January 16, 2019
Let's get a conversation started! Do you believe there are additional trends for pharmacists in 2019? Send our editor an email with your thoughts: firstname.lastname@example.org
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.
For Further Reading…
- Greenwood B. A View of the Drug Pricing Blueprint. Commonwealth Medicine; 2018 Sept 27 [cited 2019 Jan 3]. Available from: https://commed.umassmed.edu/blog/2018/09/27/view-drug-pricing-blueprint.
- Food and Drug Administration (FDA). 2019. Available from: https://www.fda.gov/.
- Rimer BK. The Imperative of Addressing Cancer Drug Costs and Value. National Cancer Institute; 2018 Mar 15 [cited 2019 Jan 3]. Available from: https://www.cancer.gov/news-events/cancer-currents-blog/2018/presidents-cancer-panel-drug-prices.
- Drug Pricing. U.S. Department of Health & Human Services; 2018 Jun 14 [cited 2019 Jan 3]. Available from: https://www.hhs.gov/about/leadership/secretary/priorities/drug-prices/index.html.
- Institute for Clinical and Economic Review (ICER). 2019. Available from: https://icer-review.org/.
- Frakt A. How to Cut U.S. Drug Prices: Experts Weigh In. New York Times; 2018 Dec 10 [cited 2019 Jan 11]. Available from: https://www.nytimes.com/2018/12/10/upshot/how-to-cut-drug-prices-experts-weigh-in.html.
- General Session: Is the PBM Industry Evolving or Disrupting? First Report Managed Care; 2018 May 7 [cited 2019 Jan 3]. Available from: https://www.managedhealthcareconnect.com/article/general-session-pbm-industry-evolving-or-disrupting.
- Arnold A. First Opinion: John Arnold: Are pharmacy benefit managers the good guys or bad guys of drug pricing? Stat News; 2018 Aug 27 [cited 2019 Jan 3]. Available from: https://www.statnews.com/2018/08/27/pharmacy-benefit-managers-good-or-bad/.
- Concerns Regarding the Pharmacy Benefit Management Industry. Applied Policy; 2015 Nov [cited 2019 Jan 3]. Available from: http://www.ncpa.co/pdf/advocacy/concerns-pbm-issue-brief.pdf.
- Beyond the PBM: A New Order for Healthcare Delivery. Decision Resources Group (DRG). Available from: http://www.pharmatimes.com/__data/assets/pdf_file/0016/1235221/Beyond_the_PBM_-_a_new_order_for_healthcare_delivery_-_DRG.pdf.
- Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Draft Guidance for Industry. U.S. Department of Health and Human Services/FDA/Center for Biologics Evaluation and Research. 2017 Nov [cited 2019 Jan 11]. Available from: https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/cellularandgenetherapy/ucm585414.pdf.
- 21st Century Cures Act; FDA; 2018 Mar 29 [cited 2019 Jan 11]. Available from: https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/21stcenturycuresact/default.htm.
- Wallach JD, Egilman AC, Dhruva SS, McCarthy ME, Miller JE, Woloshin S, et al. Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis. BMJ. 2018 May 24;361:k2031.
- Biosimilars. FDA; 2018 Sept 6 [cited 2019 Jan 3]. Available from: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/default.htm.
- Chen BK, Yang YT, Bennett CL. Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court’s Recent Rulings do not Solve Fundamental Barriers to Competition. Drugs (2018) 78:1777–1781.
- Leber MB. Optimizing Use and Addressing Challenges to Uptake of Biosimilars. Am J Manag Care. 2018;24:S457-S461.
- Boyles S. 1.2 Million Children and Teens Have Peanut Allergies —Two studies estimate current PA prevalence to be 2.2%. Medpage Today; 2018 Nov 20 [cited 2019 Jan 3]. Available from: https://www.medpagetoday.com/meetingcoverage/acaai/76459.
- Perkin MR. Editorial: Oral Desensitization to Peanuts. N Engl J Med 379;21.
For more Pharmacy Learning Network articles, visit the homepage