FDA Approval for Opdivo in Previously Treated Urothelial Carcinomas
The U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb Company) for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.
HHS Withdraws 340B "Mega-Guidance”
On Jan. 30, 2017, the White House Office of Management and Budget (OMB) marked the final 340B guidance document as withdrawn and sent it back to the Department of Health and Human Services (HHS).
The proposed guidance defined who is considered a patient for purposes of the 340B drug program and also covers drug company responsibilities, such as procedures for issuing credits and refunds. The 340B program helps safety-net providers such as hospitals obtain discounted drugs. In order to advance, the guidance would now need to be resubmitted to the OMB.
However, it could be more difficult to implement the guidance due to the recent Executive Order declaring that for every new regulation or guidance introduced, two must be eliminated.
Source: BNA Healthcare
FDA Approves Imbruvica for Marginal Zone Lymphoma Patients
The U.S. Food and Drug Administration (FDA) has approved Imbruvica® (ibrutinib) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. Accelerated approval was granted for this indication based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
ACCC Advocates for Community Oncology at the White House and on Capitol Hill
On Jan. 11, 2017, the Association of Community Cancer Centers (ACCC) joined with leading cancer organizations in discussions at the White House and on Capitol Hill that focused on issues and challenges facing community oncology and to advocate for access to care for patients in the communities where they live.
At the White House Making Health Care Better: Community Oncology event on Wednesday morning, ACCC President Jennie R. Crews, MD, MMM, FACP, and ACCC Governmental Affairs Committee member William Holden, MBA, RT(T)(R), FACHE, participated in a panel on Addressing Disparities. On behalf of the Cancer Moonshot initiative, the event explored critical aspects of community oncology including cancer disparities, survivorship and support services, advancing clinical trials, and innovative models of care delivery in the community setting.
On Capitol Hill, ACCC co-sponsored an afternoon briefing on Innovation and Access in Quality Cancer Care. Advocates heard a panel discussion and comments from patients, providers, the Centers for Medicare & Medicaid Services, and the Cancer Moonshot Task Force. Co-sponsoring the briefing along with ACCC were the Cancer Support Community, the American Cancer Society Cancer Action Network, the Community Oncology Alliance, McKesson Specialty Health, Sarah Cannon, and The US Oncology Network.
FDA Approves Rucaparib for Ovarian Cancer
On Dec. 19, 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval to rucaparib (Rubraca, Clovis Oncology Inc.) for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies.
In conjunction with the drug approval, the FDA approved the FoundationFocus CDxBRCA test (Foundation Medicine Inc.), the first FDA-approved next-generation sequencing (NGS)-based companion diagnostic to identify patients with advanced ovarian cancer eligible for treatment with rucaparib. The test detects alterations in BRCA1 and BRCA2 genes in the tumor tissue of ovarian cancer patients.
Read the FDA press release here.
CMS Officially Withdraws Part B Proposal
The Centers for Medicare and Medicaid Services (CMS) announced the agency would officially not be moving forward with the controversial Medicare Part B demonstration proposal.
Under the current Part B reimbursement model for drugs administered by infusion or injection in doctors' offices and hospital outpatient departments, Medicare pays 6% on top of the average sales price of the medication. The agency proposed dropping the payment from 6% to 2.5% of a drug's average sales price while adding a flat payment of $16.80 per drug a day, causing concern amongst oncology providers, the pharmaceutical industry, and bipartisan officials.
ACCC was vocal about the detrimental impact this experiment would have had on patients and their access to high quality, high value cancer care and is pleased the agency has withdrawn the proposal.
Learn more here.
PCORI to Fund 19 New Patient-Centered Research Projects
On December 13, 2016, the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors approved nearly $42 million to fund 19 new studies comparing the effectiveness of different healthcare approaches.
Thirteen of the projects will support research on which care options work best in treating a range of conditions and problems that impose high burdens on patients, caregivers, and the healthcare system.
- A $6 million study to compare the effectiveness of two types of palliative care, hospital-based versus home-based, in reducing patients' pain, anxiety and depression.
- A $3 million project to determine the impact of different health plans on medication use and outcomes among both adults and children with asthma.
- A $2.7 million study to determine the effect of accupressure on relieving treatment-related symptoms in children with cancer.
- A $2.3 million project to determine whether established treatment or a newer drug is more effective against treatment-resistant cases of Kawasaki disease, which can cause heart problems in children.
Learn more about the approved projects on PCORI's website.
President Obama Signs 21st Century Cures Act into Law
On December 13, 2016, President Obama signed the 21st Century Cures Act into law. This bipartisan legislation allocates $6.3 billion to fund drug development, a precision medicine initiative, and Vice President Biden's Cancer Moonshot Initiative.
"We are bringing to reality the possibility of new breakthroughs to some of the biggest health challenges of our time," Obama said.
Watch the video of the Signing Ceremony from the White House here.
Click here to read an overview of the Cures Act from Hogan Lovells.
President-Elect Trump's Nominees to Head HHS and CMS
This week, President-elect Trump announced two key healthcare positions in his Administration: Congressman Tom Price will be nominated as Secretary of Health and Human Resources (HHS) and Seema Verma as Administrator for the Centers for Medicare & Medicaid Services (CMS).
Congressman Price is a six-term Republican Congressman from Georgia, Chairman of the House Budget Committee, and an orthopedic surgeon. He has been an outspoken critic of the Affordable Care Act (ACA) and has introduced an alternative reform proposal in every congressional session since 2009.
Seema Verma, President and Founder of SVC Consultants, a national health policy consulting company, has primarily assisted states with the development of Medicaid demonstration projects under waiver authority. The past work and statements of both Congressman Price and Seema Verma may provide some insight into what we can expect from the new Administration with regards to the ACA, Medicare, and Medicaid.
For more information, click here.