What type of data do you need to advocate? You need to start with good data about the issue you are trying to change. This means you need to start getting reliable, easy to understand data to get your ideas heard. Also, once you start sharing your ideas with government entities they will ask if you have data to “back it up”. Having the right sources can make or break any advocacy strategy. From grass-roots campaigns to full advocacy efforts having the right sources for data creates a firm foundation.
What types of sources?
You will need two types of sources. The first type is the most up to date data that illustrates how you or your issue is being affected. This data could come from your own business, such as sales figures. Or it could come from a government entity or official entity that collects data for policy reasons. You are looking for the most bipartisan information you can find. This means no data from a specific political party or a political group that may be seen as only created to serve one side of the aisle. The second type of source you need is an actual person. Yes, someone that knows your industry or issue and can help you. It could be a lobbyist that you hire or an Executive Director of your industry association.
How do I find the right sources for my issue?
For the data, this can take time. Exploring the internet and taking the latest stats you see is not the best idea. You need to study how the data is being used; whether the data collection is continuous; where the data comes from and finally how much of it is there. Not knowing these things can lead to the wrong information being distributed. Having the wrong information will not only create a bad reputation for you but will also create bad policy. Bad policy will not solve your issue.
Also, having a trusted ally such as a lobbyist can help you differentiate between good and bad information. They can also tell you how to use the information to best take advantage of certain political situations.
Finally, when you have the right information from sources that can be trusted you can go to your elected representative and drive policy decisions that will not only help you; it will solve a problem that affects your industry. Contact us today for more information.
Studies show that as much as 80% of healthcare data is going unused. However, with IBM Watson unstructured and underutilized data may be a thing of the past with the help of health analytics. Many companies have trouble finding the right consultants to help them with heath analytics.
The amount of healthcare data is astronomical and beyond the scope of what the human eye can read and decipher. In fact, the volume of healthcare data is estimated to be around 150 extrabytes. IBM puts it in perspective: If the data was placed on CDs the tower of discs would reach Mars.
Unlike humans, Watson can analyze data at a rate that makes the extraordinary amount of data manageable. In fact, Watson can read 200 million pages of text in only 3 seconds. The abilities of Watson is everchanging and continues to expand. Watson’s fluency in 9 languages allows the technology to extend borders and encourage collaboration between physicians.
Unlike other systems, Watson can compare patient data with medical research and compute words beyond simple data collecting and processing. Watson can take weeks of research and compile results in minutes, producing crucial patient treatment suggestions. In time-sensitive health matters, Watson can be a lifesaver.
Watson has already been making an impact in Oncology. Watson teamed up with Quest Diagnostics regarding cancer gene sequencing. Watson takes the information of the sequenced patient tumor provided by Quest Diagnostics and analyzes the data to identify mutations that may be treatable. Watson compares the DNA from healthy tissue with cancer cells to determine what treatment would be appropriate and what treatment should be avoided.
In addition, the New York genome center has teamed up with IBM to create a national cancer tumor database which would document how patients react to treatment. As of now it includes data from roughly 200 New York patients but hopes to grow in the near future. Gathering this type of data can lead to advances in how to properly fight cancer, especially for patients who have failed to respond to more conventional treatment.
IBM Watson has also tackled diabetes by joining the American Diabetes Association in designing apps that would aid in prevention and management of diabetes. The Medtronic and Watson app would help patients track and control their diabetes on a daily basis. The app can monitor nutrition and insulin levels to gather information in real time. This information can lead to additional discoveries in the correlation between lifestyle and diabetes as well as assist patients with being more aware of their diabetic condition.
Watson isn’t the final solution to fighting diseases but rather a valuable tool that can aid physicians and patients in choosing the appropriate treatment. It will also continue to evolve as information is added. For instance, when Watson analyzes information from specific genes and provides connections between that mutated gene and potential treatments, the physician can relay back to Watson what treatment did in fact work. This information is saved in Watson’s system and allows for a more accurate and comprehensive Watson analysis the next time a similar gene is sequenced.
Watson is expected to continue expanding and encompass other areas of healthcare by bringing crucial data and information to patients and doctors. Healthcare data will no longer be wasted or go unanalyzed but will fulfill a purpose of helping current and future patients obtain optimal treatment. Contact us today for more information regarding health analytics.
With the continued policy dialogue of how rising drug costs impact patient access, the theoretical cost savings that biosimilar medications may offer have intrigued many. A recent IMS Institute Report found several interesting points regarding the potential of biosimilars:
• By 2020, biosimilars will start competing with original biologics that currently have sales of $50 billion annually.
• Biosimilar use in the European Union and United States may yield total savings of $56 to $110 billion over the next 5 years.
• Within three years, 8 major biologic medicines are expected to lose exclusivity protection, including treatments for autoimmune disorders and diabetes.
• Health care systems, by opening markets to biosimilar competition, could realize a 30% reduction in price per treatment day compared with originator biologics.1
While biosimilars have the potential to slow the dramatic rise in the overall drug spend, many questions remain about what biosimilars are, how they will get to market, and whether they will be fully integrated into our health care system. This article will examine the basics of biosimilars and shed insight into the latest discussions surrounding this topic.
The first question to ask is what is a biosimilar? A biosimilar is a biological product that is approved based on demonstrating that it is highly similar to an FDA-approved biological product—known as a reference product—and has no clinically meaningful differences in terms of safety and efficacy. Only minor differences in clinically inactive components are allowable in biosimilar products. The concept of a biosimilar originated under the Biologicals Price Competition and Innovation Act of 2009, and was enacted by the Patient Protection and Affordable Care Act in early 2010. This legislation created an abbreviated licensure pathway for biological products deemed biosimilar or interchangeable with an FDA-licensed biological product.2
There is a common misconception that biosimilars are classified informally as generics, but the FDA said this is not true. “Generic drugs are copies of brand-name drugs, have the same active ingredient, and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. That means the brand name and the generic are bioequivalent.
Biosimilars are highly similar to the reference product they were compared with, but have no clinically meaningful differences in terms of safety, purity and potency from the reference product,”2 the FDA noted in a biosimilar consumer guidance. Interchangeability is among the hot topics surrounding biosimilars.
An interchangeable biological product must not only be shown to be biosimilar to the reference product, but the sponsor also must demonstrate that the proposed interchangeable product is expected to produce the same clinical result as the reference product in any given patient. Additionally, when a product will be administered more than once to an individual, the sponsor must also demonstrate that the risk (in terms of safety or reduced efficacy) of alternating or switching between use of the proposed interchangeable biological product and the reference product is not greater than the risk of using the reference product without such a switch.2
In an industry guidance for biosimilars, the FDA notes that to have a product evaluated as a biosimilar, manufacturers must submit a 351(k) biologics license application (BLA) that includes data showing biosimilarity based on analytical studies that demonstrate the biological product is “highly similar” to the reference product, besides minor differences in clinically inactive components; animal studies that include a toxicity assessment; and clinical studies that demonstrate the biosimilar is safe and effective in 1 or more of the conditions that the reference product was approved for.3
Recently, the FDA released new guidance on interchangeability, titled “Considerations in Demonstrating Interchangeability With a Reference Product.” The guidance expands on the FDA’s current stated positions governing interchangeability by recommending that sponsors submit data from a switching study, or studies, to the agency in order to deem a biosimilar interchangeable.4
The regulatory arena is not the only forum shaping this debate. While it is too early to tell how the Trump administration and the 115th Congress will handle biosimilars, the 114th Congress was busy laying the groundwork for future discussions surrounding this issue. Legislators have considered ways to speed generics to market, considered alternatives to reduce market exclusivity time for biologics, and passed the 21st Century CURES bill, which seeks to get innovative products to patients faster.
Even the Medicare Payment Advisory Commission continues the debate over how to pay for these products through its discussions on the future of the Average Sales Price metric. State legislatures have also been active over the last 4 years, in which at least 36 states have debated legislation establishing varied standards for substituting a biosimilar product as a replacement for an original biologic.
Notwithstanding the advancements discussed thus far, US biosimilar policy still has a long way to go before it is fully developed. Along with recently released CMS guidance documents on biosimilar reimbursement, the FDA guidance on labeling, and the FDA’s approval of 4 biosimilars within the last 2 years, there are still a number of significant unknowns.
First, will the payer community see biosimilars as a way to lower drug costs, since it is not necessarily a given that biosimilars will be cheaper than the biologic?
Second, will the prescribing community feel comfortable enough to prescribe these new products?
Third, will patients be willing to accept biosimilars? Finally, and most importantly, what role will the US Supreme Court play? On April 26, the court will hear arguments in a case between Amgen and Sandoz where 2 critical questions will be asked:
1. Must there be FDA approval before providing the brand with a 180-day notice of intent to market?
2. Is the patent-sharing process required?
If both questions are answered in favor of Sandoz, we can expect biosimilars to come to market faster than previously expected.
References
1. IMS Health: Surge in Biosimilars to Drive Significant Change in Health System Costs, Patient Access and Competition by 2020, March 2016.
2. U.S. Food & Drug Administration information for Consumers (Biosimilars),
3. Ibid.
4. Ibid.
5. U.S. Food & Drug Administration Information for Industry (Biosimilars)
6. U.S. FDA Guidance titled Considerations in Demonstrating Interchangeability With a Reference Product
Now more than ever it is important to choose the right lobbyist. Since the early 2000s, there has been a steady increase in the amount of government activity that has directly affected healthcare stakeholders. Prior to this time-period, companies could afford to focus only on differentiating their products from their competitors. Now companies are finding that during their strategic planning meetings, they must account for how state and federal government activity may impact their bottom line. In addition to having a Government Affairs staff, these same companies are starting to realize the importance of having established a relationship with a lobbyist. The question is how to choose a lobbyist that is right for your organization?
First you want to make sure the lobbyist has experience. To be a good lobbyist there is no magic number of how many years you have worked within the political system. However; many lobbyists have worked an average of six months in the legislature as an aide to a legislator or on the other side of the spectrum, many legislators have left the legislature to work as a lobbyist. These individuals have an insider’s perspective into how the legislature works such as when a bill filing deadline date is and whether or not a bill can be introduced due to if a state is in an emergency session where the rules for introducing legislation is different from regular session.
Second the lobbyist should have a minimum number of contacts in the legislature. Whether it is in Congress or on the state level, the lobbyist should be able to have a go to legislator that can get a bill introduced quickly. However; the most successful lobbyist will not be limited to one party. Having contacts on both sides of the aisle will allow the lobbyist the opportunity to bring any bill at any time regardless of what political party has the majority.
Third the best lobbyist should be strategic. He or she should be able to know when a good time to introduce legislation is. The lobbyist should know what legislator to target as the bill sponsor. This is important because the bill sponsor will be the champion for your particular bill from start to finish. The lobbyist will need to educate the bill sponsor on the nuances of the bill so that the sponsor will be educated enough to be able to respond to technical questions during a hearing or when the sponsor is in caucus meetings; explaining to their respective party about why your bill should be voted on. The lobbyists should be able to pick and choose what committee will be best for your bill to go into, who to use as strategic allies for your legislation and be intuitive enough on when to negotiate and when not to.
Next it is important for your lobbyist to know the industry and to have foresight. You need to be comfortable knowing that your lobbyist understands your industry because if not, how can you be sure that your lobbyist is communicating the correct outcome for you? The lobbyist should be skilled enough to draft a bill that solves your problem without having to continuously ask you how something works. Additionally, while many lobbyists only focus on the legislature, the best lobbyists will think long-term to determine if a regulatory body will be involved once your bill passes. If so a lobbyist should be able to guide you through the regulatory process without leaving you to fend for yourself after a bill has passed.
Finally, as with any other professional, you need to be aware of the reputation your lobbyist has. Do they take the time to make sure their clients understand everything that is happening? Does the lobbyist prepare the client and relevant legislators ahead of time for crucial hearings? Does the lobbyist make everything easy to understand? Does the lobbyist dress appropriately for meetings and do they have the needed respect from the legislature? Does the lobbyist closely follow the bill from start to finish or are they overloaded with too many clients? These are important issues to talk with your prospective lobbyist about before entering into a contractual relationship.
While there are other nuances to the lobbying relationship, these should be enough for you to think about as your organization considers whether to engage a lobbyist. A lobbyist should no longer be considered a luxury item. The best lobbyist are quickly becoming essential parts of today’s corporate environment for the value they bring to their clients in either advancing their interests through legislation, or being available to respond to legislative targeting that has been on the rise. You know you have picked the right lobbyist when you can breathe a sigh of relief knowing that they have your back. Contact us today for more information regarding lobbying.
