Mike Hennessy

 publishing this annual oncology-focused issue of 

 6 years ago, in our wildest imagination we could not have dreamed of the astounding progress that would be achieved treating this horrific disease over just a few short years.

The most significant recent development in the cancer treatment landscape has been the emergence of new immunotherapies that block the PD-1/PD-L1 immune checkpoint across multiple tumor types. The approvals of nivolumab (Opdivo) and pembrolizumab (Keytruda) offered patients more effective and less toxic treatments than traditional chemotherapy.

As a result, there are nearly 140 clinical trials currently underway for just these 2 therapies across 30 different tumor types, as thousands of other trials evaluate other potentially transformative immunotherapies. The end result of these advances has been significant spending growth, as the IMS Institute for Healthcare Informatics reported in April that oncology spending increased by $6 billion to $39.1 billion in 2015.

This growth shows no signs of slowing, as IMS noted that one-quarter of the R&D pipeline is currently comprised of oncology drugs. But, with all of the progress gained in oncology, the giant elephant of cancer care remains in the corner of the room: the cost and accessibility of these high-cost therapies for patients. A study published in 

 in April 2016 found that the average amount insurers and patients paid for a new oral cancer medication spiked from less than $2000 in the year 2000 to $11,325 in 2014.

This is especially concerning, as stakeholders predict the future of cancer care lies in the development of oral immunotherapies. The burden for this spending growth is increasingly being taken on by patients, as payers move toward using higher deductibles and co-insurance, where a patient pays a percentage of the drug cost instead of a flat copay, which potentially deals a devastating blow to medication adherence.

The implications of rising out-of-pocket costs on patients and spending growth for payers are explored in the latest article by 

 editorial board member Marc O’Connor, of Curant Health. I urge you to read his article this month, which notes that payers and pharmacy benefit managers may end up facing an enormous financial burden as cancer becomes more of a chronic condition treated by oral oncolytics and, eventually, oral immunotherapies.

It will ultimately be incumbent on these various industry stakeholders to work together for a solution that ensures these potentially life-saving medications end up in the hands of the patients in dire need of hope. As always, the latest developments in this exciting area of health care will be covered extensively in 

 via our print journal, daily news website, e-newsletters, and on mobile devices.

® (www.curetoday.com), and our other oncology-focused publications, will also continue to bring cutting-edge commentaries and news from the physician side of this fast-paced environment. 

Articles

Overcoming Challenges to Progress in Oncology

DESPITE THE SIGNIFICANT ADVANCES IN SPECIALTY DRUG DEVELOPMENT

 in recent years, it can seem like a slow crawl getting these treatments from FDA evaluation to market, especially for patients anxiously awaiting these life-changing therapies. But the tide, it would seem, has started to turn.

A recent report by the California Life Sciences Association and The Boston Consulting Group found that significant progress has been gained by the FDA in accelerating review times. The study revealed that FDA review times dropped from an average of 21 months in 2009 to 10 months in 2015. 

The researchers found that review times in the therapeutic areas of oncology, infectious diseases, and rare diseases were particularly fast. This progress is especially notable because getting new treatments into the hands of these patients is literally a matter of life and death, in many cases.

For patients with rare diseases, the new treatments are often the first drugs to gain approval for these conditions. In fact, 36% of the medications approved in 2015 were first-in-class drugs, of which nearly half were for rare diseases. While the continued concerns surrounding the high cost for many of these drugs continues, relief may be looming as the accelerated FDA review process should also speed the impending arrival of new biosimilars.

This is significant, as the entry of biosimilars into the prescription drug market could generate a projected total savings of $110 billion over the next 5 years across the United States and Europe, according to a report released by the IMS Institute for Healthcare Informatics. The report found that opening markets to biosimilar competition could result in a 30% reduction for health systems in price per treatment day compared with originator biologics.

In terms of research and development, 30 companies are actively pursuing biosimilars for 16 distinct molecules that could increase competition by 2020. As these new treatments hit the market, specialty pharmacy will be at the forefront helping patients get the most out of these therapies. For that reason, it’s incumbent for stakeholders to stay abreast of the myriad issues facing the specialty landscape.

I urge you to read the feature article in this edition of 

 by National Association of Specialty Pharmacy board member Mike Agostino, who goes in depth on the urgent need for health care professionals to stay involved and stay true to specialty pharmacy. Staying on top of the latest developments in the specialty landscape is our mission in the print edition of Specialty Pharmacy Times, and our daily news website, www.SpecialtyPharmacyTimes.com, which keeps you abreast of all the latest news you need to know. Follow our coverage in print, online, in our e-newsletters, and on mobile devices. 

At Long Last, Progress

, it is fair to say that the year in specialty pharmacy has been tumultuous, to put it mildly.

Driven by the root problems that stem from the deeply-flawed Affordable Care Act, patients are being assailed by cost increases from growing insurance rates and higher deductibles that leave many out in the cold and unable to afford their medications.

In the wake of the recent controversies surrounding Turing Pharmaceuticals raising the cost of the drug Daraprim by 5000% and the relationship between manufacturer Valeant Pharmaceuticals and so-called specialty pharmacy Philidor Rx Services, medication spending has been placed squarely in the spotlight.

The cost of prescription drugs for patients is troubling for stakeholders across the health care landscape in an era when government overreach has ultimately limited the freedom of citizens in choosing their physicians and optimal insurance plan.

The growth of multitiered formularies that place specialty drugs on the fourth or fifth tier has resulted in out-of-pocket costs that are crippling to many patients.

A recent survey from the Deloitte Center for Health Solutions found that 1 in 3 individuals enrolled in public health insurance exchanges have trouble paying out-of-pocket costs for health care, while just 16% indicated they are financially prepared to handle future health care costs.

This collateral damage from Obamacare was all too predictable and just further illustrates the real world consequences of deceptive legislation that failed to significantly improve the lives of patients.

This is an issue that will continue to grow in importance, as analysis released this month by the IMS Institute for Healthcare Informatics showed total worldwide medication spending will reach $1.4 trillion by 2020 as a flood of breakthrough therapy innovations continues to hit the market.

The balance between reducing the price of specialty drugs for patients while still incentivizing innovative research must not end up limiting the freedom to profit in an open market. If we diminish the ability for manufacturers to recoup their investment in a specific product, we may ultimately limit the scope of future drug development.

In light of this growing conundrum, I urge you to read the article by 

 editorial board member and Curant Health COO Marc O’Connor, who examines potential solutions to reduce drug costs based on the value a treatment brings, as opposed to just demonizing manufacturers for the price of breakthrough therapies.

Also in this issue is the latest editorial from Dan Steiber, RPh, our esteemed editor-in-chief, who addresses recent media reports that have misrepresented what constitutes a specialty pharmacy. Ultimately, it is the patient, not the price tag, that is at the center of a true specialty pharmacy.

As we start anew in 2016, the industry must continue fighting to prevent an uniformed media outlet from guiding the discussion that defines specialty on a larger scale. As we take on that battle together in the year ahead, we would like to wish you and your family a healthy, prosperous, and very happy New Year. 

Is the Price Right?

As we enter the final stretch of 2015, specialty drugs continue their ascendance to the top of the health care food chain.

Over the past 5 years, specialty drug spending has grown by $54 billion, which represents 73% of overall medication spending growth during that period, according to a report released earlier this year by the IMS Institute for Healthcare Informatics. With so much growth among these complex therapies, it has never been more important to closely monitor developments in the specialty drug pipeline.

Specialty drugs currently make up nearly half of the late-stage pipeline, up from just 33% 10 years ago, according to IMS. The impact of the specialty pipeline was surely felt last year, as newly approved specialty drugs accounted for $20.3 billion in spending growth last year, largely as a result of new treatments for hepatitis C, multiple sclerosis, cancer, and diabetes.

In the waning days of 2015, specialty drugs should continue to dominate the conversation with an increasing number of eyeballs fixed on the pipeline. As we do each quarter, our latest issue of Specialty Pharmacy Times brings you the latest developments in the specialty pipeline with another update from Aimee Tharaldson, PharmD, of Express Scripts.

I urge you to read her article, which notes that the FDA is expected to approve several new specialty drugs before we close the book on 2015. Among these are new treatments for cancer, orphan conditions, asthma, and perhaps most importantly, additional biosimilars and competitor hepatitis C drugs, both of which could help rein in problematic high drug costs.

Among other articles of importance in our new issue is the latest editorial from Dan Steiber, RPh, our esteemed editor-in-chief, who takes a look at the supply chain for these products once they graduate from the pipeline to the market. The approval of new drugs is typically followed by a debate over pricing and access to these therapies.

I urge you to read the new article by Marc O’Connor of Curant Health, who takes a look at this issue through the ongoing debate raging around PCSK9 inhibitors and the high cost for these cholesterol-lowering breakthrough treatments.

Staying on top of the latest developments on the specialty landscape is our mission in the print edition of 

 and our daily news web site, www.SpecialtyPharmacyTimes.com, which keeps you abreast of all the latest news you need to know. Follow our coverage in print, online, in our e-newsletters, and on mobile devices. We also invite you to share our articles, news, and commentaries with your colleagues throughout the profession. 

All Eyes on the Pipeline

The US Department of Health and Human Services Office of the National Coordinator for Health Information Technology defines health information technology (HIT) as “the application of information processing involving both computer hardware and software that deals with the storage, retrieval, sharing, and use of health care information, data, and knowledge for communication and decision making.” Much like social media, sharing health information across platforms is fast becoming the norm. Technology once thought to be unattainable in health care is now within reach, and “Big Data” is here to stay. As an entrepreneur on the forefront of health communications, this is an exciting time to be in the health care industry.

Providing high-quality, affordable health care is the goal across the globe, and innovations that address this issue are created every day. All stakeholders want to make health care more affordable and more accessible, and maximize the potential of Big Data. The emphasis is on value; namely, value for the patient. Innovators need to demonstrate this value to all stakeholders. Each article highlighted in this issue addresses a specific solution that leads to better patient outcomes. One such example is telehealth, a cost-saving way to use telecommunications and informatics technology to expand health care outside the walls of the pharmacy and into the community.

 also explains how the interoperability of HIT will help in the collection, documentation, and exchange of data on pharmacist-provided patient care services among other health care providers, patients, and payers, and how technological upgrades will change the way pharmacists practice. Since accurate analysis of Big Data is a must in today’s business environment, this issue contains an article on the importance of Big Data and its relationship with pharmacy. Let’s not forget the social media component in all of this: there is a growing movement to leverage the capabilities of social media and gamification for health care, and in this issue we address their roles as new members on the health care team.

We are at the forefront of this vital and changing industry, and as the leading provider for health care information, we are proud to bring you a taste of what’s to come. Thanks for reading!

Technology once thought to be unattainable in health care is now within reach, and "Big Data" is here to stay. 

Health Information Technology Brings Opportunities

On the heels of the pricing controversy that raged around the costly new class of hepatitis C drugs comes the next big drug launch, which is expected to have an impact that will reverberate throughout the specialty landscape.

On July 24, 2015, the FDA granted approval to the first cholesterol-lowering proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, Praluent (alirocumab). The PCSK9 inhibitor Repatha by Amgen is also expected to be approved by the FDA in the near future.

Praluent was approved for use in adult patients with heterozygous familial hypercholesterolemia or for patients with clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of low density lipoprotein (LDL) cholesterol.

As opposed to the currently available statins, which are taken orally and have less costly generic alternatives, PCSK9 inhibitors are self-injected monoclonal antibodies that block the PCSK9 protein from inhibiting removal of LDL from the liver. Although these drugs could offer a significant benefit, the devil, as they say, is in the details.

Praluent was launched with a cost of $14,600 annually. If the drugs are broadly approved for the approximately 2.3 million people who could potentially use PCSK9 inhibitors with such a price tag, the cost could be in excess of $23 billion annually, according to pharmacy benefit manager Prime Therapeutics.

An analysis by Prime estimates PCSK9 inhibitors could add between $0.93 and $6.71 per member per month (PMPM) to commercial insurance coverage costs and up to $15.66 PMPM to Medicare coverage costs, depending on the conditions they are ultimately approved to treat. If the drugs are prescribed to 40% of the approximately 600,000 Americans with abnormally high cholesterol levels who do not respond to statins, it could add an additional $2.1 billion annually in coverage costs.

The question remains as to whether these new drugs will be approved for each patient in this potentially huge population because payers may still try to steer patients toward less costly statins.

The bottom line is PCSK9 inhibitors dramatically decrease the amount of harmful LDL cholesterol in the bloodstream, which translates into fewer heart attacks, strokes, and other issues that stem from clogged arteries. With this unprecedented efficacy, these drugs have the potential to improve the lives of millions of patients struggling to lower their cholesterol.

I urge you to read the to read the editorial by our esteemed editor-in-chief Dan Steiber, RPh, as he considers how specialty pharmacy could be poised to manage the use of this significant new drug class.

 will remain laser-focused on this debate to provide context and insight through this journal, our daily news website, and our e-newsletters covering breaking news and clinical developments. SPT