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Wednesday, March 6, 2019

Statins linked to higher diabetes risk

Individuals who take cholesterol-lowering statins may be at higher risk for developing high blood sugar levels, insulin resistance, and eventually type 2 diabetes, according to an analysis published in the British Journal of Clinical Pharmacology.
The analysis examined information from 9,535 individuals older than 45 years of age who were free from diabetes at the start of the population-based Rotterdam Study and were followed up to 15 years.
Compared with participants who never used statins, those who used statins tended to have higher concentrations of serum fasting insulin and . Participants who ever used statins had a 38 percent higher risk of developing type 2 diabetes during the study. This risk was more prominent in individuals with impaired glucose balance and in overweight/.
“The findings suggest that in patients who initiate statin therapy, preventive strategies such as blood sugar control and may be warranted for minimizing the risk of diabetes,” said senior author Prof. Bruno Stricker, of the Erasmus Medical Centre, in the Netherlands.

Explore further

More information: Fariba Ahmadizar et al, Associations of statin use with glycaemic traits and incident type 2 diabetes, British Journal of Clinical Pharmacology (2019). DOI: 10.1111/bcp.13898

Why Blues, Health Care Service Corp. are teaming up to deliver food

The Health Care Service Corporation (HCSC) and Blue Cross Blue Shield (BCBS) Institute have teamed up to bring healthy food delivery options to those living in food deserts.
The partnership has debuted foodQ, which offers affordable meals delivered to a participant’s home. The program aims to improve health outcomes for people with chronic conditions, particularly those conditions which are diet related.
Ultimately, the partnership signifies the growing trend of prevention being initiated by insurance companies and other payers in an effort to reduce emergency room visits, hospital admissions and costs.
“Currently, no state in the country has less than a 20% obesity prevalence rate and we know that the lack of adequate access to nutritious meals may accelerate the complications of diabetes and hypertension,” Trent Haywood, M.D., president of the Blue Cross Blue Shield Institute, told FierceHealthcare.

Program development

FoodQ was originally developed through the BCBS Institute, the company’s experimental arm aimed at addressing the social and environmental conditions affecting 60% of health outcomes. These “Affordability Cures,” as BCBS refers to them, are the company’s commitment to long-term solutions that address the root of expensive healthcare services by investing in social preventions.
“Like other offerings by the BCBS Institute, the intent is to align business practices in a model that achieves viability and sustainability without the need for continuous grants from philanthropic organizations,” Haywood said.
The program will pilot in 25 Chicago ZIP codes followed by 15 Dallas ZIP codes, all of which are consumer coverage locations for HCSC. All people living in these ZIP codes qualify, regardless of their health insurance carrier.
“We used our Community Health Management Hub to identify the neighborhoods in Chicago with the least access to fresh, nutritious food and subsequent overutilization of emergency room and avoidable hospital visits,” Haywood added.
According to a study published in the Culture of Health in April 2018, meal delivery can reduce the cost of healthcare in dual beneficiaries of Medicare and Medicaid. According to the study, participants who participated in a meal delivery service had fewer emergency department visits, both for medically tailored and nontailored food programs. Participants in medically tailored delivery programs also had fewer inpatient admissions.
“While further, preferably randomized, evaluations are needed, this study suggests that meal delivery may be an important way to improve the health of vulnerable patients,” the study concluded.

Being a part of the solution

While BCBS and HCSC are some of the first healthcare companies to get involved with food delivery, fresh, prepared meals could become a new track for several companies and payers in 2019.
Manika Turnbull, vice president and community health and economic impact officer at HCSC, said that the ultimate goal of foodQ is to offer consumers access to affordable, healthy foods to help improve their health outcomes, particularly for diet-related, chronic conditions.
“HCSC and the BCBS Institute are working diligently to address the gaps and fragmentation in the healthcare system that often increase cost and prevent people from being healthy and at their best,” Turnbull told FierceHealthcare. “One of the areas that is widely known is nutrition, specifically for people living in food deserts that lack adequate access to fresh foods that make up a healthy diet.”
HCSC is committed to developing long-term solutions that address the root causes of expensive healthcare, which more and more point toward the social determinants of health. One of the main social determinants in 2019 is the prevalence of diet-related chronic conditions, including diabetes and obesity, which are highly influenced by a consumer’s neighborhood.
Research from the National Academy of Sciences revealed that medical care accounts for between 10% and 20% of health outcomes, with the remaining percentages attributed to environmental and socioeconomic factors—social determinants of health.

For example, in New Jersey, Horizon Blue Cross Blue Shield linked up with RWJBarnabas Health (RWJBH) in 2017 to meet the needs of a community with a high emergency room admittance rate in the state. By combining Horizon analytics with knowledgeable practitioners in the community, Horizon and RWJBH have seen a 25% drop in care costs for this population, a 24% reduction in ER visits and a 35% increase in behavioral health visits.

Costs versus results

When debating where to pilot the program, the BCBS Institute used its Community Health Management Hub to identify the specific ZIP codes in Chicago and Dallas with the least access to fresh, nutritious food.
The foodQ program is open to all consumers, including those using Medicaid, regardless of health insurance status or insurance carrier. HCSC and the BCBS Institute hope to see tangible results in the Chicago and Dallas neighborhoods. Throughout the pilot, consumers will be asked to complete a survey to provide the program with tangible data.
The pilot is set for six months and began in February in Chicago, followed by Dallas in April. The evaluation will consider potential expansion into the delivery of meal kits so that consumers can prepare meals in their homes.
So, what are the costs for consumers?
The foodQ program costs $10 per meal, with an additional $6 fee per delivery. People have an option of a monthly subscription for $10, which negates the $6 delivery cost. The monthly subscription also includes a buy-one-get-one option, allowing users to purchase a meal for $10 and receive a second meal for free. Each user can order up to 20 meals per week and a monthly subscriber can order up to 10 meals per week (with the buy-one, get-one option this equates to receiving up to 20 meals per week).
“Food choices available to these communities often consist of calorie-dense meals that may be perceived as more ‘value’ per dollar spent when compared to healthy meal options available at higher price points,” said Haywood. “Our market research helped us identify a $10 price point.”
To order, participants go to the foodqhub website and enter their ZIP code, which determines if they are eligible for the service. Once eligibility is verified, participants enter their payment information, select their meal choice, then choose a date and time for meal delivery. Participants will then receive a text message confirming the order as well as notifications as to when the order is on its way and has been delivered.
Food options include five meal categories: beef, chicken, fish, pork and vegetarian. HCSC and the BCBS Institute collaborated with Kitchfix and Front Porch Pantry in Chicago and Dallas, respectively, to develop the menu. Kitchfix and Front Porch Pantry will be responsible for cooking the meals and delivering them to users’ homes.
“Kitchfix is proud to partner with BCBSI to bring nutritious meals to food deserts in Chicago via foodQ,” Eva Lindpaintner, director of meals delivered at Kitchfix, told FierceHealthcare. “We know that diet is major determinant of health, and believe that improving access to fresh foods will have wide-ranging positive impacts for individuals and communities.”
The success of the pilot will be determined by three factors:
  • Ability to demonstrate that people in eligible communities have pent-up demand for access to healthy nutrition options if given access at an affordable price.
  • Ability to demonstrate the sustainability and scalability of the service delivery infrastructure.
  • Assessment of the correlation of nutritional consumption with healthcare utilization patterns.
Haywood believes this program is being introduced at the perfect time because overcoming barriers that limit access to healthy food will continue to grow as a priority for U.S. healthcare in 2019. Plus, online food delivery services in the U.S. are estimated to grow an additional $6 billion in the next five years from $17 billion to $23 billion.
Not to mention, this is the natural progression of healthcare prevention that moves away from the clinical setting and into the community setting.
“This transition means that food and fitness will become an integral component of how we evaluate holistic approaches to population health,” Haywood added.

Azar: HHS rethinks payments to expand access to transplants, in-home dialysis

The Trump administration is considering ways it can adjust payments to boost access to in-home dialysis and kidney transplants.
Department of Health and Human Services Secretary Alex Azar said Monday in a speech at the National Kidney Foundation’s Kidney Patient Advocate Summit that kidney care is a service line that’s ready for a value-based payment shake-up.
Kidney care has “some of the worst incentives in healthcare,” he said.
“Today, Medicare covers most patients with kidney failure, but we don’t begin spending a great deal on these patients until they’re already sick,” Azar said. “It is the epitome of a system that pays for sickness rather than health and this administration is intent on shifting these priorities.”
Azar said HHS is focusing in three areas to reform kidney care including investing more in prevention and detection, expanding treatment options, including the latest technology and making more organs—including artificial ones—available for transplantation.
Kidney care accounts for a significant portion of Medicare spending, Azar said. Medicare spent $79 billion in 2016 on people with kidney disease and $34 billion on people with end-stage renal disease, for a total of $113 billion—the equivalent of more than one in five dollars spent in the program.
Outcomes still lag, too, he said, despite all of that spending. One hundred thousand Americans begin dialysis treatment annually, and a quarter are likely to die within the same year. In addition, there are more than 100,000 people on the transplant list awaiting a kidney transplant.
To boost prevention and early detection, Azar said HHS intends to invest more in research to expand personalized care options within kidney care and find new avenues to identify kidney disease sooner.
For example, the National Institutes of Health will begin enrollment in a study on the APOL 1 gene, variants of which are common in black patients and are linked to kidney disease. Patients with this gene may be less likely to have a successful transplant, Azar said.
A cornerstone of expanding access to alternatives to clinical dialysis is growing the reach of in-home care options, Azar said. In the U.S., about 88% of dialysis patients begin treatments in a center, even though in-home hemodialysis or peritoneal dialysis may be more comfortable and less expensive.
The health system incentivizes the use of clinic dialysis centers because it’s easier for those providers to care for multiple patients simultaneously in one facility compared to traveling to different homes to treat them, Azar said. In addition, federal payers may be underpaying for alternatives, making them less attractive.
“That isn’t providing the care patients deserve, and we have the power within HHS to test out significant payment changes to boost home dialysis,” Azar said.
Finally, HHS researchers are doing more to prevent viable organs from going to waste, he said. The agency intends to submit evidence on improved testing for hepatitis A, B and C, and HIV, which could grow the pool of organs available for transplantation.
HHS is also exploring payment mechanisms that can make it easier for people to be living kidney donors. The Health Resources and Services Administration is offering funding opportunities to cover travel costs and repay donors’ lost wages.
Finally, the agency is growing access to new technology through its KidneyX innovation accelerator. Azar said KidneyX closed its first round of submissions last week, and it has received 165 proposals on ways to rethink dialysis care.
Several of these proposals include research on developing artificial kidneys, which could provide another avenue for transplantation.
“We’re thrilled with this level of interest, and it shows what a prize competition can drive in an otherwise neglected investment space,” Azar said.

Surgical infection biotech PolyPid officially withdraws $75 million IPO

PolyPid, which is developing extended-release drugs to prevent surgical site infections, officially withdrew its plans for an initial public offering on Tuesday, after postponing the deal in March 2018. It had filed to raise $75 million by offering 3.3 million shares at a price range of $21 to $24.
The Petach Tikva, Israel-based company was founded in 2008 and had planned to list on the Nasdaq under the symbol POLY. Goldman Sachs, Cowen and Cantor Fitzgerald were set to be the joint bookrunners on the deal.
https://www.renaissancecapital.com/IPO-Center/News/62075/Surgical-infection-biotech-PolyPid-officially-withdraws-$75-million-IPO

IQVIA debuts research platform to de-ID links between genomic and clinical data

IQVIA has launched a new de-identification platform aimed at real-world genomic research and protecting patient privacy.
The company is pitching its new E360 Genomics offering as a scalable genotypic-phenotypic database that assists researchers working with various genomic and clinical outcome data sets.
The platform allows life science customers to aggregate data to conduct various research projects, including association studies of genomics and observable traits, as well as comparative safety and efficacy trials. It can also securely track burden-of-illness and perform discovery analytics using de-identified data, according to the company.
E360 Genomics replaces sensitive data with symbols that represent critical information, without identifying the patient. By removing identifying and phenotypic information from the patient data—while maintaining links between genomic data and clinical outcomes—IQVIA says it can provide more flexible and less expensive approaches to drug discovery and development work.
Late last year, IQVIA began collaborating with Genomics England on a platform connecting clinical results with de-identified genomics data, to help generate evidence for drug research and personalized medicine. It works alongside a new long-term cancer strategy for the NHS, focused on improving early diagnoses.
The project employs IQVIA’s broader E360 platform to help researchers create custom data sets linking clinical and genomic information, and analyze the relationship between genes and observable traits—beginning with patients with rare diseases and their families, as well as those with common cancers.

2 months after BMS merger, Celgene’s JAK inhibitor to get priority review

Bristol-Myers Squibb splashed into 2019, announcing its $74 billion megamerger with Celgene. At the time, CEO Giovanni Caforio, M.D., expressed his excitement about the “doubling” of BMS’ pipeline and the momentum the deal would bring. Now, the FDA has granted Celgene’s JAK inhibitor, fedratinib, priority review, with a PDUFA date of Sept. 3.
Fedratinib is just one of several late-stage programs that BMS will pick up in the acquisition; the others include a CAR-T treatment for multiple myeloma, ozanimod to treat multiple sclerosis and luspatercept for beta thalassemia. The deal gives BMS the opportunity for six near-term product launches, Caforio said on a conference call with analysts after the announcement, as well as a wide-ranging early- and midstage pipeline.
Celgene is developing fedratinib for the treatment of myelofibrosis, a rare disorder in which the bone marrow is replaced with scar tissue and cannot produce enough blood cells. Fedratinib found its way to Celgene through a $1 billion acquisition unveiled a year earlier: The Big Biotech kicked offJ.P. Morgan 2018 with its $1.1 billion buyout of Impact Biomedicines. The JAK2 inhibitor, a Sanofi castoff, has gone through many hands, having been developed at TargeGen before its acquisition by Sanofi, then on to Impact and Celgene before it settles at BMS. Sanofi halted the program after the FDA placed a clinical hold on it in 2013.
The NDA for fedratinib is based on a pair of trials testing the drug in patients with primary or secondary myelofibrosis—a randomized, placebo-controlled, phase 3 study and the single-arm, open-label, phase 2 trial in patients who had previously been treated with Jakafi (ruxolitinib), the only FDA-approved treatment for the disease. Celgene also wants to test fedratinib in combination with luspatercept, which is in development for beta thalassemia and myelodysplastic syndromes, in addition to myelofibrosis.

Several players have been working on JAK inhibitors as a treatment for cancer, inflammatory disease and autoimmune disease. Novartis’ Jakafi is approved for myelofibrosis and the slow-growing blood cancer Polycythemia vera, while Pfizer’s Xeljanz (tofacitinib) and Eli Lilly’s Olumiant (baricitinib) are both approved for rheumatoid arthritis.

However, there is still room for improvement in the arthritis space, as both Xeljanz and Olumiant are saddled with black-box safety warnings. Gilead and Galapagos’ phase 3 filgotinib could quickly catch up and overtake its competitors. In the meantime, some big names are trying to make JAK inhibitors work in other diseases: Genentech is working on a JAK1 inhibitor for the localized treatment of asthma and Janssen partnered with Theravance last February to develop a JAK inhibitor for inflammatory bowel disease.

Tuesday, March 5, 2019

After November rollout, GW Pharma says Epidiolex positioned for strong growth

GW Pharmaceuticals may be the first drugmaker to roll out a cannabis-based drug in the U.S., but it’s unlikely to be the last—and that’s why so many are keeping an eye on GW’s Epidiolex launch.
So far, so good, executives and analysts said when GW rolled out its fourth quarter results last week. Between Epidiolex’s launch in November and year’s end, the drug managed to bring in $4.7 million—not a huge haul, but respectable for a new drug in a new category.
For the rollout, the company staffed up with 66 sales reps to target 5,000 potential prescribers, and more than 500 of them have now written scripts for their patients. About 4,500 new patient enrollment forms were submitted by the end of the year, GW executives said during the fourth-quarter earnings call.
The drug appears to be gathering some momentum, too: Script numbers jumped by 150% from December to January, they said.
Epidiolex won FDA approval last June to treat seizures from Lennox-Gastaut syndrome or Dravet syndrome, but couldn’t launch until after the DEA officially rescheduled it out of the illegal-drug category.
GW execs said sales should keep ramping up as Epidiolex scores more payer coverage and expands distribution, and as early access patients move into commercial sales. Plus, current patients should move up to higher doses, which will boost sales by itself. and the company is still working to expand its distribution network.
Next, the company is aiming to expand Epidiolex’s reach into tuberous sclerosis complex and Rett syndrome, CEO Justin Gover said during the call. And it’s looking forward to expanding geographically with a European launch.
Overall, Evercore ISI analyst Josh Schimmer wrote that it’s still early days, but signals so far “are very strong and should propel growth.” GW’s shares jumped 14% on last Tuesday after the update.