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Commentary

Managed Care Looks Forward: Top Five Trends for Pharmacy in 2019


January 16, 2019

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By Stephanie Tran, PharmD

As 2019 begins, pharmacists look forward to what the new year holds. Themes from 2018 will continue to develop and managed care will grapple with adapting to upcoming changes. Here are five of the top trends for 2019.

Drug Pricing: Is Affordability a Realistic Goal and Will Value be Achieved?

The past few years saw the rise of six-figure price tags for one-time, potentially curative therapies such as Kymriah (tisagenlecleucel) and Luxturna (voretigene neparvovec). We also saw the advent of costly maintenance treatments, as the price to treat one patient with cancer topped $100,000 annually.

In response to rising costs, the Trump Administration released the American Patients First blueprint in May 2018 to address high drug prices. Since that time, the Administration has taken several steps towards drug pricing reform, including proposals for publishing drug prices in television ads, expanding utilization management tools for public payers, and increasing generic competition. In 2019, further responses from industry and stakeholders are expected, as well as additional proposals regarding other parts of the blueprint, such as the Anti-Kickback Rule and removal of rebates.

Organizations such as the Institute for Clinical and Economic Review have also been reviewing and modeling drugs’ societal value, while payers and pharmaceutical companies have been pursuing new ways to contract for drugs based on value. Novel payment strategies such as outcomes-based contracts and indication-based pricing will continue to evolve to address rising drug prices.

Pharmacy Benefit Managers (PBMs): Can They Be Trusted and Will They Evolve?

The top three PBMs (CVS, Express Scripts, and OptumRx) handle more than 70% of pharmacy claims in the U.S. In 2018, Cigna merged with Express Scripts and CVS merged with Aetna, which solidifies the dominance of the integrated payer-retail-provider-PBM model.

While PBMs draw revenue from supply chain fees and manufacturer rebates, notable investigations in 2018 highlighted another source of revenue: the “spread” (i.e., the difference between what PBMs pay a pharmacy versus what PBMs are paid by a payer). Exposure of this model has created mistrust of these “middlemen.” In 2019, PBMs will continue to justify their role in the complex pharmaceutical supply while increased scrutiny provides opportunities for other PBMs to offer fully-transparent models and empowers payers to better understand their contracts with PBMs.

The Food and Drug Administration (FDA): Too Quick to Approve?

The FDA approved 46 novel drugs in 2017 and 59 in 2018 and this trend is expected to continue. The FDA approves drugs through several expedited programs including Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review. This past year, the FDA created the Regenerative Medicine Advanced Therapy Designation (a product of the 21st Century Cures Act) and launched four pilot programs (Clinical Data Summary, Real Time Oncology Review, Assessment Aid, and Complex Innovative Trial Designs).

These programs are aimed at increasing availability of cures and treatments for patients by bringing drugs to market earlier. However, many new drugs and indications are approved based on surrogate endpoints and require validation through post-marketing studies, which take years to complete. With more drugs gaining FDA approval based on less robust data, it is unclear to both prescribers and payers the optimal roles of these therapies.

Biosimilars: Will They Deliver Expected Cost-Savings?

Through the Biologics Price Competition and Innovation Act, Congress created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. In 2019, almost a decade will have passed since the Act. It was forecasted that U.S. would save $250 billion between 2014 and 2024.

The FDA has approved 16 biosimilar products, however, only a handful are available due to patent litigations which means that biosimilars are nowhere near capturing the market share needed to substantiate cost-savings predictions. Additional market access barriers include manufacturing processes and interchangeability. To date, no product has been approved that is designated to be interchangeable, a designation which requires real-world evidence and switching studies.

Finally, price is another consideration. Given complex financial and access arrangements through rebates, it remains to be seen whether the net price of biosimilars will be less than reference products. Until more biosimilars are available on the market, price competition will not be achieved.

Pipeline: Can Peanut Allergies be Treated and Pain be Safely Managed?

This year may see the approval of two immunotherapy treatments for peanut allergies: Viaskin Peanut and AR-101. This past December, DBV Technology withdrew the Viaskin Peanut application but hopes to resubmit as quickly as possible. Aimmune Therapeutics submitted an application for AR101, an oral immunotherapy agent, for the treatment of peanut allergy in children and adolescents ages 4 to 17. A decision is expected in the first half of 2019. Peanut allergies affect 1.2 million children and adolescents in the U.S. While these agents are promising and address an unmet clinical need, their uptake may be limited or gradual due to concerns of adherence and unknown response and safety in the real world.

Pain treatments have undergone great scrutiny in light of the opioid epidemic. In May, the FDA is expected to make a decision on NKTR-181, a first-in-class opioid analgesic designed to provide pain relief without high levels of euphoria. The FDA granted Priority Review to HTX-011, a non-opioid for the management of postoperative pain, with a decision date set for April. The FDA has also granted Breakthrough Therapy designation to CA-008 (a first-in-class, non-opioid therapeutic that rapidly converts to capsaicin, a potent TRPV1-agonist for postsurgical pain) as well as Fast Track designations to VVZ-149 (non-narcotic and non-NSAID pain killer) and AV-101 (non-opioid, non-sedating neuropathic pain treatment). Real strides have been made in addressing the opioid epidemic through policy, prescriber, and payer efforts. Additional options for pain treatment that include non-opioid and safer opioids will be another important tool in this toolbox.

In 2019, the health care industry will continue its transformation and new innovations will come to the market. Pharmacists will continue to play a critical role in a health care industry that is increasingly shifting its focus to innovation, value, pricing, and transparency.

Stephanie Tran, PharmD, is a Clinical Consultant Pharmacist at UMass Medical School’s Commonwealth Medicine division. 

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