.com/viewarticle/914417

Perrigo RX unit sale talks cool – Dealreporter

DealReporter sources say Perrigo’s (NYSE:PRGO) sale talks for its RX unit have gone quiet because no bidder has met PRGO’s price expectations.

Only one PE bidder remains, and if the bid isn’t raised, Perrigo could pull the sale offer.

Source: Bloomberg.

PRGO shares are up 0.5% after hours to $43.50.

https://seekingalpha.com/news/3472826-perrigo-rx-unit-sale-talks-cool-dealreporter

Mustang Bio gains as Cantor sees 108% upside

Mustang Bio (NASDAQ:MBIO) is up 8.6% after hours following an initiation at Overweight by Cantor.

The firm set its price target at $7, implying 108% upside from today’s close of $3.37.

Shares had fallen 6.9% on very light volume during the regular session.

Sell-side analysts rate the stock Buy on average, and Seeking Alpha authors are also Bullish, while the stock has a Quant Rating of Neutral.

https://seekingalpha.com/news/3472837-mustang-bio-plus-8_6-percent-cantor-sees-108-percent-upside

Exelixis lower after IMspire170 fails to meet primary endpoint

Exelixis (NASDAQ:EXEL) -3% after-hours on news that IMspire170, the phase 3 trial evaluating the combination of cobimetinib and atezolizumab, did not meet its primary endpoint of progression-free survival compared to the current standard of care in patients with previously untreated BRAF V600 wild-type advanced melanoma.

IMspire170 showed the combination did not reduce the risk of disease progression or death compared to pembrolizumab, according to partner Roche (OTCQX:RHHBY).

Cobimetinib is an Exelixis-discovered MEK inhibitor, and atezolizumab is an anti-PDL1 antibody discovered and developed by Roche’s Genentech subsidiary.

https://seekingalpha.com/news/3472874-exelixis-lower-imspire170-fails-meet-primary-endpoint