Wearable Health Monitors & Apps-Transforming Health Care Delivery

Posted by Judi Space on Wed,Oct 22, 2014 @ 07:14 PM

Wearable Health Technology - The Next Big Thing

Wearable Medical Devices

Wearable health technology is expected to be the NEXT BIG THING in the continually expanding health care field. This is driven by a number of factors including the constant pressure to lower healthcare costs, new opportunities for electronics manufacturers who see revenue dropping from sales of traditional computing hardware,

and the need for accurate information on the state of patients’ biometrics. Wearable devices make these things possible and so much more.

Evolution of this field has been swift. Only a few years ago, health apps burst on the scene so that people could monitor themselves. Pharma companies got into the app act by providing apps that helped patients monitor their symp

toms and track medication compliance. These depended on data entry by the patient, which could be quite unreliable. Many of the current apps in development are used in concert with wearable devices and often with bio-sensing technology to automatically report on the patient’s behavior and or state of health.

Barriers to Wearable Device Adoption

There are barriers to adoption however. Consumers must be equipped with a smart phone or some way to get the data from the device to themselves and their health care provider, therefore it will be important for the software to work on several platforms. Convenience is a key factor here. The device should need very little maintenance. Obviously, cost to the patient is an important factor as well. Insurance companies are scrambling to decide whether or how to cover wearable technology. On one hand they can be expensive, but if used properly, they can save a lot of money by preempting serious health events or reducing the need for doctor visits. HIPPA rules must be followed which means that developers need to ensure that patient data is secure, as well as limiting who has access to it. 

FDA Regulations

Meanwhile the FDA is attempting to reign in these devices through legislation and new regulation. There are an estimated 100,000 health care related apps available. In June of this year, the FDA issued a draft guidance titled “Medical Device Data Systems, Medical Image Storage Devices, and
Medical Image Communications Devices.” The guidance will not seek to control data systems, or imaging data systems as these are considered “low risk” of causing harm to human health. However, any device that can dispense medication or render a therapeutic affect would certainly fall under the proposed regulations.

The cost of sensors and related hardware is dropping fast. The ubiquity of cell phones facilitates the movement of data from the wearable device to the net using data delivery platforms that are off the shelf plug in modules.

Wearable biosensors eliminate the uncertainty in self-reported data, and reduce the need for patients to visit the doctor and to come to the lab for tests.  It is expected that these devices will be able to save millions of dollars by reducing office visits alone.

The Next Generation of Wearable Medical Devices

While pharma is developing a large number of applications for disease states, the actual number of wearable devices is limited. Wearables historically have been limited in the health data they passively collect. However, research is ongoing for improved biosensors and materials that will enable a more robust generation of wearable devices and capabilities  Currently most of them track very basic parameters such as heart rate, respiration and sleep patterns, however, there is a ground swell of new devices that can monitor medication compliance as well as an increasing variety of specific biomarkers.

The new Apple Watch, scheduled for launch in early 2015 will rapidly accelerate the sophistication of, and expectations for these apps. 

Opportunities

Wearable health technology is very fertile ground with lots of untapped opportunity and little competition outside of general health and fitness devices/apps. Forward looking companies are evaluating how they can take advantage of these opportunities either through a partnership or in-house development, but the path to success for pharma is not straight forward at his time

Navigating the Wearable Technology Landscape

Pennside tracks modern marketing programs and can paint the landscape in wearable devices for health and help determine where the best opportunities may lie. 


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Health Care Costs, Wearable Health Technology, Wearable Medical Devices, Wearable Health Monitors

Is Maine Right About Importing Prescription Drugs?

Posted by Judi Space on Sat,Nov 23, 2013 @ 06:00 PM

Should Maine allow imported prescription drugs from Canada? FDA and other considerations.With the rising cost of health care, many US citizens are crossing into Canada to buy less expensive prescription drugs.   In fact, a group from Maine, consisting of state employees, Portland employees, and one large company, claims to have saved approximately $10 million over several years by purchasing their drugs through a Canadian mail-order pharmacy.  However, the legality of importing drugs into the US continues to be a gray area. 

Illegal for Individuals to Import Prescription Drugs?

According to the FDA

“In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States.”  However, the FDA typically allows for exceptions under the following circumstances: 

  • The pharmaceutical drug is for use for a serious condition for which effective treatment is not available in the United States;
  • There is no commercialization or promotion of the drug to U.S. residents;
  • The drug is considered not to represent an unreasonable risk;
  • The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and
  • Generally, not more than a 3-month supply of the drug is imported.

 

Act to Facilitate the Personal Importation of Prescription Drugs from International Mail-Order Pharmacies

In 2012, a former state attorney general in Maine decided to ban companies that were importing drugs from conducting licensed business in Maine.  This move was in response to a complaint from the Maine Board of Pharmacy that foreign pharmacies were not licensed under law. This ban stopped the savings some individuals in the business community and the state and local governments were receiving. 

In response to the ban, state senator, Troy Jackson introduced the “Act to Facilitate the Personal Importation of Prescription Drugs from International Mail-Order Pharmacies”   - an act that allows its residents to purchase prescription drugs from mail-order pharmacies in Canada, the UK, New Zealand, and Australia.  Maine’s state legislature overwhelmingly passed the act and the law went into effect on October 9, 2013. 

The Lawsuit - Big Pharma & Others Weigh In

The Pharmaceutical Research and Manufacturers of America, the Maine Pharmacy Association, Maine Society of Health-System Pharmacists, and others filed a lawsuit against the state of Maine, stating that the law circumvents “the carefully constructed closed federal regulatory structure governing prescription drugs and thus posing serious health risks to consumers.”  The lawsuit further argues, “Prescription drugs shipped to Maine by foreign pharmacies pursuant to the (law) are not subject to any of the quality and safety controls put in place by the federal government in order to protect persons who rely on prescription medications.”

This discussion is not over.  Currently, Maine is seeking dismissal of the lawsuit and the plaintiffs are requesting an Oral Argument. 

For the Act

Sharon Anglin Treat, National Legislative Association on Prescription Drug Prices, said, “This legislation will save money for Maine consumers, businesses, and local and state governments and provide access to high quality medications.  Prescription drug prices in the US are the highest in the developed world… Until such time that we join other countries in making drugs affordable, importation in the manner enacted by Maine Legislature makes eminent sense.”

Against the Act

Marv Shepherd,  Partnership for Safe Medicines, stated, “However well-intentioned Maine’s importation legislation may be, the health risks of counterfeit medicines far outweigh any cost savings.  The bottom line is that the FDA cannot guarantee the safety or efficacy of any prescription medication from outside the US supply chain, and when medicines are not FDA approved patients are put in danger.”

Implications are Clear

The consumer implications for prescription drugs in Maine and elsewhere are clearShould the lawsuit by PhRMA, et al, be unsuccessful, it will open the doors for easy access to lower priced brand name prescription drugs enjoyed by residents of other countries, at least in the state of Maine. Other groups seeking to save money on prescription drug costs may use this as an example and press for similar legislation in other states.

In states where the Pharma industry has less influence, and there is generally less support for industry protection in general, these bills are more likely to succeed.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Health Care Costs, Prescription Drug Costs, Prescription Drug Importing, Big Pharma

Momentum for Biosimilars is Building. What’s Next?

Posted by Tom Penrice on Tue,Apr 23, 2013 @ 06:00 PM

Overview:
Both the FDA and the EMA are showing increasing levels of support for biosimilars, while physician resistance is declining in both the US and Europe. Cost is a big driver, among other factors.[1]

Biosimilar Drug Development Trends in Europe – Timing is Everything

Biosimilar drug development trends in US and European pharma drug development industryResistance to biosimilars in Europe is declining just as patents are expiring on many highly lucrative biologics, among them Herceptin (trastuzumab), Remicade (infliximab), and Rituxan (rituximab).  Significant cost advantages, important regulatory changes, and a growing openness to new methods of scientific analysis have combined to drive the trend.  Although the financial performance of biosimilars has been disappointing to date, nevertheless the perceived opportunities are attracting innovators and new players.

Why the Resistance to Lower Cost Biosimilars?

Resistance to date has been due primarily to two factors: pushback from physicians reluctant to switch patients to a biosimilar drug, and the lack of a systematic way for pharmacists to easily substitute a biosimilar for an originator drug.  As a result, the returns from biosimilars in Europe have been unimpressive to date. 

Meanwhile, in the US the FDA has yet to receive its first biosimilar application, despite the fact that for two years a regulatory pathway has been provided.  Innovator lobbying at the state level is a major factor contributing to the quagmire, whereby bills are being pushed to make it more difficult for automatic substitution of biosimilars for branded biologics to take place.

Doctors Signing On – Slowly

Unlike the FDA in America which has decision making power for all 50 states for such issues,  the EMA must leave it to each national government to make their own rulings on biosimilars.

In Norway, physicians are slowly growing more positive toward biosimilars partly due to price, a growing factor given sluggish European economies and rising health care costs, according to a cardiologist and medical director at Norway’s regulatory agency.

Economic incentives to prescribe cheaper drugs are also affecting physician acceptance of biosimilars in some northern European countries. For example, in Germany prescription quotas for generic drugs are imposed on physicians as a way to keep within allocated budgets. It is also helpful that Germany has declared copycat EPO’s to be the equivalent of the originals. Although not legally binding, these quotas in Germany have contributed to copycat EPO penetration growing from 30% to 39% in the past three years.[2]

Biosimilars - Impact on Price and Profits

The downward pressure on price due to the growing adoption of biosimilars has resulted in innovators making deep price cuts in order to retain market share, including with hospitals. As a result, payers are enjoying the savings.  Savings in Germany are estimated at over €1 billion per year by 2017.

Changing Definitions and Perceptions

EMA is increasingly accepting biosimilars due in part to recognizing that analytical science gains have made it possible to supply proof of similarity without requiring the time and expense of clinical data.  Last year EMU changed it’s description of biosimilars from products deemed “similar but not identical” to one stating, “the active substance of a biosimilar and the reference medicine is essentially the same biologic substance, though there may be minor differences”, thereby making it more difficult for innovators to make the case for their originals. 

FDA More Open to Biosimilars?

The FDA, while arriving late to the game, may be more open to biosimilars than EMA in terms of an easier acceptance of the analytical science argument for determining similarity. By comparison, the EMA appears to rely more on a clinical trial mindset. The US approach has not been without its rewards, as competition and savings can be significant. According to IMS Health, the US health care system has saved $1.6 billion since launch on Sandoz / Momenta Pharmaceuticals Inc.’s m-enoxaparin, the first of two competing complex copies of Sanofi’s Lovenox (enoxaparin).

Long Term Impact of Biosimilars on the Pharma & Biotech Industry

Now that payers are alert to the cost savings potential of biosimilars, there can be little doubt that the pressure to drive down prices will continue unabated. Indeed, the payers, especially the government payers, have the capability to change the game very quickly.

If prices and profits were to drop sharply and frequently for originals due to growing inroads made by biosimilars, one must wonder to what degree investment in research by innovators may suffer.


[2] http://www.elsevierbi.com/publications/the-pink-sheet/75/6/germany-may-need-to-jump-start-its-stagnant-biosimilars-market 


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Pharma Brand Strategy, FDA, Drug Developers, Biosimilars, Health Care Costs, EMA

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