Home

The Innovation-Competition-Affordability Connection and its Importance to Patients

June 15, 2021
12:49 pm

One of the biggest headlines in healthcare this month occurred when the Food and Drug Administration gave approval to a new treatment for Alzheimer’s disease developed by Biogen. This is a development that brought hope to the millions of individuals and their loved ones who have or will have a terrible and complex disease that is taking an increasing toll on our society.  The Biogen approval speaks to the importance of biomedical research and development in this country as well as the FDA’s Accelerated Approval Pathway program, which makes novel treatments available in areas of unmet need.

But the good news is not without controversy.  There is already criticism of the recommended market price of this product.  In that light, I found the blog post below from Genentech CEO Alexander Hardy to be relevant and insightful.  As he points out, the most effective pathway to achieve greater affordability for breakthrough medicines is to encourage more innovation and the development of competing therapeutics.  Remember the firestorm that occurred over price levels when Gilead Sciences developed a cure for Hepatitis C?  Those prices dropped precipitously when other biopharmaceutical companies developed competing products.  It’s an important lesson for policymakers that innovation is a more effective and patient-centered tool for achieving affordability than heavy-handed regulation.

I am pleased to share the perspectives of Genentech’s chief executive.

***

Innovative Medicines Demand Responsible Pricing

The FDA approval of Biogen’s new Alzheimer’s disease medicine will be, I hope, the first of many new treatment options for patients to help combat this devastating condition. With this news, there has also been much commentary on the price of the medicine.

At Genentech, we’re well aware of the challenges of developing treatments for Alzheimer’s disease. We’ve spent the last decade researching potential targets and have experienced a number of scientific setbacks. But we’re proud to remain in the fight and are currently developing three investigational medicines – two in Phase II and one nearing Phase III completion. Despite the challenges, we remain optimistic about our potential to launch one or more medicines in the future.

Alzheimer’s is one of the biggest public health challenges of our time. The impact of the disease on patients and caregivers is truly tragic and we applaud Biogen for their efforts to develop a treatment.

We believe, like many others in the industry, that the price of a medicine must be based on the benefits it provides to patients and society. Ultimately, the price must enable patients to have rapid and broad access and provide a reasonable return that will fund future R&D investments.

Given the growing worldwide incidence of Alzheimer’s disease, it’s imperative that people with the  disease have multiple treatment options to choose from. Hopefully, a number of additional medicines will be approved that deliver more benefits to patients and society. With those advances, the resulting competitive market dynamics will prevail and bring a decline in prices. The availability of more therapies should drive healthy competition, delivering savings to the healthcare system overall and ensuring patients and doctors have important choices in the medicines they receive.

There is an opportunity now for lawmakers and industry to work together on policies that will fuel efficient market-based competition. We must also provide a safety net in the form of a cap on Medicare out-of-pocket costs to ensure that patients have access to life-changing medicines.

At Genentech, we’re committed to working every day to bring even more hope for patients and caregivers living with Alzheimer’s disease. If we are successful, we will price our medicines responsibly so that they reflect the benefit they provide to people with Alzheimer’s disease and society as a whole. We’re committed to working with the U.S. Administration, Congress, and others to find sustainable, system-wide solutions that lower costs while also protecting scientific innovation and ensuring patients have access to the life-changing medicines they need.

An Innovative Approach in Minnesota to Close the Gap Between Mental Health Needs and Treatment

February 25, 2021
8:15 am

It has always been important to improve access to treatment for mental health and substance use disorders.  Now it’s imperative.

Even before the arrival of COVID-19, national numbers raised serious concerns.  Twenty percent of Americans reported experiencing depression or an anxiety disorder while also having substance abuse issues. Drug overdose deaths have more than tripled since 1990, and almost 21 million Americans have at least one addiction with only one of every 10 receiving treatment for the condition.  The pandemic has worsened our society’s struggles. According to the Kaiser Family Foundation, in August of 2020, 53 percent of adults reported that their mental health had been negatively impacted as a result of the changes wrought by COVID-19. This, in turn, has caused the number of people with substance use disorders to rise.

Now, more than ever, investments must be made to ensure access to treatment and innovative ideas must be pursued to address these mental health challenges.  One such innovation is taking place in Minnesota.

One clear obstacle patients face is the lag time between the initial request for care and the availability of specialists and treatment programs. While this wait time is occurring, there is a heightened risk of suicide, drug overdose, or a change of heart about pursuing treatment. Recognizing this dilemma, M Health Fairview initiated a new program to bridge this gap. The program is designed to provide same-day access to either in-person care or virtual care with trained providers.  Additionally, the health system has included a mobile unit that proactively brings the support directly into the community. Emergency Medicine Physician and Psychiatrist Dr. Richard Levine emphasized that this program does not replace any type of care, but rather simply provides the stability patients need in their transition from initial treatment to longer-term care.

These are difficult times for so many Americans. Health providers like M Health Fairview are demonstrating innovation and leadership in meeting the urgent needs of those with mental health or substance use disorders.

On the Precipice of a Major Stride in Healthcare Progress

August 13, 2020
4:49 pm

It actually seems elementary when you think about it.  To deliver the best possible and most cost-efficient care to patients, particularly those with complex chronic conditions, it is essential for all aspects of the healthcare system – primary care physicians, specialists, hospitals, pharmaceutical and medical device manufacturers, pharmacies, and others – to work together to coordinate patient care and deliver comprehensive treatment.

Currently, however, our federal laws and regulations prevent that type of patient-centered collaboration.  Measures known as the Stark Law and the Anti-Kickback Statute were created in the era of fee-for-service medicine to prevent bad actors from acting in ways adverse to a patient’s interests in order to gain some sort of financial benefit.  In our current transition to holistic value-based care, though, these fraud and abuse safeguards are serving as daunting legal barriers to the kind of working relationships that deliver optimal health outcomes.

We are hopeful this is on the verge of changing.  The Department of Health and Human Services has developed, with extensive public input, new rules to modernize these outdated laws and regulations and create opportunities for healthcare professionals and organizations to collaborate without fear of legal reprisal.  There will still be more than adequate protections against fraud and abuse, but the obstacles to patient-centered, value-based care will be significantly alleviated.

These new rules were submitted by HHS to the Office of Management and Budget for final review and approval last month. The Healthcare Leadership Council is one of more than 120 healthcare companies, associations, and patient advocacy groups that has asked President Trump to intervene and bring this critical work across the regulatory finish line.

As the letter to the president puts it, with the finalization of these rules “victory can be claimed in the name of helping get better coordinated care and reducing overall healthcare costs.”  We don’t see any reason to wait to begin reaping these benefits.

The Meaning of Personalized Healthcare

July 10, 2020
10:47 am

Personalized medicine is one of the very popular buzzphrases in healthcare, but not everyone has a complete understanding of what personalized healthcare means for patients, the healthcare system and the future of medicine.  HLC member Genentech has provided an important service by describing this branch of medical science and its potential in recently-published sponsored content in Politico.

In the Politico piece, Dr. Mark Lee, Global Head of Personalized Health Care, Product Development for Roche and Genentech describes personalized medicine succinctly, “Scientific and technological advancements are allowing us to leverage the vast amounts of data that we can access to help patients receive the right treatment at the right time.  Not every patient responds the same way, and it is incredibly challenging to predict who’s going to benefit from which medicine and how.  But there is now more data per patient than ever before, allowing us to hone in on the subtle differences that make each of us unique to deliver more personalized treatments that can yield better outcomes.”

As Dr. Lee points out, in addition to improving care at the patient level, having this detailed information about patients of different ages, ethnicities, genetic backgrounds and health conditions will transform and strengthen clinical trials and drug development in years to come.

I highly recommend this content in Politico to gain a greater understanding of how personalized medicine will change care delivery in the foreseeable future.

Guest Post: The Underutilization of Prevention

March 12, 2020
11:50 am

Robert Popovian is Vice President of U.S. Government Relations at Pfizer

One of the most underutilized ways to reduce medical costs in the U.S. is health care prevention. Unfortunately, politicians choose instead to implement draconian policies such as price controls or utilization management, which focus solely on cost management without any consideration given to patient outcomes or the value of an intervention to society.

The reason policymakers promote these types of measures is twofold. One, these policies are simple to implement and two, they reach their intended results quickly by reducing budgets, whether it be hospital costs or drug expenditures. On the other hand, promotion of preventative measures are complicated and challenging to implement and are thus ignored, despite the fact that the data show that such measures lead to better patient outcomes, including improvements in quality of life and productivity.

The two examples of preventative interventions that have not only shown to reduce costs but also improve outcomes are improving immunization rates and medication adherence.

Vaccines are one of the most cost-beneficial interventions in health care. In the U.S., we have done a great job ensuring our children are protected from various communicable diseases. Vaccination rates for most serious ailments are in the 90th percentile for children. However, the same cannot be said when it comes to adults, as their vaccination rates are abysmal. For example, less than 50% of adults get a flu shot every year.  What’s even more alarming is that approximately 20% of high-risk patients (e.g., patients suffering from lung disease) receive a pneumococcal vaccine. Both measures are well below the Healthy 2020 targets set by the Office of Disease Prevention and Health Promotion (ODPHP).

One approach to encourage adult vaccination is to further expand community-based pharmacist immunization capabilities. The evidence is clear that allowing pharmacists to provide vaccinations is the lowest cost alternative for providing this essential public health service. So it is vital that we expand and harmonize state laws governing pharmacist authority to immunize and to allow pharmacists to administer all Food and Drug Administration (FDA) approved and Advisory Committee for Immunization Practices (ACIP) recommended vaccines.

The second example of a cost-saving preventative intervention is medication adherence. One of the most cost-effective ways to improve patient adherence is through pharmacist-led medication synchronization. Medication synchronization is a service that has been offered for the past several years by pharmacists to patients who take multiple chronic medications.

A pharmacist collaborating with a physician and in consultation with the patient ensures that all of the patient’s medications are refilled on the same day. Pharmacists operationalize the concept by making an appointment with a patient to pick up their prescriptions every month, or at 60 or 90 days — depending on the refill schedule — and to discuss other issues pertinent to their care, such as over-the-counter medicine usage, smoking cessation needs or vaccination requirements. Medication synchronization has not only reduced the number of trips a patient has to take to the pharmacy and lessened the administrative burden for pharmacists and physicians, but most importantly it has led to better patient medication adherence and cost savings overall.

In 2014, for example, the Centers for Medicaid and Medicare Services (CMS) decided that patients enrolled in Medicare Part D plans should have the opportunity to synchronize their medications if they choose to and if it is deemed appropriate by their pharmacist or physician, not only because it improved adherence but also because of the overall health care cost reductions. In their analysis, CMS stated, “while the estimated total 6-year cost of this rule to Part D sponsors is $0.5 million, the savings to Part D sponsors and beneficiaries is $1.8 billion.” More recently, a research article published in Health Affairs suggested that patients with cardiovascular disease whose medications were synchronized were three times more adherent with their medications leading to 9% lower hospitalization and emergency department visits.

Fortunately, most states except for California and a handful of smaller ones have taken the lead from CMS to allow all patients in need to benefit from medication synchronization. It is now up to the pharmacists to offer this service universally to their patients.

No one denies that saving health care costs is a noble cause, and everyone agrees that it is not an easy task. However, policymakers are only focusing on the side of the ledger marked “cost”.  Instead, they should be implementing policies that guide us towards the goal of disease prevention to achieve the ultimate endpoint of reducing health care costs while improving patient outcomes.