Enrollment Rising in High-Deductible Plans

Enrollment in high-deductible health plans (HDHPs) — including some paired with health savings accounts — rose quickly during 2007-2017 among people insured through their employers, while enrollment in traditional health plans dropped sharply, according to a report released Thursday by the National Center for Health Statistics.

About 60% of adults in the 18-64 age group got their health insurance from their employer as of 2017, the researchers noted. Of this group, 43.4% were enrolled in an HDHP — with or without a health savings account — compared with 14.8% in 2007. Meanwhile, the percentage enrolled in traditional health insurance plans dropped from 85.1% in 2007 to 56.6% in 2017.

Researchers used data from the 2017 National Health Interview Survey (NHIS), a nationally representative sample of more than 46,600 U.S. adults ages 18-64. Data were collected via in-person interview with some follow-up information collected via phone.

The researchers defined HDHPs as “health insurance policies with higher deductibles than traditional health insurance plans.” They defined health savings accounts as accounts that “allow pretax income to be saved to help pay for the higher costs associated with an HDHP.”

There were differences in which types of workers were enrolling in HDHPs; those ages 18-29 and 45-64 were less likely than those ages 30-44 to enroll in an HDHP combined with a health savings account. However, no age-based differences were found among those enrolled in either traditional plans or HDHPs without savings accounts. There also was no difference between men and women in the type of health plan chosen.

On the other hand, education levels were associated with differences in enrollment — a higher percentage of workers with less than a high school education (61.1%) were enrolled in traditional health plans in 2017 compared with those with a bachelor’s degree or higher (54.3%). Conversely, more workers in the latter group (23.9%) were enrolled in an HDHP combined with a health savings account than those with less than a high school education (10.7%).

For HDHPs not combined with a health savings account, more workers with less than a high school education (28.2%) were enrolled in them compared with those with a bachelor’s degree or higher (21.8%).

Income level also was linked with enrollment differences, the investigators found. More workers with incomes at 138% or less of the federal poverty level (59.9%) enrolled in traditional coverage compared with those making more than 400% of the poverty level (55.5%). And more workers at that higher income level enrolled in an HDHP with a health savings account (22.0%) than those making the lesser amount (7.9%).

“The change in HDHP enrollment has been faster among those with employment-based coverage than among those with directly purchased coverage,” the researchers noted. “NHIS will continue to monitor the different types of private health insurance, and NHIS data can be used to examine further differences according to plan type.”

https://bit.ly/2vtgnMi

G1 Therapeutics Provides Second Quarter 2018 Corporate and Financial Update

• Presenting additional data from randomized Phase 2 trilaciclib/chemotherapy trial in first-line small cell lung cancer at ESMO 2018 in October
• Initiated Phase 2a enrollment of lerociclib (G1T38) in ER+, HER2- breast cancer; positive Phase 1b data presented at ASCO 2018
• Management to host webcast and conference call today at 4:30 p.m. ET

G1 Therapeutics, Inc. GTHX, +16.04% a clinical-stage oncology company, today provided an update on its corporate activities, product pipeline and financials for the second quarter ended June 30, 2018.

“We have made impressive clinical progress on trilaciclib in the first half of 2018 and are approaching several important clinical milestones later this year. Additional data from the randomized Phase 2 trilaciclib/chemotherapy trial in first-line small cell lung cancer have been accepted for presentation at the European Society for Medical Oncology Congress in October. We will also be reporting preliminary data from our randomized Phase 2 trials of trilaciclib in second-/third-line SCLC and triple-negative breast cancer in the fourth quarter,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “We have been engaged in productive discussions with U.S. and European regulatory authorities regarding the trilaciclib development program and expect that dialogue to continue.”

Dr. Velleca added: “We presented the first clinical data on lerociclib in patients with ER+, HER2- breast cancer in June at the 2018 American Society of Clinical Oncology Annual Meeting, which showed promising safety, tolerability and anti-tumor activity. We are currently enrolling the Phase 2a dose-expansion portion of that trial, with patients receiving 500 mg once daily without a dosing holiday. In addition, we have initiated the first clinical trial for G1T48, our oral SERD, in ER+, HER2- breast cancer and expect preliminary data next year.”

Corporate Highlights

• Completed enrollment of Phase 2 trials of trilaciclib in second-/third-line small cell lung cancer (SCLC) and triple negative breast cancer (TNBC): G1 expects to report preliminary data from both randomized trials in the fourth quarter of 2018.
• USAN name lerociclib adopted for G1T38: G1 has received approval from the United States Adopted Names Council that lerociclib has been adopted to refer to G1T38. All future communications from G1 will refer to G1T38 as lerociclib.
• Reported positive lerociclib data in breast cancer patients at ASCO 2018: in June, G1 announced preliminary Phase 1b data on lerociclib in combination with Faslodex [(R)] (fulvestrant) that showed promising safety, tolerability and anti-tumor activity when lerociclib was dosed continuously as a treatment for people with estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer.
• Initiated enrollment of Phase 2a expansion of lerociclib in combination with Faslodex in ER+, HER2- breast cancer: based on Phase 1b data, the Phase 2a dose expansion portion of the trial is enrolling. Approximately 30 patients will receive lerociclib 500 mg once daily without a dosing holiday.
• Initiated Phase 1/2a clinical trial of G1T48, an oral SERD, as monotherapy for treatment of ER+, HER2- breast cancer: in June, G1 initiated the first clinical trial of G1T48, an oral selective estrogen receptor degrader (SERD). This open-label study is expected to enroll up to 96 patients in two parts: a safety, pharmacokinetic and dose escalation portion (Phase 1); and an expansion portion at the recommended Phase 2 dose (Phase 2a). G1 plans to study a G1T48/lerociclib combination regimen for breast cancer in 2019, contingent on the Phase 1 findings.
• Expanded leadership team, appointing Chief Commercial Officer and General Counsel: in July, the company named John Demaree as Chief Commercial Officer and Stillman Hanson as General Counsel. Mr. Demaree has more than 20 years of oncology experience, building commercial capabilities and leading multiple successful product launches. Mr. Hanson most recently served as Associate General Counsel and Vice President at IQVIA, and has extensive life sciences corporate legal experience.
• Appointed Cynthia Schwalm and Willie Deese to G1 Board of Directors: in June, the company announced the election of two new Board members. Ms. Schwalm most recently served as President and Chief Executive Officer of Ipsen North America. Mr. Deese previously served as President of the Merck Manufacturing Division and as a member of the Merck Executive Committee before retiring in 2016.

Anticipated Upcoming Milestones

• Present additional data from the randomized Phase 2 trilaciclib/chemotherapy trial in first-line SCLC at ESMO 2018, being held October 19-23 in Munich, Germany.
• Report preliminary data from the randomized Phase 2 trilaciclib/chemotherapy trials in second-/third-line SCLC and first-/second-/third-line TNBC in the fourth quarter of 2018.
• Complete enrollment of the Phase 2a trial of lerociclib/Faslodex in ER+, HER2- breast cancer by the end of 2018.

Second Quarter 2018 Financial Highlights

• Cash Position: Cash, cash equivalents and short-term investments totaled $188.2 million as of June 30, 2018, compared to $103.8 million as of December 31, 2017. This increase results from the receipt of $107.9 million in net proceeds from the secondary offering in March of this year and $12.1 million in net-proceeds from “at the market offerings” in June, partially offset by cash used in operating activities.
• Operating Expenses: Operating expenses were $21.7 million for the second quarter of 2018, compared to $15.4 million for the second quarter of 2017. GAAP operating expenses include stock-based compensation expense of $2.1 million for the second quarter of 2018, compared to $0.8 million for the second quarter of 2017.
• Research and Development Expenses: Research and development (R&D) expenses for the second quarter of 2018 were $18.4 million, compared to $13.7 million for the second quarter of 2017. The increase in expense was due to an increase in clinical program costs, drug manufacturing costs to support clinical programs and personnel costs due to additional headcount.
• General and Administrative Expenses: General and administrative (G&A) expenses for the second quarter of 2018 were $3.3 million, compared to $1.7 million for the second quarter of 2017. The increase in expense was largely due to an increase in personnel-related costs.
• Net Loss: G1 reported a net loss of $20.9 million for the second quarter of 2018, compared to $15.2 million for the second quarter of 2017.

Webcast and Conference Call
The G1 management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the second quarter of 2018. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 3088562. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com.

https://on.mktw.net/2KI0RAH

American Public Education (APEI) Target Lowered to $41 at Piper Jaffray

on Mixed 2Q Report; ‘Updated 3Q Guidance Weak… Visibility Still Limited.’

https://bit.ly/2OU23UV

MedEquities Realty Downgraded Amid Tenant Troubles

MedEquities Realty Trust Inc MRT 2.11% — a real estate investment trust focused on health care properties and related real estate debt investments — reported second-quarter results Wednesday and said its top tenant hasn’t paid rent since May.

The disclosure goes against prior assumptions and prompted KeyBanc Capital Markets to drop its bullish stance.

The Analyst

KeyBanc Capital Markets’ Jordan Sadler downgraded MedEquities Realty Trust from Overweight to Sector Weight.

The Thesis

MedEquities said in conjunction with its Q2 print that its top tenant OnPointe Health has not paid rent it owed since May, and security deposits only covered May and June’s payments, Sadler said in the downgrade note. (See the analyst’s track record here.)

In late June, MedEquities said OnPointe was up-to-date on rent, but Wednesday’s earnings report and disclosure stand “in stark contrast” to the prior narrative, the analyst said.

The company did say it’s seeking new tenants for the facilities occupied by OnPointe, but MedEquities may need to accept a meaningful rent cut, Sadler said. The market rent coverage of 1.4 to 1.5 times EBITDAR suggests a rent reduction could be as steep as 30-50 percent, he said.

The process of finding a new tenant could take as long as six months, although Sadler said the company has known of its tenant’s troubles for some time, so the company could have already identified potential replacements.

Another MedEquities tenant that contributes 15 percent of total rent, Fundamental Healthcare, is seeing substantial declines in facility-level performance, Sadler said. While Fundamental is still in compliance under its guarantor agreement, the news comes at a bad time for MedEquities’ investors and “incrementally hurts” management’s credibility, according to KeyBanc.

https://bit.ly/2vS6VRH

Sesen Med Granted FDA Fast Track for Bladder Cancer

Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Vicinium™ for the treatment of BCG-unresponsive high-grade non-muscle invasive bladder cancer (NMIBC). Vicinium, Sesen Bio’s lead product candidate, is currently being evaluated in a Phase 3 registration trial, the VISTA Trial, for the treatment of patients with high-grade NMIBC who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive.

“The granting of this designation is an important milestone for Sesen Bio, and we believe it exemplifies the urgent need for a new treatment option for people with NMIBC for whom bladder removal is the recommended course after BCG,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “We are highly encouraged by the differentiated product profile of Vicinium in NMIBC, with a unique mechanism of action, positive three-month data presented earlier this year and favorable tolerability in patients treated to-date. With Fast Track designation, we look forward to determining the optimal registration path and assessing the opportunity for accelerated approval to bring Vicinium to patients as quickly as possible.”

The FDA’s Fast Track process is designed to expedite the development and review of drugs used to treat serious or life-threatening conditions and fill an unmet medical need. Fast Track designation allows for frequent communication and interactions with the review team at the FDA throughout the drug development and review process, with the goal of providing faster drug approval and greater patient access.

Enrollment is complete in the Phase 3 VISTA Trial and the company expects to report 12-month efficacy results in mid-2019.

https://bit.ly/2vUVNU6

Mallinckrodt Data Show Underutilization Of Opioid-Free Analgesia

Mallinckrodt Pharmaceuticals (NYSE: MNK), a leading global specialty pharmaceutical company, today announced publication of a new retrospective, claims-based data analysis that highlights a disparity between patients currently being treated with opioid-free analgesia (OFA) for surgical procedures and those that the Joint Commission has identified as being more susceptible to opioid-related adverse events (ORADEs).

The Joint Commission is an independent, not-for-profit organization dedicated to helping health care organizations excel in providing safe and effective care of the highest quality and value. On Aug. 8, 2012, the Joint Commission issued its “Sentinel Event Alert Issue 49: Safe use of opioids in hospitals,”¹ which outlines patient groups that are more susceptible to ORADEs.

Mallinckrodt’s new study² investigating utilization patterns and predictors of opioid-free analgesia (OFA) in a surgical population in the United States found that use of post-surgical OFA in U.S. hospitals was limited overall, and, while there could be potential benefit from OFA use versus opioids, OFA was not favored in some patient groups the Joint Commission identified as being more prone to ORADEs. The Mallinckrodt-sponsored analysis was conducted in collaboration with Brigham and Women’s Hospital, Harvard Medical School, and recently published in Current Medical Research and Opinion.

“This analysis, which we believe is among the first of its kind in a large patient population, provides important insights that can inform our understanding of OFA approaches to perioperative pain management and potentially benefit patient populations who are at particular risk for opioid-related adverse events,” said Tunde Otulana, MD, Chief Medical Officer at Mallinckrodt. “A number of healthcare providers today are using opioid-sparing or opioid-free analgesia within enhanced recovery after surgery (ERAS) pathways³ with the goal to reduce opioid use and expansion of this post-surgical pain management approach could make a positive difference in the lives of some patients.”

According to the authors of the analysis, evaluation of the OFA population and drivers of OFA use can inform understanding of safe and effective approaches to OFA and highlight the potential to improve and expand this post-surgical pain management approach.²

Analysis of predictors of opioid-free analgesia for management of acute post-surgical pain in the United States² evaluated the Cerner Health Facts database from January 2011 to December 2015 to describe hospital and patient characteristics associated with OFA. Baseline characteristics, such as age, gender, race, discharge status, year of admission and chronic comorbidities at index admission were collected. Hospital characteristics and payer type at index admission were also collected, and descriptive statistics and logistic regression were used to identify statistically significant predictors of OFA, at both the patient and institutional levels.

The analysis identified 10,219 patients, from 187 hospitals, who received post-surgical OFA and 255,196 patients who received post-surgical opioids. Among the qualifying surgeries, only 3.9% of patients received OFA.

Patients more likely to receive OFA were older (odds ratio [OR] =1.06; 95% confidence interval [CI]⁴: 1.03, 1.10; p<.001); or had:

• Neurological disorders (OR=1.24; 95% CI: 1.10, 1.39; p<.001);
• Diabetes (OR=1.20; 95% CI: 1.08, 1.33; p=.001); or
• Psychosis (OR=1.18; 95% CI: 1.01, 1.37; p=.030).

Patients less likely to receive OFA had:

• Obesity (OR=0.80; 95% CI: 0.67, 0.95; p=.010); or
• Depression (OR=0.85; 95% CI: 0.73, 0.98; p=.030).

Rates of OFA varied considerably by hospital. A few hospitals contributed a substantial proportion of OFA patients, suggesting that hospital policies, institutional structure and cross-functional departmental commitment to reducing opioid use may play a large role in the implementation of OFA, as the authors note.

https://bit.ly/2AXnjX7

Paratek Antibiotic FDA Date Set for October

Shares of Paratek Pharmaceuticals are climbing in pre-market trading after the company announced a U.S. Food and Drug Administration advisory committee voted overwhelmingly in favor of the company’s intravenous and oral treatments for acute bacterial skin and skin structure infections (ABSSSI).

Omadacycline is a novel investigational antibiotic for the treatment of ABBSSSI and community-acquired bacterial pneumonia (CABP). The committee voted 17 to 1 in favor of omadacycline as a treatment for ABBSSSI and 14 to 4 in support of it as a treatment for CABP, the company announced this morning. A final FDA decision is expected in early October. The FDA does not have to follow the guidance of its advisory committee when it comes to final approval, but it typically does.

Shares of Paratek are up more than 3 percent in premarket trading following a halt called yesterday while the advisory committee deliberated over the treatment.

Michael F. Bigham, chairman and chief executive officer of Boston-based Paratek, said omadacycline has the potential to “help address the urgent and growing need for new antibiotics to treat serious community-acquired infections.” With a once-per-day dosing, the Paratek medication may lead to early hospital discharges for patients, or allow safe and effective treatment in an outpatient setting, Bigham added.

“Today’s recommendations from the Advisory Committee move us one step closer to making this important new treatment option available to patients and physicians. We look forward to working with the FDA as it considers the comments from the committee members and completes its review of the omadacycline new drug applications,” Bigham said in a statement released late Wednesday.

The FDA advisory committee looked at data from three Phase III studies of omadacycline that showed the drug hit its primary and secondary endpoints in the trials. The studies involved more than 2,000 patients. Additionally, the drug was safe and well-tolerated, Paratek said.

A modernized tetracycline, omadacycline is specifically designed to overcome tetracycline resistance and exhibits activity across a broad spectrum of bacteria, including Gram-positive, Gram-negative, anaerobes, atypical bacteria, and other drug-resistant strains, Paratek said. Omadacycline has been granted both the Qualified Infectious Disease Product designation and Fast Track designation by the FDA. The PDUFA date is set for early October. In addition to ABBSSSI and CAPB, Paratek is working with the U.S. Department of Defense to determine if omadacycline would be an effective biodefense treatment for pathogenic agents that include plague and anthrax.

Paratek said it is planning to seek marketing authorization in the European Union. The company also entered into a collaborative agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region.

https://bit.ly/2Myj0mr