Tag Archives: Centers for Medicare & Medicaid Services

FDA Revokes Approval of Avastin Use For Metastatic Breast Cancer; Major U.S. Ovarian Cancer Advocacy Organization Concerned

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Today, the U.S. Food and Drug Administration (FDA) Commissioner Hamburg revoked approval of Avastin for treatment of metastatic breast cancer in the U.S. The decision does not impact Avastin’s availability for its approved uses for other cancer types in the U.S. A major U.S. ovarian cancer advocacy organization is concerned that the FDA decision will make it more difficult for ovarian cancer patients to gain access to Avastin.

FDA Revocation of Avastin Approval For Metastatic Breast Cancer

FDA Commissioner Margaret A. Hamburg, M.D., said today she is revoking the agency’s approval of the breast cancer indication for Avastin® (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.

Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme).

“This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use,” Dr. Hamburg said. “After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.”

Avastin’s risks include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines.

Today’s decision, outlined in Dr. Hamburg’s 69-page opinion, involves Avastin used in combination with the cancer drug paclitaxel (Taxol) for those patients who have not been treated with chemotherapy for their form of metastatic breast cancer known as “HER-2 negative.” This indication must now be removed from Avastin’s product labeling.

Dr. Hamburg’s decision is based on an extensive record, which includes thousands of pages submitted to a public docket, data from several clinical trials, and the record from a two-day hearing held in June, 2011.

Avastin was approved for metastatic breast cancer in February 2008 under the FDA’s accelerated approval program, which allows a drug to be approved based on data that are not sufficiently complete to permit full approval. The accelerated approval program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted. If the clinical trials do not justify the continued approval of the drug or a specific drug indication, the agency may revoke its approval. In this case, the accelerated approval was based on promising results from one study that suggested that the drug could provide a meaningful increase in the amount of time from when treatment is started until the tumor grows or the death of the patient.

After the accelerated approval of Avastin for breast cancer, the drug’s sponsor, Genentech (a member of the Roche Group) completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone – not enough to outweigh the risk of taking the drug.

The FDA’s Center for Drug Evaluation and Research (CDER), which is responsible for the approval of this drug, ultimately concluded that the results of these additional studies did not justify continued approval and notified Genentech that it was proposing to withdraw approval of the indication.

Genentech did not agree with CDER’s evaluation of the data and, following the procedures set out in FDA regulations, requested a hearing on CDER’s withdrawal proposal, with a decision to be made by the FDA Commissioner. That two-day hearing, which took place June 28-29, 2011, included recommendations from the FDA’s Oncologic Drugs Advisory Committee (ODAC), voting 6-0 in favor of withdrawing approval of Avastin’s breast cancer indication. After the hearing, the public docket remained open until August 4, 2011. In an earlier meeting of the ODAC, that committee had voted 12-1 in favor of the removal of the breast cancer indication from the Avastin label.

“FDA is committed to working with sponsors to bring promising cancer drugs to market as quickly as possible using tools like accelerated approval,” Dr. Hamburg said. “I encourage Genentech to consider additional studies to identify if there are select subgroups of women suffering from breast cancer who might benefit from this drug.”

Genentech Response

In a press release issued earlier today, Genentech’s Hal Barron, M.D., chief medical officer and head, Global Product Development, stated:

“We are disappointed with the outcome. We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States. Despite today’s action, we will start a new Phase III study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin.”

Genentech emphasizes the following points in its press release:

  • The FDA Commissioner revoked approval of Avastin for treatment of metastatic breast cancer in the U.S.
  • The FDA’s action concludes its review of Avastin’s use for metastatic breast cancer.
  • The FDA decision does not impact Avastin’s approved uses for other cancer types in the U.S. or other countries.
  • The FDA decision does not impact the approval of Avastin for metastatic breast cancer in more than 80 foreign countries.
  • Roche will initiate a new clinical trial of Avastin plus paclitaxel in metastatic breast cancer.
  • Genentech will issue a letter to healthcare providers and will also provide them with a letter to distribute to their patients. Both letters will be made available on Genentech’s website.
  • Patients with questions or concerns about insurance coverage, or doctors with questions about reimbursement, can call Genentech’s Access Solutions Group at (866)-4- ACCESS.
  • Doctors with questions about Avastin can call Genentech’s Medical Communications group at (800) 821-8590.
  • The FDA’s action does not impact ongoing clinical trials with Avastin in breast cancer. For more information, please call Genentech’s Trial Information Support Line at (888) 662-6728 or visit clinicaltrials.gov.

Major U.S. Ovarian Cancer Advocacy Organization Concerned About Future Impact of FDA Decision

Karen Orloff Kaplan, MSW, MPH, ScD, Chief Executive Officer, Ovarian Cancer National Alliance

Karen Orloff Kaplan, MSW, MPH, ScD, the Chief Executive Officer for the Ovarian Cancer National Alliance (OCNA), expressed concern that the removal of metastatic breast cancer from the Avastin label could negatively affect women with ovarian cancer, for whom the drug is used “off-label.”  OCNA is one of the most influential advocates for women with ovarian cancer in the United States.

Dr. Kaplan stated:

“Results from three Phase III clinical studies show that Avastin is beneficial for some women with ovarian cancer. We are deeply concerned that the Food and Drug Administration’s decision regarding metastatic breast cancer will make it difficult for women with ovarian cancer to access Avastin, and that patients could be denied insurance coverage for this treatment. The Ovarian Cancer National Alliance will continue our work to ensure that drugs that are useful and medically appropriate are available to women with this disease.”

In the FDA report accompanying her decision, Commissioner Hamburg cited a lack of evidence that Avastin improved overall survival for women with metastatic breast cancer in its decision. “Given how difficult it is to measure overall survival in ovarian cancer clinical trials, we are concerned that today’s ruling may set an unfortunate precedent,” said Dr. Kaplan.

Currently, various national cancer treatment guidelines, such as the National Comprehensive Cancer Network (NCCN) Compendium™, include Avastin as a treatment for ovarian cancer. Despite that fact, the FDA’s decision could prompt a reexamination of industry treatment guidelines by various groups, including the NCCN. The NCCN  is a nonprofit alliance which consists of 21 leading U.S. cancer centers.

Specifically, OCNA is concerned that the FDA Avastin label change, mandated by today’s FDA decision, will lead to restrictions by third party payers, including the U.S. Medicare federal insurance program, who generally reimburse for Avastin when a woman’s cancer has returned. OCNA’s concern may be warranted because Reuters reported earlier today that some healthcare insurers have already started pulling back on Avastin reimbursement coverage for breast cancer.

As of now, according to Reuters, Medicare will continue to pay for Avastin used in the treatment of breast cancer, despite  the FDA’s revocation decision. “Medicare will continue to cover Avastin,” said Don McLeod, a spokesman for the Centers for Medicare and Medicaid Services (CMS). “CMS will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies.” The CMS statement may mitigate concerns that patients using the drug would lose critical drug reimbursement insurance coverage in the future.

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Addtional Information:

“Decisions Are Made By Those Who Show Up”*

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Responding to a threat of a funding reduction to the Department of Defense’s Ovarian Cancer Research Program, during the last week of October the Ovarian Cancer National Alliance urged advocates to contact their Members of Congress to appeal to the Appropriations Defense Subcommittee to increase funding for the research program. As a result of the Ovarian Cancer National Alliance’s advocacy efforts, 14 Senators and 77 Representatives showed their opposition to the funding cut by signing a Dear Colleague letter sent to the Subcommittee Tuesday, November 3, 2009. …

Advocates Work To Prevent Slash In Ovarian Cancer Research Funding

Responding to a threat of a funding reduction to the Department of Defense’s Ovarian Cancer Research Program, during the last week of October the Ovarian Cancer National Alliance (OCNA) urged advocates to contact their Members of Congress to appeal to the Appropriations Defense Subcommittee to increase funding for the research program.

OCNAadvocates1

Advocates lobbying on Capitol Hill for increased funds for ovarian cancer research. (Photo: Ovarian Cancer National Alliance)

As a result of OCNA’s advocacy efforts, 14 Senators and 77 Representatives showed their opposition to the funding cut by signing a Dear Colleague letter sent to the Subcommittee Tuesday, November 3, 2009.

The Dear Colleague letter, written by Senator Robert Menendez (D-NJ) and Congresswoman Rosa DeLauro (D-CT), requested that the Subcommittee allocate the $25 million set forth in the U.S. House of Representatives‘ version of the Defense bill, and not the $10 million outlined in the U.S. Senate version of the bill. The Senate funding level represented a 50 percent reduction from the $20 million appropriated in fiscal year (FY) 2009.

The date of the conference subcommittee meeting has yet to be announced.

Established in 1997, the Department of Defense’s Ovarian Cancer Research Program has received $10 million in funding annually from FY 1998 until FY 2008. However, for FY 2009, the program’s funding was doubled to $20 million. The Ovarian Cancer Research Program works to eliminate ovarian cancer by conducting innovative, multidisciplinary research on early detection, screening and treatment of ovarian cancer.

To read the full text of the letter and see if your elected officials signed, please click here.

The Ovarian Cancer Action Network periodically sends out action alerts to notify advocates of pressing issues that need constituent support. To sign up, please click here.

About the Ovarian Cancer National Alliance

OCNA is the advocacy arm of the ovarian cancer movement. OCNA works with federal policy makers, including the  U.S. President, U.S. Congress, and federal agencies like the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). OCNA commits its resources to be a voice for ovarian cancer survivors and significantly reduce the number of deaths from this deadly disease by advocating at the federal level for the following:

• Adequate and sustained funding for ovarian cancer research and awareness programs, and

• Legislation that improves quality of life and access to care for ovarian cancer patients.

Since 1997, when OCNA was founded, death rates from ovarian cancer have not significantly changed. However, OCNA has worked to increase funding for ovarian cancer research, with the goal that this funding will support breakthroughs to help detect ovarian cancer early, treat it more thoroughly, and allow women with ovarian cancer to survive, and thrive.

OCNA has worked to ensure that (i) necessary treatments are covered by Medicare, (ii) drugs and tests on the market are safe and effective, and (iii) federal policy makers are aware of the importance of the ovarian cancer community.

Join OCNA to fight for women with ovarian cancer, and policies that help support them and their families.

Source: Advocates Work To Prevent Slash In Ovarian Cancer Research Funding, News Update, Ovarian Cancer National Alliance, November 11, 2009.

*Title Quote:  Fictional U.S. President Josiah Edward Bartlet, What Kind of Day Has It Been Episode, The West Wing, created by Aaron Sorkin, originally aired May 17, 2000 [Sorkin attributes his teleplay quote to Woody Allen (“80% of success in life is just showing up”)].

Medicare Expands Coverage of PET Scans as Cancer Diagnostic Tool

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“The Centers for Medicare & Medicaid Services (CMS) issued a final national coverage determination (NCD) to expand coverage for initial testing with positron emission tomography (PET) for Medicare beneficiaries who are diagnosed with and treated for most solid tumor cancers.  This decision applies to PET scans used to support initial diagnosis and treatment for most types of solid tumor cancers. … It also expands coverage of PET scans for subsequent follow up testing in beneficiaries who have cervical or ovarian cancer … A minimally invasive diagnostic imaging procedure, PET uses a radioactive tracer to evaluate glucose metabolism in tumors and in normal tissue. …”

“For Immediate Release: Monday, April 06, 2009
Contact: CMS Office of Public Affairs
202-690-6145

MEDICARE EXPANDS COVERAGE OF PET SCANS AS CANCER DIAGNOSTIC TOOL

CMS’ Coverage with Evidence Development Project Shows PET Scans as “Reasonable and Necessary” for Initial Treatment Decisions of Most Solid Tumor Cancers

Centers For Medicare & Medicaid Services

Centers For Medicare & Medicaid Services

The Centers for Medicare & Medicaid Services (CMS) issued a final national coverage determination (NCD) to expand coverage for initial testing with positron emission tomography (PET) for Medicare beneficiaries who are diagnosed with and treated for most solid tumor cancers.

This NCD removes a clinical study requirement for PET scan use in these patients.

Since 2005, Medicare coverage of PET scans for diagnosing some forms of cancer and guiding treatment has been tied to a requirement that providers collect clinical information about how the scans have affected doctors’ treatment decisions. This information was gathered through the National Oncologic PET Registry (NOPR) observational study. This decision removes the requirement to report data to the NOPR when the PET scan is used to support initial treatment (or diagnosis and “staging“) of most solid tumor cancers.

Medicare collects data from the NOPR under CMS’ Coverage with Evidence Development (CED) program. CED allows Medicare to develop evidence about how a medical technology is used in clinical practice so that Medicare can do the following:

(a) clarify the impact of these items and services on the health of Medicare beneficiaries;

(b) consider future changes in coverage for the technology; and

(c) generate clinical information that will improve the evidence base upon which providers base their recommendations to Medicare beneficiaries regarding the technology.

This decision is based, in part, on the information generated as a result of CMS’ 2005 decision to require NOPR reporting for many cancer PET scans. As a result of this evidence from NOPR, CMS reconsidered its 2005 coverage policy. This decision is the first time that CMS has reconsidered a coverage policy based on new evidence developed under the CED program.

‘This expansion in coverage for PET scans shows that the Coverage with Evidence Development program is a success,’ said CMS Acting Administrator Charlene Frizzera. ‘CED allowed us to cover an emerging technology, learn more about its usage in clinical practice, and adjust our coverage policies accordingly. Thanks to CED, Medicare beneficiaries have greater access to cutting edge medical technologies and treatments.’

Positron Emission Tomography (PET) equipment (Photo Source: www.RadiologyInfo.org)

Positron Emission Tomography (PET) equipment (Photo Source: RadiologyInfo.org)

This decision applies to PET scans used to support initial diagnosis and treatment for most types of solid tumor cancers. It also expands coverage of PET scans for subsequent follow up testing in beneficiaries who have cervical or ovarian cancer, or who are being treated for myeloma, a cancer that affects white blood cells. For these cancers, NOPR data collection will no longer be required. [Emphasis added by Libby’s H*O*P*E*™]

It is important to note that today’s decision still requires clinicians to report data to the NOPR when using PET scans to monitor the progress of treatment or remission of cancer in some cases. Although the evidence generated by the NOPR study helped CMS determine that PET scans are useful in helping guide treatment when cancer is first diagnosed, scientific evidence is not as strong in showing that PET scans are as useful in making subsequent treatment decisions for some types of cancer.

A minimally invasive diagnostic imaging procedure, PET uses a radioactive tracer to evaluate glucose metabolism in tumors and in normal tissue. The test may provide important clinical information to guide the initial treatment approach (e.g., diagnosis and “staging”) for many cancers.

This additional information may help physicians to distinguish benign from cancerous lesions and better determine the extent of a tumor’s growth or metastasis. PET scans have also been used in subsequent testing for cancer patients, e.g., to monitor cancer progression or remission after cancer treatment has begun.

More information about the types of cancer covered by this new policy is available in CMS’ final decision memorandum. …”

Source:  Medicare Expands Coverage of PET Scans As Cancer Diagnostic Tool – CMS’ Coverage with Evidence Development Project Shows PET Scans as “Reasonable and Necessary” for Initial Treatment Decisions of Most Solid Tumor Cancers, Centers for Medicare & Medicaid Services, Press Release, April 6, 2009.

Secondary Sources:

Comment:  The CMS Decision Memo involving the use of PET scans for solid tumors allows an ovarian cancer patient (who is a Medicare beneficiary) to obtain a PET scan for “initial treatment strategy” purposes.  “Initial Treatment Strategy” is generally defined by CMS as encompassing initial diagnosis or staging.  An ovarian cancer patient (who is a Medicare beneficiary) can also obtain a PET scan for “subsequent treatment strategy” purposes.  “Subsequent Treatment Strategy” is generally defined by CMS as encompassing “restaging” and “monitoring response to treatment when a change in treatment is anticipated.”