Category Archives: Public Policy

Asking Congress to Get “ON IT” for Diabetes

By Topher Brooke, Vice President, U.S. Diabetes, AstraZeneca

Topher Brooke Headshot-2At AstraZeneca, we believe that real progress in improving type 2 diabetes outcomes starts with supporting patients in multiple ways, such as improving access to our medicines, providing educational programs and resources, and advocating on the patient’s behalf, to name a few. In March, we launched the ON IT Movement in partnership with Dr. Phil McGraw to raise awareness about type 2 diabetes through Dr. Phil’s personal experience, to spark further dialogue about what it’s like to live with the condition, and to motivate other patients to take action towards leading a healthier life.

Now, I’m excited that we’re taking the ON IT Movement a step further to advance the national conversation by addressing Congress on Capitol Hill, where we’ll highlight the challenges that people with type 2 diabetes face every day. Nearly 28 million Americans are living with type 2 diabetes today, with another 86 million at risk of developing it. This condition costs our society over $245 billion annually. In order for change to occur, intervention must take place at multiple levels – from prevention, education and treatment to public health and policy-making – to take early action against type 2 diabetes.

On May 11, AstraZeneca and Dr. Phil will join policymakers and advocates on Capitol Hill to ask Congress for more support of those living with and at risk for developing diabetes and call attention to the patient experience. This unique opportunity allows us to meet with members of Congress and the Senate to discuss the goals of the ON IT Movement and to advocate for their constituents whose lives are impacted by diabetes.

The highlight of the day will be the “Get ON IT for Diabetes” bicameral congressional briefing where we will discuss the growing impact of type 2 diabetes in the United States. The Congressional Diabetes Caucus co-chairs, Congresswoman Diana DeGette (D-CO) and Congressman Tom Reed (R-NY), will provide opening remarks followed by a panel discussion. In addition to Dr. Phil, the panelists will include George Grunberger, M.D., F.A.C.P., F.A.C.E., president of the American Association of Clinical Endocrinologists (AACE), Robert E. Ratner, M.D., F.A.C.P., F.A.C.E.; Chief Scientific and Medical Officer, American Diabetes Association (ADA), and Kelly Close, Founder and Editor-in-Chief of diaTribe; President and Founder, Close Concerns. Other prominent members of the type 2 diabetes community will join us to help strengthen and amplify our message to Congress, including the American Association of Diabetes Educators, Diabetes Hands Foundation, Endocrine Society and Taking Control of Your Diabetes.

So how can you help Congress get “ON IT” for type 2 diabetes and make your voice heard?

  • Visit the diabetes caucus website to learn about diabetes-related legislation that impacts Americans who live with the disease and the millions who are at risk of developing it.
  • Tell Congress the time is now to get ON IT and address the diabetes epidemic. We ask you to call or email your legislators and ask that they prioritize diabetes issues and increase support for those living with the disease. Or, you can reach out to your member of Congress via Twitter using #OnItMovement.

I also encourage you to visit OnItMovement.com to learn more about Dr. Phil and his 6 Rules for creating and sticking to a plan. While we push for progress in how type 2 diabetes is addressed and managed at a national level, it’s important to remember that even the smallest steps in the right direction can lead to significant change.

Follow @AstraZenecaUS and #OnItMovement on Twitter for updates leading up to and during our day on Capitol Hill.

“Innovation for Healthier Americans” U.S. Senate Initiative Aims to Advance R&D

On March 10, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee held its first hearing on its “Innovation for Healthier Americans” initiative. Dr. Francis Collins, Executive Director of the National Institutes of Health (NIH) and Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration (FDA) were the witnesses at the hearing. This Senate effort to accelerate the development of new cures and treatments for patients is a similar, parallel effort to the U.S. House Energy & Commerce Committee’s 21st Century Cures Initiative.  Both of these Congressional endeavors share a common goal with President Obama’s Precision Medicine Initiative, which involves increasing funding for multiple federal agencies in order to improve health information technology interoperability, while expanding and optimizing treatments for cancer in a variety of ways.

AstraZeneca supports the Senate HELP Committee’s Innovation for Healthier Americans Initiative. We provided initial recommendations to the Committee, encouraging them to focus on exploring potential enhancements to the qualification pathway for certain drug development tools, such as biomarkers. We also encouraged the exploration of ways to get the FDA to more readily embrace modern clinical trial designs and methodologies. We are encouraged that the Senate HELP Committee and the House Energy & Commerce Committee are interested in tackling this important issue and we stand ready to work with both Committees in support of their efforts to advance medical innovation during this Congressional session.

As articulated by Sen. Lamar Alexander (R-TN,) the Chair of the Committee at the hearing, the goal of this bi-partisan effort is the identification of what the Congress, along with the President, can do to reduce the cost and the amount of time it takes to discover a medicine and deliver it to patients.

While much of the discussion at the hearing centered on the need for adequate and consistent funding for the NIH and the basic science it conducts, there was also discussion of the important role that biomarkers can play in advancing personalized therapies for patients. Both Dr. Collins and Dr. Hamburg indicated their appreciation for having the opportunity to discuss what more can be done to drive innovation in our nation, with Commissioner Hamburg stating that she “wants the FDA to be a gateway, not a barrier, to getting safe and effective medicines to patients.”

Learn more about the Innovation for Healthier Americans initiative here and follow the latest on 21st Century Cures with #Cures2015 on Twitter.

AZ Supports 21st Century Cures Initiative

By Jacqueline Kirby, Vice President, US Government Affairs

Jacqui KirbyCongress recently moved biomedical innovation in the United States forward in a significant way, as the House Energy and Commerce Committee unveiled its draft 21st Century Cures Initiative legislation and the Senate HELP Committee released its “Innovation for Healthier Americans” report.

We at AstraZeneca support the 21st Century Cures Initiative as we noted last August. We believe it is an important step toward encouraging the discovery of cures and treatments for some of the most debilitating diseases and conditions while helping to ensure that the United States remains at the forefront of biomedical research.

The 21st Century Cures Initiative is designed to “take a comprehensive look at what steps we can take to accelerate the pace of cures in America.” The House E&C Committee examined “the full arc of this process – from the discovery of clues in basic science, to streamlining the drug and device development process, to unleashing the power of digital medicine and social media at the treatment delivery phase,” as noted in the mission statement.

Upon initial review, we are pleased to see that the draft of legislation addresses many of the topics we included in our written recommendations to the Committee, including biomarkers, antibiotic drug development and reimbursement, utilizing real world evidence for regulatory decision-making, modernizing clinical trials (through encouraging broader use of Bayesian statistics and adaptive trial designs), and FDA review and evaluation of combination products.

AstraZeneca likewise applauds the Senate HELP Committee’s release of the “Innovation for Healthier Americans” report. “’Innovation for Healthier Americans’ is an important call to action, soliciting input and participation from the full universe of stakeholders interested and/or involved in medical innovation in America,” former FDA Commissioner Dr. Andrew von Eschenbach wrote in introducing the report. The report aims to examine the current drug development process, identifying inefficiencies in this process that stand in the way of bringing new medicines to patients and soliciting stakeholder feedback.

AstraZeneca is committed to working closely with members of Congress on the 21st Century Cures Initiative and on the related Senate FDA reform effort in the months ahead to ensure the United States remains a leader in biomedical research.

21st Century Cures Twitter 2.2.15

Personalized Healthcare: More Targeted Medicines, Partnerships

By Paul Hudson, President, AstraZeneca US and Executive Vice President, North America

As science continues to evolve in the 21st century, medicine, treatments and diagnostics are getting smarter and more targeted to patient groups and individual patients. The healthcare system is moving away from a one-size-fits-all approach to treating diseases and toward an increased focus on personalized healthcare, which tailors treatments to patients as effectively and efficiently as possible.

141021-Hudson-0285 prefAt AstraZeneca, we’re working relentlessly to do our part to provide more targeted treatments for patients – from the molecules in our pipeline to our partnerships throughout the healthcare sector.

Pipeline

Our medicines and our pipeline of new molecules are the foundation of everything we do. We know that identifying patient subgroups in which a medicine is most effective can help doctors make faster, more accurate treatment decisions. As patients continue to become increasingly involved in their own care, we’re seeing a need for innovative approaches to better deliver personalized, end-to-end treatments. This allows us to reach the right patients in the right ways at the right times with the right medicines – an important factor in successfully treating some of the world’s most deadly diseases. Investing in targeted therapies also provides the best economic value and cost savings for the healthcare system because the treatments reach precisely the patients they are intended to help, with the greatest amount of efficacy.

In order to determine the most appropriate treatment for patients, we need to be able to analyze in rapid form. At AstraZeneca, more than 80 percent of the molecules in our pipeline have been evaluated for their personalized healthcare potential. We estimate that nearly half of our product launches between now and 2020 will use a companion diagnostic to target the patients most likely to benefit. What happens to each individual patient is becoming more relevant, and we’re facing a situation for the first time where information and data are overlapping with medicines and research & development.

For example, tumor testing has long been the gold standard for determining a patient’s epidermal growth factor receptor (EGFR) status, which is seen in many patients with non-small cell lung cancer. However, many patients do not have a tumor sample or have one of insufficient quality to test. To reach these patients, AstraZeneca is collaborating to develop blood-based testing methods that detect minute quantities of DNA that can, in turn, detect mutations like EGFR.

Put simply, blood-based testing is faster, cheaper and less invasive for patients. Over time, these personalized approaches to care could have the potential to improve the overall survival rate of patients treated for cancer, giving us the potential to change outcomes for patients on a meaningful scale.

Health System Benefits

More targeted medicines and tests alone are not the only answer. In order to forge new approaches and generate the most value from innovation, we need to recognize that no one company has all the good ideas; it takes multiple partnerships and extensive collaboration to reach our goals. Partnerships are helping to drive more intense value and delivery across the industry, as highly skilled drug development teams and diagnostic partners are working with the world’s regulatory authorities to help shape the treatment pathways for personalized healthcare and support smart clinical trial design.

Innovative technologies allow for laser-guided patient focus. We can develop integrated biomarker and diagnostic plans that will speed development and deliver personalized treatments for patients. For example, Lung Cancer Master Protocol (Lung-MAP), for which AstraZeneca is a pioneering contributor, serves as a way to use genomic profiling to match patients to one of several investigational drugs that are designed to target genomic alternations found to be driving the growth of their cancer.

Working together – with researchers, regulators, payers, policymakers and key stakeholders – we can deliver more effective treatments on a patient-by-patient basis that will ultimately improve health for individuals, families and society as whole.

Paul Hudson is President, AstraZeneca US and Executive Vice President, North America. You can see him speak on medical research at Bloomberg here.

AZ Submits Recommendations to the Committee on Energy and Commerce to Better Serve Patients

With 3D printers that create human body parts to wearable technologies that transmit patients’ vitals in real-time to physicians, the paradigm of drug development is changing more rapidly than ever before. While the opportunities for innovation are boundless, recent figures from FasterCures, a center of the Milken Institute, suggest that there are still only 500 treatments available for an estimated 7,000 known diseases.

AZ1442_screenAt AstraZeneca, we’re committed to pushing the boundaries of drug development to get our medicines in the hands of those who need them most. This isn’t easy. For example, according to PhRMA, it takes drug companies 10-15 years to develop a new medicine, and costs $1 billion on average. For good reason, there are many laws and regulations that govern every step of the development process, but we need to ensure these laws do not unnecessarily hinder  innovation.

That’s why we’re excited to see the Committee on Energy and Commerce, part of the U.S. House of Representatives, taking a comprehensive look for the first time at how they can help pave the way for new cures and treatments for patients through the 21st Century Cures Initiative. The Committee on Energy and Commerce has  responsibility for a number of the nation’s key priorities, including food and drug safety, and oversight of multiple agencies like the Food and Drug Administration. Over the next several months, the Committee will continue to focus its efforts on finding ways to expedite the discovery, development and delivery of innovative treatments to patients. Representatives will examine how we conduct research, looking at newly available technologies and assessing the need to break down outdated administrative and procedural hurdles, to ensure the U.S. remains a leader in biomedical innovation. And they’re asking for input.

21st Century CuresMany key industry stakeholders have submitted recommendations to benefit the healthcare industry and patients around the world. On August 12, the President of AstraZeneca U.S., Paul Hudson, and Chief Medical Officer, Briggs Morrison, pledged our support for the initiative and submitted our recommendations, which:

  • ask the Committee to support translational research (research that turns basic discoveries into applicable outcomes);
  • encourage the modernization of the clinical trial ecosystem;
  • promote the regulatory acceptance of modern clinical trial designs, tools and methodologies; and
  • suggest that the Committee ensure that payers and formularly committees have relevant information about medicines from manufacturers to speed patient access to newly developed medicines.

It is our hope that these recommendations, taken together, can help to transform the healthcare industry, improve the lives of patients and dramatically enhance the current standard of care. We’ve already had several discussions with the Energy and Commerce Committee, and we applaud their efforts to look at how the Congress can play a role in accelerating progress in advancing medicine. We look forward to continuing this dialogue as part of our efforts to deliver on our ambition to achieve scientific leadership.

Successful Outcome on Medicare Part D Reminds Us Why Advocacy is Important

By Chuck Ingoglia, Senior Vice President of the National Council for Behavioral Health

Chuck Ingoglia, Senior Vice President, Public Policy and Practice Improvement, National Council  for Behavioral Health

Chuck Ingoglia, Senior Vice President, Public Policy and Practice Improvement, National Council for Behavioral Health

In January, the Centers for Medicare & Medicaid Services (CMS) surprised the patient and provider community when it issued a proposed rule seeking to make unprecedented changes to the successful and popular Medicare Part D drug program.   One of the most concerning of these proposed changes was the introduction of new criteria to evaluate the “drug classes of clinical concern,” most commonly referred to as the six protected classes.  These six “protected” classes of medications were identified by CMS during the implementation of the Medicare prescription drug benefit as needing special access for patients and providers, including drugs to treat mental illness, organ transplant, cancer, HIV and seizure disorders.

The proposal not only introduced new criteria, but it applied these criteria to the  protected classes and proposed removal of two classes in plan year 2015 – immunosuppressants and antidepressants – as well as removal in plan year 2016 for antipsychotics.  After hearing from patients, providers, legislators and the pharmaceutical industry, including the National Council for Behavioral Health and AstraZeneca, CMS announced on March 10th that it would abandon its recent proposal to strip mental health and immunosuppressant drugs of their protected status in Medicare Part D.

CMS’ decision comes on the heels of an overwhelming outpouring of bi-partisan support that was the result of unified and swift advocacy.  In addition to the National Council and AstraZeneca, members of Congress, the Partnership for Part D Access, and other concerned patient and provider groups submitted well over 1,000 comments to CMS opposing the changes.  This reversal demonstrates the power of various sectors working together – providers, patients and industry.

The National Council and AstraZeneca applaud CMS for its decision not to finalize the proposed changes to the protected class policy.  This change will allow millions of the most vulnerable beneficiaries to continue to confidently rely upon Medicare to provide them the drugs they need.

CMS noted it will gather additional input and reserves the right to advance changes in these areas in future years, and this possibility necessitates ongoing vigilance and willingness to continue to work together on matters of common interest.  The National Council and AstraZeneca are committed to such a partnership to preserve patient access and choice within the Part D program.

Chuck Ingoglia is Senior Vice President, Public Policy and Practice Improvement for the National Council  for Behavioral Health. There he directs the federal and state affairs function and oversees practice improvement and technical assistance programs offered to more than half a million behavioral health professionals.

 

Keeping Prescription Drugs Accessible

The Medicare Prescription Drug program, Medicare Part D, has been a successful public-private program that has literally changed lives by providing improved access to prescription drugs.  We believe it works for the seniors who rely on it and that its competitive, market-based structure has kept overall program costs low.  For these reasons, we have suggested:  Don’t mess with success.

We do not support policy proposals that suggest altering the benefit structure for those who receive Part D’s low-income subsidy (LIS).  These patients are among the most vulnerable in the program and stand to be harmed by proposals that would lower nominal co-pays on generics, while increasing brand drug co-pays.

Changing Part D prescription drug cost-sharing policies may have negative consequences for the people the program serves.  First, decreasing or eliminating some co-pays while increasing others can impact the prescribing decisions of physicians who are best suited to provide care and make clinical treatment decisions for their patents.  Second, a policy to encourage generic medication use by increasing co-pays for brand medicines assumes that patients’ financial considerations drive physicians’ prescription choices, as opposed to severity of illness or other health factors.

At AstraZeneca, we believe in the right medicine for the right patient.  Sometimes the right medicine will be a generic drug and sometimes a patient will require a branded product.  This decision is made by the  physician, and when a branded product is recommended, arbitrary cost-sharing proposals should not render the medication out of reach for the patient.  Generics are not always medically appropriate substitutes for brand medicines in a given class of drugs, and for the treatment of some diseases, a generic version of a branded drug may not even exist.

It should be noted that MedPAC, an independent Congressional agency that advises Congress on issues affecting Medicare, shows high generic use among Part D enrollees – approximately 74 percent of LIS beneficiary prescriptions in 2011.

LIS beneficiaries  – a group that MedPAC says are more likely to be disabled and tend to have a greater disease burden than non-LIS enrollees – would as a result be gravely impacted by any proposed changes to increase brand medicine co-payment amounts.  These proposals unfairly penalize patients who need brand medicines rather than generics, and patients who need multiple brand drugs, including those with chronic conditions who need medications on a regular, sometimes monthly basis.

If faced with higher out-of-pocket expenses, the most vulnerable Part D patient population may attempt to switch to less costly alternatives or worse – may delay or forego their use of prescribed medicines.  Such an outcome may actually lead to higher overall Medicare costs.  In 2012, the Congressional Budget Office (CBO) acknowledged that policies that increase the use of prescription medicines would decrease Medicare medical spending, and we believe the converse to be true as well. We want to encourage adherence, not discourage it.

In the end, it comes down to choices we like and those we don’t.  Medicare Part D beneficiaries have an increasing number of plan options in 2014 from which to choose – that’s a good thing.  Beneficiaries making choices that vary from their physicians’ recommendations, likely leading to higher overall healthcare costs – that’s a bad thing.  That’s why we return to the same refrain about Medicare Part D:  Don’t mess with success.

New Law Protects Patients from Unsafe Medicines

While the U.S. pharmaceutical distribution supply chain is considered among the safest and strongest in the world, public health experts agree it is critical to remain vigilant in protecting it against infiltration and unsafe medicines.  In an effort to safeguard this complex and critical system and ensure Americans receive safe medications, President Obama has signed into law the Drug Quality and Security Act.

The new law enhances the security of the U.S. supply chain by establishing one uniform, federal standard for drug traceability.  Its enactment prevents the development of a patchwork of potentially conflicting state laws that would make manufacturer compliance difficult, and that would not adequately protect patients in all fifty states.

This law’s enactment is a significant and long awaited achievement.  It provides patient safety benefits through provisions based on the strongest state models.  The law also grants the Food and Drug Administration (FDA) new authorities and enhanced oversight to minimize the risk of illicit trade in the U.S. distribution network.  It requires that prescription drug packaging utilize serialization and advanced technologies to trace the source of prescription products and their distribution histories from the manufacturer to the pharmacy counter.  Further, it will institute an unprecedented accountability system that significantly improves the ability of the FDA and the industry to promptly recall products.

Working collaboratively and developing strategic alliances is an integral part of AstraZeneca’s global product strategy.  The company supported this legislation in Congress,  actively  working with legislators, industry groups and other stakeholders to ensure its passage.  AstraZeneca appreciates Congressional members’ commitment to this issue, and looks forward to continued efforts to implement this law which will help to make certain that the drugs patients receive are safe and effective as they travel through the U.S. supply chain.

Take Time to Evaluate Options During Medicare Part D Enrollment

AZ Stock_10.25.13With Medicare enrollment now open, seniors across the country have an opportunity to select the Part D prescription drug plan that best suits their needs and budgets – and that may mean making a change from the previous year.

However, a recently issued Kaiser Family Foundation report indicates that on average, only 30 percent of Medicare Part D enrollees choose to switch plans during the annual enrollment period.  The same study showed that the average premium is expected to increase by five percent across all prescription drug plans from 2013 to 2014, unless enrollees select lower-priced plans.

With a number of changes to Medicare prescription drug plans in 2014, and with 13 percent more stand-alone plan options available than last year, understanding the plans and shopping around for the right one might be warranted and might mean decreased costs for some Medicare Part D enrollees.  Premiums and out-of-pocket expenses aside, exploring different plans might also lead to increased convenience and quality in coverage.

Seniors can leverage a number of tools available, such as the government’s online plan finder and other resources to fully evaluate their options and select the right plan for them this year.

How Will the Affordable Care Act Impact Rx Savings Programs?

Fundamental changes are coming to the U.S. health system when the new health insurance marketplaces or “exchanges” established as part of the Affordable Care Act take effect on January 1.  Tens of millions more Americans are expected to be covered by health insurance – including prescription drug coverage – as a result of this and other reforms.

We are regularly asked how the new health law will impact our business and what it will mean for our prescription savings programs, which helped 562,000 patients save $1.2 billion on nearly 4.6 million free prescriptions in 2012.

But will there be a need for these savings programs if patients have insurance plans that cover prescription medicine costs? If so, how will the programs be different?

We sat down with Jennifer McGovern, who runs AstraZeneca’s prescription savings programs, to get her perspective about what – if any – changes will be coming to the AZ&Me patient assistance programs.

Watch this brief video for highlights of our conversation, and click here for a full transcript.

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