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NCCS Joins Cancer Leadership Council Recommendations to FDA Regarding the Biosimilar Action Plan

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NCCS joined with other organizations of the Cancer Leadership Council (CLC) in commenting on the Food and Drug Administration’s (FDA) Biosimilar Action Plan (BAP). The comment letter commended the FDA for the development of a plan that balances both innovation and competition. The letter stated that these products provide significant benefits to cancer patients, but that they also come at a significant expense to patients and the health care system.

In the letter, the groups explained that patient-centered communication efforts around education on biosimilars are important, and recommended product-specific efforts that will inform patient decision-making, including whether a product is a biosimilar or also an interchangeable product. The letter states, “Information about biosimilars that is accessible to the patient will support informed decision-making and long-term management of cancer and treatment side effects.”

Read the full CLC Letter below.

Download the CLC Letter

CANCER LEADERSHIP COUNCIL

A PATIENT-CENTERED FORUM OF NATIONAL ADVOCACY ORGANIZATIONS
ADDRESSING PUBLIC POLICY ISSUES IN CANCER

September 21, 2018

Scott Gottlieb, MD
Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Re: FDA-2018-N-2689, Facilitating Competition and Innovation in the Biologicals Products Marketplace; Request for Comments

Dear Dr. Gottlieb:

The undersigned cancer organizations are writing to comment on the Biosimilars Action Plan: Balancing Innovation and Competition and the proceedings of the public meeting on biosimilars held on September 4, 2018. We appreciate the opportunity to comment.

We commend the Food and Drug Administration (FDA) for the development of the Biosimilar Action Plan (BAP) articulating a strategy balancing innovation and competition. Biological products have provided significant benefits to cancer patients and are critical elements of cancer care for patients with a wide range of cancer diagnoses. As FDA noted in the BAP, these products have also come at significant expense to the health care system and to individual patients. Protecting access to the benefits of biological products and addressing the cost of these products to patients are important goals of the BAP and goals that, if realized, will benefit patients.

One of the four goals of the action plan is “developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors.” The action plan identifies deliverables related to this communications goal, including: 1) a Biosimilar Education and Outreach Campaign, including an updated FDA Biosimilars website; 2) a webinar providing an overview of the regulatory framework for approval of biosimilars; and 3) a Reddit Ask me Anything (AMA) forum to engage pharmacists on biosimilars. These initial efforts are solid, but we recommend that FDA turn its attention to communications efforts that will directly reach patients and their care teams.

The cancer organizations below are dedicated to a system of cancer care that supports informed decision-making about cancer treatment and includes access to adequate and accurate information supporting patient-centered treatment decisions. For some patients, adequate data and appropriate diagnostic testing support the choice and delivery of targeted therapies. For others, information about their treatment regimen is critical to developing a plan for managing cancer as a chronic disease, including appropriate symptom management. Information about biosimilars that is accessible to the patient will support informed decision-making and long-term management of cancer and treatment side effects.

We note that biosimilar communications efforts to date have focused on overall understanding of biosimilars and their regulatory review. These are important efforts, but we recommend product-specific efforts that will inform patient decision-making. Such educational materials might address whether a product is a biosimilar or also an interchangeable product.

The issue of patient education about biosimilars was one of many areas of focus during the September 4, 2018, meeting. FDA officials asked some patients and patient advocates if information about biological reference products is also necessary for patients, if information about the approval of biosimilars is, in the eyes of patient advocates, critical to patients. In days after the meeting, trade press publications have reported that FDA officials have recommended that the agency produce patient educational materials about the analytical studies that are used to support biosimilar approvals. At the same time, those officials have suggested that patients may not be able to interpret materials about analytics.

We agree that the development of patient-centered materials that would include information about the analytical basis for biosimilar approvals will not be an easy task. We also agree that use of these materials by patients will be a challenge, but we anticipate that these materials would be utilized by patients with their cancer care team and that this collaborative approach would increase the usefulness of the materials. Despite the obstacles, we think that the effort deserves the attention of the agency, and we stand ready to bring our expertise in development of patient materials to a collaboration with the agency. This task is worth our attention and effort because it holds the promise of reassuring patients and the patient community about biosimilars and also providing information to inform treatment decision-making, as we describe above.

There has also been some suggestion that biosimilars should be the subject of post-marketing studies. We suggest that FDA evaluate whether biological reference products and biosimilars might be the subject of real world evidence data collection. Perhaps employing real world evidence efforts in connection with biological reference products and biosimilars used in cancer treatment would be a first step and pilot project for the concept. We understand this is not a simple matter. However, the effort might yield important information for patients, providers, product developers, and the agency.

We appreciate the opportunity to comment on the BAP and look forward to collaborating with the agency on patient education materials.

Sincerely,

Cancer Leadership Council
American Society of Clinical Oncology
CancerCare
Children’s Cause for Cancer Advocacy
Fight Colorectal Cancer
Hematology/Oncology Pharmacy Association
International Myeloma Foundation
The Leukemia & Lymphoma Society
LIVESTRONG
Lymphoma Research Foundation
National Coalition for Cancer Survivorship
Ovarian Cancer Research Fund Alliance
Prevent Cancer Foundation
Sarcoma Foundation of America
Susan G. Komen

Read more NCCS Policy Comments »

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https://www.canceradvocacy.org/blog/nccs-joins-clc-letter-hhs-drug-pricing-blueprint-american-patients-first/

https://www.canceradvocacy.org/policy-comments/nccs-statement-hhs-final-rule-short-term-health-plans/

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NCCS Statement on the Passage of the STAR Childhood Cancer Act and the Right to Try Act

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Silver Spring, MD – The National Coalition for Cancer Survivorship issued the following statement regarding passage of both the Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act (S. 292) and the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act (S. 204). Both are now headed to the President’s desk to be signed into law.

“Passage of the Childhood Cancer STAR Act is a significant achievement in the effort to expand pediatric cancer research and treatments for children with cancer. We are especially encouraged by the survivorship elements included in the bill, including a provision to expand research on late effects on childhood cancer survivors to help improve their quality of life. We are grateful to Senators Jack Reed (D-RI), Shelley Moore Capito (R-WV), Chris Van Hollen (D-MD), and Johnny Isakson (R-GA) for championing the bill in the Senate, and to U.S. Representatives Michael McCaul (R-TX), Jackie Speier (D-CA), Mike Kelly (R-PA), and G.K. Butterfield (D-NC) in the House.

“While passage of the STAR Act was welcome news, we are concerned by passage of Right to Try legislation. NCCS respects the desire of individuals with terminal illness to seek access to experimental treatments. Clinical trials are the best option, and patients who are not eligible to participate in trials can request ‘compassionate access.’ There are barriers to compassionate access, but the Food and Drug Administration (FDA) approves virtually all requests for compassionate access to unapproved therapies. Removing the FDA from any oversight of unapproved therapies will not ensure access to experimental therapies and may cause unintended harm to patients by exposing them to unsafe and ineffective experimental therapies. NCCS joined with other patient advocacy organizations to oppose the Right to Try legislation, and we urge that additional patient safety protections be incorporated at the agency level.”

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Related Posts

NCCS Joins Cancer Leadership Council to Oppose Right to Try Legislation in the House

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Health Care Roundup: 2018 Cancer Status Report; Childhood Cancer STAR Act Passes; “When a Rural Hospital Shuts Down;” and More

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In order to bring you the latest cancer-related health care policy and news, we at NCCS combined our ACA Updates and What Caught Our Eye (WCOE) content into a weekly email and blog post. We aim to make this a concise, one-stop summary of what you need to know as we continue working together to make cancer care better for everyone.

Your feedback is always welcome to make our content more useful to you. Please send comments to feedback@canceradvocacy.org.

Subscribe to our email list and receive these updates in your email box each week »

HEALTH CARE HIGHLIGHTS

Annual Cancer Status Report Released

On Tuesday, the Annual Report to the Nation on the Status of Cancer was released. This report is a collaborative effort of NCI, CDC, ACS, and NAACCR. The report includes mortality data through 2015. It shows that, from 1999 to 2015, overall cancer death rates decreased by 1.8 percent per year among men and by 1.4 percent per year among women. From 2011 to 2015, death rates decreased for 11 of the 18 most common cancer types in men and for 14 of the 20 most common cancer types in women.

The annual report found that overall death rates from cancers continue to decline, and five-year survival rates are high for early-stage prostate, breast and colorectal cancer. However, survival rates are much lower for all stages of lung cancer, the report said, and a rise in liver, pancreatic and uterine cancer is stirring concern.

Congressional Budget Office Releases Report on Federal Subsidies for Health Insurance

The nonpartisan Congressional Budget Office (CBO) released a report this week entitled, “Federal Subsidies for Health Insurance Coverage for People Under Age 65: 2018 to 2028.” As The Hill reports, ACA premiums “are expected to rise an average of 15 percent next year, an increase largely due to the GOP’s repeal of the law’s individual mandate.”

The report explains the increases:

The market for nongroup health insurance (that is, insurance bought individually rather than through an employer) is expected to be stable in most areas of the country over the decade. Premiums for benchmark plans, which are the basis for determining subsidies in that market, are projected to increase by about 15 percent from 2018 to 2019 and by about 7 percent per year between 2019 and 2028.

The article from The Hill goes on to say:

The CBO estimates that gutting the requirement that Americans have health insurance or face a tax penalty will contribute to about a 10 percent rise in premiums for 2019, with insurers expected to see healthier people dropping out of the marketplaces, leaving sicker enrollees on the plans.

The nonpartisan agency attributed the rest of the expected increase to rising health-care costs and the lack of insurers receiving a key ObamaCare payment compensating them for subsidizing out-of-pocket costs for certain enrollees.

Congress Approves Right to Try Bill

This week, the House passed the same right to try bill that was approved in the Senate in August. As the New York Times explains, the bill would “allow dying patients to bypass the Food and Drug Administration and obtain an ‘investigational drug’ with the approval of their doctors, if the drug manufacturer agrees to supply it.”

Even though the FDA currently approves virtually all requests for access to unapproved therapies, once this bill is signed into law the FDA would be largely left out of the equation and would not oversee the right-to-try process. This change caused several patient advocacy organizations, including NCCS, to warn that patients may be put at risk due to unsafe and ineffective experimental therapies. Drug manufacturers would have to report “adverse events”—safety problems, including premature deaths—only once a year. The agency also would be restricted in how it used such information when considering the experimental treatments for approval.

The bill will now head to President Trump’s desk. He has urged Congress on several occasions to pass the bill.

Congress Passes Childhood Cancer STAR Act

As the Children’s Cause for Cancer Advocacy announced this week, “the House of Representatives passed the most comprehensive childhood cancer legislation ever introduced. The Childhood Cancer STAR Act now heads to President Trump to be signed into law.” The original sponsors of the Childhood Cancer STAR Act are Senators Jack Reed (RI), Shelley Moore Capito (WV), Chris Van Hollen (MD) and Johnny Isakson (GA) and Reps. Michael McCaul (TX), Jackie Speier (CA), Mike Kelly (PA) and G.K. Butterfield (NC).

While the legislation is not yet funded, “the STAR Act is an important bipartisan effort designed to advance pediatric cancer research and child-focused cancer treatments, while also improving childhood cancer surveillance and providing enhanced resources for survivors.”

CHART OF THE WEEK


Poll: Voters’ biggest health care concern is their personal costs—not the ACA or Single Payer

A Kaiser Health Tracking Poll found that “health care is among the top issues that voters want to hear candidates talk about during their congressional campaigns but ranks much lower among Republican voters, including those living in areas where there are competitive House, Senate, and Governor’s races.”

IMPORTANT READS

When a rural hospital shuts down

Via Axios

When rural hospitals close, their communities often lose their biggest employers and closest access to health care, struggling to stay afloat in the aftermath. And that’s happening a lot as the health care industry keeps consolidating—83 rural hospitals have closed since 2010, according to the North Carolina Rural Health Research Program. Read More »

New Cancer Treatments Lie Hidden Under Mountains of Paperwork

Via New York Times

In the United States, there is no single format used by all providers, and hospitals have no incentive to make it easy to transfer records from one place to another. The medical records mess is hobbling research and impeding attempts to improve patient care. Read More »

Obamacare tied to earlier cancer detection in young women

Via Reuters

Under the Affordable Care Act (ACA) provision allowing adult children to stay on their parents’ health insurance policy until age 26, young women with gynecological cancers were diagnosed and treated sooner, researchers say.

The immediate extension of insurance coverage to dependents under age 26 by the ACA in 2010 resulted in improved insurance coverage rates and earlier stage at diagnosis of uterine cancer in young women aged 21 to 25. Read More »

A related article from the New York Times: “Women With Breast Cancer Delay Care When Faced With High Deductibles”

Many cancer patients juggle care along with financial pain

Via Associated Press

Research has found that cancer patients are more than twice as likely as those without the disease to declare bankruptcy. More than 1.7 million new cancer cases will be diagnosed this year. Who winds up in financial trouble will depend on factors like the patient’s income, savings and insurance coverage. It’s not just the treatments that cause financial strain. Patients or parents of children with cancer often miss work or take on unexpected costs while traveling for care. Read More »

NCCS Policy Comments Capitol

NCCS Joins Cancer Leadership Council to Oppose Right to Try Legislation in the House

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US CapitolThe National Coalition for Cancer Survivorship joined with other organizations of the Cancer Leadership Council (CLC) in a letter to House leadership to oppose House consideration of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act (S. 204).The legislation passed the House on May 22 and goes to the President for his signature.

The barriers to access to unapproved therapies do not relate to FDA action on requests. Therefore, limiting FDA review will not ensure access to experimental therapies, as suggested by Right to Try proponents. Removing FDA from oversight of the patient requests could put patients at risk due to unsafe and ineffective experimental therapies.CLC Letter to House leaders on Right to Try bill

Read the full letter below.

CANCER LEADERSHIP COUNCIL

A PATIENT-CENTERED FORUM OF NATIONAL ADVOCACY ORGANIZATIONS
ADDRESSING PUBLIC POLICY ISSUES IN CANCER

May 21, 2018

The Honorable Paul Ryan
Speaker
United States House of Representatives
H-232, The Capitol
Washington, DC 20515

The Honorable Nancy Pelosi
Minority Leader
United States House of Representatives
H-204, The Capitol
Washington, DC 20515

Dear Speaker Ryan and Leader Pelosi:

The undersigned cancer organizations, representing patients, physicians, other health professionals, and researchers, write to express opposition to House consideration of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act (S. 204).

Our organizations have in recent months expressed serious reservations about Right to Try legislation, because we were concerned that the measures could expose patients to harm unnecessarily. The current Food and Drug Administration expanded access program results in approval of virtually all requests for access to unapproved therapies, so removing the agency from the review of such requests is not necessary. The barriers to access to unapproved therapies do not relate to FDA action on requests. Therefore, limiting FDA review will not ensure access to experimental therapies, as suggested by Right to Try proponents. Removing FDA from oversight of the patient requests could put patients at risk due to unsafe and ineffective experimental therapies.

Despite our fundamental misgivings about the Right to Try legislative effect, we have acknowledged that the House or Representatives-passed version of the bill (H.R. 5247) incorporated some patient safeguards, including more robust informed consent requirements, FDA oversight of the process, and a more precise definition of eligibility for the pathway to unapproved therapies.

The plan of the House of Representatives to consider the Senate-passed bill and essentially abandon its work in strengthening the Right to Try legislation is not in the best interests of the cancer patients and health care professionals we represent. This step moves in exactly the wrong direction.

We urge the House to withhold action on S. 204, the Senate-passed Right to Try bill, and instead stand by the current expanded access program that balances the demands of patients for access to unapproved therapies and the responsibility of FDA to protect patient safety.

Sincerely,

Cancer Leadership Council

American Society of Clinical Oncology
The Children’s Cause for Cancer Advocacy
Fight Colorectal Cancer
Hematology/Oncology Pharmacy Association
International Myeloma Foundation
Kidney Cancer Association
The Leukemia & Lymphoma Society
Lymphoma Research Foundation
National Coalition for Cancer Survivorship
Prevent Cancer Foundation
Susan G. Komen

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Download the letter » [PDF]

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NCCS Joins Cancer Leadership Council to Oppose the Latest Version of Right to Try Act

NCCS Joins Letter Expressing “Serious Reservations” About “Right to Try” Legislation

Read more NCCS Policy Comments »

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NCCS Joins Cancer Leadership Council to Oppose the Latest Version of Right to Try Act

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US CapitolNCCS joined the Cancer Leadership Council to express serious reservations about the latest version of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, released on March 10, 2018.

We oppose the latest version of right to try legislation because it makes a hollow promise to patients and removes the Food and Drug Administration (FDA) from approval and consultation in the expanded access process, a change that is not in the best interest of people with cancer.

Read the full letter below.

CANCER LEADERSHIP COUNCIL

A PATIENT-CENTERED FORUM OF NATIONAL ADVOCACY ORGANIZATIONS
ADDRESSING PUBLIC POLICY ISSUES IN CANCER

March 13, 2018

The Honorable Paul Ryan
Speaker
House of Representatives
H-232, The Capitol
Washington, DC 20515

The Honorable Nancy Pelosi
Minority Leader
House of Representatives
H-204, The Capitol
Washington, DC 20515

Dear Speaker Ryan and Leader Pelosi:

The undersigned cancer organizations, representing cancer patients, health care professionals, and researchers, are writing to express serious reservations about the latest version of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, released on March 10, 2018. We oppose the latest version of right to try legislation because it removes the Food and Drug Administration (FDA) from approval and consultation in the expanded access process, a change that is not in the best interest of people with cancer.

Our organizations have over many years sought to improve access to investigational agents while still protecting the research, development, and regulatory review of new agents. We have focused on improvements to the expanded access process, better communication about expanded access to physicians and patients, and more transparency from drug developers about their policies on expanded access. These enhancements in the process – and some efforts still underway or in implementation phase – have made a substantial difference in how patients obtain access to investigational agents.

As we have sought improvements in the process, we have maintained that FDA should remain a part of the expanded access process. The judgment of the agency about patient access to investigational agents is critical to protecting patients and ensuring them appropriate access to investigational agents.

In fact, FDA approves virtually all the expanded access requests that are presented to the agency. The agency is not the obstacle to patient access to investigational agents. If there are problems in submitting requests to the agency, those problems might be addressed through even more intensive education and outreach. Expanded access to investigational agents may be impeded by the decisions of drug developers attempting to complete their development programs. Right to try legislation will not address the decisions that drug developers make regarding expanded access.

We oppose the latest version of the right to try legislation because it makes a hollow promise to patients that, by removing FDA from the expanded access process, they will be assured access to investigational agents. And by removing FDA from the expanded access process, the legislation eliminates important protections for patients.

We urge that the House reject the right to try legislation.

Sincerely,

Cancer Leadership Council

American Society of Clinical Oncology
CancerCare
The Children’s Cause for Cancer Advocacy
Fight Colorectal Cancer
Hematology/Oncology Pharmacy Association
International Myeloma Foundation
The Leukemia & Lymphoma Society
Lymphoma Research Foundation
National Coalition for Cancer Survivorship
Prevent Cancer Foundation
Sarcoma Foundation of America
Susan G. Komen

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Download the full letter » [PDF]

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NCCS Joins Letter Expressing “Serious Reservations” About “Right to Try” Legislation

Read more NCCS Policy Comments »

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NCCS Joins Letter Expressing “Serious Reservations” About “Right to Try” Legislation

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NCCS joined with colleagues in the Cancer Leadership Council to express serious reservations about proposed “right to try” legislation that will remove the Food and Drug Administration (FDA) from the approval process for patient access to an investigational therapy outside a clinical trial. NCCS does not believe that right to try legislation removing FDA from the expanded access process will protect the interests of people with cancer and in fact may do harm to cancer patients. NCCS and the Cancer Leadership Council urge opposition to right to try bills if they are brought to the House floor for a vote.

NCCS is mindful of the wishes of patients for access to all possible treatment options, which may include access to investigational therapies outside a clinical trial. We have worked diligently over many years to improve the process for obtaining access to investigational agents, and we are pleased that we now have processes and procedures in place that result in timely FDA approval of almost all expanded access requests submitted by physicians and companies for patients who cannot participate in trials and have life-threatening illnesses. We believe the current FDA process for reviewing expanded access requests meets the needs of patients.

Read the full letter below.

CANCER LEADERSHIP COUNCIL

A PATIENT-CENTERED FORUM OF NATIONAL ADVOCACY ORGANIZATIONS
ADDRESSING PUBLIC POLICY ISSUES IN CANCER

February 16, 2018

The Honorable Paul Ryan
Speaker
House of Representatives

The Honorable Nancy Pelosi
Minority Leader
House of Representatives

The Honorable Greg Walden
Chair, Energy & Commerce Committee
House of Representatives

The Honorable Frank Pallone
Ranking Member, Energy & Commerce Committee
House of Representatives

Dear Speaker Ryan, Leader Pelosi, Chairman Walden, and Ranking Member Pallone:

The undersigned cancer patient organizations, professional societies, and research organizations are writing to express serious reservations about “right to try” legislation that will remove the Food and Drug Administration (FDA) from the approval process for patient access to an investigational therapy outside a clinical trial. We do not believe that this legislation will protect the interests of people with cancer and urge opposition to right to try bills if they are brought to the House floor for a vote.

Our organizations are dedicated to a cancer care system – including cancer research and development, regulatory review, and care delivery – that provides patients access to the best possible treatments without delay. Our public policy efforts are focused on assuring the delivery of the right treatment to the right patient at the right time. We are mindful of the wishes of patients for access to all possible treatment options, which may include access to investigational therapies outside a clinical trial, and we believe the current FDA process for reviewing expanded access requests meets the needs of patients.

We have worked diligently over many years to improve the process for obtaining access to investigational agents, and we are pleased that we now have processes and procedures in place that result in timely FDA approval of almost all expanded access requests submitted by physicians and companies for patients who cannot participate in trials and have life-threatening illnesses. Additional reforms recently enacted by Congress will likely, when fully implemented, address any lingering inefficiencies in the expanded access program.

These reforms include the provisions of the 21st Century Cures Act requiring companies to post expanded access policies on their websites and requiring clarification from FDA regarding the use of adverse event data for drugs obtained through expanded access. The Food and Drug Administration Reauthorization Act (FDARA) included a provision permitting Institutional Review Boards (IRBs) to appoint a single individual to review expanded access applications instead of requiring full IRB review, and this provision of FDARA may address a barrier that slowed the expanded access process for some.

We also note the work of the Reagan-Udall Foundation in establishing a compassionate use navigator program to help patients and their physicians in managing the expanded access process, including obtaining information about drug manufacturers’ policies on expanded access.

Patients will not be well-served by eliminating the role of FDA in reviewing expanded access requests. The agency has the expertise and experience to evaluate compassionate use applications and to assess potential risk and benefit to the patient. We believe that patients are protected by the engagement of FDA in this process.

The agency approves most requests for expanded access, but the agency of course cannot mandate that companies will make drugs available. In our experience, the major obstacle to drugs being available for expanded access requests is the limited supply of drugs that are still being investigated in clinical trials. The right to try legislation cannot address this issue, yet the bills can do harm by eliminating the important role of FDA in balancing risk and benefit to patients.

The most effective means for assuring patient access to new therapies is an efficient system of research and therapy development and rigorous and efficient regulatory review. Our organizations have contributed in many ways to improving the clinical research system and accelerating the development of new therapies. FDA has responded with urgency to the demand for new treatments by engaging in efforts to improve clinical trial design, in its approach to meetings and communication with sponsors, and in its efficiency in new drug review. The agency has also been engaged in efforts to address clinical trial enrollment criteria – an issue some of our organizations have also addressed – which may result in removing clinical trial participation barriers and may thereby enhance access to investigational therapies.

The patients, providers, and researchers we represent are among those who are pressing hard for faster access to new therapies. The reforms discussed above—to the expanded access process, to the clinical trials system, and to regulatory review—are critical to improving patient access to new therapies and saving the lives of cancer patients. We do not believe that right to try legislation removing FDA from the expanded access process is necessary and in fact may do harm to cancer patients.

We look forward to working with you on efforts to ensure access to quality care for all cancer patients. We do not believe that right to try legislation is consistent with that goal and urge your opposition to it.

Sincerely,

Cancer Leadership Council
American Society of Clinical Oncology
CancerCare
The Children’s Cause for Cancer Advocacy
Fight Colorectal Cancer
Hematology/Oncology Pharmacy Association
International Myeloma Foundation
The Leukemia & Lymphoma Society
Lymphoma Research Foundation
National Coalition for Cancer Survivorship
Prevent Cancer Foundation
Sarcoma Foundation of America
Susan G. Komen

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Download the full letter » [PDF]

Read more NCCS Policy Comments »

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What Caught Our Eye: NCI Chief Sharpless Interviewed; Expert Patients; “Why We Didn’t Seek Right to Try”; Progress in Survivorship Care; and More

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What Caught Our Eye (WCOE), March 2, 2018
What Caught Our Eye is our week-in-review blog series, where we recap the cancer policy articles, studies, and stories that caught our attention.

Health Insurance

“Bait And Switch: The Sneaky Way Your Employer Just Passed Healthcare Costs Onto You”

By Peter Ubel, Forbes.com — With increasing frequency, employers are directing their workers to the kind of high deductible, high out-of-pocket insurance plans that leave workers financially responsible for a surprising portion of their healthcare expenses.
Read More »

“Congress Races The Clock In Quest To Bring Stability To Individual Insurance Market”

By Julie Rovner, Kaiser Health News — Congress is running out of time if members want to come up with legislation to stabilize the individual insurance market. While Republicans and Democrats still feud over the fate of the Affordable Care Act, a bipartisan group of senators and House members has been working since last summer on measures to keep prices from rising out of control and undermining the individual market where people who don’t get insurance through work or the government buy policies.
Read More »

Cancer Policy

“His six-month “listening tour” almost over, Sharpless discusses his vision for NCI”

By Paul Goldberg, The Cancer Letter — “The notion that cancer’s not one disease, but thousands of diseases is really starting to sink in, and the implications of that fact are being felt throughout [NCI], and it means we have to change how we do everything. I hope that the early days of the Sharpless administration will be remembered as a time when we really bought into that reality and did some things differently,” NCI Director Norman “Ned” Sharpless said in a conversation with The Cancer Letter.
Read More »

“I have brain cancer. Drug companies and med schools should be compensating me for my expertise”

By Adam Hayden, STAT News — Expert patients offer value when it comes to medical education or the development of medical devices and drugs. It’s time for them to get the compensation they deserve for improving the health care experience for everyone.
Read More »

“A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics”

Scientific Review Published in JAMA Oncology — Accelerated approval (AA) is a US Food and Drug Administration (FDA) expedited program intended to speed the approval of drugs and biologics that may demonstrate a meaningful advantage over available therapies for diseases that are serious or life-threatening.
Read More »

Coping with Cancer

“My Mom Just Died From Cancer. Here’s Why We Didn’t Seek #RightToTry”

By Dave Kroll, Forbes.com — Few events are more jarring to the human experience than being diagnosed with an acutely life-threatening illness. Perhaps as devastating – or even worse – is when that person is a loved one, especially a child or a young life-partner.

And if you’re a young person, having a parent or close relative diagnosed with a terminal illness may be the most emotionally devastating experience you’ve faced to date.
Read More »

“Patricia A. Ganz, MD, on Progress in Cancer Survivorship Care”

Via ASCO Post — Patricia A. Ganz, MD, of the University of California, Los Angeles, and this year’s recipient of the Ellen Stovall Award for Advancement of Cancer Survivorship Care, discusses her 30-year-long career researching and advocating for survivors and quality care.
Read the post on ASCOpost.com »

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What Caught Our Eye: Idaho Allows Insurers to Ignore ACA Rules; Op-ed: Right to Try a ‘Disaster in the Making’; Financial Toxicity; and More

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What Caught Our Eye (WCOE), February 2, 2018
What Caught Our Eye is our week-in-review blog series, where we recap the cancer policy articles, studies, and stories that caught our attention.

Affordable Care Act

“Obamacare will survive as Republicans give up on repeal”

https://twitter.com/dylanlscott/status/959121990710956033

By Dylan Scott, Vox.com — The Affordable Care Act is going to survive. The 2010 health care law has slowly but surely moved out of the line of fire. President Trump barely mentioned it in his State of the Union address Tuesday night. At their annual retreat this week in West Virginia, top Republicans signaled that the repeal dream is likely over.
Read More »

“Idaho ‘Pushing Envelope’ With Health Insurance Plan. Can It Do That?”

By Julie Appleby, Kaiser Health News — For the past year, the Trump administration and Republicans in Congress have led a charge to roll back the Affordable Care Act, signaling an openness to state changes.

Now, Idaho has jumped in, saying it will allow insurers to ignore some ACA rules on plans not sold on the marketplace, aiming to make these state-based plans less costly. Several of the changes are viewed by the law’s supporters as hits to its core consumer protections.
Read More »

Cancer Policy

“Opinion: I’m the ideal person to support right to try. But I can’t — it’s a disaster in the making”

By Michael Becker, Stat News — We already have a right to try, one that offers greater protection for the already vulnerable individuals who will use it than the new law the president promoted in his State of the Union address. The federal Right to Try Act isn’t a boon for patient rights. In fact, it could dismantle the very safety system that currently protects us — and that would be a disaster.
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“Trump Pledges To Lower Drug Costs — Can We Do It?”

OnPoint from WBUR — President Trump says in his State of the Union that going after the high cost of prescription drugs is a top priority. Politicians have promised for years to bring them down. We’ll examine his medical checklist, and the prospects for fixing an intractable problem.
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“Editorial: Price of Cancer Care and Its Tax on Quality of Life”

By George Tran and Yousuf Zafar — As drug costs continue to rise and as patients are increasingly expected to shoulder the burden, we must find novel ways to mitigate this issue to provide patients with the best possible disease outcome. Until we find long-term policy solutions that reduce drug prices and improve insurance design, the solution lies in the patient-physician relationship.
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Coping with Cancer

“Chemotherapy, a Trusty Weapon Against Cancer, Falls Out of Favor”

By Lucette Lagnado, Wall Street Journal — “The medical community has underestimated the side-effects and impact on a woman’s life. … We may be able to do less without compromising outcomes.” – Dr. Eric Winer, Dana-Farber Cancer Institute
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“Breast cancer treatments can raise risk of heart disease, American Heart Association warns”

By Laurie McGinley, Washington Post — “We want to make sure they get the best treatment for breast cancer — survival is the goal,” she said. “But it’s important for people to know that the heart needs to be taken care of before, during and after treatment.” – Dr. Lakshmi Mehta, Ohio State University
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NCCS Letter to HHS Highlights “Deep Reservations” Concerning Massachusetts 1115 Waiver

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The National Coalition for Cancer Survivorship (NCCS) sent a letter to Eric Hargan, Acting Secretary of the Department of Health and Human Services (HHS), to express “deep reservations” regarding the proposal by the Commonwealth of Massachusetts to amend its Section 1115 waiver.

In the letter, NCCS states:

Many cancer patients have been assured access to care through MassHealth, the state’s Medicaid program. We are concerned that the waiver amendment request will not ensure that those who are enrolled in MassHealth will have access to appropriate cancer treatment without unreasonable delay.

The waiver amendment application from the Commonwealth includes a proposal to adopt a “commercial-style closed formulary with at least one drug available per therapeutic class” for MassHealth. The Commonwealth has not explained why the tools available to it, including a preferred drug list, prior authorization requirements, and rebates, are not adequate for management of drug utilization. Without addressing the adequacy of these tools, the Commonwealth moves to a formulary plan that may adversely affect cancer patients.

Cancer care is often combination therapy incorporating drugs from different drug classes or multiple drugs in a class. In addition, cancer treatment is increasingly targeted according to the patient’s individual profile, often established through molecular testing. An individual patient may receive a clinical benefit from one drug in a class and not another, and a closed formulary may not be responsive to these individual needs. For some cancer patients, the management of the side effects of cancer treatment poses serious medication challenges. We are concerned that the closed formulary proposed by the Commonwealth for MassHealth patients will make it more difficult – if not impossible – for cancer patients to receive the drugs necessary for appropriate treatment therapies for those enrolled in MassHealth.

Read the full letter embedded below or download the letter in PDF format.

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WCOE: Graham-Cassidy Repeal Plan Has Deep Cuts; Bipartisan ACA Hearings Set; Sticker Shock Over Leukemia Drug; New Palliative Care Study; & More

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What Caught Our Eye (WCOE), August 25, 2017
What Caught Our Eye is our week-in-review blog series, where we recap the cancer policy articles, studies, and stories that caught our attention.

Affordable Care Act

“Cassidy-Graham Would Deeply Cut and Drastically Redistribute Health Coverage Funding Among States”

Via Center on Budget and Policy Priorities (CBPP) — The Cassidy-Graham plan (which Senator Dean Heller has also co-sponsored) would have much the same damaging consequences as other Senate and House Republican repeal and replace bills. It would cause many millions of people to lose coverage, radically restructure and deeply cut Medicaid, increase out-of-pocket costs for individual market consumers, and weaken or eliminate protections for people with pre-existing conditions.
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“Five governors to testify at hearing on bipartisan healthcare bill”

Via The Hill — Five governors will testify in front of the Senate Health Committee next month on ways to fix ObamaCare. Govs. Charlie Baker (R-Mass.), Steve Bullock (D-Mont.), Bill Haslam (R-Tenn.), Gary Herbert (R-Utah) and John Hickenlooper (D-Colo.) will testify at a hearing on Sept. 7.

Many insurers have requested large premium increases for 2018 because of the uncertainty surrounding the payments. The Trump administration has made them on a month-to-month basis, but insurers have asked for long-term certainty.
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“Data Note: Strongly Held Views on the ACA”

Via Kaiser Family Foundation — …Kaiser polls have shown an overall increase in ACA favorability over the past year, with 52 percent holding a favorable view of the law in August 2017, up 10 percentage points since June 2016, and nearly 20 percentage points since a low of 33 percent in November 2013.
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“Health reform revived: Murkowski says bills will advance via committee process”

Via the Fairbanks Daily News-Miner — Sen. Lisa Murkowski of Alaska said the health care discussion in Congress is moving forward nearly a month after the failed Republican attempt to repeal the Affordable Care Act.

“The committee process, which is something that I had been pounding the drum on for months and months, is underway,” Murkowski said at a Monday interview with the Daily News-Miner editorial board.

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“States Watch Iowa’s Push to Reshape Health Law”

Via Wall Street Journal — Officials seek waiver to revamp rules, including subsidies; Ohio, Oklahoma, others consider changes.

Iowa asked for federal permission to alter major provisions of the Affordable Care Act next year, a proposal that will be closely watched by officials in other states who hope to rewrite parts of the health law as Republican efforts to do so in Congress have stalled.
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Cancer News

“‘Breakthrough’ Leukemia Drug Also Portends ‘Quantum Leap’ In Cost”

Via Kaiser Health News — When doctors talk about a new leukemia drug from Novartis, they ooze enthusiasm, using words like “breakthrough,” “revolutionary” and “a watershed moment.” But when they think about how much the therapy is likely to cost, their tone turns alarmist.
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“Palliative Care Cut Healthcare Use in Advanced Cancer: Data show real-world influence in Medicare patients”

Via Medpage Today — In elderly patients with advanced cancer, a palliative care consultation soon after diagnosis substantially decreased healthcare use, and helped caregivers manage patients’ expectations, as well as maintain their quality of life (QoL), according to researchers.
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“Reducing Racial and Ethnic Disparities in Access to Care: Has the Affordable Care Act Made a Difference?”

Via the Commonwealth Fund — Between 2013 and 2015, disparities with whites narrowed for blacks and Hispanics on three key access indicators: the percentage of uninsured working-age adults, the percentage who skipped care because of costs, and the percentage who lacked a usual care provider.
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