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Not every new drug that emerges from the FDA approval process becomes a big seller. In fact, most do not. But some new agents are better bets than others. Here are five new and potentially expensive treatments for everything from lung cancer to diabetes to multiple sclerosis that many believe will make a big financial impact in 2018 and beyond.

1. A “triplet” medicine for HIV

For patients with HIV, suppressing the virus has long required taking a combination of medicines. One approach is combining different treatments into a single formulation. Researchers hope the increased convenience will promote higher compliance, which is crucial to sustaining virologic suppression.1

Bictegravir/emtricitabine/tenofovir is a “triplet” medicine for HIV. Produced by Gilead Sciences, it combines bictegravir, a type of antiretroviral known as an integrase strand transfer inhibitor, with two other existing HIV therapies. Given expected benefits of a combination medicine and Gilead’s existing leadership in the HIV market, analysts expect the medication to reach $5 billion in sales by 2022.2

2. A new GLP-1 agonist for Type 2 diabetes

GLP-1 agonists are an important and expanding class of drugs used to treat type 2 diabetes. These drugs work to increase insulin secretion and improve glycemic control.

Approved by the FDA in 2017, Ozempic® (semaglutide) is the latest GLP-1 agonist to come to market. This drug fared well in a recent clinical trial claiming “statistically significant” improvement in glucose control and weight loss compared to the existing GLP-1 agonist dulaglutide, which is sold under brand name Trulicity®.3 In a separate trial, semaglutide also exhibited promise treating the cardiovascular risk associated with diabetes, significantly lowering the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke among trial participants receiving the drug compared with those receiving a placebo.4

Currently administered via subcutaneous injection, a pill version of Ozempic is also in clinical trials.5 Sales are estimated to peak at $2.7 billion annually.6

3. A different type of immunotherapy

The emergence of immunotherapy drugs for cancer was one of the big stories of 2017.7

One highly-anticipated cancer immunotherapy drug is epacadostat, an enzyme inhibitor. Used to treat melanoma, epacadostat is being studied in combination with an existing immunotherapy agent, Keytruda®. By suppressing a specific enzyme on the surface of tumors, epacadostat is thought to prevent cancers from evading detection by the immune system.8

In addition to melanoma, epacadostat is also in phase 3 trials for ovarian cancer, nonsmall cell lung cancer, renal cancer, bladder cancer, and head & neck cancer.9 Although the drug may not launch until 2019 or later, projected sales by 2022 are $2 billion.10

4. A biologic drug for lung cancer

Undergoing a phase III trial, Rova-T™ (rovalpituzumab tesirine) is a biologic drug for use against small-cell lung cancer. Rova-T works by targeting a protein expressed on the surface of tumor cells but not in normal adult tissues.11 Rova-T is being investigated for use after a patient has received chemotherapy.12

Given the yet-to-be-determined number of indications, estimated annual sales figures for Rova-T vary widely from $1.4 billion to $5 billion.13

5. A treatment for MS and maybe more

Currently pending FDA approval, ozanimod is a small molecule drug for people diagnosed with relapsing multiple sclerosis. While multiple sclerosis currently affects approximately 400,000 people in the U.S, ozanimod is also being investigated as a treatment for ulcerative colitis and Crohn’s disease.14

Given the potential for multiple indications, it is projected Ozanimod could bring in around $1.3 billion in peak annual sales.15

The five drugs selected above are by no means the only ones meriting consideration. Looking ahead, many novel treatments are on the horizon. For example, in December the FDA approved a gene therapy, Luxturna™, to treat a hereditary form of blindness. While confined to a relatively small population, the treatment may cost as much as $1 million per patient.

Elsewhere, a promising new class of treatments for migraine headaches known as CGRP antagonists is on the way. Stay tuned for a separate article on these drugs.

It is important to note that while many of these drugs can potentially be a blockbuster, data is limited and success is often dependent on how well a drug performs in clinical trials.

OptumRx closely monitors and evaluates the drug development pipeline landscape for upcoming brand, first-time generic, and biosimilar drug approvals. This constant vigilance extends into the post-approval world, with clinical surveillance and our cost-management strategies. In every case, we will be ready to offer members the resources, programs and clinical assistance they will need to manage their new medications effectively, safely and with confidence.   

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STATEMENT REGARDING FINANCIAL INFLUENCE:
This article is directed solely to its intended audience about important developments affecting the pharmacy benefits business. It is not intended to promote the use of any drug mentioned in the article and neither the author nor OptumRx has accepted any form of compensation for the preparation or distribution of this article.

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References

  1. Gilead. “Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens.” Accessed at: http://gilead.com/news/press-releases/2017/10/gilead-presents-results-from-phase-3-study-evaluating-patients-who-switched-to-investigational-fixeddose-combination-of-bictegravir-emtricitabine-and-tenofovir-alafenamide-from-boosted-protease-inhibitorbased-regimens
  2. Motley Fool. “5 Biggest New Drugs of 2018 -- and How You Can Profit From Their Makers." Accessed at: https://www.fool.com/investing/2018/01/07/5-biggest-new-drugs-of-2018-and-how-you-can-profit.aspx
  3. Endpoint News. “Novo’s semaglutide handily whips Eli Lilly’s Trulicity in a PhIII diabetes showdown.” Accessed at:
    https://endpts.com/novos-semaglutide-handily-whips-eli-lillys-trulicity-in-a-phiii-diabetes-showdown/
  4. New England Journal of Medicine. “Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.” Accessed at: https://www.ncbi.nlm.nih.gov/pubmed/27633186
  5. Reuters. “FDA approves Novo Nordisk diabetes drug Ozempic.” Accessed at: https://www.reuters.com/article/us-novo-nordisk-diabetes-fda/fda-approves-novo-nordisk-diabetes-drug-ozempic-idUSKBN1DZ2O9
  6. Motley Fool. “5 Biggest New Drugs of 2018 -- and How You Can Profit From Their Makers.” Accessed at:
    https://www.fool.com/investing/2018/01/07/5-biggest-new-drugs-of-2018-and-how-you-can-profit.aspx
  7. Optum. “The top 5 pharmacy topics of 2017.” Accessed at: https://www.optum.com/resources/library/biggest-pharmacy-topics-2017.html
  8. Incyte.com. “Progression-Free Survival Data from ECHO-202 Trial of Incyte’s Epacadostat in Combination with KEYTRUDA® (pembrolizumab) Underscore Durability of Response in Patients with Advanced Melanoma.” Accessed at: http://www.incyte.com/ir/press-releases.aspx
  9. Fierce Pharma. “Merck, Incyte chalk up promising melanoma data for Keytruda-epacadostat combo.” Accessed at: https://www.fiercepharma.com/pharma/merck-incyte-chalk-up-promising-melanoma-results-for-keytruda-epacadostat-combo
  10. Motley Fool. “5 Biggest New Drugs of 2018 -- and How You Can Profit From Their Makers.” Accessed at: https://www.fool.com/investing/2018/01/07/5-biggest-new-drugs-of-2018-and-how-you-can-profit.aspx
  11. National Center for Biotechnology Information. “A DLL3-targeted antibody-drug conjugate eradicates high-grade pulmonary neuroendocrine tumor-initiating cells in vivo.” Accessed at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4934375/
  12. Abbvie. “Rova-T.” Accessed at: https://www.abbvie.com/our-science/pipeline/rova-t.html
  13. Motley Fool. “5 Biggest New Drugs of 2018 -- and How You Can Profit From Their Makers.” Accessed at: https://www.fool.com/investing/2018/01/07/5-biggest-new-drugs-of-2018-and-how-you-can-profit.aspx
  14. Celgene. “Efficacy and Safety Results from First Phase III Trial of Oral Ozanimod (SUNBEAM) Versus an Active Comparator in Relapsing Multiple Sclerosis Presented at MSParis2017 - 7th Joint ECTRIMS - ACTRIMS Meeting.” Accessed at:
    http://ir.celgene.com/releasedetail.cfm?releaseid=1045797
  15. Motley Fool. “5 Biggest New Drugs of 2018 -- and How You Can Profit From Their Makers.” Accessed at: https://www.fool.com/investing/2018/01/07/5-biggest-new-drugs-of-2018-and-how-you-can-profit.aspx