Solutions to Overcome Challenges & Barriers in DTx

Digital therapeutics, in short, referred to as DTx, is rapidly growing with continuous engagement in major cities like Chennai, Bangalore and Mumbai. DTx therapeutics deliver medical interventions to patients directly using clinically evaluated software that treats, prevents and manages a wide spectrum of disorders and diseases. Let us see the major challenges digital therapeutics face in the article below.

Four Main Challenges for DTx Therapeutics

A few DTx engagements are falling victims to traps set by the clinical data. The four obstacles or hurdles that organizations must be aware of are:

• Payer reimbursement
• Clinical validation
• Regulatory approval
• Physician adoption

Payer Reimbursement

In recent times, most DTx companies in big cities like Chennai are discovering that preparations for engaging payer support have to be made mandatory at the development stages, with reimbursement and payer acceptance being essential for market viability. A few companies use DTx therapeutics and partner with pharma firms to leverage distribution pathways and traditional insurance reimbursements. A few more seek alternative payer reimbursement pathways as additional benefit programmes instead of looking for benefit management plans.

Clinical Validation

Clinical validation is the bare minimum requirement to engage with any DTx company. Every company verifies the efficacy of DTx therapeutics by comparing it with two metrics. They compare the treatment output to a minimum standard value or gold standard of treatment. When a company developing a diagnosis or treatment for autism compares its traditional therapy session to an autism specialist’s session, the comparison is called the gold standard. A few companies face challenges in seeking clinical validations for their treatments, especially when their validation precedes the regulatory body’s validation trials. Clinical validation is very important, but the hype created has overshadowed many companies’ actual value.

Also Read: An Overview of SaMD & Its Benefits

Regulatory Approval

There are two pathways for any medical product to penetrate the market. They are U.S. FDA clearance and approval. The FDA clearance makes it very clear that the medical product must be similar to the existing products in the market so as not to pose any risk to the consumers. At the same time, the FDA approval states that the medical products must undergo various efficacy and clinical trials to ensure their safety. DTx therapeutics companies partner with pharma companies to leverage their understanding and experience with regulatory bodies. But, it is now facing a different approval pathway with the advent of therapeutics-oriented software precertification approval programs. In this new pathway, pharma companies have very little experience, and it is made compulsory for DTx companies to make their own way. Startups belonging to more mature stages in cities like Chennai are gaining quick approvals for FDA’s pilot precertification program. DTx companies being a part of the precertification regulatory pathway, are also very successful in getting approvals.

Physical Adoption

Physical adoption is the final hurdle for any consumer adoption as DTx therapeutics are maturing and seeking popularity with time. There are three major approaches to gaining a physical adoption. They are:

1. Using pharmaceutical models to leverage the distribution partnerships and thereby making physicians willing to prescribe the medical product.
2. Developing a product for treating conditions by partnering with a pharmacy benefit plan which offers a digital dispensary, curating benefit-covered products that physicians use while making their therapeutic recommendations.
3. Taking a less traditional approach by using the latest technological applications, including physicians as part of the marketing campaign and offering subscription packages for patients.

Key Barriers to DTx Therapeutics Adoption

The key barriers standing in the way of DTx therapeutics adoption are:

1. Lack of awareness amongst healthcare professionals
2. Increased patient burden
3. Non-availability of comparison information between DTx and traditional treatment
4. Patient’s ability to engage with technology
5. Technical challenges at the provider’s end
6. Additional healthcare professional workload generation
7. Lack of funding

Ways to Overcome the Barriers to DTx Therapeutics Adoption

The benefits of DTx therapeutics are still not reaped by many because a majority of healthcare professionals lack awareness of its availability and advantages. The efficacy of DTx is still questioned by many due to the lack of knowledge about their clinical trial data. In a few countries where conservatism attitudes and scepticism are prominent, DTx finds it very difficult to serve needy patients. Healthcare professionals and physicians who are very old can still not accept and tune themselves to the digital technology integration with medical programs.

How Can Companies Increase Awareness of DTx?

Promoting the sales force is the primary option to create awareness when DTx is associated with pharmaceutical products. Digital channels are another effective way either through necessity or luxury. A few mature pharmaceutical digital health teams and companies in cities like Chennai pursue partnerships with health organizations to further raise DTx awareness. There are certain academies offering courses for healthcare professionals on using digital technology and tools for medical programmes. This will make healthcare professionals aware of the existence of DTx therapeutics and make things simpler by teaching them how to use DTx products.

Some companies adopt a direct-to-consumer approach by creating a direct demand and indirectly raising awareness of DTx. Telemedicine channels play a significant role in creating novel routes for patients to digital therapies. Some companies are launching their products through a non-prescription consumer version. The data from the non-prescribed product leverages the user base, gains a broad awareness, and captures a halo effect for the digital therapeutic products on their prescription. Thus, pioneers must invest in both education and promotion at a product-agnostic and product-specific level with all the above methodologies. The right solution will depend on the product, company, situation, and involvement of healthcare professionals to accommodate educational needs and other DTx therapeutics related beliefs.

Last But Not Least
Thus, with all the ways to combat today’s challenges, the barriers to DTx therapeutics can be managed effectively through careful planning at the developmental stage. The DTx manufacturers in urban areas like Chennai must consider creating scalable models to improve growth, advertising campaigns for patient awareness, designing products to fit the physician’s workflow and proving efficacy with clinical trials.