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Precision Medicines Need Precision Patient Assistance Programs
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Precision Medicines Need Precision Patient Assistance Programs

A. Mark Fendrick, MD; and Jason D. Buxbaum, MHSA
The competing strategies of patient assistance programs and co-pay accumulator adjustment programs create confusion and administrative burden for clinicians and patients, potentially reducing adherence to clinically indicated services and worsening patient outcomes.
Adding Precision to PAPs

Recognizing that blunt cost-sharing programs and opposing interventions to reduce OOP costs for high-cost medications are likely to persist, plans, PBMs, and manufacturers could minimize potential harm through new partnerships (Figure). These patient-centered collaborations could facilitate the use of patient co-pay assistance only when high-cost medications are indicated in high-value clinical scenarios. A “truce” might include the following provisions, each of which could serve to enhance access to clinically indicated therapies and decrease the financial and logistical burden on patients/families and their clinicians in these scenarios where higher-cost, high-value medications are warranted:
  • Payers would accept the use of external financial patient assistance to reduce consumer cost sharing when a particular medication is clinically indicated. This would mean forgoing utilization management (eg, step therapy, prior authorization, formulary exclusions) in these situations. Use of CAAPs would be limited to circumstances in which the medication is clearly a low-value option (eg, use of a branded drug when a generic alternative is available). This might reduce the risk of decreased medication adherence to an essential medication resulting from unexpected cost sharing a member may face if/when a PAP reaches an annual or monthly limit. Payers might also encourage their contracted providers and care managers to connect financially insecure individuals to patient assistance resources when clinically appropriate.
  • Manufacturers would ensure that information on clinical appropriateness—including scenarios in which a medication is not clinically appropriate—is well communicated in PAP materials. For manufacturer-administered programs serving those with commercial coverage who are underinsured, applications might inquire as to whether lower-cost first-line treatments had been appropriately tried.
Such collaborative arrangements would benefit from consensus on clinically indicated uses of a specific medication. Designation of high value could be based on alignment with clinical guidelines issued by professional societies, the National Comprehensive Cancer Network pathways, or other trusted third-party sources. In many instances, this designation of high value could include use of recommended first-line therapy prior to more expensive biologic or specialty medications (eg, use of methotrexate in rheumatoid arthritis prior to use of a tumor necrosis factor inhibitor or Janus kinase inhibitor). In other instances, it might include the presence of certain patient-specific characteristics (eg, biomarkers) that make a targeted therapy appropriate (eg, use of trastuzumab [Herceptin] for patients with early-stage breast cancer that is human epidermal growth factor receptor 2–positive).

Precision Medicine Needs Precision PAPs

Advances in precision medicine call for greater use of precision benefit design that encourages and enables patients to receive the right care, at the right time, in the right place, at an OOP price they can afford.7 Purchasers, PBMs, and pharmaceutical manufacturers have critical roles to play in enabling more seamless access to the right medication at the right time to improve the experiences of patients, families, and providers, and they could find common ground by piloting precision PAPs that complement these efforts. Through collaboration, stakeholders can steward limited healthcare resources while ensuring that OOP costs rarely prevent patients from accessing high-value therapies.

Author Affiliations: University of Michigan Center for Value-Based Insurance Design (AMF), Ann Arbor, MI; Harvard University (JDB), Cambridge, MA.

Source of Funding: None.

Author Disclosures: Dr Fendrick has been a consultant for AbbVie, Amgen, Bayer, Centivo, Community Oncology Alliance, Exact Sciences, Freedman Health, Lilly, Mallinckrodt, MedZed, Merck, Risalto, Sempre Health, State of Minnesota, Takeda, Wellth, and Zansors; has performed research for the Agency for Healthcare Research and Quality, Boehringer Ingelheim, Gary and Mary West Health Policy Center, Laura & John Arnold Foundation, National Pharmaceutical Council, Patient-Centered Outcomes Research Institute, PhRMA, Robert Wood Johnson Foundation, and State of Michigan/CMS; and holds outside positions as co-editor-in-chief of The American Journal of Managed Care®, member of the Medicare Evidence Development & Coverage Advisory Committee, and partner in V-BID Health, LLC. Mr Buxbaum has received payment for consulting from V-BID Health, LLC, and has received payment for involvement in the preparation of this manuscript from the University of Michigan Center for Value-Based Insurance Design.

Authorship Information: Concept and design (AMF, JDB); drafting of the manuscript (AMF, JDB); critical revision of the manuscript for important intellectual content (AMF, JDB); and administrative, technical, or logistic support (JDB).

Address Correspondence to: A. Mark Fendrick, MD, University of Michigan, 2800 Plymouth Rd, Bldg 16, Floor 4, 016-400S-25, Ann Arbor, MI 48109-2800. Email:

1. 2016 Employer Health Benefits Survey. Kaiser Family Foundation website. Published September 14, 2016. Accessed June 10, 2019.

2. Goldman DP, Joyce GF, Zheng Y. Prescription drug cost sharing: associations with medication and medical utilization and spending and health. JAMA. 2007;298(1):61-69. doi: 10.1001/jama.298.1.61.

3. Eaddy MT, Cook CL, O’Day K, Burch SP, Cantrell CR. How patient cost-sharing trends affect adherence and outcomes: a literature review. P T. 2012;37(1):45-55.

4. Reddy SR, Ross-Degnan D, Zaslavsky AM, Soumerai SB, Wharam JF. Impact of a high-deductible health plan on outpatient visits and associated diagnostic tests. Med Care. 2014;52(1):86-92. doi: 10.1097/MLR.0000000000000008.

5. Zitter Health Insights. The Managed Care Biologics & Injectables Index and Oncology Index: copay accumulator programs. Drug Channels Institute website. Published August 2018. Accessed June 10, 2019.

6. Sherman BW, Epstein AJ, Meissner B, Mittal M. Impact of a co-pay accumulator adjustment program on specialty drug adherence. Am J Manag Care. 2019;25(7):335-340.

7. Fendrick AM, Chernew ME. Precision benefit design—using “smarter” deductibles to better engage consumers and mitigate cost-related nonadherence. JAMA Intern Med. 2017;177(3):368-370. doi: 10.1001/jamainternmed.2016.8747.
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