It’s estimated that from 2012 to 2016, orphan drug requests to the FDA doubled in volume. As of June 2017, there are more than 200 designation requests awaiting response. To remedy this, the FDA has unveiled a plan to speed responses and move these critical treatments through the pipeline.
With an increasing number of rare diseases garnering attention from researchers and pharmaceutical companies, coupled with a market boom for autoimmune disorders, the specialty pharmacy pipelines for these conditions continue to grow.
All players in the industry are investing attention and resources: researchers and drug manufacturers are striving to create treatments, while clinicians and caregivers are on the cutting-edge of developments and technology to ensure that patients are receiving the best possible care.
The Obstacles and Opportunities of Rare Diseases
It’s estimated that nearly one in 10 Americans is impacted by one of 7,000 rare diseases. However, only five percent of these diseases have received treatment approval from the FDA. The lack of treatment for these conditions can create obstacles for patients and their caregivers, as more than 30 million Americans struggle to manage their daily health and wellbeing.
In comparison to more commonly-treated chronic conditions, the specialty pharmacy industry faces unique obstacles when it comes to developing new and orphan drugs for conditions like rare inflammatory diseases (RID). With the boom of new developments comes the need to assess indications, efficacy, and safety as they assimilate into the existing care continuum.
Implications of the Care Continuum
Because of the chronic and lesser-understood nature of autoimmune disorders and rare diseases, patients require high-touch, integrated care in order to manage symptoms and maintain their highest possible quality of life. From monitoring the impact of diet changes to implementing new treatment strategies like gene therapy, patients and their care teams must remain vigilant and proactive.
For a holistic and effective care process, health care teams are increasingly equipped to:
- Navigate insurance coverage and potential obstacles
- Help patients find financial assistance for covering or reimbursing out-of-pocket costs
- Provide patients with ongoing education, especially as treatment strategies evolve
- Perform routine assessments and follow-up to ensure efficacy and safety
- Be available for patient counseling and support throughout the care journey
How TherigySTM Can Help
To assist specialty pharmacies with managing these care-intensive conditions, a new RID care plan module will be added to assist in the management and outcomes of patients in this therapeutic category. The new module will support the use of Amjevita, Humira, Inflectra, and Remicade for the treatment of hidradenitis suppurativa and uveitis.
The TherigySTM platform will offer pre-configured content to help clinicians guide these patients through the continuum of care, working to reduce variations in therapy, advise on comprehensive treatment protocols, collaborate on patient care plans, and compile safety and efficacy information as the industry’s knowledge base evolves.
To learn more about how Therigy can help your specialty pharmacy better manage patients with these conditions, contact us for a demo of the TherigySTM platform.