As part of its ongoing commitment to providing available medication to patients, Janssen Products, LP, has announced the initiation of an open enrollment process for the Doxil® C.A.R.E.S. Physician Access Program, starting 12:00 noon Eastern Time on Friday, May 11, 2012.
In a May 9, 2012, letter Rob Bazemore, President, Janssen Products, LP, announced that, "Returning a reliable supply of Doxil to the marketplace remains our top priority. We are able to re-open enrollment at this time because some physician allocation requests have changed and freed up product for reallocation. Other physicians indicated Doxil earmarked for patients in the program is no longer needed, or they opted patients out of the program. We’ve met the needs of all physicians who submitted enrollment forms for their patients during the recent Doxil C.A.R.E.S. Physician Access Program re-enrollment process and this latest assessment has allowed us to re-open enrollment for the Doxil C.A.R.E.S. Physician Access Program for patients not currently enrolled."
For more information, call 1-866-298-5774. Read more.
Posted 5/11/12
On April 26, 2012, the U. S. Food and Drug Administration approved pazopanib tablets (Votrient, a registered trademark of GlaxoSmithKline) for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The efficacy of pazopanib for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors (GIST) has not been demonstrated. The approval is based on a randomized, double-blind, placebo-controlled, multicenter trial in patients with metastatic STS who had received prior chemotherapy, including an anthracycline.
For more information, click here.
Posted 4/27/12
On April 9, 2012, the Centers for Medicare & Medicaid Services (CMS) revealed plans to set the new ICD-10 compliance date at Oct. 1, 2014, a one-year delay from the planned Oct. 1, 2013, deadline, which physician groups had complained was not viable for many physicians. The agency in February agreed to delay the compliance date for the new procedure codes in response to physicians' concerns, but at the time didn't specify what the new date would be.
For more information, click here.
Posted 4/9/12
Millennium: The Takeda Oncology Company announced that Velcade (bortezomib) is now FDA-approved for subcutaneous administration in patients with multiple myeloma (MM) and relapsed mantle cell lymphoma (MCL).
Posted 2/22/12
The FDA warned healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, manufactured by Roche and does not contain the medicine's active ingredient, Bevacizumab, which may have resulted in patients not receiving needed therapy.
Nineteen medical practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tenn., is a distributor of QSP's products.
Further information from the FDA regarding this warning can be found at: http://www.fda.gov/Drugs/DrugSafety/ucm291960.htm
Posted 2/22/12
Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. Erivedge is a pill taken once a day and works by inhibiting the Hedgehog pathway, a pathway that is active in most basal cell cancers and only a few normal tissues, such as hair follicles.
Read the FDA press release.
Posted 2/9/12
The Food and Drug Administration posted a notice on its website about the risks of purchasing unapproved injectable cancer medications from unlicensed sources.
“Current shortages of injectable cancer medications may present an opportunity for unscrupulous individuals to introduce non-FDA approved products into the drug supply, which could result in serious harm to patients. Health care providers are reminded to obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the United States.”
“In certain circumstances, the FDA may authorize limited importation of medications that are in short supply. Such medications are imported from approved international sources and distributed in the U.S. through a controlled network, and would not be sold in direct-to-clinic solicitations.
Detailed information is posted on the FDA’s Drug Integrity and Supply Chain Security webpage under the "Outreach" header.
Posted 1/18/2012
The Centers for Medicare and Medicaid Services (CMS) has established a product-specific Healthcare Common Procedures Coding System (HCPCS) J-code, or permanent code, for a number of oncology drugs, effective for dates of service on or after January 1, 2012.
A new C-code has been assigned to brentuximab vedotin, injection, 1 mg, C9287.
A complete list of drugs and biologicals can be found within the Association of Community Cancer Centers' analysis (page 2) of selected provisions of the Hospital Outpatient Prospective Payment System Final Rule for 2012.
Posted 12/19/2011
Effective December 6, 2011, the Prescribing Information (PI) for Nplate (romiplostim) has changed. A summary of the changes in the Nplate PI are as follows:
Posted 12/19/2011
The debt "Super Committee" will consider cuts to Medicare, possibly including the reduction of drug reimbursement to ASP + 3 percent. If the Super Committee cannot find at least $1.2 trillion in cuts, or Congress does not act on the committee's recommendations, there will be an across-the-board 2 percent cut to all Medicare payments—including oncology drugs and services.
Send a message to your representatives today. Tell them the proposed cuts to Medicare are unacceptable. ACCC will keep members informed of our progress and will notify you of any updates.
Posted 11/2/2011
Prolia (denosumab) has been approved by the U.S. Food and Drug Administration as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.
Read the full press release here.
Posted 9/27/2011
On Sept. 1, the Centers for Medicare & Medicaid Services (CMS) provided information on accessing 2010 feedback reports for eligible professionals who participated in the 2010 Physician Quality Reporting Initiative (PQRI) and/or the 2010 Electronic Prescribing (eRx) Incentive Program. (The PQRI program name changed to the Physician Quality Reporting System, or PQRS.)
Feedback reports for the 2010 eRx Incentive Program are now available. Feedback reports for the 2010 PQRI will be available in late September or early October 2011.
Read the full post, including information on “Creating an IACS Account”, “Information on Updating IACS User Accounts and Passwords,” and CMS resources related to IACS Accounts here.
Posted 9/2/2011
Pfizer, Inc,. announced that the U.S. Food and Drug Administration (FDA) has approved Xalkori (crizotinib) capsules, the first-ever therapy targeting anaplastic lymphoma kinase (ALK), for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by an FDA-approved test. The effectiveness of Xalkori is based on objective response rates (ORR) and, as Xalkori received accelerated approval from the FDA, Pfizer is conducting post-marketing clinical trials to further evaluate its clinical benefit.
Aligned with the FDA’s latest guidance on targeted therapies and companion diagnostics, Pfizer worked closely with the FDA and partnered with Abbott Molecular’s business in Pfizer’s clinical studies to ensure the simultaneous review and approval of Xalkori along with a diagnostic test, Abbott Molecular’s Vysis ALK Break Apart FISH Probe Kit, to identify presence of the ALK fusion gene.
Xalkori is available immediately through a number of specialty pharmacies.
Posted 8/29/2011
The U.S. Food and Drug Administration (FDA) approved vemurafenib (Zelboraf) for the treatment of metastatic or unresectable melanoma. The new drug, also known as PLX4032, specifically targets patients whose tumors express the BRAF V600E gene mutation. Coinciding with the approval of vemurafenib is a companion diagnostic test, named the cobas 4800 BRAF V600 Mutation Test, which will determine if a patient's cells have the gene mutation.
Posted 8/23/2011
Seattle Genetics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Adcetris (brentuximab vedotin) for two indications: 1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and 2) the treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen. The indications for Adcetris are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with Adcetris.
Adcetris is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years, and provides a new therapeutic alternative for Hodgkin lymphoma and systemic ALCL in these settings. Adcetris is an antibody drug conjugate (ADC) directed to CD30.
Posted 8/23/2011
Abbott Laboratories announced that the U.S. Food and Drug Administration (FDA) cleared a genetic test that can help determine the prognosis of patients with chronic lymphocytic leukemia. Abbott's Vysis CLL FISH Probe Kit detects genetic abnormalities in lymphocytes. CLL is the most common type of leukemia in the U.S., around 15,000 cases diagnosed per year.
Posted 8/23/2011
Celgene has informed providers that the shortage of paclitaxel injection has NOT affected the supply of Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). Abraxane remains fully available through established distribution channels.
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
Posted 8/1/2011
On July 1, 2011, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update payment policies and rates for physicians and nonphysician practitioners for services paid under the Medicare Physician Fee Schedule in 2012. In the 2012 proposed rule, CMS is significantly expanding the potentially misvalued code initiative, an effort to ensure Medicare is paying accurately for physician services and more closely managing the payment system. This year, CMS is focusing on the highest volume and dollar codes billed by physicians to determine whether these codes are overvalued and if evaluation and management codes are undervalued. In the past, CMS has targeted specific codes for review that may have affected a few procedural specialties like cardiology, radiology or nuclear medicine but not taken a look at the highest expenditure codes across all specialties.
CMS is also proposing some changes in how it adjusts payment for geographic variation in the cost of practice.
Highlights of the Proposed Rule:
An in-depth analysis is available at the Association of Community Cancer Centers' member-only website ACCC's Members-only web section. Log in required.
Posted 7/1/2011