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As a scientist, I know first-hand how much time and energy go into the drug discovery and development process from day one. In fact, one of the highlights of my research career was seeing the first positive clinical data from a new diabetes therapy my team discovered.
Many people don’t realize that only 1 in 1,000 drugs that enter preclinical testing progress to the clinic.1 Of those, each year the FDA approves fewer than 100 new drugs, with an approval rate of 12%.2 You might ask “with those odds, what keeps scientists motivated?” It was this patient-first mindset that kept me motivated to beat the odds every day at the bench, and still motivates me today to ensure that patients have timely, affordable access to these life-changing medicines that our scientists work so hard to discover.
Developing new drugs takes time and money. In fact, the estimated cost to drugmakers in the U.S. is $2.6 billion from discovery to marketing approval.2 This process takes an average of 12 years for a drug to travel from the laboratory to your medicine cabinet.1
The FDA approved 53 new drugs in 2020, approximately two-thirds of which are specialty medications.3 This continuing pipeline shift towards specialty drugs provides more sophisticated and targeted therapies to HCPs and patients. Specialty medications have advanced the treatment of chronic and sometimes life-threatening diseases, including multiple sclerosis (MS), chronic hepatitis C viral (HCV) infection, and hematological/oncological disorders.4 Adherence and persistence to specialty medications are essential to achieving successful, potentially life-changing, clinical outcomes for these therapies.
However, the cost of medications has become a barrier - specialty drugs currently account for 2.2% of total prescription volume yet they account for 45.5% of total pharmacy spending, or $218.6 billion in 2019 (5, 6 or 2020 #s). The cost and increasing use of specialty medications has exposed unique barriers to the prescription and patient access process. When compared to “conventional” medications, specialty prescriptions require providers and patients to complete additional clinical and administrative processes. This includes complicated workflows between patients, providers, pharmacies, insurers, and manufacturers. These hurdles can impact doctor’s decision to prescribe, leading them to choose drugs perceived as less work to write rather than the most clinically appropriate therapy for their patients.
Manufacturer support programs serve as an important resource for doctors and patients during the specialty prescribing process. These programs provide much needed services to support medication access, affordability, and adherence. However, a recent survey of 10,000 patients across multiple therapeutic areas found that only 20% of patients were aware of such programs.7 Doctors and their staff can assist patients with enrollment into these programs, yet the enrollment process is often time-consuming and doctors remain dissatisfied with current patient support options available. In addition, less than 10% of patient enrollment into these support programs is currently completed electronically.8
“At OptimizeRx we are committed to developing innovative technology solutions to ensure that patients have timely, affordable access to their doctor’s first choice of therapy."
How can we improve access to specialty medications for patients who will most benefit from these therapies and ensure doctors have confidence that their patients will be able to affordably access these medications? The answer is technology. Leveraging technology to automate and accelerate workflows can remove barriers to the specialty prescribing process and ensure patients are able to readily access the life-changing innovative therapies that they need.
At OptimizeRx we are committed to developing innovative technology solutions to ensure that patients have timely, affordable access to their doctor’s first choice of therapy. We remove barriers by leveraging technology to optimize and accelerate the prescribing process for HCPs, increase the success rate of patients getting on therapy, and reduce time to fill so that patients can start their medication sooner. We do this by leveraging our extensive OptimizeRx EHR and pharmacy networks to streamline the prescription through medication fulfillment process.
OptimizeRx Specialty Solutions is uniquely positioned to help specialty brands build an optimized support ecosystem for launch and on-the-market drugs.
We look forward to sharing more details about OptimizeRx Specialty Solutions in the future as we focus on our aspirational goal: to ensure that innovative, novel, targeted therapies developed by world-class scientists and clinicians, are available and affordable for the patients who need them.
References
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Drug Approvals - From Invention to Market ... A 12- Year Trip. MedicineNet
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Innovation in the pharmaceutical industry: New estimates of R&D costs, Journal of Health Economics, 2016, 47:20-33. https://www.sciencedirect.com/science/article/abs/pii/S0167629616000291?via%3Dihub. Summarized here https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html
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Advancing Health Through Innovation: New Drug Therapy Approvals 2020. FDA’s Center for Drug Evaluation and Research. Jan, 2021. https://www.fda.gov/media/144982/download
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Zuckerman, et. al. (2019) An Integrated Health-System Specialty Pharmacy Model for Coordinating Transitions of Care: Specialty Medication Challenges and Specialty Pharmacist Opportunities. Review. Pharmacy. 2019, 7, 163.
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Medicine Use and Spending in the U.S., A Review of 2018 and Outlook to 2023, IQIVIA Institute, 2019
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Specialty Drug Spend Soars. Can Formulary Management Bring It Down to Earth?, Managed Care, 2019
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Patient Services: Pharma’s Best Kept Secret. Accenture Life Sciences, 2016.
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Automating Specialty Pharmacy: Identifying Gaps, NCPDP, 2015. https://pocp.com/wp-content/uploads/PDF/6-%20NCPDP_2015_ED_Summit_SpecialtyRx.pdf