Representatives from various patient groups offered their concerns. Donna Cryer of the Global Liver Institute criticized the use of the Institute for Clinical and Economic Review (ICER) to help determine a value-based payment framework as the Institute has little engagement with patient groups. Patient advocates have also raised concerns with the Institute's methodology.
Goldsmith added, however, that she was hopeful following a meeting with CMS Acting Administrator Andy Slavitt and Deputy Administrator Patrick Conway, where she was able to offer her concerns on the second phase of the demonstration and received a commitment from CMS to engage with patients.
The full article can be found below:
Patient Advocates Upset By Value-Based Assessments In Part B Drug Pay Demo
Patient advocacy groups are raising concerns with the proposed use of value-based assessments in the second phase of the controversial Part B drug pay demo, as one cancer patient advocate said a number of value-assessment frameworks for drugs are devoid of patients’ voices and others say there is a lack of disease-specific expertise on panels like ICER that vote on the value of a drug for patients.
Advocates for patients with cancer, liver disease, mental health and other conditions said CMS’ move to, as part of the demonstration, use value-assessment frameworks -- which focus on the value of a drug to the average patient -- goes against the agency’s focus on personalized medicine.
The agency proposed a two-part demonstration that begins by changing the physician reimbursement formula from 106 percent of drugs’ average sales price to 102.5 percent of the average, plus a flat $16.80 fee. The second phase involves value-based pay arrangements on which CMS asked for feedback, including use of: discounts or elimination of patient cost-sharing; prescribing patterns and online decision support tools; reference pricing; and risk sharing agreements based on outcomes; and indications-based pricing.
“We propose to use indications-based pricing where appropriately supported by published studies and reviews or evidenced-based clinical practice guidelines, such as the ICER reports, to more closely align drug payment with outcomes for a particular clinical indication,” CMS says in the proposed rule. “The Institute for Clinical and Economic Review (ICER) is currently producing reports on high-impact drugs that analyze comparative effectiveness and cost-effectiveness before calculating a benchmark price for each drug, ICER's reports reflect the dependence of the value of medications on evidence available for certain target populations."
The proposed rule also indicates that ICER reports would play a role in determining clinical effectiveness for drugs as part of the test of reference pricing.
Donna Cryer, president and CEO of the Global Liver Institute, said that if CMS is going to move forward with using some form of value-based framework as part of the demonstration, picking ICER is problematic. Cryer said the institute has little engagement with patient groups, and it is often difficult for patient groups that want to provide feedback to ICER to do so. Robin Tuohy, senior director of support groups for the International Myeloma Foundation, said that ICER does not have enough disease-specific expertise when making assessments on the value of a drug. Patient advocates also raised concerns with ICER’s methodology.
If the agency continues to focus on value-based frameworks as part of the demonstration, it should at least use one that signals it values patients and includes a number of experts as part of its decision making, Cryer said.
Patricia Goldsmith, chief executive officer of CancerCare, said there is a proliferation of value-based frameworks that are devoid of patient voices. These frameworks, she said, tend to focus on short-term costs, not the full spectrum of treatment. Goldsmith and Andrew Sperling, director of legislative advocacy for the National Alliance on Mental Illness, said using value-based frameworks would be at odds with CMS’ goals on personalized medicine since the frameworks focus on value for the average patient.
Goldsmith, however, said she was hopeful following a recent meeting with CMS Acting Administrator Andrew Slavitt and CMS Deputy Administrator Patrick Conway where she raised concerns with the second phase of the demonstration. She added that CMS wants to engage with patients.
CMS has received criticism on both phases of the demonstration, as well as some support, including from consumer groups. Jonathan Blum, a former CMS administrator, said at a recent Bipartisan Policy Center event that the lesson of the Part B demo appears to be that changes to the pricing system need to be driven by patients and doctors. No one can disagree that the drug pricing system needs to be reformed, Blum said. But once a reform is proposed, someone will lose money, and that creates pressure to pull back, so CMS needs to build consensus and support for models in the future.