August 17, 2018

3D Bioprinter Produces Skin for Tranplants

3D Bioprinter Prints Functional Human Skin Adequate for Transplant

3dprintedskin-frankmagliochetti-healthcareinnovationA team of researchers in Spain reports the development of a new three-dimensional (3D) printer capable of printing human skin suitable for transplant into patients. The printed skin is also suitable for testing drugs and cosmetics.

The team included several groups of researchers, including a group from the Universidad Carlos III de Madrid (UC3M) in Spain. The researchers describe their breakthrough in the scientific journal, Biofabrication.

3D Printing and Skin Production

3D printing has been around since the 1980s, when Charles (Chuck) Hull introduced the first stereolithography apparatus (SLA), but the 3D printing industry is now experience rapid growth with applications in many fields. In medicine, 3D printing holds great promise in someday giving clinicians the ability to produce personalized, complex human tissues and organs on demand. One woman has already received a 3D printed ear from one company, for example, while another frankmagliochettireport-3d-bioprintercompany provides 3D printed implants that the recipient’s body converts to bone.

Three-dimensional printing of human body parts is challenging in a number of ways. Replicating the complexity of anatomical structures is difficult. Ensuring the printed tissue survive transplantation in a living body is another problem.

The scientists in Spain have already engineered plasma-based, two-layered skin used successfully in the treatment of burns and other wounds in a large number of patients. The primary drawback to this method is that it takes 3 weeks to produce enough skin to cover an extensive burn or large wound. Another disadvantage is that the scientists must perform much of the process manually.

3D printing is similar to a desktop computer printer except that the nozzle on the 3D printer exudes biological components rather than ink. These biological components, or bio-inks, are essential to successful 3D printing of human organs and tissues.

To aid in the process, a computer controls the nozzles and flow of biological components so that the nozzles deposit the bio-inks on precise locations on the print bed.

Prints large area of skin in 35 minutes

The authors of the study describe how their 3D printing method generated a 100 x 100 centimeter area of skin in just under 35 minutes.

Like the scientists’ existing plasma-based manual method of producing skin, the 3D printing technology generates two layers of skin – the epidermis and the dermis. The printer starts by producing the epidermis, including the protective outermost layer of keratinized cells, known as the stratum corneum. Next, it prints the thicker, deeper dermis, complete with collagen-producing frank-magliochetti_bioprinter-skinfibroblasts.

The new 3D printing method is faster, but still complex. One of the authors of the report, Juan Francisco del Cañizo of the Hospital General Universitario Gregorio Marañón and Universidad Complutense de Madrid, notes:

“Knowing how to mix the biological components, in what conditions to work with them so that the cells don’t deteriorate, and how to correctly deposit the product is critical to the system.”

The research team tested the printed skin in test tubes and in immunodeficient mice. Transplantation of the printed skin into the mice helped the scientists test the long-term effects in a living animal. In both tests, the 3D printed skin was very similar to human skin and indistinguishable from the manually produced bi-layered skin from plasma.

There are two main potential uses for this 3D skin – to produce skin for research and laboratory testing of drugs and cosmetics, and to produce person-specific skin from the patient’s own cells to treat burns and other wounds. The research team is also investigating ways to use the technology to print other human tissues.

Source

http://iopscience.iop.org/article/10.1088/1758-5090/9/1/015006/meta

Frank Magliochetti is Managing Partner for Parcae Capital

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release new sites dedicated to the industry. Frank currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Rising Drug Costs: Trending 2017

2017 Trends: Rising Drug Costs

The cost of prescription drugs has been rising rapidly since 2010, and will likely continue to rise in 2017.

Frank Magliochetti

The largest drug maker in the United States, Pfizer Inc., raised prices on 133 of its U.S. brand name products in 2015. More than three-quarters of the increases were 10 percent or more. Daraprim, the antiparasitic commonly used to treat toxoplasmosis, went from $13.50 to $750 per pill overnight in September of 2015. The price of Epipens skyrocketed 500 percent, rising from $97 in 2007 to $600 in 2016 for a two-pack set of the emergency treatment for anaphylaxis.

The total net spending on prescription drugs has grown to $309.5 billion annually, according to IMS Health, including discounts, within the past year. This makes prescription drugs the fastest growing segment of the nation’s healthcare economy. At 12.2 percent, 2014 spending on drugs dwarfs the overall frank-magliochetti-2017-medical-trendsgrowth rate of healthcare spending and the rate of spending growth on physician and hospital care. The price of drugs, rather than utilization, is the predominant driving factor in this increased drug spending.

Spending on drugs rose 8.5 percent in 2015 but total prescriptions dispensed increased by a mere 1 percent. The pharmaceutical price inflation was 7.2 percent in 2015, according to the Bureau of Labor Statistics (BLS) Producer Price Index (PPI), significantly outpacing both general inflation and medical inflation at 0.7 percent and 2.7 percent, respectively.

2017 Trends towards Higher Prices

2017 will probably see more increases in drug prices, and the rises costs will likely have a significant effect on consumers and healthcare providers. Price hikes will likely affect employees and young retirees in 2017. The results of Segal’s 2017 Health Plan Cost Trend Survey suggest prescription drug costs will rise 11.6 percent in 2017 for active employees and retirees under the age of 65, on top of 11.3 percent in 2016.

That is a huge leap for most Americans. More than 48 percent of all people living in the U.S. reportcdc-frankmagliochettireport taking at least one prescription drug in the previous month, according to statistics provided by the Centers for Disease Control and Prevention (CDC), and more than 20 percent of Americans use three or more prescription medications. Health plan cost trends have slowed, according to the Segal survey, but they continue to outpace average wage increases and inflation by more than three time.

Patients carry an increasingly heavy financial burden when it comes to drug costs, and so do hospitals faced with difficult decisions regarding the allocation of scarce resources. Inpatient drug spending rose 23.4 percent on average, according to a report by theAmerican Hospital Association (AHA), and 38.6 percent per individual hospital admission. The report details the experience of one hospital that reported that last year’s price increases for just four common drugs were equivalent to the annual salaries of 55 full-time nurses there. Drug prices will likely continue to rise in unpredictable ways while reimbursement amounts from payors will probably increase only a small amount. Hospitals will continue the struggle of balancing resources in response to changes in the drug market.

The rise in specialty drug/biotech medications will be especially high in 2017 at 18.7 percent. While specialty drugs make up less than 1 percent of all medications, the 100 insurance providers responding to the Segal’s survey said that specialty drugs now account for 35 percent of total projected prescription drug cost increases for the next year.

Source

http://www.bloomberg.com/news/articles/2015-10-02/pfizer-raised-prices-on-133-drugs-this-year-and-it-s-not-alone

http://www.imshealth.com/en/about-us/news/ims-health-study-us-drug-spending-growth-reaches-8.5-percent-in-2015

http://www.bls.gov/ppi/ppidr201512.pdf

https://www.segalco.com/media/2716/me-trend-survey-2017.pdf

http://www.aha.org/content/16/aha-fah-rx-report.pdf

http://www.cdc.gov/nchs/fastats/drug-use-therapeutic.htm

 

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release new sites dedicated to the industry  – .  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Top Prescription Drugs Purchases and Trends of 2016

Top Prescription Drugs Purchases and Trends of 2016

Nearly half of all Americans take at least one prescription drug each day, according to the Centers for Disease Control and Prevention (CDC), and the cost of many of the most popular and most important medications is rising.
risingprescriptioncosts_frankmagliochettiThe Price for Prescription Drugs is Rising
Each of the past three years have seen double-digit price increases, including average rises of 12.6 percent in 2014 and over 10 percent in 2015. The average price for prescription drugs has increased an average of 10 percent in the past year. Despite pushback from insurers, scrutiny from lawmakers and outcry from consumers, many pharmaceutical companies plan to increase the price of prescription drugs.
Prescription drug spending in the United States totaled about $457 billion in 2015, according to the U.S. Department of Health and Human Services (HHS), accounting for 16.7 percent of all U.S. health care spending. In the 1990s, only about 7 percent of health care spending went towards prescription drugs.
A Wall Street Journal analysis found that prices for 30 prescription drugs increased at eight times the rate of inflation, with an average price hike of 76 percent from 2010 to 2014. Retail prices for some commonly used prescription drugs increased faster than general inflation each year from 2006 to 2013, according to AARP, which translates into an annual cost of therapy of more than $11,000 for a consumer who takes a prescription medication regularly. The total was nearly three-quarters of the average Social Security retirement benefit of $15,526, almost half the median income of a person on Medicare, and nearly one-fifth of the median U.S. household income.
Most Common Prescriptions and Average Cost by State
SearchRx compiled a list of the average costs of prescription drugs by state. At an average price of $12.82 per prescription, Mississippi tops the list as the US state with the lowest average per prescription cost. Arkansas was also low at $12.93, followed by Virginia at $13.90 and Louisiana at $13.10. Hawaii was the most expensive state to fill a prescription, at an average of $19.47, followed by North Dakota at $19.07, Alaska at $18.96 per prescription, and Delaware at $18.51.

The website also lists the most commonly prescribed medications last year:
1. Atorvastatin Calcium (generic for Lipitor) – lowers cholesterol and reduces risk of heart attack, stroke, and other complications in patients with type 2 diabetes, coronary heart disease, or other risk factors
2. Levothyroxine (generic for Synthroid) – primary use is for the treatment of hypothyroidism but it is also used to treat or prevent goiter
3. Lisinopril (generic for Prinivil) – for hypertension or congestive heart failure
4. Omeprazole (generic for Prilosec) – treats symptoms of GERD
5. Metformin (generic for Glucophage) – improves blood sugar in patients with type 2 diabetes
6. Amlodipine (generic for Norvasc) – for hypertension or anginafrank-magliochetti-report-drug-pricing
7. Simvastatin (generic for Zocor) – lowers cholesterol and triglycerides
8. Hydrocodone/Acetaminophen (generic for Lortab) – relieves moderate to moderately severe pain
9. Metoprolol ER (generic for Toprol XL) – treats angina and hypertension
10. Losartan (generic for Cozaar) – treats hypertension and reduces the risk of stroke in those with heart disease
SearchRx also ranked pharmacy chains in order of least expensive to most expensive. Walmart was the least expensive, followed by Target, “other,” Rite Aid, and CVS. Walgreens was the most expensive on the list.
If current trends continue, 2017 will see higher prescription prices, increased health premiums, and continued increases in the number of Americans who take prescription drugs every day.
Source
http://www.cdc.gov/nchs/fastats/drug-use-therapeutic.htm

https://www.washingtonpost.com/news/to-your-health/wp/2016/01/11/prescription-drug-prices-jumped-more-than-10-percent-in-2015/

http://time.com/money/4406167/prescription-drug-prices-increase-why/

https://aspe.hhs.gov/pdf-report/observations-trends-prescription-drug-spending

http://www.wsj.com/articles/for-prescription-drug-makers-price-increases-drive-revenue-1444096750

http://www.aarp.org/content/dam/aarp/ppi/2016-02/RX-Price-Watch-Trends-in-Retail-Prices-Prescription-Drugs-Widely-Used-by-Older-Americans.pdf

https://www.searchrx.com/blog/2016-prescription-prices-and-purchase-trends/

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Tdap Lead to Increased Trend in HPV Vaccines

Requiring Tdap May Increase HPV Vaccination in Adolescent Girls

About 9 in 10 people will get a human papillomavirus (HPV) infection at some point in their lives, according to the Centers for Disease Control and Prevention (CDC). HPV infections are associated with health problems, including several types of cancer in men and women, which means HPV infection is an urgent health problem. A new study shows that teenage girls were more likely to start the HPV vaccine series in states where schools required the meningococcal vaccine and/or the tetanus, diphtheria, and pertussis (Tdap) booster prior to admission.
frankmagliochetti_tdap-vaccineNationwide, 63 percent of girls have received at least one dose of the vaccine, and half of all boys have started the series. Low HPV vaccination coverage is an urgent public health problem and improving HPV vaccination rates will save lives. The nation’s high Tdap vaccination rate of 86 percent shows that high HPV vaccination coverage is possible.
Most cervical cancers, anal carcinomas, and oropharyngeal cancers are the result of infection with high-risk HPV strains. While vaccines capable of preventing HPV related cancers are available, low usage limits their utility.
Previous attempts at improving HPV vaccination included state laws requiring the vaccine, but many of these laws allowed for exemptions for any reason. Because parents could opt out for nearly any reason, these state laws have been largely ineffective at increasing HPV vaccination coverage.
Improving HPV Vaccination Coverage by Vaccinating Against Other Diseases
To identify policies that could improve suboptimal HPV vaccination rates, the authors of the study sought to evaluate the relationship between adolescent vaccination and states’ school entry requirements. In the study, published in the medical journal Pediatrics, researchers compared HPV vaccination coverage in teenage girls aged 13 to 17 years across states with different vaccination requirements for school entry.
The authors gathered information from published data regarding school entry requirements from the Immunization Action Coalition (2007-2012) and vaccination rates from the National Immunization Survey-Teen (NIS-Teen, 2008-2012). They analyzed Tdap booster and meningococcal vaccination rates and evaluated the possibility of increasing HPV vaccination rates by “spillover effect,” meaning schools that require vaccinations as a condition of attendance could have higher rates of HPV vaccination.

The Results

The researchers found that requiring vaccination for admission to school did indeed improve vaccination rates for HPV. Vaccination requirements also boostedfrankmagliochettireport__hpv_vaccine coverage for Tdap and meningococcal vaccinations.
Compared with other states, those states with Tdap booster and meningococcal vaccination had a 22 and 24 percentage point increases in coverage for these vaccines, respectively. States with HPV vaccination requirements had less than 1 percentage point increase in coverage. Requiring Tdap booster and meningococcal vaccinations caused an 8 and 4 percentage point spillover increases for HPV vaccination coverage.
The study was limited in that it failed to account for confounding variables, such as religion, ethnicity, and parental education. Furthermore, the study did not account for the types of school attended, as homeschooled adolescents and teens attending private schools may not be subject to the same vaccination requirements. Despite these limitations and considering the controversy surrounding HPV legislation, utilizing the spillover effect from meningococcal and Tdap vaccination may be an effective approach to improving HPV vaccination coverage.

SOURCE:

http://www.cdc.gov/vaccinesafety/vaccines/hpv-vaccine.html

http://pediatrics.aappublications.org/content/early/2016/11/05/peds.2016-1414?sso=1&sso_redirect_count=1&nfstatus=401&nftoken=00000000-0000-0000-0000-000000000000&nfstatusdescription=ERROR%3a+No+local+token

http://www.cdc.gov/hpv/infographics/vacc-coverage.html

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Pharmaceutical Trends for 2017: Biosimilars

Pharma Trends 2017:  Biosimilars

Frank Magliochetti Report

The FDA approved 56 new drugs in 2015 and, of these, 33 were specialty drugs and 23 were traditional. One was a biosimilar. Development, approval and acceptance of biosimilars may become an important trend in 2017.
The FDA is approving more specialty drugs than ever before and specialty medicines will likely face more competition in 2017. Increased FDA approval and frankmagliochetti-report-pharma-trends-biosimilarsdiscoveries of medications to treat orphan conditions and cancer will fuel competition. Biosimilars could overcome development hurdles and increase this competition even more.
Acceptance of biosimilars has been slow in the past. One of the reasons for the reluctance is that the development of biosimilars is different from that of generic drugs. Generic drugs for small molecules have a relative simple chemical structure that makes it easy to reproduce an identical chemical. It is more difficult to make a protein or peptide identical to the original biologic agent because of differences in the sugar residues attached to the protein, for example, or differences in the protein folding that make it unpredictable. This means that, even though a biosimilar has an identical peptide chain, it may not have an identical effect. These factors complicate the process of making biosimilars and increase the risk for problems.
Physician acceptance has been slow too but, as the cost of other medications rise, biosimilars will seem more attractive.
Approval of Biosimilars in 2015 and 2016
Biosimilars, which are products the FDA will approve with evidence that the medication up for approval is highly similar to an already-approved reference product, will probably continue to gain traction in 2017. The FDA has approved four biosimilars as of October 2016.
Zarxio is similar to Neupogen, according to an article published by Managed Healthcare Executive, except the biosimilar has a 15 percent lower list price. Both drugs treat low white blood cell counts associated with cancer and its treatment. The FDA approvedZarxio, made by Sandoz, in March 2015.
Inflectra is similar to Remicade to treat Crohn’s disease and ulcerative colitis. The FDA approved Inflectra in April 2016 but, due to litigation, the launch date is uncertain.
Erelzi, also made by Sandoz, is similar to Enbrel to treat arthritis. The FDA announced approval of Erelzi in August of 2016 and the expected launch date of biosimilar-frankmagliochetti-pharma-trends-2017February 2017 may be delayed.
Amjevita, by Amgen is similar to Humira and is for the treatment multiple inflammatory diseases. Amjevita became the fourth biosimilar drug to gain approval in September 2016. Launch date is set for March 2017 but may experience delays.
There are several biosimilars awaiting approval, including:
• Filgrastim by Grastofil, Apotex
• Pegfilgrastim by Apotex
• SB2 infliximab by Merck/Samsung Bioepis
• CHS‐1701 by Coherus Biosciences
• Epoetin alfa by Retacrit, Pfizer
The need for biosimilars will grow as the need for other drugs, especially cancer drugs and orphan drugs, increases. Doctors diagnose about 1.7 million cases of cancer each year, yet the death rate has fallen 23 percent since the early 1990s, partially due to new medications and treatments. The introduction of biosimilars could reduce cancer death rates even further.
Biosimilars may become one of the strongest trends in the pharmaceutical industry in upcoming years, as biosimilars have the potential to lower the cost for safe and effective treatments for a wider number of patients. Increased development of biosimilar cancer drugs is possible as some biopharmaceuticals lose patent protection.

Source
https://www.uspharmacist.com/article/record-number-of-fda-new-drug-approvals-in-2015
http://www.zarxio.com/index.jsp
http://managedhealthcareexecutive.modernmedicine.com/managed-healthcare-executive/news/five-specialty-pharmaceutical-trends-watch
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm
http://www.erelzi.com/
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm
http://pi.amgen.com/united_states/AMJEVITA/AMJEVITA_mg.pdf
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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CDC Warns Against Using Nasal Spray Flu Vaccine

CDC Recommends Not Using Nasal Spray Flu Vaccine for 2016/2017 Season

Frank Magliochetti Report

The Centers for Disease Control and Prevention (CDC) has issued its 2016-2017 influenza vaccination recommendations, which includes the use of inactivated influenza vaccine (IIV) and the recombinant influenza vaccine (RIV). One of the most notable changes to the yearly recommendations is that the CDC is not recommending the use of nasal spray flu vaccinations using live attenuated frankmagliochetti-report_flu-shot-vaccineinfluenza vaccine (LAIV) during 2016-2017, as studies show it is not effective against preventing the flu.
The studies show LAIV had no protective benefit from children ages 2 to 17. In contrast, children who received an injection were 63 percent less likely to catch influenza than are those who received no vaccination at all.
While researchers have not yet determined the underlying cause of the loss of efficacy, but it could be due to changes in the dominant viral strains circulating in the nation during flu season. LAIV worked just as well as the shot at protecting children from H3N3 and the influenza B strain in recent flu seasons, according to a study published in the journal Pediatrics, but youngsters who received LAIV were three times more likely to suffer infection with H1N1 than were children who got the shot.
H1N1 has been the dominant strain for the past few years, according to a February 2016 CDC report, which means LAIVs can leave patients unprotected from the strains most likely to cause illness this flu season.

About Vaccinations, LAIVs, and Flu Season

Influenza vaccinations protect millions of people in the United States from developing influenza each year. Flu shots also reduce severity of influenza symptoms when it does develop, and prevents cdc-frankmagliochettireporthospitalizations relating to the flu. CDC recommends yearly flu shots for everyone 6 months and older. Antibodies typically take about two weeks to develop.
Many patients, and parents of pediatric patients, prefer LAIVs because of the perceived pain or trauma of an injection. LAIVs have been under development in the United States since the 1960s, according to the CDC, and the intranasal, trivalent, cold-adapted, live, LAIV received approval in 2003 as an option for among health patients aged 5 to 49 years. Because the nasal spray contains live, weakened influenza viruses, LAIV theoretically stimulates a stronger immune response than the shots, which contain killed viruses.
Influenza activity often begins to increase in October and peak sometime in late winter or early spring. The peak week of flu activity for the 2015-2016 season occurred on the last week of March 2016,

according to the CDC, which was one of the later season peaks on record. The CDC’s adjusted overall vaccine effectiveness (VE) against influenza A and B viruses for all ages was 47 percent, while the overall VE against A(H1N1)pdm09 was 41 percent and the overall VE against influenza B was 55 percent.

Vaccine manufacturers will provide an estimated 157 to 168 million doses of injectable influenza vaccine for the U.S. market. This is on par with last year’s vaccine distribution.

Source
https://www.cdc.gov/mmwr/volumes/65/rr/rr6505a1.htm?s_cid=rr6505a1_w

http://pediatrics.aappublications.org/content/early/2016/01/04/peds.2015-3279?sso=1&sso_redirect_count=1&nfstatus=401&nftoken=00000000-0000-0000-0000000000000000&nfstatusdescription=ERROR%3a+No+local+token

https://emergency.cdc.gov/han/han00387.asp

https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5213a1.htm

http://www.cdc.gov/flu/about/season/flu-season-2015-2016.htm

https://www.cdc.gov/flu/professionals/vaccination/vaccinesupply.htm

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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2017 – Year of Equilibrium for Medical Costs  

Medical Costs

Frank Magliochetti Report

PwC calls 2017 the “year of equilibrium for medical costs” in its recent publication, Medical Cost Trend: Behind the Numbers 2017. Authors of the PwC report expect growth rate for 2017 to remain unchanged at apricewaterhousecoopers_frankmagliochettireport 6.5 percent.

There are two main components of healthcare costs:

  • Unit price of services
  • Utilization, which is the volume and intensity of use of those services

Identifying trends in both unit price and utilization elucidates changes in overall spending. In other words, trends in unit prices and utilization provide a clear picture of whether costs are rising or falling, or if consumers are using more or fewer specific services and products.

Price, rather than utilization, had historically been the primary force behind medical cost trends. In the early 2000s, utilization grew to become on par with price as a major contributor to healthcare trend growth. Retail clinics and urgent care centers have made it more convenient for consumers to receive healthcare, and this convenience led to higher utilization. Greater utilization often results in reduced spending later down the road, especially if consumers use these clinics for preventive screening and for treatment of minor conditions before they become serious problems, but these savings may not reduce the short-term costs of higher utilization.

Recently, however, the price trend grew while the utilization trend declined. This decline in utilization shifts the focus back on the price trend, and does it in a frankmagliochettireport-health_costs-trends-2017way that may affect utilization.

Trends in 2017

PwC predicts mainstream attention and regulatory recognition will cause behavioral health, once largely ignored as a necessary health treatment, to become a crucial part of employer health benefits. The organization also expects slower cost growth among specialty drugs for the first time in several years.

PwC expects employers to consider new benefit strategies, especially those that focus on leveraging high-performing networks with lower costs and higher quality.

At 30 percent from hospital inpatient and 19 percent from hospital outpatient, about half of employer health costs currently come from hospital spending, but costs for prescription drug care will probably see modest cost increases in 2017. Political pressure will likely suppress some of the largest drug cost increases. Furthermore, PwC predicts pharmacy benefit managers will adopt new and more aggressive strategies, which will likely contribute to deflation in the medical cost trend.

What the Trends Mean for Businesses

Always looking for new ways to reduce costs, employers will likely focus less on cost sharing and more on sharing new provider networks. They may realign cost sharing for ambulatory services, for example, evaluate current arrangements made by pharmacy benefit managers, or explore high-performance networkmedicalcoststrends_frankmagliochettireport arrangements.

Faced with competition from new sites of care, healthcare providers who want to grow their market share may consider consolidations or affiliations with other health systems. They may create new partnerships with insurers, provide a more convenient healthcare experience to consumers, or collaborate with pharmacy benefits managers.

Insurers may find it challenging to keep premiums low and control costs in 2017. Transforming business models and encouraging patients to visit lower-cost, high quality providers may help.

In all PwC predicts medical costs will continue to rise in 2017 at the same rate as they did in 2016. The authors of the study predict larger increases in the future.

Source

http://www.pwc.com/us/en/health-industries/health-research-institute/behind-the-numbers.html

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Combating Antibiotic Resistant Bacteria:

How the Fight is Progressing in 2016  

Frank Magliochetti Report

Bacteria that are resistant to common antibiotics have been around for some time. Unfortunately, they have frankmagliochetti_antibodiesbecome more widespread and more deadly than they were in times past. Following are some new major developments that may result in mankind either succumbing to antibiotic resistant bacteria or overcoming it altogether.

 

A New Danger

The civil war in Syria has nearly completely destroyed vital medical infrastructure. Thousands of doctors, nurses, medics, paramedics and other medical professionals have either been killed or have fled the country. Medical equipment is in short supply and operations are commonly conducted in caves or poorly lit basements. However, the war has brought about so many cases of antibiotic resistant bacteria that Newsweek has openly questioned whether or not the war may in fact spell the end of antibiotics altogether.

The root cause for this high level of antibiotic resistant bacteria are common the world over. Syrians, like many people around the world, used antibiotics far too freely in the past. However, the ongoing war has resulted in serious bacterial infections not seen outside of war zones. What is more, as Syrians travel in search of safety and shelter, the infections could potentially spread to others. Jordan, aware of the serious dangers that these infections may pose, has wisely implemented tight new controls on the use of Colistin to ensure that it is seldom used and thus remains effective against bacterial infections.

Another altogether different danger comes from the fact that a growing number of diseases are now becomingfrankmagliochettireport_worldhealthorganization more resistant to antibiotics than ever before. As the World Health Organization recently reported, cases of antibiotic resistant chlamydia, gonorrhea and syphilis are on the rise around the world. This has led the WHO to issue new guidelines specifying which antibiotics should and should not be used to combat these diseases. Serious fungal infections are also becoming resistant to antibiotics, a new trend that could have serious consequences for people with compromised immune systems.

New Answers

Thankfully, there are new answers on the horizon. German researchers at the University of Tubingen have recently been examining the human body to look for ways to combat infection. After analyzing bacteria found in the nose, they discovered a single gene that had the potential to help them create a completely new antibiotic. This antibiotic, currently known as lugdunin, has been tested on mice and the results show that it could effectively be used to treat both MRSA and Enterococcus infections.

Scientists at the University of Melbourne have taken a different route albeit one that is no less effective. Their new genetically engineered peptide polymers (or SNAPPs as they are more commonly known) can tear down cell walls and kill bacteria rather than simply halt the growth of infection. The SNAPPs are not toxic and pose no risk to infected people but further research is needed to determine how well the treatment works and what worldeconomicforum_frankmagliochettidangers it could pose.

It is also encouraging to see that world leaders are taking the threat seriously. On September 21, the United Nations General Assembly will host an all day, high level meeting on the topic of drug-resistant bacteria. Earlier this year, the World Economic Forum called for more research into antibiotic resistant infections while the G7 noted that tackling such infections should be a priority. The G20 recently made a united commitment to working together to reduce such infections. While only time will tell if these and other efforts will be successful, there is hope that one day antibiotic resistant bacteria will no longer result in serious infections, amputations and deaths.

Source

http://www.newsweek.com/2016/09/23/bashar-al-assads-war-syria-could-spell-end-antibiotics-498035.html

http://www.who.int/mediacentre/news/releases/2016/antibiotics-sexual-infections/en/

http://www.smithsonianmag.com/smart-news/fungal-infections-are-getting-worse-they-become-drug-resistant-180960283/?no-ist

www.bbc.com/news/health-36910766

http://news.nationalgeographic.com/2016/09/in-first–united-nations-will-consider-antibiotic-resistance/

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Prescription Drugs – The Price Game

Prescription Drugs in The US 

Frank Magliochetti Report

fda-frank-magliochetti-report

If we look back ten years ago, the price of prescription drugs were fairly low and it was easy for patients to buy their medication from the pharmacy.   2016 has not only brought new innovative medical drugs and vaccines, it has brought drug prices that are much higher than before.

We might put the blame on the companies who research and manufacturer the drugs, however, the truth is  this huge influx in pricing is simply that drug companies have the right to monopolize and set  pricing how it sees fit; many wonder if the government should get involved in the pricing of a private industry produced product.

Though the products are approved by the FDA, naturally, the company/manufacturer claims they are simply working to get back their initial investment back.  Add to that private insurers and third party pharmacies, which all benefit when from the companies producing the drugs and want the market to turn towards them. It’s a loop that goes round and round from the manufacturer to the pharmacy.

frank-magliochetti-report-drug-pricingThe influx in price does not end here. With so many rare drugs created this year to fight specific diseases, there are specific companies that are the sole manufacturer of the approved drugs. The US government allows the companies to lay claim to their drug for at least twenty years after it is released. With a price rate at 100%, many people are unable to buy these drugs and hence may have to wait years for the generics to arrive in the market. These generics are priced 45% less than the original drugs.

Many place some portion of blame on the FDA due to the lengthy process and expense it takes for a drug to be accepted by the committee and then approving a virtual monopoly for the company first to the finish line.  With years of testing and billions of dollars invested in making the drug, the company is required to make further changes if the FDA does not approve the drug.

Manufacturer’s reason that the drugs are sold at high prices because they have to recoup on the research and trail funding (among other expenses) needed to bring the product to market.

The prices for drugs to fight Hepatitis or the recent EpiPen increase are two recent examples of companies exercising their right to price the drugs however they want.frank-magliochetti-report-drug-pricing

What can be done to help curb the escalating cost of new medications entering the market?  Is it a more economical FDA approval process which will help lessen the initial trial investment or more government involvement in the research and development of these much needed drugs and their pricing matrix.

A 2016 study published in the journal of the American Medical Association cites the following five reasons for the rise in prices.

Drug manufacturers in the U.S. set their own prices, and that’s not the norm elsewhere in the world.

Go to the official post by clicking the link below:

http://time.com/money/4462919/prescription-drug-prices-too-high/

Countries with national health programs have government entities that either negotiate drug prices or decide not to cover drugs whose prices they deem excessive. No similar negotiating happens in the U.S.

When a Republican-majority Congress created the Medicare drug benefit in 2003, they barred the program that now covers 40 million Americans from negotiating drug prices. Medicaid, on the other hand, must cover all drugs approved by the Food and Drug Administration, regardless of whether a cheaper, equally or more effective drug is available. And private insurers rarely negotiate prices because the third party pharmacy benefits managers that administer prescription drugs, such as Express Scripts and CVS Health, often receive payments from drug companies to shift market share in their favor, according to the study.

We allow “government-protected monopolies” for certain drugs, preventing generics from coming to market to reduce prices.

In an effort to promote innovation, the U.S. has a patent system that allows drug manufacturers to remain the sole manufacturer of drugs they’ve patented for 20 years or more. The FDA also gives drug manufacturers exclusivity for certain products, including those that treat people with rare diseases.

But sometimes, drug companies deploy questionable strategies to maintain their monopolies, the study says. The tactics vary, but they include slightly tweaking the nontherapeutic parts of drugs, such as pill coatings, to game the patent system and paying large “pay for delay” settlements to generics manufacturers who sue them over these patents.

And this is a serious problem, the study concludes, because drug prices decline to 55% of their original brand name cost once there are two generics on the market and to 33% of original cost with five generics.

The FDA takes a long time to approve generic drugs.

Application backlogs at the FDA have led to delays of three or four years before generic manufacturers can win approval to make drugs not protected by patents, the study says.

Sometimes, state laws and other “well-intentioned” federal policies limit generics’ abilities to keep costs down.

Pharmacists in 26 states are required by law to get patient consent before switching to a generic drug, the authors wrote. This reportedly cost Medicaid $19.8 million dollars in 2006 for just one drug: a statin called simvastatin whose brand name is Zocor. Costs ran higher because pharmacists didn’t get patient consent and Medicaid had to pay for the costlier brand name drug even though a cheaper product was available.

Drug prices aren’t really justified by R&D.

Although drug manufacturers often cite research and development costs when defending high prescription prices, the connection isn’t exactly true. Most of the time, scientific research that leads to new drugs is funded by the National Institutes of Health via federal grants. If not, it’s often funded by venture capital. For example, sofosbuvir, a drug that treats hepatitis C, was acquired by Gilead after the original research occurred in academic labs.

This is an ongoing issue with little short term relief in place for patients in need of pricey medications to help them live a longer healthy life.

Related information:

Reasons for the Rise in Prices

Prescription drug prices are skyrocketing in the United States due in large part to government regulations, a new analysis finds.

These regulations allow drug manufacturers to charge monopolistic prices that aren’t opposed by competing market forces, the researchers believe.

The result? For each person in the United States, $858 was spent on prescription drugs, compared with an average of $400 per person across 19 other industrialized nations. Prescription medications now comprise an estimated 17 percent of overall health care expenses, the authors of the new report said.

Drug makers charge high prices for drugs thanks largely to “market exclusivity” regulations intended to allow them to recoup the research and development costs for new breakthrough medications

To read the entire article please click the link below to head to the official CBS site:

http://www.cbsnews.com/news/whats-behind-the-sharp-rise-in-prescription-drug-prices/

Help with the high cost of hepatitis C drugs

Information below is aggregated from a USA Today article

After legal battles and lobbying efforts, thousands of people with hepatitis C are gaining earlier access to expensive drugs that can cure this condition.

States that limited access to the medications out of concern over sky-high prices have begun to lift those restrictions – many, under the threat of legal action.   And commercial insurers such as Anthem Inc. and United HealthCare are doing the same.

Massachusetts is the latest state to decide that anyone with hepatitis C covered by its Medicaid program will qualify for the newest generation of anti-viral drugs. [https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2016-Press-releases-items/2016-06-30-2.html] Previously, managed care plans serving Medicaid members often limited the drugs, with a list price of up to $1,000 a pill or more, to people with advanced liver disease only.

The expansion follows a threatened lawsuit against drugmakers by Massachusett’s attorney general, which induced companies to offer the state bigger rebates on the medications, making them more affordable.

Click the link below to head to the official USA Today site to read the entire article

http://www.usatoday.com/story/news/2016/07/02/kaiser-help-with-high-cost-of-hep-c-drugs/86636294/

Hepatitis C drug costs leave many without care

Hepatitis C treatment costs tens of thousands of dollars per patient. The illness progresses slowly over decades, so most states’ Medicaid programs control costs by treating the sickest first and requiring others to wait.  The conflict over hepatitis C drugs heralds a challenge likely to persist into the future, as new drugs for other illnesses thrill doctors and patients with their effectiveness — and scare health plans with their prices.

Hepatitis C is a big concern for government, because it disproportionately affects low-income people, who are more likely to be on Medicaid, and prisoners, whose care is also the state’s responsibility. An estimated 3 million to 5 million Americans, and 67,000 to 100,000 people in Massachusetts, are infected with hepatitis C, although only half know it.

Click the link to jump to the official Boston Globe website to read the entire article:

https://www.bostonglobe.com/metro/2016/04/09/for-hepatitis-patients-cure-for-high-drug-prices/j2X4aVi7BEpU5BSL0YV0vN/story.html

Mylan CEO Bresch: ‘No one’s more frustrated than me’ about EpiPen price furor

Watch the video below

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

frankmagliochetti_ParcaeCapital