How we use, label, study, and think about cancer drugs could make seismic changes in the pricing and access of cancer treatments for patients, but we need to rethink what we are doing first. Thought leaders from the provider, distribution, payer, and pharmaceutical arenas addressed these challenges at the 2018 combined meeting of the Association of Community Cancer Centers and the Cancer Center Business Summit. The meeting included a panel discussion about the costs of drugs, and the significant rise in the costs of cancer drugs after the US Food and Drug Administration (FDA) approval.
Part of the challenges for patients and providers on the national landscape includes the growth of new therapies and new costs, a rising financial burden on patients, common supply and demand challenges, and a demand for greater transparency in drug pricing and value.
Practical Solutions to Drug Pricing
Ira Klein, MD, MBA, FACP, Senior Director of Health Care Quality Strategy, Strategic Customer Group, Janssen Pharmaceuticals, New York City, asked attendees whether Americans are currently extracting more value than they believe, and whether oncologists are asking the right questions. He showed reports indicating that the share of drug spending growth remains steady and in line with the growth of total health spending.
Because of rebates given back to payers, the government, and the supply chain, branded drugs net price growth is significantly lower than the drug list price growth, making list price increases only part of the story.
Dr Klein noted that just as patients and families wonder about the future of diseases such as Alzheimer’s and cancer, the pharmaceutical industry, too, is looking at that, trying to create more first-in-class drugs that will help the patients they are meant to help. When people buy drugs now, they are also buying into the growth and continued innovation of treatments, looking for first-line cures, or at least ameliorating diseases, including cancer. Drug innovations have led to declining death rates from HIV/AIDS, cancer, and cardiovascular disease.
“What’s the future going to look like? The future is going to look like more first-in-class drugs for disease that we care about,” Dr Klein told attendees. We’re buying a better future, he said, and in that better future, a better definition of value. Dr Klein’s suggestions for pragmatic solutions include:
- Modernizing the drug discovery and development process, and empowering the FDA to keep pace with scientific discovery, and to increase the efficiency of generic approvals
- Promoting value by addressing barriers in the policy arena that affect value-based contracting, creating patient-centered value assessment tools, and supporting appropriate use of medicines
- Engaging and empowering patients in their treatment decision-making, and enforcing commonsense rules to prevent discrimination against vulnerable patients
- Addressing market-distorting programs, such as the 340B Drug Pricing Program.
Targeted Therapies Can Save Costs
Allen S. Lichter, MD, FASCO, Chair, Value in Cancer Care Consortium, Ann Arbor, MI, noted that when he became Chief Executive Officer of the American Society of Clinical Oncology (ASCO) in 2006, he saw the prices of cancer drugs reach around $50,000 annually.
At that time, “I said, ‘if this continues, it will be ruinous for the field of oncology,’ and then they hit $75,000, and then they hit $100,000, and then they hit $125,000, and now they are hitting $150,000. I’ve heard a thousand ideas, I’ve been on countless panels about what we are going to do about this. I’m going to show you, in a few minutes, how we can save billions of dollars, guaranteed,” Dr Lichter said.
He discussed how using clinical research could increase the value of cancer care, by moving from Choosing Wisely (the so-titled clinical campaign of recent years through which professional societies suggested 5 things annually that clinicians could stop doing) to using wisely. The Choosing Wisely campaign, with the participation of ASCO, identified 5 areas where treatment could be adjusted to help oncologists make better choices that would primarily reduce the long-term toxicity of therapy for patients.
However, Dr Lichter told listeners, a new toxicity has taken hold in cancer care: “That is the toxicity called financial toxicity—the ruinous financial burden that we are placing on patients due to the cost of today’s therapies, including drugs,” Dr Lichter said. Few studies have been designed to question how oncologists can begin to reduce this toxicity. Most attempts at reducing the cost of care have involved proposed policy changes that require regulatory or legislative action.
Many of the new, targeted agents are administered in doses that exceed what is actually needed, which raises the question of why drugs are labeled and prescribed in such a manner. Older drugs had a steep dose-response curve, and more was considered better.
New Clinical Trials Needed
Phase 1 clinical trials were conducted to determine the maximum-tolerated dose before patients fell off of a cliff, metaphorically, and that dose was then used in phase 2 and 3 clinical trials, and became the labeled dose, Dr Lichter said. But that paradigm is no longer useful in the era of targeted agents, where the targeted biomarker is often saturated at doses far below the maximum-tolerated dose.
“It is time for us to bury the concept of maximum-tolerated dose in the world of targeted therapy,” Dr Lichter said. “But where is the constituency? Who is supposed to run that trial? It’s not exactly in a company’s self-interest to say ‘let’s find out if we can invest another $50 million or $100 million in trials to see if we can sell less of our drug.’”
The Value in Cancer Care Consortium (www.vi3c.org) is beginning to organize such trials; the first trials the consortium will focus on will measure the effect of food on oral therapies. Many of our oral agents for cancer are absorbed better with food, but they are all prescribed and labeled to be administered in the fasting state.
Dr Lichter provided examples of improved absorption rates for cancer drugs taken with food as opposed to without food, including lapatinib (Tykerb: 4 times faster absorption with food), erlotinib (Tarceva: 2.1 times better absorption), nilotinib (Tasigna: 1.7 times better absorption), and abiraterone (Zytiga: 5 times better absorption).
“This is the single most practical way I have ever seen to begin to address the problem of drug pricing, and the consequences can be dramatic,” Dr Lichter emphasized.
“So we can start to bend the cost curve and improve value by performing well-designed clinical trials—which is what we do for a living in oncology. We can show that lower doses, less-frequent administration, or shorter duration yield similar efficacy,” he said. “The potential savings here is in the billions, and in tens of billions of dollars.”
This requires no legislative or regulatory change, just the efforts of dedicated oncologists working together to improve care for the benefit of our patients, Dr Lichter explained.
Clinical trials are what we do, and we do them well, he said. The Value in Cancer Care Consortium is still in a startup mode, and seeking funding to support the clinical trials in development, he concluded.
Looming Generic Drugs Crisis: The Cost Conundrum
Barry Fortner, PhD, President, Specialty Physician Services, AmerisourceBergen, Dothan, AL, voiced his concerns about the cycle of cost, from the perspective of drug distribution.
First, we will not have a true picture of the challenges until we recognize that the true errors in looking at quality are the sins of omission, not commission, Dr Fortner said. There are decades of research that show that when physicians make mistakes, they are conservative in nature (eg, underdosing, dropped dosing, reduced dosing). Physician bias appears to lean toward undertreating, he said.
When we start to take quality seriously, treatment costs can rise, according to Dr Fortner. Some value-based pilot practices have seen that they can achieve overall savings in care, but drug spending has continued to increase.
Quality measures currently in use tend to measure when physicians do something rather than when they do not do something, he suggested. When oncologists take quality seriously, we will need to recognize that the full picture is more important than just looking at the earlier, limited measures, he said.
One problem related to the current debate about drug pricing is about media and politics.
“Policy is best formed on the rule, but you should understand that politics is generally done on the exception, or on the outlier, that which is most dramatic and can drive energy,” Dr Fortner said. The outliers in healthcare are important. However, the extreme examples rarely lead to good policy that affects the whole population.
“Our most pressing crisis, by my view, right now, is not high-brand drug prices—it is low drug prices. It is low, generic drug prices,” Dr Fortner told attendees. “We have a looming crisis of drug shortages on generic drugs, and that is happening because the prices of generic drugs are so low that manufacturers are uninterested in them,” he said.
As drug distributors, we spend every day searching for these life-saving, meaningful, and helpful cancer drugs, “and they are pennies on the dollar,” Dr Fortner said.
“You would not think that, given the media on generic prices, because the media and politics are focused on the extreme examples, and on the outliers that go in the direction of raising these prices. The fact is that we now have state legislation and the threat of national legislation that paradoxically and tragically will ensure that generic prices stay low, and they will ensure that we are going to have a tsunami of drug shortages in the near future,” he continued.
Conflicting forces and challenges will likely continue to drive the debate about drug pricing and access to care in the United States. As a free market economy, every entity is going to act in its self-interest. Systems, providers, and drug manufacturers are aggregating and changing, because it is in their best self-interest to do so.
Just as providers may feel it is easier today to compete in larger groups, drug manufacturers may choose not to continue to produce certain drugs, because of cost. The nature of our culture and markets is a factor in the debate about drug pricing and access to care that we as healthcare providers cannot forget.
Conversely, physicians and hospital providers are being required to focus on value-based payment and reimbursement, now and in the foreseeable future, and their actions and messages in the public debate may help to drive new policy. And the voice of the patient is beginning to have an impact, at least in oncology.