Heads up, brand teams, automation of specialty pharmacy is rapidly gaining momentum. Results will have implications for a drug’s selection, approval mechanisms and distribution. Hubs ultimately will be impacted, including their role in patient education and companies’ investments in them. Manufacturers have the opportunity to join in on the ground floor and affect the outcomes.
Drivers for change. Specialty pharmacy has come on everyone’s radar these days, for a variety of reasons. Costs are a big factor. The rise of chronic illnesses and the expensive medications needed to treat them have made specialty the fastest growingsegment of medications.
Growing digitization of health care is another driver. Specialty pharmacy processes still remain largely paper based and dependent on phone and fax. This stands in contrast to nonspecialty medications, nearly all of which are prescribed electronically. Everyone is interested in getting rid of paper and fax, including Seema Verma, who heads the Centers for Medicare and Medicaid Services. She recently challenged developers to “help us make every doctor’s office in America a fax-free zone by 2020.”
Addressing the hassle of prior authorization (PA) is yet another factor. Most specialty medications require PA, which is a pain point that creates delays to therapy and prescription abandonment. The industry has responded with automation. Electronic PA (ePA) rapidly is becoming deployed for medications covered under the patient’s pharmacy benefit, in response to state legislation and payer mandates. Now there are growing efforts for ePA of drugs covered under the patient’s medical benefit, or mPA. (Read more about mPA in the September issue of HIT Perspectives.)
If that isn’t enough, information about specialty drugs that are prescribed — and related information, such as adverse drug events — needs to be incorporated into electronic health records (EHRs). The capturing and sharing of such information via EHRs is essential for the growing trend toward outcomes-based reimbursement, as well as for various safety-related requirements.
Efforts for change. Initial efforts for specialty pharmacy computerization are being undertaken by the National Council for Prescription Drug Programs (NCPDP), which recently convened a Specialty Prescribing Workgroup whose expressed purpose is to improve the automation of specialty workflows. It is co-chaired by my colleague at Point-of-Care Partners (POCP), Pooja Babbrah. Brand team participation is sought to represent the needs of your patients and their prescribing physicians.
“The workgroup will become the focal point for industry stakeholders involved in specialty medications,” explained Ms. Babbrah. “We have already identified a number of processes — from enrollment and benefit verification to prior authorization, patient consent and outcomes reporting —that can benefit from standardization to improve speed to therapy.
“We need to have pharmaceutical manufacturers involved. It is critically important to understand their requirements and points of view,” she added.
The workgroup is kicking off with two focused efforts. The first is computerizing patient enrollment for a new therapy. This will allow the physician to send required information electronically to a pharmacy. Currently, NCPDP SCRIPT — the main standard used for electronic prescribing (ePrescribing) — is insufficient for the needs of specialty pharmacy. Additional detailed information along with the prescription will assist with automation. Brand team input is needed to help the workgroup understand what information is needed for specific specialty medications.
The second effort focuses on benefit identification, which is spearheaded by a task group. This group will evaluate how to begin the process of automating determination of whether a drug is covered under a patient’s medical or pharmacy benefit or both. This varies by payer, so having this information will help the prescriber know where to go for approval as well as improve speed to therapy.
These efforts will affect both parts of specialty pharmacy: the drugs themselves and distribution. Brand teams will have to figure out how their brands will be impacted by electronic approvals and extensive PA. How will brand investment in hubs be affected, since some traditional patient education and support will become electronic? How will distribution change?
These are some of the reasons why manufacturer representation is needed in the workgroup and in specific task group calls in which important issues are explored. It’s an opportunity to make your voice heard. In fact, an outreach task group will be added, which would benefit from manufacturer participation to strengthen business cases. I’d be happy to put you in touch. In the meantime, POCP is monitoring these developments. Let me keep you in the loop. You can reach me at email@example.com.
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