Weekly Policy Blog: CBSA Has Concerns About Inconsistency of Preliminary Data Review Process for Drugs Under Affordability Review by PDAB
By: Colorado BioScience Association Date: 10/30/2023
CBSA has serious concerns about the Colorado Prescription Drug Affordability Board’s inconsistent approach to the preliminary data review process for drugs under affordability review in the first cohort. CBSA submitted a letter on Friday to Board members and staff expressing those concerns.
In addition, CBSA expressed concerns about the potential imposition of upper payment limits through a letter submitted to the PDAB in advance of the October 27th meeting and public comment by CBSA’s Vice President & Counsel for Policy + Advocacy during the meeting.
The PDAB’s October 27th Meeting
The Colorado Prescription Drug Affordability Board (PDAB or Board) has selected five drugs for an affordability review and will be determining whether to deem them “unaffordable” for Colorado patients. If the PDAB does deem them unaffordable, the PDAB will then determine whether to set an upper payment limit (UPL) for each drug and, if so, will proceed with a rulemaking process to set a specific dollar amount for the UPL. For the affordability review process, the PDAB broke the five drugs into two cohorts. The Board is currently gathering data for affordability reviews of the first cohort of drugs: Trikafta, Genvoya, and Enbrel.
At the October 27th PDAB meeting, the Board had planned to discuss preliminary data for the first cohort of drugs before PDAB staff completes the first draft of an affordability review report for each drug. However, the four-hour meeting was managed in such a way that the Board only had time to discuss preliminary data for one of the three drugs—Trikafta. After discussing wholesale acquisition cost (WAC) and rebate information in executive session for Genvoya and Enbrel, the Board ran out of time to discuss preliminary data for the other two drugs. The Board decided to review all of the other preliminary data for Genvoya and Enbrel independently before they reconvene on December 8th to discuss the completed draft affordability review reports prepared by staff. That means the Board will not have an opportunity for PDAB staff to present the preliminary data in a group setting that facilitates asking questions, clarifying, and engaging in invaluable, open, public dialogue about the preliminary affordability review data for Genvoya and Enbrel in the same way they did for Trikafta.
CBSA Concerns About Inconsistency of Preliminary Data Review Process for Drugs Under Affordability Review
CBSA has serious concerns about the inconsistency of the preliminary data review process for the drugs in the first cohort and submitted a letter to Board members and staff the afternoon of the meeting to express those concerns. It was evident from the discussion of preliminary data for Trikafta on Friday that open dialogue is a critical part of the review process. The inconsistency in methods for review creates unpredictable and unfair treatment of the individual drugs.
Patients, caregivers, medical professionals, and manufacturers for all other drugs undergoing affordability review deserve to have the same opportunity for the Board to review the preliminary data in the same manner the Board reviewed Trikafta on Friday.
CBSA has strongly encouraged the PDAB to adhere to a fair and transparent process that provides equal treatment for each of the drugs under review. Specifically, CBSA has requested that the Board schedule another public meeting to discuss the other two drugs or push back the whole timeline for the affordability review of the other two drugs in the first cohort to defer the discussion of preliminary data to the next regularly scheduled Board meeting on December 8th. This change would delay the staff’s draft affordability review reports as well.
CBSA Concerns About Upper Payment Limits
CBSA shares the PDAB’s goal of improving the affordability of medicines for patients. However, we remain concerned that any future decision to deem a drug unaffordable or to set a state-mandated upper payment limit (UPL) will not actually improve affordability for patients and could have serious unintended consequences on patients’ access to life-saving and life-changing medicines and on the feasibility of bringing new, innovative biopharmaceutical therapies to patients with unmet medical needs. CBSA is advocating for our life sciences community.
CBSA submitted this letter to the PDAB in advance of the October 27th PDAB meeting. In addition, CBSA’s Vice President & Counsel for Policy + Advocacy shared the following concerns directly with the Board during the public comment period:
- You have been directed by the legislature to consider setting UPLs on drugs to lower costs for consumers and to “ensure they can access prescription drugs necessary for their health.”
- If you deem any drugs unaffordable, you have the power—and the responsibility—to determine whether setting a UPL on the drug would actually accomplish those goals.
- Just because UPLs were the tool contemplated by the legislature in SB21-175 doesn’t mean that’s the right tool to accomplish your stated goals.
- As the saying goes, “if all you have is a hammer, everything looks like a nail.” But you have the opportunity now to assess whether using that hammer will actually serve patients or whether it will have unintended consequences.
- So far, the PDAB’s process has assumed that setting UPLs on drugs will make them more accessible and affordable to patients, but significant doubts about that assumption and serious concerns have been raised by patients, providers, and various members of the supply chain.
- That assumption ignores the fact that benefit design dictates how much patients pay for drugs and ignores the fact that drug pricing and the pharmaceutical supply chain are very complicated with multiple players involved.
- The patients who this Board is endeavoring to help have come out in force asking the Board not to set UPLs because of their concerns about unintended consequences on access and innovation.
- Now is the time to consider patients’ feedback and weigh all of the potential impacts of your decisions—before you make the decision to start a rulemaking process that is simply focused on determining the specific dollar amount at which you’d set a UPL.
- You should not initiate a UPL rulemaking process unless you feel absolutely confident that you know how insurers and PBMs will react.
- Will benefit designs change to lower patients’ out-of-pocket costs?
- How will drug formulary and tiering decisions be altered?
- How will they use any savings generated?
- And what impacts will there be on patients?
- Will patients actually pay less?
- Will there be any access interruptions?
- Will investments into the research & development of new drugs be stifled?
- You must tread carefully to ensure Colorado does not harm patients in its quest to be the first in the nation to implement this experimental program.
CBSA will continue to work closely with BIO, PhRMA, and member companies on next steps. We oppose the creation and enforcement of UPLs that we believe will lead to negative unintended consequences on patient access to medicines, on healthcare providers prescribing medicines, and on the market for innovative biopharmaceutical products.