NEW YORK – The National Council for Prescription Drug Programs (NCPDP), a standards organization for the pharmacy services industry, wants to position pharmacists as central to pharmacogenomics testing and management.
The interest has come from NCPDP members who have suggested that pharmacogenomics is a matter of ensuring medication safety and improving patient outcomes, according to Pooja Babbrah, immediate past chair of the organization's board of trustees and a current board member.
"In the past, I think there was a lot of interest in doing some of this testing," said Babbrah, who is also practice lead for pharmacy and pharmacy benefit management (PBM) services at consulting firm Point-of-Care Partners (POCP). "But I think payors and others got burned because it opened up the floodgates. Pharmacists and labs started running all these panels, and you just weren't seeing [patient] outcomes from it."
Nominally based in Hollywood, Florida, but with consultants across the US, POCP's services include helping clients find ways to optimize their usage of pharmacogenomics as well as pharmacy information systems.
Scottsdale, Arizona-based NCPDP, meanwhile, has three broad categories of members: PBMs and health insurers, IT vendors, and care providers, particularly retail pharmacists. Membership also includes some drug manufacturers and wholesalers, since the organization offers standards to manage rebate programs and other activities requiring communication between pharma and pharmacy, according to Rick Sage, the organization's executive VP for innovation and standards.
NCPDP has made a concerted effort in the last two to three years to expand its membership beyond users simply looking to transmit medication orders electronically and then get paid for filling prescriptions. As part of that, the board created a work group on care coordination and innovation, which led to inquiries about how the organization might facilitate the growth of pharmacogenomics.
Sage said the first pharmacogenomics stakeholder meeting was the result of several years of informal conversations.
"That really kicked off the work action items that will help to line up what we're doing, what we need to do, and then where we see the rest of the industry," Sage said. "How do we work with the rest of the healthcare industry to support the movement of information?"
Underneath the board, NCPDP has a strategic planning committee, and Babbrah said that pharmacogenomics has "come up several times" in committee meetings. Some standardization of ordering and reporting processes and streamlining of communication could help improve the value of PGx testing, Babbrah suggested.
To this end, Point-of-Care-Partners convened an NCPDP "stakeholder action group" in March to bring payors, PBMs, IT vendors, genetic testing laboratories, pharmacogenomics organizations, and drug manufacturers together to discuss PGx data exchange to support precision medicine. The session explored regulatory barriers and how to align reimbursement for pharmacogenomics testing with value-based care models.
Notably, participants came up with a basic plan for pharmacies and pharmacists to "champion" this effort, but mostly they left with an agreement to keep talking, according to Kelee Petzelt, a POCP consultant. NCPDP will host a follow-up webinar in July or August, featuring a panel of subject-matter experts who were present at the March meeting.
Petzelt and POCP colleagues will be speaking at the National Association of Specialty Pharmacy annual meeting in September on the topic of integrating pharmacogenomics into clinical workflows as well as implementing relevant data standards.
While convincing frontline clinicians to change their ways is always difficult, NCPDP is more focused on pharmacists on the back end of the prescribing process. As pharmacists become more a part of a patient's care team, their importance will grow, according to Babbrah, who mentioned that the COVID-19 pandemic greatly expanded the role of pharmacists as providers of testing and vaccination services.
"From NCPDP's side, we believe that pharmacogenetics should be quarterbacked or run by the pharmacist," added Petzelt. She noted that pharmacists often dispense medications to a single patient from multiple physicians, who are not always coordinating with each other.
"The odds of preventing an adverse drug event are going to be better before that medication is dispensed," Petzelt said.
Since the March meeting of the stakeholder action group, NCPDP has created a series of task groups to advance the discussion from that group. Issues on the table include how to identify patients eligible for a pharmacogenomic test, who can order the test, and where and how the test should be performed. Sage noted that some US states have granted pharmacists the power to order genetic tests.
Sage said that one task group created since the stakeholder action group meeting is trying to understand how an NCPDP standard called Script can manage and communicate orders for pharmacogenetic tests. Another group is looking at incorporating pharmacogenomics into NCPDP's Pharmacist eCare Plan, a framework for specifying concerns, goals, and interventions for a patient from a pharmacist's perspective.
Sage said that the organization wants to make sure that the eCare Plan is compatible with Health Level Seven International (HL7) communication standards so data can be shared electronically with all members of a care team. NCPDP is already working with HL7 on this issue.
Script may have to be modified to give a pharmacist the ability to send a change request back to a physician if a prescribed drug might be problematic based on a patient's pharmacogenomic profile, Sage noted.
"We believe that pharmacy plays a very critical role in this moving forward," Sage said. "As we begin to see more plan sponsors supporting genetic tests, we want to make sure that we're utilizing the information as effectively as possible."
Sage said that NCPDP is writing a paper now to recap the work from the stakeholder action group to disseminate to the healthcare industry and communicate follow-up tasks.
Babbrah said that acceptance of pharmacogenomic testing by health insurers is key. "If health plans are willing to pay for these [tests], then you're actually going to see some movement in the industry," she noted.
Genetic testing companies have often said that their tests will never reach their full clinical potential until someone starts paying for testing and analysis, and have struggled to make their case to insurers.
Babbrah said that payors and PBMs came to the stakeholder action group with a mindset that they do not see a return on investment in pharmacogenomic testing. They left thinking about how PGx might help with utilization management.
As is customary with NCPDP stakeholder action groups, information that comes out of meetings gets transmitted to the organization's strategic planning committee, which now has to figure out what that means for NCPDP in terms of adapting existing or developing new standards.
Another issue to be addressed is where the data from a PGx test should reside, given that patients frequently move from payor to payor, particularly if their health insurance is tied to employers. And what format should that test result be stored in?
The POCP representatives suggested that pharmacogenetic testing should eventually become the norm before a patient starts on a biologic drug or other expensive treatment. Since NCPDP represents retail and specialty pharmacies more than hospital-based pharmacies, this likely would exclude chemotherapy and other drugs administered in clinical environments, according to Babbrah.
Sage said that NCPDP's interest in pharmacogenomics came from a desire to understand the role pharmacies could play in precision medicine.
"As payors and PBMs are becoming more involved in the overall cost and improvement of care … we're seeing more prior authorization for these costly [biologic] drugs and tying it into the genomic testing to make sure that before they spend, they actually look like [the drugs] would be effective," Sage said.
While not as expensive as biologics, mental health drugs have caught the interest of NCPDP in the context of pharmacogenomics because patients are often subjected to trial and error when they start on drugs such as selective serotonin reuptake inhibitors for depression.
Sage said that NCPDP is waiting for vendors to propose pilot projects, but noted that mental health regularly comes up in discussions. "We're trying not to limit us to any particular disease state or condition, but we will probably end up landing on mental health," he said.
NCPDP has a foundation that over the years has provided financial support for projects addressing at least one of the organization's three pillars: improving patient care, gaining efficiencies in pharmacy settings, and advancing patient safety. That foundation might be able to fund relevant pilots, according to Sage.
Standards harmonization
At its heart, NCPDP is a standards organization, not just a discussion forum.
NCPDP, which dates to 1977, came about to improve communication between pharmacies and payors, mostly for claims adjudication. Standards that the organization developed led in part to the growth of PBMs.
Later, in the mid-2000s, an NCPDP standard called Script was central to the rapid shift from paper to electronic prescribing. Today, the NCPDP Script standard supports movement of e-prescribing data between prescribers, health plans, and pharmacies, including through intermediaries like SureScripts.
In pharmacogenomics, NCPDP is both looking to set and modify its own standards if necessary and to support existing standards from other groups. Sage said that it is important for NCPDP to be able to interface its standards with outside specifications in the name of interoperability.
The Office of the National Coordinator for Health Information Technology (ONC) — the health IT advocacy arm of the US Department of Health and Human Services — is in the process of setting up a pharmacy interoperability task force through its public-private Health IT Advisory Committee (HITAC).
NCPDP expects to provide input to that task force, which will, among other things, be looking at new and emerging therapies, Babbrah said, and PGx data will be part of the discussion in terms of utilization management.
NCPDP has not yet been in direct contact with the Clinical Pharmacogenetics Implementation Consortium (CPIC), the Pharmacogenomics Research Network (PGRN), or the developers of the National Institutes of Health-backed Pharmacogenomics Knowledgebase (PharmGKB).
Sage said that NCPDP is still trying to evaluate the PGx landscape and identify gaps the organization might be able to fill before setting up formal meetings with such groups, though Petzelt said that the NCPDP has had discussions with users of those networks and resources as part of its survey of the landscape.