Biologic drugs are a driving force in the pharmaceutical industry. More than 2,700 were in pharmaceutical pipelines as of June 2017 to treat cancers (836), rare diseases (566), neurologic conditions (420), autoimmune disorders (311), and other ailments (567) — triple the number in 2013 overall (1). Biopharmaceuticals make up more than half of all drugs in development and are nudging out traditional small-molecule drugs rapidly while already bringing in billions of dollars in sales.
The success of such drugs is predicated on their ability to treat disease targets better than existing/classical pharmaceuticals and with fewer side effects. But that alone may not be sufficient to achieve the outcomes upon which reimbursement decisions increasingly depend. According to Deloitte, the drug itself represents a diminishing share of what comes together to deliver an overall patient outcome (2).
Subcutaneous Biologics
Biologics present several challenges that could limit their reach and potential. First, they are expensive. And researchers have found that their economic value may depend on their cost of administration. Applying cost-effectiveness analyses (CEAs), dosing both subcutaneously (SC) and intramuscularly (IM) are associated with lower costs (3).
However, biologic drug-substance molecules are large and complex, with molecular weights up to 150,000 Da. Biologic drug products are viscous, highly concentrated formulations that, without revolutionary new technologies for drug delivery, would require injection forces too great for SC administration. Consequently, the most prevalent mode of biopharmaceutical administration remains intravenous (IV) infusion, which requires the services of a health professional in a costly clinical setting — precisely the types of factors that can lead to unfavorable CEAs by payers. But that could change as new delivery technologies enable biopharmaceutical companies to replace IV influsions with SC delivery performed at home by patients themselves with ease.
Costly IV administration is unpopular with patients: It is inconvenient and can be painful. So it is not a promising path for drug companies racing to improve outcomes and be recognized as “patient-centric.” Accenture Life Sciences reports that 69% of patients consider product benefits to be top factors in their treatment decisions — not brands (4) — which suggests that biologic drug sponsors should consider promoting solutions that appeal to patients.
A new, patient-focused drug delivery option is coming to market (5): large-volume wearable injectors (LVWIs). Such devices are designed for biologics to be self-administered subcutaneously by patients with minimum discomfort. LVWI product development incorporates a number of human factors. For example, because patient acceptance is a top concern, needles are never visible. The most advanced LVWIs incorporate pause control for optimum personalized comfort and mobile connectivity for monitoring adherence to dosing regimens. The devices can deliver doses as large as 50 mL, and a small profile allows them to be concealed easily under clothing, leaving patients free to move around during treatment.
Integrate LVWIs Early in Drug Development
Most combination-product experts say that the time to add a delivery-device constituent is in early stages of drug development. Introducing a device platform in early clinical stages leaves time to discuss the proposal with regulatory agencies and payers as well as respond to contextual questions, decreasing cycle time for new product development.
Making a preferable delivery system available at the time of product launch speeds new-drug uptake and secures first-mover advantages. Conversely, drug developers that postpone inclusion of a delivery device until after that initial launch miss the opportunity to make a favorable first impression and could find themselves at a competitive disadvantage.
Delivery Defines a Patient’s Treatment Experience
From a patient’s perspective, the delivery device often defines his or her treatment experience. With the patient role pivotal in clinical trials today, that experience has become more important than ever before. Patients now report back on how a treatment feels, what would make it easier to use, and what they like and dislike about it.
Advanced LVWIs can facilitate delivery of larger product volumes and higher viscosities and help resolve the propensity of biologics to precipitate out of solution. Citing the ability to speed drug development, lower costs, and improve patient experiences, some analysts anticipate “explosive growth” for LVWIs — with 42 million devices sold by 2027 for a compound annual growth rate of 23% until 2024 (6, 7). A number of companies are developing LVWIs. Although only one such combination device has been approved by the US Food and Drug Administration, other products are in review.
A well-balanced biopharmaceutical product portfolio now can include a pathway for incorporating LVWI delivery technology early in clinical development. That should provide for lower-risk product development strategies and success in the marketplace.
References
1 Biologics in Development as of June 2017 By Therapeutic Category. Statista: New York, NY, 2017; www.statista.com/statistics/258152/biologic-medicines-in-development-by-therapeutic-category-2017.
2 2016 Global Life Sciences Outlook: Moving Forward with Cautious Optimism. Deloitte: New York, NY, 2015 www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-2016-life-sciences-outlook.pdf.
3 Tetteh EK, Morris S. Evaluating the Administration Costs of Biologic Drugs: Development of a Cost Algorithm. Health Econ Rev. 4(1) 2014: 26; doi:10.1186/s13561-014-0026-2.
4 Cleffi J, Bogdan B. Product Launch: The Patient Has Spoken. Accenture Life Sciences: Dublin, Ireland, January 2018. https://www.accenture.com us-en/_acnmedia/PDF-69/Accenture-Life-Sciences-Product-Launch.pdf.
5 Siew A. Wearable Injection Devices Address Delivery Challenges. BioPharm Int. April 2018: 10–13.
6 P&S Market Research. Global Industry Insight: Bolus Injectors Contribute Largest Revenue to Global Wearable Injectors Market. Psmarketresrch.blogspot.com 23 October 2017; https://psmarketresrch.blogspot.in/2017/10/bolus-injectors-contribute-largest.html.
7 Large-Volume Wearable Injectors (3rd Edition), 2017–2027. Roots Analysis: Chandigarh, India, 31 January 2017; www.rootsanalysis.com reports/view_document/large-volume-wearable-injectors-market-3rd-edition-2017-2027-/153.html.
Michael D. Hooven is president and chief executive officer of Enable Medical Technologies, LLC, 2863 East Sharon Road, Cincinnati, OH 45241; 1-513-326-2800; www.enableinjections.com. In 2010, he founded Enable Injections, LLC, for which he now serves as chief executive officer and president as well. The start-up company Smart Enfuse technology enables at-home delivery of high-volume biologic drugs that otherwise must be delivered intravenously in a healthcare setting.