Tag Archives: advocacy cancer care

Connecting the Moonshot to Patients

By Amanda Patton, ACCC Communications

ACCC President Jennie R. Crews, MD, MMM, FACP, welcomes conference attendees.

ACCC President Jennie R. Crews, MD, MMM, FACP, welcomes conference attendees.

The Cancer Moonshot framed Thursday’s  sessions at the ACCC 33rd National Oncology Conference in St. Louis. “I’ve been privileged to be part of the conversations around the Moonshot,” ACCC President Jennie R. Crews, MD, MMM, FACP, told attendees in her opening remarks. On Monday Dr. Crews participated in panel discussion at the White House as part of the Moonshot Task Force Report unveiling. With a goal of making a decade’s worth of progress in cancer prevention, diagnosis, treatment, and care in five years—it’s an “audacious” initiative that will bring challenges and significant opportunities to community oncology, she said.

In a heartfelt video message to conference attendees, Vice President Joe Biden, called community cancer centers the “bridge” between the Moonshot and cancer patients. “For the overwhelming majority of those patients who are diagnosed [with cancer], the next step leads to you,” he said. “Community oncologists treat as much as 85 percent of cancer patients . . . .Not only do your patients need you, your country needs you.”

It was a message reiterated at the end of the day by Anabella Aspiras, Director for Patient Engagement, Cancer Moonshot Task Force, in a session exploring how the Cancer Moonshot will affect providers in the community setting. “You truly connect the work of the Cancer Moonshot to cancer patients,” she told attendees. Ms. Aspiras highlighted the three Moonshot reports announced on Monday:

The Vice President’s Executive Report, a summary of work accomplished to date and challenges that must be addressed, which was presented to President Obama on Monday. The report outlines five strategic imperatives:

  • Realign incentives in the research system
  • Enhance prevention efforts
  • Engage patients as partners in research
  • Expand access to care
  • Convene a national conversation about cost.

The Task Force Report, covers the implementation plans for accelerating progress and includes Moonshot efforts underway over the past year.

The Blue Ribbon Panel Report, which integrates feedback into the panels 10 recommendations.

Anabella Aspiras and Jennie R. Crews, MD, MMM, FACP, at the ACCC National Oncology Conference.

Anabella Aspiras  with ACCC President Jennie R. Crews, MD, MMM, FACP, at the Cancer Moonshot Report unveiling earlier this week.

In her remarks, Ms. Aspiras called attention to existing ACCC initiatives that support the Blue Ribbon Panel recommendations, including the Institute for Clinical Immuno-Oncology (ICLIO) and ACCC’s educational work related to integrating biomarker testing in the community setting.

In her role at the Moonshot Task Force, Ms. Aspiras’ primary responsibility is to represent the voice of the patient in four areas: addressing cancer inequities, enhancing community cancer care, improving clinical trial participation (accrual and retention) in particular in terms of under-represented populations; and survivorship. Research must benefit all segments of society, Aspiras said. “We must ensure advances in treatment are distributed equally.”

In closing, Ms. Aspiras thanked ACCC members for the work they do. “You bridge the gap between our efforts on the Cancer Moonshot and the patients we aspire to reach,” she said. “Every day you change the face of cancer as we know it.”

Stay tuned for more from the ACCC 33rd National Oncology Conference. Follow the conferences highlights on Twitter #ACCCNOC.

 

Defining Value in Cancer Care

imagesBy Leah Ralph, Manager, Provider Economics and Public Policy, ACCC

Earlier this summer, ASCO released its much anticipated “value framework,” a proposed methodology designed to assist physicians and patients in assessing the value of different cancer treatment options. Comments on the framework were due last week, and a variety of stakeholders – including providers, patient groups, and manufacturers – provided feedback on the model.

While most would agree the framework is not yet ready for the clinical setting, it represents an important step in the broader conversation about measuring value in cancer care. As a conceptual framework, it seems to have done its job. But as ASCO points out, it is critical to consider this tool in context. The methodology contains notable limitations in data, practicality, and scope, and payers and policymakers should be cautioned that this framework is not meant to serve as a basis for reimbursement or coverage determinations.

ASCO’s approach uses randomized clinical trial data to compare new treatments with an established standard of care under two different scenarios: the advanced disease setting and the adjuvant (potentially curable) setting. A treatment receives a net health benefit (NHB) score (up to 130 points for advanced and 100 points for adjuvant) by combining a score for clinical benefit (up to 80 points), toxicity (up to 20 points), and up to 30 bonus points for quality of life measures, including palliation of symptoms and treatment-free intervals in the advanced disease setting. The NHB score is intended to demonstrate the added benefit patients may receive from a new cancer drug compared with a current standard of care.

Under the proposed framework, the clinical benefit score gives most weight to therapies that increase overall survival, followed by progression-free survival, and response rate. ASCO chose these clinical endpoints because they represent data most commonly collected and reported in clinical trials. So, for example, when survival data is not available and/or only noncomparative trials have been preformed, as is often the case with breakthrough therapies, response rate will be used to determine the effectiveness of the drug until survival data becomes available.

The combined clinical benefit, toxicity, and bonus points make up the NHB score, which is then displayed next to (and, notably, separately from) cost. Here ASCO uses drug acquisition cost, and concedes that while this is not the most complete or meaningful measure, particularly for the patient, it was the most straightforward to quantify. Of course any methodology to truly determine value should include total cost of care, including estimated costs for diagnostics, surgery, imaging, hospitalization, and provider charges. Ultimately ASCO envisions including another figure, the cost to the patient, which will have to be individualized based on the patient’s specific health benefit design. ASCO also notes the goal is that the patient will also be able to modify the importance of both clinical benefit and/or toxicity based on his or her personal values and treatment goals.

As we know, defining value is not an easy task and ASCO recognizes several limitations to this model. The first is that the NHB calculation is only valid within the context of the clinical trial, which does not allow for intertrial comparisons. Additionally, this model does not include the patient’s perspective on value, excluding critical endpoints such as quality of life and patient-reported outcomes in the calculation of NHB. We also know that the relative value of a given treatment will likely change over its lifetime; how will this conceptual framework become a practical, dynamic tool that will repopulate data and update NHB scores over time?

From the physician’s perspective, many questions remain. How exactly will this tool be used in a clinical setting? When will this conversation happen at the point of care? Who will ultimately perform the analysis, input the patient’s cost-sharing data and preferences, and present the numbers to patients? Some physicians will use the tools themselves, while others will rely on nurses, administrators, or pharmacists to perform the analytics. While ASCO is clear the proposed framework is “not meant to substitute for physician judgment or patient preference,” in current form, it may leave the patient with more questions than answers. We encourage ASCO to develop a strategy to provide the appropriate guidance, support, and education to providers to assist them in explaining these values to patients in the next iteration of this framework.

ACCC recently submitted comments on ASCO’s value framework, and we look forward to continuing to engage with ASCO and others on the challenging issue of cost and quality in the cancer care delivery system.

Ringing in the New Year

US Capitolby Leah Ralph, Manager, Provider Economics and Public Policy, ACCC

The last few months have brought big changes to Washington, D.C. We will ring in the New Year with both chambers of Congress under GOP control, which means the parties are reorganizing and, importantly, the legislative agenda is shifting. While it’s still anyone’s guess whether new leadership will mean less political infighting in 2015, issues like trade, energy, and tax reform are early contenders for potential areas of compromise next year.

The ACA (Affordable Care Act) will also make the top of the political agenda: starting in January, you can count on Republicans to look for every opportunity to take the legs out from under President Obama’s signature achievement. Although full repeal is unlikely, as it would face an all-but-guaranteed presidential veto, expect the new majority to focus their efforts on introducing a series of stand-alone bills targeting the most unpopular provisions of the law.

Predicting the fate of non-ACA healthcare legislation is a tougher call. On the one hand, healthcare fatigue still looms large among legislators, making issues like a long-term fix to the Sustainable Growth Rate (SGR), oral parity, and sequestration more of an uphill climb. On the other hand, new leadership, a renewed vow to work across the aisle, and public dissatisfaction with the status quo are bringing new energy to Congress.

Will 2015 Bring a Permanent SGR Fix?

In 2014 we saw what was arguably the best opportunity in years to finally fix the fundamentally flawed SGR formula. Congress came to agreement on a bipartisan bill that had a relatively low price tag, but in the end could not reach consensus on how to pay for the fix. As a result, the bill never came to a vote and will need to be reintroduced in the new Congress. Still the fact that Congress achieved consensus on policy is a promising sign for 2015. We have now weathered seventeen (17!) “doc fix” patches that, if added together, cost far more than the comprehensive approach lawmakers are considering today. This year’s ACCC Capitol Hill Day is scheduled for March 16, so we will be visiting with our legislators just weeks before the current “doc fix” expires on March 31.

Will We See Federal Oral Parity Legislation?

Passing a national oral parity law continues to be a top priority for ACCC membership. On the state level, oral parity efforts are gaining momentum. To date, 34 states and D.C. have enacted oral parity laws, and several other states are ramping up their grassroots efforts for 2015. Given that an estimated 25 to 35 percent of all oncology therapies in the pipeline will available only in pill form, the need for comprehensive, federal oral parity legislation is increasingly critical to patient access. While state-level legislation remains important, lawmakers need to understand that federal legislation would ensure consistency in oral parity laws across the country and would include plans that fall outside the purview of state regulation.

Will We See Any Relief from the Sequester?

Last year, legislation to exempt cancer drugs from the Medicare sequester gained more than 100 cosponsors. ACCC will be advocating for this legislation to be reintroduced in 2015.

As you can see, 2015 is the year to make your voice heard! Join us for Capitol Hill Day on March 16, and stay for the ACCC 41st Annual Meeting, CANCERSCAPE, which will follow March 17–18 in Crystal City, Va. Read our agenda and register today!

If you have additional questions, or would like to get involved with ACCC advocacy, please contact me at lralph@accc-cancer.org.

 

 

Why USP Should Reconsider Chapter 800

by Sydney Abbott, JD, Manager, Provider Economics & Public Policy, ACCC

question-markThe US Pharmacopeial Convention (USP) recently released draft guidance on the containment of hazardous drugs (HDs) to “as low as reasonably achievable” in order to ensure the safety of personnel handling these drugs.  According to the Centers for Disease Control (CDC), about 8 million people every year could be exposed to HDs, so USP developed Chapter 800 to protect this population in the transporting, receiving, compounding, and dispensing of these products. While ACCC’s Oncology Pharmacy Education Network (OPEN) supports USP’s aim to increase personnel safety, we remain concerned that implementation of these proposed standards would result in reduced access to care for patients with cancer.

USP is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide.

The guidelines outlined in the proposed Chapter 800 call for any facility compounding or mixing HDs, no matter how infrequently, to undertake a series of precautions, including separate storage locations for sterile and non-sterile drugs. For many ACCC members, adherence to Chapter 800 would not only pose a major financial concern, it would present a challenge in terms of having enough physical space to comply with guidelines—especially for those in urban settings or with facilities located within a cancer center. Ultimately, if the chapter is adopted, it could cause some cancer facilities to either stop offering mixing services for their patients, or in extreme cases, to close altogether.

However, it is important to understand that USP Chapter 800 presents guidelines—states individually adopt Chapter 800 for these to become mandatory. Still, even if a state has already adopted USP Chapter 795 and/or Chapter 797, it does not preclude that state from adopting Chapter 800, as well.  This is because Chapter 800 addresses containment matters and is designed to build on 795 and 797, not replace them.

ACCC’s Oncology Pharmacy Education Network (OPEN) and the Oncology State Society Network (OSSN) recently submitted comments to USP on proposed Chapter 800.  In addition, ACCC joined with representatives from other cancer organizations in a group letter to USP expressing common concerns regarding proposed Chapter 800.

ACCC will continue to keep members informed on this issue.