Six Questions You Should Ask a Consultant

Many drug manufacturers and healthcare consultants attempt to follow the same blueprint for commercializing mass-market therapies as they would for drugs targeting small patient populations. Recommending multiple specialty pharmacies and separate patient service organizations might work when serving hundreds of thousands of patients—but what if the drug targets only a few thousand?

The models to serve large and small patient populations should be as different as the disorders themselves. After years of collaborating with leading manufacturers and consultants, I have found that an integrated service model is the best suited to bring rare and orphan drugs to market. If you have a rare or orphan therapy in market, I encourage you to take a look at what that means and just how it can increase the potential for improved patient outcomes.

What is an integrated model?

An integrated model combines all of the services that a manufacturer needs to not only distribute a rare or orphan drug, but also provide clinical and financial support to patients. The combination of services is essential to help achieve disease stability among patients with rare and orphan disorders, as well as ensure they aren’t financially prohibited from receiving and staying on therapy.

“Manufacturers who aren’t experienced with rare and orphan drugs tend to be less knowledgeable about an integrated approach,” according to Diana Villanova, Vice President of Patient Services & Distribution at Coeus Consulting Group. “Mass market therapies don’t require the high-touch service that rare and orphan drugs do, so there’s naturally less of a focus on integrating services.”

As a result, manufacturers may take a linear approach to gaining market access for rare and orphan drugs, starting with distribution and then separately adding patient services such as a hub and financial assistance. “Manufacturers typically treat these services independently instead of collectively,” she said.

In contrast, an integrated approach is the best way to maximize and showcase the value of a rare or orphan therapy. “Manufacturers should work with stakeholders to define how their therapies add value,” she said. “For example, they can use data and analytics generated by their patient services organization to help payers better understand the patient journey and how the therapy impacts patient outcomes. Volume-driven distributors and patient services organizations are less able to partner with manufacturers in this way.”

How to create an integrated model

To maximize value for rare and orphan drugs, create an integrated model by combining these four pillars:

  1. Patient advocacy
  2. Financial assistance expertise
  3. Clinical care coordination
  4. Specialty pharmacy distribution

An all-in-one integrated model—delivered from a single source—has proven to be effective for maximizing efficiency and promoting data sharing among the pillars to demonstrate value to all stakeholders: payers, providers and manufacturers. This is especially important given that the cost of rare and orphan drugs can be significant. Indeed, the rarer the disease, the greater the need to maximize how efficiently the four pillars work together to create value.

This model is also more effective in delivering the extensive advocacy that these patients need—a level of high-touch service that mass-market drugs typically don’t require. “When you’re taking care of a rare disease patient, you need to understand the disorder at a deeper level, because it can have unique side effects or comorbidities that you wouldn’t see otherwise,” Villanova said.

“You could say that, the rarer the disease, the more this level of understanding and service is required. If you take a volume-based approach, it’s simply impossible to know all your patients at such a deep level—but that is what’s required with rare and orphan disorders.”

Those pharmaceutical companies who don’t have the in-house resources to build their own integrated models may seek the support of a consultant. Consultants who have less or no experience with rare and orphan drugs may take a traditional approach to the four pillars, recommending separate vendors for each based on current relationships. As a result, the manufacturer may receive several (and sometime competing) viewpoints of how well the drug is performing in the marketplace.

How a mass market approach can fall short

At Optime Care, we know first-hand of several examples where a large-drug strategy couldn’t adequately support a small patient population. In one case, a consultant recommended multiple specialty pharmacies, a separate patient services hub and a patient assistance company—all for 300 patients. As a result, the service was disjointed and less than optimal for them.

Both the therapy and biopharmaceutical company were failing when Optime Care was called in to consolidate services under a single source. The result: compliance improved, while serving patients was easier to manage. Costs fell and revenue increased. The patient population grew as well, as we engaged with physicians and increased their comfort level to test and identify more patients.

Today, the biopharma CEO tells us, “You saved our company.” Just as important, we’re helping this company fulfill its mission to improve quality of life for the patients it serves.

“Manufacturers need to select a partner that has everything under one roof,” Villanova said. “That partner should excel at navigating prior authorization with payers, clinically coordinating care and ensuring the financial health of patients, so they can gain access to and remain on therapy.”

Choosing a consultant

To explore how a consultant might help you build an integrated services model, start the conversation with these questions:

  • What is your experience and success rate with rare and orphan drugs? Can you provide specific examples?
  • What is your understanding of and approach to developing an integrated model for serving these patients?
  • In your view, what is the value of a patient-first approach for payers, providers and manufacturers?
  • Will you take a patient-first approach when making your recommendations? If so, how?
  • How will your recommendations differ from what they might be for a drug serving a large patient population?
  • How will your recommendations ensure success not only at launch, but also in the future?

To learn more, download our white paper, “How to create a patient-first strategy.” Or contact us directly at or call 888-287-2017.