Jan E. Berger, MD, MJâ€”Editor-in-Chief President & CEO Health Intelligence Partners

It has always been said that physicians are the greatest influencers of what medications are prescribed to patients due to their “power of the pen.” This sway has created an environment where pharmaceutical manufacturers and healthcare insurers have spent a great deal of time and money over the years “educating” providers regarding the drug choices they make.

It was not that long ago that I was meeting with large national employers for lengthy discussions on specialty medications and their availability, their potential effectiveness, and their costs. These attributes started an interesting conversation regarding both the upside and the downside of these medications, many of which targeted conditions that previously had no treatment. They were a lifeline, and in some cases allowed people to work when they previously could not be productive in the workplace. These expensive “game changers” were not new, however. Hemophilia, among other conditions, had been treated with a specialty medication since the early 1970s.

In the case of hemophilia, only approximately 17,000 people were afflicted with the condition in the United States, giving it the status of a “rare” condition. Most of these medications treated rare, also called orphan diseases (characterized by afflicting fewer than 200,000 people), a population of only about 25 million people in the United States. The number of specialty medications was also quite small until the late 20th century, and then things began to change.

As the 1990s came to a close, we began to see new specialty medications come to market. An example of this was Enbrel, launched in 1998 to treat rheumatoid arthritis. This disease was not considered a rare disease, as it affected over 1.5 million people in the United States, so a situation developed where the number of people utilizing these high-priced medications was increasing exponentially. In addition, the pipeline of new specialty medications coming to market was swelling.

In 2003, an even greater challenge arose with the launch of Xolair, a medication that treated severe asthma. Employers and health plans were now looking at a high-cost specialty medication that treated a disease with 25 million sufferers in the United States, plus an additional 25 million with allergies. The era of high-cost specialty medications for the masses had arrived. These were the changes that had put me in front of healthcare payers, health plans, and employers alike, talking to them about this increasingly impactful trend. Many of those we spoke to ignored us, thinking that we were crying wolf, as they were seeing little impact in their populations. Others nodded their heads but felt that there was little that they could do, probably believing that this was a problem for tomorrow, not one that they would need to worry about for a very long time.

Fast-forward to the fall of 2014, the year the perfect storm hit. This year, we saw the launch of a specialty drug that costs approximately $80,000 per treatment course for a disease that is estimated to affect 5.2 million people in the United States (NHANES data). Once again I am seeing payers glaze over when I speak to them about specialty medications, but this time it is not due to lack of interest or understanding. In fact, the opposite is true: payers are concerned about the number of new drugs coming to market, the number of conditions that specialty medications are treating, and the cost of the medications.

The specialty drug movement will continue to gain momentum. By 2018, the overall spending on specialty drugs is expected to exceed the total spending on smallmolecule drugs. The impact will be felt not only on the cost of the medications, as there continue to be “mega-cost” specialty medications that will come to market, but also the conditions that will be treated by these medications. Today we see at least 3 specialty drugs for hyperlipidemia, with a prevalence of 71 million adults according to CDC estimates, and several specialty medications for the treatment of diabetes mellitus with a prevalence of over 29 million. It is clear to me that the time has come when payers will have to make some decisions regarding coverage, cost, and availability, because the opportunities, although great, have the potential for taking down the system.

Articles

The New Role of Specialty Medications

My view of the world has changed in the last 35 years. I guess that is good news. A great deal of experience and learning has occurred over that period. My medical school education included a very small portion of time on pharmacology. And as an executive for a health plan, most of my energy was focused on appropriate medical care—medications were an afterthought. As a practicing physician, I, like my peers, prescribed approximately 15 drugs on a regular basis. They were drugs that I began prescribing during  my residency and continued to prescribe into my first few years of practice. It was not until I began working for a pharmacy benefit management company that I came to realize the importance of medications. Fast-forward to today&mdash;medications and medication

management have gained in importance and are recognized as being foundational to healthcare. One example of how medication management has taken its rightful place is provided by the Medicare Advantage Star Rating System. Medication management ratings comprise 44% of the total potential points in the Star Ratings. A Medicare Advantage plan cannot achieve top Star ratings without a focus on appropriate medication use and management.

If you are reading this journal, you probably have an understanding of how important medications can be and perhaps are looking to maximize the value of appropriate care within the pharmacy space. With 2014 upon us, we will find that this space has new challenges as well as some past challenges that we have yet to completely address. Some of the new areas that we will be focusing on include the use of medications within both the public and private exchanges, the role of pharmacists in new provider  models, the increase in popularity of medication therapy management programs, the increased use of transparency tools by  consumers, and the integration of medical and pharmacy benefi ts for specialty medications. In addition to paving new paths in  these areas, we will continue to focus on areas that are familiar to us all, such as appropriate utilization of medications, medication adherence, and value-based benefit designs.

I regularly get feedback that readers enjoy the monthly article that focuses on drug trends. I want to take a moment to thank CVS  Caremark, as they have been the authors of this column for the last several years. As we go forward, MedImpact will be taking over  the reins and sharing their views on healthcare trends, views from which we can all learn and to which we can all respond. 

I welcome you all to suggest new areas of focus and interest for this column. Here’s to the era of medications and medication management.  

Medication and medication management are now recognized as foundational to healthcare.

The World Has Changed: Medications Matter

This has been quite a year for genetic testing. Two events that occurred in a short time frame have created a one-two punch in the world of genetic testing. First, on May 14, Angelina Jolie shared with the world her decision to have a preventive double mastectomy after learning that she was genetically disposed to and at high risk for breast cancer. Approximately 1 month later, on June 13, the United States Supreme Court  decided to bar patenting of naturally occurring genes such as those that focus on the BRCA genes.

These 2 events put the spotlight on genetic testing, especially testing associated with breast cancer. The decision to have genetic testing is not one that is taken  lightly. The implications to participating are many, including costs, potential loss of insurance coverage, potential loss of job, treatment implications, and addressing one’s mortality.

These decisions have created an interesting environment in the clinical testing for a number of diseases. Genetic testing is not new. Genetic testing is one of the  cornerstones of the personalized medicine movement. It can inform as to whether a person is at risk for a condition.  It can also help to inform a physician as to the proper treatment plan for a patient. Genetic testing can give greater information regarding a specific patient than was previously available.

Angelina’s public announcement brought others who have made a similar decision out in the open. These announcements have created a public dialogue  on genetic testing. As I stated above, patients had to historically weigh the potential risk of losing one’s health insurance against knowledge that could be gained from the testing. The Affordable Care Act (ACA) has relieved the patient of this concern. It is unclear as  to whether the public discourse that began this spring along with the ACA regulations will create a greater demand for this testing. This is something we will be watching closely.

Next let’s focus on the second event that I mentioned above. In this case, the Supreme Court of the United States found that naturally found genes could not be patented. The direct implication of this decision is that Myriad Genetics loses the exclusive right to isolate the BRCA1 and BRCA2 genes. To date, Myriad was the only company that could legally offer this test due to its patent on these genes. The existence of these genes was determined at The University of California Berkeley. Myriad Genetics acquired patents after sequencing the genes and determining the exact location of the genes on the human genome. Myriad then created medical tests to detect the mutation of the genes that it had patented. Myriad did not create the genes, but developed a test. Patents for gene isolation are not new, and in fact patents have been given for this activity since the 1980s. Other organizations were able to run tests utilizing their own method for the test, but received letters warning them of patent infringement by Myriad. The Supreme Court decision allows these other organizations to offer their tests.

You may ask why this is important for anyone outside of Myriad and those organizations that are creating their own tests. As I stated above, genetic testing can have significant cost implications. Although testing costs vary depending on the test, most of the time these tests cost more than $1000. In the case of the BRCA1 and BRCA2 tests, the costs are approximately $4000. As competition begins to occur in the genetic testing arena, cost of testing should decrease. In fact, one competing company has a test on the market that will cost as little as $995. Another company has included the BRCA tests in a larger breast cancer panel that includes 4 other breast cancer—associated genes.

I believe that this developing competition is good for the market. It can not only address costs, but also work to create testing that may improve reliability. I am not stating that the present tests are not reliable, just that greater knowledge and competition can create improved testing. In addition to these 2 implications is the fact that the addition of more BRCA tests allows a person to get a second opinion prior to making the hard decision that is necessary in the case of a positive test.

Although the downward implications of this decision are yet unclear, it is important that those who are making coverage decisions for these tests consider the potential implications and begin to ask questions so that they can best understand the choices that will be put in front of them.

In fact, parallel to these 2 events, Cigna recently announced that it is applying new coverage rules to certain genetic tests. Cigna will require that a member speak with  a genetics counselor prior to receiving the genetic test. From what I understand, this action is not to dissuade the member or put up a barrier to getting these tests, but to make sure that the member is informed about the test and that they understand the potential implications. I find this decision an interesting one.

So get out your crystal ball. Do you think we will see an increase in people requesting genetic testing? Will costs go down as more companies begin to compete where they previously could not? And will more health plans apply new coverage rules to genetic  testing similarly to Cigna?

To achieve the triple aim, the healthcare benefit and the pharmacy benefit must evolve.