McKesson upgraded to buy from hold by Stanpoint Research.
Tuesday, July 10, 2018
Roche, Gilead, Novartis reported to nix some drug price increases
Gilead (GILD), Roche (RHHBY), Novo Nordisk (NVO) and Novartis (NVS) have all sent notices to California health plans rescinding or reducing previously announced price hikes in the wake of a new drug pricing transparency law that was enacted in the state, according to Bloomberg. The California measure, which is among the most aggressive efforts by states to rein in drug costs, is being challenged in court by the drug industry’s lobbying group, the report noted. The walk back on the price hikes also follows President Donald Trump’s recent promise that a number of drug companies will be voluntarily lowering their prices. Other large cap pharmaceutical companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Pfizer (PFE), and Sanofi (SNY)
Inspire Medical Announces Aetna Coverage for Sleep Apnea Therapy
Inspire Medical (NYSE:INSP) a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea (OSA), today announced that Aetna Inc., one of the leading health plans in the United States, will provide coverage for the Company’s Inspire therapy, effective immediately. Aetna’s plan provides coverage for approximately 22 million members.
As quoted in the press release:
“We are very pleased to receive this positive coverage decision from Aetna. We believe this coverage decision is a major milestone and has the potential to facilitate patient and physician access to and interest in Inspire therapy,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. “There is a strong body of clinical data supporting Inspire therapy, including the 5-year STAR data, the ADHERE 300-patient registry data and other supportive publications. We believe our growing body of clinical and real-world data will be the basis for further coverage decisions by other major health plans.”Under its policy, Aetna considers Inspire’s U.S. Food and Drug Administration (FDA) approved hypoglossal nerve neurostimulation device to be medically necessary for the treatment of moderate to severe OSA when a number of criteria are met. These include a previous attempt at continuous positive airway pressure (CPAP) treatment and patient selection consistent with FDA approval guidelines.
Aquinox to restructure
Aquinox Pharma (NASDAQ: AQXP) disclosed in an SEC filing:
On July 3, 2018, the Compensation Committee of the Board of Directors of Aquinox Pharmaceuticals, Inc. (the “Company”) approved a restructuring plan to reduce operating costs and better align the Company’s workforce with the needs of its business following the June 27, 2018 announcement that its Phase 3 LEADERSHIP 301 clinical trial evaluating once-daily, oral rosiptor (AQX-1125) for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) failed to meet its primary endpoint. The Company has halted all further development activities with rosiptor.
Under this plan, the Company reduced its workforce by 30 employees (approximately 53%) and closed its office in San Bruno, California. Affected employees are eligible to receive severance payments and outplacement services. Employee severance benefits are contingent upon an affected employee’s execution (and non-revocation) of a separation agreement, which includes a general release of claims against the Company.
In connection with the restructuring, the Company estimates that it will incur aggregate restructuring charges of approximately $2.5 million related to one-time termination severance payments and other employee-related costs and the shut-down of its San Bruno office. The majority of the cash payments related to the personnel-related restructuring charges will be paid during the third quarter of 2018, with the remainder to be paid during the fourth quarter of 2018. The charges that the Company expects to incur in connection with the workforce reduction is subject to a number of assumptions, and actual results may differ materially. The Company may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the workforce reduction.
More ‘Hospital at Home’ Options Coming?
Initiative gathers steam as Medicare ponders 2 APMs and new Mount Sinai study confirms improved outcomes.
With a study by the Icahn School of Medicine at Mount Sinaidemonstrating improved outcomes for patients participating in Hospital at Home (HaH) services, and two alternative payment models (APM) under review by Medicare, more healthcare systems may explore the possibility of offering this innovative model of care.
As health leaders examine the advantages of launching HaH programs to deliver acute services in the home environment versus traditional inpatient care, here’s a look at the latest developments and thoughts to consider.
2 APMS UNDER CONSIDERATION
Hospitals providing HaH services have demonstrated improved outcomes and lower costs; however, without a specific fee-for-service payment mechanism available through Medicare, adoption has been slow. That appears to be changing.
- On October 20, 2017, the Physician-Focused Payment Model Technical Advisor Committee (PTAC) recommended full implementation of an alternative payment model (APM) for HaH to the U.S. Department of Health and Human Services. HaH-Plus care, which was submitted by Icahn School of Medicine at Mount Sinai, bundles acute HaH care with a 30-day post-acute period of home-based transitional care.
- The objective of the Mount Sinai study, published in the June 25 online edition of JAMA Internal Medicine, was to evaluate the complete data on clinical outcomes, patient experiences, and safety of the HaH payment model recommended by PTAC. “Creation of an APM for such a model of HaH care,” the study says, “would establish Medicare billing codes, allowing clinicians to bill directly for HaH services and paving the way for broad-scale adoption of the HaH program in the United States.”
- On May 7, PTAC also recommended a different Home Hospitalization APM that was submitted by Personalized Recovery Care, LLC (PRC), a joint venture between Marshfield Health System, Marshfield, Wisconsin and Contessa Health, Nashville, Tennessee.
- This second recommendation explains, “Because the PRC HH-APM model addresses the important need of providing home-based hospital-level acute care for eligible patients, and the differences from the HaH-Plus APM model that we previously recommended could enable more and different physician practices to participate and more patients to benefit, implementation of both models would be desirable to enable a better understanding of the relative advantages of the different approaches.”
Both recommendations are under evaluation.
STUDY DEMONSTRATES IMPROVED OUTCOMES
The three-year Mount Sinai study demonstrated improved outcomes for patients receiving care at home, compared to those admitted to the hospital. Results included:
- Shorter length of stay (3.2 days vs. 5.5 days)
- Lower rates of hospital readmissions (8.6% vs. 15.6%)
- Lower rates of emergency department visits (5.8% vs. 11.7%)
- Fewer transfers to skilled nursing facilities (1.7% vs. 10.4%)
- More likely to rate their medical care highly (67.8% vs. 45.6%)
Historically, the study notes, cost savings for these programs range from 19% to 38%.
CAUTIONS TO CONSIDER
In an invited commentary to the JAMA Internal Medicinearticle, authors caution that “The HaH-Plus proposal also raises several important clinical and policy issues that need to be addressed before HaH programs (and the payment models to support them) could be implemented more broadly.”
The commentary outlines multiple points for consideration. A partial list of their recommendations includes:
- Quality and safety requirements do not currently do not exist for HaH programs but should be paramount to ensure a minimum standard of care.
- Bundled payments should account for unintended consequences. “For example,” the authors say, “policies would have to be in place to guard against inappropriate conversion of outpatient encounters to HaH episodes, which might unnecessarily increase care intensity and undercut potential cost savings, or inappropriate conversion of inpatient stays to HaH episodes, which might jeopardize patient safety and outcomes.”
- The authors also suggest that more work is needed to design a true bundled payment for the HaH model because the program upon which it is designed at Mount Sinai “was not actually reimbursed on a bundled basis. Certain elements (e.g., professional fees for emergency medicine and primary care providers) were billed separately outside of the program without a financial reconciliation; therefore, key technical details (e.g., benchmarking, risk-adjustment, quality measurement) require further development and refinement.”
QUESTIONS TO ASK
Researchers at the Johns Hopkins University Schools of Medicine and Public Health developed and successfully tested its Hospital at Home concept in a National Demonstration and Evaluation Study.
Johns Hopkins Healthcare Solutions now provides technical assistance to and collaboration with other health systems that want to offer these services. According to the institution’s Healthcare Solutions website, among the questions health systems should consider when exploring HaH development:
- Is your health system experiencing problems from a lack of hospital capacity?
- Does your health system have established home health-care delivery capabilities?
- Do you have physicians with the interest and ability to care for patients in the home environment?
- Does your health system experience a large volume of Medicare admissions for common problems such as community-acquired pneumonia, heart failure, or chronic pulmonary disease (COPD)?
- Does your institution view itself as an innovator in developing and implementing new models or systems of care?
- Can your health system align payment, providers, and the hospital to develop [a Hospital at Home service]?
Monday, July 9, 2018
CareTech in talks with Cambrian Group on being acquired
CareTech Holdings PLC (AIM: CTH), a pioneering provider of specialist social care services in the UK, notes the announcement released today by Cambian Group PLC (‘Cambian’) in response to media speculation regarding a possible offer for Cambian by CareTech.
CareTech confirms that it is in discussions with the board of directors of Cambian regarding a possible offer for Cambian to be satisfied by a combination of CareTech shares and a cash consideration funded through new debt facilities.
This announcement does not constitute a firm intention to make an offer under Rule 2.7 of the Code and there can be no certainty that any firm offer will be made or on what terms it would occur.
A further announcement will be made as and when appropriate.
Committed to the highest standards of care and care governance, CareTech provides its innovative care pathways through five divisions covering adult learning disabilities, specialist services, young people residential services, foster care and learning services which come under the two outcome-based sectors of Adult Services and Young People Services.
CareTech, which was founded in 1993, began trading on the AIM market of the London Stock Exchange in October 2005 under the ticker symbol AIM: CTH. Its property portfolio comprises more than 200 properties.
MediciNova details trial of med for ALS
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced clinical data from ad-hoc subgroup analyses of MediciNova’s completed clinical trial of MN-166 (ibudilast) in ALS (amyotrophic lateral sclerosis), which was conducted at Carolinas HealthCare System’s Neuromuscular/ALS-MDA Center at Carolinas HealthCare System Neurosciences Institute.
The ad-hoc subgroup analyses include data from (1) the “Early ALS subgroup” which is 31 subjects who had either bulbar onset or upper limb onset out of a total of 49 subjects without non-invasive ventilation in the full analysis set and (2) the “Early ALS + NIV subgroup” which is 39 subjects who had either bulbar onset or upper limb onset out of a total of 67 subjects with and without non-invasive ventilation in the full analysis set. The full analysis set includes all randomized subjects who received at least 14 days of study drug and had at least one post-dose efficacy measurement. The subgroup analyses were completed for the ALSFRS-R total score, the ALSAQ-5 score, and the Manual Muscle Test. A responder was defined as a subject who did not worsen on the score (i.e., the subject improved on the score or had no change on the score) at the end of the 6-month double-blind period. Results of the subgroup analyses are as follows:
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Total Score
ALSFRS-R, which includes 12 questions that can have a score of 0 to 4, measures functional activity and has been useful in diagnosing and measuring disease progression.
Early ALS subgroup
- There was a higher percentage of responders in the MN-166 (ibudilast) group compared to the placebo group. 30.0% (6/20) of subjects in the MN-166 (ibudilast) group were responders on the ALSFRS-R total score compared to 9.1% (1/11) of subjects in the placebo group.
- There was a higher percentage of subjects who improved in the MN-166 (ibudilast) group compared to the placebo group. 25.0% (5/20) of subjects in the MN-166 (ibudilast) group improved on the ALSFRS-R total score compared to 0.0% (0/11) of subjects in the placebo group at the end of the 6-month double-blind period.
Early ALS + NIV subgroup
- There was a higher percentage of responders in the MN-166 (ibudilast) group compared to the placebo group. 26.9% (7/26) of subjects in the MN-166 (ibudilast) group were responders on the ALSFRS-R total score compared to 7.7% (1/13) of subjects in the placebo group.
- There was a higher percentage of subjects who improved in the MN-166 (ibudilast) group compared to the placebo group. 23.1% (6/26) of subjects in the MN-166 (ibudilast) group improved on the ALSFRS-R total score compared to 0.0% (0/13) of subjects in the placebo group at the end of the 6-month double-blind period.
| ALSFRS-R Total Score | MN-166 + riluzole | Placebo + riluzole | p value | |
| Early ALS subgroup | Responder | 30.0% (6/20) | 9.1% (1/11) | p=0.1916 |
| Improver | 25.0% (5/20) | 0.0% (0/11) | p=0.0912 | |
| Early ALS + NIV subgroup | Responder | 26.9% (7/26) | 7.7% (1/13) | p=0.1644 |
| Improver | 23.1% (6/26) | 0.0% (0/13) | p=0.0706 | |
Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5) Score
ALSAQ-5 measures the physical mobility, activities of daily living and independence, eating and drinking, communication, and emotional functioning.
Early ALS subgroup
- There was a higher percentage of responders in the MN-166 (ibudilast) group compared to the placebo group. 60.0% (12/20) of subjects in the MN-166 (ibudilast) group were responders on the ALSAQ-5 score compared to 9.1% (1/11) of subjects in the placebo group (p=0.0071).
Early ALS + NIV subgroup
- There was a higher percentage of responders in the MN-166 (ibudilast) group compared to the placebo group. 50.0% (13/26) of subjects in the MN-166 (ibudilast) group were responders on the ALSAQ-5 score compared to 23.1% (3/13) of subjects in the placebo group.
| ALSAQ-5 Score Responder | MN-166 + riluzole | Placebo + riluzole | p value |
| Early ALS subgroup | 60.0% (12/20) | 9.1% (1/11) | p=0.0071 |
| Early ALS + NIV subgroup | 50.0% (13/26) | 23.1% (3/13) | p=0.1017 |
Manual Muscle Testing (MMT)
MMT measures the muscle strength of an ALS subject.
Early ALS subgroup
- There was a higher percentage of responders in the MN-166 (ibudilast) group compared to the placebo group. 35.0% (7/20) of subjects in the MN-166 (ibudilast) group were responders on the MMT score compared to 18.2% (2/11) of subjects in the placebo group.
Early ALS + NIV subgroup
- There was a higher percentage of responders in the MN-166 (ibudilast) group compared to the placebo group. 34.6% (9/26) of subjects in the MN-166 (ibudilast) group were responders on the MMT score compared to 23.1% (3/13) of subjects in the placebo group.
| MMT Score Responder | MN-166 + riluzole | Placebo + riluzole | p value |
| Early ALS subgroup | 35.0% (7/20) | 18.2% (2/11) | p=0.2866 |
| Early ALS + NIV subgroup | 34.6% (9/26) | 23.1% (3/13) | p=0.3626 |
MediciNova has requested a meeting with the FDA to discuss the study design for the next ALS trial.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, “We are very pleased with the results of these new analyses which indicate that MN-166 could improve outcomes in this devastating and fatal disease. We believe this is a direct result of MN-166’s mechanism of enhancing the production of neurotrophic factors including nerve growth factor. We look forward to meeting with the FDA.”
About the ALS Trial
MediciNova, in collaboration with Dr. Benjamin Rix Brooks, Director, Carolinas Neuromuscular/ALS-MDA Center at Carolinas HealthCare System Neurosciences Institute, evaluated 60 mg of MN-166 (ibudilast) per day in early and advanced stage ALS patients. All subjects in the study received 100 mg of riluzole per day. This trial was a randomized, double-blind, placebo-controlled study which included a six-month treatment period followed by a six-month open-label extension. The primary endpoint was safety and tolerability and the study also evaluated several efficacy endpoints including functional activity (ALSFRS-R). Data analyzed from the 51 early ALS subjects (the intent-to-treat/ITT population) was presented at the 28th International Symposium on ALS/MND in Boston, MA in December 2017. There was a higher percentage of responders on the ALSFRS-R total score, MMT (manual muscle testing) and ALSAQ-5 score (subjective quality-of-life questionnaire) in the MN-166 (ibudilast) group compared to the placebo group. This was the first study of MN-166 (ibudilast) in ALS and the study provides the necessary clinical data for powering assumptions for the next study of MN-166 (ibudilast) in ALS.
About ALS
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. The nerves lose the ability to trigger specific muscles, which causes the muscles to become weak. As a result, ALS affects voluntary movement and patients in the later stages of the disease may become completely paralyzed. Life expectancy of an ALS patient is usually 2-5 years. According to the ALS Association, there are approximately 20,000 ALS patients in the U.S. and approximately 6,000 people in the U.S. are diagnosed with ALS each year.
About MN-166 (ibudilast)
MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova is developing MN-166 for progressive multiple sclerosis (MS) and other neurological conditions such as ALS and substance abuse/addiction. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glia cells, which play a major role in certain neurological conditions. Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in neurodegenerative diseases (e.g., progressive MS and ALS), substance abuse/addiction and chronic neuropathic pain. MediciNova has a portfolio of patents which cover the use of MN-166 (ibudilast) to treat various diseases including progressive MS, ALS, and drug addiction.
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