New VA rules reignite privatization debate

• The Department of Veterans Affairs proposed new standards to make it easier for veterans to seek care outside the VA. The changes, due to take effect in June, include dropping the wait time requirement from 30 days to 20 days for primary and mental care and 28 days for specialties.
• Changes also include shifting one requirement from driving distance (40 miles) to driving time (30 minutes). For specialty care, the VA is proposing a 60-minute average drive time standard.
• The proposals come several years after the agency got a black eye in a scandal showing officials falsified data on patient wait times and amid fears the Trump administration wants to privatize the agency.

The measures are part of the agency’s implementation of last year’s MISSION Act, which critics say marked another step toward privatizing the VA. The right leaning Koch brothers helped fund these efforts, but most veterans’ groups oppose them. That’s in large part because, in many cases, VA care is exceptionally good — if exceptionally slow.

Veterans who rely most on VA care tend to be younger, poorer and live in rural areas, a 2016 RAND report found, while only 25% of veterans live within an hour of a VA medical facility.

Veterans’ groups held their fire for now while they study the new rules. Still, Rory Riley, a consultant for veterans organizations such as the National Organization of Veterans’ Advocates, called the new access standards a “step in the right direction.”

Changing the driving distance standard to drive time, for example, makes the standards better align with TRICARE. In all, Riley told Healthcare Dive, the VA proposed standards are similar to TRICARE’s existing standards for TRICARE Prime, which many veterans are already familiar with.

“TRICARE hasn’t been ‘privatized’ despite using very similar access standards and utilizing a mix of DoD and community providers. A good policy choice, as opposed to a political one, is integrating the best of both government and community care,” Riley said. “I’m the first one to criticize VA when I think they’ve done something that is misguided, but I actually think these standards are a good faith effort to implement the MISSION Act, which the VA is legally required to comply with.”

Other changes include the ability to access urgent care, as long as the provider is in the VA’s community care network — though they may be charged a copayment.

Leadership at the VA has been in turmoil in recent years, with the fired VA Secretary David Shulkin, warning in a New York Times op-ed days after his ousting that the private sector is “ill-prepared” to handle veterans, “particularly when it involves the mental health needs of people scarred by the horrors of war.”

Current VA Secretary Robert Wilkie tried to get an edge on critics who may lambast the access standards for enabling privatization.

“Although these new standards represent an important win for America’s Veterans, they will not be without controversy,” the secretary said. “Some will claim falsely and predictably that they represent a first step toward privatizing the department.”

He cited recent studies from Rand, Dartmouth and JAMA that show the VA is outperforming the private sector in quality and customer service.

A 2014 Congressional Budget Office report showed 70% of veterans enrolled in the VA’s system already receive most of their care in the private sector.

https://www.healthcaredive.com/news/new-va-rules-reignite-privatization-debate/547247/

Inspire Medical announces positive coverage policy by BCBSNC

Inspire Medical Systems announced that Blue Cross Blue Shield of North Carolina, or BCBSNC, has issued a positive coverage policy of Inspire therapy. This is the third coverage policy issued by a Blue Cross Blue Shield Association healthcare plan following BCBSA Evidence Street’s January 7 report, which stated that there is sufficient evidence to determine that Inspire therapy results in a meaningful improvement in net health outcomes for patients meeting specified criteria. BCBSNC, an independent licensee of BCBSA, is the state of North Carolina’s largest insurer and covers approximately 3.9M members.
https://thefly.com/landingPageNews.php?id=2857263

Brookfield Business Partners to acquire Healthscope for approximately $4.1B

Brookfield Business Partners, together with institutional partners, is pleased to announce that it has reached an agreement to acquire up to 100% of Healthscope Limited for approximately $4.1B. Healthscope is the second largest private hospital operator in Australia and the largest pathology services provider in New Zealand. The transaction will be funded with up to $1B of equity, $1.4B of long-term financing and $1.7B from the sale and long-term leaseback of 22 wholly-owned freehold hospital properties. Brookfield Business Partners expects to fund approximately one third of the equity, with the balance being funded by institutional partners. Prior to or following closing, a portion of Brookfield Business Partners’ commitment may be syndicated to other institutional investors. Closing of the transaction remains subject to necessary shareholder and court approvals, as well as customary closing conditions including, among others, regulatory approvals. Closing is expected to occur in the second quarter of 2019.
https://thefly.com/landingPageNews.php?id=2857353

Dynamic aspirin: Molecular vibrations drive electrons over large distances

Aspirin is not only an important drug but also an interesting physics model system in which molecular vibrations and electrons are coupled in a particular way. For the first time, x-ray experiments in the ultrashort time domain make electron motions visible in real time. They demonstrate that very small atomic displacements shift electrons over much larger distances within the aspirin molecules.

Aspirin pills consist of many small crystallites in which molecules of acetylsalicylic acid form a regular spatial arrangement. The molecules couple to each other via comparably weak interactions and generate electric fields which exert a force on the electrons of every molecule. Upon excitation of molecular vibrations, the distribution of electrons in space and, thus, the chemical properties should change. While this scenario has been a subject of theoretical work, there has been no experimental demonstration and understanding of the molecular dynamics so far.

Scientists of the Max Born Institute in Berlin, Germany, have now gained the first and direct insight in electrons motions during a coupled vibration of the aspirin molecules. In a recent issue of the journal Structural Dynamics [6,014503 (2019)], they report results of an x-ray experiment in the ultrashort time domain. An ultrashort optical pump pulse induces vibrations of the aspirin molecules with a vibrational period of approximately 1 picosecond (ps, a millionth of a millionth of a second). An ultrashort hard x-ray pulse, which is delayed relative to the pump pulse, is diffracted from the excited powder of crystallites to map the momentary spatial arrangement of electrons via an x-ray diffraction pattern.

The rotational motion of the methyl (CH3) group of an aspirin molecule arises upon vibrational excitation. In the animation, the atomic displacements are artificially enlarged to make them visible. The methyl rotation is connected with a spatial shift of electrons over the entire aspirin molecule (yellow clouds, so-called isosurface of constant electron density). The periodic electron motions occur in time with the vibrational motions of the atoms and the distances traveled by the electrons are typically 10000 times larger than the atom displacements in the methyl rotation. This behavior demonstrates the hybrid character of the methyl rotation which is comprised of both atomic and electron motions on totally different length scales. The hybrid character originates from the electric interaction between the aspirin molecules and the dynamic minimization of electrostatic energy in the crystallite.

These new results underline the central role of hybrid modes for the stabilization of the crystal structure, in agreement with theoretical calculations. In the case of aspirin, this property favors the so-called form 1 of the crystal structure compared to other molecular arrangements. The strong modulation of the electron distribution by vibrations is relevant for numerous crystal structures in which electric interactions prevail. Vibrational excitations of ferroelectric materials should allow for an ultrafast switching of the macroscopic electric polarization and, thus, lead to new electronic devices for extremely high frequencies.

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Story Source:

Materials provided by Forschungsverbund Berlin. Note: Content may be edited for style and length.

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Journal Reference:

1. Christoph Hauf, Antonio-Andres Hernandez Salvador, Marcel Holtz, Michael Woerner, Thomas Elsaesser. Phonon driven charge dynamics in polycrystalline acetylsalicylic acid mapped by ultrafast x-ray diffraction. Structural Dynamics, 2019; 6 (1): 014503 DOI: 10.1063/1.5079229

https://www.sciencedaily.com/releases/2019/01/190131113816.htm

Incyte 1st Patient Treated in Phase 3 Graft-Versus-Host Disease Trial

Incyte Corporation(Nasdaq:INCY) announced that the first patient has been treated in GRAVITAS-309, a pivotal Phase 3 trial for the first-line treatment of patients with chronic graft-versus-host disease (GVHD). The trial will evaluate the efficacy and safety of itacitinib, Incyte’s novel and selective JAK1 inhibitor, in combination with corticosteroids compared to corticosteroids alone as a first-line treatment for moderate or severe chronic GVHD (see also Incyte Corporation).

“Given the severity of chronic GVHD, we are pleased to announce the initiation of treatment for the first patient in the GRAVITAS-309 trial, as it represents a critical next step in our comprehensive development program aiming to bring important treatment options to market that address the significant unmet needs of GVHD patients across the spectrum of the disease,” said Steven Stein, M.D., Chief Medical Officer, Incyte.

GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor), where the donated cells initiate an immune response and attack the transplant recipients organs, leading to significant morbidity and mortality. There are two forms of GVHD, acute and chronic, which can affect multiple organ systems including the skin, gastrointestinal (digestive) tract and liver.

https://www.marketscreener.com/INCYTE-CORPORATION-9675/news/Incyte-Announces-First-Patient-Treated-in-Phase-3-Clinical-Trial-of-Itacitinib-for-Chronic-Graft-V-27946030/

Oxycodone Market Seen Up on Chronic Disease, Trauma Condition Growth

Expanding at a rather modest annual growth rate of 4.6 percent, the global market for oxycodone is projected to reach a revenue of US$ 4 Billion in 2028—showcasing an absolute dollar opportunity of US$ 181.3 Mn, through 2018-2019. Future Market Insights, in its recent analysis of the global oxycodone market, elaborates on the key market dynamics, opportunity assessment, and regional and competitive landscape analysis, for a period spanning 2018 to 2028.

With nearly 10-fold increase in the use of opioids since its inception, the oxycodone contributes to one of the largest revenue generator in the overall pharmaceutical landscape. Intensifying sales of oxycodone can be attributed to:

Increasing patent expirations for branded products and much lesser new product launches, translating into increased consumption of generics—that contribute to the maximum revenue of the global oxycodone market, thereby, fueling the net sales.

Growing number of cancer treatments, which in turn, increases the demand for supportive care medications for pain management. Increased prescriptions of oxycodone and Hydrocodone for treating cancer pain, will remain the largest contributor to the sales growth of the aforementioned medication.

“In terms of demand, high efficiency of synthetic and semi-synthetic opioids increase its use. In addition, Opioids prescription is highly regulated by a set of clinical practice guidelines, while ensuring safe access and proper dosage. Opioids are covered under such stringent regulations translates into increased consumption. Rising awareness about palliative care in terminal disease conditions combined with favorable reimbursement policies are some additional demand-side factors, augmenting the consumption of opioids”, projects a senior analyst at FMI

Elaborating further, the analyst explains that palliative care programs in US—which includes palliative care consultation teams and dedicated in-patient palliative care units—are delivered in accordance with the government and commercial reimbursement policies, further boosting the oxycodone market in the region. In addition to palliative programs, increased prescription in de-addiction programs, is well contributing to the demand of de-addiction opiates.

Innovative Drug Formulations Pushing Oxycodone Global Sales

In the in-depth analysis of the oxycodone market, FMI underlines the introduction of innovative opiate drugs, currently occupying a lion’s share. Innovations in formulations—not necessarily targeted at drug efficacy— is a critical supply-side driver in the global oxycodone market. Abuse-deterrent formulations in Oxycontin, by Purdue Pharma is one such example. Moreover, Purdue has been granted exclusive selling rights for Oxycontin till 2030, after it made formulations changes to the drug’s chemical structure, thereby marketing it as an ‘abuse-proof’, slow-releasing pill. In addition, FDA’s nod to new generation drugs, making them ‘less-addictive’, will gain prominence through 2028. Drug advancements in extended-release medications for pain control, would supplement to the sales of oxycodone, globally. This scenario is expected to create favorable adoption opportunities for long-standing oxycodone, notes FMI in its report titled “Oxycodone Market Global Industry Analysis 2013-2017 and Opportunity Assessment 2018-2028”.

Opportunity Analysis of Oxycodone Market Reveals Lucrative Growth Prospects

• In terms of business expansion opportunities, strategic investments, licensing agreements, and acquisitions hold significant potential.
• Apart from the above mentioned, investments in research and development activities would present potential growth opportunities for oxycodone manufacturers.
• Increasing strategic collaborations between manufacturers and generic drugs distributors operating in the pain management business, will prove critical to forward expansion plans.
• As demand for oxycodone remains uniform across patients of all age groups, opioids are expected to offer effective drug formulations and enhanced solubility of API, further prompting manufactures to capitalize on the emerging latent opportunity.
• Rising prevalence of chronic diseases in humans and increasing demand for parenteral formulations around the world, particularly in North American countries, will supplement to the growth of oxycodone market in the region.

https://www.biospace.com/article/oxycodone-market-increasing-prevalence-of-chronic-diseases-and-trauma-conditions-likely-to-boost-industry-growth/

Corcept sees Q4 revenue below consensus

On a preliminary basis, Corcept Therapeutics (NASDAQ:CORT) expects a 25% jump in Q4 revenue to $66.8M, below consensus of $70.4M.

2018 revenue will be up 58% to $251.2M, also shy of consensus of $254.8M.

2019 guidance: Revenue: $285M – 315M.

https://seekingalpha.com/news/3428424-corcept-sees-q4-revenue-consensus-shares-3-percent-hours