Unlocking an Affordable Future: Key #3

Support and Equip Clinicians


At the core of the pharmacy benefit specialty function lies expertise used to ensure the right patient gets the right drug in a timely manner. Pharmacy benefit companies bring together pharmacists, physicians, and other clinicians who use their specialized knowledge to evaluate prescription drugs and make recommendations to help provide people access to the safest, most effective drug to meet their needs at the best price available to them.

Following the science, pharmacy benefit companies use clinical data to support decision-making and help patients stay on course with their prescription therapy through evidence-based medication adherence and health coaching programs. Pharmacy benefit companies also help pharmacies enhance patient safety, prevent potentially harmful drug interactions, and reduce unnecessary medication. Beyond clinical expertise, patients benefit from offerings like home delivery – saving time and money while increasing access and care coordination, and medication management programs designed to provide support, promote health literacy, and improve patient outcomes.

Pharmacy benefit companies serve people along the full spectrum of life circumstances and are best able to meet patients’ needs when pharmacy benefit tools and offerings are fully available. Greater flexibility allows for person-centered care, care coordination, integrated pharmacy, and patient choice, all of which can improve health and help address existing health care inequities. To further enhance the ability of pharmacy benefit companies to support better health outcomes, PCMA recommends policymakers take the below actions.

  • Encourage transparency that gives patients and providers actionable information.
    • Pharmacy benefit companies seek to provide patients and providers with actionable transparency in the form of data and tools that allow for better decision-making and improve health literacy. RTBTReal Time Benefit Tools identifies therapeutic alternatives that meet a patient’s medical needs and provides options that are often more affordable based on the patient’s prescription drug coverage. Today, well over half a million healthcare providers are using RTBTReal Time Benefit Tools to determine what patients should expect to pay at the pharmacy counter or when they receive their home delivery drugs. According to recent data, when RTBTReal Time Benefit Tools identifies a lower cost, yet still therapeutically appropriate treatment option, patients typically save about $37 for their prescription drug therapy. Onerous transparency requirements that create extensive administrative burdens, generate unnecessary operational costs, and expose proprietary information, which enables drug manufacturers to keep prices higher, do nothing to help patients and providers. Future transparency policies should be focused on enhancing and refining information available to support patient health and affordability needs.
  • Support the use of specialty pharmacies.
    • Many pharmacy benefit companies own or partner with specialty pharmacies to dispense drugs with complex handling requirements. Permitting use of specialty pharmacies in all appropriate circumstances typically saves between 11% and 45% on specialty drugs.
      1. Safe and Secure: Specialty pharmacies are safe and secure, providing lifesaving drugs, handled safely and with chain-of-custody controls, in compliance with US Pharmacopeia guidelines and the federal Drug Supply Chain Security Act. Accreditation ensures patient safety and quality by verifying pharmacy capabilities.
      2. Seamless for Patients: Specialty pharmacies support patients by proactively confirming appointments, providing pre-testing requirements and safety reminders, and delivering drugs directly to the most convenient location for the patient, such as their home, place of work, or site of care.
      3. More Affordable: Specialty pharmacies buy “in bulk,” which enables them to avoid additional price markups and pass on savings to patients, employers and other plans sponsors, and government programs.
  • Enable home delivery.
    • Home delivery, sometimes referred to as mail order pharmacy, is a service pharmacy benefit companies provide that allows patients to have their prescription drugs shipped to their preferred location and pay lower out-of-pocket costs. Additionally, home delivery removes certain barriers connected to social determinants of health, such as lack of transportation, which enables access and aligns with pharmacy benefit companies’ commitment to addressing health inequities. 

Accelerated Approval is a faster review process for certain drugs with approval criteria based on clinical trials not designed to demonstrate the full effect of the drug and, as such, should be granted extremely rarely. Most FDA-approved drugs available to patients have demonstrated durable clinical benefits that outweigh the risks associated with their use. When new drugs come to market with limited clinical trials, a lot of questions remain related to the long-term risks and benefits. Accelerated Approval, along with other hastened review processes like Fast Track, Breakthrough Therapy, and Priority Review, can be helpful approaches to speeding patient access to drugs in rare situations of high unmet need. While pharmacy benefit companies support expeditious access to innovation, patient safety is paramount. Medicare and Medicaid spent more than $18 billion from 2018 to 2021 for 18 drugs that did not complete required confirmatory trials on which their FDA approval hinged, leaving many unanswered questions about clinical benefits for patients, health care providers, and insurers like Medicare and Medicaid. To optimize patient care PCMA recommends policymakers take the below actions.

  • Start Phase 4 trials early.
    • Require manufacturers to initiate phase 4 confirmatory trials prior to granting approval under the Accelerated Approval review process.
  • Enforce research schedules.
    • Ensure that research schedules are closely adhered to with predetermined monitoring checkpoints and swift penalties for delays. 
  • Enable VBP in all markets.
    • Enable payers to explore outcomes-based payment arrangements in both the public and private markets.
  • Empower the FDA to pull unhelpful drugs.
    • Ensure the FDA is fully empowered to exercise its authority to protect patients from ineffective drugs.
  • Increase clinical trial diversity.
    • Diversify clinical trials including through expanding eligibility criteria and reducing the burden on trial participants, as well as community-based collaboration.
  • Improve data collection and stratification.
    • Standardize and incentivize racial and ethnic data collection to allow stratification. Stratifying data collected from clinical trials will help payers optimize outcomes-based agreements.
  • Improve interagency collaboration.
    • Align CMS processes like coverage determinations with the FDA’s approval processes.