Oct - Dec, 2016
Trump Proposes to Lower Drug Prices by Basing Them on Other Countries’ Costs
In a speech at the U.S. Department of Health and Human Services on October 25, President Trump proposed that the prices Medicare pays for certain prescription drugs be based on prices in other industrial countries. If carried out, the proposal would be phased in under the Center for Medicare and Medicaid Innovation created by the Affordable Care Act, from 2020 to 2025. The new drug-pricing plan comes after the recent release of a government study arguing that Medicare pays 80 percent more than other advanced industrial countries for 27 of the most expensive, physician-administered medicines. With growing expenditure costs under Part B of Medicare, the administration projects savings of $17.2 billion for American taxpayers and patients over the five years. The demonstration project would cover half the country, and marks a shift from Trump’s campaign promise of the federal negotiation of drug prices to basing prices on negotiations in other countries. https://nyti.ms/2JfXjXn
F.D.A. Approves Powerful New Opioid Despite Warnings of Likely Abuse
AcelRx Pharmaceuticals drug Dsuvia, the tablet form of sufentanil, received FDA approval on November 2. Sufentanil is a synthetic opioid utilized intravenously and in epidurals; it is also 10 times more potent than fentanyl, a parent drug that has caused tens of thousands of overdose deaths in the past few years. Dsuvia’s approval comes weeks after Dr. Raeford Brown—the chairman of the advisory committee tasked with reviewing the drug—publicly implored the agency to reject it as it is likely to be abused. The advisory committee ultimately recommended the drug in a 10-3 vote last month, without Dr. Brown’s attendance. After final approval, FDA commissioner Dr. Scott Gottlieb stated that Dsuvia will only be available in “prefilled, single-dose applicators” and not for home use or at retail pharmacies. AcelRX plans to follow the risk evaluation and mitigation strategy approved for the drug, which will likely hit the market in early 2019.
FDA unveils sweeping anti-tobacco effort to reduce underage vaping and smoking
On November 15, the U.S. Food and Drug Administration announced that it will limit sales of flavored e-cigarettes and plans to ban menthol cigarettes and flavored cigars. The affected e-cigarette flavors are those in fruity, sweet and creamy flavors that appeal to or are marketed to underage users, and intentionally exclude mint, menthol and tobacco. Under the new plan, these flavored products will only be available in stores with age-restricted entry or areas that are inaccessible to consumers under 18. The agency will also require stricter methods of age verification online, reflecting concerns that increased adolescent e-cigarette use could lead to surges in early nicotine addiction and subsequent use of regular cigarettes. The FDA’s proposal to ban menthol and flavored cigars is more significant, and will require new regulations that could take years to enact if not overturned by the cigarette industry. https://www.washingtonpost.com/health/2018/11/15/fda-unveils-sweeping-anti-tobacco-effort-reduce-underage-vapingsmoking/?tid=ss_mail&utm_term=.f0734fc6fc46
Amgen Slashes the Price of a Promising Cholesterol Drug
In hopes of increasing sales, Amgen lowered the list price of its anti-cholesterol drug Repatha from $14,000 a year to $5,850 a year on October 25. Repatha is one of two PCSK9 inhibitors that came to market in 2015 but has been reluctantly covered by insurers in favor of cheaper statins. Its competitor Praluent—sold by Regeneron and Sanofi—lowered its net price in May to revive sales, and although Amgen has been offering deeper insurer discounts, these discounts have been largely unavailable for Medicare beneficiaries, who account for about 40 percent of Repatha prescriptions. Amgen will continue to offer Repatha under the higher list price to insurers who prefer such rebates until 2020. The price cut comes during a time when the Trump administration has aggressively focused on lowering drug costs, but it remains unclear whether Amgen’s decision signals a major shift in the industry.
Cancer Society Executive Resigns Amid Upset Over Corporate Partnerships
The American Cancer Society’s Executive Vice President and Chief Medical and Scientific Officer Dr. Otis W. Brawley resigned in early November after 11 years at his post. Although Dr. Brawley stated he was unable to disclose the terms of his departure, his resignation is largely attributed to concern over the organization’s commercial partnerships. The 105-year-old organization has recently been subject to increased criticism regarding its fundraising partnerships, which include supplements company Herbalife International and Long John Silver’s, a fast food chain known for fried fish. Due to changing donation patterns and decreasing fundraising income, the cancer society has been working to diversify its revenue portfolio, which historically relied on walks such as Relay for Life. Dr. Brawley’s leave comes during a time when patient advocacy and other health groups are increasingly sourcing funding from businesses with questionable health credentials and even colliding interests . https://nyti.ms/2yOCxdm
Alphabet stops its project to create a glucose-measuring contact lens for diabetes patients
On November 16, Alphabet Inc.’s life sciences organization Verily—previously known as Google Life Sciences—announced that it will be shelving its program on glucose-sensing contact lens in favor of other eye-related projects. First introduced in 2014, the “smart lens” project partnered with Novartis’ eye-care arm Alcon to measure blood sugar levels in tears through sensors on contact lenses, in efforts to create a less invasive method for diabetics to track glucose levels. Verily stated that due to insufficiently consistent data to support its proposed medical device, it will be moving on to lenses for age-related farsightedness and improving sight after cataract surgery. The research arm also emphasized its continued commitment to projects in the diabetes space, noting its ongoing partnerships with Dexcom and Onduo, its joint venture with Sanofi.
Obamacare early enrollment rate drops in first sign-up season since GOP changes
According to the U.S. Centers for Medicare and Medicaid Services, sign-ups for Obamacare on HealthCare.gov decreased by 20.4 percent in the first two weeks of the 2018 enrollment season compared to last year. Enrollment has been receiving increased attention as 2019 will be the first year since 2013 in which the Affordable Care Act’s individual mandate tax penalty—which was repealed by Congress in December 2017—will not be imposed. The Trump administration’s decision to increase the terms of short-term health plans from three months to up to 12 months, in addition to allowing for two renewals, is also expected to depress enrollment for 2019. The first two weeks of open enrollment saw more than 901,300 existing Obamacare customers renewing their coverage and 274,913 new consumers for a total of 1,176,232 insured.
U.K. to Allow Prescriptions for Medicinal Cannabis
U.K. Home Secretary Sajid Javid announced on October 11 that doctors in England, Wales, and Scotland will be permitted to legally prescribe medicinal cannabis starting on November 1. The new policy allows senior clinicians and specialist doctors, but not general practice doctors, to prescribe marijuana-based treatments to patients on a case-by-case basis, or “when the patient has an unmet special clinical need that cannot be met by licensed products.” The Home Office’s decision follows the cases of two children with epilepsy treatments dependent on cannabis-based medicine that were highly publicized in the British media. The subsequent public pressure led to a review of marijuana-based medicinal products that began in July. The legalization of cannabis for medical use does not indicate a shift toward legalizing recreational cannabis-derived products.
CVS Health and Aetna $69 Billion Merger Is Approved With Conditions
On October 10, the U.S. Justice Department granted preliminary approval for the $69 billion merger between CVS Health and Aetna, weeks after Aetna’s conditional selling of its private Medicare Part D drug plan business to WellCare Health Plans to address federal concerns about market share. The CVS-Aetna deal marks a shift toward the integration of pharmacy benefit managers with the rest of the drug prescription pipeline, and is expected to help tighten cost controls. The merger, which combines CVS’s 10,000 pharmacies and 1,100 retail clinics with Aetna’s 22 million customers, continues to elicit concerns over the potential control of consumer choice and increases in the cost of drugs that are likely to occur as an insurer gains control over the retail component to delivering care. The combined companies will keep CVS Health’s Larry J. Merlo as chief executive, while Aetna’s CEO Mark T. Bertolini will step down to join the new board.
Pfizer to Raise Prices on 41 Drugs in January
On November 16, Pfizer Inc. announced plans to raise list prices for 41 of its prescription drugs early next year. The price increases will affect 10% of the drugmaker’s portfolio and accompanies price increases by other pharmaceutical companies such as Bristol-Myers Squibb Co. and Allergan PLC. Although Pfizer has regularly increased prices over the years to help boost revenues, the latest announcement follows increasing scrutiny of drug pricing and pressure to lower costs by both the public and the Trump administration, which heavily criticized the decision. In July, Pfizer temporarily reversed more than 40 price increases of 9.4% after presidential rebuke. The new changes, which do not affect recently approved drugs and sterile injectables, will mostly be of 5%. Pfizer also plans to increase discounts and rebates accordingly, and does not expect the price adjustments to lead to additional revenue growth.
2018 Nobel Prize in Medicine Awarded to 2 Cancer Immunotherapy Researchers
The 2018 Nobel Prize in Physiology or Medicine was awarded to Dr. James P. Allison of the United States and Dr. Tasuku Honjo of Japan for their work on immunotherapy, or utilizing the body’s immune system to recognize and attack cancer cells. Working separately in the 1990s, Dr. Allison and Dr. Honjo demonstrated that certain proteins—checkpoints—could shut down T-cells and thus limit the immune system’s ability to fight cancer. Dr. Allison identified a checkpoint called CTLA-4, and Dr. Honjo found PD-1. The resulting class of new drugs known as checkpoint inhibitors provided treatment options for patients who had run out of conventional possibilities, and checkpoint inhibitors are now used for a number of cancers, including of the lung, kidney, bladder, head and neck, aggressive skin cancer melanoma, and Hodgkin lymphoma. In the future, Dr. Allison and Dr. Honjo plan to continue to search for ways to best combine checkpoint inhibitors and integrate them into other treatments to fight cancer.
Shingles Vaccine Shortages Result From High Demand
GlaxoSmithKline’s Shingrix—a shingles vaccine approved last year—has experienced uptake so strong that increased demand has led to production shortages. The vaccine is recommended for most adults over the age of 50, when the illness is most likely to develop, and two Shingrix injections, two to six months apart, have been shown to be about 90 percent effective at preventing shingles and the nerve complications that may follow the viral infection. The popularity of the vaccine was unanticipated, and GlaxoSmithKline has announced its increase and expedition of shipments. With many patients unable to receive their second shot within the recommended six-month time frame, after which overall immune response varies individually, the Centers for Disease Control and Prevention has advised providers to give preference to patient seeking their second dose.
Syphilis Rises Sharply Among Newborns
According to the U.S. Centers for Disease Control and Prevention, the rate of infants born with syphilis has more than doubled in the past four years to reach a 20-year high. The recent rise in congenital syphilis, passed from the mother to the baby through the placenta, accompanies a significant increase in adult infections. Syphilis can lead to miscarriage and stillbirth, in addition to a variety of infant health problems such as deformities, seizures, anemia and jaundice. The disease, which was reported to be on the brink of elimination in 2000, has experienced a resurgence in the past few years, with the number of adult cases growing every year since 2013. Although congenital syphilis can be inexpensively treated with penicillin, rates of the disease remain high, especially in communities in Louisiana, Nevada, California, Texas and Florida.
Venezuela’s Health Crisis Is Crossing the Border
The ongoing five-year-old meltdown of Venezuela’s economy has led to the swift collapse of its health system, forcing millions out of the country in search of medical assistance in addition to financial and political stability. Venezuelan refugees have carried, and continue to carry, disease into neighboring countries such as Brazil, Colombia, Peru, and even Argentina. Once Latin America’s richest country and leader in disease prevention, Venezuela has transformed into an incubator for measles, malaria, yellow fever, diphtheria, dengue, tuberculosis, and the virus that causes AIDS. With the government’s insistence that the deterioration of public health care— hospitals are unable to provide basic services or medicine—is simply a conspiracy theory, doctors who have spoken out have been fired or threatened with arrest. As the Venezuelan government continues to ignore the state of public health care, neighboring countries project increases in both refugees and disease.
Sloan Kettering Researchers Correct the Record by Revealing Company Ties
Following the September resignation of Dr. José Baselga, the Memorial Sloan Kettering Cancer Center’s chief medical officer, senior researchers at the center have filed corrections with medical journals that illuminate undisclosed financial relationships with healthcare companies. Dr. Baselga was heavily criticized after failing to report his corporate ties and stakes—including payments amounting to millions of dollars—in a number of medical journal articles. In October, the hospital’s chief executive Dr. Craig B. Thompson resigned from the boards of Merck and Charles River Laboratories after disclosing his various company relationships. Other researchers who have newly listed affiliations include Drs. Jedd Wolchok, Matthew D. Hellmann, Taha Merghoub, Michael A. Postow, and Michelle Bradbury. Public scrutiny of the nonprofit cancer center continues as it instructs its researchers to review and revise conflict-of-interest disclosures, undertakes a review of staff and industry interactions and policies, and hires a law firm to investigate specific allegations.
F.D.A. Approves New Drug for Flu
Antiviral Xofluza (baloxavir marboxil) received U.S. FDA approval on October 24, becoming the first new flu drug to win FDA approval in 20 years. The new drug is a $150 single dose treatment developed and discovered by Shionogi & Co., Ltd. and sold by Genentech in the U.S., who will offer coupons to lower the price to $30 for patients with health insurance and $90 for the uninsured. After two clinical trials, Xofluza received approval for patients aged 12 or more, and introduces a new way to combat flu strains through the inhibition of cap-dependent endonuclease, an enzyme necessary for viral replication. The drug is expected to work as well as popular anti-flu drug Tamiflu (oseltamivir), which is sold by Genentech’s parent company Roche, and against resistant strains such as the A strains of H5N1 and A H7N9.
Australia’s Sonic Healthcare to Buy U.S.-Based Aurora Diagnostics for $540 Million
Australian pathology and radiology group Sonic Healthcare Ltd (SHL.AX) said on Wednesday it had agreed to buy Florida-based Aurora Diagnostics LLC ADI.UL for $540 million. The acquisition of Aurora is expected to be about three percent EPS accretive post-placement on a pro-forma FY2019 basis before expected revenue and cost synergies, Sonic said in a statement. The acquisition, Sonic said, would help it “substantially grow” its operations in the United States. Sonic also announced a fully underwritten institutional placement to raise A$600 million ($431.88 million) and a non-underwritten share purchase plan to retail shareholders in Australia and New Zealand to raise up to A$100 million. https://www.reuters.com/article/us-aurora-m-a-sonic-healthcare/australias-sonic-healthcare-to-buy-u-s-based-auroradiagnostics-for-540-million-idUSKBN1OA2JG
Scientists to Test Tailor-Made Vaccine Tech to Fight Epidemics
A global coalition set up to fight disease epidemics is investing up to $8.4 million to develop a synthetic vaccine system that could be tailor-made to fight multiple pathogens such as flu, Ebola, Marburg and Rabies. The deal, between the Coalition for Epidemic Preparedness Innovations (CEPI) and a team of scientists at Britain’s Imperial College London is aimed at progressing a “vaccine platform” which uses synthetic self-amplifying RNA (saRNA). A vaccine platform is a system that uses the same basic components as a backbone or framework, and can be adapted to immunise against different diseases by inserting new genetic sequences from, for example, the flu or Marburg or rabies virus.
Roche’s Lung Cancer Combo Treatment Wins FDA Approval
Swiss drug maker Roche Holding AG said on Thursday that its Tecentriq immunotherapy in combination with Avastin and chemotherapy won U.S. Food and Drug Administration approval as a first-line treatment for a type of lung cancer. The drug on Wednesday had also won priority review from the U.S. regulator for treating patients with untreated extensive-stage small cell lung cancer. Tecentriq is already approved in the United States to treat certain types of lung cancers, as well as a type of bladder and urinary tract cancer.